Successful percutaneous stenting of a right gastroepiploic coronary bypass graft using monorail delivery system: a case report.

PubMed

Alam, M; Safi, A M; Mandawat, M K; Anderson, J E; Kwan, T; Feit, A; Clark, L T

2000-02-01

The right gastroepiploic artery (RGEA) is being successfully used as an arterial conduit in a selected group of patients undergoing coronary artery bypass graft surgery. However, myocardial ischemia may result due to spasm, occlusion, and stenosis of this graft. The anastamosis site at distal right coronary artery (RCA) or posterior descending artery (PDA) is the most common location for stenosis of an in situ gastroepiploic coronary bypass graft. Balloon angioplasty of such stenoses has been reported with optimal short-term results. Stent deployment would decrease the restenosis rate, so that repeat procedures could be minimized for these technically challenging lesions. We describe a case of successful deployment of a stent with monorail delivery system at the anastamotic site stenosis of an in situ gastroepiploic right coronary artery bypass graft. This percutaneous coronary intervention could prevent redo coronary artery bypass graft surgery. Cathet. Cardiovasc. Intervent. 49:197-199, 2000. Copyright 2000 Wiley-Liss, Inc.

Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial.

PubMed

Baron, Suzanne J; Lei, Yang; Chinnakondepalli, Khaja; Vilain, Katherine; Magnuson, Elizabeth A; Kereiakes, Dean J; Ellis, Stephen G; Stone, Gregg W; Cohen, David J

2017-04-24

The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906). Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Cost effectiveness of drug eluting coronary artery stenting in a UK setting: cost-utility study.

PubMed

Bagust, A; Grayson, A D; Palmer, N D; Perry, R A; Walley, T

2006-01-01

To assess the cost effectiveness of drug eluting stents (DES) compared with conventional stents for treatment of symptomatic coronary artery disease in the UK. Cost-utility analysis of audit based patient subgroups by means of a simple economic model. Tertiary care. 12 month audit data for 2884 patients receiving percutaneous coronary intervention with stenting at the Cardiothoracic Centre Liverpool between January 2000 and December 2002. Risk of repeat revascularisation within 12 months of index procedure and reduction in risk from use of DES. Economic modelling was used to estimate the cost-utility ratio and threshold price premium. Four factors were identified for patients undergoing elective surgery (n = 1951) and two for non-elective surgery (n = 933) to predict risk of repeat revascularisation within 12 months. Most patients fell within the subgroup with lowest risk (57% of the elective surgery group with 5.6% risk and 91% of the non-elective surgery group with 9.9% risk). Modelled cost-utility ratios were acceptable for only one group of high risk patients undergoing non-elective surgery (only one patient in audit data). Restricting the number of DES for each patient improved results marginally: 4% of stents could then be drug eluting on economic grounds. The threshold price premium justifying 90% substitution of conventional stents was estimated to be 112 pound sterling (212 USD, 162 pound sterling) (sirolimus stents) or 89 pound sterling (167 USD, 130 pound sterling) (paclitaxel stents). At current UK prices, DES are not cost effective compared with conventional stents except for a small minority of patients. Although the technology is clearly effective, general substitution is not justified unless the price premium falls substantially.

Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program.

PubMed

Lee, Michael S; Yang, Tae; Lasala, John; Cox, David

2016-11-15

The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2 year rates of major adverse cardiac events (18.3% vs 13.5%, p = 0.01) and death (10.3% vs 5.6%, p = 0.02). Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Bioresorbable scaffolds in the treatment of coronary artery disease

PubMed Central

Zhang, Yaojun; Bourantas, Christos V; Farooq, Vasim; Muramatsu, Takashi; Diletti, Roberto; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Serruys, Patrick W

2013-01-01

Drug-eluting stents have reduced the risk of in-stent restenosis and have broadened the application in percutaneous coronary intervention in coronary artery disease. However, the concept of using a permanent metallic endovascular device to restore the patency of a stenotic artery has inherited pitfalls, namely the presence of a foreign body within the artery causing vascular inflammation, late complications such as restenosis and stent thrombosis, and impeding the restoration of the physiologic function of the stented segment. Bioresorbable scaffolds (BRS) were introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Currently, several BRSs are available, undergoing evaluation either in clinical trials or in preclinical settings. The aim of this review is to present the new developments in BRS technology, describe the mechanisms involved in the resorption process, and discuss the potential future prospects of this innovative therapy. PMID:23662091

Effect of PlA1/A2 glycoprotein IIIa gene polymorphism on the long-term outcome after successful coronary stenting

PubMed Central

Le Hello, Claire; Morello, Rémy; Lequerrec, Agnès; Duarte, Christine; Riddell, John; Hamon, Martial

2007-01-01

Aim To prospectively determine the role of platelet glycoprotein IIIa (GP IIIa) gene PlA1/PlA2 polymorphism on the long-term clinical outcome in patients with coronary artery disease undergoing coronary stenting. Design and setting Prospective observational study in the University Hospital of Caen (France). Patients and methods 1 111 symptomatic consecutive Caucasian patients treated with percutaneous coronary intervention including stent implantation underwent genotyping for GP IIIa PlA1/A2. Main outcome measures Long-term clinical outcome in terms of the rate of major adverse cardiac events (MACE, ie death from any cause, non-fatal Q wave or non Q wave myocardial infarction, and need for coronary revascularisation) was obtained and subsequently stratified according to the GP IIIa PlA1/A2 polymorphism. Results Three groups of patients were determined according to the GP IIIa PlA1/A2 polymorphism (71.6% had the A1/A1, 25.8% had the A1/A2 and 2.6% had the A2/A2 genotype). These three groups were comparable for all clinical characteristics including sex ratio, mean age, vascular risk factors, previous coronary events, baseline angiographic exam, indication for the percutaneous coronary intervention and drug therapy). The incidence of MACE was similar in these 3 groups of patients during a mean follow-up period of 654+/-152 days. Independent risk factors for MACE were a left ventricular ejection fraction < 40%, absence of treatment with a beta-blocker and absence of treatment with an angiotensin converting enzyme inhibitor during follow-up. Conclusion The GP IIIa PlA1/A2 polymorphism does not influence the clinical long-term outcome in patients with symptomatic coronary disease undergoing percutaneous coronary intervention with stent implantation. PMID:18021403

Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study.

PubMed

Zhang, Qi; Wang, Xiao Long; Liao, Min Lei; Hu, Jian; Yang, Zhen Kun; Ding, Feng Hua; Zhang, Jian Sheng; Du, Run; Zhu, Tian Qi; Shen, Wei Feng; Zhang, Rui Yan

2015-03-01

Patients are at risk of developing periprocedural myonecrosis after percutaneous coronary intervention (PCI). We investigated whether the use of the platelet glycoprotein (GP) IIb/IIIa receptor inhibitor tirofiban could reduce periprocedural myocardial infarction (PMI) in patients with stable coronary artery disease undergoing elective PCI with overlapping stent implantation for long lesions. A total of 748 stable angina patients with long lesions (≥ 40 mm in length) treated with overlapping stent implantation were randomly assigned to receive tirofiban (tirofiban group; n = 373) or conventional therapy (control group; n = 375). Intravenous tirofiban was initiated before PCI and maintained for 12 hr after the procedure. The primary endpoint was PMI, defined as an elevation in CK-MB > 3 times the upper limit of normal 12 hr after the index procedure. The secondary endpoint was major adverse cardiac events (MACE), including cardiac death, target vessel revascularization, and recurrent MI (re-MI), at one-year of clinical follow-up. The safety end-points included Thrombolysis in Myocardial Infarction (TIMI) major bleeding and stent thrombosis. Despite comparable angiographic and procedural characteristics, in the intention-to-treatment analysis, the primary endpoint was significantly reduced in the tirofiban group (4.0% vs. 11.5%, P < 0.001). Multivariate analysis revealed that the adjunctive use of tirofiban was the only negative predictor of PMI (OR 0.41, 95% CI 0.28-0.81, P < 0.01). At one-year of clinical follow-up, the overall occurrence of MACE was significantly lower in the tirofiban group (13.4% vs. 22.7%, P = 0.001). The rate of TIMI major bleeding and stent thrombosis did not differ significantly between the two groups. Our results show that the adjunctive use of tirofiban reduces the occurrence of PMI and MACE at one year in stable coronary artery disease patients undergoing elective PCI for long lesions with overlapping stent implantation. © 2015 Wiley Periodicals, Inc.

Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis).

PubMed

Kandzari, David E; Smits, Pieter C; Love, Michael P; Ben-Yehuda, Ori; Banai, Shmuel; Robinson, Simon D; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y; Balcells, Mercedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R; Leon, Martin B; Stone, Gregg W

2017-10-03

The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, P noninferiority =0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P =0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm ( P noninferiority =0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively ( P noninferiority =0.01). In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487. © 2017 American Heart Association, Inc.

Dedicated bifurcation stents

PubMed Central

Pillai, Ajith Ananthakrishna; Jayaraman, Balachander

2012-01-01

Bifurcation percutaneous coronary intervention (PCI) is still a difficult call for the interventionist despite advancements in the instrumentation, technical skill and the imaging modalities. With major cardiac events relate to the side-branch (SB) compromise, the concept and practice of dedicated bifurcation stents seems exciting. Several designs of such dedicated stents are currently undergoing trials. This novel concept and pristine technology offers new hope notwithstanding the fact that we need to go a long way in widespread acceptance and practice of these gadgets. Some of these designs even though looks enterprising, the mere complex delivering technique and the demanding knowledge of the exact coronary anatomy makes their routine use challenging. PMID:22572498

Observational Study of Platelet Reactivity in Patients Presenting With ST-Segment Elevation Myocardial Infarction Due to Coronary Stent Thrombosis Undergoing Primary Percutaneous Coronary Intervention: Results From the European PREvention of Stent Thrombosis by an Interdisciplinary Global European Effort Registry.

PubMed

Godschalk, Thea C; Byrne, Robert A; Adriaenssens, Tom; Malik, Nikesh; Feldman, Laurent J; Guagliumi, Giulio; Alfonso, Fernando; Neumann, Franz-Josef; Trenk, Dietmar; Joner, Michael; Schulz, Christian; Steg, Philippe G; Goodall, Alison H; Wojdyla, Roman; Dudek, Dariusz; Wykrzykowska, Joanna J; Hlinomaz, Ota; Zaman, Azfar G; Curzen, Nick; Dens, Jo; Sinnaeve, Peter; Desmet, Walter; Gershlick, Anthony H; Kastrati, Adnan; Massberg, Steffen; Ten Berg, Jurriën M

2017-12-26

High platelet reactivity (HPR) was studied in patients presenting with ST-segment elevation myocardial infarction (STEMI) due to stent thrombosis (ST) undergoing immediate percutaneous coronary intervention (PCI). HPR on P2Y 12 inhibitors (HPR-ADP) is frequently observed in stable patients who have experienced ST. The HPR rates in patients presenting with ST for immediate PCI are unknown. Consecutive patients presenting with definite ST were included in a multicenter ST registry. Platelet reactivity was measured before immediate PCI with the VerifyNow P2Y 12 or Aspirin assay. Platelet reactivity was measured in 129 ST patients presenting with STEMI undergoing immediate PCI. HPR-ADP was observed in 76% of the patients, and HPR on aspirin (HPR-AA) was observed in 13% of the patients. HPR rates were similar in patients who were on maintenance P2Y 12 inhibitor or aspirin since stent placement versus those without these medications. In addition, HPR-ADP was similar in patients loaded with a P2Y 12 inhibitor shortly before immediate PCI versus those who were not. In contrast, HPR-AA trended to be lower in patients loaded with aspirin as compared with those not loaded. Approximately 3 out of 4 ST patients with STEMI undergoing immediate PCI had HPR-ADP, and 13% had HPR-AA. Whether patients were on maintenance antiplatelet therapy while developing ST or loaded with P2Y 12 inhibitors shortly before undergoing immediate PCI had no influence on the HPR rates. This raises concerns that the majority of patients with ST have suboptimal platelet inhibition undergoing immediate PCI. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design.

PubMed

Diletti, Roberto; Serruys, Patrick W; Farooq, Vasim; Sudhir, Krishnankutty; Dorange, Cecile; Miquel-Hebert, Karine; Veldhof, Susan; Rapoza, Richard; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Chevalier, Bernard

2012-11-01

Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents. The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years. The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions. Copyright © 2012 Mosby, Inc. All rights reserved.

Randomized Comparison of Ridaforolimusand Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease

PubMed Central

Kandzari, David E.; Smits, Pieter C.; Love, Michael P.; Ben-Yehuda, Ori; Banai, Shmuel; Rob-inson, Simon D.; Jonas, Michael; Kornowski, Ran; Bagur, Rodrigo; Iniguez, Andres; Danenberg, Haim; Feldman, Robert; Jauhar, Rajiv; Chandna, Harish; Parikh, Manish; Perlman, Gidon Y.; Balcells, Mer-cedes; Markham, Peter; Ozan, Melek Ozgu; Genereux, Philippe; Edelman, Elazer R.; Leon, Martin B.; Stone, Gregg W.

2018-01-01

BACKGROUND The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, Pnoninferiority=0.001). Definite/probable stent thrombosis rates were low in both groups (0.4% RES versus 0.6% zotarolimus-eluting stent, P=0.75); 13-month angiographic in-stent late lumen loss was 0.22±0.41 mm and 0.23±0.39 mm (Pnoninferiority=0.004) for the RES and zotarolimus-eluting stent groups, respectively, and intravascular ultrasound percent neointimal hyperplasia was 8.10±5.81 and 8.85±7.77, respectively (Pnoninferiority=0.01). CONCLUSIONS In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487. PMID:28794001

Effects of clopidogrel, prasugrel and ticagrelor on endothelial function, inflammatory and oxidative stress parameters and platelet function in patients undergoing coronary artery stenting for an acute coronary syndrome. A randomised, prospective, controlled study

PubMed Central

Schnorbus, Boris; Daiber, Andreas; Jurk, Kerstin; Warnke, Silke; König, Jochem; Krahn, Ulrike; Lackner, Karl; Munzel, Thomas; Gori, Tommaso

2014-01-01

Introduction Particularly in the setting of acute coronary syndromes, the interplay between vascular and platelet function has been postulated to have direct clinical implications. The present trial is designed to test the effect of clopidogrel, prasugrel and ticagrelor on multiple parameters of vascular function, platelet aggregation, oxidative and inflammatory stress before and up to 4 weeks after coronary artery stenting. Methods and analysis The study is designed as a three-arm, parallel design, randomised, investigator-blinded study. Patients with unstable angina or non-ST elevation myocardial infarction undergoing coronary intervention with a drug-eluting stent will be randomised to receive 600 mg clopidogrel, 60 mg prasugrel or 180 mg ticagrelor followed by oral therapy with the same drug. The primary endpoint of the trial is the impact of antiplatelet treatments on endothelial function as assessed by flow-mediated dilation at 1 day, 1 week and 1 month in patients who have undergone stenting. Secondary endpoints include the impact of study medications on parameters of macrovascular and microvascular function, platelet reactivity, oxidative and inflammatory stress. The study recruitment is currently ongoing and, after an interim analysis which was performed at 50% of the initially planned population, it is planned to continue until July 2015. Ethics and dissemination The protocol was approved by the local ethics committee. The trial will provide important pathophysiological insight on the relationship between platelet aggregation and endothelial function, two parameters that have been shown to influence patients’ prognosis. Trial registration number ClinicalTrials.gov Identifier: NCT01700322; EudraCT-Nr.: 2011-005305-73. Current V.1.3, from 24 February 2014. PMID:24801283

To kiss or not to kiss? Impact of final kissing-balloon inflation on early and long-term results of percutaneous coronary intervention for bifurcation lesions.

PubMed

Biondi-Zoccai, Giuseppe; Sheiban, Imad; De Servi, Stefano; Tamburino, Corrado; Sangiorgi, Giuseppe; Romagnoli, Enrico

2014-11-01

Final kissing-balloon inflation is often recommended for percutaneous coronary intervention (PCI) of bifurcation lesions. However, randomized trials focusing on kissing inflation have not confirmed its beneficial impact. We compared outcomes of kissing inflation for PCI of bifurcation lesions, explicitly stratifying results according to stenting strategy. Patients undergoing bifurcation PCI were retrospectively enrolled. Subjects receiving final kissing inflation were compared with those not undergoing kissing inflation, after stratification for a single-stent technique. The primary end point was the long-term rate of major adverse cardiac events (MACE, i.e., death, myocardial infarction, or target lesion revascularization (TLR)). A total of 4314 patients were included: 1176 (27.3 %) treated with a single stent and kissing inflation, 1637 (37.9 %) with a single stent but no kissing, 1072 (24.8 %) with two stents and kissing, and 429 (9.9 %) with two stents but no kissing. At unadjusted analyses kissing was associated with fewer short-term MACE and deaths in the two-stent group, and with fewer long-term MACE, cardiac deaths, and side-branch TLR in the two-stent group (all P < 0.05). Conversely, kissing appeared detrimental after single stenting. However, after multivariable analyses, kissing no longer significantly affected the risk of adverse events, with the exception of the risk of side-branch TLR, which was lower in those receiving two stents and final kissing inflation (hazard ratio = 0.52, 95 % confidence interval 0.30–0.90, P = 0.020). Kissing inflation can be avoided in bifurcation lesions uneventfully treated with single-stent PCI. However, final kissing-balloon inflation appears beneficial in reducing the risk of side-branch repeat revascularization after using a two-stent strategy.

Circulating endothelial progenitor cells are inversely correlated with in-stent restenosis in patients with non-ST-segment elevation acute coronary syndromes treated with EPC-capture stents (JACK-EPC trial).

PubMed

Wojakowski, W; Pyrlik, A; Król, M; Buszman, P; Ochała, A; Milewski, K; Smolka, G; Kawecki, D; Rudnik, A; Pawłowski, T; Jadczyk, T; Wyderka, R; Cybulski, W; Dworowy, S; Tendera, M

2013-06-01

Aim of the study was to evaluate the association between circulating endothelial progenitor cells (EPCs) and angiographic outcomes after implantation of GenousTM stent in patients with non-ST-segment elevation acute coronary syndromes (ACS) (NSTE-ACS) undergoing urgent percutaneous coronary intervention (PCI). Sixty patients treated with EPC-capture stent (N.=30) or bare metal stents (BMS) (N.=30) receiving 80 mg atorvastatin and dual antiplatelet therapy (DAT) for 12 months. Restenosis was assessed after 6 months by quantitative coronary angiography (QCA) and major acute coronary events (MACE) evaluated after 6 and 12 months. de novo lesion >70% in native vessel, diameter 2.5-4 mm, lesion length <30 mm. diabetes, previous revascularization, significant left main stenosis, chronic total occlusions (CTO) and multivessel disease. Majority of patients in EPC-capture stent and BMS groups presented with NSTEMI (73.3% and 70%, respectively). Mean stent length was 20.1±8 and 19.9±10 mm, diameter 3±0.97 and 3.1±0.88 mm in respective groups. The binary restenosis was significantly lower in GenousTM (13 vs. 26.6%, P=0.04). Risk of MACE after 6 and 12 months were comparable in both groups. There was no stent thrombosis. Numbers of circulating EPCs were significantly approximately 2-fold higher during the ACS than after 6 months. Mobilization of EPCs during acute ischemia was significantly lower in patients who developed restenosis after 6 months (3 vs. 4.5 cells/μL, P=0.002) and it was negatively correlated with late-loss after 6 months (R=-0.42; P<0.03). Use of GenousTM stents in NSTE-ACS is associated with lower restenosis rate than BMS at 6 months. There was no ST through 1 year. The number of circulating EPCs is inversely correlated with in-stent late loss (LL).

Coronary revascularization and adverse events in joint arthroplasty.

PubMed

Tabatabaee, Reza Mostafavi; Rasouli, Mohammad R; Rezapoor, Maryam; Maltenfort, Mitchell G; Ong, Alvin C; Parvizi, Javad

2015-09-01

There is a paucity of literature about outcome of total joint arthroplasty in patients with the history of angioplasty and/or stent or coronary artery bypass graft (CABG). The present study aimed to evaluate perioperative complications and mortality in these patients. We used the Nationwide Inpatient Sample data from 2002-2011. Using the Ninth Revision of the International Classification of Disease, Clinical Modification codes for disorders and procedures, we identified patients with a history of coronary revascularization (angioplasty and/or stent or CABG) and compared the inhospital adverse events in these patients with patients without a history of coronary revascularization. Cardiac complications occurred in 1.06% patients with a history of CABG; 0.95% of patients with a coronary angioplasty and/or stent and 0.82% of the control patients. In the multivariate analysis, neither the history of CABG (P = 0.07) nor the history of angioplasty and/or stenting (P = 0.86) was associated with a higher risk of cardiac complications. However, myocardial infarction occurred in a significantly higher proportion of patients with the history of CABG (0.66%, odds ratio, 1.24, P = 0.001) and coronary angioplasty and/or stenting (0.67%, odds ratio, 1.96, P < 0.001) compared with that in the controls (0.27%). History of coronary revascularization did not increase the risk of respiratory, renal, and wound complications, surgical site infection, and mortality. Based on the findings of this study, it appears that there is no increased risk of inhospital mortality and complications (except for myocardial infarction) in patients with a history of coronary artery revascularization undergoing total joint arthroplasty. We also found perioperative cardiac arrhythmia, particularly atrial fibrillation, to be an independent predictor of inhospital adverse events. Copyright © 2015 Elsevier Inc. All rights reserved.

Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.

PubMed

Kappetein, Arie Pieter; Serruys, Patrick W; Sabik, Joseph F; Leon, Martin B; Taggart, David P; Morice, Marie-Claude; Gersh, Bernard J; Pocock, Stuart J; Cohen, David J; Wallentin, Lars; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Simonton, Charles A; Stone, Gregg W

2016-09-18

Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

Myocardial infarction and subsequent death in a patient undergoing robotic prostatectomy.

PubMed

Thompson, Judy

2009-10-01

A 52-year-old patient, ASA physical status IV, undergoing a radical prostatectomy for cancer with a robotic system had a cardiac arrest 3 hours into the case. All attempts to resuscitate were unsuccessful, and several hours later he was pronounced dead. Underlying patient comorbidity and procedural issues contributed to the patient's death. The patient had a history of coronary artery disease that required the placement of drug-eluting stents 2 years before this surgical procedure. The preoperative cardiac evaluation and pharmacological management of patients with drug-eluting coronary stents are reviewed. There are a number of positional and technical considerations for patients undergoing robotic surgical procedures, especially in relation to the requirement of low-lithotomy and steep Trendelenburg positions. The cardiac and respiratory systems are especially vulnerable to the extreme and lengthy head-down position. The needed positioning, combined with the problems associated with insufflation, presents a unique challenge in anesthetic management. This course reviews the current literature on the surgical implications for patients with drug-eluting stents and the physiologic factors related to position and pneumoperitoneum and their associated stressors. By using a review of the contemporary literature, a best-evidence approach to anesthetic management is reviewed.

Long-term outcomes in patients with rheumatologic disorders undergoing percutaneous coronary intervention: a BAsel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination (BASKET-PROVE) sub-study.

PubMed

Nochioka, Kotaro; Biering-Sørensen, Tor; Hansen, Kim Wadt; Sørensen, Rikke; Pedersen, Sune; Jørgensen, Peter Godsk; Iversen, Allan; Shimokawa, Hiroaki; Jeger, Raban; Kaiser, Christoph; Pfisterer, Matthias; Galatius, Søren

2017-12-01

Rheumatologic disorders are characterised by inflammation and an increased risk of coronary artery disease (CAD). However, the association between rheumatologic disorders and long-term prognosis in CAD patients undergoing percutaneous coronary intervention (PCI) is unknown. Thus, we aimed to examine the association between rheumatologic disorders and long-term prognosis in CAD patients undergoing PCI. A post-hoc analysis was performed in 4605 patients (age: 63.3 ± 11.0 years; male: 76.6%) with ST-segment elevation myocardial infarction (STEMI; n = 1396), non-STEMI ( n = 1541), and stable CAD ( n = 1668) from the all-comer stent trials, the BAsel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination (BASKET-PROVE) I and II trials. We evaluated the association between rheumatologic disorders and 2-year major adverse cardiac events (MACEs; cardiac death, nonfatal myocardial infarction (MI), and target vessel revascularisation (TVR)) by Cox regression analysis. Patients with rheumatologic disorders ( n = 197) were older, more often female, had a higher prevalence of renal disease, multi-vessel coronary disease, and bifurcation lesions, and had longer total stent lengths. During the 2-year follow-up, the MACE rate was 8.6% in the total cohort. After adjustment for potential confounders, rheumatologic disorders were associated with MACEs in the total cohort (adjusted hazard ratio: 1.55; 95% confidence interval (CI): 1.04-2.31) driven by the STEMI subgroup (adjusted hazard ratio: 2.38; 95% CI: 1.26-4.51). In all patients, rheumatologic disorders were associated with all-cause death (adjusted hazard ratio: 2.05; 95% CI: 1.14-3.70), cardiac death (adjusted hazard ratio: 2.63; 95% CI: 1.27-5.43), and non-fatal MI (adjusted hazard ratio: 2.64; 95% CI: 1.36-5.13), but not with TVR (adjusted hazard ratio: 0.81; 95% CI: 0.41-1.58). The presence of rheumatologic disorders appears to be independently associated with worse outcome in CAD patients undergoing PCI. This calls for further studies and focus on this high-risk group of patients following PCI.

Perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and non-cardiac surgery: a consensus document from Italian cardiological, surgical and anaesthesiological societies.

PubMed

Rossini, Roberta; Musumeci, Giuseppe; Visconti, Luigi Oltrona; Bramucci, Ezio; Castiglioni, Battistina; De Servi, Stefano; Lettieri, Corrado; Lettino, Maddalena; Piccaluga, Emanuela; Savonitto, Stefano; Trabattoni, Daniela; Capodanno, Davide; Buffoli, Francesca; Parolari, Alessandro; Dionigi, Gianlorenzo; Boni, Luigi; Biglioli, Federico; Valdatta, Luigi; Droghetti, Andrea; Bozzani, Antonio; Setacci, Carlo; Ravelli, Paolo; Crescini, Claudio; Staurenghi, Giovanni; Scarone, Pietro; Francetti, Luca; D'Angelo, Fabio; Gadda, Franco; Comel, Andrea; Salvi, Luca; Lorini, Luca; Antonelli, Massimo; Bovenzi, Francesco; Cremonesi, Alberto; Angiolillo, Dominick J; Guagliumi, Giulio

2014-05-01

Optimal perioperative antiplatelet therapy in patients with coronary stents undergoing surgery still remains poorly defined and a matter of debate among cardiologists, surgeons and anaesthesiologists. Surgery represents one of the most common reasons for premature antiplatelet therapy discontinuation, which is associated with a significant increase in mortality and major adverse cardiac events, in particular stent thrombosis. Clinical practice guidelines provide little support with regard to managing antiplatelet therapy in the perioperative phase in the case of patients with non-deferrable surgical interventions and/or high haemorrhagic risk. Moreover, a standard definition of ischaemic and haemorrhagic risk has never been determined. Finally, recommendations shared by cardiologists, surgeons and anaesthesiologists are lacking. The present consensus document provides practical recommendations on the perioperative management of antiplatelet therapy in patients with coronary stents undergoing surgery. Cardiologists, surgeons and anaesthesiologists have contributed equally to its creation. On the basis of clinical and angiographic data, the individual thrombotic risk has been defined. All surgical interventions have been classified according to their inherent haemorrhagic risk. A consensus on the optimal antiplatelet regimen in the perioperative phase has been reached on the basis of the ischaemic and haemorrhagic risk. Aspirin should be continued perioperatively in the majority of surgical operations, whereas dual antiplatelet therapy should not be withdrawn for surgery in the case of low bleeding risk. In selected patients at high risk for both bleeding and ischaemic events, when oral antiplatelet therapy withdrawal is required, perioperative treatment with short-acting intravenous glycoprotein IIb/IIIa inhibitors (tirofiban or eptifibatide) should be taken into consideration.

Cost effectiveness of drug-eluting stents as compared with bare metal stents in patients with coronary artery disease.

PubMed

Wisløff, Torbjørn; Atar, Dan; Sønbø Kristiansen, Ivar

2013-01-01

The aim of this study was to estimate the incremental cost effectiveness of replacing bare metal stents (BMS) by drug-eluting stents (DES) when using trial data and registry data. We developed a Markov model (model of cost effectiveness of coronary artery disease) in which 60-year-old patients started by undergoing percutaneous coronary intervention for acute or subacute coronary artery disease. The patients are followed until death or 100 years of age. Data on the occurrence of events (revascularization, acute myocardial infarction, and death) were based on Scandinavian registry data. Separate analyses were conducted with data on effectiveness based on randomized controlled trials and patient registries. On using trial data, it was found that sirolimus-eluting stents (SES) yield 0.003 greater life expectancy and $3300 lower costs than do BMS (dominant strategy). Paclitaxel-eluting stents (PES) yield 0.148 more life years than do SES at additional lifetime costs of $2800 ($21,400 per life year gained). On using registry data, the cost per life year gained was found to be $4900 when replacing BMS with DES. Probabilistic sensitivity analyses, on the other hand, indicate that PES only has a 50%-75% probability of being cost effective, regardless of the type of effectiveness data. DESs are cost effective with current willingness to pay for life year gains. Whether PES or SES is the most effective DES remains uncertain.

Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries: results from the BAsel Stent Kosten-Effektivitäts Trial PROspective Validation Examination randomized trial.

PubMed

Kurz, David J; Bernheim, Alain M; Tüller, David; Zbinden, Rainer; Jeger, Raban; Kaiser, Christoph; Galatius, Soeren; Hansen, Kim W; Alber, Hannes; Pfisterer, Matthias; Eberli, Franz R

2015-10-01

Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available. Planned secondary analysis of patients ≥75 years recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy. The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years. Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates of nonfatal myocardial infarction (1.2% vs 5.5%, hazard ration (HR) 0.44 [0.21-0.83]; P = .009), all-cause death (7.4% vs 14.4%; HR 0.7 [0.51-0.95]; P = .02), and target vessel revascularization (TVR) (2.3% vs 6.2%; HR 0.59 [0.34-0.99]; P = .046) were also lower, whereas stent thrombosis and bleeding rates were similar. In contrast, among patients <75 years (n = 1,909), the only significant benefit of DES was a reduced rate of TVR (4.0% vs 8.7%, HR 0.66 [0.55-0.80]; P < .0001). In patients ≥75 years requiring large (≥3.0 mm) coronary stents, use of DES was beneficial compared with BMS and reduced the rate of ischemic events, mortality, and TVR. These data suggest that DES should be preferred over BMS in elderly patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Outcomes in Diabetic Patients Undergoing Orbital Atherectomy System.

PubMed

Lee, Michael S; Shlofmitz, Evan; Nguyen, Heajung; Shlofmitz, Richard A

2016-10-01

We evaluated the angiographic and clinical outcomes of orbital atherectomy to treat severely calcified coronary lesions in diabetic and non-diabetic patients. Diabetics have increased risk for death, myocardial infarction, and target vessel revascularization after percutaneous coronary intervention. Severely calcified coronary lesions are associated with increased cardiac events. Orbital atherectomy facilitates stent delivery and optimizes stent expansion by modifying severely calcified plaque. Outcomes in diabetic patients who undergo orbital atherectomy have not been reported. Our retrospective multicenter registry included 458 consecutive real-world patients with severely calcified coronary arteries who underwent orbital atherectomy. The primary safety endpoint was the rate of major adverse cardiac and cerebrovascular events at 30 days. Diabetics represented 42.1% (193/458) of the entire cohort. The primary endpoint was similar in diabetics and non-diabetics (1.0% vs. 3.0%%, P = 0.20), as were 30-day rates of death (0.5% vs. 1.9%, P = 0.41), myocardial infarction (0.5% vs. 1.5%, P = 0.40), target vessel revascularization (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P > 0.9). Angiographic complications and stent thrombosis rate were low and did not differ between the 2 groups. Diabetics represented a sizeable portion of patients who underwent orbital atherectomy. Diabetics who had severely calcified coronary arteries and underwent orbital atherectomy had low event rates that were similar to non-diabetics. Orbital atherectomy appears to be a viable treatment strategy for diabetic patients. Randomized trials with longer-term follow-up are needed to determine the ideal treatment strategy for diabetics. © 2016, Wiley Periodicals, Inc.

Very late stent thrombosis and late target lesion revascularization after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.

PubMed

Kimura, Takeshi; Morimoto, Takeshi; Nakagawa, Yoshihisa; Kawai, Kazuya; Miyazaki, Shunichi; Muramatsu, Toshiya; Shiode, Nobuo; Namura, Masanobu; Sone, Takahito; Oshima, Shigeru; Nishikawa, Hideo; Hiasa, Yoshikazu; Hayashi, Yasuhiko; Nobuyoshi, Masakiyo; Mitudo, Kazuaki

2012-01-31

There is a scarcity of long-term data from large-scale drug-eluting stent registries with a large enough sample to evaluate low-frequency events such as stent thrombosis (ST). Five-year outcomes were evaluated in 12 812 consecutive patients undergoing sirolimus-eluting stent (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30 day, 0.3%; 1 year, 0.6%; and 5 years, 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after sirolimus-eluting stent implantation (0.26%/y). Cumulative incidence of target lesion revascularization within the first year was low (7.3%). However, late target lesion revascularization beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/y). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting the presence of different pathophysiological mechanisms of ST according to the timing of ST onset: acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST; side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST; and current smoking and total stent length >28 mm for very late ST. Independent risk factors of late target lesion revascularization beyond 1 year were generally similar to those risk factors identified for early target lesion revascularization. Late adverse events such as very late ST and late target lesion revascularization are continuous hazards, lasting at least up to 5 years after implantation of the first-generation drug-eluting stents (sirolimus-eluting stents), which should be the targets for developing improved coronary stents.

True coronary bifurcation lesions: meta-analysis and review of literature.

PubMed

Athappan, Ganesh; Ponniah, Thirumalaikolundiusubramanian; Jeyaseelan, Lakshmanan

2010-02-01

Percutaneous intervention of true coronary bifurcation lesions is challenging. Based on the results of randomized trials and registry data, the approach of stenting of main vessel only with balloon dilatation of the side branch has become the default approach for false bifurcation lesions except when a complication occurs or in cases of suboptimal result. However, the optimal stenting strategy for true coronary bifurcation lesions - to stent or not to stent the side branch - is still a matter of debate. The purpose of this study was, therefore, to compare the clinical and angiographic outcomes of the double stent technique (stenting of the main branch and side branch) over the single stent technique (stenting of main vessel only with balloon dilatation of the side branch) for treatment of true coronary bifurcation lesions, with drug-eluting stents (DES). Comparative studies published between January 2000 and February 2009 of the double stent technique vs. single stent technique with DES for true coronary bifurcations were identified using an electronic search and reviewed using a random effects model. The primary endpoints of our study were side-branch and main-branch restenoses, all-cause mortality, myocardial infarction (MI) and target lesion revascularization (TLR) at longest available follow-up. The secondary endpoints of our analysis were postprocedural minimal luminal diameter (MLD) of the side branch and main branch, follow-up MLD of side branch and main branch and stent thrombosis. Heterogeneity was assessed and sensitivity analysis was performed to test the robustness of the overall summary odds ratios (ORs). Five studies comprising 1145 patients (616 single stent and 529 double stent) were included in the analysis. Three studies were randomized comparisons between the two techniques for true coronary bifurcation lesions. Incomplete reporting of data in the primary studies was common. The lengths of clinical and angiographic follow-up ranged between 6 and 12 months and 6 and 7 months, respectively. Postprocedural MLD of the side branch was significantly smaller in the single stent group [standardized mean difference (SMD) -0.71, 95% CI -0.88 to -0.54, P < 0.000, I2 = 0%]. The odds of side-branch restenosis (OR 1.11, 95% CI 0.47-2.67, P = 0.81, I2 = 76%), main-branch restenois (OR 0.88, 95% CI 0.56-1.39, P = 0.58, I = 0%), all-cause mortality (OR 0.52, 95% CI 0.11-2.45, P = 0.41, I2 = 0%), MI (OR 0.92, 95% CI 0.34-2.54, P = 0.87, I = 49%) and TLR (OR 0.87, 95% CI 0.46-1.65, P = 0.68, I2 = 0%) were similar between the two groups. Postprocedural MLD of the main branch [standardized mean difference (SMD) -0.08, 95% CI -0.42 to -0.26, P < 0.65, I2 = 67%], follow-up MLD of side branch (SMD -0.19, 95% CI -0.40 to 0.01, P < 0.31, I2 = 15%) and main branch MLD (SMD 0.17, 95% CI -0.18 to 0.542, P < 0.35, I2 = 65%) were also similar between the two groups. In patients undergoing percutaneous coronary intervention (PCI) for true coronary bifurcations, there is no added advantage of stenting both branches as compared with a conventional one-stent strategy. The results, however, need to be interpreted considering the poor study methods and/or poor quality of reporting in publications. We propose to move forward and consider the conduct of more systematic, well-designed and scientific trials to investigate the treatment of true coronary bifurcation lesions.

Comparison of the SYNERGY with the PROMUS (XIENCE V) and bare metal and polymer-only Element control stents in porcine coronary arteries.

PubMed

Wilson, Gregory J; Huibregtse, Barbara A; Pennington, Douglas E; Dawkins, Keith D

2012-06-20

This study evaluated vascular compatibility of the novel platinum chromium alloy Element stent platform delivering abluminal everolimus from a poly-lactide-co-glycolide bioabsorbable polymer (SYNERGY stent), currently undergoing clinical trial, compared with the PROMUS (XIENCE V) and bare metal and polymer-only Element stents. Stents (n=161) were implanted one per coronary artery in 72 swine at a stent-to-artery ratio of 1.1:1. Similar numbers of each device group were explanted at each of 30, 90, 180, and 360 days (except no PROMUS (XIENCE V) stent at 360 days) for pathological analysis. There was no stent thrombosis, myocardial infarction, or strut fractures in any group. Vascular response was similar between the SYNERGY and PROMUS (XIENCE V) stents, with no thrombi and complete endothelialisation on both scanning electron microscopy and histology at 30, 90 and 180 days. There were no significant differences for the morphologic parameters of luminal thrombus, endothelial cell coverage, strut tissue coverage, inflammation, internal elastic lamina (IEL) disruption, external elastic lamina (EEL) disruption and medial smooth muscle cell loss across device groups or between time points, but there was mild but greater (p<0.0001) para-strut fibrin at 30 days for both drug-eluting stents (DES) compared with the bare and polymer-only controls; this difference completely dissipated by 90 days. Inflammation was predominantly minimal to mild for all device types. No morphometric parameters, including intimal thickness, stent profile-based area stenosis, and EEL area were significantly different when comparing the SYNERGY stent with the bare metal Element and polymer-only Element control stents at 90, 180 and 360 days. In this non-injured porcine coronary artery model, the bioabsorbable polymer SYNERGY stent demonstrated vascular compatibility equivalent to the PROMUS (XIENCE V) stent and to the bare metal and polymer-only Element stents.

Clopidogrel plus indobufen in acute coronary syndrome patients with hypersensitivity to aspirin undergoing percutaneous coronary intervention.

PubMed

Barillà, Francesco; Pulcinelli, Fabio Maria; Mangieri, Enrico; Torromeo, Concetta; Tanzilli, Gaetano; Dominici, Tania; Pellicano, Mariano; Paravati, Vincenzo; Acconcia, Maria Cristina; Gaudio, Carlo

2013-01-01

The prescription of aspirin (acetylsalicylic acid (ASA)) to patients with a history of hypersensitivity to this drug could prove harmful. The aim of the study was to assess the antiplatelet activity and safety of a combined antiplatelet treatment with indobufen and clopidogrel in acute coronary syndrome (ACS) patients with hypersensitivity to aspirin, undergoing coronary stenting. Forty-two consecutive ACS patients treated with stent implantation were randomly assigned to receive clopidogrel 75 mg daily (loading dose 300 mg) plus indobufen 100 mg twice a day (group A), or clopidogrel 75 mg daily, after 300 mg of loading dose (group B). Platelet activity and safety were monitored in both groups at 1, 3, 6, 12, and 18 months with laboratory and clinical evaluation. A lower value of max % platelet aggregation to arachidonic acid and collagen was found in group A compared to group B (31.79 ± 27.33 vs. 73.67 ± 19.92; p < 0.0001 and 28.53 ± 21.32 vs. 73.58 ± 17.71; p < 0.0001, respectively). There was no difference in max % of platelet inhibition to adenosine diphosphate between the two groups (14.23 ± 18.92 vs. 10.30 ± 18.97; p = 0.23). In the population that was under indobufen treatment, the serum thromboxane B2 (TXB2) production at 1 week and 1 month was very low (2.6 ± 1.6 ng/ml and 3.0 ± 2.7 ng/ml, respectively; p = 0.82). The combined treatment was well tolerated in group A patients. This study suggests that the combined antiplatelet treatment with clopidogrel and indobufen could be a good option in ACS patients with hypersensitivity to aspirin undergoing coronary stenting.

Prevalence, Features, and Prognostic Importance of Edge Dissection After Drug-Eluting Stent Implantation: An ADAPT-DES Intravascular Ultrasound Substudy.

PubMed

Kobayashi, Nobuaki; Mintz, Gary S; Witzenbichler, Bernhard; Metzger, D Christopher; Rinaldi, Michael J; Duffy, Peter L; Weisz, Giora; Stuckey, Thomas D; Brodie, Bruce R; Parvataneni, Rupa; Kirtane, Ajay J; Stone, Gregg W; Maehara, Akiko

2016-07-01

Intravascular ultrasound detects stent edge dissections after percutaneous coronary intervention that are not seen angiographically. This study investigated the association between stent edge dissections and clinical outcomes. ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a large-scale, prospective, multicenter study of patients undergoing drug-eluting stent implantation. In this prospective substudy, 2062 patients (2433 lesions) were evaluated with intravascular ultrasound to characterize the morphological features and clinical outcomes of stent edge dissection after percutaneous coronary intervention. The prevalence of post-percutaneous coronary intervention stent edge dissection was 6.6% per lesion (161 of 2433). Calcified plaque at the proximal stent edge (relative risk [RR]=1.72; P=0.04) and proximal stent edge expansion (RR=1.18; P=0.004) were predictors for proximal dissection; attenuated plaque at the distal stent edge (RR=3.52; P=0.004), distal reference plaque burden (RR=1.56; P<0.0001), and distal edge stent expansion (RR=1.11; P=0.02) were predictors for distal dissection. At 1-year follow-up, target lesion revascularization was more common in lesions with versus without dissection (5.2% versus 2.7%; P=0.04). Multivariable analysis indicated that residual dissection was associated with target lesion revascularization at 1-year follow-up (RR=2.67; P=0.02). Among lesions with dissection, smaller effective lumen area increased the risk of target lesion revascularization at 1-year follow-up (cutoff value of 5.1 mm(2); P=0.05). Greater stent expansion and the presence of large, calcified, and/or attenuated plaques were independent predictors of stent edge dissection. Residual stent edge dissection, especially with a smaller effective lumen area, was associated with target lesion revascularization during 1-year follow-up after drug-eluting stent implantation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00638794. © 2016 American Heart Association, Inc.

One-year clinical outcomes of ultra long apollo polymer-based Paclitaxel-eluting stents in patients with complex, long coronary artery lesions.

PubMed

Salarifar, Mojtaba; Kassaian, Seyed Ebrahim; Alidoosti, Mohammad; Haji-Zeinali, Ali Mohammad; Poorhoseini, Hamid Reza; Nematipour, Ebrahim; Amirzadegan, Alireza; Saroukhani, Sepideh

2011-01-01

For all the wealth of research comparing the efficacy of the different types of the drug-eluting stent (DES) such as sirolimus-, paclitaxel-, and zotarolimus-eluting stents, there is still a dearth of data on the different brands of each DES type. We aimed to investigate the one-year clinical outcomes, including major adverse cardiac events (MACE), of the use of the ultra long Apollo paclitaxel-eluting stent in patients with long atherosclerotic coronary artery lesions. According to a retrospective review of the Tehran Heart Center Registry of Interventional Cardiology, a single-center nonrandomized computerized data registry in which all adult patients who undergo single or multi-vessel percutaneous coronary intervention (PCI) are enrolled without any specific exclusion criteria, the mixed use of long Apollo paclitaxel-eluting stents and other types of the DES as well as myocardial infarction within forty-eight hours prior to the procedure was excluded. In total, 122 patients were enrolled in the study, and their baseline clinical, angiographic, and procedural characteristics were obtained. In addition, the patients' follow-up data and, most importantly, MACE during a one-year period after intervention were recorded. The mean follow-up duration was 14.1 ± 3.8 months. The one-year clinical follow-up data were obtained in 95.9 % of all the patients. The incidence of MACE was 5.7% during the entire study period. There was 1 death, which occurred during the initial days after PCI. The incidence of non-fatal myocardial infarction was 2.5% (3 cases), including one patient who underwent target vessel revascularization seven months later. Also, 3 patients with single-vessel disease and in-stent restenosis underwent coronary artery bypass grafting between five to ten months later. Our results showed that the Apollo paclitaxel-eluting stent might be regarded as a safe and effective treatment for long coronary lesions.

Clinical outcomes with Biolimus (A9)™ eluting stent, 'BioMatrix' in diabetic patients--interim results from multicenter post market surveillance registry in India.

PubMed

Seth, Ashok; Hiremath, Shirish; Dani, Sameer; Kapoor, Sunil; Jain, R K; Abhaichand, Rajpal; Trivedi, Shailendra; Kaul, Upendra; Patil, Aruna; Khemnar, Bhushan; Rangnekar, Hrishikesh

2013-01-01

The objective of this registry is to establish safety and efficacy of BioMatrix, BioMatrix™-Biolimus A9™ eluting stent in diabetic population in India. Diabetes mellitus is a major predisposing factor for coronary artery disease. Prognosis for diabetic population patients presenting with coronary artery disease who undergo coronary revascularization is inferior to non diabetics and remains an independent risk factor of restenosis, need for revascularization, and overall mortality. Stent thrombosis is a potential complication of first generation, permanent polymer drug-eluting stents. Biodegradable polymer is a good relief in this era and its utility in diabetic patients will be a major advantage for them. 334 patients with diabetes mellitus and requiring angioplasty, implanted with BioMatrix stent were followed at 1, 6, 12 and 24 months who entered in a multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, 12 and 24 months. The mean age was 58.71 ± 9.2 years, 81% were males, comorbidity index was 1.6 ± 1.02, and 59.1% presented with acute coronary syndrome. The incidence of adverse event rates was: MACE 1.27%. There were no incidences of myocardial infarction (MI) and target vessel revascularization (TVR). Definite stent thrombosis occurred only in 2 patients. In this registry of diabetic population treated with BioMatrixTM-Biolimus A9TM eluting stent (BioMatrix), the reported incidence of MACE and ST were much lower than previously published results. The 1- and 2-year follow-up result supports favorable clinical outcomes of using BioMatrix stents as a suitable alternative to contemporary DES available during PCI in diabetic patients. Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Clinical outcomes with Biolimus (A9)™ eluting stent, ‘BioMatrix’ in diabetic patients – interim results from multicenter post market surveillance registry in India

PubMed Central

Seth, Ashok; Hiremath, Shirish; Dani, Sameer; Kapoor, Sunil; Jain, R.K.; Abhaichand, Rajpal; Trivedi, Shailendra; Kaul, Upendra; Patil, Aruna; Khemnar, Bhushan; Rangnekar, Hrishikesh

2013-01-01

Objective The objective of this registry is to establish safety and efficacy of BioMatrix, BioMatrix™-Biolimus A9™ eluting stent in diabetic population in India. Background Diabetes mellitus is a major predisposing factor for coronary artery disease. Prognosis for diabetic population patients presenting with coronary artery disease who undergo coronary revascularization is inferior to non diabetics and remains an independent risk factor of restenosis, need for revascularization, and overall mortality. Stent thrombosis is a potential complication of first generation, permanent polymer drug-eluting stents. Biodegradable polymer is a good relief in this era and its utility in diabetic patients will be a major advantage for them. Methods 334 patients with diabetes mellitus and requiring angioplasty, implanted with BioMatrix stent were followed at 1, 6, 12 and 24 months who entered in a multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, 12 and 24 months. Results The mean age was 58.71 ± 9.2 years, 81% were males, comorbidity index was 1.6 ± 1.02, and 59.1% presented with acute coronary syndrome. The incidence of adverse event rates was: MACE 1.27%. There were no incidences of myocardial infarction (MI) and target vessel revascularization (TVR). Definite stent thrombosis occurred only in 2 patients. Conclusion In this registry of diabetic population treated with BioMatrixTM-Biolimus A9TM eluting stent (BioMatrix), the reported incidence of MACE and ST were much lower than previously published results. The 1- and 2-year follow-up result supports favorable clinical outcomes of using BioMatrix stents as a suitable alternative to contemporary DES available during PCI in diabetic patients. PMID:24206882

Perspectives on the management of antiplatelet therapy in patients with coronary artery disease requiring cardiac and noncardiac surgery.

PubMed

Franchi, Francesco; Rollini, Fabiana; Angiolillo, Dominick J

2014-11-01

To provide an updated overview on the management of antiplatelet therapy in patients with coronary stents undergoing cardiac and noncardiac surgery. Surgical procedures are frequently performed in patients with coronary stents and are associated with an increased risk of ischemic and bleeding complications in the perioperative period. Given the lack of well-designed prospective randomized trials, guidelines recommendations are currently derived from observational studies and expert consensus. Defining the optimal balance between the risk of thrombotic events following discontinuation of antiplatelet therapy and the risk of hemorrhagic complications of having a surgical procedure while on antiplatelet therapy is pivotal. Elective surgery should be postponed for at least 4 weeks after bare metal stent implantation and 6-12 months after drug-eluting stent. If this is not possible, aspirin should be continued in the perioperative period, although the management of P2Y₁₂ inhibitors should be individualized according to the individual patient and type of surgery. In the absence of well-defined recommendations deriving from prospective randomized clinical trials, the perioperative management of antiplatelet therapy should be based on the balance between the specific thrombotic and hemorrhagic risks that characterize each patient and each surgical procedure.

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

PubMed Central

Gilgen, Nicole; Farah, Ahmed; Scheller, Bruno; Ohlow, Marc‐Alexander; Mangner, Norman; Weilenmann, Daniel; Wöhrle, Jochen; Jamshidi, Peiman; Leibundgut, Gregor; Möbius‐Winkler, Sven; Zweiker, Robert; Krackhardt, Florian; Butter, Christian; Bruch, Leonhard; Kaiser, Christoph; Hoffmann, Andreas; Rickenbacher, Peter; Mueller, Christian; Stephan, Frank‐Peter; Coslovsky, Michael

2018-01-01

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population. PMID:29527709

Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry.

PubMed

Bangalore, Sripal; Pencina, Michael J; Kleiman, Neal S; Cohen, David J

2014-06-01

The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined. The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% [-0.8% to -5.8%]; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% [4.1% to -1.8%]; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [1.3% to -1.3%]; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% [-0.4% to -3.3%]; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% [2.3% to -1.5%]; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [0.7% to -0.7%]; P=1.00) when compared with unfractionated heparin monotherapy. Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use during percutaneous coronary intervention when compared with unfractionated heparin monotherapy was associated with lower bleeding without significant increase in ischemic outcomes or stent thrombosis. © 2014 American Heart Association, Inc.

The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

Safety and efficacy of rotational atherectomy for the treatment of undilatable underexpanded stents implanted in calcific lesions.

PubMed

Ferri, Luca A; Jabbour, Richard J; Giannini, Francesco; Benincasa, Susanna; Ancona, Marco; Regazzoli, Damiano; Mangieri, Antonio; Montorfano, Matteo; Colombo, Antonio; Latib, Azeem

2017-08-01

Coronary stent underexpansion is a known risk factor for in-stent restenosis and stent thrombosis. There are limited options once noncompliant balloons have failed to achieve optimal stent expansion. Excimer Laser Coronary Angioplasty with contrast medium injection is one possibility, but not readily available. Rotational atherectomy is an alternative, and has been described in case reports, but concerns exist regarding safety. All consecutive patients undergoing rotational atherectomy for symptomatic in-stent restenosis due to stent underexpansion resistant to noncompliant balloon postdilatation between January 2005 and December 2015 were analysed. A total of 16 patients underwent treatment during the study period and the procedure was successful in 14 cases (87.5%). The mean postprocedural minimal lumen diameter increased by 2.3 ± 0.8 mm and percentage diameter stenosis decreased from 82.17% ± 17.2% to 11.9% ± 9.1%. Intraprocedural complications occurred in two patients (burr entrapment successfully managed percutaneously and periprocedural myocardial infarction). At 1-year follow-up, the incidence of target lesion revascularisation was 13.3% (2 out of 15 patients), and one patient died from noncardiac death. In this small series of underexpanded stents, rotational atherectomy was an effective treatment for resistant stent underexpansion with acceptable outcomes. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 5 years follow-up from the randomized DEDICATION trial (Drug Elution and Distal Protection in Acute Myocardial Infarction).

PubMed

Holmvang, Lene; Kelbæk, Henning; Kaltoft, Anne; Thuesen, Leif; Lassen, Jens Flensted; Clemmensen, Peter; Kløvgaard, Lene; Engstrøm, Thomas; Bøtker, Hans E; Saunamäki, Kari; Krusell, Lars R; Jørgensen, Erik; Tilsted, Hans-Henrik; Christiansen, Evald H; Ravkilde, Jan; Køber, Lars; Kofoed, Klaus Fuglsang; Terkelsen, Christian J; Helqvist, Steffen

2013-06-01

This study sought to compare the long-term effects of drug-eluting stent (DES) compared with bare-metal stent (BMS) implantation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) trial evaluated the outcome after DES compared with BMS implantation in patients with STEMI undergoing primary percutaneous coronary intervention. Patients with a high-grade stenosis/occlusion of a native coronary artery presenting with symptoms <12 h and ST-segment elevation were enrolled after giving informed consent. Patients were randomly assigned to receive a DES or a BMS in the infarct-related lesion. Patients were followed for at least 5 years, and clinical endpoints were evaluated from population registries and hospital charts. The main endpoint was the occurrence of the first major adverse cardiac event (MACE), defined as cardiac death, nonfatal recurrent myocardial infarction, and target lesion revascularization. Complete clinical status was available in 623 patients (99.5%) at 5 years follow-up. The combined MACE rate was insignificantly lower in the DES group (16.9% vs. 23%), mainly driven by a lower need of repeat revascularization (p = 0.07). Whereas the number of deaths from all causes tended to be higher in the DES group (16.3% vs. 12.1%, p = 0.17), cardiac mortality was significantly higher (7.7% vs. 3.2%, p = 0.02). The 5-year stent thrombosis rates were generally low and similar between the DES and the BMS groups. No cardiac deaths occurring within 1 month could be clearly ascribed to stent thrombosis, whereas stent thrombosis was involved in 78% of later-occurring deaths. The 5-year MACE rate was insignificantly different, but the cardiac mortality was higher after DES versus BMS implantation in patients with STEMI. Stent thrombosis was the main cause of late cardiac deaths. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy.

PubMed

Kereiakes, Dean J; Yeh, Robert W; Massaro, Joseph M; Driscoll-Shempp, Priscilla; Cutlip, Donald E; Steg, P Gabriel; Gershlick, Anthony H; Darius, Harald; Meredith, Ian T; Ormiston, John; Tanguay, Jean-François; Windecker, Stephan; Garratt, Kirk N; Kandzari, David E; Lee, David P; Simon, Daniel I; Iancu, Adrian Corneliu; Trebacz, Jaroslaw; Mauri, Laura

2015-10-01

This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p < 0.001). DES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study.

PubMed

Rodriguez, Alfredo E; Maree, Andrew; Tarragona, Sonia; Fernandez-Pereira, Carlos; Santaera, Omar; Rodriguez Granillo, Alfredo M; Rodriguez-Granillo, Gaston A; Russo-Felssen, Miguel; Kukreja, Neville; Antoniucci, David; Palacios, Igor F; Serruys, Patrick W

2009-06-01

Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Serial assessment of the index of microcirculatory resistance during primary percutaneous coronary intervention comparing manual aspiration catheter thrombectomy with balloon angioplasty (IMPACT study): a randomised controlled pilot study.

PubMed

Hoole, Stephen P; Jaworski, Catherine; Brown, Adam J; McCormick, Liam M; Agrawal, Bobby; Clarke, Sarah C; West, Nick E J

2015-01-01

Utilising a novel study design, we evaluated serial measurements of the index of microcirculatory resistance (IMR) in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) to assess the impact of device therapy on microvascular function, and determine what proportion of microvascular injury is related to the PPCI procedure, and what is an inevitable consequence of STEMI. 41 patients undergoing PPCI for STEMI were randomised to balloon angioplasty (BA, n=20) or manual thrombectomy (MT, n=21) prior to stenting. Serial IMR measurements, corrected for collaterals, were recorded at baseline and at each stage of the procedure. Microvascular obstruction (MVO) and infarct size at 24 h and 3 months were measured by troponin and cardiac MRI (CMR). IMR did not change significantly following PPCI, but patients with lower IMR values (<32, n=30) at baseline had a significant increase in IMR following PPCI (baseline: 21.2±7.9 vs post-stent: 33.0±23.7, p=0.01) attributable to prestent IRA instrumentation (baseline: 21.7±8.0 vs post-BA or MT: 36.9±25.9, p=0.006). Post-stent IMR correlated with early MVO on CMR (p=0.01). There was no significant difference in post-stent IMR, presence of early MVO or final infarct size between patients with BA and patients treated with MT. Patients with STEMI and less microcirculatory dysfunction may be susceptible to acute iatrogenic microcirculatory injury from prestent coronary devices. MT did not appear to be superior to BA in maintaining microcirculatory integrity when the guide wire partially restores IRA flow during PPCI. ISRCTN31767278.

Safety and efficacy of polymer-free biolimus-eluting stents in all-comer patients: the RUDI-FREE study.

PubMed

Sardella, Gennaro; Stefanini, Giulio G; Briguori, Carlo; Tamburino, Corrado; Fabbiocchi, Franco; Rotolo, Francesco; Tomai, Fabrizio; Paggi, Anita; Lombardi, Mario; Gioffrè, Gaetano; Sclafani, Rocco; Rolandi, Andrea; Sciahbasi, Alessandro; Scardaci, Francesco; Signore, Nicola; Calcagno, Simone; Mancone, Massimo; Chiarito, Mauro; Giordano, Arturo

2018-05-21

Polymer-free biolimus-eluting stents (PF-BES) have been shown superior to bare metal stents in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, limited evidence is available on PF-BES in non-HBR patients. We aim to evaluate the safety and efficacy of PF-BES in all-comer patients undergoing percutaneous coronary interventions (PCI). Patients with stable coronary artery disease or acute coronary syndromes (ACS) undergoing PCI with PF-BES in routine clinical practice were included in a multicenter, prospective registry. DAPT duration was left at the discretion of the operator. The primary endpoint was the composite of cardiovascular death, myocardial infarction (MI), and definite/probable stent thrombosis (ST) at 1 year. Overall, 1,104 consecutive patients treated with PF-BES were included at 16 Italian centers. Mean age was 68.7±11.2 years, 77.2% of patients were men, 30% had diabetes, 15.1% had chronic kidney disease, and 40.5% had ACS at baseline. Mean CRUSADE score was 24.1±13.1, and 83.7% of patients did not have high bleeding risk features. At 1-year, the primary endpoint occurred in 4.1% of patients, cardiovascular death in 2.4%, MI in 1.8%, and definite/probable ST in 1.1%. With respect to efficacy, target-lesion revascularization occurred in 1.2% of patients. This is the first study providing clinical evidence on the use of PF-BES in all-comer patients irrespective of HBR status. Our findings suggest that PF-BES has a favorable safety and efficacy profile in a real world clinical setting. Further investigation in randomised clinical trials against new-generation DES is warranted.

Efficacy and safety of aspirin, clopidogrel, and warfarin after coronary artery stenting in Korean patients with atrial fibrillation.

PubMed

Suh, Soon Yong; Kang, Woong Chol; Oh, Pyung Chun; Choi, Hanul; Moon, Chan Il; Lee, Kyounghoon; Han, Seung Hwan; Ahn, Taehoon; Choi, In Suck; Shin, Eak Kyun

2014-09-01

There are limited data on the optimal antithrombotic therapy for patients with atrial fibrillation (AF) who undergoing coronary stenting. We reviewed 203 patients (62.6 % men, mean age 68.3 ± 10.1 years) between 2003 and 2012, and recorded clinical and demographic characteristics of the patients. Clinical follow-up included major adverse cardiac and cerebrovascular events (MACCE) (cardiac death, myocardial infarction, target lesion revascularization, and stroke), stent thrombosis, and bleeding. The most commonly associated comorbidities were hypertension (70.4 %), diabetes mellitus (35.5 %), and congestive heart failure (26.6 %). Sixty-three percent of patients had stroke risk higher than CHADS2 score 2. At discharge, dual-antiplatelet therapy (aspirin, clopidogrel) was used in 166 patients (81.8 %; Group I), whereas 37 patients (18.2 %) were discharged with triple therapy (aspirin, clopidogrel, warfarin; Group II). The mean follow-up period was 42.0 ± 29.0 months. The mean international normalized ratio (INR) in group II was 1.83 ± 0.41. The total MACCE was 16.3 %, with stroke in 3.4 %. Compared with the group II, the incidence of MACCE (2.7 % vs 19.3 %, P = 0.012) and cardiac death (0 % vs 11.4 %, P = 0.028) were higher in the group I. Major and any bleeding, however, did not differ between the two groups. In multivariate analysis, no warfarin therapy (odds ratio 7.8, 95 % confidence interval 1.02-59.35; P = 0.048) was an independent predictor of MACCE. By Kaplan-Meier survival analysis, warfarin therapy was associated with a lower risk of MACCE (P = 0.024). In patients with AF undergoing coronary artery stenting, MACCE were reduced by warfarin therapy without increased bleeding, which might be related to tighter control with a lower INR value.

Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study

PubMed Central

Naber, Christoph K.; Urban, Philip; Ong, Paul J.; Valdes-Chavarri, Mariano; Abizaid, Alexandre A.; Pocock, Stuart J.; Fabbiocchi, Franco; Dubois, Christophe; Copt, Samuel; Greene, Samantha; Morice, Marie-Claude

2017-01-01

Aims Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients. Methods and results Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005). Conclusion We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication. PMID:27190095

Real‐World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy

PubMed Central

Shlofmitz, Evan; Kaplan, Barry; Alexandru, Dragos; Meraj, Perwaiz; Shlofmitz, Richard

2016-01-01

Objectives We evaluated the safety and efficacy of orbital atherectomy in real‐world patients with severe coronary artery calcification (CAC). Background The presence of severe CAC increases the complexity of percutaneous coronary intervention as it may impede stent delivery and optimal stent expansion. Atherectomy may be an indispensable tool for uncrossable or undilatable lesions by modifying severe CAC. Although the ORBIT I and II trials report that orbital atherectomy was safe and effective for the treatment of severe CAC, patients with kidney disease, recent myocardial infarction, long diffuse disease, severe left ventricular dysfunction, and unprotected left main disease were excluded. Methods This retrospective study included 458 consecutive patients with severe CAC who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at 3 centers. Results The primary endpoint of major adverse cardiac and cerebrovascular events at 30 days was 1.7%. Low rates of 30‐day all‐cause mortality (1.3%), myocardial infarction (1.1%), target vessel revascularization (0%), stroke (0.2%), and stent thrombosis (0.9%) were observed. Angiographic complications were low: perforation was 0.7%, dissection 0.9%, and no‐reflow 0.7%. Emergency coronary artery bypass graft surgery was performed in 0.2% of patients. Conclusion In the largest real‐world study of patients who underwent orbital atherectomy, including high‐risk patients who were not surgical candidates as well as those with very complex coronary anatomy, acute and short‐term adverse clinical event rates were low. A randomized clinical trial is needed to identify the ideal treatment strategy for patients with severe CAC. PMID:27358246

Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.

PubMed

Gilgen, Nicole; Farah, Ahmed; Scheller, Bruno; Ohlow, Marc-Alexander; Mangner, Norman; Weilenmann, Daniel; Wöhrle, Jochen; Jamshidi, Peiman; Leibundgut, Gregor; Möbius-Winkler, Sven; Zweiker, Robert; Krackhardt, Florian; Butter, Christian; Bruch, Leonhard; Kaiser, Christoph; Hoffmann, Andreas; Rickenbacher, Peter; Mueller, Christian; Stephan, Frank-Peter; Coslovsky, Michael; Jeger, Raban

2018-05-01

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population. © 2018 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

PubMed

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T; Farah, Bruno; Dubois, Christophe L; Feldman, Robert L; Dens, Joseph; Hagiwara, Nobuhisa; Allocco, Dominic J; Dawkins, Keith D

2011-04-19

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparative Case-Control analysis of a dedicated self-expanding Biolimus A9-eluting Bifurcation stent versus provisional or mandatory side branch intervention strategies in the treatment of coronary bifurcation lesions.

PubMed

Ohlow, Marc-Alexander; Farah, Ahmed; Richter, Stefan; El-Garhy, Mohamad; von Korn, Hubertus; Lauer, Bernward

2017-07-01

In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage. To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL). One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed. Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively. Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Magnetic navigation system assisted stenting of coronary bifurcation lesions.

PubMed

Simsek, Cihan; Magro, Michael; Patterson, Mark S; Onuma, Yoshinobu; Ciampichetti, Isabella; van Weenen, Sander; van Domburg, Ron T; Serruys, Patrick W; Boersma, Eric; van Geuns, Robert-Jan

2011-03-01

Magnetic guidewire assisted percutaneous coronary interventions (MPCI) could have certain advantages in coronary bifurcation lesions. We aimed to report the angiographic characteristics of the bifurcation lesions, as well as the procedural and clinical outcomes of the MPCI patients. The lesion characteristics and the treatment effect were assessed by performing diagnostic and quantitative coronary angiography with dedicated bifurcation software. A total of 76 patients (age 65 years, 78% male) were assigned to undergo MPCI, in which two-thirds of the lesions were located in LAD/D1. Fifty-seven out of 78 lesions (73%) had a diseased side branch and complex stenting techniques were used in the majority of the lesions (64%). All 59/78 (76%) fenestration attempts were successfully performed and only 13 dedicated bifurcation stents were implanted. The average acute gain in minimal luminal diameter was 1.08±0.81 mm, 0.80±0.70 mm and 0.59±0.56 mm for the proximal, distal and side branch, respectively. The procedural success was 69% with a procedure time of 107±43 minutes, fluoroscopy time of 34±24 minutes and contrast use of 338±136 ml. At a mean of 1.8-years follow-up, 15 patients (20%) had a cardiac event. MPCI is associated with good angiographic, fenestration and procedural success rates in the treatment of coronary bifurcation lesions.

New-generation stents compared with coronary bypass surgery for unprotected left main disease: A word of caution.

PubMed

Benedetto, Umberto; Taggart, David P; Sousa-Uva, Miguel; Biondi-Zoccai, Giuseppe; Di Franco, Antonino; Ohmes, Lucas B; Rahouma, Mohamed; Kamel, Mohamed; Caputo, Massimo; Girardi, Leonard N; Angelini, Gianni D; Gaudino, Mario

2018-05-01

With the advent of bare metal stents and drug-eluting stents, percutaneous coronary intervention has emerged as an alternative to coronary artery bypass grafting surgery for unprotected left main disease. However, whether the evolution of stents technology has translated into better results after percutaneous coronary intervention remains unclear. We aimed to compare coronary artery bypass grafting with stents of different generations for left main disease by performing a Bayesian network meta-analysis of available randomized controlled trials. All randomized controlled trials with at least 1 arm randomized to percutaneous coronary intervention with stents or coronary artery bypass grafting for left main disease were included. Bare metal stents and drug-eluting stents of first- and second-generation were compared with coronary artery bypass grafting. Poisson methods and Bayesian framework were used to compute the head-to-head incidence rate ratio and 95% credible intervals. Primary end points were the composite of death/myocardial infarction/stroke and repeat revascularization. Nine randomized controlled trials were included in the final analysis. Six trials compared percutaneous coronary intervention with coronary artery bypass grafting (n = 4654), and 3 trials compared different types of stents (n = 1360). Follow-up ranged from 6 months to 5 years. Second-generation drug-eluting stents (incidence rate ratio, 1.3; 95% credible interval, 1.1-1.6), but not bare metal stents (incidence rate ratio, 0.63; 95% credible interval, 0.27-1.4), and first-generation drug-eluting stents (incidence rate ratio, 0.85; 95% credible interval, 0.65-1.1) were associated with a significantly increased risk of death/myocardial infarction/stroke when compared with coronary artery bypass grafting. When compared with coronary artery bypass grafting, the highest risk of repeat revascularization was observed for bare metal stents (hazard ratio, 5.1; 95% confidence interval, 2.1-14), whereas first-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) and second-generation drug-eluting stents (incidence rate ratio, 1.8; 95% confidence interval, 1.4-2.4) were comparable. The introduction of new-generation drug-eluting stents did not translate into better outcomes for percutaneous coronary intervention when compared with coronary artery bypass grafting. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Fourth update on CT angiography of coronary stents: in vitro evaluation of 24 novel stent types.

PubMed

Hickethier, Tilman; Wenning, Justus; Doerner, Jonas; Maintz, David; Michels, Guido; Bunck, Alexander C

2017-01-01

Background Non-invasive evaluation of coronary stent patency by coronary computed tomography angiography (cCTA) remains challenging. Multiple studies showed that CT technology but also individual stent design strongly influence the assessability of coronary stents by cCTA. Purpose To expand the available data on cCTA characteristics of coronary stents by 24 novel types to help interpreting examinations of patients after stent placement and selecting which stents are suitable for assessment by cCTA. Material and Methods Twenty-four novel coronary stents (17 cobalt-chromium, six stainless-steel, one platinum-chromium) were examined in a coronary phantom. Standard cCTA parameters with stent-specific algorithms were used. Image quality was quantified for each stent using established parameters (in-stent attenuation alteration and visible lumen diameter). Results Most stents (n = 14) showed lumen visibilities of 45-55%. No severe restriction of lumen visibility (>60%) was found. The majority of stents (n = 13) caused only small intraluminal attenuation deviations and no severe alterations (>20%) were found. When grouped by manufacturing material, no significant differences were found between cobalt-chromium and stainless-steel with identical mean visible diameters (1.52 ± 0.17 mm vs. 1.52 ± 0.13 mm) and comparable attenuation alterations (35.04 ± 16.56 HU vs. 21.25 ± 14.60 HU). The only platinum-chromium stent showed a smaller visible diameter (1.23 mm) and higher attenuation alteration (41.70 HU), but was also deemed to be assessable by cCTA. Conclusion All 24 novel evaluated stents are eligible for non-invasive evaluation by cCTA without significant differences between cobalt-chromium and stainless-steel stents. This updated catalogue of CT appearances of current coronary stents may serve as reference when taking care of patients with stents in need of coronary imaging.

Consensus Document ANMCO/ANCE/ARCA/GICR-IACPR/GISE/SICOA: Long-term Antiplatelet Therapy in Patients with Coronary Artery Disease

PubMed Central

Gulizia, Michele Massimo; Colivicchi, Furio; Abrignani, Maurizio Giuseppe; Ambrosetti, Marco; Aspromonte, Nadia; Barile, Gabriella; Caporale, Roberto; Casolo, Giancarlo; Chiuini, Emilia; Di Lenarda, Andrea; Faggiano, Pompilio; Gabrielli, Domenico; Geraci, Giovanna; La Manna, Alessio Gaetano; Maggioni, Aldo Pietro; Marchese, Alfredo; Massari, Ferdinando Maria; Mureddu, Gian Francesco; Musumeci, Giuseppe; Nardi, Federico; Panno, Antonio Vittorio; Pedretti, Roberto Franco Enrico; Piredda, Massimo; Pusineri, Enrico; Riccio, Carmine; Rossini, Roberta; di Uccio, Fortunato Scotto; Urbinati, Stefano; Varbella, Ferdinando; Zito, Giovanni Battista; De Luca, Leonardo; Cappelletti, Alberto Maria; Casu, Gavino; Di Pasquale, Giuseppe; Di Tano, Giuseppe; Domenicucci, Stefano; Francese, Giuseppina Maura; Fresco, Claudio; Gensini, Gian Franco; Rovere, Maria Teresa La; Lucà, Fabiana; Mauro, Ciro; Murrone, Adriano; Rubboli, Andrea; Russo, Maria Giovanna; Santomauro, Maurizio; Tamburino, Corrado; Tarantini, Giuseppe; Vairo, Ugo; Zuin, Guerrino; Abrignani, Maurizio Giuseppe; Ambrosetti, Marco; Amico, Antonio Francesco; Aspromonte, Nadia; Aulitto, Vincenzo; Barile, Gabriella; Calculli, Giacinto; Caldarola, Pasquale; Caporale, Roberto; Cappelletti, Alberto Maria; Carbonaro, Alessandro; Casolo, Giancarlo; Casu, Gavino; Cavallini, Claudio; Chiuini, Emilia; Colivicchi, Furio; De Luca, Leonardo; Di Lenarda, Andrea; Di Pasquale, Giuseppe; Di Tano, Giuseppe; Domenicucci, Stefano; Faggiano, Pompilio; Francese, Giuseppina Maura; Fresco, Claudio; Gabrielli, Domenico; Gensini, Gian Franco; Geraci, Giovanna; Gesualdo, Loreto; Giubilato, Simona; Gulizia, Michele Massimo; La Manna, Alessio Gaetano; La Rovere, Maria Teresa; Lucà, Fabiana; Maggioni, Aldo Pietro; Marchese, Alfredo; Massari, Ferdinando Maria; Mauro, Ciro; Menozzi, Alberto; Mureddu, Gian Francesco; Murrone, Adriano; Musumeci, Giuseppe; Nardi, Federico; Noussan, Patrizia; Panno, Antonio Vittorio; Parodi, Guido; Pedretti, Roberto Franco Enrico; Perna, Gian Piero; Piredda, Massimo; Pusineri, Enrico; Riccio, Carmine; Rossini, Roberta; Rubboli, Andrea; Russo, Maria Giovanna; Saia, F; Santomauro, Maurizio; Scherillo, Marino; Scorcu, Giampaolo; di Uccio, Fortunato Scotto; Tamburino, Corrado; Tarantini, Giuseppe; Urbinati, Stefano; Vairo, Ugo; Varbella, Ferdinando; Zito, Giovanni Battista; Zuin, Guerrino

2018-01-01

Abstract Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the cornerstone of pharmacologic management of patients with acute coronary syndrome (ACS) and/or those receiving coronary stents. Long-term (>1 year) DAPT may further reduce the risk of stent thrombosis after a percutaneous coronary intervention (PCI) and may decrease the occurrence of non-stent-related ischaemic events in patients with ACS. Nevertheless, compared with aspirin alone, extended use of aspirin plus a P2Y12 receptor inhibitor may increase the risk of bleeding events that have been strongly linked to adverse outcomes including recurrent ischaemia, repeat hospitalisation and death. In the past years, multiple randomised trials have been published comparing the duration of DAPT after PCI and in ACS patients, investigating either a shorter or prolonged DAPT regimen. Although the current European Society of Cardiology guidelines provide a backup to individualised treatment, it appears to be difficult to identify the ideal patient profile which could safely reduce or prolong the DAPT duration in daily clinical practice. The aim of this consensus document is to review contemporary literature on optimal DAPT duration, and to guide clinicians in tailoring antiplatelet strategies in patients undergoing PCI or presenting with ACS. PMID:29867293

Early Ventricular Tachycardia or Fibrillation in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention and Impact on Mortality and Stent Thrombosis (from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial).

PubMed

Kosmidou, Ioanna; Embacher, Monica; McAndrew, Thomas; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

2017-11-15

The prevalence and impact of early ventricular arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]) occurring before mechanical revascularization for acute ST segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention are poorly understood. We sought to investigate the association between early VT/VF and long-term clinical outcomes using data from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. Among 3,602 patients with STEMI, 108 patients (3.0%) had early VT/VF. Baseline clinical characteristics were similar in patients with versus without early VT/VF. Patients with early VT/VF had shorter symptom-to-balloon times and lower left ventricular ejection fraction and underwent more frequent thrombectomy compared with patients without early VT/VF. Adjusted 3-year rates of all-cause death (15.7% vs 6.5%; adjusted hazard ratio 2.62, 95% confidence interval 1.48 to 4.61, p <0.001) and stent thrombosis (13.7% vs 5.7%; adjusted hazard ratio 2.74, 95% confidence interval 1.52 to 4.93, p <0.001) were significantly higher in patients with early VT/VF compared with patients without early VT/VF. In conclusion, in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, VT/VF occurring before coronary angiography and revascularization in patients with STEMI was strongly associated with increased 3-year rates of death and stent thrombosis. Further investigation into the mechanisms underlying the increased risk of early stent thrombosis in patients with early VT/VF is required. Copyright © 2017 Elsevier Inc. All rights reserved.

One-Year Clinical Outcomes of Patients Presenting With ST-Segment Elevation Myocardial Infarction Caused by Bifurcation Culprit Lesions Treated With the Stentys Self-Apposing Coronary Stent: Results From the APPOSITION III Study.

PubMed

Grundeken, Maik J; Lu, Huangling; Vos, Nicola; IJsselmuiden, Alexander; van Geuns, Robert-Jan; Wessely, Rainer; Dengler, Thomas; La Manna, Alessio; Silvain, Johanne; Montalescot, Gilles; Spaargaren, René; Tijssen, Jan G P; de Winter, Robbert J; Wykrzykowska, Joanna J; Amoroso, Giovanni; Koch, Karel T

2017-08-01

To investigate outcomes in patients with ST-segment elevation myocardial infarction (STEMI) after treatment with the Stentys self-apposing stent (Stentys SAS; Stentys S.A.) for bifurcation culprit lesions. The nitinol, self-expanding Stentys was initially developed as a dedicated bifurcation stent. The stent facilitates a provisional strategy by accommodating its diameter to both the proximal and distal reference diameters and offering an opportunity to "disconnect" the interconnectors, opening the stent toward the side branch. The APPOSITION (a post-market registry to assess the Stentys self-expanding coronary stent in acute myocardial infarction) III study was a prospective, multicenter, international, observational study including STEMI patients undergoing primary percutaneous coronary intervention (PCI) with the Stentys SAS. Clinical endpoints were evaluated and stratified by bifurcation vs non-bifurcation culprit lesions. From 965 patients included, a total of 123 (13%) were documented as having a bifurcation lesion. Target-vessel revascularization (TVR) rates were higher in the bifurcation subgroup (16.4% vs 10.0%; P=.04). Although not statistically significant, other endpoints were numerically higher in the bifurcation subgroup: major adverse cardiac events (MACE; 12.7% vs 8.8%), myocardial infarction (MI; 3.4% vs 1.8%), and definite/probable stent thrombosis (ST; 5.8% vs 3.1%). However, when postdilation was performed, clinical endpoints were similar between bifurcation and non-bifurcation lesions: MACE (8.7% vs 8.4%), MI (1.2% vs 0.7%), and definite/probable ST (3.7% vs 2.4%). The use of the Stentys SAS was safe and feasible for the treatment of bifurcation lesions in the setting of primary PCI for STEMI treatment with acceptable 1-year cardiovascular event rates, which improved when postdilation was performed.

Three-month evaluation of strut healing using a novel optical coherence tomography analytical method following bioresorbable polymer everolimus-eluting stent implantation in humans: the TIMELESS study.

PubMed

Vesga, Boris; Hernandez, Hector; Moncada, Miguel; Gasior, Pawel; Higuera, Sergio; Dager, Antonio; Arana, Camilo; Delgado, Juan A; Généreux, Philippe; Maehara, Akiko; Granada, Juan F

2017-03-01

Bioresorbable polymer drug-eluting stent technologies have been considered to have the potential to enhance vascular healing by reducing polymer exposure to the vessel wall, potentially allowing the earlier discontinuation of dual antiplatelet therapy. At present, the early vascular healing response to this type of technologies is still unclear. The TIMELESS study is a multicenter, prospective, single-arm study that enrolled real-world patients undergoing percutaneous coronary intervention. All patients underwent Synergy stent implantation, which consists of a platinum-chromium platform coated with an ultra-thin abluminal bioabsorbable poly-D,L-lactide-co-glycolide polymer-eluting everolimus. A total of 37 patients were included in the study. The majority of the patients underwent percutaneous coronary intervention because of acute coronary syndromes. At 3 months, angiographic follow-up showed a percentage diameter of stenosis of 8.1±7.5% and an angiographic late loss of 0.03±0.24 mm. In all analyzed struts, less than 1% of struts were definitely uncovered or covered with fibrin, 12.5% (5.0-18.5%) showed evidence of partial coverage, and the remaining (∼85%) were fully covered. No stent thrombosis was observed up to 12 months of clinical follow-up. In a real-world population, the implantation of a bioresorbable polymer drug-eluting stent resulted in almost complete strut coverage throughout the entire stent length at 3 months. The clinical implications for antiplatelet therapy and outcomes should be investigated further.

Drug-eluting coronary stents – focus on improved patient outcomes

PubMed Central

Jaffery, Zehra; Prasad, Amit; Lee, John H; White, Christopher J

2011-01-01

The development of stent has been a major advance in the treatment of obstructive coronary artery disease since the introduction of balloon angioplasty. Subsequently, neointimal hyperplasia within the stent leading to in-stent restenosis emerged as a major obstacle in long-term success of percutaneous coronary intervention. Recent introduction of drug-eluting stents is a major breakthrough to tackle this problem. This review article summarizes stent technology, reviews progress of drug-eluting stents and discusses quality of life, patient satisfaction, and acceptability of percutaneous coronary intervention. PMID:22915977

A Bumpy and Winding but Right Path to Domestic Drug-Eluting Coronary Stents

PubMed Central

Cho, Jae Yeong; Ahn, Youngkeun

2013-01-01

Restenosis and stent thrombosis remain major concerns after percutaneous coronary intervention for the treatment of coronary artery disease. The present review was undertaken in order to highlight the various coronary stents that have been investigated in our Heart Research Center, and how far we have come from the first heparin-coated stent first used in the late 1990s. Thereafter, from the abciximab-coated stent to the current gene-delivery stent and other newer agents, our group has applied a range of techniques in this field. However, in groups similar to ours, the restenosis rates of such stents are still high for second-generation drug-eluting stents (DESs). Moreover, our nation imports almost all of these types of stents from other countries. Thus, we need to develop domestic coronary stents. Research into newer DESs are warranted in Korea so as to achieve improved safety and efficacy outcomes. PMID:24255648

[Successful correction with stent-graft of coronary artery rupture after angioplasty].

PubMed

Demin, V V

2003-01-01

Rupture and perforation of coronary arteries complicate in average 0.5% of radiosurgical coronary interventions and often are accompanied by serious consequences and high mortality. According to-type of coronary perforation different methods of correction are used, ranging from conservative measures to urgent cardiosurgical interventions. Coronary stent-grafts with 'sandwich' type of construction ore composed from two metal stents and PTFE layer between them. Development of such stents enabled effective radioguided endovascular repair of coronary ruptures. The paper presents the first Russian experience of stout-graft implantation for coronary artery rupture occurred during direct stenting of proximal anterior descending artery and balloon angioplasty in distal segment. The rupture occurred probably because of wall fragility between affected segment and muscular bridge. Stent-graft JoStent 16 mm in length connected with 3-mm balloon was implanted with subsequent complete restitution of blood flow, resolution of pain syndrome and ECG normalization. Echocardiography in operative theatre and one day after surgery showed no intrapericardial fluid. Stent-graft devices for urgent implantation in cases of coronary rupture must be included into obligatory equipment of radiosurgical facilities.

Extended use of the GuideLiner in complex coronary interventions.

PubMed

Chan, Pak Hei; Alegria-Barrero, Eduardo; Foin, Nicholas; Paulo, Manuel; Lindsay, Alistair C; Viceconte, Nicola; Di Mario, Carlo

2015-07-01

Challenging coronary anatomies including chronic total occlusions (CTO), extreme vessel tortuosity, diseased bypass grafts, and anomalous coronary arteries pose difficulties in coronary interventions. The GuideLiner is a monorail catheter originally developed to facilitate delivery of stents to target lesions in tortuous vessels. We conducted a study on the feasibility and safety of utilising this catheter in a wider array of complex coronary interventions. Consecutive patients undergoing coronary or peripheral interventions where a GuideLiner was used were recruited into this study. Patient demographics, lesion and vessel characteristics, procedural details and outcomes were prospectively entered into our database and analysed. From September 2009 to October 2011, 54 consecutive patients underwent coronary intervention in our institution using a GuideLiner; 21 out of 54 coronary applications were motivated by the need to increase support to cross CTOs, predominantly of the RCA. Anomalous or angulated take-off of the treatment vessels (31%), previously deployed proximal stents (15%), heavy proximal calcification (9%) and tortuosity (7%) accounted for the remaining reasons. One patient had successful renal denervation with the aid of a GuideLiner catheter. Procedural success was 98% in our series with no device-related periprocedural complications such as ostial dissection or myocardial necrosis. The use of a GuideLiner facilitates the approach to complex coronary interventions including chronic total occlusion and saphenous vein graft intervention by providing greater back-up support and easier engagement of coronary ostia.

Real-World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy.

PubMed

Lee, Michael S; Shlofmitz, Evan; Kaplan, Barry; Alexandru, Dragos; Meraj, Perwaiz; Shlofmitz, Richard

2016-08-01

We evaluated the safety and efficacy of orbital atherectomy in real-world patients with severe coronary artery calcification (CAC). The presence of severe CAC increases the complexity of percutaneous coronary intervention as it may impede stent delivery and optimal stent expansion. Atherectomy may be an indispensable tool for uncrossable or undilatable lesions by modifying severe CAC. Although the ORBIT I and II trials report that orbital atherectomy was safe and effective for the treatment of severe CAC, patients with kidney disease, recent myocardial infarction, long diffuse disease, severe left ventricular dysfunction, and unprotected left main disease were excluded. This retrospective study included 458 consecutive patients with severe CAC who underwent orbital atherectomy followed by stenting from October 2013 to December 2015 at 3 centers. The primary endpoint of major adverse cardiac and cerebrovascular events at 30 days was 1.7%. Low rates of 30-day all-cause mortality (1.3%), myocardial infarction (1.1%), target vessel revascularization (0%), stroke (0.2%), and stent thrombosis (0.9%) were observed. Angiographic complications were low: perforation was 0.7%, dissection 0.9%, and no-reflow 0.7%. Emergency coronary artery bypass graft surgery was performed in 0.2% of patients. In the largest real-world study of patients who underwent orbital atherectomy, including high-risk patients who were not surgical candidates as well as those with very complex coronary anatomy, acute and short-term adverse clinical event rates were low. A randomized clinical trial is needed to identify the ideal treatment strategy for patients with severe CAC. © 2016 The Authors. Journal of Interventional Cardiology Published by Wiley Periodicals, Inc.

Drug- and Gene-eluting Stents for Preventing Coronary Restenosis

PubMed Central

Lekshmi, Kamali Manickavasagam; Che, Hui-Lian; Cho, Chong-Su

2017-01-01

Coronary artery disease (CAD) has been reported to be a major cause of death worldwide. Current treatment methods include atherectomy, coronary angioplasty (as a percutaneous coronary intervention), and coronary artery bypass. Among them, the insertion of stents into the coronary artery is one of the commonly used methods for CAD, although the formation of in-stent restenosis (ISR) is a major drawback, demanding improvement in stent technology. Stents can be improved using the delivery of DNA, siRNA, and miRNA rather than anti-inflammatory/anti-thrombotic drugs. In particular, genes that could interfere with the development of plaque around infected regions are conjugated on the stent surface to inhibit neointimal formation. Despite their potential benefits, it is necessary to explore the various properties of gene-eluting stents. Furthermore, multifunctional electronic stents that can be used as a biosensor and deliver drug- or gene-based on physiological condition will be a very promising way to the successful treatment of ISR. In this review, we have discussed the molecular mechanism of restenosis, the use of drug- and gene-eluting stents, and the possible roles that these stents have in the prevention and treatment of coronary restenosis. Further, we have explained how multifunctional electronic stents could be used as a biosensor and deliver drugs based on physiological conditions. PMID:28184335

[Magnetic resonance compatibility research for coronary mental stents].

PubMed

Wang, Ying; Liu, Li; Wang, Shuo; Shang, Ruyao; Wang, Chunren

2015-01-01

The objective of this article is to research magnetic resonance compatibility for coronary mental stents, and to evaluate the magnetic resonance compatibility based on laboratory testing results. Coronary stents magnetic resonance compatibility test includes magnetically induced displacement force test, magnetically induced torque test, radio frequency induced heating and evaluation of MR image. By magnetic displacement force and torque values, temperature, and image distortion values to determine metal coronary stent demagnetization effect. The methods can be applied to test magnetic resonance compatibility for coronary mental stents and evaluate its demagnetization effect.

Auxetic coronary stent endoprosthesis: fabrication and structural analysis.

PubMed

Amin, Faisal; Ali, Murtaza Najabat; Ansari, Umar; Mir, Mariam; Minhas, Muhammad Asim; Shahid, Wakeel

2015-07-04

Cardiovascular heart disease is one of the leading health issues in the present era and requires considerable health care resources to prevent it. The present study was focused on the development of a new coronary stent based on novel auxetic geometry which enables the stent to exhibit a negative Poisson's ratio. Commercially available coronary stents have isotropic properties, whereas the vascular system of the body shows anisotropic characteristics. This results in a mismatch between anisotropic-isotropic properties of the stent and arterial wall, and this in turn is not favorable for mechanical adhesion of the commercially available coronary stents with the arterial wall. It is believed that an auxetic coronary stent with inherent anisotropic mechanical properties and negative Poisson's ratio will have good mechanical adhesion with the arterial wall. The auxetic design was obtained via laser cutting, and surface treatment was performed with acid pickling and electropolishing, followed by an annealing process. In vitro mechanical analysis was performed to analyze the mechanical performance of the auxetic coronary stent. Scanning electronic microscopy (SEM) was used to determine the effects of fabrication processes on the topography of the auxetic stent. The elastic recoil (3.3%) of the in vitro mechanical analysis showed that the auxetic stent design effectively maintained the luminal patency of the coronary artery. Also, the auxetic coronary stent showed no foreshortening, therefore it avoids the problem of stent migration, by expanding in both the radial and longitudinal directions. By virtue of its synclastic behavior, the auxetic stent bulges outward when it is radially expanded through an inflated balloon.

Onset and extent of platelet inhibition by clopidogrel loading in patients undergoing elective coronary stenting: the Plavix Reduction Of New Thrombus Occurrence (PRONTO) trial.

PubMed

Gurbel, Paul A; Cummings, Charles C; Bell, Christopher R; Alford, Amanda B; Meister, Andrew F; Serebruany, Victor L

2003-02-01

Despite the common practice of clopidogrel loading for coronary stenting, the time dependence and degree of platelet inhibition after this therapy are not well defined. We sought to establish an optimal clopidogrel dosing regimen for sustained platelet inhibition in stented patients. Platelets were assessed by conventional aggregation with 5 micromol/L adenosine diphosphate (ADP), 1 microg/mL collagen (COLL), and 750 micromol/L arachidonic acid; whole blood aggregation by 1 microg/mL collagen (WBA); shear-induced closure time (CT); contractile force (CF); and expression of 9 surface receptors by flow cytometry in 100 patients undergoing elective stent placement without glycoprotein (GP) IIb/IIIa receptor antagonists. Blood was obtained at baseline and serially over 5 days poststenting after different clopidogrel loading regimens: 300 mg 24 hours before (Group A), 12 hours before (Group B), 3 to 6 hours before (Group C), and 75 mg at the time of intervention (Group D). Before stenting, ADP, COLL, CT, and WBA were reduced by clopidogrel loading (P <.05). CF was not affected by clopidogrel. Before stenting, GP IIb/IIIa expression increased in groups A through C (P <.05), whereas PECAM-1 and CD107a were reduced (P <.05). At 2 hours and 2 days poststenting, platelets, in general, exhibited an increase in activity that was most inhibited by clopidogrel loading. Clopidogrel inhibited GP Ib, platelet/endothelial cell adhesion molecule-1, CD 107a, CD 151, and GP IIb/IIIa expression at day 5 poststenting. A 300 mg clopidogrel load given 3 to 24 hours before stenting inhibits platelets at the time of the procedure and reduces poststent activity more than a 75 mg dose given at the time of the procedure. The inhibition of adhesive molecule expression may also contribute an antithrombotic effect. Poststent activation of platelets may warrant higher periprocedural dosing.

Coronary In-Stent Restenosis: Assessment with Corrected Coronary Opacification Difference across Coronary Stents Measured with CT Angiography.

PubMed

Gao, Yang; Lu, Bin; Hou, Zhi Hui; Yu, Fang Fang; Yin, Wei Hua; Wang, Zhi Qiang; Wu, Yong Jian; Mu, Chao Wei; Meinel, Felix G; McQuiston, Andrew D; Schoepf, U Joseph

2015-05-01

To determine whether changes in coronary opacification normalized to the aorta (corrected coronary opacification [CCO]) across stents can help identify in-stent restenosis (ISR) severity with use of invasive coronary angiography as the standard of reference. This study was approved by the institutional review board, and the requirement to obtain informed consent was waived. The authors retrospectively analyzed 106 patients (88 men, 18 women; mean age, 59.6 years ± 10.4; age range, 36-84 years) who had previously undergone stent implantation within 3 months of coronary computed tomographic (CT) angiography. Attenuation values in the coronary lumen were measured proximal and distal to the stents and normalized to the descending aorta. The CCO difference across the stent was compared with the severity of ISR. One-way analysis of variance least significant difference was used for comparison. A total of 141 stents were assessed. Seventy-six stents were normally patent, 18 had ISR of less than 50%, 28 had ISR of 50%-99%, and 19 were fully occluded. The median CCO differences in the four groups were 0.078, 0.163, 0.346, and 0.606, respectively. There was no significant difference between stents with an ISR of at least 50% and those with total occlusion (P = .056), although the other groups had significant differences at pairwise comparison (P < .01 for all). For stents smaller than 3 mm in diameter, the median CCO differences in the four groups were 0.086, 0.136, 0.390, and 0.471, respectively. The CCO differences across normal stents and stents with ISR of less than 50% were significantly less than those across stents with an ISR of at least 50% and those with total occlusion (P < .01 for all). There were no significant differences between stents with no ISR and those with an ISR of less than 50% (P = .821) and between stents with an ISR of at least 50% and those with an ISR of 100% (P = .836). The CCO difference across coronary stents is related to ISR severity in obstructive ISR in stents smaller than 3 mm in diameter. © RSNA, 2014.

Late adverse events after implantation of sirolimus-eluting stent and bare-metal stent: long-term (5-7 years) follow-up of the Coronary Revascularization Demonstrating Outcome study-Kyoto registry Cohort-2.

PubMed

Natsuaki, Masahiro; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Yamaji, Kyohei; Ando, Kenji; Shizuta, Satoshi; Shiomi, Hiroki; Tada, Tomohisa; Tazaki, Junichi; Kato, Yoshihiro; Hayano, Mamoru; Abe, Mitsuru; Tamura, Takashi; Shirotani, Manabu; Miki, Shinji; Matsuda, Mitsuo; Takahashi, Mamoru; Ishii, Katsuhisa; Tanaka, Masaru; Aoyama, Takeshi; Doi, Osamu; Hattori, Ryuichi; Kato, Masayuki; Suwa, Satoru; Takizawa, Akinori; Takatsu, Yoshiki; Shinoda, Eiji; Eizawa, Hiroshi; Takeda, Teruki; Lee, Jong-Dae; Inoko, Moriaki; Ogawa, Hisao; Hamasaki, Shuichi; Horie, Minoru; Nohara, Ryuji; Kambara, Hirofumi; Fujiwara, Hisayoshi; Mitsudo, Kazuaki; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

2014-04-01

Late adverse events such as very late stent thrombosis (VLST) or late target-lesion revascularization (TLR) after first-generation sirolimus-eluting stents (SES) implantation have not been yet fully characterized at long term in comparison with those after bare-metal stent (BMS) implantation. Among 13 058 consecutive patients undergoing first percutaneous coronary intervention in the Coronary REvascularization Demonstrating Outcome study-Kyoto registry Cohort-2, 5078 patients were treated with SES only, and 5392 patients were treated with BMS only. During 7-year follow-up, VLST and late TLR beyond 1 year after SES implantation occurred constantly and without attenuation at 0.24% per year and at 2.0% per year, respectively. Cumulative 7-year incidence of VLST was significantly higher in the SES group than that in the BMS group (1.43% versus 0.68%, P<0.0001). However, there was no excess of all-cause death beyond 1 year in the SES group as compared with that in the BMS group (20.8% versus 19.6%, P=0.91). Cumulative incidences of late TLR (both overall and clinically driven) were also significantly higher in the SES group than in the BMS group (12.0% versus 4.1%, P<0.0001 and 8.5% versus 2.6%, P<0.0001, respectively), leading to late catch-up of the SES group to the BMS group regarding TLR through the entire 7-year follow-up (18.8% versus 25.2%, and 10.6% versus 10.2%, respectively). Clinical presentation as acute coronary syndrome was more common at the time of late SES TLR compared with early SES TLR (21.2% and 10.0%). Late catch-up phenomenon regarding stent thrombosis and TLR was significantly more pronounced with SES than that with BMS. This limitation should remain the target for improvements of DES technology.

Angioplasty and stent placement - heart

MedlinePlus

PCI; Percutaneous coronary intervention; Balloon angioplasty; Coronary angioplasty; Coronary artery angioplasty; Percutaneous transluminal coronary angioplasty; Heart artery dilatation; Angina - stent placement; Acute coronary ...

The conical stent in coronary artery improves hemodynamics compared with the traditional cylindrical stent.

PubMed

Yu, Yi; Zhou, Yujie; Ma, Qian; Jia, Shuo; Wu, Sijing; Sun, Yan; Liu, Xiaoli; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei

2017-01-15

This study sought to explore the efficacy of the conical stent implantation in the coronary artery by comparing the effects of cylindrical and conical stents on wall shear stress (WSS) and velocity of flow and fractional flow reserve (FFR). The traditional cylindrical stent currently used in the percutaneous coronary intervention (PCI) has a consistent diameter, which does not match the physiological change of the coronary artery. On the contrary, as a new patent, the conical stent with tapering lumen is consistent with the physiological change of vascular diameter. However, the effect of the conical stent implantation on the coronary hemodynamics remains unclear. The coronary artery, artery stenosis and two stent models were established by Solidworks software. All models were imported into the computational fluid dynamics (CFD) software ANSYS ICEM-CFD to establish the fluid model. After the boundary conditions were set, CFD analysis was proceeded to compare the effects of two stent implantation on the change of WSS, velocity of flow and FFR. Hemodynamic indexes including FFR, blood flow velocity distribution (BVD) and WSS were improved by either the cylindrical or the conical stent implantation. However, after the conical stent implantation, the change of FFR seemed to be slower and more homogenous; the blood flow velocity was more appropriate without any obvious blood stagnation and direction changes; the WSS after the conical stent implantation was uniform from the proximal to distal side of the stent. Compared with the cylindrical stent, the conical stent implantation in the coronary artery can make the changes of vascular hemodynamic more closer to the physiological condition, which can reduce the incidence of intra-stent restenosis and thrombosis, thus making it more suitable for PCI therapy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

First in vivo head-to-head comparison of high-definition versus standard-definition stent imaging with 64-slice computed tomography.

PubMed

Fuchs, Tobias A; Stehli, Julia; Fiechter, Michael; Dougoud, Svetlana; Sah, Bert-Ram; Gebhard, Cathérine; Bull, Sacha; Gaemperli, Oliver; Kaufmann, Philipp A

2013-08-01

The aim of this study was to compare image quality characteristics from 64-slice high definition (HDCT) versus 64-slice standard definition CT (SDCT) for coronary stent imaging. In twenty-five stents of 14 patients, undergoing contrast-enhanced CCTA both on 64-slice SDCT (LightSpeedVCT, GE Healthcare) and HDCT (Discovery HD750, GE Healthcare), radiation dose, contrast, noise and stent characteristics were assessed. Two blinded observers graded stent image quality (score 1 = no, 2 = mild, 3 = moderate, and 4 = severe artefacts). All scans were reconstructed with increasing contributions of adaptive statistical iterative reconstruction (ASIR) blending (0, 20, 40, 60, 80 and 100 %). Image quality was significantly superior in HDCT versus SDCT (score 1.7 ± 0.5 vs. 2.7 ± 0.7; p < 0.05). Image noise was significantly higher in HDCT compared to SDCT irrespective of ASIR contributions (p < 0.05). Addition of 40 % ASIR or more reduced image noise significantly in both HDCT and SDCT. In HDCT in-stent luminal attenuation was significantly lower and mean measured in-stent luminal diameter was significantly larger (1.2 ± 0.4 mm vs. 0.8 ± 0.4 mm; p < 0.05) compared to SDCT. Radiation dose from HDCT was comparable to SDCT (1.8 ± 0.7 mSv vs. 1.7 ± 0.7 mSv; p = ns). Use of HDCT for coronary stent imaging reduces partial volume artefacts from stents yielding improved image quality versus SDCT at a comparable radiation dose.

Preprocedural C-Reactive Protein Predicts Outcomes after Primary Percutaneous Coronary Intervention in Patients with ST-elevation Myocardial Infarction a systematic meta-analysis

NASA Astrophysics Data System (ADS)

Mincu, Raluca-Ileana; Jánosi, Rolf Alexander; Vinereanu, Dragos; Rassaf, Tienush; Totzeck, Matthias

2017-01-01

Risk assessment in patients with acute coronary syndromes (ACS) is critical in order to provide adequate treatment. We performed a systematic meta-analysis to assess the predictive role of serum C-reactive protein (CRP) in patients with ST-segment elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI). We included 7 studies, out of 1,033 studies, with a total of 6,993 patients with STEMI undergoing PPCI, which were divided in the high or low CRP group, according to the validated cut-off values provided by the corresponding CRP assay. High CRP values were associated with increased in-hospital and follow-up all-cause mortality, in-hospital and follow-up major adverse cardiac events (MACE), and recurrent myocardial infarction (MI). The pre-procedural CRP predicted in-hospital target vessel revascularization (TVR), but was not associated with acute/subacute and follow-up in-stent restenosis (ISR), and follow-up TVR. Thus, pre-procedural serum CRP could be a valuable predictor of global cardiovascular risk, rather than a predictor of stent-related complications in patients with STEMI undergoing PPCI. This biomarker might have the potential to improve the management of these high-risk patients.

Deep intubation of 8 Fr guiding catheter to deliver coronary stent graft to seal coronary perforation: a case report.

PubMed

Salwan, R; Mathur, A; Jhamb, D K; Seth, A

2001-09-01

Coronary perforation is an uncommon complication of angioplasty and is a challenging situation to manage. We describe a case of complex multivessel coronary angioplasty complicated by coronary perforation following balloon rupture that was successfully managed with a coronary stent graft. Delivery of the stent graft to the site of vessel rupture required deep intubation of an 8 Fr guiding catheter over the shaft of an inflated balloon. In addition to the availability of covered stents, it is essential to be familiar with various skills necessary to deploy these stents. Cathet Cardiovasc Intervent 2001;54:59-62. Copyright 2001 Wiley-Liss, Inc.

[Immediate and Long-term Results of the First in Russia of IntrocoronaryMetal Stent in the Coronary Artery].

PubMed

Babunashvili, A M; Navtsishvili, Z G; Konstantinov, B A

2016-02-01

The authors present immediate and long term results of the first in Russia implantation in coronary artery of Palmaz-Shatz metal stent. Indications for stenting were urgent after complicated dissection as a result of balloon dilation of discrete bifurcational stenosis of anterior interventricular artery (IVA). Immediate angiographic and clinical result was good. At control angiography after 13 years their was no restenosis in stented IVA. However novel narrowing was found in left main coronary artery (LMCA) in which drug eluting stent was implanted. Coronary angiography carried out after 7.5 years after stenting of LMCA and in 20 years after stent implantation in IVA revealed good patency of both stented segments without signs of restenosis. This case report demonstrates possibility of long term preservation of angiographic and clinical effect of staged endovascular treatment of coronary atherosclerosis.

Nickel-free stainless steel avoids neointima formation following coronary stent implantation

PubMed Central

Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

2012-01-01

SUS316L stainless steel and cobalt–chromium and platinum–chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N2-gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni2+ increased levels of hypoxia inducible factor protein-1α (HIF-1α) and its target genes in cultured smooth muscle cells. HIF-1α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform. PMID:27877545

Nickel-free stainless steel avoids neointima formation following coronary stent implantation.

PubMed

Fujiu, Katsuhito; Manabe, Ichiro; Sasaki, Makoto; Inoue, Motoki; Iwata, Hiroshi; Hasumi, Eriko; Komuro, Issei; Katada, Yasuyuki; Taguchi, Tetsushi; Nagai, Ryozo

2012-12-01

SUS316L stainless steel and cobalt-chromium and platinum-chromium alloys are widely used platforms for coronary stents. These alloys also contain nickel (Ni), which reportedly induces allergic reactions in some subjects and is known to have various cellular effects. The effects of Ni on neointima formation after stent implantation remain unknown, however. We developed coronary stents made of Ni-free high-nitrogen austenitic stainless steel prepared using a N 2 -gas pressurized electroslag remelting (P-ESR) process. Neointima formation and inflammatory responses following stent implantation in porcine coronary arteries were then compared between the Ni-free and SUS316L stainless steel stents. We found significantly less neointima formation and inflammation in arteries implanted with Ni-free stents, as compared to SUS316L stents. Notably, Ni 2+ was eluted into the medium from SUS316L but not from Ni-free stainless steel. Mechanistically, Ni 2+ increased levels of hypoxia inducible factor protein-1 α (HIF-1 α ) and its target genes in cultured smooth muscle cells. HIF-1 α and their target gene levels were also increased in the vascular wall at SUS316L stent sites but not at Ni-free stent sites. The Ni-free stainless steel coronary stent reduces neointima formation, in part by avoiding activation of inflammatory processes via the Ni-HIF pathway. The Ni-free-stainless steel stent is a promising new coronary stent platform.

Advances in drug eluting stents – focus on the Endeavor® zotarolimus stent

PubMed Central

Bridges, Jonathan; Cutlip, Donald

2009-01-01

Coronary artery disease remains one of the leading causes of death in the United States. Over the last 30 years, the development of coronary artery angioplasty and stenting has drastically reduced mortality during acute coronary syndromes while also reducing symptoms of chronic coronary artery disease. Unfortunately, the placement of stents in a coronary artery can be complicated by in-stent thrombosis or restenosis. In 2003–2004, a new generation of stents was introduced to the market with the goal of reducing the rate of restenosis. These stents, called drug eluting stents (DES), are coated with a pharmacological agent designed to reduce the neointimal hyperplasia associated with restenosis. Within a year, approximately 80% of all percutaneous coronary interventions performed within the US involved placement of a DES. In 2006, a controversy arose about the possibility of a statistically significant increased risk of acute stent thrombosis associated with DES especially when used for an “off label” indication. This risk was attributed to delayed endothelization. This controversy has led to a reduction in the use of DES along with longer use of dual platelet inhibition with aspirin and clopidogrel. Recently Medtronic introduced a new DES to the market called the Endeavor® stent – a zotarolimus eluting stent. PMID:22915908

Stent Thrombosis With Drug-Eluting Stents and Bioresorbable Scaffolds: Evidence From a Network Meta-Analysis of 147 Trials.

PubMed

Kang, Si-Hyuck; Chae, In-Ho; Park, Jin-Joo; Lee, Hak Seung; Kang, Do-Yoon; Hwang, Seung-Sik; Youn, Tae-Jin; Kim, Hyo-Soo

2016-06-27

This study sought to perform a systematic review and network meta-analysis to compare the relative safety and efficacy of contemporary DES and BVS. To improve outcomes of patients undergoing percutaneous coronary revascularization, there have been advances in the design of drug-eluting stents (DES), including the development of drug-eluting bioresorbable vascular scaffolds (BVS). Prospective, randomized, controlled trials comparing bare-metal stents (BMS), paclitaxel-eluting stents (PES), sirolimus-eluting stents (SES), Endeavor zotarolimus-eluting stents (E-ZES), cobalt-chromium (CoCr) everolimus-eluting stents (EES), platinum-chromium (PtCr)-EES, biodegradable polymer (BP)-EES, Resolute zotarolimus-eluting stents (R-ZES), BP biolimus-eluting stents (BP-BES), hybrid sirolimus-eluting stents (H [Orsiro]-SES), polymer-free sirolimus- and probucol-eluting stents, or BVS were searched in online databases. The primary endpoint was definite or probable stent thrombosis at 1 year. A total of 147 trials including 126,526 patients were analyzed in this study. All contemporary DES were superior to BMS and PES in terms of definite or probable stent thrombosis at 1 year. CoCr-EES, PtCr-EES, and H-SES were associated with significantly lower risk than BVS. CoCr-EES and H-SES were superior to SES and BP-BES. The risk of myocardial infarction was significantly lower with H-SES than with BVS. There were no significant differences regarding all-cause or cardiac mortality. Contemporary devices including BVS showed comparably low risks of repeat revascularization. Contemporary DES, including biocompatible DP-DES, BP-DES, and polymer-free DES, showed a low risk of definite or probable stent thrombosis at 1 year. BVS had an increased risk of device thrombosis compared with CoCr-EES, PtCr-EES, and H-SES. Data from extended follow-up are warranted to confirm the long-term safety of contemporary coronary devices. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Biodegradable Polymer Biolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With Coronary Artery Disease: Final 5-Year Report From the COMPARE II Trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent).

PubMed

Vlachojannis, Georgios J; Smits, Pieter C; Hofma, Sjoerd H; Togni, Mario; Vázquez, Nicolás; Valdés, Mariano; Voudris, Vassilis; Slagboom, Ton; Goy, Jean-Jaques; den Heijer, Peter; van der Ent, Martin

2017-06-26

This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17). The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial.

PubMed

Roguin, Ariel; Camenzind, Edoardo; Kerner, Arthur; Beyar, Rafael; Boersma, Eric; Mauri, Laura; Steg, Ph Gabriel; Wijns, William

2017-03-27

This study sought to compare the outcomes of patients undergoing drug-eluting stent implantation according to lesion location within or outside the proximal left anterior descending (LAD) artery. Proximal LAD artery involvement is considered uniquely in revascularization guidelines. The impact of LAD lesion location on long-term outcomes after revascularization is poorly understood in context of current percutaneous coronary intervention and medical therapy. Among 8,709 patients enrolled in PROTECT (Patient Related Outcomes with Endeavor Versus Cypher Stenting Trial), a multicenter percutaneous coronary intervention trial, we compared the outcomes of 2,534 patients (29.1%) (3,871 lesions [31.5%]) with stents implanted in the proximal LAD to 6,172 patients (70.9%) (8,419 lesions [68.5%]) with stents implanted outside the proximal LAD. At the 4-year follow-up, death rates were the same (5.8% vs. 5.8%; p > 0.999), but more myocardial infarctions occurred in the proximal LAD group (6.2% vs. 4.9%; p = 0.015). The rate of clinically driven target vessel failure (TVF) (14.8% vs. 13.5%; p = 0.109), major adverse cardiac event(s) (MACE) (15.0% vs. 13.7%; hazard ratio: 1.1; 95% confidence interval: 0.97 to 1.31; p = 0.139), and stent thrombosis (2.1% vs. 2.0%; p = 0.800) were similar. Drug-eluting stent type had no interaction with MACE or TVF. In multivariate analysis, the proximal LAD was a predictor of myocardial infarction (p = 0.038) but not of TVF (p = 0.149) or MACE (p = 0.069). In this study of contemporary percutaneous coronary intervention, proximal LAD location was associated with higher rates of myocardial infarction during the long-term follow-up, but there were no differences in stent thrombosis, death, TVF, or overall MACE. This finding may suggest that, in the drug-eluting stent era, proximal LAD no longer confers a different prognosis than other lesion sites. (Randomized Study Comparing Endeavor With Cypher Stents [PROTECT]; NCT00476957). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Enhancement of endothelialisation of coronary stents by laser surface engineering.

PubMed

Li, Lin; Mirhosseini, Nazanin; Michael, Alun; Liu, Zhu; Wang, Tao

2013-11-01

Coronary stents have been widely used in the treatment of coronary heart disease. However, complications have hampered the long-term success of the device. Bare-metal stents (BMS) have a high rate of restenosis and poor endothelialisation. The drug-eluting stents (DES), although dramatically reduce restenosis, significantly prevent endothelialisation leading to late thrombosis and behave the same way as BMS after drug releasing. Rapid adhesion and growth of endothelial cells on the stent surface is a key process for early vascular healing after coronary stenting which contributes to the reduction of major complications. Surface properties manipulate cell growth and directly determine the success and life-span of the implants. However, the ideal surface properties of coronary stents are not yet fully understood. The objective of this research is to understand how surface micro/nano textures and associated material chemistry changes generated by a laser beam affect the behavior of endothelial cells on bare metal 316L stents. A high power laser beam was applied to modifying the surface properties of 316L coronary stent material and the commercial coronary stents, followed by examination of the adhesion and proliferation of human coronary endothelial cells that were growing on the surfaces. Surface properties were examined by scanning electron microscopy, contact angle measurement, and X-ray photoelectron spectroscopy. A novel surface with combined micro/nano features was created on stent material 316L and coronary stent with a specific surface chemistry. This surface gives rise to a threefold increase in the adhesion and eightfold increase in the proliferation of endothelial cells. Interestingly, such effects were only observed when the surface texture was produced in the nitrogen atmosphere suggesting the importance of the surface chemistry, including the dramatic increase of chromium nitride, for the interaction of endothelial cells with the material surface. This novel surface is also super-hydrophilic with close to zero water/cell culture fluid contact angles and low cytotoxicity. A novel surface created by laser surface-engineering with a combination of defined surface texture and surface chemistry was found beneficial for the improvement of coronary stent endothelialisation. The technology presented here could work with both DES and BMS with added benefit for the improvement of the biocompatibility of current coronary stents. © 2013 Wiley Periodicals, Inc.

Comparison of in-hospital and follow-up results of directional atherectomy and stenting for ostial lesions of the left anterior descending coronary artery.

PubMed

Gambhir, D S; Batra, R; Singh, S; Sudha, R; Trehen, V; Arora, R

1998-01-01

Lesions at the ostium of the left anterior descending coronary artery constitute a distinct group because of suboptimal results and higher restenosis rate after balloon angioplasty. Several non-balloon devices have been used to improve the outcome of dilatation of such lesions. We retrospectively compared the in-hospital and follow-up results of directional coronary artherectomy and stents for the treatment of ostial lesions of the left anterior descending artery. Out of 37 patients, 12 underwent directional coronary atherectomy and 25, stent implantation. The two strategies were deployed at different periods over the past five years. The baseline clinical and angiographic characteristics were comparable in the two groups. Directional coronary atherectomy was done using 7Fr atherocath with adjunctive balloon angioplasty in all. All the stents were deployed using moderate to high pressure balloon inflation after adequate predilatation. While the pre-procedure luminal diameter stenosis was similar in the two groups (87.3 +/- 8.8% vs 89.3 +/- 7.2%; p = NS), the residual stenosis was significantly lower in the stent group (5 +/- 2.8%) compared to directional coronary atherectomy (18.7 +/- 9.8; p = 0.02). There was no significant difference in the primary success rate between the two devices (91.6% directional coronary atherectomy vs 100% stent; p = NS). One patient in the directional coronary atherectomy group developed acute closure followed by emergency coronary artery bypass graft surgery and death. No major complication was observed in the stent group. Over a mean follow-up of 9.9 +/- 11.6 months following directional coronary atherectomy and 8.6 +/- 4.4 months after stenting, significantly higher number of patients (60%) developed recurrence of angina or any event following directional coronary atherectomy compared to stent (15.8%; p < 0.02). There was no myocardial infarction, coronary artery bypass graft surgery or death in either group on follow-up. The need for target lesion revascularisation was significantly higher in the directional coronary atherectomy group (50%) compared to stenting (10.5%; p < 0.02). Comparing directional coronary atherectomy with stent, the event-free survival was 80 percent vs 94.7 percent at three months and 50 percent vs 84.7 percent, both at six and nine months, respectively. In conclusion, stenting of the left anterior descending artery ostial lesion results in a significantly lesser post-procedure residual stenosis, improved in-hospital outcome, a lesser need for target lesion revascularisation and much improved event-free survival on follow-up as compared to directional coronary atherectomy. Therefore, stenting appears to be a more favourable treatment option compared to directional coronary atherectomy for the treatment of ostial lesions in the left anterior descending artery.

Red blood cell distribution width and long-term outcome in patients undergoing percutaneous coronary intervention in the drug-eluting stenting era: a two-year cohort study.

PubMed

Yao, Hai-Mu; Sun, Tong-Wen; Zhang, Xiao-Juan; Shen, De-Liang; Du, You-You; Wan, You-Dong; Zhang, Jin-Ying; Li, Ling; Zhao, Luo-Sha

2014-01-01

Previous studies suggest the higher the red blood cell distribution width (RDW) the greater the risk of mortality in patients with coronary artery disease (CAD). However, the relationship between RDW and long-term outcome in CAD patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) remains unclear. This study was designed to evaluate the long-term effect of RDW in patients treated with drug-eluting stent for CAD. In total of 2169 non-anemic patients (1468 men, mean age 60.2 ± 10.9 years) with CAD who had undergone successful PCI and had at least one drug-eluting stent were included in this study. Patients were grouped according to their baseline RDW: Quartile 1 (RDW<12.27%), Quartile 2 (12.27% ≤ RDW <13%), Quartile 3 (13% ≤ RDW<13.5%), and Quartile 4 (RDW ≥ 13.5). The incidence of in-hospital mortality and death or myocardial infarction was significantly higher in Quartiles 3 and 4 compared with Quartile 1 (P<0.05). After a follow-up of 29 months, the incidence of all-cause death and stent thrombosis in Quartile 4 was higher than in Quartiles 1, 2, and 3 (P<0.05). The incidence of death/myocardial infarction/stroke and cardiac death in Quartile 4 was higher than in Quartiles 1 and 2 (P<0.05). Multivariate Cox regression analysis showed that RDW was an independent predictor of all-cause death (hazard ratio (HR) = 1.37, 95% confidence interval (CI) = 1.15-1.62, P<0.001) and outcomes of death/myocardial infarction/stroke (HR = 1.21, 95% CI = 1.04-1.39, P = 0.013). The cumulative survival rate of Quartile 4 was lower than that of Quartiles 1, 2, and 3 (P<0.05). High RDW is an independent predictor of long-term adverse clinical outcomes in non-anemic patients with CAD treated with DES.

Design and modeling balloon-expandable coronary stent for manufacturability

NASA Astrophysics Data System (ADS)

Suryawan, D.; Suyitno

2017-02-01

Coronary artery disease (CAD) is a disease that caused by narrowing of the coronary artery. The narrowing coronary artery is usually caused by cholesterol-containing deposit (plaque) which can cause a heart attack. CAD is the most common cause mortality in Indonesia. The commonly CAD treatment use the stent to opens or alleviate the narrowing coronary artery. In this study, the stent design is optimized for the manufacturability. Modeling is used to determine the free stent expansion due to applied pressure in the inner surface of the stent. The stress distribution, outer diameter change, and dogboning phenomena are investigated in the simulation. The result of modeling and simulating was analyzed and used to optimize the stent design before it is manufactured using EDM (Electric Discharge Machine) in the next research.

Experimental Evaluation of a New Tubular Coronary Stent (V-Flexª).

PubMed

Shun; Wang; Zhou; Verbeken; Ping; Szilard; Yanming; Jianhua; De Scheerder IK

1998-11-01

The safety, efficacy, angiographic and histological effects of a new 316 L, SS seamless stainless steel tubular stent (V-Flexª, Global Therapeutics, Broomfield, Colorado) was evaluated in a porcine coronary and peripheral artery model. Implantation in the right coronary artery was successful in all 16 pigs. Eight pigs were angiographically controlled after 6 weeks and then sacrificed for morphometric analysis. All stented coronary vessels were widely patent at this moment and morphometric analysis showed only a mild fibromuscular neointimal hyperplasia resulting in a neointimal hyperplasia of 1.15 +/- 0.38 mm2. The remaining 8 pigs were controlled and sacrificed at 12 weeks. At that time, all stented vessels were patent and neointimal hyperplasia was 1.22 +/- 0.34 mm2. Comparison with the Palmaz-Schatzª coronary stent (Cordis, Miami, Florida) in a porcine peripheral artery model demonstrated significantly less neointimal hyperplasia at 6 weeks (1.11 +/- 0.73 vs. 2.40 +/- 0.36, p = 0.001) and at 12 weeks (1.53 +/- 0.42 vs. 2.47 +/- 0.63, p = 0.003) for the V-Flex stent. In conclusion, V-Flex coronary stent implantation in a porcine coronary and peripheral arteries results in a high procedural success rate without subacute thrombotic occlusions, despite no further anticoagulation nor antiplatelet therapy. Six and 12 week histopathological and morphometric evaluation demonstrated only a mild fibromuscular neointimal hyperplasia. Comparison with the Palmaz-Schatz coronary stent in a peripheral artery model showed significantly less neointimal hyperplasia in the V-Flex stent.

Comparison of self-expandable and balloon-expanding stents for hybrid ductal stenting in hypoplastic left heart complex.

PubMed

Goreczny, Sebastian; Qureshi, Shakeel A; Rosenthal, Eric; Krasemann, Thomas; Nassar, Mohamed S; Anderson, David R; Morgan, Gareth J

2017-07-01

We aimed to compare the procedural and mid-term performance of a specifically designed self-expanding stent with balloon-expandable stents in patients undergoing hybrid palliation for hypoplastic left heart syndrome and its variants. The lack of specifically designed stents has led to off-label use of coronary, biliary, or peripheral stents in the neonatal ductus arteriosus. Recently, a self-expanding stent, specifically designed for use in hypoplastic left heart syndrome, has become available. We carried out a retrospective cohort comparison of 69 neonates who underwent hybrid ductal stenting with balloon-expandable and self-expanding stents from December, 2005 to July, 2014. In total, 43 balloon-expandable stents were implanted in 41 neonates and more recently 47 self-expanding stents in 28 neonates. In the balloon-expandable stents group, stent-related complications occurred in nine patients (22%), compared with one patient in the self-expanding stent group (4%). During follow-up, percutaneous re-intervention related to the ductal stent was performed in five patients (17%) in the balloon-expandable stent group and seven patients (28%) in self-expanding stents group. Hybrid ductal stenting with self-expanding stents produced favourable results when compared with the results obtained with balloon-expandable stents. Immediate additional interventions and follow-up re-interventions were similar in both groups with complications more common in those with balloon-expandable stents.

Comparison of symptoms, treatment, and outcomes of coronary artery disease among rheumatoid arthritis and matched subjects undergoing percutaneous coronary intervention.

PubMed

Desai, Sonali P; Januzzi, James L; Pande, Ashvin N; Pomerantsev, Eugene V; Resnic, Frederic S; Fossel, Anne; Chibnik, Lori B; Solomon, Daniel H

2010-12-01

Rheumatoid arthritis (RA) is associated with an increased prevalence of coronary artery disease (CAD). We investigated the presenting symptoms of CAD, coronary anatomy (single versus multi-vessel CAD), and treatment among a group of subjects undergoing percutaneous coronary intervention (PCI) with angioplasty and/or stenting. We evaluated a retrospective cohort of 43 RA subjects and 43 matched non-RA subjects undergoing PCI at 2 academic referral centers. RA subjects were matched to non-RA subjects on age, gender, history of coronary artery bypass grafting, date of PCI, and interventional cardiologist. We compared cardiac risk factors, presentation, treatment, and outcomes. The mean age of the study cohort was 71 ± 10 years, and the distribution of traditional cardiac risk factors was similar in the subjects with RA compared with the matched non-RA subjects (all P values > 0.05). Seventy-four percent of subjects with RA compared with 67% of those without RA presented with an acute coronary syndrome before PCI (P = 0.48). All subjects in this cohort undergoing PCI had at least 1 stenosis in a major epicardial vessel and similar percentages of subjects with RA (44%) and without RA (40%) had multi-vessel CAD (P = 0.66). The administration of cardiac medications both at PCI and at hospital discharge was not different among subjects with RA compared with matched non-RA subjects. Among this cohort with significant CAD undergoing PCI, clinical characteristics, presentation, severity of CAD, treatment modalities, and outcomes were similar in subjects with RA and well-matched non-RA subjects. Copyright © 2010 Elsevier Inc. All rights reserved.

Orbital atherectomy for severely calcified lesions: More dissections in women but similar 30-day outcomes to men.

PubMed

Chandrasekhar, Jaya; Mehran, Roxana

2016-03-01

Calcified lesions are associated with lower rates of successful percutaneous coronary intervention (PCI), greater stent thrombosis, and increased target vessel revascularization. Women undergoing PCI are more often older than men and likely to present with severe lesion calcification. The ORBIT II study, for the first time compares the effect of the orbital atherectomy system (OAS) in men and women undergoing PCI for severely calcified lesions. Although the adjusted risk of severe dissections was higher in women, the incidence of in-hospital and 30-day outcomes was similar to men. Randomized comparisons of the OAS with rotational atherectomy and with stenting without atherectomy are needed to further elucidate sex-based differences in calcified lesion PCI. © 2016 Wiley Periodicals, Inc.

Influence of Prior Coronary Stenting on the Immediate and Mid-term Outcome of Isolated Coronary Artery Bypass Surgery.

PubMed

Pliam, Michael B; Zapolanski, Alex; Anastassiou, Peter; Ryan, Colman J; Manila, Louis L; Shaw, Richard E; Pira, Bob-Kenneth

2007-09-01

: There has been little emphasis on the possible consequences of prior stent placement on the outcome of coronary bypass surgery (CABG). We compared the results of isolated CABG patients who had prior stents with those who had not with respect to preoperative status, operative procedure, and postoperative immediate and long-term outcome. : Records of 1471 patients undergoing isolated CABG at our institution between January 1, 2000, and March 31, 2005, were reviewed. Patients were divided into three groups. Group I had no stents (n = 1317). Group II had one to three stents (n = 137). Group III had more than three stents (n = 17). Groups were compared with respect to preoperative risk factors, operative procedures, and postoperative results. Long-term survival data were obtained on 97.6% of patients with a mean follow-up, 4.1 ± 2.3 years. : Stented patients were younger (66.1 ± 10.8 vs. 69.1 ± 10.8 years, P = 0.006), had more unstable angina (68.2% vs. 58.9%, P = 0.02), hypercholesterolemia (83.8% vs. 61.2%, P = 0.00), chronic obstructive pulmonary disease (13.6% vs. 8.4%, P = 0.03), peripheral vascular disease (15.2% vs. 8.4%, P = 0.00), and previous CABG (10.1% vs. 4.2%, P = 0.00), fewer low ejection fractions (1.3% vs. 5.2%, P = 0.02), left main disease (25.3% vs. 32.6%, P = 0.04), diabetes (31.2% vs. 40.8%, P = 0.01), or diffuse disease (19.5 ± 10.5 vs. 22.5 ± 10.9, P = 0.00), had more off pump procedures (53.2% vs. 45.3%, P = 0.03), fewer internal thoracic artery grafts (80.5% vs. 86.6%, P = 0.03), fewer grafts placed (>3: 52.6% vs. 61.8%, P = 0.02), more complications (76.5% vs. 42.6%, P = 0.005), atrial fibrillation (47.1% vs. 19.7%, P = 0.011), longer hospital stays (12.2 vs. 8.3 days, P = 0.019). Percentage survival for groups I, II, and III at 60 months was 82.1%, 84.7%, and 72.6%, respectively. : Stents placed before surgery in isolated CABG patients may be associated with higher preoperative risk, altered operative procedures, more postoperative complications, longer hospitalizations, and more readmissions. Overall, stented patients experienced more preoperative hospitalizations, catheterizations, and percutaneous coronary interventions (PCIs) than nonstented patients. Survival for those with more than three stents may be diminished.

Absence of gender disparity in short-term clinical outcomes in patients with acute ST-segment elevation myocardial infarction undergoing sirolimus-eluting stent based primary coronary intervention: a report from Shanghai Acute Coronary Event (SACE) Registry.

PubMed

Zhang, Qi; Qiu, Jian-Ping; Zhang, Rui-Yan; Li, Yi-Gang; He, Ben; Jin, Hui-Gen; Zhang, Jun-Feng; Wang, Xiao-Long; Jiang, Li; Liao, Min-Lei; Hu, Jian; Shen, Wei-Feng

2010-04-05

Randomized, controlled trials have demonstrated the superiority of sirolimus-eluting stent (SES) implantation during primary percutaneous coronary intervention (PCI), as opposed to bare-metal stents, in patients with ST-elevation myocardial infarction (STEMI). This study aimed to test the hypothesis that clinical benefits of SES treatment were independent of gender in this setting. A total of 2042 patients with STEMI undergoing SES-based primary PCI were prospectively enrolled into Shanghai Acute Coronary Event (SACE) registry (1574 men and 468 women). Baseline demographics, angiographic and PCI features, and in-hospital and 30-day major adverse cardiac events (MACE) were analyzed as a function of gender. Compared with men, women were older and more frequently had hypertension, diabetes, and hypercholesterolemia. Use of platelet glycoprotein IIb/IIIa receptor inhibitor (GPI, 65.5% vs. 62.2%, P = 0.10) and procedural success rate (95.0% vs. 94.2%, P = 0.52) were similar in both genders. In-hospital death and MACE occurred in 3.8% and 7.6%, and 4.5% and 8.1% in the male and female patients, respectively (all P > 0.05). At 30-day follow-up, survival (94.3% vs. 93.8%, P = 0.66) and MACE-free survival (90.2% vs. 89.3%, P = 0.52) did not significantly differ between men and women. After adjustment for differences in patient demographics, angiographic and procedural features, there were no significant difference in either in-hospital (OR = 0.77, 95%CI of 0.48 to 1.22, P = 0.30) or 30-day mortality (OR = 1.28, 95%CI of 0.73 to 2.23, P = 0.38) between women and men. Despite more advanced age and clustering of risk factors in women, female patients with STEMI treated by SES-based primary PCI had similar in-hospital and short-term clinical outcomes as their male counterparts.

Suppressive effects of standard-dose rosuvastatin therapy on the progression of coronary atherosclerosis in Japanese patients: the APOLLO study.

PubMed

Amemiya, Kisaki; Yokoi, Hiroyoshi; Domei, Takenori; Shirai, Shinichi; Ando, Kenji; Goya, Masahiko; Iwabuchi, Masashi

2014-01-01

We used quantitative coronary angiography (QCA) to investigate whether coronary plaque progression can be inhibited by controlling lipids with rosuvastatin at Japanese standard doses following elective percutaneous coronary intervention (PCI). A total of 143 patients who underwent elective PCI were randomized to either the rosuvastatin (5 or 2.5mg/day) or non-statin group. Changes from baseline in the minimal lumen diameter (MLD) and average lumen diameter (ALD) measured using QCA were analyzed in both target and non-target lesions. The changes in MLD and ALD from baseline to 24 months in the non-target lesions were significantly smaller in the rosuvastatin group than in the non-statin group (-0.079 ± 0.014 mm vs.-0.135 ± 0.019 mm, p=0.022; -0.062 ± 0.012 mmvs. -0.109 ± 0.016mm, p=0.025). The changes in MLD from six to 24 months in the target lesions were significantly lower in the rosuvastatin group than in the non-statin group among the patients treated with drug-eluting stents (-0.046 ± 0.108 mm vs. -0.133 ± 0.108 mm, p=0.009) versus those treated with bare-metal stents (-0.011 ± 0.094 mm vs. -0.015 ± 0.040 mm, p=0.255). The present study demonstrated that the administration of a standard dose of rosuvastatin slows coronary plaque progression and may prevent the late catch-up phenomenon associated with drug-eluting stents in patients who undergo elective PCI.

Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

PubMed

Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

2011-10-01

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001). Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

General thoracic surgery is safe in patients taking clopidogrel (Plavix).

PubMed

Cerfolio, Robert James; Minnich, Douglas J; Bryant, Ayesha S

2010-11-01

The objective of this study was to assess the safety of general thoracic surgery in patients taking antiplatelet (clopidogrel) therapy. A prospective study was conducted of consecutive patients who underwent general thoracic surgery and who were taking clopidogrel perioperatively. They were matched using a propensity score from our prospective database of 11,768 patients. Intraoperative and postoperative outcomes were compared. Between January 2009 and April 2010 there were 33 patients on clopidogrel at the time of surgery and 132 controls. The most common procedures were thoracotomy with lobectomy in 11 patients (robotic in 1), video-assisted wedge resection in 6, mediastinoscopy in 4, and Ivor Lewis esophagogastrectomy in 2. Epidurals were not used. There was no intraoperative morbidity or bleeding in primary thoracotomy; however, 2 of the 4 patients who underwent redo thoracotomy had bleeding that required transfusions. None of the 8 patients receiving clopidogrel who had a coronary artery stent and underwent lobectomy had a perioperative myocardial infarction whereas 5 of the 14 control patients undergoing lobectomy who had a coronary artery stent did (P = .05). Otherwise, morbidity, mortality, and length of stay were no different. Patients who are receiving clopidogrel and who have a coronary artery stent placed can safely undergo general thoracic surgery. The widely held belief that surgery cannot be performed without bleeding is untrue. This new finding not only eliminates much of the preoperative dilemma posed by these patients but also may reduce their risk of a postoperative myocardial infarction. However, patients who require a redo thoracotomy may be at increased risk of bleeding. Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Drug-eluting versus bare-metal coronary stents: where are we now?

PubMed

Amoroso, Nicholas S; Bangalore, Sripal

2012-11-01

Drug-eluting stents have dramatically reduced the risk of restenosis, but concerns of an increased risk of stent thrombosis have provided uncertainty about their use. Recent studies have continued to show improved procedural and clinical outcomes with drug-eluting stents both in the setting of acute coronary syndromes and stable coronary artery disease. Newer generation drug-eluting stents (especially everolimus-eluting stents) have been shown to be not only efficacious but also safe with reduced risk of stent thrombosis when compared with bare-metal stents, potentially changing the benchmark for stent safety from bare-metal stents to everolimus-eluting stents. While much progress is being made in the development of bioabsorbable polymer stents, nonpolymer stents and bioabsorbable stent technology, it remains to be seen whether these stents will have superior safety and efficacy outcomes compared with the already much improved rates of revascularization and stent thrombosis seen with newer generation stents (everolimus-eluting stents and resolute zotarolimus-eluting stents).

Angioplasty and stent - heart - discharge

MedlinePlus

Drug-eluting stents - discharge; PCI - discharge; Percutaneous coronary intervention - discharge; Balloon angioplasty - discharge; Coronary angioplasty - discharge; Coronary artery angioplasty - discharge; Cardiac ...

Effectiveness and safety of drug-eluting stents in Ontario.

PubMed

Tu, Jack V; Bowen, James; Chiu, Maria; Ko, Dennis T; Austin, Peter C; He, Yaohua; Hopkins, Robert; Tarride, Jean-Eric; Blackhouse, Gord; Lazzam, Charles; Cohen, Eric A; Goeree, Ron

2007-10-04

The placement of drug-eluting stents decreases the frequency of repeat revascularization procedures in patients undergoing percutaneous coronary intervention (PCI) in randomized clinical trials. However, there is uncertainty about the effectiveness of drug-eluting stents, and increasing concern about their safety, in routine clinical practice. From the Cardiac Care Network of Ontario's population-based clinical registry of all patients undergoing PCI in Ontario, Canada, we identified a well-balanced cohort of 3751 pairs of patients, matched on the basis of propensity score, who received either bare-metal stents alone or drug-eluting stents alone during an index PCI procedure between December 1, 2003, and March 31, 2005. The primary outcomes of the study were the rates of target-vessel revascularization, myocardial infarction, and death. The 2-year rate of target-vessel revascularization was significantly lower among patients who received drug-eluting stents than among those who received bare-metal stents (7.4% vs. 10.7%, P<0.001). Drug-eluting stents were associated with significant reductions in the rate of target-vessel revascularization among patients with two or three risk factors for restenosis (i.e., presence of diabetes, small vessels [<3 mm in diameter], and long lesions [> or =20 mm]) but not among lower-risk patients. The 3-year mortality rate was significantly higher in the bare-metal-stent group than in the drug-eluting-stent group (7.8% vs. 5.5%, P<0.001), whereas the 2-year rate of myocardial infarction was similar in the two groups (5.2% and 5.7%, respectively; P=0.95). Drug-eluting stents are effective in reducing the need for target-vessel revascularization in patients at highest risk for restenosis, without a significantly increased rate of death or myocardial infarction. Copyright 2007 Massachusetts Medical Society.

High-definition computed tomography for coronary artery stents imaging: Initial evaluation of the optimal reconstruction algorithm.

PubMed

Cui, Xiaoming; Li, Tao; Li, Xin; Zhou, Weihua

2015-05-01

The aim of this study was to evaluate the in vivo performance of four image reconstruction algorithms in a high-definition CT (HDCT) scanner with improved spatial resolution for the evaluation of coronary artery stents and intrastent lumina. Thirty-nine consecutive patients with a total of 71 implanted coronary stents underwent coronary CT angiography (CCTA) on a HDCT (Discovery CT 750 HD; GE Healthcare) with the high-resolution scanning mode. Four different reconstruction algorithms (HD-stand, HD-detail; HD-stand-plus; HD-detail-plus) were applied to reconstruct the stented coronary arteries. Image quality for stent characterization was assessed. Image noise and intrastent luminal diameter were measured. The relationship between the measurement of inner stent diameter (ISD) and the true stent diameter (TSD) and stent type were analysed. The stent-dedicated kernel (HD-detail) offered the highest percentage (53.5%) of good image quality for stent characterization and the highest ratio (68.0±8.4%) of visible stent lumen/true stent lumen for luminal diameter measurement at the expense of an increased overall image noise. The Pearson correlation coefficient between the ISD and TSD measurement and spearman correlation coefficient between the ISD measurement and stent type were 0.83 and 0.48, respectively. Compared with standard reconstruction algorithms, high-definition CT imaging technique with dedicated high-resolution reconstruction algorithm provides more accurate stent characterization and intrastent luminal diameter measurement. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans

PubMed Central

Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

2017-01-01

Objective To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. Background In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). Methods A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. Results At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75–95.52) compared with the MSG group (74.21%, 58.85–86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. Conclusions MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. Classifications BMS, OCT, clinical trials. PMID:28674616

Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans.

PubMed

Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

2017-01-01

To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75-95.52) compared with the MSG group (74.21%, 58.85-86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. BMS, OCT, clinical trials.

Distribution of angiographic measures of restenosis after drug-eluting stent implantation.

PubMed

Byrne, R A; Eberle, S; Kastrati, A; Dibra, A; Ndrepepa, G; Iijima, R; Mehilli, J; Schömig, A

2009-10-01

A bimodal distribution of measures of restenosis has been demonstrated at 6-8 months after bare metal stent implantation. Drug-eluting stent (DES) treatment has attenuated the impact of certain factors (eg, diabetes) on restenosis but its effect on the distribution of indices of restenosis is not known. To perform a detailed analysis of the metrics of restenosis indices after DES implantation. Design, settings, Prospective observational study of patients undergoing DES implantation (Cypher, sirolimus-eluting stent; or Taxus, paclitaxel-eluting stent) at two German centres, with repeat angiography scheduled at 6-8 months after coronary stenting. In-stent late luminal loss (LLL) and in-segment percentage diameter stenosis (%DS) as determined by quantitative coronary angiography at recatheterisation. Paired cineangiograms were available for 2057 patients. Overall mean (SD) LLL was 0.31 (0.50) mm; mean (SD) %DS was 30.3 (15.7)%. Distribution of both LLL and %DS differed significantly from normal (Kolmogorov-Smirnov test; p<0.001 for each). For both parameters a mixed distribution model better described the data (likelihood ratio test with 3df; p<0.001 for each). This consisted of two normally distributed subpopulations with means (SD) of 0.10 (0.25) mm and 0.69 (0.60) mm for LLL, and means (SD) of 22.2 (8.6)% and 40.1 (16.6)% for %DS. The results were consistent across subgroups of DES type, "on-label" versus "off-label" indication, and presence or absence of diabetes. LLL and %DS at follow-up angiography after DES implantation have a complex mixed distribution that may be accurately represented by a bimodal distribution model. The introduction of DES treatment has not resulted in elimination of a variable propensity to restenosis among subpopulations of patients with stented lesions.

The 'MAP strategy' (Maximum aspiration of atherothrombus and adjunctive glycoprotein IIb/IIIa inhibitor utilization combined with prolonged inflation of balloon/stent) for preventing no-reflow in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: A retrospective analysis of seventy-one cases.

PubMed

Potdar, Anil; Sharma, Satyavan

2015-12-01

'No-reflow' phenomenon is a common occurrence in percutaneous coronary intervention (PCI). A three-component 'MAP strategy' was designed to prevent no-reflow by addressing both intralesional and intraluminal thrombus in patients with ST-segment elevation myocardial infarction (STEMI). In this analysis, we observed Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 or 2 in all patients, with no incidence of no-reflow. Myocardial blush grade (MBG) 3 or 2 was observed in most (87.32%) patients. Left ventricular ejection fraction (LVEF) was improved, without any incidence of death up to 9-month follow-up. All patients safely tolerated the strategy-driven prolonged, 35-s inflation of the balloon/stent. Copyright © 2016. Published by Elsevier B.V.

Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

PubMed

Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

2016-02-01

Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

Bioabsorbable coronary stents--are these the next big thing in coronary angioplasty?

PubMed

Balla, Sudarshan; Aggarwal, Kul; Nistala, Ravi

2010-06-01

The role of percutaneous coronary intervention (PCI) in the treatment of coronary artery disease has grown at an astronomical pace. Drug eluting stents (DES) offer advantages over bare metal stents (BMS) such as reduction in early in-stent restenosis rates. However, they have disadvantages like from increased late stent thrombosis when compared with BMS. Furthermore, recent data suggest endothelial dysfunction in the DES stented segments of the arteries. Currently, bioabsorbable stents are under development to avert the complications of DES such as stent thrombosis via degradation of the stent over time. The hypothetical advantage of leaving behind a natural vessel and restoring vasoreactivity may be the almost normal physiology which can be achieved after an intervention with a stent. The ABSORB and the PROGRESS AMS are two of the recent clinical trials that have looked at the outcomes of using bioabsorbable stents. So far, data from these and other studies has yielded mixed results in terms of angiographic and clinical outcomes. Newer stents such as REVA and WHISPER are presently being tested in preclinical and clinical trials. The landscape for bioabsorbable stents is constantly evolving through continued improvisation on existing technology and emergence of new technology. Large scale randomized trials are still needed with adequate long term follow-up for safety and benefits to have mainstream application in coronary artery disease, bioabsorbable stents are a promising innovation in the field of PCI. We review some of the patents and the data that is emerging on bioabsorbable stents in addition to currently ongoing clinical trials.

Evaluation of clinical outcomes in patients undergoing dual vessel percutaneous coronary intervention using sirolimus-eluting coronary stent system in India.

PubMed

Chandwani, Prakash; Prajapati, Jayesh; Porwal, Sanjay; Khambhati, Bhavesh; Thakkar, Ashok

2015-02-01

Coronary artery disease is the most common catastrophic disease in India. The safety and effectiveness of dual vessel sirolimus-eluting stent (SES) implantation (used as an intervention in CAD) is currently unknown in Indian population. The purpose of this study was to investigate one year clinical outcomes of patients with dual vessel coronary artery disease after implantation of the Supralimus-Core SES, in a "real-world" setting. We evaluated 60 patients between April-2011 and August-2012, who underwent dual vessel percutaneous coronary intervention (PCI) with the Supralimus-Core SES implantation at the same index procedure. Dual vessels were defined as involvement of two major epicardial vessels (right, left anterior descending, circumflex, or left main coronary arteries) or one major epicardial vessel and a branch (≥2.5 mm in diameter) originating from another major epicardial vessel. The primary endpoint was target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR) at one year. Secondary endpoint included combined (definite, probable and possible) stent thrombosis (ST). A total of 120 lesions were treated in 60 enrolled patients (mean age 56.0±9.2 y; 80.0% male) with average stent length of 23.1±8.5 mm. Among 60 patients, diabetes, hypertension and hypercholesterolemia were present in 15 (25.0%), 22 (36.7%) and 25 (41.7%) patients respectively. Indications for PCI were unstable angina in 30 (50.0%) patients and stable angina in 11 (18.3%) patients. Overall, 40 (33.3%) lesions were classified as complex (American College of Cardiology/American Heart Association type B2/C). The cumulative TLF rate was 5.0% (n=3) at one year. Cardiac death, MI and clinically-driven TLR occurred in 1 (1.7%), 0 (0%) and 2 (3.3%) patients, respectively at one year follow-up. The Kaplan-Meier curve of the freedom from overall events at one year was 95.0%. According to the Academic Research Consortium definition, there were no events of stent thrombosis during one year. Our study shows that, dual vessel Supralimus-Core SES implantation allows safe and effective treatment with low rates of TLF at one year follow-up in Indian population.

Relation of Nickel Allergy with in-Stent Restenosis in Patients Treated with Cobalt Chromium Stents.

PubMed

Aliağaoğlu, Cihangir; Turan, Hakan; Erden, Ismail; Albayrak, Hülya; Ozhan, Hakan; Başar, Cengiz; Gürlevik, Zehra; Alçelik, Ayşegül

2012-11-01

In-stent restenosis (ISR) is the major limitation of percutaneous coronary stenting procedure. The elements like nickel, chromate and molybdenum are known to cause contact allergy. Hypersensitivity reaction, against these metal ions, may be one of the reasons of ISR. Cobalt chromium coronary stents, which are increasingly being used in percutaneous coronary interventions, have more nickel amount than the stainless steel stents. We aimed to investigate the association between nickel hypersensitivity reaction and ISR in patients treated with cobalt chromium coronary stents. Epicutaneous patch tests for nickel were applied to 31 patients who had undergone elective cobalt chromium coronary stent implantation and had ISR in control angiogram. Thirty patients, without ISR, were included as the control group. Patch test results and other clinical variables were compared. There was no statistically significant difference of the mean age, sex, body mass index, rate of hypercholesterolemia, diabetes, hypertension and smoking between the patients with and without ISR. All other lesion characteristics were similar in the 2 groups. According to the patch test results, 7 patients had nickel contact allergy. All of these patients were in the ISR group, which was statistically significant (p<0.006). Patients treated with cobalt chromium coronary stents and had ISR were found to have significantly more nickel allergy than the control group. Nickel allergy may play role in restenosis pathophysiology.

Impact of high lipoprotein(a) levels on in-stent restenosis and long-term clinical outcomes of angina pectoris patients undergoing percutaneous coronary intervention with drug-eluting stents in Asian population.

PubMed

Park, Sang-Ho; Rha, Seung-Woon; Choi, Byoung-Geol; Park, Ji-Young; Jeon, Ung; Seo, Hong-Seog; Kim, Eung-Ju; Na, Jin-Oh; Choi, Cheol-Ung; Kim, Jin-Won; Lim, Hong-Euy; Park, Chang-Gyu; Oh, Dong-Joo

2015-06-01

Lipoprotein(a) (Lp(a)) is known to be associated with cardiovascular complications and atherothrombotic properties in general populations. However, it has not been examined whether Lp(a) levels are able to predict adverse cardiovascular outcomes in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). A total of 595 consecutive patients with angina pectoris who underwent elective PCI with DES were enrolled from 2004 to 2010. The patients were divided into two groups according to the levels of Lp(a): Lp(a) < 50 mg/dL (n = 485 patients), and Lp(a) ≥ 50 mg/dL (n = 111 patients). The 6-9-month angiographic outcomes and 3-year cumulative major clinical outcomes were compared between the two groups. Binary restenosis occurred in 26 of 133 lesions (19.8%) in the high Lp(a) group and 43 of 550 lesions (7.9%) in the low Lp(a) group (P = 0.001). In multivariate analysis, the reference vessel diameter, low density lipoprotein cholesterol, total lesion length, and Lp(a) ≥ 50 mg/dL were predictors of binary restenosis. In the Cox proportional hazards regression analysis, Lp(a) > 50 mg/dL was significantly associated with the 3-year adverse clinical outcomes including any myocardial infarction, revascularization (target lesion revascularization (TLR) and target vessel revascularization (TVR)), TLR-major adverse cardiac events (MACEs), TVR-MACE, and All-MACEs. In our study, high Lp(a) level ≥ 50 mg/dL in angina pectoris patients undergoing elective PCI with DES was significantly associated with binary restenosis and 3-year adverse clinical outcomes in an Asian population. © 2015 Wiley Publishing Asia Pty Ltd.

[Myocardial ischemia in general medicine and the revolution of coronary stents].

PubMed

El-Mourad, M; Merveille, P; Preumont, N

2014-09-01

Since Gruentizg's first percutaneous transluminal ballon angioplasty in 1977 in Zurich, percuta. neous coronary intervention evolved significantly in order to overcome the numerous associated complications of each technique. Bare-metal stents (BMS) made their initial appearance followed by three generations of drug-eluting stents (DES). The use of bioabsorbable vascular scaffold stents (BVS) has become more frequent creating a temporary scaffold allowing healing of the endothelium within 2 years. In this article, we discuss the nomenclature of the main intravascular complications linked to percuta. neous coronary intervention such as stent thrombosis (ST), Instent restenosis (ISR), neoatherosclerosis, and stents evolution to overcome these complications. We will finally mention the new technologies of intracoronary imaging such as OCT (Optical Coherence Tomography) having an increasing vital role in percutaneous coronary intervention,

A new self-expandable aortic valved stent deployed above native leaflets for aortic insufficiency: an in vitro study.

PubMed

Huang, H; Zhou, Y; Shao, J; Cai, J; Mei, Y; Wang, Y

2012-12-01

The aim of this paper was to develop a new self-expandable aortic valved stent following the shape of the sinus of Valsalva, which can be deployed above native leaflets for aortic regurgitation, and study it's effect on coronary artery flow when orthotopic implantation in and above native leaflets. New self-expandable aortic valved stent consist of nitinol stent and bovine pericardium, and was designed following the shape of the sinus of Valsalva, the bovine pericardium was tailed as native leaflet. Thirty-six swine hearts were divided into three equal groups of twelve. In Group A (N.=12), the new self-expandable aortic valved stents deployed in native leaflets. In Group B (N.=12), the new self-expandable aortic valved stents deployed above native leaflets. In Group C (N.=12), the cylinder-like valved stents deployed only in native leaflets. The measurements of each coronary flow rate and endoscopic inspections were repeated post-implantation. In Group A and C, valve implantation in native leaflets resulted in a significant decrease in both left and right coronary flows. In Group B, no significant change in either right or left coronary flow was found after new self-expandable aortic valved stent placement. Endoscopic inspections showed that in group A and C the native leaflets sandwiched between valved stent and aortic wall, whereas, in group B the native leaflets were under the artificial leaflets. Two kinds of stents deployed in native leaflets affect left and right coronary flows significantly. No significant effect was found when the new self-expandable aortic valved stent deployed above native leaflets. This new self-expandable aortic valved stent can be deployed above the native leaflets, which avoids the obstruction of native leaflets on coronary flow.

Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis

PubMed Central

Stortecky, Stefan; Stefanini, Giulio G; daCosta, Bruno R; Rutjes, Anne Wilhelmina; Di Nisio, Marcello; Siletta, Maria G; Maione, Ausilia; Alfonso, Fernando; Clemmensen, Peter M; Collet, Jean-Philippe; Cremer, Jochen; Falk, Volkmar; Filippatos, Gerasimos; Hamm, Christian; Head, Stuart; Kappetein, Arie Pieter; Kastrati, Adnan; Knuuti, Juhani; Landmesser, Ulf; Laufer, Günther; Neumann, Franz-Joseph; Richter, Dimitri; Schauerte, Patrick; Sousa Uva, Miguel; Taggart, David P; Torracca, Lucia; Valgimigli, Marco; Wijns, William; Witkowski, Adam; Kolh, Philippe; Juni, Peter

2014-01-01

Objective To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease. Design Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation. Eligibility criteria for selecting studies A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease. Data sources Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation. Main outcome measure All cause mortality. Results 100 trials in 93 553 patients with 262 090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably reduced by coronary artery bypass grafting (0.16, 0.13 to 0.20) followed by new generation drug eluting stents (zotarolimus (Resolute): 0.26, 0.17 to 0.40; everolimus: 0.27, 0.21 to 0.35), early generation drug eluting stents (zotarolimus (Endeavor): 0.37, 0.28 to 0.50; sirolimus: 0.29, 0.24 to 0.36; paclitaxel: 0.44, 0.35 to 0.54), and bare metal stents (0.69, 0.59 to 0.81) compared with medical treatment. Conclusion Among patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation to a variable degree. Our results provide evidence for improved survival with new generation drug eluting stents but no other percutaneous revascularisation technology compared with medical treatment. PMID:24958153

A rare complication with remarkable stent shortening and successful recovery from the trouble.

PubMed

Goto, Yoshitaka; Kawasaki, Tomohiro; Koga, Hisashi

2012-05-01

Deployed coronary stent distortion is a rare complication, but can potentially occur during coronary intervention. We herein report a rare complicated case with remarkable stent distortion of longitudinal stent shortening and successful recovery from a trouble using a Corsair microcatheter.

[Assessment of the course of ischemic heart disease after placement of stents with drug covering and uncovered metal stents: data of 3 years follow-up].

PubMed

Buza, V V; Karpov, Iu A; Samko, A N; Deev, A D; Lopukhova, V V; Levitskiĭ, I V; Sozykin, A V

2009-01-01

The placement of sirolimus-eluting stents decreases the frequency of repeat revascularization procedures in patients undergoing percutaneous coronary intervention (PCI) in randomized clinical trials. However, there is uncertainty about the effectiveness of sirolimus-eluting stents, and increasing concern about their safety in routine clinical practice. From the prof. Samko PCI laboratory in Moscow, Russia, we identified 426 patients, who received either bare-metal stents alone or sirolimus-eluting stents alone during an index PCI procedure between March 1, 2002, and September 31, 2004.The primary outcomes of the study were the rates of target-lesion revascularization, myocardial infarction, death, late stent thrombosis. The 3-year rate of target-lesion revascularization was significantly lower among patients who received sirolimus-eluting stents than among those who received bare-metal stents (3.1% vs. 19 %, p=0.001). The 3-year mortality rate was not different between the bare-metal stent group and the sirolimus eluting stent group (5.9% vs. 7.2%, p=0.68), the 3-year rate of all ARC late stent thrombosis was similar in the two groups (5.9% and 7.2%, respectively; p=0.95). Sirolimus-eluting stents are effective in reducing the need for target-vessel revascularization without significantly increased rates of death, late stent thrombosis, myocardial infarction.

Prognostic value of N-terminal pro-B-type natriuretic peptide in patients with acute coronary syndromes undergoing left main percutaneous coronary intervention.

PubMed

Jaberg, Laurenz; Toggweiler, Stefan; Puck, Marietta; Frank, Michelle; Rufibach, Kaspar; Lüscher, Thomas F; Corti, Roberto

2011-01-01

Patients undergoing acute left main (LM) coronary artery revascularization have a high mortality and natriuretic peptides such as N-terminal pro-B-type (NT-proBNP) have been shown to have prognostic value in patients with acute coronary syndromes. The present study looked at the prognostic value of NT-proBNP in these patients. We studied all consecutive patients undergoing acute LM coronary artery percutaneous coronary intervention between January 2005 and December 2008 in whom NT-proBNP was measured (n=71). We analyzed the clinical characteristics and the short- and long-term outcomes in relation to NT-proBNP level at admission. Median NT-proBNP was 1,364 ng/L, ranging from 46 to 70,000 ng/L. NT-proBNP was elevated in 63 (89%) patients and was ≥1,000ng/L in 42 (59%). Log NT-proBNP (hazard ratio [HR] 3.51, 95% confidence interval [CI] 1.55-7.97, P=0.003) and left ventricular ejection fraction (HR 0.95, 95%CI 0.91-0.99, P=0.007) were predictors for all-cause mortality. Log NT-proBNP was the only independent significant predictor of cardiovascular mortality. In-hospital mortality was 0% for patients with NT-proBNP <1,000, but 17% for those with NT-proBNP ≥1,000 (P=0.036). NT-proBNP is a strong predictor of outcome in patients undergoing acute LM coronary artery stenting. Mortality in such patients is high, but those with NT-proBNP < 1,000ng/L may have a favorable short- and long-term prognosis. Further research, including a larger patient population, is needed to determine the optimal cut-off value for NT-proBNP in patients undergoing acute LM coronary artery intervention.

Triple antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention: a viewpoint.

PubMed

Gwyn, Jennifer C V; Thomas, Mark R; Kirchhof, Paulus

2017-07-01

Patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy to reduce the risk of subsequent myocardial infarction (MI) and stent thrombosis. Approximately 5-10% of patients undergoing PCI also have atrial fibrillation (AF). Patients with AF have an additional requirement for anticoagulation, as dual antiplatelet therapy alone is insufficient to adequately reduce the risk of stroke in patients with AF. However, it is now well established that combining anticoagulants with dual antiplatelet therapy also causes a significant increase in the risk of bleeding. Hence, there is great interest in discovering the optimal blend of antiplatelet therapy and oral anticoagulation in this situation, aiming to reduce the risk of stent thrombosis, recurrent MI, and stroke, while also minimizing the risk of bleeding. Recent studies have experimented with combining oral anticoagulation with a single antiplatelet agent, rather than combining oral anticoagulation with dual antiplatelet therapy. These studies show that this reduces the risk of bleeding but are underpowered to determine whether this still provides as much cardiovascular benefit. This review summarizes the currently available evidence on this topic and highlights the key questions that remain to be answered including ongoing clinical trials in the field. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries.

PubMed

Takimura, Celso K; Galon, Micheli Z; Gutierrez, Paulo S; Sojitra, Prakash; Vyas, Ashwin; Doshi, Manish; Lemos, Pedro A

2015-04-01

Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors). In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response. According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS. The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies.

[Interventional catheter treatment of bypass graft stenosis: comparison of intracoronary stent implantation and balloon angioplasty].

PubMed

Heidland, U E; Heintzen, M P; Schoppmann, D; Michel, C J; Strauer, B E

2000-02-25

Balloon angioplasty of a stenosed bypass graft has a much higher risk of recurrent stenosis than dilatation of a stenosed native coronary artery. Intracoronary stent implantation has established itself as the better treatment of native coronary artery stenosis than conventional balloon angioplasty. However, there is still uncertainty whether intracoronary stent implantation in stenosed bypass vessels gives better long-term results than conventional balloon angioplasty. Results were retrospectively analyzed of unrandomized 224 primarily successful interventions--122 balloon dilatations and 102 stent implantations--performed between January 1996 and June 1998 on stenosed coronary bypass grafts, re-examined by coronary angiography an average of 6 months later. All but 11 patients were on combined aspirin and ticlopidine antiplatelet aggregation treatment. There was a significantly lower 6-month restenosis rate (30.4%) after stent implantation than after balloon dilatation (51.6%). The re-intervention rate was also significantly lower after stent implantation. These data suggest that stent implantation of stenosed coronary bypass grafts under cover of platelet-aggregation inhibition with aspirin and ticlopidine provides a lower restenosis and thus higher revascularization rate than conventional balloon dilatation.

Financial impact of coronary stenting in emergency for acute coronary syndromes.

PubMed

Nidegger, Delphine; Metz, Damien; Vacter, Christophe; Tassan-Mangina, Sophie; Deschildre, Alain; Gawron, Michel; Bourgeois, Jacqueline

2009-05-01

Since the prospective payment system, health institutions have only specific payments for the emergency care in the emergency room. The direct urgent admissions in coronary care units for acute coronary syndrome (ACS) do not collect this complementary refund. For the patient's stay, hospital is remunerated with fixed national prices which are similar even in case of emergent or planed coronary revascularization when realized. To analyze and compare the financial impact between emergent and planed coronary stenting in the setting of ACS. This retrospective study was based on patients suffering from ACS who experienced emergent coronary stenting during the year 2005. On 154 patients, 127 were age-, sex- and diagnosis-related group (called "groupe homogène de malades" in the French Health Care system)-matched with 127 suffering from same ACS but with planed "ad hoc" coronary stenting. The overall charges (medical and paramedical team, pharmacy, biology, implantable coronary devices, radiology) were compared between the two groups. Mean stay duration was 6.7 days and did not differ between the two groups. Mean financial retributions were significantly higher in the emergent group (7338 euro [6831-7846] IC95 vs 6509 euro [5994-7023]; p=0,02) but with a much more raised consumption (6810 euro [6283-7336] vs 5223 euro [4632-5814]; p=0,001). This overcost was due especially to drugs and biological expenses. The hospitalization payments did not cover the overall expenses for 25% of the patients' stays (N=64) among whom 39 have had emergent coronary stenting (30.7%, p=0.04). Among the different GHM, the most important difference was observed in non-STEMI without complication with a negative receipts/costs ratio for 37.8% of the stay with coronary stenting in emergency. The application of the recent guidelines for coronary revascularization in the management of ACS represents a financial venture for hospital institutions. The engaged charges for emergent coronary stenting are covered with difficulties contrary to planed revascularization.

[The value of SYNTAX score in predicting outcome patients undergoing percutaneous coronary intervention].

PubMed

Gao, Yue-chun; Yu, Xian-peng; He, Ji-qiang; Chen, Fang

2012-01-01

To assess the value of SYNTAX score to predict major adverse cardiac and cerebrovascular events (MACCE) among patients with three-vessel or left-main coronary artery disease undergoing percutaneous coronary intervention. 190 patients with three-vessel or left-main coronary artery disease undergoing percutaneous coronary intervention (PCI) with Cypher select drug-eluting stent were enrolled. SYNTAX score and clinical SYNTAX score were retrospectively calculated. Our clinical Endpoint focused on MACCE, a composite of death, nonfatal myocardial infarction (MI), stroke and repeat revascularization. The value of SYNTAX score and clinical SYNTAX score to predict MACCE were studied respectively. 29 patients were observed to suffer from MACCE, accounting 18.5% of the overall 190 patients. MACCE rates of low (≤ 20.5), intermediate (21.0 - 31.0), and high (≥ 31.5) tertiles according to SYNTAX score were 9.1%, 16.2% and 30.9% respectively. Both univariate and multivariate analysis showed that SYNTAX score was the independent predictor of MACCE. MACCE rates of low (≤ 19.5), intermediate (19.6 - 29.1), and high (≥ 29.2) tertiles according to clinical SYNTAX score were 14.9%, 9.8% and 30.6% respectively. Both univariate and multivariate analysis showed that clinical SYNTAX score was the independent predictor of MACCE. ROC analysis showed both SYNTAX score (AUC = 0.667, P = 0.004) and clinical SYNTAX score (AUC = 0.636, P = 0.020) had predictive value of MACCE. Clinical SYNTAX score failed to show better predictive ability than the SYNTAX score. Both SYNTAX score and clinical SYNTAX score could be independent risk predictors for MACCE among patients with three-vessel or left-main coronary artery disease undergoing percutaneous coronary intervention. Clinical SYNTAX score failed to show better predictive ability than the SYNTAX score in this group of patients.

Stent-induced coronary artery stenosis characterized by multimodal nonlinear optical microscopy

NASA Astrophysics Data System (ADS)

Wang, Han-Wei; Simianu, Vlad; Locker, Mattew J.; Cheng, Ji-Xin; Sturek, Michael

2011-02-01

We demonstrate for the first time the applicability of multimodal nonlinear optical (NLO) microscopy to the interrogation of stented coronary arteries under different diet and stent deployment conditions. Bare metal stents and Taxus drug-eluting stents (DES) were placed in coronary arteries of Ossabaw pigs of control and atherogenic diet groups. Multimodal NLO imaging was performed to inspect changes in arterial structures and compositions after stenting. Sum frequency generation, one of the multimodalities, was used for the quantitative analysis of collagen content in the peristent and in-stent artery segments of both pig groups. Atherogenic diet increased lipid and collagen in peristent segments. In-stent segments showed decreased collagen expression in neointima compared to media. Deployment of DES in atheromatous arteries inhibited collagen expression in the arterial media.

Retrieving a deformed stent during transradial intervention: An alternative femoral approach using guide catheter shortening

PubMed Central

Trehan, Vijay K.; Jain, Gagan; Kathuria, Sanjeev; Pandit, Bhagya N.

2013-01-01

Stent dislodgment during percutaneous coronary intervention is a rare complication. We report a case of successful retrieval of a deformed coronary stent through alternative transfemoral approach while performing transradial procedure when the stent could not be retrieved safely from transradial route. PMID:23809390

Percutaneous coronary intervention strategies and prognosis for graft lesions following coronary artery bypass grafting

PubMed Central

LIU, YIN; ZHOU, XIUJUN; JIANG, HUA; GAO, MINGDONG; WANG, LIN; SHI, YUTIAN; GAO, JING

2015-01-01

The purpose of this study was to compare the prognosis of graft-percutaneous coronary intervention (PCI) and native vessel (NV)-PCI, drug-eluting stents (DESs) and bare-metal stents (BMSs) for the treatment of graft lesions following coronary artery bypass grafting (CABG), and to determine the risk factors for major adverse cardiac events (MACEs). A total of 289 patients who underwent PCI following CABG between August 2005 and March 2010 were retrospectively analyzed. The effects on survival were compared among patients who underwent NV- and graft-PCI, and DES and BMS implantation. Additionally, the risk factors for MACEs following PCI for graft lesions were analyzed. The findings showed that MACE-free and revascularization-free survival rates were significantly higher in the NV-PCI group compared with those in the graft-PCI group. There were 63 cases (29.0%) of MACEs in the DES group and 25 cases (52.1%) in the BMS group. In patients undergoing NV-PCI, the DES group had significantly fewer MACEs and less target vessel revascularization (TVR) than the BMS group. In patients undergoing graft-PCI, the DES group showed a tendency for fewer MACEs and a lower incidence of cardiac mortality, myocardial infarction and TVR compared with the BMS group. Diabetes, an age of >70 years and graft-PCI were independent risk factors for MACEs in patients post-PCI. It is concluded that NV-PCI has superior long-term outcomes compared with graft-PCI, and should therefore be considered as the first-line treatment for graft disease following CABG. Despite this, graft-PCI remains a viable option. DESs are the first choice for graft-PCI due to their safety and efficacy and their association with reduced mortality and MACE rate. Diabetes, older age and graft-PCI are independent risk factors for MACEs in patients post-CABG who are undergoing revascularization. PMID:26136874

The STENTYS self-apposing stent technology in coronary artery disease: literature review and future directions.

PubMed

Lu, Huangling; de Winter, Robbert J; Koch, Karel T

2018-06-21

Coronary stent designs have been through extensive developments in the past few decades. Since the first introduction of the self-apposing STENTYS stent, several theoretical advantages of its nitinol platform have been clinically evaluated. This paper reviews the current status, ongoing work and future directions of this device. Areas covered: The OPEN (STENTYS Coronary Bifurcation Stent System fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries) trials revealed high technical success rates of the STENTYS performance in bifurcation lesions. The APPOSITION (Assessment of the Safety and Performance of the STENTYS self-expanding Coronary Stent in Acute Myocardial Infarction) trials demonstrated the safety and feasibility of the device in patients with acute myocardial infarction. Optical coherence tomography showed better short-term strut apposition in patients treated with the STENTYS stent in APPOSITION IV. The clinical outcomes of the device in saphenous vein graft lesions and left main coronary artery disease are favourable. Expert Commentary: Despite numerous theoretical advantages of the nitinol platform, superiority of the STENTYS self-apposing stent over currently available DES has not yet been proven. However, the ongoing registries evaluating the performance of the STENTYS Xposition will provide more insights in its clinical performance.

The nature and pattern of coronary stent recalls.

PubMed

Kumar, Sanjay; Innasimuthu, Antony L; Marmur, Jonathan D

2014-09-01

Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall. To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls. The Food and Drug Administration (FDA; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, "coronary stent" or "stent." Dates were searched between November 2002 and June 2013. There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/ packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types. The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.

Diabetes mellitus: a prothrombotic state Implications for outcomes after coronary revascularization

PubMed Central

Cola, Clarissa; Brugaletta, Salvatore; Yuste, Victoria Martín; Campos, Bieito; Angiolillo, Dominick J; Sabaté, Manel

2009-01-01

Coronary stent thrombosis is a serious problem in the drug-eluting stent era. Despite aggressive antiplatelet therapy during and after percutaneous coronary intervention (PCI), the incidence of sub-acute stent thrombosis remains approximately 0.5%–2%, which may represent a catastrophic clinical situation. Both procedural factors and discontinuation of antiplatelet therapy are normally associated with this event. We report on simultaneous stent thromboses of two drug-eluting stents implanted in two different vessels, which resulted in a life-threatening clinical condition. Possible contributing factors that led to synergistic thrombotic effects are discussed. PMID:19436654

Optical Coherence Tomography and Stent Boost Imaging Guided Bioresorbable Vascular Scaffold Overlapping for Coronary Chronic Total Occlusion Lesion

PubMed Central

Li, Hu; Choi, Cheol Ung; Oh, Dong Joo

2017-01-01

We report herein the optical coherence tomography (OCT) and stent boost imaging guided bioresorbable vascular scaffold (BVS) implantation for right coronary artery (RCA) chronic total occlusion (CTO) lesion. The gold standard for evaluating BVS expansion after percutaneous coronary intervention is OCT. However, stent boost imaging is a new technique that improves fluoroscopy-based assessments of stent overlapping, and the present case shows clinical usefulness of OCT and stent boost imaging guided ‘overlapping’ BVS implantation via antegrade approach for a typical RCA CTO lesion. PMID:28792157

Three-dimensional reconstruction of coronary stents in vivo based on motion compensated X-ray angiography

NASA Astrophysics Data System (ADS)

Schäfer, Dirk; Movassaghi, Babak; Grass, Michael; Schoonenberg, Gert; Florent, Raoul; Wink, Onno; Klein, Andrew J. P.; Chen, James Y.; Garcia, Joel; Messenger, John C.; Carroll, John D.

2007-03-01

The complete expansion of the stent during a percutaneous transluminal coronary angioplasty (PTCA) procedure is essential for treatment of a stenotic segment of a coronary artery. Inadequate expansion of the stent is a major predisposing factor to in-stent restenosis and acute thrombosis. Stents are positioned and deployed by fluoroscopic guidance. Although the current generation of stents are made of materials with some degree of radio-opacity to detect their location after deployment, proper stent expansion is hard to asses. In this work, we introduce a new method for the three-dimensional (3D) reconstruction of the coronary stents in-vivo utilizing two-dimensional projection images acquired during rotational angiography (RA). The acquisition protocol consist of a propeller rotation of the X-ray C-arm system of 180°, which ensures sufficient angular coverage for volume reconstruction. The angiographic projections were acquired at 30 frames per second resulting in 180 projections during a 7 second rotational run. The motion of the stent is estimated from the automatically tracked 2D coordinates of the markers on the balloon catheter. This information is used within a motion-compensated reconstruction algorithm. Therefore, projections from different cardiac phases and motion states can be used, resulting in improved signal-to-noise ratio of the stent. Results of 3D reconstructed coronary stents in vivo, with high spatial resolution are presented. The proposed method allows for a comprehensive and unique quantitative 3D assessment of stent expansion that rivals current X-ray and intravascular ultrasound techniques.

Update on perioperative care of the cardiac patient for noncardiac surgery.

PubMed

Ghadimi, Kamrouz; Thompson, Annemarie

2015-06-01

The current review will address key topics and recommendations of the recent 2014 update of the American College of Cardiology and American Heart Association clinical practice guideline for the perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery. The completely rewritten guideline provides a stepwise approach for the identification and management of patients at highest risk for major adverse cardiac events and discusses new or updated recommendations. For example, β-blockers should be continued perioperatively but treatment should not be initiated within 24 h of noncardiac surgery. Angiotensin-converting enzyme inhibitors should be continued, but if held, may be restarted as soon as feasible. Routine aspirin therapy is not recommended without previous coronary stent implantation or risk assessment for myocardial ischemia. Elective noncardiac surgery should not be performed within 30 days of bare metal stent or 12 months of drug-eluting stent implantation because of in-stent thrombosis as well as bleeding risk from dual antiplatelet therapy during surgery. Noncardiac surgery may be considered, however, in patients on antiplatelet agents 180 days after drug-eluting stent placement if risk of surgical delay exceeds risk of stent thrombosis from cessation of antiplatelet therapy. In conclusion, this review will discuss the important topics from the 2014 American College of Cardiology/American Heart Association guideline in order to provide the perioperative physician with the most recent evidence necessary to minimize major adverse cardiac events in patients undergoing noncardiac surgery.

Effects of incomplete stent apposition on the changes in hemodynamics inside a curved and calcified coronary artery

NASA Astrophysics Data System (ADS)

Poon, Eric; Ooi, Andrew; Barlis, Peter; Hayat, Umair; Moore, Stephen

2014-11-01

Percutaneous coronary intervention (PCI) is the modern gold standard for treatment of coronary artery disease. Stenting (a common PCI procedure) of simple lesion inside a relatively straight segment of coronary artery has proven to be highly successful. However, incomplete stent apposition (ISA) where there is a lack of contact between the stent struts and lumen wall is not uncommon in curved and calcified coronary arteries. Computational fluid dynamics simulations are carried out to study the changes in hemodynamics as a result of ISA inside a curved and calcified coronary artery. For a 3 mm coronary artery, we simulate a resting condition at 80 mL/min and a range of hyperemic conditions with coronary flow reserve in between 1 and 2. The heartbeat is fixed at 75 BPM. Five different curvatures of the coronary artery are considered. Negative effects on hemodynamic variables, such as low wall shear stress (<0.5 Pa); high wall shear stress gradient (>5,000 Pa/m) and oscillation shear index (0 <= OSI <= 0.5), are employed to identify locations with high possibilities of adverse clinical events. This study will lead to better understandings of ISA in curved and calcified coronary arteries and help improve future coronary stent deployment. Supported by the Australian Research Council (LP120100233) and Victorian Life Sciences Computation Initiative (VR0210).

Cost-effectiveness of drug-eluting stents versus bare-metal stents in patients undergoing percutaneous coronary intervention.

PubMed

Baschet, Louise; Bourguignon, Sandrine; Marque, Sébastien; Durand-Zaleski, Isabelle; Teiger, Emmanuel; Wilquin, Fanny; Levesque, Karine

2016-01-01

To determine the cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients requiring a percutaneous coronary intervention in France, using a recent meta-analysis including second-generation DES. A cost-effectiveness analysis was performed in the French National Health Insurance setting. Effectiveness settings were taken from a meta-analysis of 117 762 patient-years with 76 randomised trials. The main effectiveness criterion was major cardiac event-free survival. Effectiveness and costs were modelled over a 5-year horizon using a three-state Markov model. Incremental cost-effectiveness ratios and a cost-effectiveness acceptability curve were calculated for a range of thresholds for willingness to pay per year without major cardiac event gain. Deterministic and probabilistic sensitivity analyses were performed. Base case results demonstrated that DES are dominant over BMS, with an increase in event-free survival and a cost-reduction of €184, primarily due to a diminution of second revascularisations, and an absence of myocardial infarction and stent thrombosis. These results are robust for uncertainty on one-way deterministic and probabilistic sensitivity analyses. Using a cost-effectiveness threshold of €7000 per major cardiac event-free year gained, DES has a >95% probability of being cost-effective versus BMS. Following DES price decrease, new-generation DES development and taking into account recent meta-analyses results, the DES can now be considered cost-effective regardless of selective indication in France, according to European recommendations.

Incremental benefit of three-dimensional transesophageal echocardiography in the assessment of left main coronary artery stent protrusion.

PubMed

Arisha, Mohammed J; Hsiung, Ming C; Ahmad, Amier; Nanda, Navin C; Elkaryoni, Ahmed; Mohamed, Ahmed H; Yin, Wei-Hsian

2017-06-01

Ostial lesions represent a challenging clinical scenario and percutaneous intervention (PCI) of left main coronary artery ostial lesions has been associated with postintervention complications, including protrusion of deployed stents into a sinus of Valsalva or aortic root. We report a case of stent protrusion into the aortic root following aorto-ostial left main coronary artery PCI, in which three-dimensional transesophageal echocardiography (3DTEE) provided incremental benefit over standard two-dimensional images. Specifically, 3DTEE confirmed the presence of stent protrusion by allowing clear visualization of the stent scaffold, in addition to characterizing the relationship between the stent and surrounding structures. © 2017, Wiley Periodicals, Inc.

A new polymer-free drug-eluting stent with nanocarriers eluting sirolimus from stent-plus-balloon compared with bare-metal stent and with biolimus A9 eluting stent in porcine coronary arteries

PubMed Central

Galon, Micheli Z.; Gutierrez, Paulo S.; Sojitra, Prakash; Vyas, Ashwin; Doshi, Manish; Lemos, Pedro A.

2015-01-01

Background Permanent polymers in first generation drug-eluting stent (DES) have been imputed to be a possible cause of persistent inflammation, remodeling, malapposition and late stent thrombosis. We aim to describe the in vivo experimental result of a new polymer-free DES eluting sirolimus from stent-plus-balloon (Focus np stent, Envision Scientific) compared with a bare-metal stent (BMS) (Amazonia CroCo, Minvasys) and with a biolimus A9 eluting stent (Biomatrix, Biosensors). Methods In 10 juvenile pigs, 23 coronary stents were implanted in the coronary arteries (8 Amazonia CroCo, 8 Focus np, and 7 Biomatrix). At 28-day follow-up, optical coherence tomography (OCT) and histology were used to evaluate neointimal hyperplasia and healing response. Results According to OCT analysis, Focus np stents had a greater lumen area and less neointimal hyperplasia response than BMS and Biomatrix had. Histomorphometry results showed less neointimal hyperplasia in Focus np than in BMS. Histology showed a higher fibrin deposition in Biomatrix stent compared to Focus np and BMS. Conclusions The new polymer-free DES with sirolimus eluted from stent-plus-balloon demonstrated safety and reduced neointimal proliferation compared with the BMS and Biomatrix stents at 28-day follow-up in this porcine coronary model. This new polymer-free DES is promising and warrants further clinical studies. PMID:25984451

Treatment of a coronary artery aneurysm by use of a covered stent graft – a case report

PubMed Central

Gundoğdu, Fuat; Arslan, Sakir; Buyukkaya, Eyup; Senocak, Huseyin

2007-01-01

Coronary artery aneurysm is a rare finding at coronary angiography. Most coronary aneurysms remain asymptomatic. There is no consensus on its management; some advocate aggressive approach while others advocate conservative management. A case of coronary artery aneurysm successfully treated by implantation of a polytetrafluoroethylene-covered coronary stent is presented. PMID:22477247

Computational hemodynamics of an implanted coronary stent based on three-dimensional cine angiography reconstruction.

PubMed

Chen, Mounter C Y; Lu, Po-Chien; Chen, James S Y; Hwang, Ned H C

2005-01-01

Coronary stents are supportive wire meshes that keep narrow coronary arteries patent, reducing the risk of restenosis. Despite the common use of coronary stents, approximately 20-35% of them fail due to restenosis. Flow phenomena adjacent to the stent may contribute to restenosis. Three-dimensional computational fluid dynamics (CFD) and reconstruction based on biplane cine angiography were used to assess coronary geometry and volumetric blood flows. A patient-specific left anterior descending (LAD) artery was reconstructed from single-plane x-ray imaging. With corresponding electrocardiographic signals, images from the same time phase were selected from the angiograms for dynamic three-dimensional reconstruction. The resultant three-dimensional LAD artery at end-diastole was adopted for detailed analysis. Both the geometries and flow fields, based on a computational model from CAE software (ANSYS and CATIA) and full three-dimensional Navier-Stroke equations in the CFD-ACE+ software, respectively, changed dramatically after stent placement. Flow fields showed a complex three-dimensional spiral motion due to arterial tortuosity. The corresponding wall shear stresses, pressure gradient, and flow field all varied significantly after stent placement. Combined angiography and CFD techniques allow more detailed investigation of flow patterns in various segments. The implanted stent(s) may be quantitatively studied from the proposed hemodynamic modeling approach.

Three-dimensional virtual surgery models for percutaneous coronary intervention (PCI) optimization strategies

NASA Astrophysics Data System (ADS)

Wang, Hujun; Liu, Jinghua; Zheng, Xu; Rong, Xiaohui; Zheng, Xuwei; Peng, Hongyu; Silber-Li, Zhanghua; Li, Mujun; Liu, Liyu

2015-06-01

Percutaneous coronary intervention (PCI), especially coronary stent implantation, has been shown to be an effective treatment for coronary artery disease. However, in-stent restenosis is one of the longstanding unsolvable problems following PCI. Although stents implanted inside narrowed vessels recover normal flux of blood flows, they instantaneously change the wall shear stress (WSS) distribution on the vessel surface. Improper stent implantation positions bring high possibilities of restenosis as it enlarges the low WSS regions and subsequently stimulates more epithelial cell outgrowth on vessel walls. To optimize the stent position for lowering the risk of restenosis, we successfully established a digital three-dimensional (3-D) model based on a real clinical coronary artery and analysed the optimal stenting strategies by computational simulation. Via microfabrication and 3-D printing technology, the digital model was also converted into in vitro microfluidic models with 3-D micro channels. Simultaneously, physicians placed real stents inside them; i.e., they performed “virtual surgeries”. The hydrodynamic experimental results showed that the microfluidic models highly inosculated the simulations. Therefore, our study not only demonstrated that the half-cross stenting strategy could maximally reduce restenosis risks but also indicated that 3-D printing combined with clinical image reconstruction is a promising method for future angiocardiopathy research.

Experimental Evaluation of a New Single Wire Stainless Steel Fishscale Coronary Stent (Freedomª).

PubMed

Wang; Verbeken; Mukherjee; Zhou; De Scheerder IK

1996-10-01

Recent randomized clinical trials revealed a significant reduction in angiographic restenosis rates when adjunctive stenting was performed after conventional coronary balloon angioplasty. Current approved coronary stents are however hampered by their rigidity, limiting their trackability in tortuous vessels and furthermore, needing high pressure deployment for optimal vessel apposition. New coronary stents are currently under development, using more biocompatible metal alloys and/or designs which better align to the vessel wall at moderate deployment pressures. We evaluated the safety, efficacy, angiographic and histological effect of a new stainless steel fishscale designed stent (Freedomª, Global Therapeutics, Co., USA) in a porcine coronary and peripheral artery model. Implantation in the right coronary artery was successful in all 20 pigs. Control angiograms at 6 weeks follow-up demonstrated patent vessels and morphologic evaluation showed only a mild fibromuscular neointimal response resulting in an area stenosis of 28.7 +/- 0.18% and a mean neointimal hyperplasia of 0.18 +/- 0.25 mm. Comparison with the Palmaz-Schatzª coronary stent in a porcine peripheral artery model demonstrated similar quantitative angiographic and morphologic vessel analysis results. Also the morphometric data were comparable. Area stenosis: Palmaz-Schatz: 37 +/- 0.24%, Freedom: 21 +/- 0.14%, p = 0.07. Mean neointimal hyperplasia: Palmaz-Schatz: 0.33 +/- 0.24 mm, Freedom: 0.18 +/- 0.08 mm, p = 0.08. CONCLUSION: Freedom coronary stent implantation in a porcine model resulted in a high procedural success without subacute thrombotic occlusions, despite no further anticoagulation nor antiplatelet therapy. Six weeks histopathological and morphometric evaluation demonstrated only a mild fibromuscular neointimal hyperplasia.

[ECG and ST-elevation myocardial infarction in multivessel coronary disease].

PubMed

Slavich, Gianaugusto; Spedicato, Leonardo; Poli, Stefano; Sappa, Roberta; Piccoli, Gianluca

2010-12-01

Percutaneous coronary intervention is the first-line treatment for ST-elevation myocardial infarction. In the setting of multivessel disease, concomitant reperfusion of all obstructed vessels is controversial, notably when the culprit vessel cannot be easily identified. We describe two cases with acute inferior-posterior myocardial infarction (ST-segment elevation in the inferior leads and ST-segment depression in the precordial leads). In the first case, angiography revealed severe three-vessel disease and the culprit vessel could not be identified. Following standard pharmacological therapy, the clinical picture and the ECG pattern improved, so that coronary revascularization was postponed. In the second case, angiography showed two-vessel disease with total occlusion of the right coronary and left circumflex arteries, which was treated with coronary angioplasty and drug-eluting stent implantation on the right coronary artery. In patients who undergo coronary angioplasty immediately, careful reading of the ECG can be a reliable tool for the identification of the culprit vessel in ST-elevation myocardial infarction associated with multivessel disease, allowing to choose the appropriate reperfusion strategy.

Stenting and surgery for coronary vasospasm : the wrong solution fails to solve the problem.

PubMed

Nedeljkovic, Milan A; Ostojic, Miodrag; Lalic, Nebojsa; Beleslin, Branko; Nedeljkovic, Ivana; Lalic, Katarina; Ristic, Miljko; Giga, Vojislav; Angelkov, Lazar; Tomasevic, Miloje; Kanjuh, Vladimir

2009-11-01

A 55-year-old man, with a history of medically uncontrolled coronary vasospasm, presented for evaluation of chest pain 6 months after implantation of left internal mammary artery. Due to recurrent episodes of vasospastic angina and serious complications of coronary spasm (ventricular fibrillation, myocardial infarction), a stent had previously been implanted in the proximal part of left anterior descending artery at the site of angiographically and ergonovine-proven coronary spasm, with subsequent in-stent restenosis.

Surface Topographical Modification of Coronary Stent: A Review

NASA Astrophysics Data System (ADS)

Tan, C. H.; Muhamad, N.; Abdullah, M. M. A. B.

2017-06-01

Driven by the urge of mediating the inflammatory response from coronary stent implant to improve patency rates of the current coronary stent, concern has been focusing on reducing the risk of in-stent restenosis and thrombosis for long-term safety. Surface modification approach has been found to carry great potential due to the surface is the vital parts that act as a buffer layer between the biomaterial and the organic material like blood and vessel tissues. Nevertheless, manipulating cell response in situ using physical patterning is very complex as the exact mechanism were yet elucidated. Thus, the aim of this review is to summarise the recent efforts on modifying the surface topography of coronary stent at the micro- and nanometer scale with the purpose of inducing rapid in situ endothelialization to regenerate a healthy endothelium layer on biomaterial surface. In particular, a discussion on the surface patterns that have been investigated on cell selective behaviour together with the methods used to generate them are presented. Furthermore, the probable future work involving the surface modification of coronary stent were indicated.

Unprotected Left Main Disease: Indications and Optimal Strategies for Percutaneous Intervention.

PubMed

Li, Jun; Patel, Sandeep M; Parikh, Manish A; Parikh, Sahil A

2016-03-01

Although the incidence of left main (LM) coronary artery disease is relatively low in patients undergoing routine angiography, it is a common presentation in patients with acute coronary syndromes. With the current interventional tools and techniques, percutaneous intervention for LM disease has become a viable alternative to the traditional coronary artery bypass grafting. Factors that contribute to the success and appropriateness of percutaneous intervention for LM disease include coronary anatomy and patient-specific factors such as left ventricular function. Multiple considerations should be taken into account prior to intervention, including hemodynamic support if necessary, intravascular imaging to guide therapy, and stent technique. This review provides an overview of the current body of literature to support the use of percutaneous intervention in LM disease and serves as guideline for the interventionalist approaching LM revascularization.

Impact of lesion morphology and associated procedures for left main coronary stenting on angiographic outcome after intervention: sub-analysis of Heart Research Group of Kanazawa, HERZ, Study.

PubMed

Kawashiri, Masa-aki; Sakata, Kenji; Uchiyama, Katsuharru; Konno, Tetsuo; Namura, Masanobu; Mizuno, Sumio; Tatami, Ryozo; Kanaya, Honin; Nitta, Yutaka; Michishita, Ichiro; Hirase, Hiroaki; Ueda, Kosei; Aoyama, Takashi; Okeie, Kazuyasu; Haraki, Tatsuo; Mori, Kiyoo; Araki, Tsutomu; Minamoto, Masaharu; Oiwake, Hisanori; Ino, Hidekazu; Hayashi, Kenshi; Yamagishi, Masakazu

2014-04-01

Whether the lesion morphology and associated interventional procedures for the left main coronary artery disease (LMCA) could affect clinical outcome is still controversial. Therefore, we examined the impact of lesion morphology and associated procedures on clinical and angiographic outcomes of stenting for the LMCA. Among 7,660 patients with coronary intervention registered, we analyzed early angiographic results of 228 patients (179 men, mean age 69.4 years) concerned with LMCA lesions. In 121 out of 228 patients having long-term angiographic results, we examined the occurrence of major adverse coronary events (MACE) particularly in terms of the presence of acute coronary syndrome (ACS), the kind of stents, bear metal or drug eluting, the lesion morphology and associated procedures. Early angiographic success rate of LMCA stenting was 100 %, and clinical success rate was 94.3 %. During follow-up period for 3 years, MACE was observed in 17 patients. Under these conditions, multiple stenting (p < 0.01) and complicated procedures such as such as Y-stent, T-stent and crush stent (p < 0.01) were listed as risks for MACE, although there was no statistical difference in kinds of stent. Multivariate analysis demonstrated the significant disadvantage of complicated procedures using the bear metal stent on the occurrence of MACE (p < 0.01). These results demonstrate that the complicated procedures have great impact on clinical and angiographic outcomes after stenting for LMCA lesions, and suggest the simple procedure with a single stent for LMCA lesions in the present cohort. Whether the presence of ACS can affect the prognosis should further be sought.

Sirolimus eluting stent (Cypher) in patients with diabetes mellitus: results from the German Cypher Stent Registry.

PubMed

Weber, Frank D; Schneider, Henrik; Wiemer, Marcus; Pfannebecker, Thomas; Tebbe, Ulrich; Hamm, Christian W; Senges, Jochen; Schneider, Steffen; Nienaber, Christoph A

2008-02-01

Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary. 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS). The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.

Percutaneous Coronary Intervention of Left Main Disease: Pre- and Post-EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) Era.

PubMed

Park, Duk-Woo; Park, Seung-Jung

2017-06-01

For nearly half a century, coronary artery bypass grafting has been the standard treatment for patients with obstructive left main coronary artery (LMCA) disease. However, there has been considerable evolution in the field of percutaneous coronary intervention, and especially, percutaneous coronary intervention for LMCA disease has been rapidly expanded with adoption of drug-eluting stents. Some, but not all randomized trials, have shown that percutaneous coronary intervention with drug-eluting stents might be a suitable alternative for selected patients with LMCA disease instead of bypass surgery. However, none of previous trials involving early-generation drug-eluting stents was sufficiently powered and comparative trials using contemporary drug-eluting stents were limited. Recently, primary results of 2 new trials of EXCEL (Evaluation of XIENCE Everolimus Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) and NOBLE (Nordic-Baltic-British Left Main Revascularization Study) were reported. However, these trials showed conflicting results, which might pose uncertainty on the optimal revascularization strategy for LMCA disease. In this article, with the incorporation of a key review on evolution of LMCA treatment, we summarize the similarity or disparity of the EXCEL and NOBLE trials, focus on how they relate to previous trials in the field, and finally speculate on how the treatment strategy may be changed or recommended for LMCA treatment. © 2017 American Heart Association, Inc.

Two-year safety and effectiveness of sirolimus-eluting stents (from a prospective registry).

PubMed

Claessen, Bimmer E; Mehran, Roxana; Leon, Martin B; Heller, Eric A; Weisz, Giora; Syros, George; Mintz, Gary S; Franklin-Bond, Theresa; Apostolidou, Irene; Henriques, Jose P S; Stone, Gregg W; Moses, Jeffrey W; Dangas, George D

2011-02-15

Uncertainty exists about the long-term safety and efficacy outcomes of sirolimus-eluting stents (SESs) in unselected patients. The present study was performed to evaluate the safety and efficacy of the SES in treatment of patients with coronary artery disease in an unselected population. Over a 2-year period, 1,504 consecutive patients undergoing percutaneous coronary intervention with ≥1 SES were enrolled. The primary end point was the occurrence of target vessel failure (TVF; a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization). An independent clinical event committee adjudicated all adverse events up to 2-year follow-up. Dual antiplatelet therapy was recommended for ≥1 year throughout the study period. Mean age was 65 ± 11 years; 75% were men, and 34% were diabetics. SESs were implanted for off-label indications in 86% of cases. TVF rates were 3.3%, 6.9%, 11.5%, and 15.5% at 30-day, 6-month, 1-year, and 2-year follow-ups, respectively. The 2-year cumulative rate of definite/probable stent thrombosis was 0.9%; 0.2% was very late thrombosis, occurring from 1 year to 2 years. Patients off dual antiplatelet therapy at 6 months had a significantly increased rate of subsequent death from noncardiac causes. Patients off dual antiplatelet therapy at 1 year had a significantly decreased rate of subsequent clinically driven target lesion revascularization. In conclusion, use of SESs in unselected patients with coronary artery disease was associated with a low TVF rate at 2 years with an acceptable incidence of stent thrombosis. Copyright © 2011 Elsevier Inc. All rights reserved.

Impact of hepatitis B virus (HBV) infection on platelet response to clopidogrel in patients undergoing coronary stent implantation.

PubMed

Ying, Lianghong; Wang, Fei; Zhang, Jing; Yang, Lu; Gong, Xiaoxuan; Fan, Yuansheng; Xu, Ke; Li, Juan; Lu, Yi; Mei, Lianlian; Zhou, Zihao; Li, Chunjian

2018-04-19

Hepatitis B virus (HBV) infection has been reported to down-regulate the expression of CYP2C19 gene, which may decrease the bioactivation of clopidogrel into active metabolites. We aimed to evaluate the impact of HBV infection on platelet response to clopidogrel in patients undergoing coronary stent implantation. A total of 1805 patients who had received coronary stent implantation and taken aspirin 100 mg in combination with clopidogrel 75 mg daily ≥5 days were consecutively recruited. The serologic identifications for HBV, platelet aggregations in response to arachidonic acid (PL AA ) and adenosine diphosphate (PL ADP ), as well as ABCB1, CYP2C19, CYP3A5, PON1 and P2RY12 genotypes were determined. Clopidogrel low response (CLR) was defined as PL ADP  > 40%. Among the recruited subjects, 102 patients showed hepatitis B surface antigen (HBsAg) positive and 1703 patients negative. PL ADP was significantly higher in HBsAg positive group than that in HBsAg negative group [38 (24-48) % vs. 29 (20-39) %, p < 0.001] while the difference of PL AA was not statistically significant (p = 0.329). The incidence of CLR was significantly higher in HBsAg positive group compared with that in HBsAg negative group (43.1% vs. 23.4%, p < 0.001). After adjusted for CYP2C19 genotype and known risk factors, HBsAg positive patients exhibited a significantly higher risk of CLR (adjusted odds ratio: 2.81, 95% confidence interval: 1.73 to 4.58, p < 0.001). HBV infection is an independent risk factor of CLR, in addition to CYP2C19 gene mutations. (Pharmacogenetic and Pharmacokinetic Study of Clopidogrel; NCT01968499). Copyright © 2018. Published by Elsevier Ltd.

Multislice spiral computed tomography for the evaluation of stent patency after left main coronary artery stenting: a comparison with conventional coronary angiography and intravascular ultrasound.

PubMed

Van Mieghem, Carlos A G; Cademartiri, Filippo; Mollet, Nico R; Malagutti, Patrizia; Valgimigli, Marco; Meijboom, Willem B; Pugliese, Francesca; McFadden, Eugene P; Ligthart, Jurgen; Runza, Giuseppe; Bruining, Nico; Smits, Pieter C; Regar, Evelyn; van der Giessen, Willem J; Sianos, Georgios; van Domburg, Ron; de Jaegere, Peter; Krestin, Gabriel P; Serruys, Patrick W; de Feyter, Pim J

2006-08-15

Surveillance conventional coronary angiography (CCA) is recommended 2 to 6 months after stent-supported left main coronary artery (LMCA) percutaneous coronary intervention due to the unpredictable occurrence of in-stent restenosis (ISR), with its attendant risks. Multislice computed tomography (MSCT) is a promising technique for noninvasive coronary evaluation. We evaluated the diagnostic performance of high-resolution MSCT to detect ISR after stenting of the LMCA. Seventy-four patients were prospectively identified from a consecutive patient population scheduled for follow-up CCA after LMCA stenting and underwent MSCT before CCA. Until August 2004, a 16-slice scanner was used (n = 27), but we switched to the 64-slice scanner after that period (n = 43). Patients with initial heart rates > 65 bpm received beta-blockers, which resulted in a mean periscan heart rate of 57 +/- 7 bpm. Among patients with technically adequate scans (n = 70), MSCT correctly identified all patients with ISR (10 of 70) but misclassified 5 patients without ISR (false-positives). Overall, the accuracy of MSCT for detection of angiographic ISR was 93%. The sensitivity, specificity, and positive and negative predictive values were 100%, 91%, 67%, and 100%, respectively. When analysis was restricted to patients with stenting of the LMCA with or without extension into a single major side branch, accuracy was 98%. When both branches of the LMCA bifurcation were stented, accuracy was 83%. For the assessment of stent diameter and area, MSCT showed good correlation with intravascular ultrasound (r = 0.78 and 0.73, respectively). An intravascular ultrasound threshold value > or = 1 mm was identified to reliably detect in-stent neointima hyperplasia with MSCT. Current MSCT technology, in combination with optimal heart rate control, allows reliable noninvasive evaluation of selected patients after LMCA stenting. MSCT is safe to exclude left main ISR and may therefore be an acceptable first-line alternative to CCA.

Impact of P2Y12 inhibition by clopidogrel on cardiovascular mortality in unselected patients treated by percutaneous coronary angioplasty: a prospective registry.

PubMed

El Ghannudi, Soraya; Ohlmann, Patrick; Meyer, Nicolas; Wiesel, Marie-Louise; Radulescu, Bogdan; Chauvin, Michel; Bareiss, Pierre; Gachet, Christian; Morel, Olivier

2010-06-01

The aim of this study was to determine whether low platelet response to the P2Y(12) receptor antagonist clopidogrel as assessed by Vasodilator-stimulated phosphoprotein flow cytometry test (VASP- FCT) predicts cardiovascular events in a high-risk population undergoing percutaneous coronary intervention (PCI). Impaired platelet responsiveness to clopidogrel is thought to be a determinant of cardiovascular events after PCI. The platelet VASP-FCT is a new assay specific to the P2Y(12) adenosine diphosphate receptor-pathway. In this test, platelet activation is expressed as platelet reactivity index (PRI). Four-hundred sixty-one unselected patients undergoing urgent (n = 346) or planned (n = 115) PCI were prospectively enrolled. Patients were classified as low-response (LR) and response (R) to clopidogrel, depending on their PRI. Optimal PRI cutoff was determined by receiver-operator characteristic curve analysis to 61% (LR: PRI > or =61% and R: PRI <61%). Follow-up was obtained at a mean of 9 +/- 2 months in 453 patients (98.3%). At follow-up, total cardiac mortality rates and possible and total stent thrombosis were higher in LR patients. Multivariate analysis identified creatinine clearance (hazard ratio [HR]: 0.95; 95% confidence interval [CI]: 0.93 to 0.98, p < 0.001), drug-eluting stent (HR: 5.73; 95% CI: 1.40 to 23.43, p = 0.015), C-reactive protein (HR: 1.01; 95% CI: 1.001 to 1.019, p = 0.024), and LR to clopidogrel (HR: 4.00; 95% CI: 1.08 to 14.80, p = 0.037) as independent predictors of cardiac death. The deleterious impact of LR to clopidogrel on cardiovascular death was significantly higher in patients implanted with drug-eluting stent. In patients undergoing PCI, LR to clopidogrel assessed by VASP-FCT is an independent predictor of cardiovascular death at the PRI cutoff value of > or =61%. The LR clinical impact seems to be dependent on the type of stent implanted. Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study)☆

PubMed Central

Legutko, Jacek; Zasada, Wojciech; Kałuża, Grzegorz L.; Heba, Grzegorz; Rzeszutko, Lukasz; Jakala, Jacek; Dragan, Jacek; Klecha, Artur; Giszterowicz, Dawid; Dobrowolski, Wojciech; Partyka, Łukasz; Jayaraman, Swaminathan; Dudek, Dariusz

2013-01-01

Aims Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. Methods and results Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. Conclusions In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up. PMID:23992999

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

PubMed

Chandra, Praveen; Kumar, Tarun

2014-01-01

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Behaviour of two typical stents towards a new stent evolution.

PubMed

Simão, M; Ferreira, J M; Mora-Rodriguez, J; Fragata, J; Ramos, H M

2017-06-01

This study explores the analysis of a new stent geometry from two typical stents used to treat the coronary artery disease. Two different finite element methods are applied with different boundary conditions to investigate the stenosis region. Computational fluid dynamics (CFD) models including fluid-structure interaction are used to assess the haemodynamic impact of two types of coronary stents implantation: (1) type 1-based on a strut-link stent geometry and (2) type 2-a continuous helical stent. Using data from a recent clinical stenosis, flow disturbances and consequent shear stress alterations introduced by the stent treatment are investigated. A relationship between stenosis and the induced flow fields for the two types of stent designs is analysed as well as the correlation between haemodynamics and vessel wall biomechanical factors during the initiation and development of stenosis formation in the coronary artery. Both stents exhibit a good performance in reducing the obstruction artery. However, stent type 1 presents higher radial deformation than the type 2. This deformation can be seen as a limitation with a long-term clinical impact.

Biomechanical analysis on stent materials used as cardiovascular implants

NASA Astrophysics Data System (ADS)

Kumar, Vasantha; Ramesha, C. M.; Sajjan, Sudheer S.

2018-04-01

Atherosclerosis is the most common cause of death in the world, accounting for 48% of all deaths in the world. Atherosclerosis, also known as coronary artery disease occurs when excess cholesterol attaches itself to the walls of blood vessels. Coronary stent implantation is one of the most important procedures to treating coronary artery disease such atherosclerosis. Due to its efficiency, flexibility and simplicity, the use of coronary stents procedures has increased rapidly. In order to have better output of stent implantation, it is needed to study and analyze the biomechanical behavior of this device before manufacturing and put into use. Biomaterials are commonly used for medical application in cardiovascular stent implantation. A biomaterial is a non-viable material used as medical implant, so it is intended to interact with biological system. In this paper, an explicit dynamic analysis is used for analyzing the biomechanical behavior of cardiovascular stent by using finite element analysis tool, ABAQUS 6.10. Results showed that a best suitable biomaterial for cardiovascular stent implants, which exhibits an outstanding biocompatibility and biomechanical characteristics will be aimed at which will be quite useful to the human beings worldwide.

Cost-effectiveness analysis of biodegradable polymer versus durable polymer drug-eluting stents incorporating real-world evidence.

PubMed

Teng, Monica; Zhao, Ying Jiao; Khoo, Ai Leng; Ananthakrishna, Rajiv; Yeo, Tiong Cheng; Lim, Boon Peng; Chan, Mark Y; Loh, Joshua P

2018-06-05

Compared with second-generation durable polymer drug-eluting stents (DP-DES), the cost-effectiveness of biodegradable polymer drug-eluting stents (BP-DES) remains unclear in the real-world setting. We assessed the cost-effectiveness of BP-DES in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). We developed a decision-analytic model to compare the cost-effectiveness of BP-DES to DP-DES over one year and five years from healthcare payer perspective. Relative treatment effects during the first year post-PCI were obtained from a real-world population analysis while clinical event risks in the subsequent four years were derived from a meta-analysis of published studies. At one year, based on the clinical data analysis of 497 propensity-score matched pairs of patients, BP-DES were associated with an incremental cost-effectiveness ratio (ICER) of USD20,503 per quality-adjusted life-year (QALY) gained. At five years, BP-DES yielded an ICER of USD4,062 per QALY gained. At the willingness-to-pay threshold of USD50,400 (one gross domestic product per capita in Singapore in 2015), BP-DES were cost-effective. Sensitivity analysis showed that the cost of stents had a significant impact on the cost-effectiveness of BP-DES. Threshold analysis demonstrated that if the cost difference between BP-DES and DP-DES exceeded USD493, BP-DES would not be cost-effective in patients with one-year of follow-up. BP-DES were cost-effective compared with DP-DES in patients with coronary artery disease at one year and five years after PCI. It is worth noting that the cost of stents had a significant impact on the findings. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Computational fluid dynamics evaluation of incomplete stent apposition in a tapered artery

NASA Astrophysics Data System (ADS)

Poon, Eric; Thondapu, Vikas; Ooi, Andrew; Hayat, Umair; Barlis, Peter; Moore, Stephen

2015-11-01

Coronary stents are deployed to prop open blocked arteries and restore normal blood flow, however in-stent restenosis (ISR) and stent thrombosis (ST) remain possibly catastrophic complications. Computational fluid dynamics (CFD) analyses can elucidate the pathological impact of alterations in coronary hemodynamics and correlate wall shear stress (WSS) with atherosclerotic processes. The natural tapering of a coronary artery often leads to proximal incomplete stent apposition (ISA) where stent struts are not in contact with the vessel wall. By employing state-of-the-art computer-aided design (CAD) software, generic open-cell and closed-cell coronary stent designs were virtually deployed in an idealised tapered coronary artery. Pulsatile blood flow (80 mL/min at 75 beats/min) was carried out numerically on these CAD models using a finite volume solver. CFD results reveal significant fluctuations in proximal WSS and large recirculation regions in the setting of proximal ISA, resulting in regions of high wall shear stress gradient (WSSG) that have been previously linked to poor endothelial cell coverage and vascular injury. The clinical significance of these proximal high WSSG regions will be correlated with findings from high-resolution in-vivo imaging. Supported by the Australian Research Council (LP120100233) and Victorian Life Sciences Computation Initiative (VR0210).

Perioperative antiplatelet management in patients with coronary artery stenting.

PubMed

Tandar, Anwar; Velagapudi, Krishna N; Wilson, Brent D; Boden, William E

2012-04-01

Coronary artery disease is the primary cause of mortality in men and women in the United States. Transcatheter coronary intervention is the mainstay of treatment for patients with acute coronary artery disease presentations and patients with stable disease. Although percutaneous intervention initially only included balloon angioplasty, it now typically involves the placement of intracoronary stents. To overcome the limitations of bare-metal stents, namely in-stent restenosis, stents have been developed that remove pharmaceuticals that reduce neointimal hyperplasia and in-stent restenosis. However, these pharmaceutical agents also delay stent endothelialization, posing a prolonged risk of in situ thrombosis. Placement of an intracoronary stent (eg, bare-metal or drug-eluting stent) requires dual antiplatelet therapy to prevent the potentially life-threatening complication of stent thrombosis. The optimal duration of dual antiplatelet therapy following stent placement is unknown. This article discusses the factors to be considered when deciding when dual antiplatelet therapy can be safely discontinued. Unfortunately, in the hospital setting, this decision to interrupt dual antiplatelet therapy frequently must be made shortly after stent placement because of unanticipated surgical procedures or other unforeseen complications. The decision of when dual antiplatelet therapy can be safely interrupted needs to be individualized for each patient and involves factoring in the type of stent; the location and complexity of the lesion stented; post-stent lesion characteristics; the amount of time since stent placement; and the antiplatelet regimen currently in use, along with its implication for bleeding during the proposed procedure. Having a protocol in place, such as the protocol described in this article, can help guide this decision-making process and avoid confusion and potential error.

Temporal trends in the use of drug-eluting stents for approved and off-label indications: a longitudinal analysis of a large multicenter percutaneous coronary intervention registry.

PubMed

Gualano, Sarah K; Gurm, Hitinder S; Share, David; Smith, Dean; Aronow, Herbert D; LaLonde, Thomas; Bates, Eric R; Changezi, Hameem; McNamara, Richard; Moscucci, Mauro

2010-02-01

We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC). To determine whether the decrease in use of DES has affected both on and off-label indications. The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated. The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected, though it also fell 25% (from 79%-56%). The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies. Copyright 2010 Wiley Periodicals, Inc.

Bioresorbable scaffolds for percutaneous coronary interventions

PubMed Central

Gogas, Bill D.

2014-01-01

Innovations in drug-eluting stents (DES) have substantially reduced rates of in-segment restenosis and early stent thrombosis, improving clinical outcomes following percutaneous coronary interventions (PCI). However a fixed metallic implant in a vessel wall with restored patency and residual disease remains a precipitating factor for sustained local inflammation, in-stent neo-atherosclerosis and impaired vasomotor function increasing the risk for late complications attributed to late or very late stent thrombosis and late target lesion revascularization (TLR) (late catch-up). The quest for optimal coronary stenting continues by further innovations in stent design and by using biocompatible materials other than cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding, local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics have been recently developed. These devices have been utilized in selected clinical applications so far providing preliminary evidence of safety showing comparable performance with current generation drug-eluting stents (DES). Herein we provide a comprehensive overview of the current status of these technologies, we elaborate on the potential benefits of transient coronary scaffolds over permanent stents in the context of vascular reparation therapy, and we further focus on the evolving challenges these devices have to overcome to compete with current generation DES. Condensed Abstract:: The quest for optimizing percutaneous coronary interventions continues by iterative innovations in device materials beyond cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding; local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics were recently developed. These devices have been utilized in selected clinical applications providing preliminary evidence of safety showing comparable intermediate term clinical outcomes with current generation drug-eluting stents. PMID:25780795

Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries: the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination part II (BASKET-PROVE II) trial design.

PubMed

Jeger, Raban; Pfisterer, Matthias; Alber, Hannes; Eberli, Franz; Galatius, Søren; Naber, Christoph; Pedrazzini, Giovanni; Rickli, Hans; Jensen, Jan Skov; Vuilliomenet, André; Gilgen, Nicole; Kaiser, Christoph

2012-02-01

In the BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination (BASKET-PROVE), drug-eluting stents (DESs) had similar 2-year rates of death and myocardial infarction but lower rates of target vessel revascularization and major adverse cardiac events compared with bare-metal stents (BMSs). However, comparative clinical effects of newest-generation DES with biodegradable polymers vs second-generation DES or newest-generation BMS with biocompatible coatings, all combined with a prasugrel-based antiplatelet therapy, on 2-year outcomes are not known. In BASKET-PROVE II, 2,400 patients with de novo lesions in native vessels ≥3 mm in diameter are randomized 1:1:1 to receive a conventional DES, a DES with a biodegradable polymer, or a BMS with biocompatible coating. In addition to aspirin, stable patients with BMS will receive prasugrel for 1 month, whereas all others will receive prasugrel for 12 months. The primary end point will be combined cardiac death, nonfatal myocardial infarction, and target vessel revascularization up to 2 years. Secondary end points include stent thrombosis and major bleeding. The primary aim is to test (1) the noninferiority of a biodegradable-polymer DES to a conventional DES and (2) the superiority of both DESs to BMS. A secondary aim is to compare the outcomes with those of BASKET-PROVE regarding the effects of prasugrel-based vs clopidogrel-based antiplatelet therapy. By the end of 2010, 878 patients (37% of those planned) were enrolled. This study will test the comparative long-term safety and efficacy of newest-generation stents on the background of contemporary antiplatelet therapy in a large all-comer population undergoing large native coronary artery stenting. Copyright © 2012 Mosby, Inc. All rights reserved.

Clinical presentation and outcomes of coronary in-stent restenosis across 3-stent generations.

PubMed

Magalhaes, Marco A; Minha, Sa'ar; Chen, Fang; Torguson, Rebecca; Omar, Al Fazir; Loh, Joshua P; Escarcega, Ricardo O; Lipinski, Michael J; Baker, Nevin C; Kitabata, Hironori; Ota, Hideaki; Suddath, William O; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2014-12-01

Clinical presentation of bare metal stent in-stent restenosis (ISR) in patients undergoing target lesion revascularization is well characterized and negatively affects on outcomes, whereas the presentation and outcomes of first- and second-generation drug-eluting stents (DESs) remains under-reported. The study included 909 patients (1077 ISR lesions) distributed as follows: bare metal stent (n=388), first-generation DES (n=425), and second-generation DES (n=96), categorized into acute coronary syndrome (ACS) or non-ACS presentation mode at the time of first target lesion revascularization. ACS was further classified as myocardial infarction (MI) and unstable angina. For bare metal stent, first-generation DES and second-generation DES, ACS was the clinical presentation in 67.8%, 71.0%, and 66.7% of patients, respectively (P=0.470), whereas MI occurred in 10.6%, 10.1%, and 5.2% of patients, respectively (P=0.273). The correlates for MI as ISR presentation were current smokers (odds ratio, 3.02; 95% confidence interval [CI], 1.78-5.13; P<0.001), and chronic renal failure (odds ratio, 2.73; 95% CI, 1.60-4.70; P<0.001), with a protective trend for the second-generation DES ISR (odds ratio, 0.35; 95% CI, 0.12-1.03; P=0.060). ACS presentations had an independent effect on major adverse cardiac events (death, MI, and re-target lesion revascularization) at 6 months (MI versus non-ACS: adjusted hazard ratio, 4.06; 95% CI, 1.84-8.94; P<0.001; unstable angina versus non-ACS: adjusted hazard ratio, 1.98; 95% CI, 1.01-3.87; P=0.046). ISR clinical presentation is similar irrespective of stent type. MI as ISR presentation seems to be associated with patient and not device-related factors. ACS as ISR presentation has an independent effect on major adverse cardiac events, suggesting that ISR remains a hazard and should be minimized. © 2014 American Heart Association, Inc.

Economic evaluation of drug-eluting stents in coronary angioplasty.

PubMed

Santos, Ricardo; Pereira, Hélder

2005-11-01

Coronary angioplasty has revolutionized the treatment of coronary artery disease, from the first balloon angioplasty to the current era of drug-eluting stents (DES), which were developed to eliminate the bare metal stent's (BMS) Achilles' heel, restenosis. DES have an extremely low restenosis rate but are significantly more expensive and need more prolonged dual antiplatelet therapy. Restenosis has a generally benign prognosis and is not associated with higher mortality or major adverse cardiovascular events, which has limited the penetration of DES, whose only advantage is the reduction of restenosis. Economic evaluation of DES is therefore of paramount importance for assessing their appropriate use. In randomized trials in which they are compared with BMS, economic evaluation is advantageous for DES, with good cost-effectiveness ratios for both cost per quality-adjusted life year (QALY) and cost per revascularization avoided. However, these trials have two major limitations--the angiographic follow-up protocol and selection of patients with lower risk--and so their results do not accurately reflect reality. Other studies with unselected populations and cost-effectiveness models show that there is an economic advantage in the use of DES in groups with higher risk of restenosis, but not for the whole population undergoing angioplasty. Use of DES will be more appropriate if we can identify populations with a higher likelihood of restenosis, because these are the patients that will benefit most from their use and in whom they will be economically advantageous.

Genous™ endothelial progenitor cell capturing stent vs. the Taxus Liberté stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study

PubMed Central

Beijk, Marcel A.M.; Klomp, Margo; Verouden, Niels J.W.; van Geloven, Nan; Koch, Karel T.; Henriques, José P.S.; Baan, Jan; Vis, Marije M.; Scheunhage, Esther; Piek, Jan J.; Tijssen, Jan G.P.; de Winter, Robbert J.

2010-01-01

Aims The purpose of this study was to evaluate the GenousTM endothelial progenitor cell capturing stent vs. the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions with a high-risk of coronary restenosis. Methods and results We randomly assigned 193 patients with lesions carrying a high risk of restenosis to have the Genous stent or the Taxus stent implanted. Lesions were considered high risk of restenosis if one of the following applied: chronic total occlusion, lesion length >23 mm, vessel diameter <2.8 mm, or any lesion in a diabetic patient. At 1-year, the rate of the primary end point, target vessel failure (TVF), was 17.3% in the Genous stent group when compared with 10.5% in the Taxus stent group [risk difference (RD) 6.8%, 95% CI −3.1 to 16.7%], a difference predominantly due to a higher incidence of repeat revascularization in patients treated with the Genous stent. In contrast, no stent thrombosis was observed in the Genous stent group compared to 4 stent thromboses in the Taxus stent group (RD −4.2%; 95% CI −10.3 to 0.3%). Repeat angiography between 6 and 12 months in a subgroup of patients showed a significantly higher late loss in the Genous stent compared with the Taxus stent (1.14 ± 0.64 and 0.55 ± 0.61 mm). Conclusion In patients with lesions carrying a high risk of restenosis, the Genous stent resulted in a non-significant higher rate of TVF compared with the Taxus stent mainly due to more repeat revascularizations in the Genous stent group. There were four stent thromboses with Taxus stent, none with the Genous stent. PMID:19933225

Study design and baseline characteristics of the national observational study of diagnostic and interventional cardiac catheterization by the French Society of Cardiology.

PubMed

Puymirat, Etienne; Blanchard, Didier; Perier, Marie-Cécile; PiaDonataccio, Maria; Gilard, Martine; Lefèvre, Thierry; Mulak, Geneviève; le Breton, Hervé; Danchin, Nicolas; Spaulding, Christian; Jouven, Xavier

2013-08-01

The national observational study of diagnostic and interventional cardiac catheterization (ONACI) is a prospective multicenter registry of the French Society of Cardiology including all interventional cardiology procedures performed from 2004. We aimed to evaluate "real-world" management of patients with coronary artery disease in France from this registry. The present study was focused on data collected from 2004 to 2008. Patient demographics and co-morbidities, invasive parameters, treatment options, and procedural techniques were prospectively collected. Patients were recruited from 99 hospitals (55% of patients were hospitalized in private clinics and 45% in public institutions). During a 5-year period, a total of 298,105 patients underwent coronary angiography and 176,166 patients underwent percutaneous coronary intervention. Diagnosis was acute coronary syndrome in 22%, stable angina or silent ischemia in 23%, and atypical chest pain in 9% of cases. Normal coronary arteries or nonsignificant coronary narrowing were found in 26% of patients. Radial access was increasingly used over the years regardless of the indication. The average number of percutaneous coronary interventions per procedure was 1.5 ± 0.7 (range, 1.3 ± 0.7 to 1.5 ± 0.7) and that of stents per procedure was 1.5 ± 0.8 (range, 1.5 ± 0.8 to 1.6 ± 0.8). Drug-eluting stents were used in 45% (range, 34% to 62%), increasing from 2004 to 2006, and then decreasing after the 2006 controversy. In conclusion, ONACI is one of the largest catheterization registries during this period, providing a detailed and comprehensive global description of the spectrum and management of patients with suspected coronary artery disease undergoing cardiac catheterization. Copyright © 2013 Elsevier Inc. All rights reserved.

Randomized comparison of deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents.

PubMed

Thuesen, Leif; Galløe, Anders; Thayssen, Per; Rasmussen, Klaus; Kelbæk, Henning; Lassen, Jens Flensted; Hansen, Peter Riis; Pedersen, Knud Erik; Ravkilde, Jan; Helquist, Steffen; Abildgaard, Ulrik; Andersen, Henning Rud; Bøtker, Hans Erik; Kristensen, Steen Dalby; Hjort, Jacob; Krusell, Lars Romer

2005-11-01

To compare deliverability and in-hospital complications in implantation of BxSonic(R), Express(R), and Flexmaster(R) coronary stents in a randomized multicenter trial in five Danish interventional centres. Patients with planned stenting of at least one stenotic lesion in a native coronary artery were included in the study. There were 494 (664) patients (treated lesions) in the BxSonic(R), 499 (657) in the Express(R) and 500 (658) in the Flexmaster(R) groups. The groups were well matched with regard to age, sex, diabetes, smoking, hypercholesterolemia, hypertension, indication for PCI and coronary artery lesion complexity. The study stents were implanted with or without predilatation according to ordinary -clinical practice.Rates of successful stent implantation and in-hospital stent thrombosis, re-intervention, non-fatal myocardial infarction or death. The BxSonic(R), Express(R) and Flexmaster(R) stents were successfully implanted in 92,2%, 89,3% and 91,6% of all lesions (ns). There were no in-hospital deaths and the rates of in-hospital complications were similar in the three stent groups. We found similar deliverability and in-hospital complication rates of the BxSonic(R), Express(R) and Flexmaster(R) stents.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

PubMed

Stone, Gregg W; Sabik, Joseph F; Serruys, Patrick W; Simonton, Charles A; Généreux, Philippe; Puskas, John; Kandzari, David E; Morice, Marie-Claude; Lembo, Nicholas; Brown, W Morris; Taggart, David P; Banning, Adrian; Merkely, Béla; Horkay, Ferenc; Boonstra, Piet W; van Boven, Ad J; Ungi, Imre; Bogáts, Gabor; Mansour, Samer; Noiseux, Nicolas; Sabaté, Manel; Pomar, José; Hickey, Mark; Gershlick, Anthony; Buszman, Pawel; Bochenek, Andrzej; Schampaert, Erick; Pagé, Pierre; Dressler, Ovidiu; Kosmidou, Ioanna; Mehran, Roxana; Pocock, Stuart J; Kappetein, A Pieter

2016-12-08

Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).

Evaluation of a bifurcation drug-eluting stent system versus provisional T-stenting in a perfused synthetic coronary artery model.

PubMed

Rizik, David G; Klag, Joseph M; Tenaglia, Alan; Hatten, Thomas R; Barnhart, Marianne; Warnack, Boris

2009-12-01

Provisional T-stenting is a widely used strategy for the treatment of coronary artery bifurcation lesions. However, the use of conventional stents in this setting is limited by multiple factors; this includes technical considerations such as wire wrap when accessing the involved vessel, and stent overlap at or near the carina of the lesion. In addition, current slotted tube stent technology tends to be associated with gaps in the coverage of the side branch ostium, which may result in restenosis in that segment of the lesion. The Pathfinder device, now more commonly referred to as the Xience Side Branch Access System (Xience SBA) is a drug-eluting stent (DES) designed specifically to assist in the treatment of bifurcation lesions by allowing wire access into the side branch, irrespective of the treatment strategy to be employed. The Xience SBA drug-eluting stent was compared with the standard Vision coronary stent system using a provisional T-stenting strategy in a perfused synthetic model of the coronary vasculature with side branch angulations of 30 degrees , 50 degrees , 70 degrees , and 90 degrees . Stent delivery was performed under fluoroscopic guidance. Following the procedure, high-resolution 2D Faxitron imaging was used to evaluate deployment accuracy of the side branch stent relative to the main branch stent. Deployment of the Xience SBA was accomplished in the same total time as the standard stents in a provisional T-stenting approach (14.9 vs. 14.6 minutes). However, the time required to achieve stent deployment in the main branch was less with the Xience SBA (4.0 vs. 6.6 minutes), and as a result, total contrast usage (49.4 vs. 69.4 cm(3)) and fluoroscopy time (5.1 vs. 6.2 minutes) was lower. Additionally, the Xience SBA had a lower incidence of wire wrap (22% vs. 89%) and less distal protrusion of the side branch stent into the main branch (0.54 vs. 1.21 mm). Significant gaps in ostial side branch coverage were not seen in either group. The Xience Side Branch Access DES is a viable device for consistently accessing coronary bifurcation lesions; it allows for easy wire access into the side branch. This may assist the operator in overcoming those well-recognized limitations associated with use of standard one- or two-stent strategies. In this perfused synthetic coronary model, Xience SBA deployment required less contrast usage and shorter fluoroscopy times. Further testing of this device is warranted.

Computer Simulation of the Mechanical Behaviour of Implanted Biodegradable Stents in a Remodelling Artery

NASA Astrophysics Data System (ADS)

Boland, Enda L.; Grogan, James A.; Conway, Claire; McHugh, Peter E.

2016-04-01

Coronary stents have revolutionised the treatment of coronary artery disease. While coronary artery stenting is now relatively mature, significant scientific and technological challenges still remain. One of the most fertile technological growth areas is biodegradable stents; here, there is the possibility to generate stents that will break down in the body once the initial necessary scaffolding period is past (6-12 months) (Grogan et al. in Acta Biomater 7:3523, 2011) and when the artery has remodelled (including the formation of neo-intima). A stent angioplasty computational test-bed has been developed by the authors, based on the Abaqus software (DS-SIMULIA, USA), capable of simulating stent tracking, balloon expansion, recoil and in vivo loading in a atherosclerotic artery model. Additionally, a surface corrosion model to simulate uniform and pitting corrosion of biodegradable stents and a representation of the active response of the arterial tissue following stent implantation, i.e. neointimal remodelling, has been developed. The arterial neointimal remodelling simulations with biodegradable stent corrosion demonstrate that the development of new arterial tissue around the stent struts has a substantial effect on the mechanical behaviour of degrading stents.

Conformability of balloon-expandable stents to the carotid siphon: an in vitro study.

PubMed

du Mesnil de Rochemont, R; Yan, B; Zanella, F E; Rüfenacht, D A; Berkefeld, J

2006-02-01

Endovascular placement of coronary balloon-expandable stents in patients with recurrent cerebral ischemia has emerged as a treatment option for intracranial arterial occlusive disease. We have developed an in vitro model matching the tortuous curve of the carotid siphon that allows the assessment of apposition of stents to a curved vessel wall. Six types of balloon-expandable coronary stents were implanted in a silicone model of the carotid siphon. Digital radiographs and 3D rotational angiograms were obtained. Stent morphology was evaluated and the degree of apposition between stent and wall of the model was measured on a digital workstation. All 6 stents showed lack of apposition between stent and the wall at the convexity of the anterior segment of the carotid siphon and the wall at the concavity at both extremities of the stent. In and around the curve, the modules of the stents did not expand completely to their nominal diameter and were distorted to an oval shape. The tested coronary balloon-expandable stents did not completely conform to the vessel wall of the model of the carotid siphon and further development is needed to approach the goal of an "ideal intracranial stent."

Computational fluid dynamics analysis of balloon-expandable coronary stents: influence of stent and vessel deformation.

PubMed

Martin, David M; Murphy, Eoin A; Boyle, Fergal J

2014-08-01

In many computational fluid dynamics (CFD) studies of stented vessel haemodynamics, the geometry of the stented vessel is described using non-deformed (NDF) geometrical models. These NDF models neglect complex physical features, such as stent and vessel deformation, which may have a major impact on the haemodynamic environment in stented coronary arteries. In this study, CFD analyses were carried out to simulate pulsatile flow conditions in both NDF and realistically-deformed (RDF) models of three stented coronary arteries. While the NDF models were completely idealised, the RDF models were obtained from nonlinear structural analyses and accounted for both stent and vessel deformation. Following the completion of the CFD analyses, major differences were observed in the time-averaged wall shear stress (TAWSS), time-averaged wall shear stress gradient (TAWSSG) and oscillatory shear index (OSI) distributions predicted on the luminal surface of the artery for the NDF and RDF models. Specifically, the inclusion of stent and vessel deformation in the CFD analyses resulted in a 32%, 30% and 31% increase in the area-weighted mean TAWSS, a 3%, 7% and 16% increase in the area-weighted mean TAWSSG and a 21%, 13% and 21% decrease in the area-weighted mean OSI for Stents A, B and C, respectively. These results suggest that stent and vessel deformation are likely to have a major impact on the haemodynamic environment in stented coronary arteries. In light of this observation, it is recommended that these features are considered in future CFD studies of stented vessel haemodynamics. Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.

Interaction of intraluminal tissue and coronary sinus lead stabilized with stent placement.

PubMed

Balázs, Tibor; Merkely, Béla; Bognár, Eszter; Zima, Endre

2013-04-01

The aim of our investigation was to examine the intraluminal interaction of the vascular tissue and the implanted coronary sinus lead stabilized with stent on two human hearts removed before transplantation. The coronary sinus lumen was sectioned under operational microscope and opened carefully. The leads and stents were found separately positioned beside each other completely covered by an intact intimal tissue layer. No sign of occluding proliferative tissue was observed. Stent fixation technique and extraction of the CS lead in our cases did not have any particular damaging effect on the vascular system. © 2012 Wiley Periodicals, Inc.

A practical method to rapidly dissolve metallic stents.

PubMed

Bradshaw, Scott H; Kennedy, Lloyd; Dexter, David F; Veinot, John P

2009-01-01

Metallic stents are commonly used in many clinical applications including peripheral vascular disease intervention, biliary obstruction, endovascular repair of aneurysms, and percutaneous coronary interventions. In the examination of vascular stent placement, it is important to determine if the stent is open or has become obstructed. This is increasingly important in the era of drug-eluting stent usage in coronary arteries. We describe a practical, rapid and cost-effective method to dissolve most metallic stents leaving the vascular and luminal tissues intact. This practical method may replace the laborious and expensive plastic embedding methods currently utilized.

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial.

PubMed

Brilakis, Emmanouil S; Edson, Robert; Bhatt, Deepak L; Goldman, Steven; Holmes, David R; Rao, Sunil V; Shunk, Kendrick; Rangan, Bavana V; Mavromatis, Kreton; Ramanathan, Kodangudi; Bavry, Anthony A; Garcia, Santiago; Latif, Faisal; Armstrong, Ehrin; Jneid, Hani; Conner, Todd A; Wagner, Todd; Karacsonyi, Judit; Uyeda, Lauren; Ventura, Beverly; Alsleben, Aaron; Lu, Ying; Shih, Mei-Chiung; Banerjee, Subhash

2018-05-19

Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. US Department of Veterans Affairs Cooperative Studies Program. Copyright © 2018 Elsevier Ltd. All rights reserved.

Ezetimibe in Combination With Statins Ameliorates Endothelial Dysfunction in Coronary Arteries After Stenting: The CuVIC Trial (Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction After Coronary Stenting), a Multicenter Randomized Controlled Trial.

PubMed

Takase, Susumu; Matoba, Tetsuya; Nakashiro, Soichi; Mukai, Yasushi; Inoue, Shujiro; Oi, Keiji; Higo, Taiki; Katsuki, Shunsuke; Takemoto, Masao; Suematsu, Nobuhiro; Eshima, Kenichi; Miyata, Kenji; Yamamoto, Mitsutaka; Usui, Makoto; Sadamatsu, Kenji; Satoh, Shinji; Kadokami, Toshiaki; Hironaga, Kiyoshi; Ichi, Ikuyo; Todaka, Koji; Kishimoto, Junji; Egashira, Kensuke; Sunagawa, Kenji

2017-02-01

We sought to investigate whether treatment with ezetimibe in combination with statins improves coronary endothelial function in target vessels in coronary artery disease patients after coronary stenting. We conducted a multicenter, prospective, randomized, open-label, blinded-end point trial among 11 cardiovascular treatment centers. From 2011 to 2013, 260 coronary artery disease patients who underwent coronary stenting were randomly allocated to 2 arms (statin monotherapy, S versus ezetimibe [10 mg/d]+statin combinational therapy, E+S). We defined target vessel dysfunction as the primary composite outcome, which comprised target vessel failure during treatment and at the 6- to 8-month follow-up coronary angiography and coronary endothelial dysfunction determined via intracoronary acetylcholine testing performed in cases without target vessel failure at the follow-up coronary angiography. Coadministration of ezetimibe with statins further lowered low-density lipoprotein cholesterol levels (83±23 mg/dL in S versus 67±23 mg/dL in E+S; P<0.0001), with significant decreases in oxidized low-density lipoprotein and oxysterol levels. Among patients without target vessel failure, 46 out of 89 patients (52%) in the S arm and 34 out of 96 patients (35%) in the E+S arm were found to have coronary endothelial dysfunction (P=0.0256), and the incidence of target vessel dysfunction at follow-up was significantly decreased in the E+S arm (69/112 (62%) in S versus 47/109 (43%) in E+S; P=0.0059). A post hoc analysis of post-treatment low-density lipoprotein cholesterol-matched subgroups revealed that the incidence of both target vessel dysfunction and coronary endothelial dysfunction significantly decreased in the E+S arm, with significant reductions in oxysterol levels. The CuVIC trial (Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting) has shown that ezetimibe with statins, compared with statin monotherapy, improves functional prognoses, ameliorating endothelial dysfunction in stented coronary arteries, and was associated with larger decreases in oxysterol levels. © 2016 American Heart Association, Inc.

Molecular intravascular imaging approaches for atherosclerosis.

PubMed

Press, Marcella Calfon; Jaffer, Farouc A

2014-10-01

Coronary artery disease (CAD) is an inflammatory process that results in buildup of atherosclerosis, typically lipid-rich plaque in the arterial wall. Progressive narrowing of the vessel wall and subsequent plaque rupture can lead to myocardial infarction and death. Recent advances in intravascular fluorescence imaging techniques have provided exciting coronary artery-targeted platforms to further characterize the molecular changes that occur within the vascular wall as a result of atherosclerosis and following coronary stent-induced vascular injury. This review will summarize exciting recent developments in catheter-based imaging of coronary arterial-sized vessels; focusing on two-dimensional near-infrared fluorescence imaging (NIRF) molecular imaging technology as an approach to specifically identify inflammation and fibrin directly within coronary artery-sized vessels. Intravascular NIRF is anticipated to provide new insights into the in vivo biology underlying high-risk plaques, as well as high-risks stents prone to stent restenosis or stent thrombosis.

Bioresorbable Scaffolds: Current Evidences in the Treatment of Coronary Artery Disease

PubMed Central

2016-01-01

Percutaneous coronary revascularization strategies have gradually progressed over a period of last few decades. The advent of newer generation drug-eluting stents has significantly improved the outcomes of Percutaneous Coronary Intervention (PCI) by substantially reducing in-stent restenosis and stent thrombosis. However, vascular inflammation, restenosis, thrombosis, and neoatherosclerosis due to the permanent presence of a metallic foreign body within the artery limit their usage in complex Coronary Artery Disease (CAD). Bioresorbable Scaffolds (BRS) represent a novel approach in coronary stent technology. Complete resorption of the scaffold liberates the treated vessel from its cage and restores pulsatility, cyclical strain, physiological shear stress, and mechanotransduction. In this review article, we describe the advances in this rapidly evolving technology, present the evidence from the pre-clinical and clinical evaluation of these devices, and provide an overview of the ongoing clinical trials that were designed to examine the effectiveness of BRS in the clinical setting. PMID:27891384

Impact of an endothelial progenitor cell capturing stent on coronary microvascular function: comparison with drug-eluting stents.

PubMed

Choi, Woong Gil; Kim, Soo Hyun; Yoon, Hyung Seok; Lee, Eun Joo; Kim, Dong Woon

2015-01-01

Although drug-eluting stents (DESs) effectively reduce restenosis following percutaneous coronary intervention (PCI), they also delay re-endothelialization and impair microvascular function, resulting in adverse clinical outcomes. Endothelial progenitor cell (EPC) capturing stents, by providing a functional endothelial layer on the stent, have beneficial effects on microvascular function. However, data on coronary microvascular function in patients with EPC stents versus DESs are lacking. Seventy-four patients who previously underwent PCI were enrolled in this study. Microvascular function was evaluated 6 months after PCI based on the index of microvascular resistance (IMR) and the coronary flow reserve (CFR). IMR was calculated as the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of the hyperemic mean transit time (hTmn). The CFR was calculated by dividing the hTmn by the baseline mean transit time. Twenty-one patients (age, 67.2 ± 9.6 years; male:female, 15:6) with an EPC stent and 53 patients (age, 61.5 ± 14.7 years; male:female, 40:13) with second-generation DESs were included in the study. There were no significant differences in the baseline clinical and angiographic characteristics of the two groups. Angiography performed 6 months postoperatively did not show significant differences in their CFR values. However, patients with the EPC stent had a significantly lower IMR than patients with second-generation DESs (median, 25.5 [interquartile range, 12.85 to 28.18] vs. 29.0 [interquartile range, 15.42 to 39.23]; p = 0.043). Microvascular dysfunction was significantly improved after 6 months in patients with EPC stents compared to those with DESs. The complete re-endothelialization achieved with the EPC stent may provide clinical benefits over DESs, especially in patients with microvascular dysfunction.

High-definition computed tomography for coronary artery stents imaging compared with standard-definition 64-row multidectector computed tomography: an initial in vivo study.

PubMed

Yang, Wen Jie; Zhang, Huan; Xiao, Hua; Li, Jian Ying; Liu, Yan; Pan, Zi Lai; Chen, Ke Min

2012-01-01

The evaluation of coronary stents by computed tomography (CT) remains difficult. We assessed the imaging performance of a high-definition CT scanner (HDCT) by comparing with a conventional 64-row standard-definition CT (SDCT). One hundred thirty-eight consecutive stented patients underwent coronary CT angiography, among whom 66 patients were examined by HDCT, and 72 patients by SDCT (LightSpeed VCT XT; GE Healthcare, Waukesha, Wis). The image quality score, the inner stent diameter (ISD), and the radiation dose were analyzed. All data were statistically tested by SPSS 13.0 software (SPSS Inc, Chicago, Ill). In 72 patients examined using SDCT, 135 stents were detected; in 66 patients examined using HDCT, 119 stents were detected. The image quality score on HDCT was significantly better than that on SDCT (1.4 [SD, 0.7] vs 1.9 [SD, 0.8]). The ISD on HDCT was significantly higher than that on SDCT (1.8 [SD, 0.5] vs 1.6 [SD, 0.4]). There was no significant difference of either image quality score or ISD between the HDCT and SDCT groups in stents with 2.5-mm diameter. Images on HDCT showed significantly better image quality score and larger ISD than images on SDCT in 2.75-, 3-, and 3.5-mm stents. For patients examined by retrospective electrocardiogram-gated technique, the radiation dose on HDCT was significantly lower than that on SDCT (11.3 [SD, 2.9] vs 15.1 [SD, 3.8] mSv). High-definition CT scanner offered improved image quality and measurement accuracy for imaging coronary stents compared with conventional SDCT, providing higher spatial resolution and lower dose for evaluating coronary stents with 2.75- to 3.5-mm diameter.

A prospective study of external stenting of saphenous vein grafts to the right coronary artery: the VEST II study.

PubMed

Taggart, David P; Amin, Sanaz; Djordjevic, Jasmina; Oikonomou, Evangelos K; Thomas, Sheena; Kampoli, Anna-Maria; Sabharwal, Nikant; Antoniades, Charalambos; Krasopoulos, George

2017-05-01

External stents significantly reduce intimal hyperplasia and improve lumen uniformity and flow pattern in saphenous vein grafts (SVG) 1 year after coronary artery bypass grafting. However, recent studies have shown that at 1 year there is a lower patency of externally stented SVG to the right coronary artery (RCA) (55-60%) when compared to the left sided coronary arteries (85-90%). In the current study, we investigated whether avoidance of both fixation of the external stent to the anastomoses and the use of metal clips to ligate SVG side branches would improve the early patency of externally stented SVG to the RCA. Thirty patients received a SVG to the right territory supported with an external stent. Graft patency was confirmed at the end of surgery in all patients. The primary endpoint was SVG patency assessed by computed tomography angiography (CTA) at 3-6 months. Graft failure was defined as > 50% stenosis. Twenty-nine patients (96.6%) completed the follow up period and CT angiography data was available for a total of 43 SVGs, (29 supported and 14 unsupported SVGs) and 47 arterial grafts. Patency of stented SVGs was 86.2% (25/29 on CTA). All non-stented SVGs to the left territory were patent. Patency rates of the left internal mammary arteries and right internal mammary arteries grafts were 96.6% and 83.3%, respectively. Avoidance of both metallic clips to ligate side branches and of fixation of venous external support trial (VEST) stents to the anastomoses mark a significant improvement in patency of stented SVG to the right coronary territory. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Emergency coronary artery bypass surgery in the contemporary percutaneous coronary intervention era.

PubMed

Seshadri, Niranjan; Whitlow, Patrick L; Acharya, Naveen; Houghtaling, Penny; Blackstone, Eugene H; Ellis, Stephen G

2002-10-29

Since the advent of percutaneous coronary interventions (PCIs), technological advances, adjunctive pharmacotherapy, and increasing operator experience have contributed to lowering the occurrence of major complications. However, emergency coronary artery bypass surgery (CABG) for failed PCI is still associated with important morbidity and mortality, even in the era of coronary stenting. We sought to determine the prevalence, indications, predictors, and complications of emergency CABG after PCI in the past decade. We reviewed 18 593 PCIs performed from 1992 through 2000. There was a need for emergency CABG in 113 (0.61%) cases. The major indications were extensive dissection (n=61, 54%), perforation/tamponade (n=23, 20%), and recurrent acute closure (n=23, 20%). Prevalence of emergency CABG decreased from 1.5% of PCIs in 1992 to 0.14% in 2000 (P<0.001). Independent predictors of the need for emergency CABG included the worst ACC/AHA scoring of the intervened lesion (P<0.001) and female sex (P= 0.028), whereas history of prior bypass surgery and use of stents resulted in a decreased need for emergency CABG (P<0.001 for both). In patients undergoing emergency CABG, there were 17 (15%) in-hospital deaths, 14 (12%) perioperative Q-wave myocardial infarctions, and 6 (5%) cerebrovascular accidents. The need for emergency CABG has considerably decreased over time. Risk factors include female sex and a higher ACC/AHA score of the intervened lesion. However, morbidity and mortality of emergency CABG remain high even in the new millennium.

Acute ST-Elevation Myocardial Infarction after Coronary Stent Fracture.

PubMed

Rafighdust, Abbasali; Eshraghi, Ali

2015-10-27

The invention of the drug-eluting stent (DES) has brought about revolutionary changes in the field of interventional cardiology. In the DES era, in-stent restenosis has declined but new issues such as stent thrombosis have emerged. One of the emerging paradigms in the DES era is stent fracture. There are reports about stent fracture leading to in-stent restenosis or stent thrombosis. Most of these reports concern the Sirolimus-eluting stent. The present case is a representation of a Biolimus-eluting stent fracture. We introduce a 64-year-old male patient, for whom the BioMatrix stent was deployed in the right coronary artery. Five months after the implantation, he experienced acute myocardial infarction, with stent fracture leading to stent thrombosis being the causative mechanism. Another DES (Cypher) was used to manage this situation, and the final result was good.

True double bifurcation lesions: new application of the self-expandable Axxess stent and review of literature with dedicated bifurcation devices.

PubMed

Borgia, Francesco; Niglio, Tullio; De Luca, Nicola; Di Serafino, Luigi; Esposito, Giovanni; Trimarco, Bruno; Cirillo, Plinio

2018-04-21

Complex coronary artery bifurcation lesions occurred in hard clinical scenarios, such as acute coronary syndromes, may represent a challenge for interventional cardiologists, with not-defined general consensus on treatment. Even if provisional stenting is the most common option used to restore rapidly the coronary branches flow, improvements in industrial technologies and design of new dedicated bifurcation devices might open new modalities of treatment in these complex cases. The Axxess stent (Biosensors Europe SA, Morges, Switzerland) is a self-expanding biolimus-eluting conical V-shape stent, specifically designed to treat "easily" coronary artery bifurcation lesions, with reported favorable long-term clinical results in stable patients compared to a provisional technique. We report for the first time the feasibility to use this device in a case of "true double coronary bifurcation lesion" occurred in the context of acute coronary syndrome. Moreover, we reviewed studies with bifurcation dedicated devices and available cases of "true double bifurcation lesions", underlying advantages/disadvantages of using one device over the others during acute coronary syndrome. Copyright © 2018 Elsevier Inc. All rights reserved.

Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial.

PubMed

Wiviott, Stephen D; Braunwald, Eugene; McCabe, Carolyn H; Horvath, Ivan; Keltai, Matyas; Herrman, Jean-Paul R; Van de Werf, Frans; Downey, William E; Scirica, Benjamin M; Murphy, Sabina A; Antman, Elliott M

2008-04-19

Intracoronary stenting can improve procedural success and reduce restenosis compared with balloon angioplasty in patients with acute coronary syndromes, but can also increase the rate of thrombotic complications including stent thrombosis. The TRITON-TIMI 38 trial has shown that prasugrel-a novel, potent thienopyridine-can reduce ischaemic events compared with standard clopidogrel therapy. We assessed the rate, outcomes, and prevention of ischaemic events in patients treated with prasugrel or clopidogrel with stents in the TRITON-TIMI 38 study. Patients with moderate-risk to high-risk acute coronary syndromes were included in our analysis if they had received at least one coronary stent at the time of the index procedure following randomisation in TRITON-TIMI 38, and were further subdivided by type of stent received. Patients were randomly assigned in a 1 to 1 fashion to receive a loading dose of study drug (prasugrel 60 mg or clopidogrel 300 mg) as soon as possible after randomisation, followed by daily maintenance therapy (prasugrel 10 mg or clopidogrel 75 mg). All patients were to receive aspirin therapy. Treatment was to be continued for a minimum of 6 months and a maximum of 15 months. Randomisation was not stratified by stents used or stent type. The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Stent thrombosis was assessed using Academic Research Consortium definitions, and analysis was by intention to treat. TRITON-TIMI 38 is registered with ClinicalTrials.gov, number NCT00097591. 12,844 patients received at least one coronary stent; 5743 received only drug-eluting stents, and 6461 received only bare-metal stents. Prasugrel compared with clopidogrel reduced the primary endpoint (9.7 vs 11.9%, HR 0.81, p=0.0001) in the stented cohort, in patients with only drug-eluting stents (9.0 vs 11.1%, HR 0.82, p=0.019), and in patients with only bare-metal stents (10.0 vs 12.2%, HR 0.80, p=0.003). Stent thrombosis was associated with death or myocardial infarction in 89% (186/210) of patients. Stent thrombosis was reduced with prasugrel overall (1.13 vs 2.35%, HR 0.48, p<0.0001), in patients with drug-eluting stents only (0.84 vs 2.31%, HR 0.36, p<0.0001), and in those with bare-metal stents only (1.27 vs 2.41%, HR 0.52, p=0.0009). Intensive antiplatelet therapy with prasugrel resulted in fewer ischaemic outcomes including stent thrombosis than with standard clopidogrel. These findings were statistically robust irrespective of stent type, and the data affirm the importance of intensive platelet inhibition in patients with intracoronary stents.

Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial.

PubMed

Chen, Shao-Liang; Zhang, Jue-Jie; Han, Yaling; Kan, Jing; Chen, Lianglong; Qiu, Chunguang; Jiang, Tiemin; Tao, Ling; Zeng, Hesong; Li, Li; Xia, Yong; Gao, Chuanyu; Santoso, Teguh; Paiboon, Chootopol; Wang, Yan; Kwan, Tak W; Ye, Fei; Tian, Nailiang; Liu, Zhizhong; Lin, Song; Lu, Chengzhi; Wen, Shangyu; Hong, Lang; Zhang, Qi; Sheiban, Imad; Xu, Yawei; Wang, Lefeng; Rab, Tanveer S; Li, Zhanquan; Cheng, Guanchang; Cui, Lianqun; Leon, Martin B; Stone, Gregg W

2017-11-28

Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (Double Kissing and Double Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-Center Clinical Trial [DKCRUSH-V]; ChiCTR-TRC-11001213). Copyright © 2017 American College of Cardiology Foundation. All rights reserved.

Stent implantation influence wall shear stress evolution

NASA Astrophysics Data System (ADS)

Bernad, S. I.; Totorean, A. F.; Bosioc, A. I.; Petre, I.; Bernad, E. S.

2016-06-01

Local hemodynamic factors are known affect the natural history of the restenosis critically after coronary stenting of atherosclerosis. Stent-induced flows disturbance magnitude dependent directly on the strut design. The impact of flow alterations around struts vary as the strut geometrical parameters change. Our results provide data regarding the hemodynamic parameters for the blood flow in both stenosed and stented coronary artery under physiological conditions, namely wall shear stress and pressure drop.

Center for Innovative Minimally Invasive Therapy

DTIC Science & Technology

1999-11-01

discrete layers within the image. In vivo OCT image of a stent deployed in a swine coronary artery. Shadowing of the metallic stent is seen as areas of...Task 3: Vascular Stent -Grafts Specific Aim 1: Develop novel procedures for the treatment of aneurysms and vascular trauma using percutaneous...applied to coronary anastomoses in chronic studies. One particularly interesting application may be as an external stent to maintain or increase the

Direct stenting with a combined intravascular ultrasound-coronary stent delivery platform: a feasibility trial.

PubMed

Eeckhout, Eric; Berger, Alexandre; Roguelov, Christan; Lyon, Xavier; Imsand, Christophe; Fivaz-Arbane, Malika; Girod, Grégoire; De Benedetti, Edoardo

2003-08-01

IVUS is considered as the most accurate tool for the assessment of optimal stent deployment. Direct stenting has shown to be a safe, efficient, and resource-saving procedure in selected patients. In a prospective 1-month feasibility trial, a new combined IVUS-coronary stent delivery platform (Josonics Flex, Jomed, Helsingborn, Sweden) was evaluated during direct stenting in consecutive patients considered eligible for direct stenting. The feasibility endpoint was successful stent deployment without any clinical adverse event, while the efficacy endpoint was strategic adaptation according to standard IVUS criteria for optimal stent deployment at the intermediate phase (after a result considered angiographically optimal) and at the end of the intervention (after optimization according to IVUS standards). A total of 16 patients were successfully treated with this device without any major clinical complication. At the intermediate phase, optimal stent deployment was achieved in four patients only, while at the end only one patient had nonoptimal IVUS stent deployment. In particular, the minimal in-stent cross-section area increased from 6.3 +/- 1.2 to 8.3 +/- 2.5 mm(2). These preliminary data demonstrate the feasibility of direct stenting with a combined IVUS-stent catheter in selected patients and confirm the results from larger randomized trials on the impact of IVUS on strategic adaptations during coronary stent placement. Copyright 2003 Wiley-Liss, Inc.

Use of tailored loading-dose clopidogrel in patients undergoing selected percutaneous coronary intervention based on adenosine diphosphate-mediated platelet aggregation.

PubMed

Meng, Kang; Lü, Shu-Zheng; Zhu, Hua-Gang; Chen, Xin; Ge, Chang-Jiang; Song, Xian-Tao

2010-12-01

Adenosine phosphate-mediated platelet aggregation is a prognostic factor for major adverse cardiac events in patients who have undergone selective percutaneous coronary interventions. This study aimed to assess whether an adjusted loading dose of clopidogrel could more effectively inhibit platelet aggregation in patients undergoing selected percutaneous coronary intervention. A total of 205 patients undergoing selected percutaneous coronary intervention were enrolled in this multicenter, prospective, randomized study. Patients receiving domestic clopidogrel (n = 104) served as the Talcom (Taijia) group; others (n = 101) received Plavix, the Plavix group. Patients received up to 3 additional 300-mg loading doses of clopidogrel to decrease the adenosine phosphate-mediated platelet aggregation index by more than 50% (the primary endpoint) compared with the baseline. The secondary endpoint was major adverse cardiovascular events at 12 months. Compared with the rational loading dosage, the tailored loading dosage better inhibited platelet aggregation based on a > 50% decrease in adenosine phosphate-mediated platelet aggregation (rational loading dosage vs. tailored loading dosage, 48% vs. 73%, P = 0.028). There was no significant difference in the eligible index between the Talcom and Plavix groups (47% vs. 49% at 300 mg; 62% vs. 59% at 600 mg; 74% vs. 72% at 900 mg; P > 0.05) based on a standard adenosine diphosphate-mediated platelet aggregation decrease of > 50%. After 12 months of follow-up, there were no significant differences in major adverse cardiac events (2.5% vs. 2.9%, P = 5.43). No acute or subacute stent thrombosis events occurred. An adjusted loading dose of clopidogrel could have significant effects on antiplatelet aggregation compared with a rational dose, decreasing 1-year major adverse cardiac events in patients undergoing percutaneous coronary interventions based on adenosine phosphate-mediated platelet aggregation with no increase in bleeding.

Coronary and peripheral stenting in aorto-ostial protruding stents: The balloon assisted access to protruding stent technique.

PubMed

Helmy, Tarek A; Sanchez, Carlos E; Bailey, Steven R

2016-03-01

Treatment of aorto-ostial in-stent restenosis lesions represents a challenge for interventional cardiologists. Excessive protrusion of the stent into the aorta may lead to multiple technical problems, such as difficult catheter reengagement of the vessel ostium or inability to re-wire through the stent lumen in repeat interventions. We describe a balloon assisted access to protruding stent technique in cases where conventional coaxial engagement of an aorto-ostial protruding stent with the guide catheter or passage of the guide wire through the true lumen is not feasible. This technique is applicable both in coronary and peripheral arteries. © 2015 Wiley Periodicals, Inc.

High event rate after a first percutaneous coronary intervention in patients with diabetes mellitus: results from the Swedish coronary angiography and angioplasty registry.

PubMed

Ritsinger, Viveca; Saleh, Nawsad; Lagerqvist, Bo; Norhammar, Anna

2015-06-01

Patients with diabetes mellitus have reduced longevity after acute coronary syndromes and revascularization. However, knowledge of the long-term complication rates and patterns from an everyday life setting is lacking. Consecutive patients undergoing percutaneous coronary intervention included in the Swedish Coronary Angiography Angioplasty Registry (SCAAR) between 2006 and 2010 and with no previous revascularization were prospectively followed up for combined cardiovascular events (first of all-cause mortality, myocardial infarction, stroke, and heart failure) until December 31, 2010. The mean follow-up period was 920 days (SD, 530 days). Differences in background and procedural characteristics were adjusted for in a multivariate Cox regression model. Of 58 891 patients, mean age 67 years, 19% had diabetes mellitus; 27% of them were on diet treatment, 33% on oral glucose lowering, and 40% on insulin treatment. At admission, cardiovascular risk factors, multiple coronary vessel, and left main stem disease were more frequent in patients with diabetes mellitus and their revascularization was less often complete. The adjusted risk for combined cardiovascular events was higher in patients on insulin (hazard ratio [95% confidence interval], 1.63 [1.55-1.72]), on oral treatment (1.23 [1.15-1.31]), and on diet alone (1.21 [1.12-1.29]) compared with patients without diabetes mellitus. Insulin-treated patients ran an increased risk of restenosis (1.54 [1.39-1.71]) and stent thrombosis (1.56 [1.25-1.96]). The prognosis after a first percutaneous coronary intervention is more severe in patients with diabetes mellitus, in particular, in patients treated with insulin, with higher rates of mortality, cardiovascular events, and stent thrombosis over the following 5 years. © 2015 American Heart Association, Inc.

Successful Treatment of Symptomatic Intracranial Carotid Artery Stenosis Using a 24-mm Long Bare Metal Coronary Stent.

PubMed

Rehman, Azeem A; Turner, Ryan C; Lucke-Wold, Brandon P; Boo, SoHyun

2017-06-01

Intracranial arterial atherosclerosis represents a common cause of stroke. Despite aggressive and optimal medical management, many patients will unfortunately suffer additional cerebrovascular events. The role of endovascular intervention for intracranial atherosclerotic disease continues to be uncertain, particularly in regard to extensive, symptomatic stenosis. We present a case of a 42-year-old man with a complex medical history who presented with recurrent ischemic stroke in the ipsilateral hemisphere despite optimal medical management. Given the length of stenosis and the luminal size of the intracranial cavernous and petrous segments of the internal carotid artery, we used a bare metal coronary stent (4.0 mm × 24 mm). This represents one of the longest stents deployed for intracranial disease reported in the literature. This case illustrates that a long coronary stent might be successfully used to manage extensive intracranial lesions. We also review the efficacy of using 1 very long stent versus multiple overlapping stents, with reference to the coronary angiography literature. Copyright © 2017 Elsevier Inc. All rights reserved.

Correlation of Admission Heart Rate With Angiographic and Clinical Outcomes in Patients With Right Coronary Artery ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: HORIZONS-AMI (The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial.

PubMed

Kosmidou, Ioanna; McAndrew, Thomas; Redfors, Björn; Embacher, Monica; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

2017-07-19

Bradycardia on presentation is frequently observed in patients with right coronary artery ST-segment elevation myocardial infarction, but it is largely unknown whether it predicts poor angiographic or clinical outcomes in that patient population. We sought to determine the prognostic implications of admission heart rate (AHR) in patients with ST-segment elevation myocardial infarction and a right coronary artery culprit lesion. We analyzed 1460 patients with ST-segment elevation myocardial infarction and a right coronary artery culprit lesion enrolled in the randomized HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial who underwent primary percutaneous coronary intervention. Patients presenting with high-grade atrioventricular block were excluded. Outcomes were examined according to AHR range (AHR <60, 61-79, 80-99, and ≥100 beats per minute). Baseline and procedural characteristics did not vary significantly with AHR except for a more frequent history of diabetes mellitus, longer symptom-to-balloon time, more frequent cardiogenic shock, and less frequent restoration of thrombolysis in myocardial infarction 3 flow in patients with admission tachycardia (AHR >100 beats per minute). Angiographic analysis showed no significant association between AHR and lesion location or complexity. On multivariate analysis, admission bradycardia (AHR <60 beats per minute) was not associated with increased 1-year mortality (hazard ratio 1.33; 95% CI 0.41-4.34, P =0.64) or major adverse cardiac events (hazard ratio 1.08; 95% CI 0.62-1.88, P =0.78), whereas admission tachycardia was a strong independent predictor of mortality (hazard ratio 5.02; 95% CI 1.95-12.88, P =0.0008) and major adverse cardiac events (hazard ratio 2.20; 95% CI 1.29-3.75, P =0.0004). In patients with ST-segment elevation myocardial infarction and a right coronary artery culprit lesion undergoing primary percutaneous coronary intervention, admission bradycardia was not associated with increased mortality or major adverse cardiac events at 1 year. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00433966. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Cost-effectiveness of percutaneous coronary intervention with cobalt-chromium everolimus eluting stents versus bare metal stents: Results from a patient level meta-analysis of randomized trials.

PubMed

Ferko, Nicole; Ferrante, Giuseppe; Hasegawa, James T; Schikorr, Tanya; Soleas, Ireena M; Hernandez, John B; Sabaté, Manel; Kaiser, Christoph; Brugaletta, Salvatore; de la Torre Hernandez, Jose Maria; Galatius, Soeren; Cequier, Angel; Eberli, Franz; de Belder, Adam; Serruys, Patrick W; Valgimigli, Marco

2017-05-01

Second-generation drug eluting stents (DES) may reduce costs and improve clinical outcomes compared to first-generation DES with improved cost-effectiveness when compared to bare metal stents (BMS). We aimed to conduct an economic evaluation of a cobalt-chromium everolimus eluting stent (Co-Cr EES) compared with BMS in percutaneous coronary intervention (PCI). To conduct a cost-effectiveness analysis (CEA) of a cobalt-chromium everolimus eluting stent (Co-Cr EES) versus BMS in PCI. A Markov state transition model with a 2-year time horizon was applied from a US Medicare setting with patients undergoing PCI with Co-Cr EES or BMS. Baseline characteristics, treatment effects, and safety measures were taken from a patient level meta-analysis of 5 RCTs (n = 4,896). The base-case analysis evaluated stent-related outcomes; a secondary analysis considered the broader set of outcomes reported in the meta-analysis. The base-case and secondary analyses reported an additional 0.018 and 0.013 quality-adjusted life years (QALYs) and cost savings of $236 and $288, respectively with Co-Cr EES versus BMS. Results were robust to sensitivity analyses and were most sensitive to the price of clopidogrel. In the probabilistic sensitivity analysis, Co-Cr EES was associated with a greater than 99% chance of being cost saving or cost effective (at a cost per QALY threshold of $50,000) versus BMS. Using data from a recent patient level meta-analysis and contemporary cost data, this analysis found that PCI with Co-Cr EES is more effective and less costly than PCI with BMS. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. © 2016 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Morphology characterization and biocompatibility study of PLLA (Poly-L-Llactid-Acid) coating chitosan as stent for coronary heart disease

NASA Astrophysics Data System (ADS)

Widiyanti, Prihartini; Paramadini, Adanti W.; Jabbar, Hajria; Fatimah, Inas; Nisak, Fadila N. K.; Puspitasari, Rahma A.

2016-03-01

Cardiovascular disease is a global disease with high urgency. In the severe case of coronary heart disease while a blockage in the coronary arteries reach 75% or more, the patient required stent implantation. Stents are made of metal which has many limitations that can lead to blood clots and stent incompatibility toward the size of the blood vessels. There is a metal stent replacement solution that made from polymer material which is biocompatible. PLLA also has biocompatibility and good mechanical strength. PLLA stent will be coated with chitosan as a candidate for drug-coated stents which is able to work as a drug carrier. The aim of this study is to know the morphology information and biocompability status of PLLA coating chitosan as candidate of heart stent. Morphological results using SEM showed a smooth surface structure which reinforced clinical standard of stent material. Results of cytotoxicity test by MTT Assay method showed that the result of four samples in this experiment living cells is reached 90% which is non toxic and safe to use in the human body. %). The conclusion of this study is PLLA is polymer has potency to be used as stent material.

Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.

PubMed

Verheye, Stefan; Khattab, Ahmed A; Carrie, Didier; Stella, Pieter; Slagboom, Ton; Bartunek, Jozef; Onuma, Yoshinobu; Serruys, Patrick W

2016-08-05

Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively). DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Fabrication of hydrophobic structures on coronary stent surface based on direct three-beam laser interference lithography

NASA Astrophysics Data System (ADS)

Gao, Long-yue; Zhou, Wei-qi; Wang, Yuan-bo; Wang, Si-qi; Bai, Chong; Li, Shi-ming; Liu, Bin; Wang, Jun-nan; Cui, Cheng-kun; Li, Yong-liang

2016-05-01

To solve the problems with coronary stent implantation, coronary artery stent surface was directly modified by three-beam laser interference lithography through imitating the water-repellent surface of lotus leaf, and uniform micro-nano structures with the controllable period were fabricated. The morphological properties and contact angle (CA) of the microstructure were measured by scanning electron microscope (SEM) and CA system. The water repellency of stent was also evaluated by the contact and then separation between the water drop and the stent. The results show that the close-packed concave structure with the period of about 12 μm can be fabricated on the stent surface with special parameters (incident angle of 3°, laser energy density of 2.2 J·cm-2 and exposure time of 80 s) by using the three-beam laser at 1 064 nm, and the structure has good water repellency with CA of 120°.

The Integrity bare-metal stent made by continuous sinusoid technology.

PubMed

Turco, Mark A

2011-05-01

The Integrity Coronary Stent System (Medtronic Vascular, CA, USA) is a low-profile, open-cell, cobalt-chromium-alloy advanced bare-metal iteration of the well-known Driver/Micro-Driver Coronary Stent System (Medtronic Vascular). The Integrity stent is made with a process called continuous sinusoid technology. This process allows stent construction via wrapping a single thin strand of wire around a mandrel in a sinusoid configuration, with laser fusion of adjacent crowns. The wire-forming process and fusion pattern provide the stent with a continuous preferential bending plane, intended to allow easier access to, and smoother tracking within, distal and tortuous vessels while radial strength is maintained. Continuous sinusoid technology represents innovation in the design of stent platforms and will provide a future stent platform for newer technology, including drug-eluting stent platforms, drug-filled stents and core wire stents.

Frequency of Angina Pectoris After Percutaneous Coronary Intervention and the Effect of Metallic Stent Type.

PubMed

Gaglia, Michael A; Torguson, Rebecca; Lipinski, Michael J; Gai, Jiaxiang; Koifman, Edward; Kiramijyan, Sarkis; Negi, Smita; Rogers, Toby; Steinvil, Arie; Suddath, William O; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2016-02-15

Although metallic coronary stents significantly reduce angina pectoris compared with optimal medical therapy, angina after percutaneous coronary intervention (PCI) remains frequent. We, therefore, sought to compare the incidence of any angina during the 1 year after PCI among the spectrum of commercially available metallic stents. Metallic stent type was classified as bare metal stent, Cypher, Taxus Express, Xience V, Promus Element, and Resolute. The primary end point was patient-reported angina within 1 year of PCI. Multivariable logistic regression was performed to assess the independent association of stent type with any angina at 1 year. Overall, 8,804 patients were queried in regard to angina symptoms; 32.3% experienced angina at some point in the first year after PCI. Major adverse cardiovascular events, a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, increased with angina severity: 6.8% for patients without angina, 10.0% for patients with class 1 or 2 angina, and 19.7% for patients with class 3 or 4 angina (p <0.001 for trend). After multivariable adjustment, there was no significant association between stent type and angina at 1 year after PCI. Baseline Canadian Cardiovascular Society class 3 or 4 angina, history of coronary artery bypass grafting, and history of PCI were associated with a higher likelihood of angina at 1 year; increasing age, male gender, presentation with acute coronary syndrome, and higher stented length were associated with less angina. In conclusion, metallic stent type is not associated with the occurrence of angina at up to 1 year after PCI. Copyright © 2016 Elsevier Inc. All rights reserved.

First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: clinical, Angiographic, and OCT outcomes of CREDIT-1.

PubMed

Wang, Geng; Sun, Zhongwei; Jin, Quanmin; Xu, Kai; Li, Yi; Wang, Xiaozeng; Ma, Yingyan; Liu, Haiwei; Zhao, Xin; Wang, Bin; Deng, Jie; Guan, Shaoyi; Ge, Meiling; Wang, Xiaoyan; Xu, Bo; Han, Yaling

2015-03-01

To evaluate the preliminary safety and efficacy of the EXCEL II stent system. Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy. Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI. No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01). This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation. © 2015 Wiley Periodicals, Inc.

Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial.

PubMed

Sambola, Antonia; Montoro, J Bruno; Del Blanco, Bruno García; Llavero, Nadia; Barrabés, José A; Alfonso, Fernando; Bueno, Héctor; Cequier, Angel; Serra, Antonio; Zueco, Javier; Sabaté, Manel; Rodríguez-Leor, Oriol; García-Dorado, David

2013-10-01

Oral anticoagulation (OAC) is the recommended therapy for patients with atrial fibrillation (AF) because it reduces the risk of stroke and other thromboembolic events. Dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention and stenting (PCI-S). In patients with AF requiring PCI-S, the association of DAPT and OAC carries an increased risk of bleeding, whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events. The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy (TT) in patients with nonvalvular AF at low-to-moderate risk of stroke (CHADS2 score ≤2) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications. The MUSICA-2 is a multicenter, open-label randomized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S. The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events: death, myocardial infarction, stent thrombosis, or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients. The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications. © 2013.

Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P; Boersma, Eric; Vranckx, Pascal; McFadden, Eugene; Serruys, Patrick W; O'Neil, William W; Jorissen, Brenda; Van Leeuwen, Frank; Steg, Ph Gabriel

2012-10-20

We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. Medtronic, Inc. Copyright © 2012 Elsevier Ltd. All rights reserved.

EXCEL Clinical Trial

ClinicalTrials.gov

2018-03-01

Chronic Coronary Occlusion; Unprotected Left Main Coronary Artery Disease; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Hybrid coronary revascularization in the era of drug-eluting stents.

PubMed

Murphy, Gavin J; Bryan, Alan J; Angelini, Gianni D

2004-11-01

Left internal mammary artery to left anterior descending coronary artery bypass grafting integrated with percutaneous coronary angioplasty (hybrid procedure) offers multivessel revascularization with minimal morbidity in high-risk patients. This is caused in part by the avoidance of cardiopulmonary bypass-related morbidity and manipulation of the aorta coupled with minimally invasive techniques. Hybrid revascularization is currently reserved for particularly high-risk patients or those with favorable anatomic variants however, largely because of the emergence of off-pump coronary artery bypass grafting, which permits more complete multivessel revascularization, with low morbidity in high-risk groups. The wider introduction of hybrid revascularization is limited chiefly by the high number of repeat interventions compared with off-pump coronary artery bypass grafting, which occurs because of the target vessel failure rate of percutaneous coronary intervention. Other demerits are the costs and logistic problems associated with performing two procedures with differing periprocedural management protocols. Recently, drug-eluting stents have reduced the need for repeat intervention after percutaneous coronary intervention, and this has raised the possibility that the results of hybrid revascularization may now equal or even better those of off-pump coronary artery bypass grafting. Although undoubtedly effective at reducing in-stent restenosis, drug-eluting stents will not address the issues of incomplete revascularization or the logistic problems associated with hybrid. Uncertainty regarding the long-term effectiveness of drug-eluting stents in many patients, as well as their high cost when compared with those of off-pump coronary artery bypass grafting surgery, also militates against the wider introduction of hybrid revascularization.

Cardiac rehabilitation after percutaneous coronary intervention: Results from a nationwide survey.

PubMed

Olsen, Siv Js; Schirmer, Henrik; Bønaa, Kaare H; Hanssen, Tove A

2018-03-01

The purpose of this study was to estimate the proportion of Norwegian coronary heart disease patients participating in cardiac rehabilitation programmes after percutaneous coronary intervention, and to determine predictors of cardiac rehabilitation participation. Participants were patients enrolled in the Norwegian Coronary Stent Trial. We assessed cardiac rehabilitation participation in 9013 of these patients who had undergone their first percutaneous coronary intervention during 2008-2011. Of these, 7068 patients (82%) completed a self-administered questionnaire on cardiac rehabilitation participation within three years after their percutaneous coronary intervention. Twenty-eight per cent of the participants reported engaging in cardiac rehabilitation. Participation rate differed among the four regional health authorities in Norway, varying from 20%-31%. Patients undergoing percutaneous coronary intervention for an acute coronary syndrome were more likely to participate in cardiac rehabilitation than patients with stable angina (odds ratio 3.2; 95% confidence interval 2.74-3.76). A multivariate statistical model revealed that men had a 28% lower probability ( p<0.001) of participating in cardiac rehabilitation, and the odds of attending cardiac rehabilitation decreased with increasing age ( p<0.001). Contributors to higher odds of cardiac rehabilitation participation were educational level >12 years (odds ratio 1.50; 95% confidence interval 1.32-1.71) and body mass index>25 (odds ratio 1.19; 95% confidence interval 1.05-1.36). Prior coronary artery bypass graft was associated with lower odds of cardiac rehabilitation participation (odds ratio 0.47; 95% confidence interval 0.32-0.70) Conclusion: The estimated cardiac rehabilitation participation rate among patients undergoing first-time percutaneous coronary intervention is low in Norway. The typical participant is young, overweight, well-educated, and had an acute coronary event. These results varied by geographical region.

Biomechanical Impact of Wrong Positioning of a Dedicated Stent for Coronary Bifurcations: A Virtual Bench Testing Study.

PubMed

Chiastra, Claudio; Grundeken, Maik J; Collet, Carlos; Wu, Wei; Wykrzykowska, Joanna J; Pennati, Giancarlo; Dubini, Gabriele; Migliavacca, Francesco

2018-05-17

The treatment of coronary bifurcations is challenging for interventional cardiologists. The Tryton stent (Tryton Medical, Inc., USA) is one of the few devices specifically designed for coronary bifurcations that underwent large clinical trials. Although the manufacturer provides specific recommendations to position the stent in the bifurcation side branch (SB) according to four radio-opaque markers under angiographic guidance, wrong device positioning may accidentally occur. In this study, the virtual bench testing approach was used to investigate the impact of wrong positioning of the Tryton stent in coronary bifurcations in terms of geometrical and biomechanical criteria. A finite element model of the left anterior descending/first diagonal coronary bifurcation was created with a 45° distal angle and realistic lumen diameters. A validated model of the Tryton stent mounted on stepped delivery balloon was used. All steps of the Tryton deployment sequence were simulated. Three Tryton positions, namely 'proximal', 'recommended', and 'distal' positions, obtained by progressively implanting the stent more distally in the SB, were compared. The 'recommended' case exhibited the lowest ostial area stenosis (44.8 vs. 74.3% ('proximal') and 51.5% ('distal')), the highest diameter at the SB ostium (2.81 vs. 2.70 mm ('proximal') and 2.54 mm ('distal')), low stent malapposition (9.9 vs. 16.3% ('proximal') and 8.5% ('distal')), and the lowest peak wall stress (0.37 vs. 2.20 MPa ('proximal') and 0.71 MPa ('distal')). In conclusion, the study shows that a 'recommended' Tryton stent positioning may be required for optimal clinical results.

77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... 26, 2011. iliac balloon- expandable stent system. P100042, FDA-2011-M-0792 Gen-Probe APTIMA HPV assay..., 2011. XIENCE PRIME LL EVEROLIMUS-eluting coronary stent system. P100041, FDA-2011-M-0837 Edwards.... EVEROLIMUS-eluting platinum chromium coronary stent system. P100024, FDA-2011-M-0866 Dako Denmark A/S...

Breakthrough: NETL's Research Saving Lives with Coronary Stents

ScienceCinema

Turner, Paul

2018-02-14

NETL's Albany location is world renown for its expertise in materials research. One recent offshoot of this expertise was the assistance in developing a new material for coronary stents. This research led to the development of a stent which now has a 33% global market share and has produced over four hundred sustainable jobs in the United States.

Optimal Anticoagulant Therapy in ST Elevation Myocardial Infarction Interventions.

PubMed

Oliveros, Estefania; Mehta, Sameer; Flores, Ana Isabel; Pena, Camilo; Cohen, Salomon; Kostela, Jennifer C; Rowen, Rebecca; Treto, Kevin

2012-10-01

Bivalirudin is a direct thrombin inhibitor. It is a new recommendation for the treatment of patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention. Bivalirudin combined with aspirin and P2Y 12 inhibitors has proved to be an effective and safe choice for the management of thrombus in coronary artery disease. The use of bivalirudin compared with the combination of heparin plus glycoprotein IIb/IIIa inhibitors as anticoagulant therapy is associated with reduced severe bleeding and inpatient mortality, as well as diminished costs. There is only a slight increase of late stent thrombosis, which may be controlled with the use of thienopyridines. Copyright © 2012 Elsevier Inc. All rights reserved.

Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial.

PubMed

Lee, Michael; Généreux, Philippe; Shlofmitz, Richard; Phillipson, Daniel; Anose, Bynthia M; Martinsen, Brad J; Himmelstein, Stevan I; Chambers, Jeff W

2017-06-01

The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.). ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II. The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%. In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions. The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions. Copyright © 2017 Elsevier Inc. All rights reserved.

Coronary artery aneurysm after stent implantation: acute and long-term results after percutaneous treatment with a stent graft.

PubMed

Rubartelli, Paolo; Terzi, Giacomo; Borgo, Lorenzo; Giachero, Corinna

2002-03-01

A patient with unstable angina was treated with elective Palmaz-Schatz stent implantation on a focal stenosis of the left circumflex artery. One year later, a large (13 mm in diameter) coronary artery aneurysm was diagnosed at angiography in the stented site. Intravascular ultrasound examination confirmed the presence of a true aneurysm located at the proximal end of the stent. The aneurysm was successfully treated with a Jostent Graft (Jomed Implantate) consisting of two slotted tube stainless steel stents supporting a polytetrafluoroethylene tube. The stent graft was implanted under intravascular ultrasound guidance. The 18-month angiographic follow-up showed good patency of the stent graft and complete exclusion of the aneurysm.

Current evidence for the safety and efficacy of the bio-engineered dual therapy COMBO stent.

PubMed

Kalkman, Deborah N; Chandrasekhar, Jaya; de Winter, Robbert J; Mehran, Roxana

2018-06-01

The novel dual-therapy COMBO stent aims to promote vessel healing after percutaneous coronary intervention (PCI) in patients with coronary artery disease. The pro-healing technique consists of an anti-CD34+ antibody layer that attracts circulating endothelial progenitor cells (EPCs), which bind to the stent surface and allow rapid endothelialization by differentiation of the EPCs into normal endothelial cells. The COMBO stent combines this pro-healing technique with an abluminal drug elution of sirolimus. The promise of this dual-therapy stent is that it may safely allow a shortened duration of dual-antiplatelet therapy (DAPT) after stent placement. Moreover, with a mature endothelial layer, lower rates of in-stent restenosis may be expected. Clinical outcomes after COMBO stent implantation have been recently evaluated in both randomized trials and large, prospective, multicenter registries, showing low clinical event rates of in-stent restenosis and stent thrombosis. Randomized clinical trials (HARMONEE and RECOVERY) have demonstrated the non-inferiority of COMBO versus "first in class" second generation and newer generation drug-eluting stents. Safety and efficacy of 3 months of DAPT after COMBO stent placement in patients presenting with acute coronary syndrome has been evaluated in the large REDUCE randomized controlled trial, showing non-inferiority to standard duration of 12-month DAPT. In this review we provide an overview of the current pre-clinical and clinical evidence for the performance of the COMBO stent.

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions.

PubMed

Lee, Seung Yul; Shin, Dong Ho; Kim, Jung Sun; Kim, Byeong Keuk; Ko, Young Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong Ki

2017-03-01

To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI). From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions. For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423-0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160-35.206, p=0.033). Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height.

The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

PubMed

Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

2012-01-01

There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect its deliverability in patients with stable coronary disease.

Coronary Stent Artifact Reduction with an Edge-Enhancing Reconstruction Kernel - A Prospective Cross-Sectional Study with 256-Slice CT.

PubMed

Tan, Stéphanie; Soulez, Gilles; Diez Martinez, Patricia; Larrivée, Sandra; Stevens, Louis-Mathieu; Goussard, Yves; Mansour, Samer; Chartrand-Lefebvre, Carl

2016-01-01

Metallic artifacts can result in an artificial thickening of the coronary stent wall which can significantly impair computed tomography (CT) imaging in patients with coronary stents. The objective of this study is to assess in vivo visualization of coronary stent wall and lumen with an edge-enhancing CT reconstruction kernel, as compared to a standard kernel. This is a prospective cross-sectional study involving the assessment of 71 coronary stents (24 patients), with blinded observers. After 256-slice CT angiography, image reconstruction was done with medium-smooth and edge-enhancing kernels. Stent wall thickness was measured with both orthogonal and circumference methods, averaging thickness from diameter and circumference measurements, respectively. Image quality was assessed quantitatively using objective parameters (noise, signal to noise (SNR) and contrast to noise (CNR) ratios), as well as visually using a 5-point Likert scale. Stent wall thickness was decreased with the edge-enhancing kernel in comparison to the standard kernel, either with the orthogonal (0.97 ± 0.02 versus 1.09 ± 0.03 mm, respectively; p<0.001) or the circumference method (1.13 ± 0.02 versus 1.21 ± 0.02 mm, respectively; p = 0.001). The edge-enhancing kernel generated less overestimation from nominal thickness compared to the standard kernel, both with the orthogonal (0.89 ± 0.19 versus 1.00 ± 0.26 mm, respectively; p<0.001) and the circumference (1.06 ± 0.26 versus 1.13 ± 0.31 mm, respectively; p = 0.005) methods. The edge-enhancing kernel was associated with lower SNR and CNR, as well as higher background noise (all p < 0.001), in comparison to the medium-smooth kernel. Stent visual scores were higher with the edge-enhancing kernel (p<0.001). In vivo 256-slice CT assessment of coronary stents shows that the edge-enhancing CT reconstruction kernel generates thinner stent walls, less overestimation from nominal thickness, and better image quality scores than the standard kernel.

Sirolimus- versus paclitaxel-eluting stents in patients with stenosis in a native coronary artery.

PubMed

Doggrell, Sheila A

2004-06-01

With stenting, restenosis occurs in approximately 25% of patients and the incidence is even higher in patients with diabetes, small coronary vessels and long lesions. The sirolimus-eluting balloon-expandable stent in the treatment of patients with de novo native coronary-artery lesions (SIRIUS) trial, enrolled patients with more challenging conditions, including a higher frequency of diabetes, more complex lesion morphology and longer lesions and showed benefits in all groups. After 240 days, the frequency of stenosis of at least 50% of the luminal diameter was 3.2 and 35.4% in the sirolimus and standard stents groups, respectively. The TAXUS-IV trial was the first large-scale trial on the safety and efficacy of paclitaxel-eluting stents in a broad population of patients and lesions, and established the safety and effectiveness of this agent. After 9 months, there was a mean stenosis of 17% in the paclitaxel group compared to 37% of patients treated with a bare stent. Thus, the local delivery of potent cell cycle inhibitors (sirolimus, paclitaxel) from stents being used for revascularisation dramatically decreases the incidence of restenosis in the populations of patients studied so far and represents a major advancement in the treatment of coronary artery disease.

Exclusion of Atherosclerotic Plaque from the Circulation Using Stent-Grafts: Alternative to Carotid Stenting with a Protection Device?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Peynircioglu, Bora, E-mail: borapeynir@gmail.com; Geyik, Serdar; Yavuz, Kivilcim

2007-09-15

Purpose. To retrospectively assess the feasibility, safety, and clinical mid-term outcome of patients undergoing carotid artery stenting with stent-grafts. Methods. Over a 4 year period stent-grafts were used in the endovascular treatment of symptomatic internal carotid artery stenosis in 12 patients (2 women, 10 men, aged 47-83 (mean 64) years). Protection devices were not used. Possible microembolic complications were evaluated by magnetic resonance imaging (MRI) examinations of the brain before and the day after the procedure in all patients. Mean follow-up was 22 months (range 1-42 months), by Doppler ultrasonography and conventional angiography as well as clinical examination .Results. Themore » technical success rate was 100%. A total of 13 coronary stent-grafts were used. The mean stenosis rate (in terms of diameter) was 85% and the mean length of stent-grafts used was 20.9 mm. The mean diameter to which the stent-grafts were dilated was 4.66 mm. In-hospital complications occurred in 1 patient who suffered a minor femoral access hematoma that did not require transfusion or surgical decompression. Post-stenting diffusion-weighted MRI revealed several ipsilateral silent microemboli in only 1 case, which was completely asymptomatic. Two patients had a major stroke after 2 years of follow-up. Restenosis was found in 2 patients who underwent successful balloon dilatation followed by placement of a self-expandable bare stent within the stent-grafts. Conclusions. Stent-grafts may prevent microembolic complications during stenting of atherosclerotic carotid lesions in selected cases, offering immediate exclusion of the atherosclerotic lesion from the circulation by pressing the plaque against the vessel wall. Comparative, randomized studies in larger series of patients are needed with carotid-dedicated stent-graft designs.« less

Computed tomography coronary stent imaging with iterative reconstruction: a trade-off study between medium kernel and sharp kernel.

PubMed

Zhou, Qijing; Jiang, Biao; Dong, Fei; Huang, Peiyu; Liu, Hongtao; Zhang, Minming

2014-01-01

To evaluate the improvement of iterative reconstruction in image space (IRIS) technique in computed tomographic (CT) coronary stent imaging with sharp kernel, and to make a trade-off analysis. Fifty-six patients with 105 stents were examined by 128-slice dual-source CT coronary angiography (CTCA). Images were reconstructed using standard filtered back projection (FBP) and IRIS with both medium kernel and sharp kernel applied. Image noise and the stent diameter were investigated. Image noise was measured both in background vessel and in-stent lumen as objective image evaluation. Image noise score and stent score were performed as subjective image evaluation. The CTCA images reconstructed with IRIS were associated with significant noise reduction compared to that of CTCA images reconstructed using FBP technique in both of background vessel and in-stent lumen (the background noise decreased by approximately 25.4% ± 8.2% in medium kernel (P

Self-expanding stent for spontaneous coronary artery dissection: a rational choice.

PubMed

Mele, Marco; Langialonga, Tommaso; Maggi, Alessandro; Villella, Massimo; Villella, Alessandro

2016-12-01

: Spontaneous coronary artery dissection (SCAD) is a rare and poorly understood cause of acute coronary syndrome in relatively young patients. Nowadays, the optimal treatment of SCAD is uncertain. A conservative approach seems to be preferable, but in particular conditions, an invasive strategy is necessary. The poor rate of procedural success, the high risk of procedural complications and the uncertain long and mid-term results make the interventional treatment of SCAD a challenge. We report a case of a young male patient presenting with SCAD successfully treated with a sirolimus-eluting self-expanding coronary stent. To our knowledge, the use of self-expanding coronary stent for SCAD has never been described yet and we discuss about the rationale of a possible larger use in clinical practice.

Preconditioning, postconditioning and their application to clinical cardiology.

PubMed

Kloner, Robert A; Rezkalla, Shereif H

2006-05-01

Ischemic preconditioning is a well-established phenomenon first described in experimental preparations in which brief episodes of ischemia/reperfusion applied prior to a longer coronary artery occlusion reduce myocardial infarct size. There are ample correlates of ischemic preconditioning in the clinical realm. Preconditioning mimetic agents that stimulate the biochemical pathways of ischemic preconditioning and protect the heart without inducing ischemia have been examined in numerous experimental studies. However, despite the effectiveness of ischemic preconditioning and preconditioning mimetics for protecting ischemic myocardium, there are no preconditioning-based therapies that are routinely used in clinical medicine at the current time. Part of the problem is the need to administer therapy prior to the known ischemic event. Other issues are that percutaneous coronary intervention technology has advanced so far (with the development of stents and drug-eluting stents) that ischemic preconditioning or preconditioning mimetics have not been needed in most interventional cases. Recent clinical trials such as AMISTAD I and II (Acute Myocardial Infarction STudy of ADenosine) suggest that some preconditioning mimetics may reduce myocardial infarct size when given along with reperfusion or, as in the IONA trial, have benefit on clinical events when administered chronically in patients with known coronary artery disease. It is possible that some of the benefit described for adenosine in the AMISTAD 1 and 2 trials represents a manifestation of the recently described postconditioning phenomenon. It is probable that postconditioning--in which reperfusion is interrupted with brief coronary occlusions and reperfusion sequences--is more likely than preconditioning to be feasible as a clinical application to patients undergoing percutaneous coronary intervention for acute myocardial infarction.

Alterations in regional vascular geometry produced by theoretical stent implantation influence distributions of wall shear stress: analysis of a curved coronary artery using 3D computational fluid dynamics modeling.

PubMed

LaDisa, John F; Olson, Lars E; Douglas, Hettrick A; Warltier, David C; Kersten, Judy R; Pagel, Paul S

2006-06-16

The success of stent implantation in the restoration of blood flow through areas of vascular narrowing is limited by restenosis. Several recent studies have suggested that the local geometric environment created by a deployed stent may influence regional blood flow characteristics and alter distributions of wall shear stress (WSS) after implantation, thereby rendering specific areas of the vessel wall more susceptible to neointimal hyperplasia and restenosis. Stents are most frequently implanted in curved vessels such as the coronary arteries, but most computational studies examining blood flow patterns through stented vessels conducted to date use linear, cylindrical geometric models. It appears highly probable that restenosis occurring after stent implantation in curved arteries also occurs as a consequence of changes in fluid dynamics that are established immediately after stent implantation. In the current investigation, we tested the hypothesis that acute changes in stent-induced regional geometry influence distributions of WSS using 3D coronary artery CFD models implanted with stents that either conformed to or caused straightening of the primary curvature of the left anterior descending coronary artery. WSS obtained at several intervals during the cardiac cycle, time averaged WSS, and WSS gradients were calculated using conventional techniques. Implantation of a stent that causes straightening, rather than conforms to the natural curvature of the artery causes a reduction in the radius of curvature and subsequent increase in the Dean number within the stented region. This straightening leads to modest skewing of the velocity profile at the inlet and outlet of the stented region where alterations in indices of WSS are most pronounced. For example, time-averaged WSS in the proximal portion of the stent ranged from 8.91 to 11.7 dynes/cm2 along the pericardial luminal surface and 4.26 to 4.88 dynes/cm2 along the myocardial luminal surface of curved coronary arteries as compared to 8.31 dynes/cm2 observed throughout the stented region of a straight vessel implanted with an equivalent stent. The current results predicting large spatial and temporal variations in WSS at specific locations in curved arterial 3D CFD simulations are consistent with clinically observed sites of restenosis. If the findings of this idealized study translate to the clinical situation, the regional geometry established immediately after stent implantation may predispose portions of the stented vessel to a higher risk of neointimal hyperplasia and subsequent restenosis.

Repeated unit cell (RUC) approach for pure bending analysis of coronary stents.

PubMed

Ju, Feng; Xia, Zihui; Zhou, Chuwei

2008-08-01

Flexibility is one of the key properties of coronary stents. The objective of this paper is to characterize the bending behaviour of stents through finite element analysis with repeated unit cell (RUC) models. General periodic boundary conditions for the RUC under the pure bending condition are formulated. It is found that the proposed RUC approach can provide accurate numerical results of bending behaviour of stents with much less computational costs. Bending stiffness, post-yield bending behaviour and the relationship between moment and bending curvature are investigated for Palmaz-Schatz stents and stents with the V- and S-shaped links. It is found that the effect of link geometry on the bending behaviour of stent is significant. The behaviour of stents subjected to cyclic bending is also investigated.

Outcomes in Elderly Patients With Severely Calcified Coronary Lesions Undergoing Orbital Atherectomy.

PubMed

Lee, Michael S; Shlofmitz, Evan; Lluri, Gentian; Shlofmitz, Richard A

2017-04-01

We evaluated the clinical outcomes of elderly patients who underwent orbital atherectomy for the treatment of severe coronary artery calcification (CAC) prior to stenting. Percutaneous coronary intervention (PCI) of severe CAC is associated with worse clinical outcomes including death, myocardial infarction (MI), and target vessel revascularization (TVR). The elderly represents a high-risk group of patients, often have more comorbid conditions, and have worse outcomes after PCI compared to younger patients. Clinical trials and a large multicenter registry have demonstrated the safety and efficacy of orbital atherectomy for the treatment of severe CAC. Clinical outcomes of elderly patients who undergo orbital atherectomy are unknown. Of the 458 patients, 229 were ≥75 years old (elderly) and 229 were <75 years old (younger). The primary endpoint was rate of 30-day major adverse cardiac and cerebrovascular events (MACCE), comprised of cardiac death, MI, TVR, and stroke. The primary endpoint was similar in the elderly and younger groups (2.2% vs. 2.2%, P = 1), as were the individual endpoints of death (2.2% vs. 0.4%, P = 0.1), MI (0.9% vs. 1.3%, P = 0.65), TVR (0% vs. 0%, P = 1), and stroke (0% vs. 0.4%, P = 0.32). The rates of angiographic complications and stent thrombosis were similarly low in both groups. The elderly represented a sizeable number of patients who underwent orbital atherectomy. It is a safe and effective treatment strategy for elderly patients with severe CAC as the clinical outcomes were similar to their younger counterparts. A randomized trial should further clarify the role of orbital atherectomy in these patients. © 2017, Wiley Periodicals, Inc.

Associations Between Complex PCI and Prasugrel or Clopidogrel Use in Patients With Acute Coronary Syndrome Who Undergo PCI: From the PROMETHEUS Study.

PubMed

Chandrasekhar, Jaya; Baber, Usman; Sartori, Samantha; Aquino, Melissa; Kini, Annapoorna S; Rao, Sunil; Weintraub, William; Henry, Timothy D; Farhan, Serdar; Vogel, Birgit; Sorrentino, Sabato; Ge, Zhen; Kapadia, Samir; Muhlestein, Joseph B; Weiss, Sandra; Strauss, Craig; Toma, Catalin; DeFranco, Anthony; Effron, Mark B; Keller, Stuart; Baker, Brian A; Pocock, Stuart; Dangas, George; Mehran, Roxana

2018-03-01

Potent P2Y 12 inhibitors might offer enhanced benefit against thrombotic events in complex percutaneous coronary intervention (PCI). We examined prasugrel use and outcomes according to PCI complexity, as well as analyzing treatment effects according to thienopyridine type. PROMETHEUS was a multicentre observational study that compared clopidogrel vs prasugrel in acute coronary syndrome patients who underwent PCI (n = 19,914). Complex PCI was defined as PCI of the left main, bifurcation lesion, moderate-severely calcified lesion, or total stent length ≥ 30 mm. Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke, or unplanned revascularization. Outcomes were adjusted using multivariable Cox regression for effect of PCI complexity and propensity-stratified analysis for effect of thienopyridine type. The study cohort included 48.9% (n = 9735) complex and 51.1% (n = 10,179) noncomplex patients. Second generation drug-eluting stents were used in 70.1% complex and 66.2% noncomplex PCI patients (P < 0.0001). Complex PCI was associated with greater adjusted risk of 1-year MACE (hazard ratio [HR], 1.29; 95% confidence interval [CI], 1.20-1.39; P < 0.001). Prasugrel was prescribed in 20.7% of complex and 20.1% of noncomplex PCI patients (P = 0.30). Compared with clopidogrel, prasugrel significantly decreased adjusted risk for 1-year MACE in complex PCI (HR, 0.79; 95% CI, 0.68-0.92) but not noncomplex PCI (HR, 0.91; 95% CI, 0.77-1.08), albeit there was no evidence of interaction (P interaction = 0.281). Despite the use of contemporary techniques, acute coronary syndrome patients who undergo complex PCI had significantly higher rates of 1-year MACE. Adjusted magnitude of treatment effects with prasugrel vs clopidogrel were consistent in complex and noncomplex PCI without evidence of interaction. Copyright © 2018. Published by Elsevier Inc.

Outcomes of Middle Eastern Patients Undergoing Percutaneous Coronary Intervention: The Primary Analysis of the First Jordanian PCI Registry.

PubMed

Alhaddad, Imad A; Tabbalat, Ramzi; Khader, Yousef; Al-Mousa, Eyas; Izraiq, Mahmoud; Nammas, Assem; Jarrah, Mohammad; Saleh, Akram; Hammoudeh, Ayman

2017-01-01

This is a prospective multicenter registry designed to evaluate the incidence of adverse cardiovascular events in Middle Eastern patients undergoing percutaneous coronary interventions (PCI). The registry was also designed to determine the predictors of poor outcomes in such patients. We enrolled 2426 consecutive patients who underwent PCI at 12 tertiary care centers in Jordan between January 2013 and February 2014. A case report form was used to record data prospectively at hospital admission, discharge, and 12 months of follow-up. Mean age was 56 ± 11 years, females comprised 21% of the study patients, 62% had hypertension, 53% were diabetics, and 57% were cigarette smokers. Most patients (77%) underwent PCI for acute coronary syndrome. In-hospital and 1-year mortality rates were 0.78% and 1.94%, respectively. Definite or probable stent thrombosis occurred in 9 patients (0.37%) during hospitalization and in 47 (1.94%) at 1 year. Rates of target vessel repeat PCI and coronary artery bypass graft surgery at 1 year were 3.4% and 0.6%, respectively. The multivariate analysis revealed that cardiogenic shock, congestive heart failure, ST-segment deviation, diabetes, and major bleeding were significantly associated with higher risk of 1-year mortality. In this first large Jordanian registry of Middle Eastern patients undergoing PCI, patients treated were relatively young age population with low in-hospital and 1-year adverse cardiovascular events. Certain clinical features were associated with worse outcomes and may warrant aggressive therapeutic strategies.

Gender differences in risk profile and outcome of Middle Eastern patients undergoing percutaneous coronary intervention.

PubMed

Jarrah, Mohamad I; Hammoudeh, Ayman J; Al-Natour, Dalal B; Khader, Yousef S; Tabbalat, Ramzi A; Alhaddad, Imad A; Kullab, Susan M

2017-02-01

To determine the gender differences in cardiovascular risk profile and outcomes among patients undergoing percutaneous coronary intervention (PCI). Methods: In a prospective multicenter study of consecutive Middle Eastern patients managed with PCI from January 2013 to February 2014 in 12 tertiary care centers in Amman and Irbid, Jordan. Clinical and coronary angiographic features, and major cardiovascular events were assessed for both genders from hospital stay to 1 year. Results: Women comprised 20.6% of 2426 enrolled patients, were older (mean age 62.9 years versus 57.2 years), had higher prevalence of hypertension (81% versus 57%), diabetes (66% versus 44%), dyslipidemia (58% versus 46%), and obesity (44% versus 25%) compared with men, p less than 0.001. The PCI for ST-segment elevation myocardial infarction was indicated for fewer women than men (23% versus 33%; p=0.001). Prevalence of single or multi-vessel coronary artery disease was similar in women and men. More women than men had major bleeding during hospitalization (2.2% versus 0.6%; p=0.003) and at one year (2.5% versus 0.9%; p=0.007). There were no significant differences between women and men in mortality (3.1% versus 1.7%) or stent thrombosis (2.1% versus 1.8%) at 1 year. Conclusion: Middle Eastern women undergoing PCI had worse baseline risk profile compared with men.Except for major bleeding, no gender differences in the incidence of major adverse cardiovascular events were demonstrated.

Prolonged high-pressure is required for optimal stent deployment as assessed by optical coherence tomography.

PubMed

Cook, Jeffrey R; Mhatre, Ajay; Wang, Fen Wei; Uretsky, Barry F

2014-03-01

Optimizing stent deployment is important for both acute- and long-term outcomes. High-pressure balloon inflation is the standard for coronary stent implantation. However, there is no standardized inflation protocol. We hypothesized that prolonged high-pressure balloon inflation until stabilization of inflation pressure is superior to a rapid inflation/deflation sequence for both stent expansion and strut apposition. A high-pressure rapid inflation/deflation sequence was deployed followed by angiography to assure no residual stenosis. Optical coherence tomography (OCT) was then performed followed by prolonged inflation until balloon pressure was stabilized for 30 sec using the same balloon at the same pressure as the rapid sequence. A second OCT run was then done. Thirteen thousand nine hundred thirteen stent struts were evaluated by OCT in 12 patients undergoing successful stenting. Stent expansion improved with prolonged (206 ± 115 sec) vs. rapid (28 ± 17 sec) inflation for both minimal stent diameter (3.0 ± 0.5 vs. 2.75 ± 0.44 mm, P < 0.0001) and area (7.83 ± 2.45 vs. 6.63 ± 1.85 mm(2) , P = 0.0003). The number of malapposed struts decreased (45 ± 41 vs. 88 ± 75, P = 0.005) as did the maximal malapposed strut distance (0.31 ± 0.2 vs. 0.43 ± 0.2 mm, P = 0.0001). Factors related to strut malapposition after rapid inflation included localized asymmetry in 67%, stent underexpansion in 75%, and stent undersizing in 67%. These data demonstrate that prolonged inflation is superior to a rapid inflation/deflation technique for both stent expansion and strut apposition. We recommend for routine stent deployment a prolonged inflation protocol as described above to optimize stent deployment. Copyright © 2012 Wiley Periodicals, Inc.

Emergency coronary angioplasty with stenting using Cordis® diagnostic coronary catheters when there is difficulty in engaging guide catheters and bench evaluation of diagnostic and guide catheters.

PubMed

Arokiaraj, Mark Christopher

2018-02-01

Difficulty in engaging with guide catheters is not uncommon in acute emergencies. We aimed to evaluate the use of Cordis ® INFINITI diagnostic catheters to perform angioplasty in patients in whom the coronaries cannot be engaged using standard guide catheters. In 34 cases of acute coronary syndrome, when difficulty in engagement with two standard guide catheters was encountered with reasonable manipulations, angioplasty was performed using diagnostic catheters. In total, 40 stents were placed by this technique. Pushability and trackability, distal tip flexion and three-point bending tests were performed to evaluate the performance of the guide and diagnostic catheters. Angioplasty was performed easily in a setting where it would have been very difficult to perform. Coronary dissection occurred in one patient, treated by a stent. The stent and dilatation balloons were easily passed through the diagnostic catheters. Pressure tracings were clearly preserved with certain stent delivery systems, and at angioplasty, although there was slightly reduced opacification of the respective artery, the coronary anatomy was sufficiently visualized to perform angioplasty. No periprocedural target lesion complications were seen in any cases. Pushability and trackability tests showed good force transmission along a tortuous path with diagnostic catheters, and balanced force-displacement curves from three-point bending tests and distal tip softness tests. Angioplasty with stenting can be performed safely through 6F Cordis ® infiniti diagnostic catheters when difficulty in engaging guide catheters is encountered. Copyright © 2018 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Advantages of novel BioMimeTM Sirolimus Eluting Coronary Stent system. Moving towards biomimicry.

PubMed

Upendra, K; Sanjeev, B

2012-02-01

Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advancements in interventional cardiology arena have been fast paced. Within the last ten years, these developments have been exponential. Developers & clinicians are fast adapting from the learning curve awarded by the time course of DES evolution. In that light BioMimeTM Sirolimus Eluting Coronary Stent comes as a fresh thought in taking stents towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65 µm) cobalt chromium stent platform, using an intelligent hybrid of close and open cells allowing for morphology mediated expansion, employs a well known anti-proliferative - Sirolimus that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and low coating thickness of 2 µm. The resultant stent demonstrates almost 100% endothelialization at 30 days in preclinical model and zero percent MACE >18 months in the primary efficacy and safety clinical study.

Long-term results of a sirolimus-eluting stent with biodegradable polymer (RAPSTROM™) in de novo coronary stenoses.

PubMed

Figini, Filippo; Manjunath, Chaman Nadish; Srinivas, Balaji Chandra; Sadananda, Kanvar Sarat; Sreedharan, Madhu; Fischer, Louie; Pillai, Ramakrishna; Varghese, Kiron; Gopal, Ajay K; Nagesh, Chamarajnagar Mahadevappa; Sheiban, Imad

2017-10-07

To report long-term results of a novel sirolimus-eluting stent with biodegradable polymer BACKGROUND: Newer generation drug-eluting stents are characterized by thin struts, improved platform design and highly biocompatible polymer carrying the antiproliferative drug. The RapstromTM stent, sharing these features, showed promising outcomes in preclinical models and in a first-in-man trial. The present study is a multicenter, non-randomized post-market registry, including patients with de novo coronary artery disease treated with implantation of one or more Rapstrom stents. Primary endpoint of the study was the rate of major adverse cardiac events (MACE) at three-year follow-up. 1073 patients were enrolled, with a high prevalence of diabetes (35%) and acute coronary syndrome at presentation (82%); at three-year follow up, MACE rate was 14.8%, with a low incidence of definite or probable stent thrombosis (0.75%). These data confirm the good clinical performance of the Rapstrom stent, supporting the concept that the combination of thin struts and biodegradable polymer is associated with positive clinical outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

The carina angle-new geometrical parameter associated with periprocedural side branch compromise and the long-term results in coronary bifurcation lesions with main vessel stenting only.

PubMed

Gil, Robert J; Vassilev, Dobrin; Formuszewicz, Radoslaw; Rusicka-Piekarz, Teresa; Doganov, Alexander

2009-12-01

The two main problems unresolved in coronary bifurcation stenting are periprocedural side branch compromise and higher restenosis at long term. The purpose of this study is to reveal the link between periprocedural side branch compromise and long-term results after main vessel stenting only in coronary bifurcations. Eighty-four patients formed the study population. The inclusion criteria were good-quality angiograms, with maximal between-branch angle opening, no overlap, permitting accurate angiographic analysis. Carina angle (alpha)-the distal angle between main vessel (MV) before bifurcation and side branch (SB)-was measured pre- and poststenting. Clinical follow-up 9-12 months was obtained with coronary angiography if needed. The patient population was high-risk with 33% diabetics and 84% two- and three-vessel disease. Ninety-five stents were implanted in 92 lesions, with three T-stenting cases. Drug-eluting stents were implanted in 54%. Kissing-balloon (KBI) or sequential inflation was performed in 35%. SB functional closure occurred in 17.4%, with independent predictors alpha < 40 degrees and diameter ratio MB/SB >1.22. After 12+/-4 months there were five myocardial infarctions (6%) and 13 (15%) target lesion revascularization procedures. Independent predictors of major cardiovascular events were carina angle <40 degrees , MB lesion length >8 mm, negative change of between-branch angle, DES usage, and KBI. Smaller carina angle with straightening of MV-main branch from stent implantation in coronary bifurcations predicted higher SB compromise, restenosis, and MACE rates during follow-up of 1 year.

The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions.

PubMed

Grube, Eberhard; Chevalier, Bernard; Smits, Peter; Džavík, Vladimir; Patel, Tejas M; Mullasari, Ajit S; Wöhrle, Jochen; Stuteville, Marrianne; Dorange, Cécile; Kaul, Upendra

2011-02-01

The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice) trials. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial.

PubMed

Waseda, Katsuhisa; Ako, Junya; Yamasaki, Masao; Koizumi, Tomomi; Sakurai, Ryota; Hongo, Yoichiro; Koo, Bon-Kwon; Ormiston, John; Worthley, Stephen G; Whitbourn, Robert J; Walters, Darren L; Meredith, Ian T; Fitzgerald, Peter J; Honda, Yasuhiro

2011-06-01

Polymer formulation may affect the efficacy of drug-eluting stents. Resolute, Endeavor, and ZoMaxx are zotarolimus-eluting stents with different stent platforms and different polymer coatings and have been tested in clinical trials. The aim of this analysis was to compare the efficacy of zotarolimus-eluting stents with different polymers. Data were obtained from the first-in man trial or first randomized trials of each stent, The Clinical RESpOnse EvaLUation of the MedTronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (RESOLUTE), Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions (ENDEAVOR II), and ZoMaxx I trials. Follow-up intravascular ultrasound analyses (8 to 9 months of follow-up) were possible in 353 patients (Resolute: 88, Endeavor: 98, ZoMaxx: 82, Driver: 85). Volume index (volume/stent length) was obtained for vessel, stent, lumen, peristent plaque, and neointima. Cross-sectional narrowing was defined as neointimal area divided by stent area (%). Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. At baseline, vessel, lumen, and peristent plaque volume index were not significantly different among the 4 stent groups. At follow-up, percent neointimal obstruction was significantly lower in Resolute compared with Endeavor, ZoMaxx, and Driver (Resolute: 3.7±4.0, Endeavor: 17.5±10.1, ZoMaxx: 14.6±8.1, Driver: 29.4±17.2%; P<0.001). Greater maximum cross-sectional narrowing and higher neointima-free frame ratio, suggesting less neointimal coverage, were observed in Resolute compared with other stent groups. Multiple regression analysis confirmed that the biodurable polymer used in Resolute independently correlated with neointimal suppression among 3 zotarolimus-eluting stents. The different polymer formulations significantly affect the relative amount of neointima for zotarolimus-eluting stents. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00248079.

Evaluation of XIENCE V everolimus-eluting and Taxus Express2 paclitaxel-eluting coronary stents in patients with jailed side branches from the SPIRIT IV trial at 2 years.

PubMed

Forrest, John K; Lansky, Alexandra J; Meller, Stephanie M; Hou, Liming; Sood, Poornima; Applegate, Robert J; Wang, John C; Skelding, Kimberly A; Shah, Aakar; Kereiakes, Dean J; Sudhir, Krishnankutty; Cristea, Ecaterina; Yaqub, Manejeh; Stone, Gregg W

2013-06-01

The aim of this study was to determine whether patients from the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions (SPIRIT) IV trial who underwent percutaneous coronary intervention, who had target lesions with jailed side branches, had improved clinical outcomes when treated with the XIENCE V versus Taxus Express(2) drug-eluting stent. In the SPIRIT III randomized trial, patients with target lesions with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had lower 2-year rates of major adverse cardiac events. The SPIRIT IV trial represents a larger more diverse patient population compared with SPIRIT III. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, 3,687 patients who underwent coronary stenting with up to 3 de novo native coronary artery lesions were randomized 2:1 to receive XIENCE V versus Taxus Express(2) stents. Two-year clinical outcomes of patients with or without jailed side branches after stenting were compared. A jailed side branch was defined as any side branch >1.0 mm in diameter within the target segment being stented, excluding bifurcations deemed to require treatment. Of the 3,687 patients in SPIRIT IV, a total of 1,426 had side branches that were jailed during angioplasty of the target lesion. Patients with jailed side branches after XIENCE V compared with Taxus Express(2) implantation had significantly lower 2-year rates of target lesion failure (6.5% vs 11.9%, p = 0.001), major adverse cardiac events (6.6% vs 12.2%, p = 0.0008), ischemia-driven target vessel revascularization (4.1% vs 7.9%, p = 0.004), and stent thrombosis (0.6% vs 2.8%, p = 0.001). In conclusion, patients with jailed side branches after stenting with XIENCE V compared to Taxus Express(2) devices had superior clinical outcomes at 2 years in the large-scale randomized SPIRIT IV trial. Copyright © 2013 Elsevier Inc. All rights reserved.

[The bioresorbable coronary stent: a revolution].

PubMed

Koegler, Flora; De Benedetti, Edoardo

2013-04-10

Coronary angioplasty has undergone several technological revolutions: starting with balloon angioplasty, then with bare metal stent and finally with drug eluting stent (DES), this technique is now mature. However, once we thought the problem of instent restenosis solved with DES, new concerns arise with late and very late stent thrombosis. Should we therefore proscribe DES? How long should be the duration of dual antiplatelet therapy? And how should we manage the patients who need a surgery and are at high risk of bleeding? Are bioresorbable stents the final solution with their initial mechanical properties, then with their drug eluting effect against intra-stent restenosis, and finally with their complete resorption which leaves the artery free of any foreign material?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Cheng-Hung; Department of Mechanical Engineering, Chang Gung University, Tao-Yuan, Taiwan; Jhong, Guan-Heng

The deployment of metallic stents during percutaneous coronary intervention has become common in the treatment of coronary bifurcation lesions. However, restenosis occurs mostly at the bifurcation area even in present era of drug-eluting stents. To achieve adequate deployment, physicians may unintentionally apply force to the strut of the stents through balloon, guiding catheters, or other devices. This force may deform the struts and impose excessive mechanical stresses on the arterial vessels, resulting in detrimental outcomes. This study investigated the relationship between the distribution of stress in a stent and bifurcation angle using finite element analysis. The unintentionally applied force followingmore » stent implantation was measured using a force sensor that was made in the laboratory. Geometrical information on the coronary arteries of 11 subjects was extracted from contrast-enhanced computed tomography scan data. The numerical results reveal that the application of force by physicians generated significantly higher mechanical stresses in the arterial bifurcation than in the proximal and distal parts of the stent (post hoc P < 0.01). The maximal stress on the vessels was significantly higher at bifurcation angle <70° than at angle ≧70° (P < 0.05). The maximal stress on the vessels was negatively correlated with bifurcation angle (P < 0.01). Stresses at the bifurcation ostium may cause arterial wall injury and restenosis, especially at small bifurcation angles. These finding highlight the effect of force-induced mechanical stress at coronary artery bifurcation stenting, and potential mechanisms of in-stent restenosis, along with their relationship with bifurcation angle.« less

Measurement of in vitro and in vivo stent geometry and deformation by means of 3D imaging and stereo-photogrammetry.

PubMed

Zwierzak, Iwona; Cosentino, Daria; Narracott, Andrew J; Bonhoeffer, Philipp; Diaz, Vanessa; Fenner, John W; Schievano, Silvia

2014-12-01

To quantify variability of in vitro and in vivo measurement of 3D device geometry using 3D and biplanar imaging. Comparison of stent reconstruction is reported for in vitro coronary stent deployment (using micro-CT and optical stereo-photogrammetry) and in vivo pulmonary valve stent deformation (using 4DCT and biplanar fluoroscopy). Coronary stent strut length and inter-strut angle were compared in the fully deployed configuration. Local (inter-strut angle) and global (dog-boning ratio) measures of stent deformation were reported during stent deployment. Pulmonary valve stent geometry was assessed throughout the cardiac cycle by reconstruction of stent geometry and measurement of stent diameter. Good agreement was obtained between methods for assessment of coronary stent geometry with maximum disagreement of +/- 0.03 mm (length) and +/- 3 degrees (angle). The stent underwent large, non-uniform, local deformations during balloon inflation, which did not always correlate with changes in stent diameter. Three-dimensional reconstruction of the pulmonary valve stent was feasible for all frames of the fluoroscopy and for 4DCT images, with good correlation between the diameters calculated from the two methods. The largest compression of the stent during the cardiac cycle was 6.98% measured from fluoroscopy and 7.92% from 4DCT, both in the most distal ring. Quantitative assessment of stent geometry reconstructed from biplanar imaging methods in vitro and in vivo has shown good agreement with geometry reconstructed from 3D techniques. As a result of their short image acquisition time, biplanar methods may have significant advantages in the measurement of dynamic 3D stent deformation.

Flat panel digital detector cinefluoroscopy late following SES or BMS implantation for detection of coronary stent fracture in asymptomatic patients.

PubMed

Davlouros, Periklis A; Chefneux, Corina; Xanthopoulou, Ioanna; Papathanasiou, Maria; Zaharioglou, Evaggelia; Tsigkas, Grigorios; Alexopoulos, Dimitrios

2012-05-03

Coronary stent fracture (SF), is rare and confined mainly in patients treated with sirolimus eluting stents (SES). The role of flat panel digital detector (FPDD) fluoroscopy in detecting SF has not been investigated. Assessment with FPDD fluoroscopy of asymptomatic patients, with 200 SES (Cypher, Cordis, J&J, Miami, Florida, US), and 200 bare metal stents (BMS), at 45.5 ± 15.7 and 38.4 ± 3.9 months post-stenting respectively. SF was defined as discontinuity of stent struts on fluoroscopy. Coronary angiography was reserved for patients with documented SF. Effective radiation dose was 0.26 ± 0.14 mSv. SF was depicted in 6 (3%) SES, and 1 BMS (0.5%). Stent length was an independent predictor of SF (OR 1.19, 95% CI 1.03-1.4, p=0.024). RCA location and vessel angulation were marginally significant (OR 7.7, 95% CI 0.8-74.2, p=0.077 and OR 5.1, 95% CI 0.8-34, p=0.089). Significant angiographic restenosis was detected in 4 SES (66.6%), and 1 BMS (0.5%). Re-intervention was needed in 3 (42.8%) cases, (2 SES and 1 BMS). Detection of SF with FPDD cinefluoroscopy late following coronary stenting is feasible, involves low radiation and is confined mainly to SES compared to BMS. Application of cinefluoroscopy as part of a routine stent surveillance programme in asymptomatic patients may be more appropriate in "high risk" settings (SES, long stents and adverse angiographic characteristics). The role of invasive imaging and subsequent management of such patients need further studying. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Double Guiding Catheters for Complex Percutaneous Coronary Intervention

PubMed Central

Chou, Shing-Hsien; Lin, Chia-Pin; Lin, Yen-Chen; Kuo, Chi-Tai; Lin, Ming-Shyan; Chang, Chi-Jen

2012-01-01

A large-lumen guiding catheter is often used for complex percutaneous coronary intervention—particularly when a final kissing-balloon or 2-stent technique is required. However, catheter insertion is sometimes restricted by diseased vascular access sites or a tortuous vascular route. We report 2 cases in which a unique double guiding catheter technique was used to create a lumen of sufficient size for complex percutaneous coronary intervention. In each patient, two 6F guiding catheters were used concurrently to engage the ostium of 1 target vessel. In 1 patient, these catheters were used for the delivery of 2 balloons to complete kissing-balloon dilation after single-stent placement. In the other patient, the catheters were used to deliver 2 stents sequentially to their respective target lesions. The stents were then deployed simultaneously as kissing stents, followed by high-pressure kissing-balloon postdilation. PMID:22412243

Drug-eluting stents and glycoprotein IIb/IIIa inhibitors in vessels at low anatomic risk: a retrospective analysis of previously published data from the Basel Stent Kosten Effektivitäts Trial.

PubMed

Jeger, Raban V; Brunner-La Rocca, Hans Peter; Hunziker, Patrick R; Tsakiris, Dimitrios A; Kaiser, Christoph A; Pfisterer, Matthias E

2009-12-01

Drug-eluting stents (DESs) are associated with late stent thromboses, but the exact mechanism of action is unknown. The goal of this article was to assess the clinical interaction of glycoprotein IIb/IIIa inhibitors (GPIs) with different stent and vessel types in unselected patients undergoing percutaneous coronary intervention (PCI). This was a predefined retrospective analysis of the randomized controlled Basel Stent Kosten Effektivitats Trial (BASKET), which compared DES with bare-metal stents (BMSs) in patients undergoing PCI. Patients were compared for major adverse clinical events in relation to GPI use (abciximab and tirofiban) after 18 months. In a subgroup analysis prespecified in the study protocol, specific regard was given to angiographic groups at different risk levels for late events (high-risk vessels [ie, small vessels with a diameter <3.0 mm and saphenous vein grafts], and low-risk vessels [ie, large native vessels > or =3.0 mm]). Baseline differences between patients with or without GPI use were identified and incorporated into a multivariable Cox proportional hazards regression analysis if different at a <0.05 level. A total of 826 patients (650 males, 176 females) were enrolled in BASKET; 301 (36%) received GPI therapy. Of these 301 patients, 255 (85%) received abciximab and 46 (15%) received tirofiban. After 18 months, the rate of cardiac death and nonfatal myocardial infarction was higher in patients with GPI use than in those without GPI use (35/301 [12%] vs 32/525 [6%]; P = 0.005). In patients undergoing PCI in anatomically low-risk vessels and receiving GPI therapy, there was a higher rate of cardiac death and nonfatal myocardial infarction at 18 months with a DES versus a BMS (22/151 [15%] vs 3/66 [5%]; P = 0.033). In patients undergoing PCI in anatomically low-risk vessels and without GPI therapy, there was no significant difference for cardiac death and nonfatal myocardial infarction (DES vs BMS, 11/207 [5%] vs 6/134 [4%]). In the multivariable analysis, GPI use (hazard ratio = 2.93; 95% CI, 1.53-5.63; P = 0.001) and age (hazard ratio = 1.034 per year increase; 95% CI, 1.008-1.062; P = 0.012) remained the only significant independent predictors of outcome. Interaction of stent type and GPI use was significant (P = 0.006). This retrospective analysis of the BASKET data found that GPIs and DESs used in patients with large native vessels may have an adverse interaction in terms of late stent thromboses. However, large prospective studies are needed to confirm these findings. Copyright 2009 Excerpta Medica Inc. All rights reserved.

New stent design for use in small coronary arteries during percutaneous coronary intervention

PubMed Central

Granada, Juan F; Huibregtse, Barbara A; Dawkins, Keith D

2010-01-01

Patients with diabetes mellitus, of female gender, increased age, and/or with peripheral vascular disease often develop coronary stenoses in small caliber vessels. This review describes treatment of these lesions with the paclitaxel-eluting 2.25 mm TAXUS® Liberté® Atom™ stent. Given the same stent composition, polymer, antirestenotic drug (paclitaxel), and release kinetics as the first-generation 2.25 mm TAXUS® Express® Atom™ stent, the second-generation TAXUS Liberté Atom stent incorporates improved stent design characteristics, including thinner struts (0.0038 versus 0.0052 inches), intended to increase conformability and deliverability. In a porcine noninjured coronary artery model, TAXUS Liberté Atom stent implantation in small vessels demonstrated complete strut tissue coverage compared with the bare metal stent control, suggesting a similar degree of tissue healing between the groups at 30, 90, and 180 days. The prospective, single-armed TAXUS ATLAS Small Vessel trial demonstrated improved instent late loss (0.28 ± 0.45 versus 0.84 ± 0.57 mm, P < 0.001), instent binary restenosis (13.0% versus 38.1%, P < 0.001), and target lesion revascularization (5.8% versus 17.6%, P < 0.001) at nine months with the TAXUS Liberté Atom stent as compared with the bare metal Express stent control, with similar safety measures between the two groups. The TAXUS Liberté Atom also significantly reduced nine-month angiographic rates of both instent late loss (0.28 ± 0.45 versus 0.44 ± 0.61 mm, P = 0.03) and instent binary restenosis (13.0% versus 25.9%, P = 0.02) when compared with the 2.25 mm TAXUS Express Atom control. The observed reduction in target lesion revascularization with the TAXUS Liberté Atom compared with the TAXUS Express Atom at nine months (5.8% versus 13.7%, P = 0.02) was sustained through three years (10.0% versus 22.1%, P = 0.008) with similar, stable safety outcomes between the groups. In conclusion, these data confirm the safety and favorable performance of the TAXUS Liberté Atom stent in the treatment of small coronary vessels. PMID:22915922

Ultra-hydrophilic stent platforms promote early vascular healing and minimise late tissue response: a potential alternative to second-generation drug-eluting stents.

PubMed

Kolandaivelu, Kumaran; Bailey, Lynn; Buzzi, Stefano; Zucker, Arik; Milleret, Vincent; Ziogas, Algirdas; Ehrbar, Martin; Khattab, Ahmed A; Stanley, James R L; Wong, Gee K; Zani, Brett; Markham, Peter M; Tzafriri, Abraham R; Bhatt, Deepak L; Edelman, Elazer R

2017-04-20

Simple surface modifications can enhance coronary stent performance. Ultra-hydrophilic surface (UHS) treatment of contemporary bare metal stents (BMS) was assessed in vivo to verify whether such stents can provide long-term efficacy comparable to second-generation drug-eluting stents (DES) while promoting healing comparably to BMS. UHS-treated BMS, untreated BMS and corresponding DES were tested for three commercial platforms. A thirty-day and a 90-day porcine coronary model were used to characterise late tissue response. Three-day porcine coronary and seven-day rabbit iliac models were used for early healing assessment. In porcine coronary arteries, hydrophilic treatment reduced intimal hyperplasia relative to the BMS and corresponding DES platforms (1.5-fold to threefold reduction in 30-day angiographic and histological stenosis; p<0.04). Endothelialisation was similar on UHS-treated BMS and untreated BMS, both in swine and rabbit models, and lower on DES. Elevation in thrombotic indices was infrequent (never observed with UHS, rare with BMS, most often with DES), but, when present, correlated with reduced endothelialisation (p<0.01). Ultra-hydrophilic surface treatment of contemporary stents conferred good healing while moderating neointimal and thrombotic responses. Such surfaces may offer safe alternatives to DES, particularly when rapid healing and short dual antiplatelet therapy (DAPT) are crucial.

Adequate antiplatelet regimen in patients on chronic anti-vitamin K treatment undergoing percutaneous coronary intervention

PubMed Central

Brugaletta, Salvatore; Martin-Yuste, Victoria; Ferreira-González, Ignacio; Cola, Clarissa; Alvarez-Contreras, Luis; Antonio, Marta De; Garcia-Moll, Xavier; García-Picart, Joan; Martí, Vicens; Balcells-Iranzo, Jordi; Sabaté, Manel

2011-01-01

AIM: To investigate the impact of dual antiplatelet therapy (DAT) in patients on anti-vitamin K (AVK) regimen requiring percutaneous coronary intervention (PCI). METHODS: Between February 2006 and February 2008, 138 consecutive patients under chronic AVK treatment were enrolled in this registry. Of them, 122 received bare metal stent implantation and 16 received drug eluting stent implantation. The duration of DAT, on top of AVK treatment, was decided at the discretion of the clinician. Adequate duration of DAT was defined according to type of stent implanted and to its clinical indication. RESULTS: The baseline clinical characteristics of patients reflect their high risk, with high incidence of comorbid conditions (Charlson score ≥ 3 in 89% of the patients). At a mean follow-up of 17 ± 11 mo, 22.9% of patients developed a major adverse cardiac event (MACE): 12.6% died from cardiovascular disease and almost 6% had an acute myocardial infarction. Major hemorrhagic events were observed in 7.4%. Adequate DAT was obtained in only 44% of patients. In the multivariate analysis, no adequate DAT and Charlson score were the only independent predictors of MACE (both P = 0.02). CONCLUSION: Patients on chronic AVK therapy represent a high risk population and suffer from a high MACE rate after PCI. An adequate DAT regimen and absence of comorbid conditions are strongly associated with better clinical outcomes. PMID:22125672

A Finite Element Study on Variations in Mass Transport in Stented Porcine Coronary Arteries Based on Location in the Coronary Arterial Tree

PubMed Central

Keyes, Joseph T.; Simon, Bruce R.; Vande Geest, Jonathan P.

2013-01-01

Drug-eluting stents have a significant clinical advantage in late-stage restenosis due to the antiproliferative drug release. Understanding how drug transport occurs between coronary arterial locations can better help guide localized drug treatment options. Finite element models with properties from specific porcine coronary artery sections (left anterior descending (LAD), right (RCA); proximal, middle, distal regions) were created for stent deployment and drug delivery simulations. Stress, strain, pore fluid velocity, and drug concentrations were exported at different time points of simulation (0–180 days). Tests indicated that the highest stresses occurred in LAD sections. Higher-than-resting homeostatic levels of stress and strain existed at upwards of 3. mm away from the stented region, whereas concentration of species only reached 2.7 mm away from the stented region. Region-specific concentration showed 2.2 times higher concentrations in RCA artery sections at times corresponding to vascular remodeling (peak in the middle segment) compared to all other segments. These results suggest that wall transport can occur differently based on coronary artery location. Awareness of peak growth stimulators and where drug accumulation occurs in the vasculature can better help guide local drug delivery therapies. PMID:23699720

1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.

PubMed

Muramatsu, Takashi; Onuma, Yoshinobu; van Geuns, Robert-Jan; Chevalier, Bernard; Patel, Tejas M; Seth, Ashok; Diletti, Roberto; García-García, Hector M; Dorange, Cécile C; Veldhof, Susan; Cheong, Wai-Fung; Ozaki, Yukio; Whitbourn, Robert; Bartorelli, Antonio; Stone, Gregg W; Abizaid, Alexandre; Serruys, Patrick W

2014-05-01

The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Clinical outcomes of diabetic patients after BVS implantation have been unreported. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Innovative Chimney-Graft Technique for Endovascular Repair of a Pararenal Abdominal Aortic Aneurysm

PubMed Central

Galiñanes, Edgar Luis; Hernandez-Vila, Eduardo A.

2015-01-01

After abdominal aortic aneurysm repair, progressive degeneration of the aneurysm can be challenging to treat. Multiple comorbidities and previous operations place such patients at high risk for repeat surgery. Endovascular repair is a possible alternative; however, challenging anatomy can push the limits of available technology. We describe the case of a 71-year-old man who presented with a 5.3-cm pararenal aneurysm 4 years after undergoing open abdominal aortic aneurysm repair. To avoid reoperation, we excluded the aneurysm by endovascular means, using visceral-artery stenting, a chimney-graft technique. Low-profile balloons on a monorail system enabled the rapid exchange of coronary wires via a buddy-wire technique. This novel approach facilitated stenting and simultaneous angioplasty of multiple visceral vessels and the abdominal aorta. PMID:25873796

Innovative chimney-graft technique for endovascular repair of a pararenal abdominal aortic aneurysm.

PubMed

Galiñanes, Edgar Luis; Hernandez-Vila, Eduardo A; Krajcer, Zvonimir

2015-02-01

After abdominal aortic aneurysm repair, progressive degeneration of the aneurysm can be challenging to treat. Multiple comorbidities and previous operations place such patients at high risk for repeat surgery. Endovascular repair is a possible alternative; however, challenging anatomy can push the limits of available technology. We describe the case of a 71-year-old man who presented with a 5.3-cm pararenal aneurysm 4 years after undergoing open abdominal aortic aneurysm repair. To avoid reoperation, we excluded the aneurysm by endovascular means, using visceral-artery stenting, a chimney-graft technique. Low-profile balloons on a monorail system enabled the rapid exchange of coronary wires via a buddy-wire technique. This novel approach facilitated stenting and simultaneous angioplasty of multiple visceral vessels and the abdominal aorta.

Stent design favorably influences the vascular response in normal porcine coronary arteries.

PubMed

Carter, A J; Scott, D; Rahdert, D; Bailey, L; De Vries J; Ayerdi, K; Turnlund, T; Jones, R; Virmani, R; Fischell, T A

1999-03-01

The purpose of this study was to compare the arterial response following implantation of a stainless-steel, balloon-expandable, tubular slotted stent with that of a novel computer-designed, multi-cellular stent in normal porcine coronary arteries. Intracoronary stent placement has evolved into the primary strategy for percutaneous revascularization of symptomatic coronary arterial lesions. Presently there is intense interest in developing new stent designs to improve stent delivery and biocompatability. Computer-assisted design was utilized to develop a balloon-expandable stent with symmetric expansion properties, uniform arterial wall coverage, longitudinal flexibility and radial strength. Quantitative coronary angiography and histological assessment of the stented arteries was used to evaluate the acute and chronic vascular responses to a stainless-steel, balloon-expandable, tubular slotted stent as compared to the computer-designed BX stent in the normolipemic swine. Forty stents (24 BX, 16 tubular slotted) were implanted in 19 miniature swine at a mean inflation pressure of 9 atm using identical delivery systems. Eight of the BX and none of the tubular slotted stents were post-dilated with a non-compliant balloon at 12-14 atm. The mean stent-to-artery ratio was similar for the BX (1.03 +/- 0.06) and tubular slotted (1.04 +/- 0.11; p = 0.59) designs. Protrusion or asymmetric radial flaring of a strut at the stent margin was present in 1 of 23 BX stents (4.3%) and 10 of 15 tubular slotted stents (66.7%; p < 0.0001). The mean arterial injury score was significantly less for the BX stent (0.2 +/- 0.2) as compared with the tubular slotted stents (0.4 +/- 0.4; p = 0.025). At 3 days, thrombus area was similar for the BX and tubular slotted designs (0.42 +/- 0.16 mm2 versus 0.44 +/- 0.18 mm2, respectively; p = 0.88). The mean neointimal area was significantly less for the BX at 2 months (1.09 +/- 0.25 mm2 versus 2.93 +/- 2.26 mm2 in the tubular slotted stent) and at 6 months (1.10 +/- 0.26 mm2 versus 2.07 +/- 0.65 mm2 in the tubular slotted stent; p = 0.01), resulting in approximately 50% less in-stent stenosis. The arterial response to a balloon-expandable stent can be favorably influenced by computer-assisted modification of design in an experimental model. Further study is warranted to determine the impact of stent design upon clinical in-stent restenosis.

A prospective randomised trial comparing the novel ridaforolimus-eluting BioNIR stent to the zotarolimus-eluting Resolute stent: six-month angiographic and one-year clinical results of the NIREUS trial.

PubMed

Paradies, Valeria; Ben-Yehuda, Ori; Jonas, Michael; Banai, Shmuel; Iñiguez, Andres; Perlman, Gidon Y; Kandzari, David E; Stone, Gregg W; Smits, Pieter C

2018-05-20

The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease. This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority<0.0001). At 12-month follow-up, target lesion failure occurred in 3.4% in the BioNIR group and 5.9% in the Resolute Integrity group (p=0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs. 5.9%, respectively, p=0.45). The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Quantitative optical coherence tomography analysis for late in-stent restenotic lesions.

PubMed

Fu, Qiang; Suzuki, Nobuaki; Kozuma, Ken; Miyagawa, Mutsuki; Nomura, Takahiro; Kawashima, Hideyuki; Shiratori, Yoshitaka; Ishikawa, Shuichi; Kyono, Hiroyuki; Isshiki, Takaaki

2015-01-01

Coronary optical coherence tomography (OCT) has the potential to identify in-stent neoatherosclerosis, which is a possible risk factor for late acute coronary events after drug-eluting stent implantation. The purpose of this study was to investigate differences between mid-term and late in-stent restenosis after stent implantation by quantitative and semiautomated tissue property analysis using OCT. In total, 1063 OCT image frames of 16 lesions in 15 patients were analyzed. This included 346 frames of 6 lesions in late in-stent restenosis, which was defined as restenosis that was not detected at 6 to 12 months but ≥ 12 months after follow-up coronary angiography. Signal attenuation was circumferentially analyzed using a dedicated semiautomated software. Attenuation was assessed along 200 lines delineated radially for analysis of the in-stent restenotic lesions (between the lumen and stent contours). All lines were anchored by the image wire to avoid artifacts resulting from wire location. Stronger signal attenuation at the frame level (2.46 ± 0.78 versus 1.47 ± 0.32, P < 0.001) and higher maximum signal intensity at the lesion level (9.19 ± 0.19 versus 8.84 ± 0.32, P = 0.018) were observed in late in-stent restenotic lesions than in mid-term in-stent restenotic lesions. OCT demonstrated stronger signal attenuation and higher maximum signal intensity in late in-stent restenotic lesions than in mid-term in-stent restenotic lesions, indicating the possibility of neoatherosclerosis.

High-definition computed tomography for coronary artery stent imaging: a phantom study.

PubMed

Yang, Wen Jie; Chen, Ke Min; Pang, Li Fang; Guo, Ying; Li, Jian Ying; Zhang, Huang; Pan, Zi Lai

2012-01-01

To assess the performance of a high-definition CT (HDCT) for imaging small caliber coronary stents (≤ 3 mm) by comparing different scan modes of a conventional 64-row standard-definition CT (SDCT). A cardiac phantom with twelve stents (2.5 mm and 3.0 mm in diameter) was scanned by HDCT and SDCT. The scan modes were retrospective electrocardiography (ECG)-gated helical and prospective ECG-triggered axial with tube voltages of 120 kVp and 100 kVp, respectively. The inner stent diameters (ISD) and the in-stent attenuation value (AV(in-stent)) and the in-vessel extra-stent attenuation value (AV(in-vessel)) were measured by two observers. The artificial lumen narrowing (ALN = [ISD - ISD(measured)]/ISD) and artificial attenuation increase between in-stent and in-vessel (AAI = AV(in-stent) - AV(in-vessel)) were calculated. All data was analyzed by intraclass correlation and ANOVA-test. The correlation coefficient of ISD, AV(in-vessel) and AV(in-stent) between the two observers was good. The ALNs of HDCT were statistically lower than that of SDCT (30 ± 5.7% versus 35 ± 5.4%, p < 0.05). HDCT had statistically lower AAI values than SDCT (15.7 ± 81.4 HU versus 71.4 ± 90.5 HU, p < 0.05). The prospective axial dataset demonstrated smaller ALN than the retrospective helical dataset on both HDCT and SDCT (p < 0.05). Additionally, there were no differences in ALN between the 120 kVp and 100 kVp tube voltages on HDCT (p = 0.05). High-definition CT helps improve measurement accuracy for imaging coronary stents compared to SDCT. HDCT with 100 kVp and the prospective ECG-triggered axial technique, with a lower radiation dose than 120 kVp application, may be advantageous in evaluating coronary stents with smaller calibers (≤ 3 mm).

Effect of long-term clopidogrel treatment on platelet function and inflammation in patients undergoing coronary arterial stenting.

PubMed

Antonino, Mark J; Mahla, Elisabeth; Bliden, Kevin P; Tantry, Udaya S; Gurbel, Paul A

2009-06-01

A clopidogrel loading dose administered during stenting attenuates inflammation marker release. However, less is known of the anti-inflammatory effect of clopidogrel maintenance therapy. Platelet reactivity to adenosine diphosphate and inflammation markers were measured in 110 consecutive patients (69 clopidogrel-naive patients and 41 patients receiving long-term clopidogrel therapy for >6 months) before nonemergent stenting by turbidimetric aggregometry and flow cytometry and multianalyte profiling, respectively. All patients were treated with aspirin. Prestenting adenosine diphosphate-induced platelet aggregation, P-selectin, and activated glycoprotein IIb/IIIa expression were lower in patients receiving long-term clopidogrel therapy compared with the clopidogrel-naive group (p <0.001), accompanied by lower levels of selected inflammation markers (p < or = 0.05). Additionally, there were strong correlations between platelet aggregation and flow cytometric measurements (p < or = 0.04) and between specific inflammation markers (p < or = 0.02). In conclusion, in addition to markedly lowering platelet reactivity to adenosine diphosphate, long-term clopidogrel therapy is associated with an anti-inflammatory effect.

First-in-man study of simvastatin-eluting stent in de novo coronary lesions: the SIMVASTENT study.

PubMed

Zago, Alexandre C; Matte, Bruno S; Reginato, Luciana; Iturry-Yamamoto, Germán; Krepsky, Ana; Bergoli, Luiz Carlos C; Balvedi, Julise; Raudales, José C; Saadi, Eduardo K; Zago, Alcides J

2012-01-01

Statins have anti-inflammatory and antiproliferative properties irrespective of their cholesterol-lowering effects. The aim of the present study was to evaluate a simvastatin-eluting stent (SimvES) in the treatment of de novo coronary lesions. Forty-two patients with de novo coronary artery lesions were assigned to SimvES, bare-metal stent (BMS) or everolimus-eluting stent (EES) implantation followed by intravascular ultrasound (IVUS) for neointimal quantitative analysis. Six months later, quantitative coronary angiography (QCA) and IVUS were repeated. QCA showed no binary restenosis, a mean in-stent late loss of 1.05 ± 0.25 mm (BMS, 1.12 ± 0.48 mm; EES, 0.20 ± 0.16 mm) and a diameter stenosis of 33.5 ± 7.1% (BMS, 35.5 ± 15.30%; EES, 7.2 ± 3.12%). Control IVUS showed a mean in-stent obstruction of 18.3 ± 9.4% (BMS, 32.8 ± 19.1%; EES, 9.8 ± 2.4%) and a neointimal volume index of 1.58 ± 0.75 mm(3)/mm (BMS, 2.93 ± 1.76 mm(3)/mm; EES, 0.80 ± 0.16 mm(3)/mm). Thrombus, late incomplete apposition and major adverse cardiac events were not observed. In this sample of patients with de novo coronary lesions, the use of a SimvES was not related to major adverse cardiac events, but it was associated with a higher level of neointimal proliferation than expected.

Retrieval of a subintimal fractured guide wire from the brachial artery following saphenous vein graft stenting.

PubMed

Danson, Edward J; Ward, Michael

2015-06-01

We present a case of a 58-year-old woman with diabetes mellitus with a history of angina, coronary artery bypass 24 years previously and who underwent retrieval of a fractured coronary buddy wire from the right brachial artery following attempted coronary intervention to a saphenous vein graft via the right radial route. Attempted removal of the guide wire had caused guide catheter-induced dissection of the vein graft in addition to a distal stent edge dissection before fracture in the brachial artery. The fractured end of the buddy wire was found to be in the subintimal space and could only be retrieved by advancing the wire into the subclavian artery by means of wrapping its free portion around the guiding catheter. Its fractured end could then be snared into the guiding catheter but could only be withdrawn from behind the stented segment in the vein graft by means of a trap balloon in the guiding catheter. Successful stenting of a guide catheter-induced dissection and distal stent edge dissection within the vein graft was then performed. This case highlights the hazards of deploying stents over buddy wires and of fractured guide wires in coronary intervention. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

In vivo evaluation of axial integrity of coronary stents using intravascular ultrasound: Insights on longitudinal stent deformation.

PubMed

Dvir, Danny; Kitabata, Hironori; Barbash, Israel M; Minha, Sa'ar; Badr, Salem; Loh, Joshua P; Chen, Fang; Torguson, Rebecca; Waksman, Ron

2014-09-01

To evaluate the axial integrity of different coronary stents using intravascular ultrasound (IVUS). Longitudinal stent deformation was recently reported. Consecutive patients who underwent IVUS analysis after drug-eluting stent (DES) implantation for de novo coronary lesions were evaluated. Stent length was compared with label length for calculation of absolute change and relative difference (absolute change divided by label length). A total of 233 DES utilizing five different platforms were included. The median absolute change in stent length was 0.90 mm (interquartile range [IQR] 0.48-1.39) and the relative difference was 5.24% (IQR 2.55-8.29). There was no significant difference among the groups in median absolute or relative change: Cypher 0.89 mm/3.89%, Taxus 0.88 mm/5.39%, Endeavor 1.16 mm/6.77%, Xience V 0.86 mm/5.80%, and PROMUS Element 0.79 mm/5.34% (P = 0.085, P = 0.072, respectively). Multivariate logistic regression revealed that the Cypher stent was independently correlated with a lower change in length, whereas stent label length and deployment pressure were correlated with higher absolute change. The axial integrity of DES platforms examined in vivo was high, with only mild changes in stent length after implantation. While there are differences between first- and second-generation DES, axial integrity among second-generation DES was similar. © 2013 Wiley Periodicals, Inc.

The Effect of Sex and Anthropometry on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Intervention for Complex Coronary Lesions

PubMed Central

Lee, Seung-Yul; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

2017-01-01

Purpose To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI). Materials and Methods From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions. Results For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion–related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423–0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160–35.206, p=0.033). Conclusion Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height. PMID:28120559

Incidence and causes of new-onset dyspnea in 3,719 patients treated with clopidogrel and aspirin combination after coronary stenting.

PubMed

Serebruany, Victor; Pokov, Ilya; Kuliczkowski, Wiktor; Vahabi, Javad; Atar, Dan

2008-08-01

The experimental oral antiplatelet agent AZD6140 causes dyspnea in randomized trials. Whether clopidogrel may also cause dyspnea remains controversial. We sought to define the incidence and causes of dyspnea in a large post-percutaneous coronary intervention (PCI) cohort based on open-labeled consecutive registry analysis of in-hospital charts and discharge diagnoses. Data were collected at six-month follow-up by means of telephone interviews or returned questionnaires during outpatient visits. Patients undergoing coronary stent implantation were loaded with 600 mg clopidogrel followed by 75 mg/daily in combination with 75-325 mg of aspirin daily for at least six months. Data from 3,719 patients were analyzed. Dyspnea was diagnosed in 157 (4.2%) patients caused by chronic obstructive pulmonary disease (n = 43 or 27% of the dyspnea group), heart failure (n = 30 or 19%), cancer (n = 22 or 14%), pneumonia (n = 17 or 11%); asthma (n = 8 or 5%), pulmonary hypertension (n = 8 or 5%); pericarditis (n = 5 or 3%); cardiac arrhythmias (n = 4 or 2.5%); pleural effusion (n = 1), pulmonary embolism (n = 1), anxiety (n = 1), or unknown (n = 17, or 11%). The incidence of dyspnea at six months in a post-stent cohort treated with aspirin and clopidogrel is low (4.2%). The majority of patients with dyspnea (140/157) exhibit a distinct underlying disease or condition, in contrast to only 17 patients (0.45% of total cohort) in whom the pathogenesis of dyspnea remained unidentified. These data closely match the frequency of dyspnea that was observed in the CAPRIE trial, suggesting that therapy with clopidogrel, and/or aspirin holds very small (if any) risk for dyspnea.

Metabolic Syndrome and Coronary Artery Disease in Ossabaw Compared with Yucatan Swine

PubMed Central

Neeb, Zachary P; Edwards, Jason M; Alloosh, Mouhamad; Long, Xin; Mokelke, Eric A; Sturek, Michael

2010-01-01

Metabolic syndrome (MetS), a compilation of associated risk factors, increases the risk of type 2 diabetes and coronary artery disease (CAD, atherosclerosis), which can progress to the point of artery occlusion. Stents are the primary interventional treatment for occlusive CAD, and patients with MetS and hyperinsulinemia have increased restenosis. Because of its thrifty genotype, the Ossabaw pig is a model of MetS. We tested the hypothesis that, when fed high-fat diet, Ossabaw swine develop more features of MetS, greater native CAD, and greater stent-induced CAD than do Yucatan swine. Animals of each breed were divided randomly into 2 groups and fed 2 different calorie-matched diets for 40 wk: control diet (C) and high-fat, high-cholesterol atherogenic diet (H). A bare metal stent was placed in the circumflex artery, and pigs were allowed to recover for 3 wk. Characteristics of MetS, macrovascular and microvascular CAD, in-stent stenosis, and Ca2+ signaling in coronary smooth muscle cells were evaluated. MetS characteristics including, obesity, glucose intolerance, hyperinsulinemia, and elevated arterial pressure were elevated in Ossabaw swine compared to Yucatan swine. Ossabaw swine with MetS had more extensive and diffuse native CAD and in-stent stenosis and impaired coronary blood flow regulation compared with Yucatan. In-stent atherosclerotic lesions in Ossabaw coronary arteries were less fibrous and more cellular. Coronary smooth muscle cells from Ossabaw had impaired Ca2+ efflux and intracellular sequestration versus cells from Yucatan swine. Therefore, Ossabaw swine are a superior model of MetS, subsequent CAD, and cellular Ca2+ signaling defects, whereas Yucatan swine are leaner and relatively resistant to MetS and CAD. PMID:20819380

Immediate and late clinical and angiographic outcomes after GFX coronary stenting: is high-pressure balloon dilatation necessary?

PubMed

Park, S W; Hong, M K; Lee, C W; Kim, J J; Park, H K; Cho, G Y; Kang, D H; Song, J K; Park, S J

2000-08-01

The GFX stent is a balloon-expandable stent made of sinusoidal element of stainless steel. The adjunct high-pressure balloon dilatations were usually recommended in routine stenting procedure. The aim of this study was to evaluate the immediate and long-term clinical and angiographic outcomes and to investigate the necessity of high-pressure balloon dilatation during GFX stenting. In all, 172 consecutive patients underwent single 12 or 18 mm GFX stent implantation in 188 native coronary lesions. Two types of stenting technique were used: (1) stent size of a final stent-to-artery ratio of 1:1 (inflation pressure > 10 atm, high-pressure group), and (2) stent size of 0.5 mm bigger than reference vessel (inflation pressure < or = 10 atm, low-pressure group). The adjunct high-pressure balloon dilatations were performed only in cases of suboptimal results. The adjunct high-pressure balloon dilatation was required in 11 of 83 lesions (13%) in the high-pressure group and in 7 of 105 lesions (7%) in the low-pressure group (p = 0.203). Procedural success rate was 100%. There were no significant differences of in-hospital and long-term clinical events between the two groups. The overall angiographic restenosis rate was 17.7%; 18.4% in the high-pressure group and 17.1% in the low-pressure group (p = 0.991). The GFX stent is a safe and effective device with a high procedural success rate and favorable late clinical outcome for treatment of native coronary artery disease. Further randomized trials may be needed to compare stenting techniques in GFX stent implantation.

The peri-operative management of anti-platelet therapy in elective, non-cardiac surgery.

PubMed

Alcock, Richard F; Naoum, Chris; Aliprandi-Costa, Bernadette; Hillis, Graham S; Brieger, David B

2013-07-31

Cardiovascular complications are important causes of morbidity and mortality in patients undergoing elective non-cardiac surgery, with adverse cardiac outcomes estimated to occur in approximately 4% of all patients. Anti-platelet therapy withdrawal may precede up to 10% of acute cardiovascular syndromes, with withdrawal in the peri-operative setting incompletely appraised. The aims of our study were to determine the proportion of patients undergoing elective non-cardiac surgery currently prescribed anti-platelet therapy, and identify current practice in peri-operative management. In addition, the relationship between management of anti-platelet therapy and peri-operative cardiac risk was assessed. We evaluated consecutive patients attending elective non-cardiac surgery at a major tertiary referral centre. Clinical and biochemical data were collected and analysed on patients currently prescribed anti-platelet therapy. Peri-operative management of anti-platelet therapy was compared with estimated peri-operative cardiac risk. Included were 2950 consecutive patients, with 516 (17%) prescribed anti-platelet therapy, primarily for ischaemic heart disease. Two hundred and eighty nine (56%) patients had all anti-platelet therapy ceased in the peri-operative period, including 49% of patients with ischaemic heart disease and 46% of patients with previous coronary stenting. Peri-operative cardiac risk score did not influence anti-platelet therapy management. Approximately 17% of patients undergoing elective non-cardiac surgery are prescribed anti-platelet therapy, the predominant indication being for ischaemic heart disease. Almost half of all patients with previous coronary stenting had no anti-platelet therapy during the peri-operative period. The decision to cease anti-platelet therapy, which occurred commonly, did not appear to be guided by peri-operative cardiac risk stratification. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Nanoparticle Drug- and Gene-eluting Stents for the Prevention and Treatment of Coronary Restenosis

PubMed Central

Yin, Rui-Xing; Yang, De-Zhai; Wu, Jin-Zhen

2014-01-01

Percutaneous coronary intervention (PCI) has become the most common revascularization procedure for coronary artery disease. The use of stents has reduced the rate of restenosis by preventing elastic recoil and negative remodeling. However, in-stent restenosis remains one of the major drawbacks of this procedure. Drug-eluting stents (DESs) have proven to be effective in reducing the risk of late restenosis, but the use of currently marketed DESs presents safety concerns, including the non-specificity of therapeutics, incomplete endothelialization leading to late thrombosis, the need for long-term anti-platelet agents, and local hypersensitivity to polymer delivery matrices. In addition, the current DESs lack the capacity for adjustment of the drug dose and release kinetics appropriate to the disease status of the treated vessel. The development of efficacious therapeutic strategies to prevent and inhibit restenosis after PCI is critical for the treatment of coronary artery disease. The administration of drugs using biodegradable polymer nanoparticles as carriers has generated immense interest due to their excellent biocompatibility and ability to facilitate prolonged drug release. Despite the potential benefits of nanoparticles as smart drug delivery and diagnostic systems, much research is still required to evaluate potential toxicity issues related to the chemical properties of nanoparticle materials, as well as to their size and shape. This review describes the molecular mechanism of coronary restenosis, the use of DESs, and progress in nanoparticle drug- or gene-eluting stents for the prevention and treatment of coronary restenosis. PMID:24465275

Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Boersma, Eric; Parikh, Keyur; Kurowski, Volkhard; Gao, Runlin; Bode, Christoph; Greenwood, John P; Gershlick, Anthony; O'Neill, William; Serruys, Patrick W; Jorissen, Brenda; Steg, P Gabriel

2009-12-01

Drug-eluting stents (DES) reduce restenosis rates compared to bare-metal stents. Most trials using DES enrolled selected patient and lesion subtypes, and primary endpoint focused on angiographic metrics or relatively short-term outcomes. When DES are used in broader types of lesions and patients, important differences may emerge in long-term outcomes between stent types, particularly the incidence of late stent thrombosis. PROTECT is a randomized, open-label trial comparing the long-term safety of the zotarolimus-eluting stent and the sirolimus-eluting stent. The trial has enrolled 8,800 patients representative of those seen in routine clinical practice, undergoing elective, unplanned, or emergency procedures in native coronary arteries in 196 centers in 36 countries. Indications for the procedure and selection of target vessel and lesion characteristics were at the operator's discretion. Procedures could be staged, but no more than 4 target lesions could be treated per patient. Duration of dual antiplatelet therapy was prespecified to achieve similar lengths of treatment in both study arms. The shortest predefined duration was 3 months, as per the manufacturer's instructions. The primary outcome measure is the composite rate of definite and probable stent thrombosis at 3 years, centrally adjudicated using Academic Research Consortium definitions. The main secondary end points are 3-year all-cause mortality, cardiac death, large nonfatal myocardial infarction, and all myocardial infarctions. This large, international, randomized, controlled trial will provide important information on comparative rates of stent thrombosis between 2 different DES systems and safety as assessed by patient-relevant long-term clinical outcomes.

Adopting an early invasive strategy for non-ST-elevation myocardial infarction: Analysis of the Portuguese Registry on Acute Coronary Syndromes.

PubMed

Morgado, Gonçalo; Pereira, Hélder; Caldeira, Daniel

2018-01-01

In patients with non-ST-elevation myocardial infarction (NSTEMI), the best timing for coronary angiography is not definitely established, although it is recognized that in high-risk patients it should be performed within the first 24 hours. The aim of this work was to describe the evolution over time of the use of an invasive strategy in the treatment of NSTEMI and in-hospital mortality. We performed a retrospective analysis of patients admitted with NSTEMI included in the Portuguese Registry on Acute Coronary Syndromes (ProACS) between 2002 and 2015. The annual proportion of patients undergoing coronary angiography and the time from admission to coronary angiography were assessed, as were changes in mortality and length of stay. A total of 18 639 patients with NSTEMI were included in the ProACS registry between 2002 and 2015. Over this period there were significant increases in the proportion of patients undergoing coronary angiography (from 52.0 to 83.6%) and angioplasty (from 23.3 to 53.0%), as well as in the proportion of patients who underwent coronary angiography within 24 hours of admission (from 21.0 to 48.1%). In-hospital mortality decreased in those aged over 74 years (from 9.5 to 3.7%) and in males. The progressive adoption of an invasive strategy, particularly an early one (within 24 hours), was accompanied by a reduction in in-hospital mortality. Since coronary angiography is performed late (>24 hours) in half of NSTEMI patients, these patients could benefit from initiatives similar to Stent for Life. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

A novel high nitrogen nickel-free coronary stents system: evaluation in a porcine model.

PubMed

Zhang, Bin; Chen, Ming; Zheng, Bo; Wang, Xin Gang; Wang, Xi Ting; Fan, Yuan Yuan; Huo, Yong

2014-04-01

To study the safety of the novel high nitrogen nickel-free austenitic stainless steel bare metal stents (BMS) in a recognized porcine coronary model and to select a better grid structure of it. Three types of stents were randomly implanted in different coronary arteries of the same pig: 316 L stainless steel BMS (316 L-BMS) (n=12), novel high nitrogen nickel-free stents Grid A (NF-A-BMS) (n=12) and novel high nitrogen nickel-free stents Grid B (NF-B-BMS) (n=12). In total, eighteen animals underwent successful random placement of 36 oversized stents in the coronary arteries. Coronary angiography was performed after 36 d of stents implantation. Nine animals were respectively sacrificed after 14 d and 36 d for histomorphologic analysis. Quantitative coronary angiography (QCA) showed similar luminal loss (LL) in the three groups: (0.21 ± 0.17) mm for 316 L-BMS, (0.16 ± 0.12) mm for NF-A-BMS, (0.24 ± 0.15) mm for NF-B-BMS (P>0.05). Histomorphomeric analysis after 15 d and 36 d revealed that there was also no significant difference among the three groups in neointimal area (NA) with similar injury scores respectively. High magnification histomorphologic examination showed similar inflammation scores in the three groups, but NF-A-BMS group had poorer endothelialization scores compared with NF-B-BMS group, 2.00 ± 0.63 vs. 2.83 ± 0.41 (P=0.015) at 15 d, which also could be proved by the scanning electron microscope. However, the difference could not been observed at 36 d. The novel NF-BMS showed similar safety as 316 L-BMS during the short-term study. NF-B-BMS had better endothelialization than NF-A-BMS and this may owe to the specific strut units. Copyright © 2014 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

Association of neointimal morphology by optical coherence tomography with rupture of neoatherosclerotic plaque very late after coronary stent implantation.

NASA Astrophysics Data System (ADS)

Karanasos, Antonios; Ligthart, Jurgen; Witberg, Karen; Toutouzas, Konstantinos; Daemen, Joost; van Soest, Gijs; Gnanadesigan, Muthukaruppan; van Geuns, Robert-Jan; de Jaegere, Peter; Regar, Evelyn

2013-03-01

Purpose: Neoatherosclerosis within a stent has been recently described as a culprit of late stent failure. We investigated by optical coherence tomography (OCT) the association of neoatherosclerotic plaque morphology with neointimal rupture (NR) and clinical presentation in patients late after coronary stent implantation. Methods: From 1/1/2007 to 31/1/2012, 74 patients from two institutions underwent OCT assessment of a coronary stent implanted at least 18 months prior to OCT study. Native atherosclerosis criteria were used for neointimal characterization. Results: Neoatherosclerosis was observed in 59.5% of the stents (n=44). Stents with neoatherosclerosis were more often associated with symptoms compared to stents without neoatherosclerosis (59.1% acute coronary syndrome (ACS), 25% stable angina (SA), and 15.9% asymptomatic versus 43.3% ACS, 6.7% SA, 50% asymptomatic, p<0.01). Among neoatherosclerotic lesions (n=44), NR was detected in 19 (43.2%) and had higher incidence in ACS (61.5%) than in SA (18.2%) and asymptomatic (14.3%) (p<0.05). Thrombus was detected in all NR cases. Fibrous cap thickness was lower in NR lesions compared to lesions without NR (48+/-21 μm versus 104+/-58μm, p<0.01). Lipid content tended to be higher in lesions with NR (260+/-103° versus 203+/-85°, p=0.051). Lesions with NR had more often dense macrophage infiltration (84.2% versus 44.0%, p<0.05). There were no differences in neovascularization or calcifications between lesions with or without NR. Conclusions: Neoatherosclerosis is frequent and more common among symptomatic patients. Importantly, neointimal rupture is associated with ACS late after stent implantation. Specific morphological characteristics, such as cap thickness and macrophage infiltration are associated with rupture of neoatherosclerotic plaques.

New predictors of in-stent restenosis in patients with diabetes mellitus undergoing percutaneous coronary intervention with drug-eluting stent.

PubMed

Wang, Jian-Long; Qin, Zheng; Wang, Zhi-Jian; Shi, Dong-Mei; Liu, Yu-Yang; Zhao, Ying-Xin; Yang, Li-Xia; Cheng, Wan-Jun; Zhou, Yu-Jie

2018-02-01

Percutaneous coronary intervention (PCI) had become the major therapeutic procedure for coronary artery disease (CAD), but the high rate of in-stent restenosis (ISR) still remained an unsolved clinical problem in clinical practice. Increasing evidences suggested that diabetes mellitus (DM) was a major risk factor for ISR, but the risk predictors of ISR in CAD patients with DM had not been well characterized. The aim of this study was to investigate the clinical and angiographic characteristic predictors significantly associated with the occurrence of ISR in diabetic patients following coronary stenting with drug-eluting stent (DES). A total of 920 patients with diabetes who diagnosed CAD and underwent coronary DES implantation at Beijing Anzhen Hospital in China were consecutively enrolled from January 2012 to December 2012. Of these, 440 patients underwent the second angiography within ≥ 6 months due to the progression of treated target lesions. Finally, 368 of these patients who met the inclusion and exclusion criteria were followed up by angiography after baseline PCI. According to whether ISR was detected at follow-up angiography, patients were divided into the ISR group ( n = 74) and the non-ISR group ( n = 294). The independent predictors of ISR in patients with DM were explored by multivariate Cox's proportional hazards regression models. A total of 368 patients (260 women and 108 men) with a mean ages of 58.71 ± 10.25 years were finally enrolled in this study. Of these, ISR occurred in 74/368 diabetic patients (20.11%) by follow-up angiography. Univariate analysis showed that most baseline characteristics of the ISR and non-ISR group were similar. Patients in the ISR group had significantly higher serum very low density lipoprotein cholesterol (VLDL-C), triglyceride (TG) and uric acid (UA) levels, more numbers of target vessel lesions, higher prevalence of multi-vessel disease, higher SYNTAX score, higher rate of previous but lower rate of drinking compared with patients in the non-ISR group. The independent predictors of ISR in patients with DM after DES implantation included VLDL-C (HR = 1.85, 95% CI: 1.24-2.77, P = 0.002), UA (per 50 µmol/L increments, HR = 1.19, 95% CI: 1.05-1.34, P = 0.006), SYNTAX score (per 5 increments, HR = 1.34, 95% CI: 1.03-1.74, P = 0.031) and the history of PCI (HR = 3.43, 95% CI: 1.57-7.80, P = 0.003) by the multivariate Cox's proportional hazards regression analysis. The increased serum VLDL-C and UA level, higher SYNTAX score and the history of previous PCI were independent predictors of ISR in patients with DM after coronary DES implantation. It provided new evidence for physicians to take measures to lower the risk of ISR for the better management of diabetic patients after PCI.

Anticoagulant and Antiplatelet Prescribing Patterns for Patients with Atrial Fibrillation after Percutaneous Coronary Intervention.

PubMed

Woods, Erin A; Ackman, Margaret L; Graham, Michelle M; Koshman, Sheri L; Boswell, Rosaleen M; Barry, Arden R

2016-01-01

Current guidelines recommend triple antithrombotic therapy (TAT), defined as acetylsalicylic acid (ASA), clopidogrel, and warfarin, for patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention with stent implantation. The choice of anticoagulant/antiplatelet therapy in this population is ambiguous and complex, and prescribing patterns are not well documented. To characterize local prescribing patterns for anticoagulant/antiplatelet therapy after percutaneous coronary intervention in patients with nonvalvular atrial fibrillation. A chart review was conducted at a single quaternary cardiology centre. Patients with nonvalvular atrial fibrillation were identified via medical records, and those who underwent percutaneous coronary intervention were identified using a local clinical patient registry. Adult inpatients with nonvalvular atrial fibrillation and a CHADS2 score (based on congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke) of 1 or higher who underwent percutaneous coronary intervention from 2011 to 2013 were included. Patients undergoing cardiovascular surgery or transcatheter aortic valve replacement, those with mechanical devices requiring anticoagulation, and those with an allergy to any component of TAT were excluded. Seventy patients were included. The median age was 75 years, and 52 (74%) were men. At discharge, 30 (43%) were receiving TAT and 27 (39%) were receiving dual antiplatelet therapy (clopidogrel and ASA). No patients received the combination of warfarin and clopidogrel. Among those who received TAT, 90% (19 of 21) who received a bare metal stent had a recommended duration of 1 month, and 75% (6 of 8) who received a drug-eluting stent had a recommended duration of 1 year. Direct-acting oral anticoagulants with 2 antiplatelet drugs were prescribed for 9% (6 of 70) of the patients, and 10% (7 of 70) received ticagrelor and ASA with or without warfarin. Overall, the combination of ASA, oral anticoagulant, and P2Y12 inhibitor was used for 54% (38/70) of the patients. Fewer than half of the patients in this study received TAT, and almost 20% received non-evidence-based therapy with a direct-acting oral anticoagulant or ticagrelor, alone or in combination. Despite current guideline recommendations, the rate of TAT utilization was lower than rates reported in the literature.

Use of the Dual-Antiplatelet Therapy Score to Guide Treatment Duration After Percutaneous Coronary Intervention.

PubMed

Piccolo, Raffaele; Gargiulo, Giuseppe; Franzone, Anna; Santucci, Andrea; Ariotti, Sara; Baldo, Andrea; Tumscitz, Carlo; Moschovitis, Aris; Windecker, Stephan; Valgimigli, Marco

2017-07-04

The dual-antiplatelet therapy (DAPT) score was developed to identify patients more likely to derive harm (score <2) or benefit (score ≥2) from prolonged DAPT after percutaneous coronary intervention (PCI). To evaluate the safety and efficacy of DAPT duration according to DAPT score. Retrospective assessment of DAPT score-guided treatment duration in a randomized clinical trial. (ClinicalTrials.gov: NCT00611286). PCI patients. 1970 patients undergoing PCI. DAPT (aspirin and clopidogrel) for 24 versus 6 months. Primary efficacy outcomes were death, myocardial infarction, or cerebrovascular accident. The primary safety outcome was type 3 or 5 bleeding according to the Bleeding Academic Research Consortium definition. Outcomes were assessed between 6 and 24 months. 884 patients (44.9%) had a DAPT score of at least 2, and 1086 (55.1%) had a score less than 2. The reduction in the primary efficacy outcome with 24- versus 6-month DAPT was greater in patients with high scores (risk difference [RD] for score ≥2, -2.05 percentage points [95% CI, -5.04 to 0.95 percentage points]; RD for score <2, 2.91 percentage points [CI, -0.43 to 6.25 percentage points]; P = 0.030). However, the difference by score for the primary efficacy outcome varied by stent type; prolonged DAPT with high scores was effective only in patients receiving paclitaxel-eluting stents (RD, -7.55 percentage points [CI, -12.85 to -2.25 percentage points]). The increase in the primary safety outcome with 24- versus 6-month DAPT was greater in patients with low scores (RD for score ≥2, 0.20 percentage point [CI, -1.20 to 1.60 percentage points]; RD for score <2, 2.58 percentage points [CI, 0.71 to 4.46 percentage points]; P = 0.046). Retrospective calculation of the DAPT score. Prolonged DAPT resulted in harm in patients with low DAPT scores undergoing PCI but reduced risk for ischemic events in patients with high scores receiving paclitaxel-eluting stents. Whether prolonged DAPT benefits patients with high scores treated with contemporary drug-eluting stents requires further study. None.

Aortocoronary dissection with acute left main artery occlusion: successful treatment with emergent stenting.

PubMed

Wykrzykowska, Joanna J; Carrozza, Joseph; Laham, Roger J

2006-08-01

Iatrogenic aortocoronary dissection is a rare but devastating complication of percutaneous coronary interventions and cardiac surgery, with a mortality rate up to 35%. Of the type-A dissections in the International Registry of Aortic Dissections (IRAD), 27% were caused by coronary interventions. The mechanism involves an initial dissection in the coronary artery, which then propagates in a retrograde fashion past the sinuses of Valsalva, often several centimeters beyond the aortic valve. With the advent of complex interventions such as left main stent implantation, revascularization of chronic total occlusions and mechanical thrombectomy, this complication may become more prevalent. Here we present a unique case of percutaneous coronary intervention (PCI) of the left circumflex (LCx) artery complicated by a left main coronary dissection that propagated approximately 8 cm into the ascending aorta and caused abrupt left main coronary artery occlusion and hemodynamic collapse. Rescue of the left main artery and sealing of the aortic dissection with stabilization of the patient was possible with rapid ostial left main artery stenting.

Influence of cardiac motion on stent lumen visualization in third generation dual-source CT employing a pulsatile heart model.

PubMed

Petri, Nils; Gassenmaier, Tobias; Allmendinger, Thomas; Flohr, Thomas; Voelker, Wolfram; Bley, Thorsten A

2017-02-01

To detect an in-stent restenosis, an invasive coronary angiography is commonly performed. Owing to the risk associated with this procedure, a non-invasive method to detect or exclude an in-stent restenosis is desirable. The purpose of this study was to evaluate the influence of cardiac motion on stent lumen visibility in a third-generation dual-source CT scanner (SOMATOM Force; Siemens Healthcare, Forchheim, Germany), employing a pulsatile heart model (CoroSim ® ; Mecora, Aachen, Germany). 13 coronary stents with a diameter of 3.0 mm were implanted in plastic tubes filled with a contrast medium and then fixed onto the pulsatile phantom heart model. The scans were performed while the heart model mimicked the heartbeat. Coronary stents were scanned in an orientation parallel to the scanner z-axis. The evaluation of the stents was performed by employing a medium sharp convolution kernel optimized for vascular imaging. The mean visible stent lumen was reduced from 65.6 ± 5.7% for the stents at rest to 60.8 ± 4.4% for the stents in motion (p-value: <0.001). While the difference in lumen visibility between stents in motion and at rest was significant, the use of this third-generation dual-source CT scanner enabled a high stent lumen visibility under the influence of cardiac motion. Whether this translates into a clinical setting has to be evaluated in further patient studies. Advances in knowledge: The employed modern CT scanner enables a high stent lumen visibility even under the influence of cardiac motion, which is important to detect or exclude an in-stent restenosis.

ST-Segment Elevation Myocardial Infarction with Acute Stent Thrombosis Presenting as Intractable Hiccups: An Unusual Case.

PubMed

Zhang, Fan; Tongo, Nosakhare Douglas; Hastings, Victoria; Kanzali, Parisa; Zhu, Ziqiang; Chadow, Hal; Rafii, Shahrokh E

2017-04-29

BACKGROUND Acute coronary syndrome (ACS) can present with atypical chest pain or symptoms not attributed to heart disease, such as indigestion. Hiccups, a benign and self-limited condition, can become persistent or intractable with overlooked underlying etiology. There are various causes of protracted hiccups, including metabolic abnormalities, psychogenic disorders, malignancy, central nervous system pathology, medications, pulmonary disorders, or gastrointestinal etiologies. It is rarely attributed to cardiac disease. CASE REPORT We report a case of intractable hiccups in a 51-year-old male with cocaine related myocardial infarction (MI) before and after stent placement. Coronary angiogram showed in-stent thrombosis of the initial intervention. Following thrombectomy, balloon angioplasty, and stent, the patient recovered well without additional episodes of hiccups. Although hiccups are not known to present with a predilection for a particular cause of myocardial ischemia, this case may additionally be explained by the sympathomimetic effects of cocaine, which lead to vasoconstriction of coronary arteries. CONCLUSIONS Hiccups associated with cardiac enzyme elevation and EKG ST-segment elevation before and after percutaneous coronary intervention (PCI) maybe a manifestation of acute MI with or without stent. The fact that this patient was a cocaine user may have contributed to the unique presentation.

Strategies for multivessel revascularization in patients with diabetes.

PubMed

Farkouh, Michael E; Domanski, Michael; Sleeper, Lynn A; Siami, Flora S; Dangas, George; Mack, Michael; Yang, May; Cohen, David J; Rosenberg, Yves; Solomon, Scott D; Desai, Akshay S; Gersh, Bernard J; Magnuson, Elizabeth A; Lansky, Alexandra; Boineau, Robin; Weinberger, Jesse; Ramanathan, Krishnan; Sousa, J Eduardo; Rankin, Jamie; Bhargava, Balram; Buse, John; Hueb, Whady; Smith, Craig R; Muratov, Victoria; Bansilal, Sameer; King, Spencer; Bertrand, Michel; Fuster, Valentin

2012-12-20

In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease. In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0.001) and death from any cause (P=0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P=0.03). For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.).

Detailing radio frequency heating induced by coronary stents: a 7.0 Tesla magnetic resonance study.

PubMed

Santoro, Davide; Winter, Lukas; Müller, Alexander; Vogt, Julia; Renz, Wolfgang; Ozerdem, Celal; Grässl, Andreas; Tkachenko, Valeriy; Schulz-Menger, Jeanette; Niendorf, Thoralf

2012-01-01

The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR) holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF) power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR) limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study.

Detailing Radio Frequency Heating Induced by Coronary Stents: A 7.0 Tesla Magnetic Resonance Study

PubMed Central

Santoro, Davide; Winter, Lukas; Müller, Alexander; Vogt, Julia; Renz, Wolfgang; Özerdem, Celal; Grässl, Andreas; Tkachenko, Valeriy; Schulz-Menger, Jeanette; Niendorf, Thoralf

2012-01-01

The sensitivity gain of ultrahigh field Magnetic Resonance (UHF-MR) holds the promise to enhance spatial and temporal resolution. Such improvements could be beneficial for cardiovascular MR. However, intracoronary stents used for treatment of coronary artery disease are currently considered to be contra-indications for UHF-MR. The antenna effect induced by a stent together with RF wavelength shortening could increase local radiofrequency (RF) power deposition at 7.0 T and bears the potential to induce local heating, which might cause tissue damage. Realizing these constraints, this work examines RF heating effects of stents using electro-magnetic field (EMF) simulations and phantoms with properties that mimic myocardium. For this purpose, RF power deposition that exceeds the clinical limits was induced by a dedicated birdcage coil. Fiber optic probes and MR thermometry were applied for temperature monitoring using agarose phantoms containing copper tubes or coronary stents. The results demonstrate an agreement between RF heating induced temperature changes derived from EMF simulations versus MR thermometry. The birdcage coil tailored for RF heating was capable of irradiating power exceeding the specific-absorption rate (SAR) limits defined by the IEC guidelines by a factor of three. This setup afforded RF induced temperature changes up to +27 K in a reference phantom. The maximum extra temperature increase, induced by a copper tube or a coronary stent was less than 3 K. The coronary stents examined showed an RF heating behavior similar to a copper tube. Our results suggest that, if IEC guidelines for local/global SAR are followed, the extra RF heating induced in myocardial tissue by stents may not be significant versus the baseline heating induced by the energy deposited by a tailored cardiac transmit RF coil at 7.0 T, and may be smaller if not insignificant than the extra RF heating observed under the circumstances used in this study. PMID:23185498

Reality of obesity paradox: Results of percutaneous coronary intervention in Middle Eastern patients.

PubMed

Jarrah, Mohamad; Hammoudeh, Ayman J; Khader, Yousef; Tabbalat, Ramzi; Al-Mousa, Eyas; Okkeh, Osama; Alhaddad, Imad A; Tawalbeh, Loai Issa; Hweidi, Issa M

2018-04-01

Objective The aim of this study was to assess the baseline clinical characteristics, coronary angiographic features, and adverse cardiovascular events during hospitalization and at 1 year of follow-up in obese patients compared with overweight and normal/underweight patients. Methods A prospective, multicenter study of consecutive patients undergoing percutaneous coronary intervention was performed. Results Of 2425 enrolled patients, 699 (28.8%) were obese, 1178 (48.6%) were overweight, and 548 (22.6%) were normal/underweight. Obese patients were more likely to be female and to have a higher prevalence of diabetes, hypertension, hypercholesterolemia, or previous percutaneous coronary intervention. Acute coronary syndrome was the indication for percutaneous coronary intervention in 77.0% of obese, 76.4% of overweight, and 77.4% of normal/underweight patients. No significant differences in the prevalence of multi-vessel coronary artery disease or multi-vessel percutaneous coronary intervention were found among the three groups. Additionally, no significant differences were found in stent thrombosis, readmission bleeding rates, or cardiac mortality among the three groups during hospitalization, at 1 month, and at 1 year. Conclusion The major adverse cardiovascular event rate was the same among the three groups throughout the study period. Accordingly, body mass index is considered a weak risk factor for cardiovascular comorbidities in Arab Jordanian patients.

Same-day discharge after coronary stenting and femoral artery device closure: A randomized study in stable and low-risk acute coronary syndrome patients.

PubMed

Clavijo, Leonardo C; Cortes, Guillermo A; Jolly, Aaron; Tun, Han; Mehra, Anilkumar; Gaglia, Michael A; Shavelle, David; Matthews, Ray V

2016-01-01

To compare same-day (SD) vs. delayed hospital discharge (DD) after single and multivessel coronary stenting facilitated by femoral closure device in patients with stable angina and low-risk acute coronary syndrome (ACS). University of Southern California patients were screened and coronary stenting was performed in 2480 patients. Four hundred ninety-three patients met screening criteria and consented. Four hours after percutaneous coronary intervention, 100 were randomized to SD (n=50) or DD (n=50). Patients were followed for one year; outcomes-, patient satisfaction-, and cost analyses were performed. Groups were well distributed, with similar baseline demographic and angiographic characteristics. Mean age was 58.1±8.8years and 86% were male. Non-ST-elevation myocardial infarction and unstable angina were the clinical presentations in 30% and 44% of the SD and DD groups, respectively (p=0.2). Multivessel stenting was performed in 36% and 30% of SD and DD groups, respectively (p=0.14). At one year, two patients from each group (4%) required unplanned revascularization and one patient in the SD group had a gastrointestinal bleed that required a blood transfusion. Six SD and four DD patients required repeat hospitalization (p=0.74). There were no femoral artery vascular complications in either group. Patient satisfaction scores were equivalent. SD discharge was associated with $1200 savings per patient. SD discharge after uncomplicated single and multivessel coronary stenting of patients with stable, low-risk ACS, via the femoral approach facilitated by a closure device, is associated with similar clinical outcomes, patient satisfaction, and cost savings compared to overnight (DD) hospital stay. Copyright © 2016 Elsevier Inc. All rights reserved.

Optical coherence tomography assessment of the mechanistic effects of rotational and orbital atherectomy in severely calcified coronary lesions.

PubMed

Kini, Annapoorna S; Vengrenyuk, Yuliya; Pena, Jacobo; Motoyama, Sadako; Feig, Jonathan E; Meelu, Omar A; Rajamanickam, Anitha; Bhat, Arjun M; Panwar, Sadik; Baber, Usman; Sharma, Samin K

2015-11-15

This study sought to assess the mechanistic effect of rotational atherectomy (RA) and orbital atherectomy (OA) on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography (OCT). RA and OA are two main approaches to ablate coronary calcium. While small case reports have described the mechanistic effect of RA in calcified coronary lesions, there has been no imaging study to assess the effect of OA on coronary artery architecture and/or compare the effects of two atherectomy devices. This study analyzed 20 consecutive patients with OCT imaging performed after atherectomy and after stent implantation, RA (n = 10) and OA (n = 10). Postatherectomy OCT analysis identified tissue modification with deep dissections in around a third of lesions after RA and OA; however, post OA dissections ("lacunae") were significantly deeper (1.14 vs. 0.82 mm, P = 0.048). Post OA/RA lesions with dissections had significantly higher percentage of lipid rich plaques and smaller calcification arcs as compared to plaques without dissections. Stents after OA were associated with a significantly lower percent of stent strut malapposition than post RA stents (4.36 vs. 8.02%, P = 0.038). Although the incidence of dissections was comparable between RA and OA cases, OA resulted in deeper tissue modifications (lacunae) as shown by OCT imaging. The finding might provide an explanation for a better stent apposition after OA as compared to RA. Their impact on long-term outcome needs to be determined. © 2015 Wiley Periodicals, Inc.

Quantitative multi-modality imaging analysis of a bioabsorbable poly-L-lactic acid stent design in the acute phase: a comparison between 2- and 3D-QCA, QCU and QMSCT-CA.

PubMed

Bruining, Nico; Tanimoto, Shuzou; Otsuka, Masato; Weustink, Annick; Ligthart, Jurgen; de Winter, Sebastiaan; van Mieghem, Carlos; Nieman, Koen; de Feyter, Pim J; van Domburg, Ron T; Serruys, Patrick W

2008-08-01

To investigate if three-dimensional (3D) based quantitative techniques are comparable to each other and to explore possible differences with respect to the reference method of 2D-QCA in the acute phase and to study whether non-invasive MSCT could potentially be applied to quantify luminal dimensions of a stented coronary segment with a novel bioabsorable drug-eluting stent made of poly-l-lactic-acid (PLLA). Quantitative imaging data derived from 16 patients enrolled at our institution in a first-in-man trial (ABSORB) receiving a biodegradable stent and who were imaged with standard coronary angiography and intravascular ultrasound were compared. Shortly, after stenting the patients also underwent a MSCT procedure. Standard 2D-QCA showed significant smaller stent lengths (p < 0.01). Although, the absolute measured stent diameters and areas by 2D-QCA tend to be smaller, the differences failed to be statistically different when compared to the 3D based quantitative modalities. Measurements made by non-invasive QMSCT-CA of implanted PLLA stents appeared to be comparable to the other 3D modalities without significant differences. Three-dimensional based quantitative analyses showed similar results quantifying luminal dimensions as compared to 2D-QCA during an evaluation of a new bioabsorbable coronary stent design in the acute phase. Furthermore, in biodegradable stents made of PLLA, non-invasive QMSCT-CA can be used to quantify luminal dimensions.

Outcomes of Patients Treated with the Everolimus- versus the Paclitaxel-Eluting Stents in a Consecutive Cohort of Patients at a Tertiary Medical Center.

PubMed

Shammas, Nicolas W; Shammas, Gail A; Nader, Elie; Jerin, Michael; Mrad, Luay; Ehrecke, Nicholas; Shammas, Waheeb J; Voelliger, Cara M; Hafez, Alexander; Kelly, Ryan; Reynolds, Emily

2013-09-01

In this study, we compare the outcomes of the paclitaxel-eluting stent (PES) versus the everolimus-eluting stent (EES) treated patients at a tertiary medical center and up to 2 years follow-up. Unselected consecutive patients were retrospectively recruited following stenting with PES (159 patients) or EES (189 patients). The primary endpoint of the study was target lesion failure (TLF), defined as the combined endpoint of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR). Secondary endpoints included target vessel revascularization (TVR), TLR, target vessel failure (TVF), acute stent thrombosis (ST), total death, cardiac death, and nonfatal MI. Patients treated with the PES stent had less congestive heart failure and restenotic lesions, but a higher prevalence of longer lesions, nonleft main bifurcations, required more stents per patient (4.3 ± 2.8 vs. 2.9 ± 2.1). TLF occurred in 32.3% PES versus 21.5% EES (p = 0.027). The secondary unadjusted endpoints for PES versus EES, respectively, were TVF 38.6 versus 30.7% (p = 0.140), TVR 35.7 versus 26.5% (p = 0.079), definite and probable ST 1.2 versus 0.0%, nonfatal MI 4.5 versus 4.2%, and mortality 9.6 versus 4.0%. Logistic regression analysis showed that the numbers of stents per patient (p = 0.001), age (p = 0.01), and renal failure (p = 0.045) were independent predictors of TLF. Using univariate analysis, EES had lower TLF than PES in a cohort of unselected patients undergoing percutaneous coronary intervention at 2 years follow-up. Multivariate analysis showed that the numbers of stents per patient, age, and renal failure, but not stent type, were predictors of TLF.

Differentiated analysis of an everolimus-eluting stent and a paclitaxel-eluting stent among higher risk subgroups for restenosis: results from the SPIRIT II trial.

PubMed

Khattab, Ahmed A; Richardt, Gert; Verin, Vitali; Kelbaek, Henning; Macaya, Carlos; Berland, Jacques; Miquel-Hebert, Karine; Dorange, Cécile; Serruys, Patrick W

2008-03-01

Restenosis is higher among certain subpopulations when subjected to percutaneous coronary interventions even when using drug-eluting stents. The randomised SPIRIT II trial demonstrated the superiority of the XIENCE V Everolimus Eluting Coronary Stent System over the TAXUS Paclitaxel-Eluting Stent System in terms of in-stent late loss at six months among 300 patients treated for de novo native coronary artery lesions. In this post-hoc analysis of SPIRIT II we focused on six-month angiographic outcomes of diabetic patients (n=69), left anterior descending arteries (n=149), long lesions >20 mm (n=43), small vessels <3.0 mm (n=209) and type B2 and C lesions (n=233). In-stent late loss was consistently less among all subgroups when treated by everolimus-eluting stents compared to paclitaxel-eluting stents: diabetics 0.15+/-0.26 mm versus 0.39+/-0.34 mm, p=0.006; LAD 0.12+/-0.23 mm versus 0.44+/-0.37 mm, p<0.001; long lesions 0.13+/-0.26 mm versus 0.43+/-0.46 mm, p=0.070; small vessels 0.17+/-0.28 mm versus 0.37+/-0.39 mm, p<0.001; B2/C lesions 0.12+/-0.31 mm versus 0.36+/-0.36 mm, p<0.001. The everolimus-eluting stent remained superior in terms of in-stent late loss in a variety of higher risk populations for restenosis compared to the paclitaxel-eluting stent. These analyses were consistent with the in-stent late loss results of the overall SPIRIT II trial population.

Stents: Biomechanics, Biomaterials, and Insights from Computational Modeling.

PubMed

Karanasiou, Georgia S; Papafaklis, Michail I; Conway, Claire; Michalis, Lampros K; Tzafriri, Rami; Edelman, Elazer R; Fotiadis, Dimitrios I

2017-04-01

Coronary stents have revolutionized the treatment of coronary artery disease. Improvement in clinical outcomes requires detailed evaluation of the performance of stent biomechanics and the effectiveness as well as safety of biomaterials aiming at optimization of endovascular devices. Stents need to harmonize the hemodynamic environment and promote beneficial vessel healing processes with decreased thrombogenicity. Stent design variables and expansion properties are critical for vessel scaffolding. Drug-elution from stents, can help inhibit in-stent restenosis, but adds further complexity as drug release kinetics and coating formulations can dominate tissue responses. Biodegradable and bioabsorbable stents go one step further providing complete absorption over time governed by corrosion and erosion mechanisms. The advances in computing power and computational methods have enabled the application of numerical simulations and the in silico evaluation of the performance of stent devices made up of complex alloys and bioerodible materials in a range of dimensions and designs and with the capacity to retain and elute bioactive agents. This review presents the current knowledge on stent biomechanics, stent fatigue as well as drug release and mechanisms governing biodegradability focusing on the insights from computational modeling approaches.

ST-Segment Elevation Myocardial Infarction with Acute Stent Thrombosis Presenting as Intractable Hiccups: An Unusual Case

PubMed Central

Zhang, Fan; Tongo, Nosakhare Douglas; Hastings, Victoria; Kanzali, Parisa; Zhu, Ziqiang; Chadow, Hal; Rafii, Shahrokh E.

2017-01-01

Patient: Male, 51 Final Diagnosis: ST-segment elevation myocardial infarction with acute stent thrombosis Symptoms: Chest pain • hiccups Medication: — Clinical Procedure: — Specialty: Cardiology Objective: Unusual clinical course Background: Acute coronary syndrome (ACS) can present with atypical chest pain or symptoms not attributed to heart disease, such as indigestion. Hiccups, a benign and self-limited condition, can become persistent or intractable with overlooked underlying etiology. There are various causes of protracted hiccups, including metabolic abnormalities, psychogenic disorders, malignancy, central nervous system pathology, medications, pulmonary disorders, or gastrointestinal etiologies. It is rarely attributed to cardiac disease. Case Report: We report a case of intractable hiccups in a 51-year-old male with cocaine related myocardial infarction (MI) before and after stent placement. Coronary angiogram showed in-stent thrombosis of the initial intervention. Following thrombectomy, balloon angioplasty, and stent, the patient recovered well without additional episodes of hiccups. Although hiccups are not known to present with a predilection for a particular cause of myocardial ischemia, this case may additionally be explained by the sympathomimetic effects of cocaine, which lead to vasoconstriction of coronary arteries. Conclusions: Hiccups associated with cardiac enzyme elevation and EKG ST-segment elevation before and after percutaneous coronary intervention (PCI) maybe a manifestation of acute MI with or without stent. The fact that this patient was a cocaine user may have contributed to the unique presentation. PMID:28455489

Optimal treatment of coronary-to-pulmonary artery fistula: surgery, coil or stent graft?

PubMed Central

Lipiec, Piotr; Peruga, Jan Zbigniew; Jaszewski, Ryszard; Pawłowski, Witold; Kasprzak, Jarosław

2013-01-01

We report a case of a 57-year-old man with typical angina due to a coronary artery-to-pulmonary artery fistula, which was evident on transthoracic and transesophageal echocardiography with color Doppler flow mapping. The diagnosis was confirmed by coronary angiography. The patient underwent surgical ligation of the fistula. However, repeated transesophageal echocardiography and coronary angiography revealed persistence of the fistula with significant left-to-right shunt. The orifice of the fistula was then obliterated by stent-graft implantation, which was proven successful by angiography and echocardiography. PMID:24570733

Expansion of the Multi-Link Frontier™ Coronary Bifurcation Stent: Micro-Computed Tomographic Assessment in Human Autopsy and Porcine Heart Samples

PubMed Central

Kralev, Stefan; Haag, Benjamin; Spannenberger, Jens; Lang, Siegfried; Brockmann, Marc A.; Bartling, Soenke; Marx, Alexander; Haase, Karl-Konstantin; Borggrefe, Martin; Süselbeck, Tim

2011-01-01

Background Treatment of coronary bifurcation lesions remains challenging, beyond the introduction of drug eluting stents. Dedicated stent systems are available to improve the technical approach to the treatment of these lesions. However dedicated stent systems have so far not reduced the incidence of stent restenosis. The aim of this study was to assess the expansion of the Multi-Link (ML) Frontier™ stent in human and porcine coronary arteries to provide the cardiologist with useful in-vitro information for stent implantation and selection. Methodology/Principal Findings Nine ML Frontier™ stents were implanted in seven human autopsy heart samples with known coronary artery disease and five ML Frontier™ stents were implanted in five porcine hearts. Proximal, distal and side branch diameters (PD, DD, SBD, respectively), corresponding opening areas (PA, DA, SBA) and the mean stent length (L) were assessed by micro-computed tomography (micro-CT). PD and PA were significantly smaller in human autopsy heart samples than in porcine heart samples (3.54±0.47 mm vs. 4.04±0.22 mm, p = 0.048; 10.00±2.42 mm2 vs. 12.84±1.38 mm2, p = 0.034, respectively) and than those given by the manufacturer (3.54±0.47 mm vs. 4.03 mm, p = 0.014). L was smaller in human autopsy heart samples than in porcine heart samples, although data did not reach significance (16.66±1.30 mm vs. 17.30±0.51 mm, p = 0.32), and significantly smaller than that given by the manufacturer (16.66±1.30 mm vs. 18 mm, p = 0.015). Conclusions/Significance Micro-CT is a feasible tool for exact surveying of dedicated stent systems and could make a contribution to the development of these devices. The proximal diameter and proximal area of the stent system were considerably smaller in human autopsy heart samples than in porcine heart samples and than those given by the manufacturer. Special consideration should be given to the stent deployment procedure (and to the follow-up) of dedicated stent systems, considering final intravascular ultrasound or optical coherence tomography to visualize (and if necessary optimize) stent expansion. PMID:21814552

Results of completion arteriography after minimally invasive off-pump coronary artery bypass.

PubMed

Hoff, Steven J; Ball, Stephen K; Leacche, Marzia; Solenkova, Natalia; Umakanthan, Ramanan; Petracek, Michael R; Ahmad, Rashid; Greelish, James P; Walker, Kristie; Byrne, John G

2011-01-01

The benefits of a minimally invasive approach to off-pump coronary artery bypass remain controversial. The value of completion arteriography in validating this technique has not been investigated. From April 2007 to October 2009, fifty-six patients underwent isolated minimally invasive coronary artery bypass grafting through a left thoracotomy without cardiopulmonary bypass. Forty-three of these patients underwent completion arteriography. Sixty-five grafts were performed in these 56 patients, (average, 1.2 grafts per patient; range, 1 to 3). Forty-eight grafts were studied in the 43 patients undergoing completion arteriography. There were 4 findings on arteriogram leading to further immediate intervention (8.3%). These included 3 grafts with anastomotic stenoses or spasm requiring stent placement, and 1 patient who had limited dissection in the left internal mammary artery graft and underwent placement of an additional vein graft. These findings were independent of electrocardiographic changes or hemodynamic instability. The remainder of the studies showed no significant abnormalities. There were no deaths. One patient who did not have a completion arteriogram suffered a postoperative myocardial infarction requiring stent placement for anastomotic stenosis. Patients were discharged home an average of 6.8 days postoperatively. There were no instances of renal dysfunction postoperatively attributable to catheterization. Minimally invasive coronary artery bypass is safe and effective. Findings of completion arteriography occasionally reveal previously under-recognized findings that, if corrected in a timely fashion, could potentially impact graft patency and clinical outcomes. Our experience validates this minimally invasive technique. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Drug-Eluting Versus Bare-Metal Stents During PCI in Patients With End-Stage Renal Disease on Dialysis

PubMed Central

Chang, Tara I.; Montez-Rath, Maria E.; Tsai, Thomas T.; Hlatky, Mark A.; Winkelmayer, Wolfgang C.

2016-01-01

BACKGROUND In patients undergoing percutaneous coronary intervention (PCI), drug-eluting stents (DES) reduce repeat revascularizations compared with bare metal stents (BMS), but their effects on death and myocardial infarction (MI) are mixed. Few studies have focused on patients with end-stage renal disease (ESRD). OBJECTIVES We compared mortality and cardiovascular morbidity during PCI with DES and with BMS in dialysis patients. METHODS We identified 36,117 dialysis patients from the U.S. Renal Data System who had coronary stenting in the U.S. between 4/23/03 and 12/31/10, and examined the association of DES versus BMS with 1-year outcomes: death; death or MI; and death, MI or repeat revascularization. We conducted a temporal analysis by dividing the study period into 3 DES eras: Transitional (4/23/03 – 6/30/04); Liberal (7/1/04 – 12/31/06); and Selective (1/1/07 – 12/31/10). RESULTS One-year event rates were high, with 38 deaths, 55 death or MI events and 71 death, MI or repeat revascularization events per 100 person-years. DES was associated with a significant 18% lower risk of death, 16% lower risk of death or MI, and 13% lower risk of death, MI or repeat revascularization, compared with BMS. DES use varied, from 56% in the Transitional era to 85% in the Liberal era and 62% in the Selective era. DES outcomes in the Liberal era were significantly better than in the Transitional Era, but not significantly better than in the Selective Era. CONCLUSIONS DES for PCI appears safe in U.S. dialysis patients, and is associated with lower rates of death, MI and repeat revascularization. PMID:27012407

Tube focal spot size and power capability impact image quality in the evaluation of intracoronary stents

NASA Astrophysics Data System (ADS)

Cesmeli, Erdogan; Berry, Joel L.; Carr, J. J.

2005-04-01

Proliferation of coronary stent deployment for treatment of coronary heart disease (CHD) creates a need for imaging-based follow-up examinations to assess patency. Technological improvements in multi-detector computer tomography (MDCT) make it a potential non-invasive alternative to coronary catheterization for evaluation of stent patency; however, image quality with MDCT varies based on the size and composition of the stent. We studied the role of tube focal spot size and power in the optimization of image quality in a stationary phantom. A standard uniform physical phantom with a tubular insert was used where coronary stents (4 mm in diameter) were deployed in a tube filled with contrast to simulate a typical imaging condition observed in clinical practice. We utilized different commercially available stents and scanned them with different tube voltage and current settings (LightSpeed Pro16, GE Healthcare Technologies, Waukesha, WI, USA). The scanner used different focal spot size depending on the power load and thus allowed us to assess the combined effect of the focal spot size and the power. A radiologist evaluated the resulting images in terms of image quality and artifacts. For all stents, we found that the small focal spot size yielded better image quality and reduced artifacts. In general, higher power capability for the given focal spot size improved the signal-to-noise ratio in the images allowing improved assessment. Our preliminary study in a non-moving phantom suggests that a CT scanner that can deliver the same power on a small focal spot size is better suited to have an optimized scan protocol for reliable stent assessment.

An everolimus-eluting stent versus a paclitaxel-eluting stent in small vessel coronary artery disease: a pooled analysis from the SPIRIT II and SPIRIT III trials.

PubMed

Bartorelli, Antonio L; Serruys, Patrick W; Miquel-Hébert, Karine; Yu, Shui; Pierson, Wes; Stone, Gregg W

2010-07-01

To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels. The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control. Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES. (c) 2010 Wiley-Liss, Inc.

Use of drug-eluting stents in Victorian public hospitals.

PubMed

Yan, Bryan P; Ajani, Andrew E; Duffy, Stephen J; New, Gishel; Horrigan, Mark; Szto, Gregory; Walton, Antony; Eccleston, David; Lefkovits, Jeffery; Black, Alexander; Sebastian, Martin; Brennan, Angela L; Reid, Christopher M; Clark, David J

2006-10-02

We aimed to assess the pattern of use of drug-eluting stents (DESs) in patients undergoing percutaneous coronary interventions (PCIs) in Victorian public hospitals. Prospective study comparing the use of one or more DESs versus bare-metal stents (BMSs) only, in consecutive patients undergoing 2428 PCIs with stent implantation from 1 April 2004 to 31 December 2005 at seven Victorian public hospitals. Adherence to current Victorian Department of Human Services guidelines which recommend DES use in patients with high-risk features for restenosis (diabetes, small vessels, long lesions, in-stent restenotic lesions, chronic total occlusions and bifurcation lesions). Of the 2428 PCIs performed, at least one DES was implanted in 1101 (45.3%) and BMSs only were implanted in 1327 (54.7%). In 87.7% (966/1101) of PCI with DESs, there was at least one criterion for high risk of restenosis. DESs were more likely to be used in patients with diabetes (risk ratio [RR], 2.45; 95% CI, 2.02-2.97), small vessels (RR, 3.35; 95%CI, 2.35-4.76), long lesions (RR, 3.87; 95% CI, 3.23-4.65), in-stent restenotic lesions (RR, 3.98; 95%CI, 2.67-6.06), chronic total occlusions (RR, 1.30; 95% CI, 0.51-2.88) and bifurcation lesions (RR, 2.23; 95%CI, 1.57-3.17). However, 66.2% (1608/2428) of all PCIs were in patients eligible for DESs according to Victorian guidelines, and in 39.9% (642/1608) of these PCIs, a BMS was used. In Victorian public hospitals, DESs have been largely reserved for patients at high risk of restenosis in accordance with Department of Human Services guidelines. However, many patients with high-risk criteria for restenosis did not receive DESs. Greater use of DESs in these patients may improve outcomes by reducing the need for repeat revascularisation.

Steam-deformed Judkins-left guiding catheter with use of the GuideLiner(®) catheter to deliver stents for anomalous right coronary artery.

PubMed

Kuno, Toshiki; Fujisawa, Taishi; Yamazaki, Hiroyuki; Motoda, Hiroyuki; Kodaira, Masaki; Numasawa, Yohei

2015-01-01

Percutaneous coronary intervention for anomalous right coronary artery (RCA) originating from the left coronary cusp is challenging because of our current inability to coaxially engage the guiding catheter. We report a case of an 88-year-old woman with non-ST segment elevation myocardial infarction, with an anomalous RCA origin. Using either the Judkins-Left catheter or Amplatz-Left catheter was difficult because of RCA ostium tortuosity. Thus, we used steam to deform the Judkins-Left catheter, but back-up support was insufficient to deliver the stent. We used GuideLiner®, a novel pediatric catheter with rapid exchange/monorail systems, to enhance back-up support. We were able to successfully stent with both the deformed Judkins-Left guiding catheter and GuideLiner® for an anomalous RCA origin.

Intravascular Ultrasound to Guide Percutaneous Coronary Interventions

PubMed Central

2006-01-01

Executive Summary Objective The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of using intravascular ultrasound (IVUS) as an adjunctive imaging tool to coronary angiography for guiding percutaneous coronary interventions. Background Intravascular Ultrasound Intravascular ultrasound is a procedure that uses high frequency sound waves to acquire 3-dimensional images from the lumen of a blood vessel. The equipment for performing IVUS consists of a percutaneous transducer catheter and a console for reconstructing images. IVUS has been used to study the structure of the arterial wall and nature of atherosclerotic plaques, and obtain measurements of the vessel lumen. Its role in guiding stent placement is also being investigated. IVUS is presently not an insured health service in Ontario. Clinical Need Coronary artery disease accounts for approximately 55% of cardiovascular deaths, the leading cause of death in Canada. In Ontario, the annual mortality rate due to ischemic heart disease was 141.8 per 100,000 population between 1995 and 1997. Percutaneous coronary intervention (PCI), a less invasive approach to treating coronary artery disease, is used more frequently than coronary bypass surgery in Ontario. The number of percutaneous coronary intervention procedures funded by the Ontario Ministry of Health and Long-term Care is expected to increase from approximately 17, 780 in 2004/2005 to 22,355 in 2006/2007 (an increase of 26%), with about 95% requiring the placement of one or more stents. Restenosis following percutaneous coronary interventions involving bare metal stents occurs in 15% to 30% of the cases, mainly because of smooth muscle proliferation and migration, and production of extracellular matrix. In-stent restenosis has been linked to suboptimal stent expansion and inadequate lesion coverage, while stent thrombosis has been attributed to incomplete stent-to-vessel wall apposition. Since coronary angiography (the imaging tool used to guide stent placement) has been shown to be inaccurate in assessing optimal stent placement, and IVUS can provide better views of the vessel lumen, the clinical utility of IVUS as an imaging tool adjunctive to coronary angiography in coronary intervention procedures has been explored in clinical studies. Method A systematic review was conducted to answer the following questions: What are the procedure-related complications associated with IVUS? Does IVUS used in conjunction with angiography to guide percutaneous interventions improve patient outcomes compared to angiographic guidance without IVUS? Who would benefit most in terms of clinical outcomes from the use of IVUS adjunctive to coronary angiography in guiding PCIs? What is the effectiveness of IVUS guidance in the context of drug-eluting stents? What is the cost-effectiveness ratio and budget impact of adjunctive IVUS in PCIs in Ontario? A systematic search of databases OVID MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) database for the period beginning in May 2001 until the day of the search, November 4, 2005 yielded 2 systematic reviews, 1 meta-analysis, 6 randomized controlled trials, and 2 non-randomized studies on left main coronary arteries. The quality of the studies ranged from moderate to high. These reports were combined with reports from a previous systematic review for analysis. In addition to qualitative synthesis, pooled analyses of data from randomized controlled studies using a random effect model in the Cochrane Review Manager 4.2 software were conducted when possible. Findings of Literature Review & Analysis Safety Intravascular ultrasound appears to be a safe tool when used in coronary interventions. Periprocedural complications associated with the use of IVUS in coronary interventions ranged from 0.5% in the largest study to 4%. Coronary rupture was reported in 1 study (1/54). Other complications included prolonged spasms of the artery after stenting, dissection, and femoral aneurysm. Effectiveness Based on pooled analyses of data from randomized controlled studies, the use of intravascular ultrasound adjunctive to coronary intervention in percutaneous coronary interventions using bare metal stents yielded the following findings: For lesions predominantly at low risk of restenosis: There were no significant differences in preintervention angiographic minimal lumen diameter between the IVUS-guided and angiography-guided groups. IVUS guidance resulted in a significantly larger mean postintervention angiographic minimal lumen diameter (weighted mean difference of 0.11 mm, P = .0003) compared to angiographic guidance alone. The benefit in angiographic minimal lumen diameter from IVUS guidance was not maintained at 6-month follow-up, when no significant difference in angiographic minimal lumen diameter could be detected between the two arms (weighted mean difference 0.08, P = .13). There were no statistically significant differences in angiographic binary restenosis rates between IVUS-guidance and no IVUS guidance (Odds ratio [OR] 0.87 in favour of IVUS, 95% Confidence Interval [CI] [0.64–1.18], P = 0.37). IVUS guidance resulted in a reduction in the odds of target lesion revascularization (repeat percutaneous coronary intervention or coronary bypass graft) compared to angiographic guidance alone. The reduction was statistically significant at a follow-up period of 6 months to 1 year, and at a follow-up period of 18 month to 2 years (OR 0.52 in favour of IVUS, 95% CI [0.33–0.81], P = .004). Total revascularization rate (either target lesion or target vessel revascularization) was significantly lower for IVUS-guided patients at 18 months to 2.5 years after intervention (OR 0.43 in favour of IVUS, 95% CI [0.29–0.63], p < .0001). There were no statistically significant differences in the odds of death (OR 1.36 in favour of no IVUS, P =0.65) or myocardial infarction (OR 0.95 in favour of IVUS, P = 0.93) between IVUS-guidance and angiographic guidance alone at up to 2.5 years of follow-up The odds of having a major cardiac event (defined as death, myocardial infarction, and target lesion or target vessel revascularization) were significantly lower for patients with IVUS guidance compared to angiographic guidance alone during follow-up periods of up to 2.5 years (OR 0.53, 95% CI [0.36–0.78], P = 0.001). Since there were no significant reductions in the odds of death or myocardial infarction, the reduction in the odds of combined events reflected mainly the reduction in revascularization rates. For lesions at High Risk of Restenosis: There is evidence from one small, randomized controlled trial (n=150) that IVUS-guided percutaneous coronary intervention in long de novo lesions (>20 mm) of native coronary arteries resulted in statistically significant larger minimal lumen Diameter, and statistically significant lower 6-month angiographic binary restenosis rate. Target vessel revascularization rate and the rate of combined events were also significantly reduced at 12 months. A small subgroup analysis of a randomized controlled trial reported no benefit in clinical or angiographic outcomes for IVUS-guided percutaneous coronary interventions in patients with diabetes compared to those guided by angiography. However, due to the nature and size of the analysis, no firm conclusions could be reached. Based on 2 small, prospective, non-randomized controlled studies, IVUS guidance in percutaneous coronary interventions of left main coronary lesions using bare metal stents or drug-eluting stents did not result in any benefits in angiographic or clinical outcomes. These findings need to be confirmed. Interventions Using Drug-Eluting Stents There is presently no evidence on whether the addition of IVUS guidance during the implantation of drug-eluting stents would reduce incomplete stent apposition, or improve the angiographic or clinical outcomes of patients. Ontario-Based Economic Analysis Cost-effectiveness analysis showed that PCIs using IVUS guidance would likely be less costly and more effective than PCIs without IVUS guidance. The upfront cost of adjunctive use of IVUS in PCIs ranged from $1.56 million at 6% uptake to $13.04 million at 50% uptake. Taking into consideration cost avoidance from reduction in revascularization associated with the use of IVUS, a net saving of $0.63 million to $5.2 million is expected. However, since it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS can be generalized to clinical settings in Ontario, further analysis on the budget impact and cost-effectiveness need to be conducted once Ontario-specific revascularization rates are verified. Factors to be Considered in the Ontario Context Applicability of Findings to Ontario The interim analysis of an Ontario field evaluation that compared drug-eluting stents to bare metal stents showed that the revascularization rates in low-risk patients with bare metal stents were much lower in Ontario compared to rates reported in randomized controlled trials (7.2% vs >17 %). Even though IVUS is presently not routinely used in the stenting of low-risk patients in Ontario, the revascularization rates in these patients in Ontario were shown to be lower than those reported for the IVUS groups reported in published studies. Based on this information and previous findings from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rates from IVUS guidance can be generalized to Ontario. In light of the above findings, it is advisable to validate the reported benefits of IVUS guidance in percutaneous coronary interventions involving bare metal stents in the Ontario context. Licensing Status As of January 16, 2006, Health Canada has licensed 10 intravascular ultrasound imaging systems/catheters for transluminal intervention procedures, most as class 4 medical devices. Current Funding IVUS is presently not an insured procedure under the Ontario Health Insurance Plan and there are no professional fees for this procedure. All costs related to the use of IVUS are covered within hospitals’ global budgets. A single use IVUS catheter costs approximately $900CDN and the procedure adds approximately 20 minutes to 30 minutes to a percutaneous coronary intervention procedure. Diffusion According to an expert consultant, current use of IVUS in coronary interventions in Ontario is probably limited to high-risk cases such as interventions in long lesions, small vessels, and bifurcated lesions for which images from coronary angiography are indeterminate. It was estimated that IVUS is being used in about 6% of all percutaneous coronary interventions at a large Ontario cardiac centre. Expert Opinion IVUS greatly enhances the cardiac interventionists’ ability to visualize and assess high-risk lesions such as long lesions, narrow lesions, and bifurcated lesions that may have indeterminate angiographic images. Information from IVUS in these cases facilitates the choice of the most appropriate approach for the intervention. Conclusion The use of adjunctive IVUS in PCIs using bare metal stents in lesions predominantly at low risk for restenosis had no significant impact on survival, myocardial infarction, or angiographic restenosis rates up to 2.5 years after intervention. The use of IVUS adjunctive to coronary angiography in percutaneous coronary interventions using bare metal stents in lesions predominantly at low risk for restenosis significantly reduced the target lesion and target vessel revascularization at a follow-up period of 18 months to 2.5 years. One small study suggests that adjunctive IVUS in PCIs using bare metal stents in long lesions (>20 mm) significantly improved the 6-month angiographic restenosis rate and one-year target lesion revascularization rate. These results need to be confirmed with large randomized controlled trials. Based on information from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS in the placement of bare metal stents can be generalized to clinical settings in Ontario. There is presently insufficient evidence available to determine the impact of adjunctive IVUS in percutaneous interventions in high-risk lesions (other than long lesions) or in PCIs using drug-eluting stents. PMID:23074482

Optical coherence tomography assessment of efficacy of thrombus aspiration in patients undergoing a primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

PubMed Central

Yamaguchi, Tomoyuki; Ino, Yasushi; Matsuo, Yoshiki; Shiono, Yasutsugu; Yamano, Takashi; Taruya, Akira; Nishiguchi, Tsuyoshi; Shimokado, Aiko; Orii, Makoto; Tanaka, Atsushi; Hozumi, Takeshi; Akasaka, Takashi

2015-01-01

Objective We used optical coherence tomography (OCT) to assess the impact of thrombus aspiration before angioplasty on poststenting tissue protrusions in patients undergoing a primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Methods and results A total of 188 patients with STEMI who underwent thrombus-aspiration PCI (n=113) or standard PCI (n=75) were examined in this study. OCT was performed immediately after primary PCI to assess lesion morphology in the stented segment. The minimum stent area was similar between the thrombus-aspiration PCI group and the standard PCI group [7.4 interquartile range (IQR): 5.8–9.4 vs. 7.4 IQR: 5.8–8.9 mm2, P=0.788]. The maximum tissue protrusion area [0.6 (IQR: 0.3–1.1) vs. 1.2 (IQR: 0.8–1.9) mm2, P<0.001], the mean tissue protrusion area [0.1 (IQR: 0.1–0.2) vs. 0.5 (IQR: 0.3–0.8) mm2, P<0.001], and tissue protrusion volume [2.3 (IQR: 1.3–4.3) vs. 8.3 (IQR: 5.4–14.6) mm3, P<0.001] were significantly smaller in the thrombus-aspiration PCI group compared with the standard PCI group. Minimum lumen area was significantly greater in the thrombus-aspiration PCI group compared with the standard PCI group [6.9 (IQR: 5.4–8.8) vs. 6.3 (IQR: 4.6–7.8) mm2, P=0.033]. Conclusion Thrombus aspiration before angioplasty in patients with STEMI was associated with significantly smaller tissue protrusion and larger lumen poststenting compared with standard PCI. Thrombus aspiration in primary PCI favorably influenced lesion morphologies in the stented segment. PMID:26230885

Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial.

PubMed

Montalescot, Gilles; Wiviott, Stephen D; Braunwald, Eugene; Murphy, Sabina A; Gibson, C Michael; McCabe, Carolyn H; Antman, Elliott M

2009-02-28

Mechanical reperfusion with stenting for ST-elevation myocardial infarction (STEMI) is supported by dual antiplatelet treatment with aspirin and clopidogrel. Prasugrel, a potent and rapid-acting thienopyridine, is a potential alternative to clopidogrel. We aimed to assess prasugrel versus clopidogrel in patients undergoing percutaneous coronary intervention (PCI) for STEMI. We undertook a double-blind, randomised controlled trial in 707 sites in 30 countries. 3534 participants presenting with STEMI were randomly assigned by interactive voice response system either prasugrel (60 mg loading, 10 mg maintenance [n=1769]) or clopidogrel (300 mg loading, 75 mg maintenance [n=1765]) and were unaware of the allocation. The primary endpoint was cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Efficacy analyses were by intention to treat. Follow-up was to 15 months, with secondary analyses at 30 days. This trial is registered with ClinicalTrials.gov, number NCT00097591. At 30 days, 115 (6.5%) individuals assigned prasugrel had met the primary endpoint compared with 166 (9.5%) allocated clopidogrel (hazard ratio 0.68 [95% CI 0.54-0.87]; p=0.0017). This effect continued to 15 months (174 [10.0%] vs 216 [12.4%]; 0.79 [0.65-0.97]; p=0.0221). The key secondary endpoint of cardiovascular death, myocardial infarction, or urgent target vessel revascularisation was also significantly reduced with prasugrel at 30 days (0.75 [0.59-0.96]; p=0.0205) and 15 months (0.79 [0.65-0.97]; p=0.0250), as was stent thrombosis. Treatments did not differ with respect to thrombolysis in myocardial infarction (TIMI) major bleeding unrelated to coronary-artery bypass graft (CABG) surgery at 30 days (p=0.3359) and 15 months (p=0.6451). TIMI life-threatening bleeding and TIMI major or minor bleeding were also similar with the two treatments, and only TIMI major bleeding after CABG surgery was significantly increased with prasugrel (p=0.0033). In patients with STEMI undergoing PCI, prasugrel is more effective than clopidogrel for prevention of ischaemic events, without an apparent excess in bleeding.

Changes of High Sensitivity C-Reactive Protein During Clopidogrel Therapy in Patients Undergoing Percutaneous Coronary Intervention.

PubMed

Hajsadeghi, Shokoufeh; Chitsazan, Mandana; Chitsazan, Mitra; Salehi, Negar; Amin, Ahmad; Maleki, Majid; Babaali, Nima; Abdi, Seifollah; Mohsenian, Maryam

2016-02-01

The crucial role of inflammation in the development and progression of atherosclerosis has been previously described. However, there is insufficient data available to demonstrate the changes in high sensitivity C-reactive protein (hs-CRP) during clopidogrel therapy. In the present study, we aimed to assess the changes in the inflammatory marker of coronary heart disease, i.e., hs-CRP during clopidogrel therapy, in patients undergoing percutaneous coronary intervention (PCI). We also evaluated the anti-inflammatory effects of clopidogrel, if any, in different groups of patients. The study population included 650 consecutive patients who underwent elective, urgent, or emergent PCI. Patients received a 300-mg loading dose of clopidogrel (Plavix(®)) and aspirin either 24 hours before the planned PCI, or immediately before the procedure in patients with urgent or emergent PCI, followed by a 75-mg daily maintenance dose for up to 12 weeks. At the end of the 12(th) week, hs-CRP was re-assessed. Six hundred-fifty patients including 386 (59.4%) male and 264 (40.6%) female subjects were enrolled in the study. The mean hs-CRP level was 15.36 ± 9.83 mg/L with a median of 14 mg/L (interquartile range 8 to 19.6 mg/L). Female, hypertensive, diabetic, and non-smoking patients had higher reductions in hs-CRP in response to clopidogrel therapy compared to male, non-hypertensive, non-diabetic and smoker patients, respectively (all P < 0.005). The changes in the hs-CRP levels were also statistically different in patients with various index events before PCI (P < 0.001). No significant differences were observed in the mean reduction of hs-CRP between the patients without stent implantation and those with bare metal or drug-eluting stents (P = 0.07), respectively. We found that the use of clopidogrel in patients undergoing PCI had favorable effects on the suppression of hs-CRP. This effect appears to be heightened and more apparent in some group of patients with co-morbidities such as diabetes and hypertension.

Angiographic and Clinical Impact of Successful Manual Thrombus Aspiration in Diabetic Patients Undergoing Primary PCI

PubMed Central

2014-01-01

Background. Diabetes mellitus is associated with worse angiographic and clinical outcomes after percutaneous coronary intervention (PCI). Aim. To investigate the impact of manual thrombus aspiration on in-stent restenosis (ISR) and clinical outcome in patients treated by bare-metal stent (BMS) implantation for ST-segment elevation myocardial infarction (STEMI). Methods. 100 diabetic patients were prospectively enrolled. They were randomly assigned to undergo either standard primary PCI (group A, 50 patients) or PCI with thrombus aspiration using Export catheter (group B, 50 patients). The primary endpoint was the rate of eight-month ISR. The secondary endpoint included follow-up for major adverse cardiac events (MACE). Results. Mean age of the study cohort was 59.86 ± 8.3 years, with 64 (64%) being males. Baseline characteristics did not differ between both groups. Eight-month angiogram showed that group B patients had significantly less late lumen loss (0.17 ± 0.35 versus 0.60 ± 0.42 mm, P < 0.001), with lower incidence of ISR (4% versus 16.6%, P < 0.001). There was a trend towards lower rate of MACE in the same group of patients. Conclusion. In diabetic patients undergoing primary PCI, manual thrombus aspiration (compared with standard PCI) was associated with better ISR rate after BMS implantation. PMID:24804102

Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial.

PubMed

Ali, Ziad A; Maehara, Akiko; Généreux, Philippe; Shlofmitz, Richard A; Fabbiocchi, Franco; Nazif, Tamim M; Guagliumi, Giulio; Meraj, Perwaiz M; Alfonso, Fernando; Samady, Habib; Akasaka, Takashi; Carlson, Eric B; Leesar, Massoud A; Matsumura, Mitsuaki; Ozan, Melek Ozgu; Mintz, Gary S; Ben-Yehuda, Ori; Stone, Gregg W

2016-11-26

Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm 2 ), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586. Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm 2 (IQR 4·54-7·34) with OCT guidance, 5·89 mm 2 (4·67-7·80) with IVUS guidance, and 5·49 mm 2 (4·39-6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI -0·70 mm 2 ; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. St Jude Medical. Copyright © 2016 Elsevier Ltd. All rights reserved.

Sensor to detect endothelialization on an active coronary stent

PubMed Central

2010-01-01

Background A serious complication with drug-eluting coronary stents is late thrombosis, caused by exposed stent struts not covered by endothelial cells in the healing process. Real-time detection of this healing process could guide physicians for more individualized anti-platelet therapy. Here we present work towards developing a sensor to detect this healing process. Sensors on several stent struts could give information about the heterogeneity of healing across the stent. Methods A piezoelectric microcantilever was insulated with parylene and demonstrated as an endothelialization detector for incorporation within an active coronary stent. After initial characterization, endothelial cells were plated onto the cantilever surface. After they attached to the surface, they caused an increase in mass, and thus a decrease in the resonant frequencies of the cantilever. This shift was then detected electrically with an LCR meter. The self-sensing, self-actuating cantilever does not require an external, optical detection system, thus allowing for implanted applications. Results A cell density of 1300 cells/mm2 on the cantilever surface is detected. Conclusions We have developed a self-actuating, self-sensing device for detecting the presence of endothelial cells on a surface. The device is biocompatible and functions reliably in ionic liquids, making it appropriate for implantable applications. This sensor can be placed along the struts of a coronary stent to detect when the struts have been covered with a layer of endothelial cells and are no longer available surfaces for clot formation. Anti-platelet therapy can be adjusted in real-time with respect to a patient's level of healing and hemorrhaging risks. PMID:21050471

Intravascular ultrasound for intracranial angioplasty and stent placement: technical case report.

PubMed

Wehman, J Christopher; Holmes, David R; Hanel, Ricardo A; Levy, Elad I; Hopkins, L Nelson

2006-10-01

Intravascular ultrasound (IVUS) imaging has been used extensively in coronary artery interventions and has provided invaluable information for the understanding and treatment of coronary arterial disease. We present here the first description, to our knowledge, of IVUS-guided intracranial arterial interventions in the clinical setting. Two patients underwent intracranial angioplasty and stent placement with the assistance of IVUS for the evaluation of their lesions. One patient underwent stenting to treat an occlusive dissection of the left internal carotid artery that occurred during arteriovenous malformation embolization. Another patient underwent angioplasty and stenting for high-grade restenosis of a basilar artery atherosclerotic lesion. Both patients underwent successful revascularization procedures. The patient with the dissection had a small intraventricular and parenchymal hemorrhage documented by computed tomography 4 hours after treatment, but did not develop hydrocephalus or further hemorrhage. Both patients did well clinically and had no permanent neurological deficits. IVUS provided important information in terms of lesion evaluation, stent selection, and stent placement in each case. IVUS of the intracranial circulation may assist the performance of intracranial angioplasty and stenting. It provides useful information that can affect clinical decisions. It may prove to be a valuable tool in clinical use and enhance our understanding of vascular disease of the intracranial circulation, as it has in the coronary circulation.

Drug eluting stents: To evolve or dissolve?

PubMed

Bharadwaj, Prashant; Chadha, D S

2016-10-01

Currently, percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is the most commonly employed modality in the treatment of patients with coronary artery disease. PCI has come of age over the last four decades with enormous forays in the technology and drugs which have greatly enhanced its capability. Angioplasty and bare metal stents were plagued by high failure rates on account of restenosis leading to repeat revascularization procedures. Insights into pathophysiology of instent restenosis (ISR) and neointimal hyperplasia triggered the development of DES. The dreamlike remarkable reduction in ISR with DES was enthusiastically welcomed. Soon thereafter emerged the spectre of very late stent thrombosis (VLST) with DES. VLST was a new entity seen predominantly with DES and pathological insights as to the cause was instrumental in the development and efficacy of new generation DES. This review will highlight the evolution and present day DES for coronary interventions.

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents.

PubMed

Uthamaraj, Susheil; Tefft, Brandon J; Jana, Soumen; Hlinomaz, Ota; Kalra, Manju; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S

2016-10-26

Stent-grafts are widely used for the treatment of various conditions such as aortic lesions, aneurysms, emboli due to coronary intervention procedures and perforations in vasculature. Such stent-grafts are manufactured by covering a stent with a polymer membrane. An ideal stent-graft should have a biocompatible stent covered by a porous, thromboresistant, and biocompatible polymer membrane which mimics the extracellular matrix thereby promoting injury site healing. The goal of this protocol is to manufacture a small caliber stent-graft by encapsulating a balloon expandable stent within two layers of electrospun polyurethane nanofibers. Electrospinning of polyurethane has been shown to assist in healing by mimicking native extracellular matrix, thereby promoting endothelialization. Electrospinning polyurethane nanofibers on a slowly rotating mandrel enabled us to precisely control the thickness of the nanofibrous membrane, which is essential to achieve a small caliber balloon expandable stent-graft. Mechanical validation by crimping and expansion of the stent-graft has shown that the nanofibrous polyurethane membrane is sufficiently flexible to crimp and expand while staying patent without showing any signs of tearing or delamination. Furthermore, stent-grafts fabricated using the methods described here are capable of being implanted using a coronary intervention procedure using standard size guide catheters.

A rare complication: Undeflatable balloon of the stent

PubMed Central

Şatiroğlu, Ömer; Erdoğan, Turan; Durakoğlugil, Murtaza Emre; Uğurlu, Yavuz

2013-01-01

Percutaneous coronary intervention is an important modality in the treatment of coronary artery disease. These procedures are usually completed successfully, but occasionally serious complications are encountered. In this paper, we present the case of an undeflatable stent balloon, which is an extremely rare complication that has not been described in the literature. PMID:24265889

2012 Aerospace Medical Certification Statistical Handbook

DTIC Science & Technology

2013-12-01

cardiac stents , cardiac angioplasty 37 Table 22. Medical Conditions by Issued Medical Class 52 Table 22. Medical Conditions by Issued Medical Class...0.31) 344 (0.27) 2,099 (0.79) 3,014 (0.52) Coronary angioplasty with a stent 779 (0.41) 464 (0.37) 3,012 (1.13) 4,255 (0.73) Coronary angioplasty

Monoenergetic reconstructions for imaging of coronary artery stents using spectral detector CT: In-vitro experience and comparison to conventional images.

PubMed

Hickethier, Tilman; Baeßler, Bettina; Kroeger, Jan Robert; Doerner, Jonas; Pahn, Gregor; Maintz, David; Michels, Guido; Bunck, Alexander C

Accurate assessment of coronary stents using non-invasive CT imaging remains challenging despite new stent materials and improvements in CT technology. Virtual monoenergetic (monoE) images reconstructed from dual energy CT acquisitions potentially decrease artifacts caused by coronary stents. A novel spectral detector technology provides monoE and conventional images simultaneously for all conducted scans. The purpose of our study was to systematically investigate the influence of different monoE reconstructions on the visualization of coronary stent lumen in comparison to conventional images. Ten different coronary stents (diameter 3.0 mm) embedded in plastic tubes filled with contrast agent (500 HU) were scanned with a 128-row spectral detector CT (IQon, Philips, 120 kV, 125 mAs). Images were reconstructed (0.67 mm slice thickness, 0.35 mm increment) with a stent-specific conventional reconstruction kernel and 6 different monoE settings (60, 70, 80, 90, 100, 150 keV). Image quality for each stent and reconstruction was quantified using established parameters: image noise (standard deviation (SD) within a standardized ROI), in-stent attenuation difference (mean attenuation difference between stented and non-stented lumen) and visible lumen diameter (mean visible diameter of the stented tube). Image noise was significantly lower in all monoE data dets compared to conventional images (conventional: 13.41, 60 keV: 11.62, 70 keV: 11.67, 80 keV: 11.69, 90 keV: 11.71, 100 keV: 11.75, 150 keV: 11.80 HU SD; p < 0.01). The in-stent attenuation difference was significantly smaller in monoE data with higher keV levels than in conventional images (conventional: 148.18, 60 keV: 154.13 p = 0.036, 70 keV: 143.43 p = 0.109, 80 keV: 137.25 p = 0.052, 90 keV: 133.02 p = 0.043, 100 keV: 130.12 p = 0.039, 150 keV: 123.99 HU p = 0.035). The visible lumen diameter was significantly greater in monoE data with higher keV levels than in conventional images (conventional: 0.65, 60 keV: 0.68 p = 0.542, 70 keV: 0.71 p = 0.053, 80 keV: 0.74 p < 0.01, 90 keV: 0.77 p < 0.01, 100 keV: 0.82 p < 0.01, 150 keV: 0.87 mm p < 0.01). In comparison to conventional CT images, well-established parameters for objective assessment of CT image quality for coronary stents are significantly improved by utilization of monoE reconstructions with adequate keV levels derived from data acquired on a novel spectral detector CT platform. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Assessment of In-Stent Restenosis Using 64-MDCT: Analysis of the CORE-64 Multicenter International Trial

PubMed Central

Wykrzykowska, Joanna J.; Arbab-Zadeh, Armin; Godoy, Gustavo; Miller, Julie M.; Lin, Shezhang; Vavere, Andrea; Paul, Narinder; Niinuma, Hiroyuki; Hoe, John; Brinker, Jeffrey; Khosa, Faisal; Sarwar, Sheryar; Lima, Joao; Clouse, Melvin E.

2012-01-01

OBJECTIVE Evaluations of stents by MDCT from studies performed at single centers have yielded variable results with a high proportion of unassessable stents. The purpose of this study was to evaluate the accuracy of 64-MDCT angiography (MDCTA) in identifying in-stent restenosis in a multicenter trial. MATERIALS AND METHODS The Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography Using 64 Detectors (CORE-64) Multicenter Trial and Registry evaluated the accuracy of 64-MDCTA in assessing 405 patients referred for coronary angiography. A total of 75 stents in 52 patients were assessed: 48 of 75 stents (64%) in 36 of 52 patients (69%) could be evaluated. The prevalence of in-stent restenosis by quantitative coronary angiography (QCA) in this subgroup was 23% (17/75). Eighty percent of the stents were ≤ 3.0 mm in diameter. RESULTS The overall sensitivity, specificity, positive predictive value, and negative predictive value to detect 50% in-stent stenosis visually using MDCT compared with QCA was 33.3%, 91.7%, 57.1%, and 80.5%, respectively, with an overall accuracy of 77.1% for the 48 assessable stents. The ability to evaluate stents on MDCTA varied by stent type: Thick-strut stents such as Bx Velocity were assessable in 50% of the cases; Cypher, 62.5% of the cases; and thinner-strut stents such as Taxus, 75% of the cases. We performed quantitative assessment of in-stent contrast attenuation in Hounsfield units and correlated that value with the quantitative percentage of stenosis by QCA. The correlation coefficient between the average attenuation decrease and ≥ 50% stenosis by QCA was 0.25 (p = 0.073). Quantitative assessment failed to improve the accuracy of MDCT over qualitative assessment. CONCLUSION The results of our study showed that 64-MDCT has poor ability to detect in-stent restenosis in small-diameter stents. Evaluability and negative predictive value were better in large-diameter stents. Thus, 64-MDCT may be appropriate for stent assessment in only selected patients. PMID:20028909

Origins of medical innovation: the case of coronary artery stents.

PubMed

Xu, Shuai; Avorn, Jerry; Kesselheim, Aaron S

2012-11-01

Innovative medical devices make major contributions to patient welfare, and coronary stents have been among the most important device developments of recent decades. However, the origins of such breakthrough medical technologies remain poorly understood. Using a comprehensive database of patents, we identified all individuals and institutions that developed intellectual property related to stent technology early in its development process. The patents were categorized and described using a predetermined qualitative coding strategy. We found 245 granted patents related to bare metal coronary artery stents from 1984 (when the first patent issued in this field) to 1994 (after the first stents were approved). Each year showed an increase in the number of patent filings: from 1 in 1984 to 97 in 1994. The largest fraction of patents was issued to private entities (44.9% of the total). Public companies, individual inventors, and nonprofit institutions represented 31.4%, 18.0%, and 5.7%, respectively. The top 10 most-cited patents in the field were dominated by 2 private entities, Expandable Grafts Partnership and Cook Inc, organizations created by or dependent on the work of independent academic physician-inventors. Coronary artery stent technology first arose from individual physician-inventors within academic medical centers and their associated private companies. After these initial innovations were in place, the field became dominated by large public companies. This history suggests that policies aimed at encouraging transformative medical device development would have their greatest effect if focused on individual inventors and scientists performing the early stages of technology development.

Computational replication of the patient-specific stenting procedure for coronary artery bifurcations: From OCT and CT imaging to structural and hemodynamics analyses.

PubMed

Chiastra, Claudio; Wu, Wei; Dickerhoff, Benjamin; Aleiou, Ali; Dubini, Gabriele; Otake, Hiromasa; Migliavacca, Francesco; LaDisa, John F

2016-07-26

The optimal stenting technique for coronary artery bifurcations is still debated. With additional advances computational simulations can soon be used to compare stent designs or strategies based on verified structural and hemodynamics results in order to identify the optimal solution for each individual's anatomy. In this study, patient-specific simulations of stent deployment were performed for 2 cases to replicate the complete procedure conducted by interventional cardiologists. Subsequent computational fluid dynamics (CFD) analyses were conducted to quantify hemodynamic quantities linked to restenosis. Patient-specific pre-operative models of coronary bifurcations were reconstructed from CT angiography and optical coherence tomography (OCT). Plaque location and composition were estimated from OCT and assigned to models, and structural simulations were performed in Abaqus. Artery geometries after virtual stent expansion of Xience Prime or Nobori stents created in SolidWorks were compared to post-operative geometry from OCT and CT before being extracted and used for CFD simulations in SimVascular. Inflow boundary conditions based on body surface area, and downstream vascular resistances and capacitances were applied at branches to mimic physiology. Artery geometries obtained after virtual expansion were in good agreement with those reconstructed from patient images. Quantitative comparison of the distance between reconstructed and post-stent geometries revealed a maximum difference in area of 20.4%. Adverse indices of wall shear stress were more pronounced for thicker Nobori stents in both patients. These findings verify structural analyses of stent expansion, introduce a workflow to combine software packages for solid and fluid mechanics analysis, and underscore important stent design features from prior idealized studies. The proposed approach may ultimately be useful in determining an optimal choice of stent and position for each patient. Copyright © 2015 Elsevier Ltd. All rights reserved.

Anticoagulant and Antiplatelet Therapy in Patients with Atrial Fibrillation and Coronary Artery Disease

PubMed Central

Mischke, Karl; Knackstedt, Christian; Marx, Nikolaus

2012-01-01

Anticoagulation represents the mainstay of therapy for most patients with atrial fibrillation. Patients on oral anticoagulation often require concomitant antiplatelet therapy, mostly because of coronary artery disease. After coronary stent implantation, dual antiplatelet therapy is necessary. However, the combination of oral anticoagulation and antiplatelet therapy increases the bleeding risk. Risk scores such as the CHA2DS2-Vasc score and the HAS-BLED score help to identify both bleeding and stroke risk in individual patients. The guidelines of the European Society of Cardiology provide a rather detailed recommendation for patients on oral anticoagulation after coronary stent implantation. However, robust evidence is lacking for some of the recommendations, and especially for new oral anticoagulants and new antiplatelets few or no data are available. This review addresses some of the critical points of the guidelines and discusses potential advantages of new anticoagulants in patients with atrial fibrillation after stent implantation. PMID:22577538

Steam-deformed Judkins-left guiding catheter with use of the GuideLiner® catheter to deliver stents for anomalous right coronary artery

PubMed Central

Kuno, Toshiki; Fujisawa, Taishi; Yamazaki, Hiroyuki; Motoda, Hiroyuki; Kodaira, Masaki; Numasawa, Yohei

2015-01-01

Objective: Percutaneous coronary intervention for anomalous right coronary artery (RCA) originating from the left coronary cusp is challenging because of our current inability to coaxially engage the guiding catheter. Methods: We report a case of an 88-year-old woman with non-ST segment elevation myocardial infarction, with an anomalous RCA origin. Using either the Judkins-Left catheter or Amplatz-Left catheter was difficult because of RCA ostium tortuosity. Thus, we used steam to deform the Judkins-Left catheter, but back-up support was insufficient to deliver the stent. Results: We used GuideLiner®, a novel pediatric catheter with rapid exchange/monorail systems, to enhance back-up support. Conclusions: We were able to successfully stent with both the deformed Judkins-Left guiding catheter and GuideLiner® for an anomalous RCA origin. PMID:27489700

Airport and superficial femoral artery obstruction due to a wandering coronary stent: the possibility of airport detection of modern implant metals.

PubMed

Teijink, J A W; van Herwaarden, J A; van den Berg, J C; Overtoom, T C; Moll, F L

2004-06-01

In the treatment of coronary artery disease, peripheral loss of a coronary stent is an unusual complication. We present the case of a patient who suggested that his right leg claudication was caused by a slipped coronary stent 2 years previously. The patient was convinced about this unusual finding based on an airport security check. Examination proved him to be right. However, the ability to detect an object using eddy currents is dependent on the object's permeability and its conductivity. Ferrous (iron) content is not the critical factor. Modern implant materials and processing techniques result in implants that are difficult to magnetize i.e. their permeability is very low. In addition their conductivity is very low. This enables modern implants to escape detection at airports. For this reason the event at the airport, as described by our patient, is considered coincidental.

Cangrelor: A New Route for P2Y12 Inhibition.

PubMed

Sible, Alexandra M; Nawarskas, James J

Antiplatelet therapy with a P2Y12 inhibitor is a key component of treatment for patients with acute coronary syndromes undergoing percutaneous coronary intervention. Before the development of cangrelor (Kengreal, The Medicines Company, Parsippany, NJ), only oral P2Y12 inhibitors were available. Cangrelor is a reversible P2Y12 inhibitor that is administered as an intravenous infusion, and its quick onset and offset make it an appealing option for antiplatelet therapy, particularly for patients who are unable to take oral medications. Although cangrelor struggled to show benefit in early trials, the positive results of the CHAMPION PHOENIX trial led to its approval for use as an adjunct to percutaneous coronary intervention to reduce the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients who have not been treated with another P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. Cangrelor has also been evaluated as an option for bridging therapy in patients who must discontinue their oral P2Y12 inhibitor before coronary artery bypass grafting. This review of cangrelor will discuss its mechanism of action, its pharmacodynamics and pharmacokinetics, the clinical trial experience, and its potential place in therapy.

The use of cold sprayed alloys for metallic stents

NASA Astrophysics Data System (ADS)

AL-Mangour, Bandar

With the invention of the coronary stent, which is a wire metal mesh tube designed to keep the arteries open in the treatment of heart diseases, promising clinical outcomes were generated. However, the long term successes of stents have been delayed by significant in-stent restenosis (blockages) and stent fracture. In this research work, it has been proposed to use Cold Gas Dynamic Spraying (CGDS) coating material as an alternative choice to manufacture metallic stent. In CGDS, fine particles are accelerated to a high velocity and undergo solid-state plastic deformation upon impact on the substrate, which leads to particle-particle bonding. The feature of CGDS distinct from other thermal spray techniques is that the processing gas temperature is below the melting point of the feedstock. Therefore, unwanted effects of high temperatures, such as oxidation, grain growth and thermal stresses, are absent. In response to the fact that the majority of stents are made from stainless steel (316L) or Co-Cr alloy (L605), this study specifically addresses the development and characterization of 316L and 316L mixed with L605 coatings produced by the CGDS process. Scanning electron microscopy and electron backscatter diffraction were used to investigate the microstructural changes of these coatings before and after annealing. The effect of gas type on the microstructure of 316L coatings and the role of post-heat treatment in the microstructure and properties are also studied. Of particular interest are grain refinement, heat treatment, mechanical properties and corrosion behavior of the cold sprayed material.

Impact of Clinical Presentation (Stable Angina Pectoris vs Unstable Angina Pectoris or Non-ST-Elevation Myocardial Infarction vs ST-Elevation Myocardial Infarction) on Long-Term Outcomes in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents.

PubMed

Giustino, Gennaro; Baber, Usman; Stefanini, Giulio Giuseppe; Aquino, Melissa; Stone, Gregg W; Sartori, Samantha; Steg, Philippe Gabriel; Wijns, William; Smits, Pieter C; Jeger, Raban V; Leon, Martin B; Windecker, Stephan; Serruys, Patrick W; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Kandzari, David; Dangas, George D; Mastoris, Ioannis; Von Birgelen, Clemens; Galatius, Soren; Kimura, Takeshi; Mikhail, Ghada; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Valgimigli, Marco; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

2015-09-15

The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5,760 (57%) had stable angina pectoris (SAP), 3,594 (35%) had unstable angina pectoris (UAP) or non-ST-segment-elevation myocardial infarction (NSTEMI), and 779 (8%) had ST-segment-elevation myocardial infarction (STEMI) as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs 6.1% vs 9.4%; p <0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. After multivariable adjustment, STEMI was independently associated with greater risk of 3-year mortality (hazard ratio [HR] 3.45; 95% confidence interval [CI] 1.99 to 5.98; p <0.01), whereas no differences were observed between UAP or NSTEMI and SAP (HR 0.99; 95% CI 0.73 to 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR 0.58; 95% CI 0.34 to 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (pinteraction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a greater risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women. Published by Elsevier Inc.

A higher volume of fibrotic tissue on virtual histology prior to coronary stent implantation predisposes to more pronounced neointima proliferation.

PubMed

Haine, Steven; Wouters, Kristien; Miljoen, Hielko; Vandendriessche, Tom; Claeys, Marc; Bosmans, Johan; Vrints, Christiaan

2018-04-01

Since neointima smooth muscle cells (SMC) mainly originate from the vessel wall, we investigated whether atherosclerotic plaque composition influences subsequent in-stent neointima proliferation and restenosis. We performed intravascular ultrasound (IVUS) with virtual histology in 98 patients prior to elective bare-metal stent (BMS) implantation in de novo coronary artery lesions. Virtual histology variables pre-percutaneous coronary intervention (PCI) were related to in-stent neointima proliferation six months after implantation assessed as late luminal loss of 0.88 mm (interquartile range (IQR) 0.37-1.23 mm) on angiography and as maximal percentage area stenosis of 42% (IQR 33-59%) and percentage volume intima hyperplasia of 27% (IQR 20-36%) on IVUS. A ridge-trace based multiple linear regression model was constructed to account for multicollinearity of the virtual histology variables and was corrected for implanted stent length (18 mm, IQR 15-23 mm), stent diameter (3.0 mm, IQR 2.75-3.5 mm) and lesion volume (146 mm³, IQR 80-201 mm³) prior to PCI. Fibrous tissue volume prior to PCI (49 mm³, IQR 30-77 mm³) was significantly and independently related to late luminal loss (p = .038), maximal percentage area stenosis (p = .041) and percentage volume intima hyperplasia (p = .004). Neither absolute nor relative amounts of fibrofatty, calcified or necrotic core tissue appeared related to any of the restenosis parameters. Subgroup analysis after exclusion of acute coronary syndrome (ACS) patients yielded similar results. Lesions with more voluminous fibrotic tissue pre-PCI show more pronounced in-stent neointima proliferation, even after correction for lesion plaque volume.

Prevalence, correlates, and impact of coronary calcification on adverse events following PCI with newer-generation DES: Findings from a large multiethnic registry.

PubMed

Copeland-Halperin, Robert S; Baber, Usman; Aquino, Melissa; Rajamanickam, Anitha; Roy, Swathi; Hasan, Choudhury; Barman, Nitin; Kovacic, Jason C; Moreno, Pedro; Krishnan, Prakash; Sweeny, Joseph M; Mehran, Roxana; Dangas, George; Kini, Annapoorna S; Sharma, Samin K

2018-04-01

We sought to determine the prevalence, predictors, and clinical impact of target lesion calcification in patients undergoing percutaneous coronary intervention (PCI) with newer generation drug-eluting stents (DES) and devices. Coronary calcification is independently associated with adverse outcomes following PCI. While newer DES and contemporary devices are considered safer and more efficacious, their influence on outcomes following PCI of heavily calcified lesions is unknown. We performed a retrospective analysis of a large, multiethnic cohort of patients undergoing PCI with new generation DES at an academic center between 2009 and 2013. Coronary calcification was qualitatively assessed as none/mild, moderate, or severe. Independent demographic, clinical, and anatomic predictors of moderate/severe calcification were identified using logistic regression. Associations between coronary calcification and 1-year MACE (death, myocardial infarction, or target vessel revascularization) were examined using Cox modeling. Compared to patients with none/mild (n = 10,180; 82.0%), those with moderate (n = 1,271; 10.0%) or severe (n = 994; 8.0%) calcification were older, more often Caucasian, had more complex target lesions, and worse renal function. The strongest demographic, clinical, and anatomic correlates of moderate/severe calcification were age, Caucasian race, renal dysfunction, lesion length, and left main location. Unadjusted MACE rates among those with none/mild, moderate, and severe calcification were 8.3, 14.6, and 17.8%, respectively (P < 0.001). After multivariable adjustment, the hazard ratio (95% CI) for MACE associated with moderate or severe coronary calcification was 1.63. Target lesion calcification remains independently associated with adverse outcomes in patients treated with newer generation DES and modern devices. © 2017 Wiley Periodicals, Inc.

Application of Near Infrared Spectroscopy, Intravascular Ultrasound and the Coronary Calcium Score to Predict Adverse Coronary Events

DTIC Science & Technology

2014-10-01

Kenneth&&Moore& 6/12/14 Smith RCA& stent ,&LAD&small&with&70%&lesion&poor&target,&Circ&too&tortuous Salvatore&Maccaron 12DJunD14 Smith Declined Edward...VanWingerden 9/10/14 Smith advanced&age,&no&targets&for&imaging&due&to&bypass&grafts&and&several& stents Van&McGlavan 10/1/14 Hopkins life&expectancy&less...than&3&years&&very&advanced&age Gene&Church 10/3/14 Marques no&IVUS&targets&due&to&bypass&grafts,& stents Ronald&Berry 10/3/14 Tabesh no&IVUS&targets&due

Restenosis of the CYPHER-Select, TAXUS-Express, and Polyzene-F Nanocoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model

DOE Office of Scientific and Technical Information (OSTI.GOV)

Radeleff, Boris, E-mail: Boris.radeleff@med.uni-heidelberg.de; Thierjung, Heidi; Stampfl, Ulrike

2008-09-15

PurposeTo date no direct experimental comparison between the CYPHER-Select and TAXUS-Express stents is available. Therefore, we investigated late in-stent stenosis, thrombogenicity, and inflammation, comparing the CYPHER-Select, TAXUS-Express, and custom-made cobalt chromium Polyzene-F nanocoated stents (CCPS) in the minipig coronary artery model.MethodsThe three stent types were implanted in the right coronary artery of 30 minipigs. The primary endpoint was in-stent stenosis assessed by quantitative angiography and microscopy. Secondary endpoints were inflammation and thrombogenicity evaluated by scores for inflammation and immunoreactivity (C-reactive protein and transforming growth factor beta). Follow-up was at 4 and 12 weeks.ResultsStent placement was successful in all animals; nomore » thrombus deposition occurred. Quantitative angiography did not depict statistically significant differences between the three stent types after 4 and 12 weeks. Quantitative microscopy at 4 weeks showed a statistically significant thicker neointima (p = 0.0431) for the CYPHER (105.034 {+-} 62.52 {mu}m) versus the TAXUS (74.864 {+-} 66.03 {mu}m) and versus the CCPS (63.542 {+-} 39.57 {mu}m). At 12 weeks there were no statistically significant differences. Inflammation scores at 4 weeks were significantly lower for the CCPS and CYPHER compared with the TAXUS stent (p = 0.0431). After 12 weeks statistical significance was only found for the CYPHER versus the TAXUS stent (p = 0.0431). The semiquantitative immunoreactivity scores for C-reactive protein and transforming growth factor beta showed no statistically significant differences between the three stent types after 4 and 12 weeks.ConclusionsThe CCPS provided effective control of late in-stent stenosis and thrombogenicity in this porcine model compared with the two drug-eluting stents. Its low inflammation score underscores its noninflammatory potential and might explain its equivalence to the two DES.« less

Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience.

PubMed

Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

2015-10-01

Transplant renal artery stenosis (TRAS) is a vascular complication frequently seen because of increase in the number of renal transplantations. Early diagnosis and management is essential to optimize a proper graft function. Currently, the endovascular treatment of TRAS using angioplasty and/or stenting is considered the treatment of choice with the advantage that it does not preclude subsequent surgical correction. Treatment of TRAS with the use of stents, particularly in tortuous transplant renal anatomy presents a unique challenge to an interventional radiologist. In this study, we present three cases from our practice highlighting the use of a balloon-expandable Multi-Link RX Ultra coronary stent system (Abbott Laboratories, Abbott Park, Illinois, USA) for treating high grade focal stenosis along very tortuous renal arterial segments. Cobalt-Chromium alloy stent scaffold provides excellent radial force, whereas the flexible stent design conforms to the vessel course allowing for optimal stent alignment.

In-stent neoatherosclerosis and tissue characteristics of restenotic lesions following implantation of second generation drug-eluting stents in unrestricted coronary lesions: Optical frequency domain imaging study.

PubMed

Sabbah, Mahmoud; Kadota, Kazushige; El-Eraky, Azza; Kamal, Hanan M; Abdellah, Ahmed-Tageldien; El Hawary, Ahmed

2017-06-01

Differences in stent platform, polymer coatings, and antirestenotic drugs among the current in use second-generation drug-eluting stents (G2-DESs) may induce significant variations in neointimal response and vascular healing, which may impact the prevalence of neoatherosclerosis (NA) and morphological appearance of the restenotic tissue. Utilizing Optical frequency domain imaging, two independent reviewers, retrospectively compared the prevalence of neoatherosclerosis (NA), and the morphological differences, and tissue characteristics of 50 G2-DESs in-stent restenosis (ISR) lesions (35 everolimus-eluting stent [22 cobalt-chromium (CoCr), 13 platinum-chromium (PtCr)], and 15 biolimus-eluting stent [BES]) implanted liberally in unrestricted coronary lesions. More than half of the stents were implanted in type C lesions, while 40% of the stents were implanted primarily in lesions with recanalized chronic total occlusion. NA, defined as a neointima formation with the presence of lipids or calcification, was observed in fewer than half (24/50) of all ISR lesions with no significant in-between group differences (41%, 69%, and 40% in CoCr, PtCr, and BES respectively, P = 0.22), nor were there any significant differences in the morphological appearance or tissue characteristics between all G2-DESs subtypes. Acknowledging some limitations, our results may suggest that the prevalence of NA and the morphological appearance of restenotic lesions might not differ when G2-DESs are implanted in unrestricted, rather complex, coronary lesions. © 2017, Wiley Periodicals, Inc.

Satisfactory arterial repair 1 year after ultrathin strut biodegradable polymer sirolimus-eluting stent implantation: an angioscopic observation.

PubMed

Ishihara, Takayuki; Awata, Masaki; Iida, Osamu; Fujita, Masashi; Masuda, Masaharu; Okamoto, Shin; Nanto, Kiyonori; Kanda, Takashi; Tsujimura, Takuya; Uematsu, Masaaki; Mano, Toshiaki

2018-01-15

The ultrathin strut biodegradable polymer sirolimus-eluting stent (Orsiro, O-SES) exhibits satisfactory clinical outcomes. However, no report to date has documented the intravascular status of artery repair after O-SES implantation. We examined 5 O-SES placed in 4 patients (age 65 ± 12 years, male 75%) presenting with stable angina pectoris due to de novo lesions in native coronary arteries. Coronary angioscopy was performed immediately after percutaneous coronary intervention and 1 year later. Angioscopic images were analyzed to determine the following: (1) dominant grade of neointimal coverage (NIC) over the stent; (2) maximum yellow plaque grade; and (3) existence of thrombus. Yellow plaque grade was evaluated both immediately after stent implantation and at the time of follow-up observation. The other parameters were evaluated at the time of follow-up examination. NIC was graded as: grade 0, stent struts exposed; grade 1, struts bulging into the lumen, although covered; grade 2, struts embedded in the neointima, but translucent; grade 3, struts fully embedded and invisible. Yellow plaque severity was graded as: grade 0, white; grade 1, light yellow; grade 2, yellow; and grade 3, intensive yellow. Angioscopic findings at 1 year demonstrated the following: dominant NIC grade 1, grade 2, and grade 3 in 1, 2, and 2 stents, respectively; all stents were covered to some extent; focal thrombus adhesion was observed in only 1 stent. Yellow plaque grade did not change from immediately after stent implantation to follow-up. O-SES demonstrated satisfactory arterial repair 1 year after implantation.

Fabrication of Small Caliber Stent-grafts Using Electrospinning and Balloon Expandable Bare Metal Stents

PubMed Central

Uthamaraj, Susheil; Tefft, Brandon J.; Jana, Soumen; Hlinomaz, Ota; Kalra, Manju; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S.

2016-01-01

Stent-grafts are widely used for the treatment of various conditions such as aortic lesions, aneurysms, emboli due to coronary intervention procedures and perforations in vasculature. Such stent-grafts are manufactured by covering a stent with a polymer membrane. An ideal stent-graft should have a biocompatible stent covered by a porous, thromboresistant, and biocompatible polymer membrane which mimics the extracellular matrix thereby promoting injury site healing. The goal of this protocol is to manufacture a small caliber stent-graft by encapsulating a balloon expandable stent within two layers of electrospun polyurethane nanofibers. Electrospinning of polyurethane has been shown to assist in healing by mimicking native extracellular matrix, thereby promoting endothelialization. Electrospinning polyurethane nanofibers on a slowly rotating mandrel enabled us to precisely control the thickness of the nanofibrous membrane, which is essential to achieve a small caliber balloon expandable stent-graft. Mechanical validation by crimping and expansion of the stent-graft has shown that the nanofibrous polyurethane membrane is sufficiently flexible to crimp and expand while staying patent without showing any signs of tearing or delamination. Furthermore, stent-grafts fabricated using the methods described here are capable of being implanted using a coronary intervention procedure using standard size guide catheters. PMID:27805589

Finite element analysis of the biomechanical interaction between coronary sinus and proximal anchoring stent in coronary sinus annuloplasty

PubMed Central

Pham, Thuy; Deherrera, Milton; Sun, Wei

2013-01-01

Recent clinical studies of the percutaneous transvenous mitral annuloplasty (PTMA) devices have shown a short-term reduction of mitral regurgitation (MR) after implantation. However, adverse events associated with the devices such as compression and perforation of vessel branches, device migration and fracture were reported. In this study, a finite element analysis was performed to investigate the biomechanical interaction between the proximal anchor stent of a PTMA device and the coronary sinus (CS) vessel in three steps including i) the stent release and contact with the CS wall, ii) the axial pull at the stent connector and iii) the pressure inflation of the vessel wall. To investigate the impact of the material properties of tissues and stents on the interactive responses, the CS vessel was modeled with human and porcine material properties, and the proximal stent was modeled with two different Nitinol materials with one being stiffer than the other. The results indicated that the vessel wall stresses and contact forces imposed by the stents were much higher in human than porcine models. However, the mechanical differences induced by the two stent types were relatively small. The softer stent exhibited a better fatigue safety factor when deployed in the human model than in the porcine model. These results underscored the importance of the CS tissue mechanical properties. Higher vessel wall stress and stent radial force were obtained in human model than those in porcine model, which also brought up questions as to the validity of using porcine model to assess device mechanical function. The quantification of these biomechanical interactions can offer scientific insight into the development and optimization of PTMA device design. PMID:23405942

[Two cases of acute coronary syndrome after intake of Clavis Panax].

PubMed

Atar, Aslı İnci; Er, Okan; Güven, Abdullah; Eryonucu, Beyhan

2012-04-01

Atherosclerotic cardiovascular disease is an epidemic in today's world. It is one of the most common causes of hospitalization and death. Therefore, remedies to control or heal the disease are continuously sought. In addition to scientifically researched therapies, patients frequently utilize alternative medicine. However, effective and toxic doses, metabolisms, and drug interactions of the herbs and herbal nutrition supplements are largely unknown. Herein, we present two cases with acute coronary syndrome. The first case was admitted with a diagnosis of acute inferior myocardial infaction (MI) and a stent was implanted to the occluded right coronary artery (RCA). There was a 50% stenosis in his left anterior descending artery (LAD). He was admitted with a diagnosis of non-ST elevation MI (NSTEMI) 6 months later. In the coronary angiogram, there was stent restenosis in RCA, the lesion in LAD had become thrombotic and progressed to a stenosis of 90%. He was referred to surgical revascularization. The second case was admitted for acute inferior MI and a stent was implanted to the occluded circumflex artery. Two months later, he was hospitalized for NSTEMI. Progression of coronary plaques to stenosis and stent restenosis was detected and he was referred to surgical revascularization. Both patients used the product sold as Clavis Panax, which contains panax ginseng, tribulus terrestris, and oat, after their first coronary intervention. Intake of a mixture of plant extracts may have serious consequences in humans as drug interactions and side effects are unknown.

[Values of computed tomography angiogram in non-cardiac surgery planning and cardiac risk assessment of coronary atherosclerosis during perioperative period].

PubMed

Chang, Rui-ping; Ju, Hai-yue; Zhang, Xing-hua; Wu, Jian; Zhang, Fan; Mi, Wei-dong; Cao, Xiu-tang; Gao, Chang-qing; Yang, Li

2013-02-19

To explore the values of detecting coronary atherosclerosis by computed tomography angiogram (CTA) on non-cardiac surgery planning and cardiac risk assessment of coronary atherosclerosis during perioperative period. A total of 89 patients with suspected coronary heart disease (CHD) scheduled for non-cardiac surgery underwent coronary CTA to evaluate luminal stenosis and calculate calcification score. There were 56 males and 33 females with a mean age of 65.1 years. Operative sites included chests (n = 29), abdomens and pelvis (n = 26), large vessels (n = 3), bones and joints (n = 19) and other regions (n = 12). Reasons of abandoned or postponed surgery were documented to analyze the influence of CTA results on surgery planning. Cardiac events were recorded to assess the correlation with coronary atherosclerosis. Among them, 75 patients (84.27%) were diagnosed as atherosclerosis while 10 patients (11.24%) were negative; 2 patients had coronary artery bypass and another 2 had stent implantation. According to the results of CTA, 12 operations (13.48%) were canceled and 8 (8.98%) postponed after interventions. Severe stenosis of coronary lumen had significant effects on surgery planning (P = 0.003) while calcification score did not. In patients undergoing surgery as scheduled or after intervention, 1 had atrial fibrillation at post-operation. For the patients with suspected CHD scheduled for non-cardiac surgery, severity of coronary stenosis may greatly influence surgery planning. Preoperative coronary CTA may decrease the incidence of cardiac events during perioperative period.

Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction) analysis.

PubMed

Antman, Elliott M; Wiviott, Stephen D; Murphy, Sabina A; Voitk, Juri; Hasin, Yonathan; Widimsky, Petr; Chandna, Harish; Macias, William; McCabe, Carolyn H; Braunwald, Eugene

2008-05-27

We evaluated the relative contributions of the loading and maintenance doses of prasugrel on events in a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction) analysis. Prasugrel is superior to clopidogrel in preventing ischemic events in patients with an acute coronary syndrome who are undergoing percutaneous coronary intervention, but it is associated with an increased risk of major bleeding. Landmark analyses for efficacy, safety, and net clinical benefit were performed from randomization to day 3 and from day 3 to the end of the trial. Significant reductions in ischemic events, including myocardial infarction, stent thrombosis, and urgent target vessel revascularization, were observed with the use of prasugrel both during the first 3 days and from 3 days to the end of the trial. Thrombolysis In Myocardial Infarction major non-coronary artery bypass graft bleeding was similar to clopidogrel during the first 3 days but was significantly greater with the use of prasugrel from 3 days to the end of the study. Net clinical benefit significantly favored prasugrel both early and late in the trial. Both the loading dose and maintenance dose of prasugrel were superior to clopidogrel for the reduction of ischemic events. This result emphasizes the importance of maintaining high levels of inhibition of platelet aggregation via P2Y(12) receptor inhibition, not only for the prevention of periprocedural ischemic events but also during long-term follow-up. The excess major bleeding observed with the use of prasugrel occurred predominantly during the maintenance phase. Approaches to reduce the relative excess of bleeding with prasugrel should focus on the maintenance dose (e.g., reduction in maintenance dose in previously reported high-risk subgroups, such as the elderly and those patients with low body weight). (A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention; NCT00097591).

The basics of intravascular optical coherence tomography

PubMed Central

Jąkała, Jacek; Kałuża, Grzegorz L.; Partyka, Łukasz; Proniewska, Klaudia; Pociask, Elżbieta; Zasada, Wojciech; Wojakowski, Wojciech; Gąsior, Zbigniew; Dudek, Dariusz

2015-01-01

Optical coherence tomography (OCT) has opened new horizons for intravascular coronary imaging. It utilizes near-infrared light to provide a microscopic insight into the pathology of coronary arteries in vivo. Optical coherence tomography is also capable of identifying the chemical composition of atherosclerotic plaques and detecting traits of their vulnerability. At present it is the only tool to measure the thickness of the fibrous cap covering the lipid core of the atheroma, and thus it is an exceptional modality to detect plaques that are prone to rupture (thin fibrous cap atheromas). Moreover, it facilitates distinguishing between plaque rupture and plaque erosion as a cause of acute intracoronary thrombosis. Optical coherence tomography is applied to guide angioplasties of coronary lesions and to assess outcomes of percutaneous coronary interventions broadly. It identifies stent malapposition, dissections, and thrombosis with unprecedented precision. Furthermore, OCT helps to monitor vessel healing after stenting. It evaluates the coverage of stent struts by the neointima and detects in-stent neoatherosclerosis. With so much potential, new studies are warranted to determine OCT's clinical impact. The following review presents the technical background, basics of OCT image interpretation, and practical tips for adequate OCT imaging, and outlines its established and potential clinical application. PMID:26161097

Reliable porcine coronary model of chronic total occlusion using copper wire stents and bioabsorbable levo-polylactic acid polymer.

PubMed

Sim, Doo Sun; Jeong, Myung Ho; Cha, Kyoung Rae; Park, Suk Ho; Park, Jong Oh; Shin, Young Min; Shin, Heungsoo; Hong, Young Joon; Ahn, Youngkeun; Schwartz, Robert S; Kang, Jung Chaee

2012-12-01

Chronic total occlusion (CTO) remains a challenge in interventional cardiology. We investigated the feasibility and reliability of copper wire stents and levo-polylactic acid (l-PLA) as a means of CTO induction in a porcine model. In one group of 20 swine, copper stents were crimped on a 3.0mm angioplasty balloon and inserted into the mid-left anterior descending coronary artery (LAD). In the other group of 20 swine, l-PLA was wrapped on a guidewire and pushed into the distal LAD with a 3.0mm balloon catheter to induce embolization. Of 20 swine which underwent copper stent implantation, 13 died of stent thrombosis. In the remaining 7 swine, total or near total occlusion with collateral circulation was observed at 5 weeks. Of 20 swine which underwent l-PLA embolization, 4 died of ventricular fibrillation during or shortly after the procedure. Serial histopathologic studies showed complete absorption of the polymer with replacement by fibrotic tissue approximately 4 weeks following the polymer implantation. CTO could be reliably induced in porcine coronary arteries by copper stents and l-PLA. These models may support investigation of new percutaneous devices to facilitate CTO interventions. Copyright © 2012 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Materials and Manufacturing Technologies Available for Production of a Pediatric Bioabsorbable Stent

PubMed Central

Alexy, Ryan D.; Levi, Daniel S.

2013-01-01

Transcatheter treatment of children with congenital heart disease such as coarctation of the aorta and pulmonary artery stenosis currently involves the use of metal stents. While these provide good short term results, there are long term complications with their use. Children outgrow metal stents, obligating them to future transcatheter dilations and eventual surgical removal. A bioabsorbable stent, or a stent that goes away with time, would solve this problem. Bioabsorbable stents are being developed for use in coronary arteries, however these are too small for use in pediatric congenital heart disease. A bioabsorbable stent for use in pediatric congenital heart disease needs to be low profile, expandable to a diameter 8 mm, provide sufficient radial strength, and absorb quickly enough to allow vessel growth. Development of absorbable coronary stents has led to a great understanding of the available production techniques and materials such as bioabsorbable polymers and biocorrodable metals. Children with congenital heart disease will hopefully soon benefit from the current generation of bioabsorbable and biocorrodable materials and devices. PMID:24089660

Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis.

PubMed

Kang, Si-Hyuck; Park, Kyung Woo; Kang, Do-Yoon; Lim, Woo-Hyun; Park, Kyung Taek; Han, Jung-Kyu; Kang, Hyun-Jae; Koo, Bon-Kwon; Oh, Byung-Hee; Park, Young-Bae; Kandzari, David E; Cohen, David J; Hwang, Seung-Sik; Kim, Hyo-Soo

2014-05-01

The aim of this study was to compare the safety and efficacy of biodegradable-polymer (BP) drug-eluting stents (DES), bare metal stents (BMS), and durable-polymer DES in patients undergoing coronary revascularization, we performed a systematic review and network meta-analysis using a Bayesian framework. Study stents included BMS, paclitaxel-eluting (PES), sirolimus-eluting (SES), endeavor zotarolimus-eluting (ZES-E), cobalt-chromium everolimus-eluting (CoCr-EES), platinium-chromium everolimus-eluting (PtCr-EES), resolute zotarolimus-eluting (ZES-R), and BP biolimus-eluting stents (BP-BES). After a systematic electronic search, 113 trials with 90 584 patients were selected. The principal endpoint was definite or probable stent thrombosis (ST) defined according to the Academic Research Consortium within 1 year. Biodegradable polymer-biolimus-eluting stents [OR, 0.56; 95% credible interval (CrI), 0.33-0.90], SES (OR, 0.53; 95% CrI, 0.38-0.73), CoCr-EES (OR, 0.34; 95% CrI, 0.23-0.52), and PtCr-EES (OR, 0.31; 95% CrI, 0.10-0.90) were all superior to BMS in terms of definite or probable ST within 1 year. Cobalt-chromium everolimus-eluting stents demonstrated the lowest risk of ST of all stents at all times after stent implantation. Biodegradable polymer-biolimus-eluting stents was associated with a higher risk of definite or probable ST than CoCr-EES (OR, 1.72; 95% CrI, 1.04-2.98). All DES reduced the need for repeat revascularization, and all but PES reduced the risk of myocardial infarction compared with BMS. All DESs but PES and ZES-E were superior to BMS in terms of ST within 1 year. Cobalt-chromium everolimus-eluting stents was safer than any DES even including BP-BES. Our results suggest that not only the biodegradability of polymer, but the optimal combination of stent alloy, design, strut thickness, polymer, and drug all combined determine the safety of DES.

Periprocedural myocardial infarction during percutaneous coronary intervention in an academic tertiary centre in Johannesburg.

PubMed

Tsabedze, Nqoba; McCutcheon, Keir; Mkhwanazi, Lancelot; Garda, Riaz; Vachiat, Ahmed; Ramjee, Rohan; Moosa, Jameel; Maluleke, Themba; Mukeshimana, Gloria; Karolia, Saffiyyah; Mpanya, Dineo; Manga, Pravin

2017-03-01

Percutaneous coronary intervention (PCI) is effective therapy for significant atherosclerotic coronary artery disease. Despite medical and technological advances in PCI, periprocedural myocardial infarction (PMI) remains a common complication. The frequency and factors associated with PMI have been well investigated in the developed world, yet there is a paucity of data from the developing world, especially Sub-Saharan Africa. We prospectively enrolled 153 adult patients undergoing PCI at the Charlotte Maxeke Johannesburg Academic Hospital from the 1st of February 2014 to 31st October 2014. Periprocedural Creatinine Kinase-MB and hs-Troponin I were routinely measured before PCI and at 16-24h post-procedure. The third universal definition of myocardial infarction was used to define a PMI event. 152 participants met the inclusion criteria and were analysed for PMI. 70.4% participants were male. The mean age was 58.8 (SD 10.9) years old. Sixteen (10.5%) participants fulfilled the criteria for PMI. Side branch pinching with preserved TIMI III flow was noted in 62.5% of PMI cases. Duration of procedure (P=0.007), right coronary artery intervention (p=0.042) and total stent length (p=0.045) were independently associated with PMI. PMI occurred in 10.5% of cases undergoing PCI. This is consistent with the prevalence of PMI internationally. Larger multicentre studies are required in our demographic region to further define relevant predictors and outcomes associated with PMI. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model.

PubMed

Scheller, Bruno; Speck, Ulrich; Romeike, Bernd; Schmitt, Alexander; Sovak, Milos; Böhm, Michael; Stoll, Hans Peter

2003-08-01

Lipophilic taxanes can be dissolved in contrast media at significantly higher concentration than in saline. As contrast media have occasionally been observed to delineate the contour of coronary arteries for some seconds they may serve as a matrix for an antiproliferative drug aimed at preventing restenosis. The aim of this study was to test a novel taxane-contrast agent formulation for this new approach in the setting of coronary stenting. In cell culture experiments (bovine vascular smooth muscle cells), 60-min incubation with contrast agent-taxane formulations (iopromide-paclitaxel, iopromide-protaxel) induced a significant, concentration-dependent inhibition of vascular smooth muscle cell (VSMC) proliferation over 12 days. Shorter incubation times of 10 and 3 min showed the same efficacy. For in vivo investigation, 16 stents were implanted into the coronary arteries of eight pigs using a 1.3 to 1 overstretch ratio. A control group received iopromide 370 alone while the treatment group was injected with a iopromide-protaxel formulation at a dose of 74 micromol/l, which is far below protaxel levels inducing systemic toxicity. Quantitative angiography and histomorphometry of the stented arteries asserted statistic equality of the baseline parameters between the control and treatment groups. After 28 days, the treatment group showed a marked reduction of the parameters characterizing in-stent restenosis, especially a 34% reduction of the neointimal area. First evidence is provided that using a contrast agent as solvent for a taxane constitutes a new drug delivery mechanism able to inhibit in-stent restenosis in the porcine restenosis model.

CT Evaluation of Small-Diameter Coronary Artery Stents: Effect of an Integrated Circuit Detector with Iterative Reconstruction.

PubMed

Geyer, Lucas L; Glenn, G Russell; De Cecco, Carlo Nicola; Van Horn, Mark; Canstein, Christian; Silverman, Justin R; Krazinski, Aleksander W; Kemper, Jenny M; Bucher, Andreas; Ebersberger, Ullrich; Costello, Philip; Bamberg, Fabian; Schoepf, U Joseph

2015-09-01

To use suitable objective methods of analysis to assess the influence of the combination of an integrated-circuit computed tomographic (CT) detector and iterative reconstruction (IR) algorithms on the visualization of small (≤3-mm) coronary artery stents. By using a moving heart phantom, 18 data sets obtained from three coronary artery stents with small diameters were investigated. A second-generation dual-source CT system equipped with an integrated-circuit detector was used. Images were reconstructed with filtered back-projection (FBP) and IR at a section thickness of 0.75 mm (FBP75 and IR75, respectively) and IR at a section thickness of 0.50 mm (IR50). Multirow intensity profiles in Hounsfield units were modeled by using a sum-of-Gaussians fit to analyze in-plane image characteristics. Out-of-plane image characteristics were analyzed with z upslope of multicolumn intensity profiles in Hounsfield units. Statistical analysis was conducted with one-way analysis of variance and the Student t test. Independent of stent diameter and heart rate, IR75 resulted in significantly increased xy sharpness, signal-to-noise ratio, and contrast-to-noise ratio, as well as decreased blurring and noise compared with FBP75 (eg, 2.25-mm stent, 0 beats per minute; xy sharpness, 278.2 vs 252.3; signal-to-noise ratio, 46.6 vs 33.5; contrast-to-noise ratio, 26.0 vs 16.8; blurring, 1.4 vs 1.5; noise, 15.4 vs 21.2; all P < .001). In the z direction, the upslopes were substantially higher in the IR50 reconstructions (2.25-mm stent: IR50, 94.0; IR75, 53.1; and FBP75, 48.1; P < .001). The implementation of an integrated-circuit CT detector provides substantially sharper out-of-plane resolution of coronary artery stents at 0.5-mm section thickness, while the use of iterative image reconstruction mostly improves in-plane stent visualization.

High-definition multidetector computed tomography for evaluation of coronary artery stents: comparison to standard-definition 64-detector row computed tomography.

PubMed

Min, James K; Swaminathan, Rajesh V; Vass, Melissa; Gallagher, Scott; Weinsaft, Jonathan W

2009-01-01

The assessment of coronary stents with present-generation 64-detector row computed tomography scanners that use filtered backprojection and operating at standard definition of 0.5-0.75 mm (standard definition, SDCT) is limited by imaging artifacts and noise. We evaluated the performance of a novel, high-definition 64-slice CT scanner (HDCT), with improved spatial resolution (0.23 mm) and applied statistical iterative reconstruction (ASIR) for evaluation of coronary artery stents. HDCT and SDCT stent imaging was performed with the use of an ex vivo phantom. HDCT was compared with SDCT with both smooth and sharp kernels for stent intraluminal diameter, intraluminal area, and image noise. Intrastent visualization was assessed with an ASIR algorithm on HDCT scans, compared with the filtered backprojection algorithms by SDCT. Six coronary stents (2.5, 2.5, 2.75, 3.0, 3.5, 4.0mm) were analyzed by 2 independent readers. Interobserver correlation was high for both HDCT and SDCT. HDCT yielded substantially larger luminal area visualization compared with SDCT, both for smooth (29.4+/-14.5 versus 20.1+/-13.0; P<0.001) and sharp (32.0+/-15.2 versus 25.5+/-12.0; P<0.001) kernels. Stent diameter was higher with HDCT compared with SDCT, for both smooth (1.54+/-0.59 versus1.00+/-0.50; P<0.0001) and detailed (1.47+/-0.65 versus 1.08+/-0.54; P<0.0001) kernels. With detailed kernels, HDCT scans that used algorithms showed a trend toward decreased image noise compared with SDCT-filtered backprojection algorithms. On the basis of this ex vivo study, HDCT provides superior detection of intrastent luminal area and diameter visualization, compared with SDCT. ASIR image reconstruction techniques for HDCT scans enhance the in-stent assessment while decreasing image noise.

The link between heightened thrombogenicity and inflammation: pre-procedure characterization of the patient at high risk for recurrent events after stenting.

PubMed

Gurbel, Paul A; Bliden, Kevin P; Kreutz, Rolf P; Dichiara, Joseph; Antonino, Mark J; Tantry, Udaya S

2009-03-01

Heightened thrombogenicity and biomarker evidence of inflammation have been independently associated with ischemic risk in patients with coronary artery disease. However, a study examining their relation has not been reported. We analysed the relation between measurements of thrombogenicity and biomarkers in patients undergoing stenting and followed for 24 months recurrent ischemic events. In 84 consecutive patients undergoing stenting, pre-procedure thrombogenicity was measured by thrombelastography (TEG) and conventional aggregometry whereas biomarkers were measured by fluorokine multi-analyte profiling. Patients were stratified into quartiles based on platelet-fibrin clot strength (MA) by TEG and correlated with ischemic event occurrence. Patients in the highest MA quartile (high MA) had greater ADP-induced platelet aggregation (57.5 +/- 15.0% vs. 47.9 +/- 17.6%, p = 0.05), C-reactive protein (25.0 +/- 5.6 vs. 4.2 +/- 1.0 microg/mL, p = 0.006) and interleukin-8 (23.8 +/- 2.8 vs. 14.1 +/- 1.6 pg/mL, p < 0.001) than patients within the lowest MA quartile (low MA). Epidermal growth factor (7.7 +/- 2.2 vs. 1.2 +/- 0.3 pg/mL, p = 0.006) and vascular endothelial growth factor (296 +/- 35 vs. 190 +/- 10 pg/mL, p = 0.05) were also higher. Patients with high-MA had an ischemic event more often than patients with low-MA (48% vs. 13%, p = 0.02). Our study suggests that a link is present between inflammation and heightened thrombogenicity measured pre-procedurally in the patient at high risk for recurrent ischemic events after stenting. Larger studies are required to solidify these observations and their clinical relevance.

Saphenous Vein Graft Perforation During Percutaneous Coronary Intervention - A Nightmare to be Avoided.

PubMed

Deora, Surender; Shah, Sanjay C; Patel, Tejas M

2015-01-01

Percutaneous coronary interventions (PCIs) of saphenous vein grafts (SVGs) is challenging and is associated with adverse short- and long-term clinical outcome as compared to native coronary arteries. SVG perforation is rare but catastrophic and needs immediate attention. Various factors predisposing for SVG perforation are old degenerated graft, ulcerated plaque, severe fibrotic, or calcified lesion necessitating high pressure balloon or stent inflation, use of intravascular ultrasound (IVUS) or other atheroablative devices. Management includes prolonged balloon occlusion, reversal of anticoagulation, use of covered stent, and emergency pericadiocentesis if required.

Glycoprotein IIB/IIIA inhibitor to reduce postpercutaneous coronary intervention myonecrosis and improve coronary flow in diabetics: the 'OPTIMIZE-IT' pilot randomized study.

PubMed

Talarico, Giovanni Paolo; Brancati, Marta; Burzotta, Francesco; Porto, Italo; Trani, Carlo; De Vita, Maria; Todaro, Daniel; Giammarinaro, Maura; Leone, Antonio Maria; Niccoli, Giampaolo; Andreotti, Felicita; Mazzari, Mario Attilio; Schiavoni, Giovanni; Crea, Filippo

2009-03-01

Subgroup analyses of trials enrolling acute coronary syndrome patients suggest that inhibition of glycoprotein IIb/IIIa can improve the outcome of diabetic patients undergoing percutaneous coronary interventions (PCIs), possibly by improving microvascular perfusion. However, the efficacy of small-molecule IIb/IIIa receptor inhibitors to improve microvascular perfusion in stable diabetic patients undergoing elective PCI has not been specifically investigated. We randomized consecutive stable diabetic patients, undergoing elective PCI, to tirofiban or placebo groups along with double antiplatelet therapy. High-dose bolus (25 microg/kg per 3 min) of tirofiban was administered immediately before PCI followed by 8 h continuous infusion (0.15 microg/kg per min). Postprocedural myonecrosis was assessed prospectively by measurement of cardiac troponin T (cTnT) at 6 and 24 h after PCI. The primary end-points were post-PCI coronary flow estimated by corrected thrombolysis in myocardial infarction frame count and post-PCI myocardial infarction. Platelet aggregation was measured by platelet function analyser-100 values. Forty-six patients entered the study (22 randomized to placebo and 24 randomized to tirofiban). The study drug was associated with a significant increase of platelet function analyser-100 values that peaked immediately after PCI and was maintained at 6 h (pre-PCI: 131 +/- 65 s; post-PCI: 222 +/- 49 s; after 6 h: 219 +/- 55 s).Post-PCI corrected thrombolysis in myocardial infarction frame count was similar in tirofiban and in placebo groups (10.2 +/- 3.6 vs. 12.0 +/- 7.6, P = 0.30, respectively). The prevalence of raised cTnT levels was similar in the two groups (25 vs. 30%, P = 0.56, respectively). At multivariate analysis, direct stenting (associated with reduced myonecrosis) and postdilatation (associated with increased myonecrosis) predicted cTnT elevation. A high-dose bolus of tirofiban in stable diabetic patients undergoing elective PCI, along with double antiplatelet therapy, was associated with a significant further inhibition of platelet aggregation which, however, did not translate in a lower incidence of post-PCI distal embolization.

Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

PubMed

Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

2015-07-01

The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

Analysis of trends and prospects regarding stents for human blood vessels.

PubMed

Lee, Jeong Hee; Kim, Eung Do; Jun, Eun Jung; Yoo, Hyoung Sun; Lee, Joon Woo

2018-01-01

The purpose of this paper is to provide technology trends and information regarding market and prospects in stents used for human blood vessels in Korea and the world.A stent is a medical device in the form of a cylindrical metal net used to normalize flow when blood or other bodily fluids such as biliary fluids are obstructed in blood vessels, gastrointestinal tracts, etc. by inserting the stent into a narrowed or clogged area. Stents are classified into vascular and non-vascular stents. The coronary artery stent is avascular stent that is used for coronary atherosclerosis.The demand is increasing for stents to treat diseases such as those affecting the heart and blood vessels of elderly and middle-aged patients. Due to the current shift in the demographic structure caused by an aging society, the prospect for stents seems to be very bright.The use of a stent designed to prevent acute vascular occlusion and restenosis, which is a side effect of conventional balloon angioplasty, has rapidly become popular because it can prevent acute complications and improve clinical outcomes. Since the initial release of this stent, there have been significant developments in its design, the most notable of which has been the introduction of drug-eluting stents (DES). Bioresorbable scaffolds (BRS) have the potential to introduce a paradigm shift in interventional cardiology, a true anatomical and functional "vascular restoration" instead of an artificial stiff tube encased by a persistent metallic foreign body. Data for this research were gathered from primary and secondary sources as well as the databases of the Korea Institute of Science Technology Information (KISTI) located in Seoul, Korea like KISTI Market Report. The sources used for primary research included the databases available from the Korea Institute of Science Technology Information, past industry research services/studies, economic and demographic data, and trade and industry journals. Secondary research was used to supplement and complement the primary research. Interviews were conducted with physicians and surgeons from the key hospitals and senior sale/marketing managers from stent product suppliers in South Korea. The global stent market is estimated at US $ 7.98 billion in 2016 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.8% over the next 5 years. As of 2016, the global market for vascular stents is estimated at $ 7.22 billion, with coronary artery stents accounting for 67.3% of the vascular stent market. Among the coronary artery stents, BRS is notably expected to grow at an annual average rate of 8.8% by 2020, but the global adoption rate of BRS remains low at present. In the Korean market, stents for blood vessels account for most of the market, and the market size of stents for blood vessels in Korea was estimated to be 145 billion won as of 2016. In comparison to the sales growth rate of other medical devices, the future stent technology market is judged to be higher in growth potential.

Coronary artery stent (image)

MedlinePlus

... with a balloon catheter and expands when the balloon is inflated. The stent is then left there to help keep the artery open. ... with a balloon catheter and expands when the balloon is inflated. The stent is then left there to help keep the artery open.

Incidence, determinants and clinical impact of definite stent thrombosis on mortality in women: From the WIN-DES collaborative patient-level pooled analysis.

PubMed

Kerkmeijer, Laura S; Claessen, Bimmer E; Baber, Usman; Sartori, Samantha; Chandrasekhar, Jaya; Stefanini, Giulio G; Stone, Gregg W; Steg, P Gabriel; Chieffo, Alaide; Weisz, Giora; Windecker, Stephan; Mikhail, Ghada W; Kastrati, Adnan; Morice, Marie-Claude; Dangas, George D; de Winter, Robbert J; Mehran, Roxana

2018-07-15

Predictors and clinical outcomes of stent thrombosis (ST) in women have not been well investigated. Present study aimed to identify predictors of definite ST and its impact on mortality in women undergoing percutaneous coronary intervention (PCI). Patient-level data of women enrolled in 26 randomized trials of DES was pooled. The study population was stratified based on the presence or absence of definite ST. Cox proportional hazards models were used to determine the predictors of definite ST. To analyze the temporal impact of definite ST on mortality Cox regression with ST entered as time-updated covariate was used. Of 11,557 patients undergoing PCI with stent implantation, definite ST occurred in 105 patients (0.9%) over median follow-up of 3years. Independent predictors of ST were age (HR 1.03 per year decrease, 95% CI 1.00-1.05; p=0.041), diabetes mellitus (HR 2.25, 95% CI 1.27-3.99; p=0.005), non-ST-segment elevation myocardial infarction (NSTEMI) at presentation (HR 1.97, 95% CI 1.04-3.75; p=0.037) and stent diameter (HR 3.76 per mm decrease, 95% CI 1.66-8.53; p=0.002). Compared to women without ST, the adjusted hazard ratios for mortality in the first 7days, 8-30days, and beyond 30days from ST were 115.81 (95% CI 68.96-194.47); 37.44 (95% CI 17.31-80.98); 3.54 (95% CI 2.20-5.69), respectively. In this large-scale pooled analysis of women, definite ST was uncommon yet associated with substantial mortality risk, which peaked early and rapidly attenuated over time. Younger age, diabetes, NSTEMI and stent diameter were found to be predictors of ST. Copyright © 2018 Elsevier B.V. All rights reserved.

Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology?

PubMed Central

Heublein, B; Rohde, R; Kaese, V; Niemeyer, M; Hartung, W; Haverich, A

2003-01-01

Objectives: To develop and test a new concept of the degradation kinetics of newly developed coronary stents consisting of magnesium alloys. Methods: Design of a coronary stent prototype consisting of the non-commercial magnesium based alloy AE21 (containing 2% aluminium and 1% rare earths) with an expected 50% loss of mass within six months. Eleven domestic pigs underwent coronary implantation of 20 stents (overstretch injury). Results: No stent caused major problems during implantation or showed signs of initial breakage in the histological evaluation. There were no thromboembolic events. Quantitative angiography at follow up showed a significant (p < 0.01) 40% loss of perfused lumen diameter between days 10 and 35, corresponding to neointima formation seen on histological analysis, and a 25% re-enlargement (p < 0.05) between days 35 and 56 caused by vascular remodelling (based on intravascular ultrasound) resulting from the loss of mechanical integrity of the stent. Inflammation (p < 0.001) and neointimal plaque area (p < 0.05) depended significantly on injury score. Planimetric degradation correlated with time (r = 0.67, p < 0.01). Conclusion: Vascular implants consisting of magnesium alloy degradable by biocorrosion seem to be a realistic alternative to permanent implants. PMID:12748224

Biocorrosion of magnesium alloys: a new principle in cardiovascular implant technology?

PubMed

Heublein, B; Rohde, R; Kaese, V; Niemeyer, M; Hartung, W; Haverich, A

2003-06-01

To develop and test a new concept of the degradation kinetics of newly developed coronary stents consisting of magnesium alloys. Design of a coronary stent prototype consisting of the non-commercial magnesium based alloy AE21 (containing 2% aluminium and 1% rare earths) with an expected 50% loss of mass within six months. Eleven domestic pigs underwent coronary implantation of 20 stents (overstretch injury). No stent caused major problems during implantation or showed signs of initial breakage in the histological evaluation. There were no thromboembolic events. Quantitative angiography at follow up showed a significant (p < 0.01) 40% loss of perfused lumen diameter between days 10 and 35, corresponding to neointima formation seen on histological analysis, and a 25% re-enlargement (p < 0.05) between days 35 and 56 caused by vascular remodelling (based on intravascular ultrasound) resulting from the loss of mechanical integrity of the stent. Inflammation (p < 0.001) and neointimal plaque area (p < 0.05) depended significantly on injury score. Planimetric degradation correlated with time (r = 0.67, p < 0.01). Vascular implants consisting of magnesium alloy degradable by biocorrosion seem to be a realistic alternative to permanent implants.

Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

PubMed Central

Giacoppo, Daniele; Gargiulo, Giuseppe; Aruta, Patrizia; Capranzano, Piera; Tamburino, Corrado

2015-01-01

Study question What is the most safe and effective interventional treatment for coronary in-stent restenosis? Methods In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses. Study answer and limitations Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval −0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons. What this study adds Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy. Funding, competing interests, data sharing This study received no external funding. The authors declare no competing interests. No additional data available. PMID:26537292

Does stent strut design impact clinical outcomes: comparative safety and efficacy of Endeavor Resolute versus Resolute Integrity zotarolimus-eluting stents.

PubMed

Di Santo, Pietro; Simard, Trevor; Ramirez, F Daniel; Pourdjabbar, Ali; Harnett, David T; Singh, Kuljit; Moreland, Robert; Chong, Aun-Yeong; Dick, Alexander; Labinaz, Marino; Froeschl, Michael; Froeschl, Michael; Le May, Michael R; So, Derek Y; Hibbert, Benjamin

2015-10-07

Percutaneous coronary intervention is the most commonly performed method of revascularizing obstructive coronary artery disease. The impact of stent strut design on clinical outcomes remains unclear. The Endeavour Resolute (ER-ZES) and the Resolute Integrity (RI-ZES) zotarolimus-eluting stents utilize identical polymers and anti-proliferative agents, differing only in their respective strut design. This study assessed the comparative safety and efficacy of these two stents in unrestricted contemporary real-world practice. A total of 542 patients were identified, corresponding to 340 ER-ZES and 480 RI-ZES. The primary endpoint was major adverse cardiac events (MACE) defined by a composite of death, nonfatal myocardial infarction and stroke. Secondary endpoints included post-procedural length of stay, in-stent restenosis, target lesion revascularization, target vessel revascularization, coronary artery bypass grafting and stent thrombosis. MACE occurred in 3.2% of the ER-ZES cohort and 5.0% of the RI-ZES cohort (p= 0.43). Adjusted analysis utilizing propensity score-adjusted odds ratio for MACE, was 1.37 (95% CI 0.46-4.07, p=0.57). The mortality rate (0.9% ER-ZES vs. 1.9% RI-ZES, p=0.59), non-fatal MI (2.3% ER-ZES vs. 3.1% RI-ZES, p=0.75) and stroke (0.0% ER-ZES vs. 0.3% RI-ZES, p=0.85) were not different. Additionally, there was no difference in any of secondary outcomes. The clinical performance and safety of both ER-ZES and RI-ZES were not statistically different, despite differences in stent strut design.

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease.

PubMed

Yang, Yue-jin; Xu, Bo; Kang, Sheng; Pei, Wei-dong; Chen, Ji-lin; Qiao, Shu-bin; Qin, Xue-wen; Yao, Min; Chen, Jue; Wu, Yong-jian; Liu, Hai-Bo; You, Shi-Jie; Li, Jian-Jun; Dai, Jun; Gao, Run-Lin

2007-11-05

The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conducted to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes. One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC). The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P > 0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P = 0.524), re-MI (0 vs 2.0%, P = 0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P = 0.299) and very late thrombosis (0 vs 3.0%, P = 0.295) between 1-year and 3-year follow-up. The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

Ductal recanalization and stenting for late presenters with TGA intact ventricular septum

PubMed Central

Kothari, Shyam S; Ramakrishnan, Sivasubramanian; Senguttuvan, Nagendra Boopathy; Gupta, Saurabh Kumar; Bisoi, Akshay K

2011-01-01

Introduction: The ideal management strategy for patients presenting late with transposition of great arteries (TGA), intact ventricular septum (IVS), and regressed left ventricle (LV) is not clear. Primary switch, two-stage switch, and Senning operation are the options. Left ventricular retraining prior to arterial switch by ductal stenting may be effective, but the experience is very limited. Methods: Five of six children aged 3–6 months with TGA-IVS and regressed LV underwent recanalization and transcatheter stenting of ductus arteriosus. The ductal stent was removed during arterial switch surgery. Results: The procedure was successful in 5/6 patients. All the patients had totally occluded ductus and needed recanalization with coronary total occlusion hardware. The ductus was dilated and stented with coronary stents. In all the patients, there was significant luminal narrowing despite adequate stent placement and deployment. Two patients needed reintervention for abrupt closure of the stent. Ductal stenting resulted in left ventricular preparedness within 7–14 days. One patient died of progressive sepsis after 14 days of stenting, even though the LV was prepared. Four patients underwent successful uneventful arterial switch surgery. During surgery, it was observed that the mucosal folds of duct were protruding through the struts of the stent in one patient. Conclusions: Ductal stenting is a good alternative strategy for left ventricular retraining in TGA with regressed LV even in patients with occluded ducts. PMID:21976872

Titanium-nitride-oxide-coated coronary stents: insights from the available evidence.

PubMed

Karjalainen, Pasi P; Nammas, Wail

2017-06-01

Coating of stent surface with a biocompatible material is suggested to improve stent safety profile. A proprietary process was developed to coat titanium-nitride-oxide on the stent surface, based on plasma technology that uses the nano-synthesis of gas and metal. Preclinical in vitro and in vivo investigation confirmed blood compatibility of titanium (nitride-) oxide films. Titanium-nitride-oxide-coated stents demonstrated a better angiographic outcome, compared with bare-metal stents at mid-term follow-up; however, they failed to achieve non-inferiority for angiographic outcome versus second-generation drug-eluting stents. Observational studies showed adequate clinical outcome at mid-term follow-up. Non-randomized studies showed an outcome of titanium-nitride-oxide-coated stents comparable to - or better than - first-generation drug-eluting stents at long-term follow-up. Two randomized controlled trials demonstrated comparable efficacy outcome, and a better safety outcome of titanium-nitride-oxide-coated stents versus drug-eluting stents at long-term follow-up. Evaluation by optical coherence tomography at mid-term follow-up revealed better neointimal strut coverage associated with titanium-nitride-oxide-coated stents versus drug-eluting stents; yet, neointimal hyperplasia thickness was greater. Key messages Stents coated with titanium-nitride-oxide demonstrated biocompatibility in preclinical studies: they inhibit platelet and fibrin deposition, and reduce neointimal growth. In observational and non-randomized studies, titanium-nitride-oxide-coated stents were associated with adequate safety and efficacy outcome. In randomized trials of patients with acute coronary syndrome, titanium-nitride-oxide-coated stents were associated with a better safety outcome, compared with drug-eluting stents; efficacy outcome was comparable.

Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDia (Coronary Artery Revascularization in Diabetes) trial.

PubMed

Kapur, Akhil; Hall, Roger J; Malik, Iqbal S; Qureshi, Ayesha C; Butts, Jeremy; de Belder, Mark; Baumbach, Andreas; Angelini, Gianni; de Belder, Adam; Oldroyd, Keith G; Flather, Marcus; Roughton, Michael; Nihoyannopoulos, Petros; Bagger, Jens Peder; Morgan, Kenneth; Beatt, Kevin J

2010-02-02

The purpose of this study was to compare the safety and efficacy of percutaneous coronary intervention (PCI) with stenting against coronary artery bypass grafting (CABG) in patients with diabetes and symptomatic multivessel coronary artery disease. CABG is the established method of revascularization in patients with diabetes and multivessel coronary disease, but with advances in PCI, there is uncertainty whether CABG remains the preferred method of revascularization. The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), and stroke, and the main secondary outcome included the addition of repeat revascularization to the primary outcome events. A total of 510 diabetic patients with multivessel or complex single-vessel coronary disease from 24 centers were randomized to PCI plus stenting (and routine abciximab) or CABG. The primary comparison used a noninferiority method with the upper boundary of the 95% confidence interval (CI) not to exceed 1.3 to declare PCI noninferior. Bare-metal stents were used initially, but a switch to Cypher (sirolimus drug-eluting) stents (Cordis, Johnson & Johnson, Bridgewater, New Jersey) was made when these became available. At 1 year of follow-up, the composite rate of death, MI, and stroke was 10.5% in the CABG group and 13.0% in the PCI group (hazard ratio [HR]: 1.25, 95% CI: 0.75 to 2.09; p=0.39), all-cause mortality rates were 3.2% and 3.2%, and the rates of death, MI, stroke, or repeat revascularization were 11.3% and 19.3% (HR: 1.77, 95% CI: 1.11 to 2.82; p=0.02), respectively. When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p=0.82), respectively. The CARDia (Coronary Artery Revascularization in Diabetes) trial is the first randomized trial of coronary revascularization in diabetic patients, but the 1-year results did not show that PCI is noninferior to CABG. However, the CARDia trial did show that multivessel PCI is feasible in patients with diabetes, but longer-term follow-up and data from other trials will be needed to provide a more precise comparison of the efficacy of these 2 revascularization strategies. (The Coronary Artery Revascularisation in Diabetes trial; ISRCTN19872154). Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial.

PubMed

Baron, Suzanne J; Chinnakondepalli, Khaja; Magnuson, Elizabeth A; Kandzari, David E; Puskas, John D; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Taggart, David P; Morice, Marie-Claude; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian; Simonton, Charles A; Kappetein, A Pieter; Sabik, Joseph F; Serruys, Patrick W; Stone, Gregg W; Cohen, David J

2017-12-26

The EXCEL (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial compared outcomes in patients with unprotected left main coronary artery disease (LMCAD) treated with coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) using everolimus-eluting stents. Whereas rates of death, stroke, and myocardial infarction were similar at 36 months, event timing and repeat revascularization rates differed by treatment group. To understand the effects of revascularization strategy from the patient's perspective, a prospective quality of life (QoL) substudy was performed alongside the EXCEL trial. Between September 2010 and March 2014, 1,905 patients with LMCAD were randomized to undergo CABG or PCI, of whom 1,788 participated in the QoL substudy. QoL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the 12-Item Short Form Health Survey, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models. Over 36 months, both PCI and CABG were associated with significant improvements in QoL compared with baseline. At 1 month, PCI was associated with better QoL than CABG. By 12 months though, these differences were largely attenuated, and by 36 months, there were no significant QoL differences between PCI and CABG. Among selected patients with LMCAD, both PCI and CABG result in similar QoL improvement through 36 months, although a greater early benefit is seen with PCI. Taken together with the 3-year clinical results of EXCEL, these findings suggest that PCI and CABG provide similar intermediate-term outcomes for patients with LMCAD. (Evaluation of Xience Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Integrity(®) bare-metal coronary stent-induced platelet and endothelial cell activation results in a higher risk of restenosis compared to Xience(®) everolimus-eluting stents in stable angina patients.

PubMed

Szük, Tibor; Fejes, Zsolt; Debreceni, Ildikó Beke; Kerényi, Adrienne; Édes, István; Kappelmayer, János; Nagy, Béla

2016-07-01

Drug-eluting stenting (DES) has become a reliable tool for coronary stenting; however, its direct effects on platelet and endothelium function differ from those of bare-metal stenting (BMS). This study involved a periprocedural analysis of various biomarkers of cellular activation after elective DES (Xience(®), Abbott Vascular, Santa Clara, CA, USA) or BMS (Integrity(®), Medtronic, Minneapolis, MI, USA). Forty-nine stable angina patients were recruited: 28 underwent BMS, and 21 received everolimus-eluting stents. Samples were collected (i) prior to stenting, (ii) at 24 hours after procedure, and (iii) after 1 month of dual antiplatelet therapy. Platelet activation was analyzed by surface P-selectin positivity in parallel with plasma levels of soluble P-selectin, CD40L and platelet-derived growth factor (PDGF). Endothelial cell (EC) activation was detected by measuring markers of early (von Willebrand factor) and delayed response (VCAM-1, ICAM-1, E-selectin). Patients were followed for 6 months for the occurrence of restenosis or stent thrombosis. Increased platelet activation was sustained regardless of stent type or antiplatelet medication. Concentrations of most EC markers were more elevated after BMS than after DES. No stent thrombosis was seen, but six BMS subjects displayed restenosis with significantly higher sCD40L (779 [397-899] vs. 381 [229-498] pg/mL; p = 0.032) and sICAM-1 (222 [181-272] vs. 162 [153-223] ng/mL; p = 0.046) levels than in those without complication, while DES patients exhibited significantly decreased PDGF (572 [428-626] vs. 244 [228-311] pg/mL; p = 0.004) after 1 month. Nonresponsiveness to antiplatelet drugs did not influence these changes. In conclusion, the degree of platelet and EC activation suggests that Xience(®) DES may be regarded a safer coronary intervention than Integrity(®) BMS, with a lower risk of in-stent restenosis.

Correction of Stent Distortion and Overhanging Stent Struts during Left Main Bifurcation Stenting by Selective Distal Stent Cell Re-Wiring: A Novel Guidewire Approach

PubMed Central

Sabbah, Mahmoud; Kadota, Kazushige; Fuku, Yasushi; Mitsudo, Kazuaki

2015-01-01

Stent malapposition and overhanging stent struts in front of the side branch (SB) ostium are not uncommon following bifurcation stenting that might lead to stent thrombosis. We herein present 2 cases, in which optical frequency domain imaging and intravascular ultrasound effectively revealed stent malapposition and overhanging struts inside the ostium of the SB following left main coronary artery stenting. Therefore, we introduced a novel technique for rectification of these incidental findings by selective SB re-wiring through the most distal stent cell with the adjunctive help of a double lumen microcatheter. PMID:27122906

Left subclavian artery stenting: an option for the treatment of the coronary-subclavian steal syndrome

PubMed Central

de Almeida, Bruno Lorenção; Kambara, Antonio Massamitsu; Rossi, Fabio Henrique; Moreira, Samuel Martins; de Oliveira, Eduardo Silva Jordao; Linhares Filho, Frederico Augusto de Carvalho; Metzger, Patrick Bastos; Passalacqua, Aldo Zampieri

2014-01-01

Introduction The subclavian steal syndrome is characterized by the vertebral artery flow inversion, due to a stenotic lesion in the origin of the subclavian artery. The Coronary-subclavian Steal Syndrome is a variation of the Subclavian Steal Syndrome and is characterized by inversion of flow in the Internal Thracic artery that has been used as conduct in a myocardial revascularization. Its diagnosis must be suspected in patients with difference in pulse and arterial pressure in the upper limbs, that present with angina pectoris and that have done a myocardial revascularization. Its treatment must be a surgical bypass or a transluminal angioplasty. Objective The objective is to show the left subclavian artery stenting as a safe and effective method to treat the coronary-subclavian steal syndrome. Methods Historical prospective, non-randomized trial, through revision of the hospital records of the patients treated with the stenting of the left subclavian artery, from January 2006 to September 2012. Results In the mentioned period, 4.291 miocardial revascularizations were performed with the use of the left mammary artery, and 16 patients were identified to have the Coronary-subclavian steal syndrome. All of them were submitted to endovascular treatment. The success rate was 100%; two patients experienced minor complications; none of them presented with major complications. Eleven of the 16 patients had ultrassonographic documentation of patent stent for at least one year; two patients lost follow up and other two died. Conclusion The stenting of the left subclavian artery is a good option for the treatment of the Coronary-subclavian Steal Syndrome, with high level of technical and clinical success. PMID:25140474

Efficacy of stent angioplasty for symptomatic stenoses of the proximal vertebral artery.

PubMed

Weber, W; Mayer, T E; Henkes, H; Kis, B; Hamann, G F; Holtmannspoetter, M; Brueckmann, H; Kuehne, D

2005-11-01

To evaluate the safety and efficacy of stent angioplasty in the treatment of symptomatic arteriosclerotic stenoses of the proximal vertebral artery (VA). Thirty-eight symptomatic stenoses of the vertebral origin were treated with flexible balloon-expandable coronary stents. Angiographic and clinical follow-up examinations were obtained in 26 patients at a mean of 11 months. The immediate post-procedural angiographic results showed no residual stenosis in 33 vessels and mild residual stenoses in five vessels. Periprocedurally, there were two asymptomatic technical complications and one TIA. During follow-up re-stenosis could be detected in 10 cases (36%), and vessel occlusions in two patients. Two stents were broken. One of the restenosis caused a TIA within the follow-up period. Flexible balloon-expandable coronary stents proved to be save and effective in preventing vertebrobasilar stroke but were incapable to preserve the proximal vertebral artery lumen. For the VA origine an adequate stent, self-expanding, bioresorbable, or drug-eluting has to be found.

In vitro study of role of trace amount of Cu release from Cu-bearing stainless steel targeting for reduction of in-stent restenosis.

PubMed

Ren, Ling; Xu, Lu; Feng, Jingwen; Zhang, Yang; Yang, Ke

2012-05-01

A novel 316L type Cu-bearing stainless steel was developed in present work, aiming at reducing the occurrence of the in-stent restenosis after implantations of coronary stents, through trace amount of Cu release from surface of the steel in body fluid. It was found that there was a trace amount of Cu released from the Cu-bearing steel in a simulated body fluid, with no cytotoxicity. All the in vitro experimental results proved that this Cu-bearing steel could not only inhibit the proliferation of vascular smooth muscle cells, reducing the formation of thrombosis, which are the main reasons for happening of the in-stent restenosis, but also promote the proliferation of vascular endothelial cells needed for the revascularization, showing that this novel steel is prospective to be a new material for manufacturing coronary stents with function of reducing the in-stent restenosis.

Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: mixed treatment comparison analysis of 22 844 patient years of follow-up from randomised trials

PubMed Central

Kumar, Sunil; Fusaro, Mario; Amoroso, Nicholas; Kirtane, Ajay J; Byrne, Robert A; Williams, David O; Slater, James; Cutlip, Donald E; Feit, Frederick

2012-01-01

Objectives To evaluate the efficacy and safety of currently used drug eluting stents compared with each other and compared with bare metal stents in patients with diabetes. Design Mixed treatment comparison meta-analysis. Data sources and study selection PubMed, Embase, and CENTRAL were searched for randomised clinical trials, until April 2012, of four durable polymer drug eluting stents (sirolimus eluting stents, paclitaxel eluting stents, everolimus eluting stents, and zotarolimus eluting stents) compared with each other or with bare metal stents for the treatment of de novo coronary lesions and enrolling at least 50 patients with diabetes. Primary outcomes Efficacy (target vessel revascularisation) and safety (death, myocardial infarction, stent thrombosis). Results From 42 trials with 22 844 patient years of follow-up, when compared with bare metal stents (reference rate ratio 1) all of the currently used drug eluting stents were associated with a significant reduction in target vessel revascularisation (37% to 69%), though the efficacy varied with the type of stent (everolimus eluting stents∼sirolimus eluting stents>paclitaxel eluting stents∼zotarolimus eluting stent>bare metal stents). There was about an 87% probability that everolimus eluting stents were the most efficacious compared with all others, though there were limited usable data for the zotarolimus eluting Resolute stent in patients with diabetes. Moreover, there was no increased risk of any safety outcome (including very late stent thrombosis) with any drug eluting stents compared with bare metal stents. There was about a 62% probability that the everolimus eluting stent was the safest stent for the outcome of “any” stent thrombosis. Conclusions Among patients with diabetes treated with coronary stents all currently available drug eluting stents were efficacious without compromising safety compared with bare metal stents. There were relative differences among the drug eluting stents, such that the everolimus eluting stent was the most efficacious and safe. PMID:22885395

Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians.

PubMed

Grines, Cindy L; Bonow, Robert O; Casey, Donald E; Gardner, Timothy J; Lockhart, Peter B; Moliterno, David J; O'Gara, Patrick; Whitlow, Patrick

2007-02-13

Dual antiplatelet therapy with aspirin and a thienopyridine has been shown to reduce cardiac events after coronary stenting. However, many patients and healthcare providers prematurely discontinue dual antiplatelet therapy, which greatly increases the risk of stent thrombosis, myocardial infarction, and death. This advisory stresses the importance of 12 months of dual antiplatelet therapy after placement of a drug-eluting stent and educating the patient and healthcare providers about hazards of premature discontinuation. It also recommends postponing elective surgery for 1 year, and if surgery cannot be deferred, considering the continuation of aspirin during the perioperative period in high-risk patients with drug-eluting stents.

Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians.

PubMed

Grines, Cindy L; Bonow, Robert O; Casey, Donald E; Gardner, Timothy J; Lockhart, Peter B; Moliterno, David J; O'Gara, Patrick; Whitlow, Patrick

2007-05-01

and Overview. Dual antiplatelet therapy with aspirin and a thienopyridine has been shown to reduce cardiac events after coronary stenting. However, many patients and health care providers prematurely discontinue dual antiplatelet therapy, which greatly increases the risk of stent thrombosis, myocardial infarction and death. This advisory stresses the importance of 12 months of dual antiplatelet therapy after placement of a drug-eluting stent and educating patients and health care providers about hazards of premature discontinuation. It also recommends postponing elective surgery for one year, and if surgery cannot be deferred, considering the continuation of aspirin during the perioperative period in high-risk patients with drug-eluting stents.

Increased major bleeding complications related to triple antithrombotic therapy usage in patients with atrial fibrillation undergoing percutaneous coronary artery stenting.

PubMed

Manzano-Fernández, Sergio; Pastor, Francisco J; Marín, Francisco; Cambronero, Francisco; Caro, Cesar; Pascual-Figal, Domingo A; Garrido, Iris P; Pinar, Eduardo; Valdés, Mariano; Lip, Gregory Y H

2008-09-01

The optimal antithrombotic therapy strategy for atrial fibrillation (AF) patients who undergo percutaneous coronary intervention with stent implantation (PCI-S) is unknown. We assessed the safety of antithrombotic therapy strategies in AF patients with indication for oral anticoagulation (OAC) undergoing PCI-S. We studied consecutive AF patients with indication for OAC who underwent PCI-S. We compared patients that received triple antithrombotic therapy (TT) [aspirin, clopidogrel, and coumadin] against other regimes (non-TT) after PCI-S. The primary end point was defined as the occurrence of major bleeding complications that were termed as early major bleeding (EMB) [< or = 48 h] or late major bleeding (LMB) [> 48 h]. Clinical follow-up was performed, and complications were recorded. We studied 104 patients (mean age +/- SD, 72 +/- 8 years; 70% men); TT was used in 51 patients (49%). TT was associated with a higher incidence of LMB (21.6% vs non-TT, 3.8%; p = 0.006) but not of EMB (5.8% vs non-TT, 11.3%; p = 0.33). In multivariate analyses, glycoprotein (GP) IIb/IIIa inhibitor use (hazard ratio [HR], 13.5; 95% confidence interval [CI], 1.7 to 108.3; p = 0.014) and PCI-S of three vessels or left main artery disease (HR, 7.9; 95% CI, 1.6 to 39.2; p = 0.01) were independent predictors for EMB. TT use (HR, 7.1; 95% CI, 1.5 to 32.4; p = 0.012), the occurrence of EMB (HR, 6.7; 95% CI, 1.8 to 25.3; p = 0.005), and baseline anemia (HR, 3.8; 95% CI, 1.2 to 12.5; p = 0.027) were independent predictors for LMB. No differences in major cardiovascular events were observed in patients treated with TT vs non-TT (25.5% vs 21.0%; p = 0.53). A high rate of major bleeding is observed in AF patients with indication for OAC undergoing PCI-S who receive TT. GP IIb/IIIa inhibitor use and multivessel/left main artery disease during PCI-S were independent predictors for EMB, while TT use, occurrence of EMB, and baseline anemia were independent predictors for LMB.

Impact of coronary artery stent edge dissections on long-term clinical outcome in patients with acute coronary syndrome: an optical coherence tomography study.

PubMed

Bouki, Konstantina P; Sakkali, Eleni; Toutouzas, Konstantinos; Vlad, Delia; Barmperis, Dimitrios; Phychari, Stavroula; Riga, Maria; Apostolou, Thomas; Stefanadis, Christodoulos

2015-08-01

The purpose of the present study was to assess the incidence, predictors and long term prognosis of stent edge dissections identified by (OCT) after the implantation of bare metal (BMS) and drug eluting stents (DES). We studied 74 patients who underwent percutaneous coronary intervention (PCI) because of an acute coronary syndrome. Edge dissections were found in 29 of 74 patients (39.1%). Independent predictors of edge dissections were: the presence of ST-elevation myocardial infarction (STEMI) (P = 0.005, odds ratio 11.78; 95% Cl 2.06-67.10), the small reference lumen diameter (P = 0.009, odds ratio 0.11; 95% Cl 0.02-0.58) and the short stents implanted (P = 0.013, odds ratio 0.83; 95% Cl 0.72-0.96). During a follow-up period of 25.6 ± 9.4 months 11 patients presented with at least one major adverse cardiac event. Event free survival was significantly decreased in patients with edge dissection with a flap thickness >0.31 mm compared to patients with thinner flap or without any dissection (P < 0.001). OCT frequently detects edge dissections, usually related to STEMI presentation and to PCI technique. Deep vessel wall injury at stent edges with a dissection flap thickness more than 0.31mm carries an adverse clinical impact on long-term clinical outcome. © 2015 Wiley Periodicals, Inc.

Efficacy and safety of a biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials.

PubMed

Wang, Geng; Wang, Heyang; Xu, Bo; Yang, Yuejin; Yang, Zhiming; Li, Hui; Zhang, Zheng; Wang, Haichang; Yang, Lixia; Han, Yaling

2017-03-01

The safety and efficacy of the second-generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in daily clinical practice remains unknown. Additionally, to meet the China Food and Drug Administration requirements, we conducted an objective performance criterion study from the CREDIT II and CREDIT III trials. CREDIT II was a randomized trial comparing the EXCEL2 versus EXCEL stent in patients with up to 2 de novo coronary lesions. CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCEL2 in broad types of de novo coronary artery lesions. This pooled analysis included patients in the CREDIT III and EXCEL2 arm of the CREDIT II trial. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinical indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed. A total of 833 patients were included, consisting of 625 in the CREDIT III trial and 208 in the EXCEL2 arm of the CREDIT II trial. Twelve-month TLF occurred in 6.1% patients, cardiac death in 0.4%, TV-MI in 5%, and CI-TLR in 1.1%. Additionally, 64 (7.7%) PoCE and 3 probable late stent thromboses (0.4%) were recorded. EXCEL2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF as well as stent thrombosis when treating patients with de novo coronary lesions. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Clinical Outcomes from Unselected "Real-World" Patients with Long Coronary Lesion Receiving 40 mm Biodegradable Polymer Coated Sirolimus-Eluting Stent.

PubMed

Polavarapu, Anurag; Polavarapu, Raghava Sarma; Prajapati, Jayesh; Thakkar, Kamlesh; Raheem, Asif; Mayall, Tamanpreet; Thakkar, Ashok

2015-01-01

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events. Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions. Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up. Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up. Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in "real-world" patients.

Clopidogrel

MedlinePlus

... of heart surgery) that may involve inserting coronary stents (metal tubes surgically placed in clogged blood vessels ... heart attack or stroke. If you have a stent, there is also a higher risk that you ...

Ticagrelor

MedlinePlus

... blood clots from forming in people with coronary stents (metal tubes surgically placed in clogged blood vessels ... heart attack or stroke. If you have a stent, there is also a higher risk that you ...

Correlation between balloon release pressure and no-reflow in patients with acute myocardial infarction undergoing direct percutaneous coronary intervention.

PubMed

Wang, Yanfei; Yao, Min; Liu, Haibo; Yang, Yuejin; Xie, Junmin; Jia, Xinwei; Pan, Huanjun; Wang, Chunyan

2014-01-01

Balloon release pressure may increase the incidence of no reflow after direct percutaneous coronary intervention (PCI). This randomized controlled study was designed to analyze the correlation between balloon release pressure and no-reflow in patients with acute myocardial infarction (AMI) undergoing direct PCI. There were 156 AMI patients who underwent PCI from January 1, 2010 to December 31, 2012, and were divided into two groups according to the stent inflation pressure: a conventional pressure group and a high pressure group. After PCI, angiography was conducted to assess the thrombolysis in myocardial infarction (TIMI) grade with related artery. Examinations were undertaken on all patients before and after the operation including cardiac enzymes, total cholesterol, low-density lipoprotein, blood glucose, homocysteine , β-thromboglobulin (β-TG), Hamilton depression scale (HAMD) and self-rating anxiety scale (SAS). After interventional therapy, the afore-mentioned parameters in both the conventional pressure group and high pressure group were again analyzed. The results showed that CK-MB, HAMD, SAS were significantly different (P < 0.05) in all patients after PCI, especially the CK-MB in the high pressure group ((25.7 ± 7.6) U/L vs. (76.7 ± 11.8) U/L). CK-MB, HAMD, SAS, and β-TG were comparative before PCI but they were significantly changed (P < 0.05) after intervention. No-reflow phenomenon occurred in 13 patients in the high pressure group, which was significantly higher than in the conventional pressure group (17.11% vs. 6.25%, P < 0.05). In stent implantation, using a pressure less than 1823.4 kPa balloon to release pressure may be the better choice to reduce the occurrence of no-reflow following direct PCI.

Impact of Multiple Complex Plaques on Short-and Long-Term Clinical in Patients Presenting with ST-Segment Elevation Myocardial Infarction (From the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Trial)

PubMed Central

Keeley, Ellen C.; Mehran, Roxana; Brener, Sorin J.; Witzenbichler, Bernhard; Guagliumi, Giulio; Dudek, Dariusz; Kornowski, Ran; Dressler, Ovidiu; Fahy, Martin; Xu, Ke; Grines, Cindy L.; Stone, Gregg W.

2014-01-01

It is not known whether the extent and severity of non-culprit coronary lesions correlate with outcomes in patients with STEMI referred for primary PCI. We sought to quantify complex plaques in ST-segment elevation myocardial infarction (STEMI) patients referred for primary percutaneous coronary intervention (PCI) and to determine their effect on short- and long-term clinical outcomes by examining the core laboratory database for plaque analysis from the HORIZONS-AMI study. Baseline demographic, angiographic, and procedural details were compared between patients with single vs. multiple complex plaques undergoing single vessel PCI. Multivariable analysis was performed for predictors of long-term major adverse cardiac events (MACE), a combined end point of death, reinfarction, ischemic target vessel revascularization, or stroke, and for death alone. Single vessel PCI was performed in 3,137 patients (87%): 2,174 (69%) had multiple complex plaques and 963 (31%) had a single complex plaque. Compared to those with a single complex plaque, patients with multiple complex plaques were older (p<0.0001) and had more comorbidities. The presence of multiple complex plaques was an independent predictor of 3-year MACE (hazard ratio [HR]: 1.58; 95% confidence interval [CI]: 1.26–1.98, p<0.0001), and death alone (HR: 1.68; 95% CI: 1.05–2.70, p=0.03). In conclusion, multiple complex plaques are present in the majority of STEMI patients undergoing primary PCI and their presence is an independent predictor of short- and long-term MACE, including death. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966) PMID:24703369

Advantages and disadvantages of biodegradable platforms in drug eluting stents.

PubMed

Rodriguez-Granillo, Agustina; Rubilar, Bibiana; Rodriguez-Granillo, Gaston; Rodriguez, Alfredo E

2011-03-26

Coronary angioplasty with drug-eluting stent (DES) implantation is currently the most common stent procedure worldwide. Since the introduction of DES, coronary restenosis as well as the incidence of target vessel and target lesion revascularization have been significantly reduced. However, the incidence of very late stent thrombosis beyond the first year after stent deployment has more commonly been linked to DES than to bare-metal stent (BMS) implantation. Several factors have been associated with very late stent thrombosis after DES implantation, such as delayed healing, inflammation, stent mal-apposition and endothelial dysfunction. Some of these adverse events were associated with the presence of durable polymers, which were essential to allow the elution of the immunosuppressive drug in the first DES designs. The introduction of erodable polymers in DES technology has provided the potential to complete the degradation of the polymer simultaneously or immediately after the release of the immunosuppressive drug, after which a BMS remains in place. Several DES designs with biodegradable (BIO) polymers have been introduced in preclinical and clinical studies, including randomized trials. In this review, we analyze the clinical results from 6 observational and randomized studies with BIO polymers and discuss advantages and disadvantages of this new technology.

Can the optimal type of stent be predicted based on clinical risk factors? A subgroup analysis of the randomized BASKET-PROVE trial.

PubMed

Vassalli, Giuseppe; Klersy, Catherine; De Servi, Stefano; Galatius, Soeren; Erne, Paul; Eberli, Franz; Rickli, Hans; Hornig, Burkhard; Bertel, Osmund; Bonetti, Piero; Moccetti, Tiziano; Kaiser, Christoph; Pfisterer, Matthias; Pedrazzini, Giovanni

2016-03-01

The randomized BASKET-PROVE study showed no significant differences between sirolimus-eluting stents (SES), everolimus-eluting stents (EES), and bare-metal stents (BMS) with respect to the primary end point, rates of death from cardiac causes, or myocardial infarction (MI) at 2 years of follow-up, in patients requiring stenting of a large coronary artery. Clinical risk factors may affect clinical outcomes after percutaneous coronary interventions. We present a retrospective analysis of the BASKET-PROVE data addressing the question as to whether the optimal type of stent can be predicted based on a cumulative clinical risk score. A total of 2,314 patients (mean age 66 years) who underwent coronary angioplasty and implantation of ≥1 stents that were ≥3.0 mm in diameter were randomly assigned to receive SES, EES, or BMS. A cumulative clinical risk score was derived using a Cox model that included age, gender, cardiovascular risk factors (hypercholesterolemia, hypertension, family history of cardiovascular disease, diabetes, smoking), presence of ≥2 comorbidities (stroke, peripheral artery disease, chronic kidney disease, chronic rheumatic disease), a history of MI or coronary revascularization, and clinical presentation (stable angina, unstable angina, ST-segment elevation MI). An aggregate drug-eluting stent (DES) group (n = 1,549) comprising 775 patients receiving SES and 774 patients receiving EES was compared to 765 patients receiving BMS. Rates of death from cardiac causes or nonfatal MI at 2 years of follow-up were significantly increased in patients who were in the high tertile of risk stratification for the clinical risk score compared to those who were in the aggregate low-mid tertiles. In patients with a high clinical risk score, rates of death from cardiac causes or nonfatal MI were lower in patients receiving DES (2.4 per 100 person-years, 95% CI 1.6-3.6) compared with BMS (5.5 per 100 person-years, 95% CI 3.7-8.2, hazard ratio 0.45, 95% CI 0.26-0.80, P = .007). However, they were not significantly different between receivers of DES and BMS in patients in the low-mid risk tertiles. This exploratory analysis suggests that, in patients who require stenting of a large coronary artery, use of a clinical risk score may identify those patients for whom DES use may confer a clinical advantage over BMS, beyond lower restenosis rates. Copyright © 2015 Elsevier Inc. All rights reserved.

Risk of death and myocardial infarction in patients with peripheral arterial disease undergoing percutaneous coronary intervention (from the National Heart, Lung and Blood Institute Dynamic Registry).

PubMed

Parikh, Shailja V; Saya, Shoaib; Divanji, Punag; Banerjee, Subhash; Selzer, Faith; Abbott, J Dawn; Naidu, Srihari S; Wilensky, Robert L; Faxon, David P; Jacobs, Alice K; Holper, Elizabeth M

2011-04-01

Patients with peripheral arterial disease (PAD) undergoing percutaneous coronary intervention (PCI) are at high risk for adverse cardiovascular events. Trends over time in outcomes with advances in PCI and medical therapy are unknown. We evaluated 866 patients with PAD in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry undergoing PCI according to treatment eras: the early bare metal stent (BMS) era (wave 1, 1997 to 1998, n = 180), the BMS era (waves 2 and 3, 1999 and 2001 to 2002, n = 339), and the drug-eluting stent (DES) era (waves 4 and 5, 2004 and 2006, n = 347). We compared in-hospital and 1-year outcomes by recruitment era. In-hospital coronary artery bypass graft surgery rates were significantly lower in the later eras (3.9%, 0.9%, and 0.6% for the early BMS, BMS, and DES eras, respectively, p for trend = 0.005), and an increasing percentage of patients were discharged on aspirin, β blockers, statins, and thienopyridines (p for trend <0.001 for all comparisons). Cumulative 1-year event rates in patients with PAD in the early BMS era, BMS era, and DES era for death were 13.7%, 10.5%, and 9.8% (p for trend = 0.21), those for myocardial infarction (MI) were 9.8%, 8.8%, and 10.0% (p for trend = 0.95), and those for repeat revascularization were 26.8%, 21.0%, and 17.2% (p for trend = 0.008). The 1-year adjusted hazard ratios of adverse events in patients with PAD using the early BMS era as the reference were 0.84 for death in the BMS era (95% confidence interval [CI] 0.46 to 1.55, p = 0.58) and 1.35 in the DES era (95% CI 0.71 to 2.56, p = 0.36), 0.89 for MI in the BMS era (95% CI 0.48 to 1.66, p = 0.72) and 1.02 in the DES era (95% CI 0.55 to 1.87, p = 0.95), and 0.63 for repeat revascularization in the BMS era (95% CI 0.41 to 0.97, p = 0.04) and 0.46 in the DES era (95% CI 0.29 to 0.73, p = 0.001). In conclusion, despite significant improvements in medical therapy and a decrease in repeat revascularization over time, patients with PAD who undergo PCI have a persistent high rate of death and MI. Copyright © 2011 Elsevier Inc. All rights reserved.

Polymer-Free Drug-Coated Coronary Stents Are Cost-Effective in Patients at High Bleeding Risk: Economic Evaluation of the LEADERS FREE Trial.

PubMed

Filipovic-Pierucci, Antoine; Durand-Zaleski, Isabelle; Butel, Thibault; Greene, Samantha; Hovasse, Thomas; Iñiguez, Andres; Nazzaro, Marco Stefano; Oldroyd, Keith G; Talwar, Suneel; Richardt, Gert; Windhovel, Ute; Urban, Philip; Morice, Marie-Claude

2018-02-20

In patients at high risk of bleeding who undergo PCI the biolimus A9 polymer-free drug coated stent (DCS) has superior efficacy and safety compared to a bare metal stent (BMS). We estimated the cost effectiveness of DCS vs. BMS. The Leaders FREE-based economic evaluation estimated service use and quality of life data collected prospectively. The entire trial population was analysed using cost-weights from England, France, Germany, Italy, Scotland and Spain. Country-specific QALYs were derived from EQ-5D scores. We estimated cost per event averted and per QALY gained. DCS use resulted in -0.095 cardiac deaths, target vessel MI, stent thrombosis and revascularization per patient (0.152 vs. 0.237;p<0.001). One-year QALYs were non-significantly higher in the DCS group. Total costs for the index admission were similar between groups. One-year costs using cost-weights from each of the 6 countries, including the additional €300 per DCS stent, ranged from €4,664-8,593 for DCS and €4,845-9,742 for BMS and were lower in the DCS group (England:€-428, France:€-137, Germany:€-33, Italy:€-522, Scotland:€-298, Spain:€-854). The probability that DCS dominated BMS was >50% in all countries. At a threshold of €10,000 per event averted DCS had a 98% probability of being cost-effective in all 6 countries.

Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study.

PubMed

Nakamura, M; Yock, P G; Bonneau, H N; Kitamura, K; Aizawa, T; Tamai, H; Fitzgerald, P J; Honda, Y

2001-05-01

Vessel remodeling is an important mechanism of late lumen loss after nonstent coronary interventions. However, its impact on in-stent restenosis has not been systematically investigated. Serial volumetric intravascular ultrasound analyses (poststent and follow-up) were performed in 55 lesions treated with a balloon-expandable stent (ACS MultiLink) using standard stent deployment techniques. The vessel volume (VV), lumen volume (LV), and volume bordered by the stent (SV) were measured using Simpson's method. The volume of plaque and neointima outside the stent (peri-stent volume, PSV) and volume of neointima within the stent (intrastent volume) were also measured. The change of each parameter during the follow-up period (follow-up minus poststent) was calculated and then divided by SV to normalize these values (designated as percent change [%]). As expected, %PSV directly correlated with %VV (P<0.0001, r=0.935), with no significant SV. A highly significant inverse correlation was seen between %PSV and the percent change of intrastent volume (P<0.0001, r=0.517). Consequently, %LV significantly correlated with peri-stent remodeling, as measured by %VV (P<0.0001, r=0.602). Positive remodeling of the vessel exterior to a coronary stent occurs to a variable degree after stent implantation. There is a distinct trade-off between positive remodeling and in-stent hyperplasia: in segments in which the degree of peri-stent remodeling is less, intrastent neointimal proliferation is greater and accompanied by more significant late lumen loss.

Cardiac surgery or interventional cardiology? Why not both? Let's go hybrid.

PubMed

Papakonstantinou, Nikolaos A; Baikoussis, Nikolaos G; Dedeilias, Panagiotis; Argiriou, Michalis; Charitos, Christos

2017-01-01

A hybrid strategy, firstly performed in the 1990s, is a combination of tools available only in the catheterization laboratory with those available only in the operating room in order to minimize surgical morbidity and face with any cardiovascular lesion. The continuous evolution of stent technology along with the adoption of minimally invasive surgical approaches, make hybrid approaches an attractive alternative to standard surgical or transcatheter techniques for any given set of cardiovascular lesions. Examples include hybrid coronary revascularization, when an open surgical anastomosis of the left internal mammary artery to the left anterior descending coronary artery is performed along with stent implantation in non-left anterior descending coronary vessels, open heart valve surgery combined with percutaneous coronary interventions to coronary lesions, hybrid aortic arch debranching combined with endovascular grafting for thoracic aortic aneurysms, hybrid endocardial and epicardial atrial fibrillation procedures, and carotid artery stenting along with coronary artery bypass grafting. The cornerstone of success for all of these methods is the productive collaboration between cardiac surgeons and interventional cardiologists. The indications and patient selection of these procedures are still to be defined. However, high-risk patients have already been shown to benefit from hybrid approaches. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Systemic inflammatory response syndromes in the era of interventional cardiology.

PubMed

Gorla, Riccardo; Erbel, Raimund; Eagle, Kim A; Bossone, Eduardo

2018-04-12

Systemic inflammatory response syndrome (SIRS), initially reported after cardiovascular surgery, has been described after various interventional cardiology procedures, including endovascular/thoracic aortic repair (EVAR/TEVAR), implantation of heart rhythm devices, percutaneous coronary intervention (PCI), electrophysiology procedures (EP), and transcatheter aortic valve implantation (TAVI). In these settings, a comprehensive understanding of the triggers, pathogenesis as well as a common diagnostic/therapeutic algorithm is lacking and will be discussed in this review. SIRS occurs in about 40% and 50% of patients undergoing TEVAR/EVAR and TAVI respectively; it affects 0.1% of patients undergoing implantation of heart rhythm devices. Prevalence is unknown after PCI or EP. Clinical presentation includes fever, dyspnoea/tachypnoea, tachycardia, weakness, chest pain and pericardial/pleural effusion. Several triggers can be identified, related to implanted devices, biomaterial, and procedural aspects (prolonged hypotension, aneurysm thrombus manipulation, active fixation atrial leads, coronary microembolization, balloon dilatation/stent implantantation, contrast medium, coronary/myocardial microperforation). Nonetheless, these triggers share three main pathogenic pathways leading to SIRS clinical manifestations: leucocytes activation, endothelial injury/activation, and myocardial/pericardial injury. Therapy consists of non-steroidal agents, with corticosteroids as second-line treatment in non-responders. Although a benign evolution is reported after implantation of heart rhythm devices, PCI and EP, major adverse events may occur after EVAR/TEVAR and TAVI at short- and mid-term follow up. Copyright © 2018 Elsevier Inc. All rights reserved.

Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions.

PubMed

Seto, Arnold H; Shroff, Adhir; Abu-Fadel, Mazen; Blankenship, James C; Boudoulas, Konstantinos Dean; Cigarroa, Joaquin E; Dehmer, Gregory J; Feldman, Dmitriy N; Kolansky, Daniel M; Lata, Kusum; Swaminathan, Rajesh V; Rao, Sunil V

2018-04-24

Since the publication of the 2009 SCAI Expert Consensus Document on Length of Stay Following percutaneous coronary intervention (PCI), advances in vascular access techniques, stent technology, and antiplatelet pharmacology have facilitated changes in discharge patterns following PCI. Additional clinical studies have demonstrated the safety of early and same day discharge in selected patients with uncomplicated PCI, while reimbursement policies have discouraged unnecessary hospitalization. This consensus update: (1) clarifies clinical and reimbursement definitions of discharge strategies, (2) reviews the technological advances and literature supporting reduced hospitalization duration and risk assessment, and (3) describes changes to the consensus recommendations on length of stay following PCI (Supporting Information Table S1). These recommendations are intended to support reasonable clinical decision making regarding postprocedure length of stay for a broad spectrum of patients undergoing PCI, rather than prescribing a specific period of observation for individual patients. © 2018 Wiley Periodicals, Inc.

Reduction of Late In-Stent Stenosis in a Porcine Coronary Artery Model by Cobalt Chromium Stents with a Nanocoat of Polyphosphazene (Polyzene-F)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stampfl, Ulrike; Sommer, Christof-Matthias; Thierjung, Heidi

2008-11-15

The purpose of this study was to investigate the potential of nanoscale coating with the highly biocompatible polymer Polyzene-F (PZF), in combination with cobalt chromium and stainless steel stents, to reduce in-stent stenosis, thrombogenicity, and vessel wall injury and inflammation. One bare cobalt chromium, PZF-nanocoated stainless steel or PZF-nanocoated cobalt chromium stent was implanted in right coronary artery of 30 mini-pigs (4- or 12-week follow-up). Primary study end points were in-stent stenosis and thrombogenicity. Secondary study end points were vessel wall injury and inflammation as evaluated by microscopy and a new immunoreactivity score applying C-reactive protein (CRP), tumor-necrosis factor alphamore » (TNF{alpha}), and TGF{beta}. At 12 weeks, angiography showed a significantly lower average loss in lumen diameter (2.1% {+-} 3.05%) in PZF-nanocoated cobalt chromium stents compared with stents in the other groups (9.73% {+-} 4.93% for bare cobalt chromium stents and 9.71% {+-} 7% for PZF-nanocoated stainless steel stents; p = 0.04), which was confirmed at microscopy (neointima 40.7 {+-} 16 {mu}m in PZF-nanocoated cobalt chromium stents, 74.7 {+-} 57.6 {mu}m in bare cobalt chromium stents, and 141.5 {+-} 109 {mu}m in PZF-nanocoated stainless steel stents; p = 0.04). Injury and inflammation scores were low in all stents and were without significant differences. PZF-nanocoated cobalt chromium stents provided the highest efficacy in reducing in-stent stenosis at long-term follow-up. The PZF nanocoat proved to be biocompatible with respect to thromboresistance and inflammation. Our data suggest that its combination with cobalt chromium stents might provide an interesting passive stent platform.« less

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

PubMed

Suwannasom, Pannipa; Sotomi, Yohei; Ishibashi, Yuki; Cavalcante, Rafael; Albuquerque, Felipe N; Macaya, Carlos; Ormiston, John A; Hill, Jonathan; Lang, Irene M; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; Tijssen, Jan G; Wykrzykowska, Joanna J; de Winter, Robbert J; Chevalier, Bernard; Serruys, Patrick W; Onuma, Yoshinobu

2016-06-27

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Friable but treatable: coronary artery dissections in Ehlers-Danlos syndrome.

PubMed

Zago, Alexandre C; Matte, Bruno S

2013-01-01

Vascular Ehlers-Danlos syndrome is a rare connective tissue disorder associated with arterial dissection or rupture. Percutaneous coronary intervention (PCI) is often critical in patients with this syndrome because their coronary arteries are prone to dissection, enhancing the risk of stent borders dissection when conventional stent deployment pressures are used. Coronary artery bypass graft (CABG) treatment for these patients may also raise concerns because the left internal mammary artery is probably friable. Therefore, coronary artery revascularization in vascular Ehlers-Danlos syndrome either using PCI or CABG is challenging due to the arteries friability. A small number of cases have been published describing the friability of the vessels and associated complications; nevertheless, the optimum treatment remains unclear. We report the case of a 54-year-old woman treated successfully with PCI and CABG in two different acute coronary syndrome episodes, in which specific technical issues related to both procedures were decisive. Copyright © 2011 Wiley Periodicals, Inc.

Impending rupture of saphenous vein graft aneurysm with floating fractured bare metal stent treated by coil embolization and covered stent implantation.

PubMed

Kodama, Atsuko; Kurita, Tairo; Kato, Osamu; Suzuki, Takahiko

2016-11-01

Aneurysmal degeneration of a saphenous vein graft (SVG) is a rare, but potentially fatal complication of coronary artery bypass graft (CABG) surgery. In this case report, a patient that had undergone prior CABG surgery and bare metal stent (BMS) implantation at the site of a stenotic SVG lesion presented at our hospital with chest pain, and an SVG aneurysm was detected at the previous BMS implantation site. In addition, the implanted BMS was fractured and floating in the SVG aneurysm. The SVG aneurysm was successfully occluded by percutaneous intervention, using a combination of distal covered stent deployment at the site of the anastomosis between the native coronary artery and the SVG and proximal coil embolization of the aneurysm.

Sex differences in left main coronary artery stenting: Different characteristics but similar outcomes for women compared with men.

PubMed

Shin, Eun-Seok; Lee, Cheol Whan; Ahn, Jung-Min; Lee, Pil Hyung; Chang, Mineok; Kim, Min-Ju; Yoon, Sung-Han; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

2018-02-15

The clinical outcomes for women compared with men undergoing left main PCI were sparse. We compared the characteristics and long-term outcomes in women versus men after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main CAD. We identified 2328 patients (545 women; 1783 men) with unprotected left main CAD who received PCI with DES between January 2007 and December 2013 in the Interventional Cardiology Research In-cooperation Society-left MAIN revascularization (IRIS-MAIN) registry. The primary outcome was a composite of death from any cause, myocardial infarction, or stroke. The median follow-up time was 2.9years (interquartile range: 1.0-4.1years). Women were older, had a higher incidence of insulin-requiring diabetes mellitus and hypertension, and more commonly presented with acute coronary syndrome than men. Left main ostial lesion was more common in women, whereas left main bifurcation lesion with more extensive CAD was more common in men. The incidence of primary outcome was similar between the two groups (10.8% vs. 10.8%, respectively, log-rank p=0.587). The results were similar after adjustment for baseline variables and consistent across major subgroups. The need for target lesion revascularization was significantly higher in women than in men (8.8% vs. 5.7%, respectively, p<0.05) but the sex bias was not confirmed after adjusting for confounders. Women, as compared to men, had different clinical and lesion characteristics but similar long-term outcomes after PCI with DES for left main CAD. Copyright © 2017 Elsevier B.V. All rights reserved.

75 FR 54493 - Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... catheters when used for treatment of acute myocardial infarction (MI), treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. III. Device Description FDA identifies this generic type of... for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post...

78 FR 53773 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

...] Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and... Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's...

Acute stent thrombosis after a "stroll for fresh air". A case of the smoking gun.

PubMed

Gotsman, I; Helman, Y; Planer, D

2013-02-01

We present a case of a patient who underwent a percutaneous coronary intervention and excused himself for some "fresh air". He subsequently developed acute stent thrombosis. We discuss the contribution of acute cigarette smoking to this serious complication after stent implantation.

Comparative Analysis of Sequential Proximal Optimizing Technique Versus Kissing Balloon Inflation Technique in Provisional Bifurcation Stenting: Fractal Coronary Bifurcation Bench Test.

PubMed

Finet, Gérard; Derimay, François; Motreff, Pascal; Guerin, Patrice; Pilet, Paul; Ohayon, Jacques; Darremont, Olivier; Rioufol, Gilles

2015-08-24

This study used a fractal bifurcation bench model to compare 6 optimization sequences for coronary bifurcation provisional stenting, including 1 novel sequence without kissing balloon inflation (KBI), comprising initial proximal optimizing technique (POT) + side-branch inflation (SBI) + final POT, called "re-POT." In provisional bifurcation stenting, KBI fails to improve the rate of major adverse cardiac events. Proximal geometric deformation increases the rate of in-stent restenosis and target lesion revascularization. A bifurcation bench model was used to compare KBI alone, KBI after POT, KBI with asymmetric inflation pressure after POT, and 2 sequences without KBI: initial POT plus SBI, and initial POT plus SBI with final POT (called "re-POT"). For each protocol, 5 stents were tested using 2 different drug-eluting stent designs: that is, a total of 60 tests. Compared with the classic KBI-only sequence and those associating POT with modified KBI, the re-POT sequence gave significantly (p < 0.05) better geometric results: it reduced SB ostium stent-strut obstruction from 23.2 ± 6.0% to 5.6 ± 8.3%, provided perfect proximal stent apposition with almost perfect circularity (ellipticity index reduced from 1.23 ± 0.02 to 1.04 ± 0.01), reduced proximal area overstretch from 24.2 ± 7.6% to 8.0 ± 0.4%, and reduced global strut malapposition from 40 ± 6.2% to 2.6 ± 1.4%. In comparison with 5 other techniques, the re-POT sequence significantly optimized the final result of provisional coronary bifurcation stenting, maintaining circular geometry while significantly reducing SB ostium strut obstruction and global strut malapposition. These experimental findings confirm that provisional stenting may be optimized more effectively without KBI using re-POT. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Experience with the use of the bio-active stent coated with titanium nitric oxide compared with zotarolimus-eluting stent: experience of a unit medical high specialty].

PubMed

Garcia-Gutierrez, Juan C; Palacios-Rodríguez, Juan M; Cordova-Correa, Horacio G; Becerra-Laguna, Carlos A; López-López, Hugo A; Salinas Aragón, Miguel A; García-Bonilla, Jorge

2016-01-01

The use of coronary stents in coronary angioplasty has evolved dramatically in its design, type materials, polymers, and a variety of drugs, the use of coronary stents covered nitric oxide have shown satisfactory results in practice, however compared to the results reported drug-eluting stents, there is little information. The aim of this study was to compare clinical outcomes of a stainless steel stent Bioactive nitric oxide coated titanium (BAS) and a drug-eluting stent zotarolimus (DES) in daily clinical practice. A retrospective, analytical, descriptive and comparative study aimed at evaluating the safety and efficacy of two devices with different characteristics in our population. The primary endpoints were: death, acute infarction (AMI), and re intervention injury Treated (RLT). A total of 759 patients were included in the study which was performed angioplasty to a single vessel. Were divided into two arms 382 with DES and 377 patients with BAS, the one year follow up was carried in 95%. After this follow-up period, primary points (cardiovascular death, myocardial infarction, TLR and stent thrombosis) for arm DES vs BAS; 9.5% vs 8.5% P=NS but with shorter periods of dual antiplatelet therapy for arm BAS 6.9±4.1 vs 11.1±2.5 months DES P=.0001. The results were independent of the clinical syndrome of presentation. After one year of follow no statistically significant difference in major clinical events, there was a trend in favour of BAS vs SM with respect to revascularization of the target lesion without reaching statistical significance. Copyright © 2015 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Magnetizable stent-grafts enable endothelial cell capture

NASA Astrophysics Data System (ADS)

Tefft, Brandon J.; Uthamaraj, Susheil; Harburn, J. Jonathan; Hlinomaz, Ota; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S.

2017-04-01

Emerging nanotechnologies have enabled the use of magnetic forces to guide the movement of magnetically-labeled cells, drugs, and other therapeutic agents. Endothelial cells labeled with superparamagnetic iron oxide nanoparticles (SPION) have previously been captured on the surface of magnetizable 2205 duplex stainless steel stents in a porcine coronary implantation model. Recently, we have coated these stents with electrospun polyurethane nanofibers to fabricate prototype stent-grafts. Facilitated endothelialization may help improve the healing of arteries treated with stent-grafts, reduce the risk of thrombosis and restenosis, and enable small-caliber applications. When placed in a SPION-labeled endothelial cell suspension in the presence of an external magnetic field, magnetized stent-grafts successfully captured cells to the surface regions adjacent to the stent struts. Implantation within the coronary circulation of pigs (n=13) followed immediately by SPION-labeled autologous endothelial cell delivery resulted in widely patent devices with a thin, uniform neointima and no signs of thrombosis or inflammation at 7 days. Furthermore, the magnetized stent-grafts successfully captured and retained SPION-labeled endothelial cells to select regions adjacent to stent struts and between stent struts, whereas the non-magnetized control stent-grafts did not. Early results with these prototype devices are encouraging and further refinements will be necessary in order to achieve more uniform cell capture and complete endothelialization. Once optimized, this approach may lead to more rapid and complete healing of vascular stent-grafts with a concomitant improvement in long-term device performance.

A novel sax-stent method in treatment of ascending aorta and aortic arch aneurysms evaluated by finite element simulations.

PubMed

Arokiaraj, M C; De Beule, M; De Santis, G

2017-02-01

A novel stent method to simplify treatment of proximal ascending aorta and aortic arch aneurysms was developed and investigated by finite element analysis. Therapy of ascending aortic and aortic arch aneurysms is difficult and challenging and is associated with various complications. A 55mm wide×120mm long stent was designed without the stent graft and the stent was deployed by an endovascular method in a virtual patient-specific aneurysm model. The stress-strain analysis and deployment characteristics were performed in a finite element analysis using the Abaqus software. The stent, when embedded in the aortic wall, significantly reduced aortic wall stresses, while preserving the side coronary ostia and side branches in the aortic arch. When tissue growth was modeled computationally over the stent struts the wall stresses in aorta was reduced. This effect became more pronounced when increasing the thickness of the tissue growth. There were no abnormal stresses in the aorta, coronary ostium and at the origin of aortic branches. The stent reduced aneurysm expansion cause by hypertensive condition from 2mm without stenting to 1.3mm after stenting and embedding. In summary, we uncovered a simple treatment method using a bare nitinol stent without stent graft in the treatment of the proximal aorta and aortic arch aneurysms, which could eventually replace the complex treatment methods for this disease. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Magnetizable stent-grafts enable endothelial cell capture.

PubMed

Tefft, Brandon J; Uthamaraj, Susheil; Harburn, J Jonathan; Hlinomaz, Ota; Lerman, Amir; Dragomir-Daescu, Dan; Sandhu, Gurpreet S

2017-04-01

Emerging nanotechnologies have enabled the use of magnetic forces to guide the movement of magnetically-labeled cells, drugs, and other therapeutic agents. Endothelial cells labeled with superparamagnetic iron oxide nanoparticles (SPION) have previously been captured on the surface of magnetizable 2205 duplex stainless steel stents in a porcine coronary implantation model. Recently, we have coated these stents with electrospun polyurethane nanofibers to fabricate prototype stent-grafts. Facilitated endothelialization may help improve the healing of arteries treated with stent-grafts, reduce the risk of thrombosis and restenosis, and enable small-caliber applications. When placed in a SPION-labeled endothelial cell suspension in the presence of an external magnetic field, magnetized stent-grafts successfully captured cells to the surface regions adjacent to the stent struts. Implantation within the coronary circulation of pigs (n=13) followed immediately by SPION-labeled autologous endothelial cell delivery resulted in widely patent devices with a thin, uniform neointima and no signs of thrombosis or inflammation at 7 days. Furthermore, the magnetized stent-grafts successfully captured and retained SPION-labeled endothelial cells to select regions adjacent to stent struts and between stent struts, whereas the non-magnetized control stent-grafts did not. Early results with these prototype devices are encouraging and further refinements will be necessary in order to achieve more uniform cell capture and complete endothelialization. Once optimized, this approach may lead to more rapid and complete healing of vascular stent-grafts with a concomitant improvement in long-term device performance.

Fenestration of a Papyrus PK covered stent to recover the occluded left main bifurcation after sealing a left main perforation during a CTO procedure.

PubMed

Werner, Gerald S; Ahmed, Waqar H

2017-09-01

Covered stents are indicated for coronary perforations, but they may seal off major side branches in that process. We report the successful sealing of an ostial left main perforation, induced by a guide catheter in the course of a retrograde approach to treat a chronic total occlusion (CTO) of the right coronary artery (RCA) in a 76year old woman with prior CABG. The implanted Papyrus covered stent, however, overlapped the left main bifurcation and occluded the non-grafted circumflex artery (CX) resulting in acute ischemia. Through a double lumen catheter advanced over the wire located in the left anterior descending coronary artery (LAD) territory, a stiff recanalization wire could be advanced from the side-port to penetrate the stent membrane towards the CX. This was successfully achieved, and after subsequent dilatation, a drug-eluting stent was implanted in Culotte-fashion from the CX to the left main with subsequent kissing-balloon dilatation. The clinical symptoms subsided immediately, and the RCA was finally recanalized in antegrade parallel wire technique. No periprocedural infarct was observed during 48h of follow-up before discharge. At clinical follow-up of 6months the patient is symptom-free. Copyright © 2017 Elsevier Inc. All rights reserved.

Costs and clinical outcomes for non-invasive versus invasive diagnostic approaches to patients with suspected in-stent restenosis.

PubMed

Min, James K; Hasegawa, James T; Machacz, Susanne F; O'Day, Ken

2016-02-01

This study compared costs and clinical outcomes of invasive versus non-invasive diagnostic evaluations for patients with suspected in-stent restenosis (ISR) after percutaneous coronary intervention. We developed a decision model to compare 2 year diagnosis-related costs for patients who presented with suspected ISR and were evaluated by: (1) invasive coronary angiography (ICA); (2) non-invasive stress testing strategy of myocardial perfusion imaging (MPI) with referral to ICA based on MPI; (3) coronary CT angiography-based testing strategy with referral to ICA based on CCTA. Costs were modeled from the payer's perspective using 2014 Medicare rates. 56 % of patients underwent follow-up diagnostic testing over 2 years. Compared to ICA, MPI (98.6 %) and CCTA (98.1 %) exhibited lower rates of correct diagnoses. Non-invasive strategies were associated with reduced referrals to ICA and costs compared to an ICA-based strategy, with diagnostic costs lower for CCTA than MPI. Overall 2-year costs were highest for ICA for both metallic as well as BVS stents ($1656 and $1656, respectively) when compared to MPI ($1444 and $1411) and CCTA. CCTA costs differed based upon stent size and type, and were highest for metallic stents >3.0 mm followed by metallic stents <3.0 mm, BVS < 3.0 mm and BVS > 3.0 mm ($1466 vs. $1242 vs. $855 vs. $490, respectively). MPI for suspected ISR results in lower costs and rates of complications than invasive strategies using ICA while maintaining high diagnostic performance. Depending upon stent size and type, CCTA results in lower costs than MPI.

A systematic review of the quality of economic models comparing thrombosis inhibitors in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

PubMed

Hatz, Maximilian H M; Leidl, Reiner; Yates, Nichola A; Stollenwerk, Björn

2014-04-01

Thrombosis inhibitors can be used to treat acute coronary syndromes (ACS). However, there are various alternative treatment strategies, of which some have been compared using health economic decision models. To assess the quality of health economic decision models comparing thrombosis inhibitors in patients with ACS undergoing percutaneous coronary intervention, and to identify areas for quality improvement. The literature databases MEDLINE, EMBASE, EconLit, National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). A review of the quality of health economic decision models was conducted by two independent reviewers, using the Philips checklist. Twenty-one relevant studies were identified. Differences were apparent regarding the model type (six decision trees, four Markov models, eight combinations, three undefined models), the model structure (types of events, Markov states) and the incorporation of data (efficacy, cost and utility data). Critical issues were the absence of particular events (e.g. thrombocytopenia, stroke) and questionable usage of utility values within some studies. As we restricted our search to health economic decision models comparing thrombosis inhibitors, interesting aspects related to the quality of studies of adjacent medical areas that compared stents or procedures could have been missed. This review identified areas where recommendations are indicated regarding the quality of future ACS decision models. For example, all critical events and relevant treatment options should be included. Models also need to allow for changing event probabilities to correctly reflect ACS and to incorporate appropriate, age-specific utility values and decrements when conducting cost-utility analyses.

Comparing treatment outcomes of fractional flow reserve-guided and angiography-guided percutaneous coronary intervention in patients with multi-vessel coronary artery diseases: a systematic review and meta-analysis.

PubMed

Xiu, Jiancheng; Chen, Gangbin; Zheng, Hua; Wang, Yuegang; Chen, Haibin; Liu, Xuewei; Wu, Juefei; Bin, Jianping

2016-02-01

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is used to assess the need for angioplasty in vessels with intermediate blockages. The treatment outcomes of FFR-guided vs. conventional angiography-guided PCI were evaluated in patients with multi-vessel coronary artery disease (CAD). Prospective and retrospective studies comparing FFR-guided vs. angiography-guided PCI in patients with multi-vessel CAD were identified from medical databases by two independent reviewers using the terms "percutaneous coronary intervention, fractional flow reserve, angiography, coronary heart disease, major adverse cardiac events (MACE) and myocardial infarction". The primary outcome was the number of stents placed, and the secondary outcomes were procedure time, mortality, myocardial infarction (MI) and MACE rates. Seven studies (three retrospective and four prospective), which included 49,517 patients, were included in this review. A total of 4,755 patients underwent FFR, while 44,697 received angiography-guided PCI. The mean patient age ranged from 58 to 71.7 years. The average number of stents used in FFR patients ranged from 0.3-1.9, and in angiography-guided PCI patients ranged from 0.7-2.7. Analysis indicated there was a greater number of stents placed in the angiography-guided group compared with the FFR group (pooled difference in means: -0.64, 95% confidence interval [CI]: -0.81 to -0.47, P < 0.001). There were no differences in the secondary outcomes between the two groups. Both procedures produce similar clinical outcomes, but the fewer number of stents used with FFR may have clinical as was as cost implications.

The C4280A (rs5705) gene polymorphism of the renin (REN) gene is associated with risk of developing coronary artery disease, but not with restenosis after coronary stenting.

PubMed

Fragoso, Jose Manuel; Alvarez-León, Edith; Delgadillo-Rodríguez, Hilda; Arellano-González, Marva; López-Pacheco, Filogonio Caín; Cruz-Robles, David; Peña-Duque, Marco Antonio; Pérez-Méndez, Oscar; Martínez-Ríos, Marco Antonio; Vargas-Alarcón, Gilberto

2015-08-01

The aim of the present study was to evaluate the role of AGT and REN gene polymorphisms as susceptibility markers for coronary artery disease (CAD) and/or restenosis after coronary stent placement in a group of Mexican patients. Five polymorphisms of the AGT (rs699, rs4762, rs5051, rs5049, rs5046) and two of the REN (rs5707, rs5705) genes were analyzed by 5' exonuclease TaqMan genotyping assays in 240 patients with CAD who underwent coronary artery stenting (76 with restenosis and 164 without restenosis). A group of 610 individuals without clinical and familial antecedents of cardiovascular diseases were included as controls. The results showed that the distribution of AGT and REN polymorphisms were similar in patients with and without restenosis. However, when the whole group of patients (with and without restenosis) was compared to healthy controls, under co-dominant, dominant, heterozygous and additive models, the REN A4280C (rs5705) polymorphism was associated with increased risk of CAD (OR=1.76, PCo-dom=0.006, OR=1.81, PDom=0.001, OR=1.75, PHet=0.003 and OR=1.59, PAdd=0.003, respectively). All models were adjusted for age, gender, diabetes, dyslipidemia, hypertension and smoking habit. The TC haplotype of the REN gene was associated with increased risk of CAD (OR=1.53, P=0.014). The data suggest that the REN C4280A (rs5705) polymorphism plays an important role in the risk of developing CAD with the highest risk for C allele, but do not support its role as a risk factor for developing restenosis after coronary stenting. Copyright © 2015. Published by Elsevier Inc.

Significant differences between vascular and nonvascular surgeons in the perioperative management of antiplatelet therapies in patients with coronary stents.

PubMed

Kilic, Arman; Sultan, Ibrahim S; Arnaoutakis, George J; Black, James H; Reifsnyder, Thomas

2015-04-01

An increasing number of patients undergoing noncardiac surgery have coronary stents. Although guidelines regarding perioperative management of antiplatelet therapies in this patient population exist, practice patterns remain incompletely understood. This study evaluated these practice patterns, with particular attention to differences in management between vascular and nonvascular surgeons. A link to a 16-question survey was displayed in the American College of Surgeons (ACS) electronic newsletter NewsScope, which is posted on the ACS Web site. Questions were focused on perioperative management of antiplatelets (aspirin, clopidogrel) for bare-metal (BMS; placed within 2 months) and drug-eluting stents (DES; placed within the past year) during low- and high-risk bleeding procedures, assuming a patient with no other confounding medical issues. Primary stratification was by surgeon specialty. A total of 244 surgical providers responded to the survey, of which 40 (17%) were vascular surgeons. The majority of respondents were attending surgeons in practice for at least 10 years (79%, n = 190). A significantly higher percentage of vascular versus nonvascular surgeons would not stop aspirin preoperatively in low bleeding risk procedures (BMS: 90% vs. 54%, P = 0.001; DES: 88% vs. 58%, P = 0.009). A higher percentage of vascular surgeons would not stop aspirin preoperatively in high bleeding risk procedures as well (BMS: 70% vs. 28%, P < 0.001; DES: 78% vs. 32%, P < 0.001). Most vascular surgeons would not stop clopidogrel in a low-risk BMS patient (53% vs. 21% of nonvascular surgeons, P = 0.001). Similar findings with clopidogrel were observed in low- (would not stop: 65% vascular versus 30% nonvascular, P < 0.001) and high-risk DES patients (would not stop: 30% vascular versus 8% nonvascular, P = 0.001). The same trends were observed in resuming antiplatelets in the postoperative period. The majority of respondents were not familiar with professional guidelines regarding perioperative antiplatelet management (52%, n = 128), with no differences between vascular and nonvascular surgeons (45% vs. 54%, P = 0.30). This national survey demonstrates significant variation in perioperative antiplatelet management in patients with coronary stents, with marked differences between vascular and nonvascular surgeons. More effective communication of existing guidelines or the development of new specialty-specific professional guidelines appears prudent in reducing this variability in practice. Copyright © 2015 Elsevier Inc. All rights reserved.

Early clinical outcomes of primary percutaneous coronary intervention in bharatpur, Nepal.

PubMed

Dubey, Laxman; Bhattacharya, Rabindra; Guruprasad, Sogunuu; Subramanyam, Gangapatnam

2013-06-01

Primary percutaneous coronary intervention represents one of the cornerstone management modalities for patients with acute ST-elevation myocardial infarction and has undergone tremendous growth over the past two decades. This study was aimed to determine the early clinical outcomes of primary percutaneous coronary interventions in a tertiary-level teaching hospital without onsite cardiac surgery backup. This was a prospective descriptive study which included all consecutive patients who were admitted for primary percutaneous coronary interventions between March 2011 and January 2013 at the College of Medical Sciences and Teaching Hospital, Bharatpur, Nepal. Total 68 patients underwent primary percutaneous coronary interventions as a mode of revascularization. The primary end point of the study was to identify in-hospital as well as 30-day clinical outcomes of primary percutaneous coronary interventions. The mean age was 56.31 ± 11.47 years, with age range of 32 years to 91 years. Of the 68 primary percutaneous coronary interventions performed, 15 (22.05%) were carried out in women and 10 (14.70%) in patients over 75 years of age. Primary percutaneous coronary intervention for anterior wall myocardial infarction was more common than for non-anterior wall myocardial infarction (55.88% vs. 44.12%). Proximal artery stenting was performed in 38.50% and the non proximal artery stenting in 61.50%. The outcomes were mortality (5.88%), cardiogenic shock (5.88%), contrast-induced nephropathy requiring dialysis (2.94%), arrhythmias requiring treatment (4.41%), early stent thrombosis (2.94%) and minor complications (14.70%). Primary percutaneous coronary intervention improves the early clinical outcomes in patient with acute ST-elevation myocardial infarction. Despite having no onsite cardiac surgery backup, primary percutaneous coronary intervention was feasible with acceptable complications in a tertiary-care teaching hospital.

Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study).

PubMed

Madder, Ryan D; VanOosterhout, Stacie M; Jacoby, Mark E; Collins, J Stewart; Borgman, Andrew S; Mulder, Abbey N; Elmore, Matthew A; Campbell, Jessica L; McNamara, Richard F; Wohns, David H

2017-01-20

The present study explores the feasibility of telestenting, wherein a physician operator performs stenting on a patient in a separate physical location using a combination of robotics and telecommunications. Patients undergoing robotic stenting were eligible for inclusion. All manipulations of guidewires, balloons, and stents were performed robotically by a physician operator located in an isolated separate room outside the procedure room housing the patient. Communication between the operating physician and laboratory personnel was via telecommunication devices providing real-time audio and video connectivity. Among 20 patients who consented to participate, technical success, defined as successful advancement and retraction of guidewires, balloons, and stents by the robotic system without conversion to manual operation, was achieved in 19 of 22 lesions (86.4%). Procedural success, defined as <30% residual stenosis upon completion of the procedure in the absence of death or repeat revascularisation prior to hospital discharge, was achieved in 19 of 20 patients (95.0%). There were no deaths or repeat revascularisations prior to hospital discharge. To the best of our knowledge, the present study is the first to explore the feasibility of telestenting. Additional studies are required to determine if future advancements in robotics will facilitate telestenting over greater geographic distances.

Iliac artery stenting in patients with poor distal runoff: Influence of concomitant infrainguinal arterial reconstruction.

PubMed

Timaran, Carlos H; Ohki, Takao; Gargiulo, Nicholas J; Veith, Frank J; Stevens, Scott L; Freeman, Michael B; Goldman, Mitchell H

2003-09-01

Inadequate infrainguinal runoff is considered an important risk factor for iliac stent failure. However, the influence of concomitant infrainguinal arterial reconstruction (CIAR) on iliac stent patency is unknown. This study evaluated the influence of CIAR on outcome of iliac angioplasty and stenting (IAS) in patients with poor distal runoff. Over 5 years (1996 to 2001), 68 IAS procedures (78 stents) were performed in 62 patients with poor distal runoff (angiographic runoff score >or=5). The SVS/AAVS reporting standards were followed to define outcome variables and risk factors. Data were analyzed with both univariate analysis (Kaplan-Meier method [K-M]) and regression analysis (Cox proportional hazards model). Indications for iliac artery stenting were disabling claudication (59%) and limb salvage (41%). Of the 68 procedures, IAS with CIAR was performed in 31 patients (46%), and IAS alone was performed in 37 patients (54%). Patients undergoing IAS with CIAR were older (P =.03) and had more extensive and multifocal iliac artery occlusive disease, with more TASC (TransAtlantic Inter-Society Consensus) type C lesions (P =.03), compared with patients undergoing IAS alone. No other significant differences in risk factors were noted. Runoff scores between patients undergoing IAS with CIAR and those undergoing IAS alone were not significantly different (median runoff scores, 6 [range, 5-8] and 7 [range, 5-9], respectively; P =.77). Primary stent patency rate at 1, 3, and 5 years was 87%, 54%, and 42%, respectively, for patients undergoing IAS with CIAR, and was 76%, 66%, and 55%, respectively, for patients undergoing IAS. Univariate analysis revealed that primary stent patency rate was not significantly different between the 2 groups (K-M, log-rank test, P =.81). Primary graft patency rate for CIAR was 81%, 52%, and 46% at 1, 3, and 5 years, respectively. Performing CIAR did not affect primary iliac stent patency (relative risk, 1.1; 95% confidence interval, 0.49-2.47; P =.81). Overall, there was a trend toward improved limb salvage in patients undergoing IAS with CIAR, compared with those undergoing IAS alone (K-M, log rank test, P =.07). In patients undergoing IAS with poor distal runoff, CIAR does not improve iliac artery stent patency. Infrainguinal bypass procedures should therefore be reserved for patients who do not demonstrate clinical improvement and possibly for those with limb-threatening ischemia.

Therapeutic strategies after coronary stenting in chronically anticoagulated patients: the MUSICA study.

PubMed

Sambola, A; Ferreira-González, I; Angel, J; Alfonso, F; Maristany, J; Rodríguez, O; Bueno, H; López-Minguez, J R; Zueco, J; Fernández-Avilés, F; San Román, A; Prendergast, B; Mainar, V; García-Dorado, D; Tornos, P

2009-09-01

To identify the therapeutic regimens used at discharge in patients receiving oral anticoagulant therapy (OAT) who undergo stenting percutaneous coronary intervention and stent implantation (PCI-S), and to assess the safety and efficacy associated with different therapeutic regimens according to thromboembolic risk. A prospective multicentre registry. In hospital, after discharge and follow-up by telephone call. 405 patients (328 male/77 female; mean (SD) age 71 (9) years) receiving OAT who underwent PCI-S between November 2003 and June 2006 from nine catheterisation laboratories of tertiary care teaching hospitals in Spain and one in the United Kingdom were included. Three therapeutic regimens were identified at discharge: triple therapy (TT) -- that is, any anticoagulant (AC) plus double antiplatelet therapy (DAT; 278 patients (68.6%); AC and a single antiplatelet (AC+AT; 46 (11.4%)) and DAT only (81 (20%)). At 6 months, patients receiving TT showed the greatest rate of bleeding events. No patients receiving DAT at low thromboembolic risk presented a bleeding event (14.8% receiving TT, 11.8% receiving AC+AT and 0% receiving DAT, p = 0.033) or cardiovascular event (6.7% receiving TT, 0% receiving AC+AT and 0% receiving DAT, p = 0.126). The combination of AC+AT showed the worst rate of adverse events in the whole cohort, especially in patients at moderate-high thromboembolic risk. In patients receiving OAT, TT was the most commonly used regimen after PCI-S. DAT was associated with the lowest rate of bleeding events and a similar efficacy to TT in patients at low thromboembolic risk. TT should probably be restricted to patients at moderate-high thromboembolic risk.

Clinical Outcomes of Patients Undergoing Rotational Atherectomy Followed by Drug-eluting Stent Implantation: A Single-center Real-world Experience

PubMed Central

Cuenza, Lucky R.; Jayme, Ada Cherryl; Khe Sui, James Ho

2017-01-01

Background: Rotational atherectomy (RA) is used to improve procedural success of percutaneous catheter interventions (PCIs) of complex and heavily calcified coronary lesions. We report the clinical experience and outcomes in our institution with the use of RA, followed by drug-eluting stent implantation. Materials and Methods: Data of 81 patients treated with PCI and adjunctive RA were analyzed. Clinical follow-up for the occurrence of major adverse events (MAEs) was obtained in all patients and correlated with significant variables using multivariate Cox proportional hazards analysis. Results: Mean age was 67.9 ± 9.2 years, 61.7% had diabetes, 20.9% had chronic kidney disease, and 48.1% had previous acute coronary syndrome (ACS). Mean SYNTAX score was 29.8 ± 12.2, with a 92.5% angiographic success rate achieved. In-hospital MAEs rate was 7.4% while mortality rate was 8.6%. On median follow-up of 12.2 months, incidence of MAEs of 13.5% with a 75% free incidence from MAEs at 34 months. Multivariate analysis revealed that a history of previous ACS, ejection fraction, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, SYNTAX score, burr to artery ratio, and attainment of angiographic success were significant predictors of MAEs. Conclusion: RA followed by drug-eluting stent implantation is a safe and effective method in improving procedural success as well as short- and long-term outcomes of PCI in our center. A combination of clinical and procedural factors is predictive for the occurrence of MAEs and should be taken into account in the application of this technique. PMID:29326773

Prevalence and impact of high platelet reactivity in chronic kidney disease: results from the Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents registry.

PubMed

Baber, Usman; Mehran, Roxana; Kirtane, Ajay J; Gurbel, Paul A; Christodoulidis, Georgios; Maehara, Akiko; Witzenbichler, Bernhard; Weisz, Giora; Rinaldi, Michael J; Metzger, D Christopher; Henry, Timothy D; Cox, David A; Duffy, Peter L; Mazzaferri, Ernest L; Xu, Ke; Parise, Helen; Brodie, Bruce R; Stuckey, Thomas D; Stone, Gregg W

2015-06-01

Chronic kidney disease (CKD) is associated with increased rates of adverse events after percutaneous coronary intervention. We sought to determine the impact of CKD on platelet reactivity in clopidogrel-treated patients and whether high platelet reactivity (HPR) confers a similar or differential risk for adverse events among patients with CKD and non-CKD. We performed a post hoc analysis of the Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents (ADAPT-DES) registry, which included 8582 patients undergoing percutaneous coronary intervention with drug-eluting stents and platelet function testing using the VerifyNow assay. We compared HPR and its impact on ischemic and bleeding events >2 years among patients with CKD and non-CKD. Patients with CKD (n=1367) were older, more often female, diabetic, and had lower ejection fraction compared with their non-CKD counterparts (n=7043). Although HPR prevalence increased with worsening renal function in unadjusted analyses, these associations were no longer present after adjustment. Major adverse cardiac event rates at 2 years among those without CKD or HPR, HPR alone, CKD alone, and both CKD and HPR were 9.0%, 11.2%, 13.3%, and 17.5%, respectively (P<0.001). Associations between HPR and adverse events were uniform across CKD strata without evidence of interaction. HPR is more common among those with versus without CKD, an association that is attributable to confounding risk factors that are more prevalent in CKD. The impact of HPR on ischemic and bleeding events is similar irrespective of CKD status. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00638794. © 2015 American Heart Association, Inc.

Pharmacodynamic effects of a new fixed-dose clopidogrel-aspirin combination compared with separate administration of clopidogrel and aspirin in patients treated with coronary stents: The ACCEL-COMBO trial.

PubMed

Koh, Jin-Sin; Park, Yongwhi; Tantry, Udaya S; Ahn, Jong-Hwa; Kang, Min Gyu; Kim, Kyehwan; Jang, Jeong Yoon; Park, Hyun Woong; Park, Jeong Rang; Hwang, Seok-Jae; Kwak, Choong Hwan; Hwang, Jin-Yong; Gurbel, Paul A; Jeong, Young-Hoon

2017-03-01

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is a widely prescribed regimen to prevent ischemic events in patients undergoing percutaneous coronary intervention (PCI). A fixed-dose combination (FDC) capsule (HCP0911) has been developed to provide dosing convenience and improve adherence. We compared the antiplatelet effects of single daily dose HCP0911 with separate treatment with daily 75 mg clopidogrel plus 100 mg aspirin. This was a randomized, open-label, two-period, crossover, non-inferiority study conducted in stented patients who had been treated for at least 6 months with clopidogrel and aspirin. Thirty patients were randomly assigned to receive either daily 75 mg clopidogrel plus 100 mg aspirin treatment or HCP0911 for 2 weeks and then were crossed over to the other treatment for 2 weeks. Pharmacodynamic effects were measured with VerifyNow, light transmittance aggregometry (LTA), and thromboelastography (TEG ® ). The primary endpoint was P2Y12 Reaction Units (PRU) measured by VerifyNow. PRUs during treatment with HCP0911 were not inferior to those during separate treatment (202 ± 52 vs. 207 ± 60 PRU; mean difference, -5 PRU; 90% confidence interval of difference, -23 to 13 PRU; P for non-inferiority = 0.015 for predetermined limit). "BASE" and Aspirin Reaction Units by VerifyNow did not differ between the two treatments. During each treatment, there were no differences in maximal and final platelet aggregations by LTA (all P values ≥0.822) and TEG ® measurements. In conclusion, in stented patients, the antiplatelet effect of a fixed-dose clopidogrel-aspirin combination, HCP0911, was not inferior to separate administration of clopidogrel and aspirin.

Oxygen Mass Transport in Stented Coronary Arteries.

PubMed

Murphy, Eoin A; Dunne, Adrian S; Martin, David M; Boyle, Fergal J

2016-02-01

Oxygen deficiency, known as hypoxia, in arterial walls has been linked to increased intimal hyperplasia, which is the main adverse biological process causing in-stent restenosis. Stent implantation has significant effects on the oxygen transport into the arterial wall. Elucidating these effects is critical to optimizing future stent designs. In this study the most advanced oxygen transport model developed to date was assessed in two test cases and used to compare three coronary stent designs. Additionally, the predicted results from four simplified blood oxygen transport models are compared in the two test cases. The advanced model showed good agreement with experimental measurements within the mass-transfer boundary layer and at the luminal surface; however, more work is needed in predicting the oxygen transport within the arterial wall. Simplifying the oxygen transport model within the blood flow produces significant errors in predicting the oxygen transport in arteries. This study can be used as a guide for all future numerical studies in this area and the advanced model could provide a powerful tool in aiding design of stents and other cardiovascular devices.

Percutaneous Transluminal Cerebral Angioplasty and Stenting in Acute Vertebrobasilar Ischemic Stroke

PubMed Central

Nistri, M.; Mangiafico, S.; Cellerini, M.; Villa, G.; Mennonna, P.; Ammannati, F.; Giordano, G. P.

2002-01-01

Summary Reports of cerebral transluminal angioplasty and stenting in patients with vertebrobasilar ischemic stroke are scanty. Herein we report on the use of “monorail” coronary balloon angioplasty and stent balloon mounted catheters in two patients with acute vertebrobasilar ischemic stroke, focussing on the differences and possible advantages of the “monorail” technique in comparison with the “over-the-wire” technique. In both patients, the clinical picture was characterized by progressive brainstem symptoms followed by acute loss of consciousness related to an atherothrombotic occlusion and subocclusion of the dominant intracranial vertebral artery, respectively. In one patient, superselective thrombolytic therapy and balloon angioplasty resulted in a dissection flap at the vertebrobasilar junction. The latter was treated by successful deployment of a coronary stent. In the other patient, the subocclusive lesion was directly treated by angioplasty and stenting without thrombolytic therapy. The clinical outcome was poor for one patient (“locked in” syndrome) while the other had a complete clinical recovery. In acute atherothrombotic vertebrobasilar stroke transluminal cerebral angioplasty and stenting may be successfully performed allowing vessel recanalization. PMID:20594522

Angina Treatment: Stents, Drugs, Lifestyle Changes -- What's Best?

MedlinePlus

... doctor may recommend angioplasty or coronary bypass surgery. Making a decision on how to treat your angina can be difficult, but knowing the benefits and risks of stents and medications may help ...

Benchmark for Numerical Models of Stented Coronary Bifurcation Flow.

PubMed

García Carrascal, P; García García, J; Sierra Pallares, J; Castro Ruiz, F; Manuel Martín, F J

2018-09-01

In-stent restenosis ails many patients who have undergone stenting. When the stented artery is a bifurcation, the intervention is particularly critical because of the complex stent geometry involved in these structures. Computational fluid dynamics (CFD) has been shown to be an effective approach when modeling blood flow behavior and understanding the mechanisms that underlie in-stent restenosis. However, these CFD models require validation through experimental data in order to be reliable. It is with this purpose in mind that we performed particle image velocimetry (PIV) measurements of velocity fields within flows through a simplified coronary bifurcation. Although the flow in this simplified bifurcation differs from the actual blood flow, it emulates the main fluid dynamic mechanisms found in hemodynamic flow. Experimental measurements were performed for several stenting techniques in both steady and unsteady flow conditions. The test conditions were strictly controlled, and uncertainty was accurately predicted. The results obtained in this research represent readily accessible, easy to emulate, detailed velocity fields and geometry, and they have been successfully used to validate our numerical model. These data can be used as a benchmark for further development of numerical CFD modeling in terms of comparison of the main flow pattern characteristics.

Clinical Outcomes of Drug-Coated Balloons in Coronary Artery Disease Unsuitable for Drug-Eluting Stent Implantation.

PubMed

Iijima, Raisuke; Kougame, Norihiro; Hara, Hidehiko; Moroi, Masao; Nakamura, Masato

2018-06-12

The aim of this study was to investigate whether drug-coated balloon (DCB) treatment is effective for de novo coronary lesions that are unsuitable for drug-eluting stent (DES) implantation.Methods and Results:This retrospective study included 118 de novo lesions that were not suitable for DES implantation. Of the lesions, 40% was treated because of very small vessel disease. Patients with planned non-cardiac surgery and at high bleeding risk were 3% and 19%, respectively, and lesions that easily develop stent fracture comprised 26%. Clinically driven target lesion revascularization (TLR) was the primary endpoint. The rate of suboptimal lesion preparation before DCB treatment was set as the secondary endpoint. Optimal lesion preparation was defined as acquisition of Thrombolysis in Myocardial Infarction flow grade 3, minor coronary dissection, and residual stenosis ≤30%. The rate of suboptimal lesion preparation was 2.5% and 3 patients needed bail-out stenting. Accordingly, 115 patients were treated with a DCB. Clinically driven TLR had occurred in 8 patients (7.0%) at the 8-month follow-up. The presence of chronic total occlusion was identified as an independent predictor for TLR (odds 11.57; 95% confidence interval, 1.38-135.54; P=0.02). For lesions that are unsuitable for stent implantation, stent-less intervention using a DCB should be considered initially. The present study also highlighted that lesion preparation is key to a successful DCB strategy.

Bioabsorbable Stent Quo Vadis: A Case for Nano-Theranostics

PubMed Central

Gundogan, Buket; Tan, Aaron; Farhatnia, Yasmin; Alavijeh, Mohammad S.; Cui, Zhanfeng; Seifalian, Alexander M.

2014-01-01

Percutaneous coronary intervention (PCI) is one of the most commonly performed invasive medical procedures in medicine today. Since the first coronary balloon angioplasty in 1977, interventional cardiology has seen a wide array of developments in PCI. Bare metal stents (BMS) were soon superseded by the revolutionary drug-eluting stents (DES), which aimed to address the issue of restenosis found with BMS. However, evidence began to mount against DES, with late-stent thrombosis (ST) rates being higher than that of BMS. The bioabsorbable stent may be a promising alternative, providing vessel patency and support for the necessary time required and thereafter degrade into safe non-toxic compounds which are reabsorbed by the body. This temporary presence provides no triggers for ST, which is brought about by non-endothelialized stent struts and drug polymers remaining in vivo for extended periods of time. Likewise, nano-theranostics incorporated into a bioabsorbable stent of the future may provide an incredibly valuable single platform offering both therapeutic and diagnostic capabilities. Such a stent may allow delivery of therapeutic particles to specific sites thus keeping potential toxicity to a minimum, improved ease of tracking delivery in vivo by embedding imaging agents, controlled rate of therapy release and protection of the implanted therapy. Indeed, nanocarriers may allow an increased therapeutic index as well as offer novel post-stent implantation imaging and diagnostic methods for atherosclerosis, restenosis and thrombosis. It is envisioned that a nano-theranostic stent may well form the cornerstone of future stent designs in clinical practice. PMID:24672583

Drug eluting balloons for de novo coronary lesions – a systematic review and meta-analysis

PubMed Central

2013-01-01

Background The role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results. Methods This is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/− bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals. Results Eight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (− 0.26 mm (−0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)). Conclusion Overall, drug-eluting balloons (+/− bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used. PMID:23657123

The current role of vascular stents.

PubMed

Busquet, J

1993-09-01

The limitations of percutaneous balloon angioplasty have favoured the development and the use of vascular endoprostheses or stents. These thin-walled metal devices maintain after expansion, an optimal and constant diameter for the vascular lumen. Restenosis, dissection, abrupt closure, residual stenosis or re-opened total occlusion represent appropriate indications for stenting. A large experience with non-coronary application of stents is currently available in iliac, femoro-popliteal and renal arteries, aorta, large veins.

ALCAPA and massive pulmonary atelectasis: how a stent in the airway can be life-saving.

PubMed

Serio, Paola; Chiappa, Enrico; Fainardi, Valentina; Favilli, Silvia; Murzi, Bruno; Baggi, Roberto; Arcieri, Luigi; Leone, Roberto; Mirabile, Lorenzo

2014-11-01

Anomalous left coronary artery from pulmonary artery (ALCAPA) is a rare congenital anomaly in which left coronary artery arises from the pulmonary artery resulting in progressive myocardial ischemia and dysfunction of the left ventricle. We report a case of ALCAPA with severe cardiac and respiratory failure and huge heart dilation compressing the left main bronchus and preventing from an effective ventilation. Emergency bronchial stenting allowed to improve left lung atelectasis, reduce pulmonary hypertension, resume anterograde left coronary artery perfusion and stabilize cardiovascular conditions to undertake a successful surgical correction. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Culotte stenting for coronary bifurcation lesions with 2nd and 3rd generation everolimus-eluting stents: the CELTIC Bifurcation Study.

PubMed

Walsh, Simon J; Hanratty, Colm G; Watkins, Stuart; Oldroyd, Keith G; Mulvihill, Niall T; Hensey, Mark; Chase, Alex; Smith, Dave; Cruden, Nick; Spratt, James C; Mylotte, Darren; Johnson, Tom; Hill, Jonathan; Hussein, Hafiz M; Bogaerts, Kris; Morice, Marie-Claude; Foley, David P

2018-05-24

The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare the performance of two modern-generation drug-eluting stent (DES) platforms, the 3-connector XIENCE and the 2-connector SYNERGY. Patients with Medina 1,1,1 bifurcation lesions who had disease that was amenable to culotte stenting were randomised 1:1 to treatment with XIENCE or SYNERGY DES. A total of 170 patients were included. Technical success and final kissing balloon inflation occurred in >96% of cases. Major adverse cardiovascular or cerebrovascular events (MACCE: a composite of death, myocardial infarction [MI], cerebrovascular accident [CVA] and target vessel revascularisation [TVR]) occurred in 5.9% of patients by nine months. The primary endpoint was a composite of death, MI, CVA, target vessel failure (TVF), stent thrombosis and binary angiographic restenosis. At nine months, the primary endpoint occurred in 19% of XIENCE patients and 16% of SYNERGY patients (p=0.003 for non-inferiority for platform performance). MACCE rates for culotte stenting using contemporary everolimus-eluting DES are low at nine months. The XIENCE and SYNERGY stents demonstrated comparable performance for the primary endpoint.

Effectiveness of Drug-Eluting Stents versus Bare-Metal Stents in Large Coronary Arteries in Patients with Acute Myocardial Infarction

PubMed Central

Sim, Doo Sun; Ahn, Youngkeun; Kim, Young Jo; Chae, Shung Chull; Hong, Taek Jong; Seong, In Whan; Chae, Jei Keon; Kim, Chong Jin; Cho, Myeong Chan; Seung, Ki Bae; Park, Seung Jung

2011-01-01

This study compared clinical outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries in patients with acute myocardial infarction (MI). A total of 985 patients who underwent single-vessel percutaneous coronary intervention (PCI) in large coronary arteries (≥ 3.5 mm) in lesions < 25 mm were divided into DES group (n = 841) and BMS group (n = 144). Clinical outcomes during 12 months were compared. In-hospital outcome was similar between the groups. At six months, death/MI rate was not different. However, DES group had significantly lower rates of target-lesion revascularization (TLR) (1.7% vs 5.6%, P = 0.021), target-vessel revascularization (TVR) (2.2% vs 5.6%, P = 0.032), and total major adverse cardiac events (MACE) (3.4% vs 11.9%, P = 0.025). At 12 months, the rates of TLR and TVR remained lower in the DES group (2.5% vs 5.9%, P = 0.032 and 5.9% vs 3.1%, P = 0.041), but the rates of death/MI and total MACE were not statistically different. The use of DES in large vessels in the setting of acute MI is associated with lower need for repeat revascularization compared to BMS without compromising the overall safety over the course of one-year follow-up. PMID:21468259

2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study.

PubMed

Gyöngyösi, Mariann; Christ, Günter; Lang, Irene; Kreiner, Gerhard; Sochor, Heinz; Probst, Peter; Neunteufl, Thomas; Badr-Eslam, Rosa; Winkler, Susanne; Nyolczas, Noemi; Posa, Aniko; Leisch, Franz; Karnik, Ronald; Siostrzonek, Peter; Harb, Stefan; Heigert, Matthias; Zenker, Gerald; Benzer, Werner; Bonner, Gerhard; Kaider, Alexandra; Glogar, Dietmar

2009-08-01

The multicenter AUTAX (Austrian Multivessel TAXUS-Stent) registry investigated the 2-year clinical/angiographic outcomes of patients with multivessel coronary artery disease after implantation of TAXUS Express stents (Boston Scientific, Natick, Massachusetts), in a "real-world" setting. The AUTAX registry included patients with 2- or 3-vessel disease, with/without previous percutaneous coronary intervention (PCI) and concomitant surgery. Patients (n = 441, 64 +/- 12 years, 78% men) (n = 1,080 lesions) with possible complete revascularization by PCI were prospectively included. Median clinical follow-up was 753 (quartiles 728 to 775) days after PCI in 95.7%, with control angiography of 78% at 6 months. The primary end point was the composite of major adverse cardiac (nonfatal acute myocardial infarction [AMI], all-cause mortality, target lesion revascularization [TLR]) and cerebrovascular events (MACCE). Potential risk factor effects on 2-year MACCE were evaluated using Cox regression. Complete revascularization was successful in 90.5%, with left main PCI of 6.8%. Rates of acute, subacute, and late stent thrombosis were 0.7%, 0.5%, and 0.5%. Two-year follow-up identified AMI (1.4%), death (3.6%), stroke (0.2%), and TLR (13.1%), for a composite MACCE of 18.3%. The binary restenosis rate was 10.8%. The median of cumulative SYNTAX score was 23.0 (range 12.0 to 56.5). The SYNTAX score did not predict TLR or MACCE, due to lack of scoring of restenotic or bypass stenoses (29.8%). Age (hazard ratio [HR]: 1.03, p = 0.019) and acute coronary syndrome (HR: 2.1, p = 0.001) were significant predictors of 2-year MACCE. Incomplete revascularization predicted death or AMI (HR: 3.84, p = 0.002). With the aim of complete revascularization, TAXUS stent implantations can be safe for patients with multivessel disease. The AUTAX registry including patients with post-PCI lesions provides additional information to the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) study. (Austrian Multivessel TAXUS-Stent Registry; NCT00738686).

Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians.

PubMed

Grines, Cindy L; Bonow, Robert O; Casey, Donald E; Gardner, Timothy J; Lockhart, Peter B; Moliterno, David J; O'Gara, Patrick; Whitlow, Patrick

2007-02-15

Dual antiplatelet therapy with aspirin and a thienopyridine has been shown to reduce cardiac events after coronary stenting. However, many patients and healthcare providers prematurely discontinue dual antiplatelet therapy, which greatly increases the risk of stent thrombosis, myocardial infarction, and death. This advisory stresses the importance of 12 months of dual antiplatelet therapy after placement of a drug-eluting stent and educating the patient and healthcare providers about hazards of premature discontinuation. It also recommends postponing elective surgery for 1 year, and if surgery cannot be deferred, considering the continuation of aspirin during the perioperative period in high-risk patients with drug-eluting stents. (c) 2007 the American Heart Association, Inc., the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the American College of Surgeons, and the American Dental Association

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

PubMed

Philip, Femi; Stewart, Susan; Southard, Jeffrey A

2016-07-01

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Clinical experience in coronary stenting with the Vivant Z Stent.

PubMed

Chee, K H; Siaw, F S; Chan, C G; Chong, W P; Imran, Z A; Haizal, H K; Azman, W; Tan, K H

2005-06-01

This single centre study was designed to demonstrate feasibility, safety and efficacy of the Vivant Z stent (PFM AG, Cologne, Germany). Patients with de novo lesion were recruited. Coronary angioplasty was performed with either direct stenting or after balloon predilatation. Repeated angiogram was performed 6 months later or earlier if clinically indicated. Between January to June 2003, a total of 50 patients were recruited (mean age 55.8 +/- 9 years). A total of 52 lesions were stented successfully. Mean reference diameter was 2.77 mm (+/-0.59 SD, range 2.05-4.39 mm) with mean target lesion stenosis of 65.5% (+/-11.6 SD, range 50.1-93.3%). Forty-six lesions (88.5%) were American College of Cardiologist/American Heart Association class B/C types. Direct stenting was performed in 18 (34.6%) lesions. Mean stent diameter was 3.18 mm (+/-0.41 SD, range 2.5-4 mm), and mean stent length was 14.86 mm (+/-2.72 SD, range 9-18 mm). The procedure was complicated in only one case which involved the loss of side branch with no clinical sequelae. All treated lesions achieved Thrombolysis In Myocardial Infarction 3 flow. Mean residual diameter stenosis was 12.2% (+/-7.55 SD, range 0-22.6%) with acute gain of 1.72 mm (+/-0.50 SD, range 0.5-2.8). At 6 months, there was no major adverse cardiovascular event. Repeated angiography after 6 months showed a restenosis rate of 17% (defined as >50% diameter restenosis). Mean late loss was 0.96 mm (+/-0.48 SD) with loss index of 0.61 (+/-0.38 SD). The restenosis rate of those lesions less than 3.0 mm in diameter was 22.2% compared with 6.25% in those lesions more than 3.0 mm in diameter. The Vivant Z stent was shown to be safe and efficacious with low restenosis rate in de novo coronary artery lesion.

Quantification of thrombus formation in malapposed coronary stents deployed in vitro through imaging analysis.

PubMed

Brown, Jonathan; O'Brien, Caroline C; Lopes, Augusto C; Kolandaivelu, Kumaran; Edelman, Elazer R

2018-04-11

Stent thrombosis is a major complication of coronary stent and scaffold intervention. While often unanticipated and lethal, its incidence is low making mechanistic examination difficult through clinical investigation alone. Thus, throughout the technological advancement of these devices, experimental models have been indispensable in furthering our understanding of device safety and efficacy. As we refine model systems to gain deeper insight into adverse events, it is equally important that we continue to refine our measurement methods. We used digital signal processing in an established flow loop model to investigate local flow effects due to geometric stent features and ultimately its relationship to thrombus formation. A new metric of clot distribution on each microCT slice termed normalized clot ratio was defined to quantify this distribution. Three under expanded coronary bare-metal stents were run in a flow loop model to induce clotting. Samples were then scanned in a MicroCT machine and digital signal processing methods applied to analyze geometric stent conformation and spatial clot formation. Results indicated that geometric stent features play a significant role in clotting patterns, specifically at a frequency of 0.6225 Hz corresponding to a geometric distance of 1.606 mm. The magnitude-squared coherence between geometric features and clot distribution was greater than 0.4 in all samples. In stents with poor wall apposition, ranging from 0.27 mm to 0.64 mm maximum malapposition (model of real-world heterogeneity), clots were found to have formed in between stent struts rather than directly adjacent to struts. This early work shows how the combination of tools in the areas of image processing and signal analysis can advance the resolution at which we are able to define thrombotic mechanisms in in vitro models, and ultimately, gain further insight into clinical performance. Copyright © 2018 Elsevier Ltd. All rights reserved.

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

PubMed

López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

2014-07-01

Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Five-year outcomes of staged percutaneous coronary intervention in the SYNTAX study.

PubMed

Watkins, Stuart; Oldroyd, Keith G; Preda, Istvan; Holmes, David R; Colombo, Antonio; Morice, Marie-Claude; Leadley, Katrin; Dawkins, Keith D; Mohr, Friedrich W; Serruys, Patrick W; Feldman, Ted E

2015-04-01

The SYNTAX study compared PCI with TAXUS Express stents to CABG for the treatment of de novo 3-vessel and/or left main coronary disease. This study aimed to determine patient characteristics and five-year outcomes after a staged PCI strategy compared to single-session PCI. In the SYNTAX trial, staged procedures were discouraged but were allowed within 72 hours or, if renal insufficiency or contrast-induced nephropathy occurred, within 14 days (mean 9.8±18.1 days post initial procedure). A total of 125 (14%) patients underwent staged PCI. These patients had greater disease severity and/or required a more complex procedure. MACCE was significantly increased in staged patients (48.1% vs. 35.5%, p=0.004), as was the composite of death/stroke/MI (32.2% vs. 19%, p=0.0007). Individually, cardiac death and stroke occurred more frequently in the staged PCI group (p=0.03). Repeat revascularisation was significantly higher in staged patients (32.8% vs 24.8%, p=0.035), as was stent thrombosis (10.9% vs. 4.7%, p=0.005). There is a higher incidence of MACCE in patients undergoing staged compared to single-session PCI for 3-vessel and/or left main disease over the first five years of follow-up. However, these patients had more comorbidities and more diffuse disease.

Prognostic implications of Q waves at presentation in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: An analysis of the HORIZONS-AMI study.

PubMed

Kosmidou, Ioanna; Redfors, Björn; Crowley, Aaron; Gersh, Bernard; Chen, Shmuel; Dizon, José M; Embacher, Monica; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

2017-11-01

Presence of Q waves on the presenting electrocardiogram (ECG) in patients with ST-segment elevation myocardial infarction (STEMI) has been associated with worse prognosis; however, whether the prognostic value of Q waves is influenced by baseline characteristics and/or rapidity of revascularization based on the guideline-based metric of door-to-balloon time remains unknown. We hypothesized that Q waves in the presenting ECG will be predictive of long term mortality regardless of time to reperfusion. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial enrolled 3602 patients with STEMI undergoing primary percutaneous coronary intervention. We stratified patients without prior history of myocardial infarction or coronary revascularization according to presence or absence of pathological Q waves on their presenting ECG. Associations between Q waves, death, and cardiovascular outcomes within 3 years were assessed using Cox proportional hazards regression. Among 2723 patients with evaluable ECGs, 1084 (39.8%) had Q waves on their presenting ECG. Male sex and time from symptom onset to balloon inflation were independent predictors of presence of Q waves. Patients with Q waves had higher adjusted risks of all-cause death (adjusted hazard ratio: 1.45, 95% confidence interval: 1.02-2.05, P = 0.04) and cardiac death (adjusted hazard ratio: 1.72, 95% confidence interval: 1.08-2.72, P = 0.02). The association between Q waves and cardiac death was consistent regardless of sex, diabetes status, target vessel, or door-to-balloon time (P interaction > 0.4 for all). Presence of Q waves on the presenting ECG in patients undergoing primary percutaneous coronary intervention due to STEMI is an independent predictor of mortality and adds prognostic value, regardless of sex or rapidity of revascularization. © 2017 Wiley Periodicals, Inc.

Combining PCI and CABG: the role of hybrid revascularization.

PubMed

Green, Kelly D; Lynch, Donald R; Chen, Tyffany P; Zhao, David

2013-04-01

Hybrid coronary revascularization combines the benefits of both percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in the treatment of multivessel coronary artery disease (CAD) by combining the benefits of the LIMA-to-LAD graft and drug eluting stent (DES) to non-LAD regions. Through this approach, a patient receives the long-term benefit of the LIMA graft and avoids the morbidity of a full sternotomy and saphenous vein grafts. Available data related to outcomes following hybrid revascularization is limited to small studies. In this review we seek to provide an overview of hybrid revascularization in the era of modern drug eluting stent technology, discuss appropriate patient selection, and comment on future trial design. Additionally, we review the recent literature pertaining to the hybrid approach.

The Impact of Prediabetes on Two-Year Clinical Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention.

PubMed

Choi, Woong Gil; Rha, Seung Woon; Choi, Byoung Geol; Choi, Se Yeon; Byun, Jae Kyeong; Mashaly, Ahmed; Park, Yoonjee; Jang, Won Young; Kim, Woohyeun; Choi, Jah Yeon; Park, Eun Jin; Na, Jin Oh; Choi, Cheol Ung; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog

2018-06-01

Prediabetes is an independent risk factor for cardiovascular disease. However, data on the long term adverse clinical outcomes of prediabetic patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) are scarce. The study population comprised 674 consecutive non-diabetic patients who underwent elective PCI between April 2007 and November 2010. Prediabetes was defined as hemoglobin A1c (HbA1c) of 5.7% to 6.4%. Two-year cumulative clinical outcomes of prediabetic patients (HbA1c of 5.7% to 6.4%, n=242) were compared with those of a normoglycemic group (<5.7%, n=432). Baseline clinical and angiographic characteristics were similar between the two groups, except for higher glucose levels (104.8±51.27 mg/dL vs. 131.0±47.22 mg/dL, p<0.001) on admission in the prediabetes group. There was no significant difference between the two groups in coronary angiographic parameters, except for a higher incidence of diffuse long lesion in the prediabetes group. For prediabetic patients, trends toward higher incidences of binary restenosis (15.6% vs. 9.8 %, p=0.066) and late loss (0.71±0.70 mm vs. 0.59±0.62 mm, p=0.076) were noted. During the 24 months of follow up, the incidence of mortality in prediabetic patients was higher than that in normoglycemic patients (5.5% vs. 1.5%, p=0.007). In our study, a higher death rate and a trend toward a higher incidence of restenosis in patients with prediabetes up to 2 years, compared to those in normoglycemic patients, undergoing elective PCI with contemporary DESs. © Copyright: Yonsei University College of Medicine 2018.

Photon Counting Computed Tomography With Dedicated Sharp Convolution Kernels: Tapping the Potential of a New Technology for Stent Imaging.

PubMed

von Spiczak, Jochen; Mannil, Manoj; Peters, Benjamin; Hickethier, Tilman; Baer, Matthias; Henning, André; Schmidt, Bernhard; Flohr, Thomas; Manka, Robert; Maintz, David; Alkadhi, Hatem

2018-05-23

The aims of this study were to assess the value of a dedicated sharp convolution kernel for photon counting detector (PCD) computed tomography (CT) for coronary stent imaging and to evaluate to which extent iterative reconstructions can compensate for potential increases in image noise. For this in vitro study, a phantom simulating coronary artery stenting was prepared. Eighteen different coronary stents were expanded in plastic tubes of 3 mm diameter. Tubes were filled with diluted contrast agent, sealed, and immersed in oil calibrated to an attenuation of -100 HU simulating epicardial fat. The phantom was scanned in a modified second generation 128-slice dual-source CT scanner (SOMATOM Definition Flash, Siemens Healthcare, Erlangen, Germany) equipped with both a conventional energy integrating detector and PCD. Image data were acquired using the PCD part of the scanner with 48 × 0.25 mm slices, a tube voltage of 100 kVp, and tube current-time product of 100 mAs. Images were reconstructed using a conventional convolution kernel for stent imaging with filtered back-projection (B46) and with sinogram-affirmed iterative reconstruction (SAFIRE) at level 3 (I463). For comparison, a dedicated sharp convolution kernel with filtered back-projection (D70) and SAFIRE level 3 (Q703) and level 5 (Q705) was used. The D70 and Q70 kernels were specifically designed for coronary stent imaging with PCD CT by optimizing the image modulation transfer function and the separation of contrast edges. Two independent, blinded readers evaluated subjective image quality (Likert scale 0-3, where 3 = excellent), in-stent diameter difference, in-stent attenuation difference, mathematically defined image sharpness, and noise of each reconstruction. Interreader reliability was calculated using Goodman and Kruskal's γ and intraclass correlation coefficients (ICCs). Differences in image quality were evaluated using a Wilcoxon signed-rank test. Differences in in-stent diameter difference, in-stent attenuation difference, image sharpness, and image noise were tested using a paired-sample t test corrected for multiple comparisons. Interreader and intrareader reliability were excellent (γ = 0.953, ICCs = 0.891-0.999, and γ = 0.996, ICCs = 0.918-0.999, respectively). Reconstructions using the dedicated sharp convolution kernel yielded significantly better results regarding image quality (B46: 0.4 ± 0.5 vs D70: 2.9 ± 0.3; P < 0.001), in-stent diameter difference (1.5 ± 0.3 vs 1.0 ± 0.3 mm; P < 0.001), and image sharpness (728 ± 246 vs 2069 ± 411 CT numbers/voxel; P < 0.001). Regarding in-stent attenuation difference, no significant difference was observed between the 2 kernels (151 ± 76 vs 158 ± 92 CT numbers; P = 0.627). Noise was significantly higher in all sharp convolution kernel images but was reduced by 41% and 59% by applying SAFIRE levels 3 and 5, respectively (B46: 16 ± 1, D70: 111 ± 3, Q703: 65 ± 2, Q705: 46 ± 2 CT numbers; P < 0.001 for all comparisons). A dedicated sharp convolution kernel for PCD CT imaging of coronary stents yields superior qualitative and quantitative image characteristics compared with conventional reconstruction kernels. Resulting higher noise levels in sharp kernel PCD imaging can be partially compensated with iterative image reconstruction techniques.

Five-year follow-up of the endothelial progenitor cell capturing stent versus the paxlitaxel-eluting stent in de novo coronary lesions with a high risk of coronary restenosis.

PubMed

Woudstra, Pier; Kalkman, Deborah N; Beijk, Marcel A; Klomp, Margo; Damman, Peter; Koch, Karel T; Henriques, Jose P S; Baan, Jan; Vis, Marije M; Piek, Jan J; Tijssen, Jan G P; de Winter, Robbert J

2018-06-01

To assess the long-term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberté paclitaxel-eluting stent (PES) in lesions with a high risk of restenosis. Instead of the use of cytotoxic or cytostatic drugs in drug-eluting stents, a "pro-healing" approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts. In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for ≥1 month after ECS and for ≥6 months after PES. At 5 years follow-up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) -17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI -20.8% to -2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group. This is the first randomized study providing very long-term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow-up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure. © 2017 Wiley Periodicals, Inc.

Stenting of the ascending aorta revisited.

PubMed

Moiduddin, Nasser J; Rios, Rodrigo; El-Said, Howaida; Moore, John W

2017-10-01

Despite few institutions stenting the ascending aorta, it has been discouraged because of the proximity of the aortic valve, the coronary artery orifices, and the aortic arch branches. We describe a small case series of patients having acquired stenosis of the ascending that was relieved successfully by stenting. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

.......... Medtronic Vascular.... Valiant thoracic stent graft April 1, 2011. system. H100002 FDA-2011-M-0241... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire..., 2011. toric IOL. P040012 (S34) FDA-2011-M-0343. Abbott Vascular, Inc.. RX Acculink carotid stent system...

77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

...] Fenestrated April 4, 2012. AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent). P110029, FDA...\\ plus CoCr April 12, 2012. Coronary Stent on RX System. P110035, FDA-2012-M-0373 Boston Scientific Epic\\TM\\ Vascular Self- April 13, 2012. Corp. Expanding Stent System. P090015, FDA-2012-M-0390 Leica...

Heart valve bioprosthesis durability: a challenge to the new generation of porcine valves.

PubMed

Valente, M; Minarini, M; Maizza, A F; Bortolotti, U; Thiene, G

1992-01-01

Long-term experience with first generation porcine valve xenografts enabled identification of the major limitations to their durability: (1) prosthetic-ventricular mismatch due to the high profile of the stent in patients with mitral stenosis and a small left ventricle; (2) high-pressure fixation with loss of natural collagen crimping in the fibrosa, and wash-out of proteoglycans in the spongiosa; (3) xenograft tissue autolysis, due to the long interval between animal slaughter and aortic valve removal fixation; (4) muscle shelf in the right coronary cusp, which created a gradient and could undergo accelerated calcification and/or spontaneous perforation with time; (5) a flexible polypropylene stent, which could creep or even fracture with consequent inward bending of the stent; (6) progressive time-related dystrophic calcification; (7) host fibrous tissue ingrowth. An awareness of these limitations stimulated technical modifications, which frequently brought about distinct improvements: (1) the reduction of the stent profile eliminated the problem of mismatch, but resulted in a higher tendency towards cusp prolapse and earlier commissural tearing; (2) natural collagen waviness, proteoglycans and cusp extensibility were preserved by employing low or even zero pressure during the fixation process; (3) earlier valve fixation enabled preservation of cell integrity; (4) a new orifice for small valves was designed by replacing the right muscular cusp, thus achieving less gradient and avoiding muscle-shelf-related complications; (5) polypropylene was replaced by Delrin as stent material; (6) calcium-retarding agents like T6 and toluidine blue were applied during commercial processing and storage in order to mitigate tissue mineralization.(ABSTRACT TRUNCATED AT 250 WORDS)

78 FR 35284 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

.... Stent Graft System. P040046, FDA-2013-M-0255 Allergan Natrelle[supreg] 410 February 20, 2013. Highly... Vascular, Resolute Integrity February 22, 2013. Inc. Zotarolimus-Eluting Coronary Stent System. P100030...

Economic impact of angioplasty salvage techniques, with an emphasis on coronary stents: a method incorporating costs, revenues, clinical effectiveness and payer mix.

PubMed

Vaitkus, P T; Witmer, W T; Brandenburg, R G; Wells, S K; Zehnacker, J B

1997-10-01

We sought to broaden assessment of the economic impact of percutaneous transluminal coronary angioplasty (PTCA) revascularization salvage strategies by taking into account costs, revenues, the off-setting effects of prevented clinical complications and the effects of payer mix. Previous economic analyses of PTCA have focused on the direct costs of treatment but have not accounted either for associated revenues or for the ability of costly salvage techniques such as coronary stenting to reduce even costlier complications. Procedural costs, revenues and contribution margins (i.e., "profit") were measured for 765 consecutive PTCA cases to assess the economic impact of salvage techniques (prolonged heparin administration, thrombolysis, intracoronary stenting or use of perfusion balloon catheters) and clinical complications (myocardial infarction, coronary artery bypass graft surgery [CABG] or acute vessel closure with repeat PTCA). To assess the economic impact of various salvage techniques for failed PTCA, we used actual 1995 financial data as well as models of various mixes of fee-for-service, diagnosis-related group (DRG) and capitated payers. Under fee-for-service arrangements, most salvage techniques were profitable for the hospital. Stents were profitable at almost any level of clinical effectiveness. Under DRG-based systems, most salvage techniques such as stenting produced a financial loss to the hospital because one complication (CABG) remained profitable. Under capitated arrangements, stenting and other salvage modalities were profitable only if they were clinically effective in preventing complications in > 50% of cases in which they were used. The economic impact of PTCA salvage techniques depends on their clinical effectiveness, costs and revenues. In reimbursement systems dominated by DRG payers, salvage techniques are not rewarded, whereas complications are. Under capitated systems, the level of clinical effectiveness needed to achieve cost savings is probably not achievable in current practice. Further studies are needed to define equitable reimbursement schedules that will promote clinically effective practice.

Delayed relapse in pseudotumor cerebri due to new stenosis after transverse sinus stenting

PubMed Central

Winters, Hugh Stephen; Parker, Geoff; Halmagyi, Gabor Michael; Mehta, Ankur; Atkins, Thomas

2015-01-01

A patient presented with recurrent severe pseudotumor cerebri (PTC). Transverse sinus stenting is a very effective treatment option, however stenosis and intracranial hypertension can recur. In our patient, stenting initially resulted in resolution of papilloedema. However, after 5 years, a new stenosis developed which required further stenting. This case highlights the fact that, in patients with PTC who undergo transverse sinus stenting, a small proportion require repeat treatment due to formation of a new stenosis, usually adjacent to the existing stent. Patients with severe disease, such as ours, may be at higher risk of recurrence. Regardless of the severity, all patients who undergo stenting should have regular ocular follow-up. PMID:26351311

Drug-eluting stents and acute myocardial infarction: A lethal combination or friends?

PubMed Central

Otsuki, Shuji; Sabaté, Manel

2014-01-01

Primary percutaneous coronary intervention is the preferred reperfusion strategy for patients presenting with ST-segment elevation myocardial infarction (STEMI). First generation drug-eluting stents (DES), (sirolimus drug-eluting stents and paclitaxel drug-eluting stents), reduce the risk of restenosis and target vessel revascularization compared to bare metal stents. However, stent thrombosis emerged as a major safety concern with first generation DES. In response to these safety issues, second generation DES were developed with different drugs, improved stent platforms and more biocompatible durable or bioabsorbable polymeric coating. This article presents an overview of safety and efficacy of the first and second generation DES in STEMI. PMID:25276295

Impact of very high pressure stent deployment on angiographic and long-term clinical outcomes in true coronary bifurcation lesions treated by the mini-crush stent technique: A single center experience.

PubMed

Gerbay, Antoine; Terreaux, Jeremy; Cerisier, Alexis; Vola, Marco; Isaaz, Karl

Percutaneous coronary intervention (PCI) for bifurcation lesions (BL) using 2 stents technique is known to be associated with high rates of procedural failure especially on the side branch (SB) mainly due to stent incomplete apposition. Stent deployment at very high pressure (SDHP) may lead to better stent expansion and apposition. However, SDHP may also be at the origin of deeper wall injury resulting into major cardiac adverse events. No data are available on evaluation of SDHP in BL treated by a mini-crush stent technique. One hundred and thirteen consecutive patients underwent PCI for BL (Medina 1, 1, 1) using a mini-crush stent technique with SDHP defined as ≥20atm. An angiographic follow-up was performed at 6 month and clinical follow-up was obtained at a median of 3 years. Stent deployment mean pressures were 20±1.4atm (range 20-25) in the main vessel (MV) and 20±1.5atm (range 20-25) in SB. Simultaneous final kissing balloon was used in 92% of cases. PCI was successful in 100%. Angiographic follow-up was obtained in 83% of patients. Restenosis rate was 13% (12% restenosis in the SB) with only one case (0.8%) of SB probable thrombosis. Another case of late stent thrombosis occurred at a 3 years clinical follow-up. Compared with previously published studies in which stents were deployed at lower pressure, SDHP does not increase the restenosis rate in BL using mini-crush stent technique but seems to reduce the rate of stent thrombosis. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Urological surgery and antiplatelet drugs after cardiac and cerebrovascular accidents.

PubMed

Eberli, Daniel; Chassot, Pierre-Guy; Sulser, Tullio; Samama, Charles Marc; Mantz, Jean; Delabays, Alain; Spahn, Donat R

2010-06-01

The perioperative treatment of patients on dual antiplatelet therapy after myocardial infarction, cerebrovascular event or coronary stent implantation represents an increasingly frequent issue for urologists and anesthesiologists. We assess the current scientific evidence and propose strategies concerning treatment of these patients. A MEDLINE and PubMed search was conducted for articles related to antiplatelet therapy after myocardial infarction, coronary stents and cerebrovascular events, as well as the use of aspirin and/or clopidogrel in the context of surgery. Early discontinuation of antiplatelet therapy for secondary prevention is associated with a high risk of coronary thrombosis, which is further increased by the hypercoagulable state induced by surgery. Aspirin has recently been recommended as a lifelong therapy. Clopidogrel is mandatory for 6 weeks after myocardial infarction and bare metal stents, and for 12 months after drug-eluting stents. Surgery must be postponed beyond these waiting periods or performed with patients receiving dual antiplatelet therapy because withdrawal therapy increases 5 to 10 times the risk of postoperative myocardial infarction, stent thrombosis or death. The shorter the waiting period between revascularization and surgery the greater the risk of adverse cardiac events. The risk of surgical hemorrhage is increased approximately 20% by aspirin and 50% by clopidogrel. The risk of coronary thrombosis when antiplatelet agents are withdrawn before surgery is generally higher than the risk of surgical hemorrhage when antiplatelet agents are maintained. However, this issue has not yet been sufficiently evaluated in urological patients and in many instances during urological surgery the risk of bleeding can be dangerous. A thorough dialogue among surgeon, cardiologist and anesthesiologist is essential to determine all risk factors and define the best possible strategy for each patient. Copyright 2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Significance of off-pump coronary artery bypass grafting compared with percutaneous coronary intervention: a propensity score analysis.

PubMed

Marui, Akira; Kimura, Takeshi; Tanaka, Shiro; Furukawa, Yutaka; Kita, Toru; Sakata, Ryuzo

2012-01-01

Although there have been several studies that compared the efficacy of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the impact of off-pump CABG (OPCAB) has not been well elucidated. The objective of the present study was to compare the outcomes after PCI, on-pump CABG (ONCAB), and OPCAB in patients with multivessel and/or left main disease. Among the 9877 patients undergoing first PCI using bare-metal stents or CABG who were enrolled in the CREDO-Kyoto Registry, 6327 patients with multivessel and/or left main disease were enrolled into the present study (67.9±9.8 years old). Among them, 3877 patients received PCI, 1388 ONCAB, and 1069 OPCAB. Median follow-up was 3.5 years. Comparing PCI with all CABG (ONCAB and OPCAB), propensity-score-adjusted all-cause mortality after PCI was higher than that CABG (hazard ratio (95% confidence interval): 1.37 (1.15-1.63), p<0.01). The incidence of stroke was lower after PCI than that after CABG (0.75 (0.59-0.96), p=0.02). CABG was associated with better survival outcomes than PCI in the elderly (interaction p=0.04). Comparing OPCAB with PCI or ONCAB, propensity-score-adjusted all-cause mortality after PCI was higher than that after OPCAB (1.50 (1.20-1.86), p<0.01). Adjusted mortality was similar between ONCAB and OPCAB (1.18 (0.93-1.51), p=0.33). The incidence of stroke after OPCAB was similar to that after PCI (0.98 (0.71-1.34), p>0.99), but incidence of stroke after ONCAB was higher than that after OPCAB (1.59 (1.16-2.18), p<0.01). In patients with multivessel and/or left main disease, CABG, particularly OPCAB, is associated with better survival outcomes than PCI using bare-metal stents. Survival outcomes are similar between ONCAB and OPCAB.

Preoperative platelet transfusions to reverse antiplatelet therapy for urgent non-cardiac surgery: an observational cohort study.

PubMed

Baschin, M; Selleng, S; Hummel, A; Diedrich, S; Schroeder, H W; Kohlmann, T; Westphal, A; Greinacher, A; Thiele, T

2018-04-01

Essentials An increasing number of patients requiring surgery receive antiplatelet therapy (APT). We analyzed 181 patients receiving presurgery platelet transfusions to reverse APT. No coronary thrombosis occurred after platelet transfusion. This justifies a prospective trial to test preoperative platelet transfusions to reverse APT. Background Patients receiving antiplatelet therapy (APT) have an increased risk of perioperative bleeding and cardiac adverse events (CAE). Preoperative platelet transfusions may reduce the bleeding risk but may also increase the risk of CAE, particularly coronary thrombosis in patients after recent stent implantation. Objectives To analyze the incidence of perioperative CAE and bleeding in patients undergoing non-cardiac surgery using a standardized management of transfusing two platelet concentrates preoperatively and restart of APT within 24-72 h after surgery. Methods A cohort of consecutive patients on APT treated with two platelet concentrates before non-cardiac surgery between January 2012 and December 2014 was retrospectively identified. Patients were stratified by the risk of major adverse cardiac and cerebrovascular events (MACCE). The primary objective was the incidence of CAE (myocardial infarction, acute heart failure and cardiac troponine T increase). Secondary objectives were incidences of other thromboembolic events, bleedings, transfusions and mortality. Results Among 181 patients, 88 received aspirin, 21 clopidogrel and 72 dual APT. MACCE risk was high in 63, moderate in 103 and low in 15 patients; 67 had cardiac stents. Ten patients (5.5%; 95% CI, 3.0-9.9%) developed a CAE (three myocardial infarctions, four cardiac failures and three troponin T increases). None was caused by coronary thrombosis. Surgery-related bleeding occurred in 22 patients (12.2%; 95% CI, 8.2-17.7%), making 12 re-interventions necessary (6.6%; 95% CI, 3.8-11.2%). Conclusion Preoperative platelet transfusions and early restart of APT allowed urgent surgery and did not cause coronary thromboses, but non-thrombotic CAEs and re-bleeding occurred. Randomized trials are warranted to test platelet transfusion against other management strategies. © 2018 International Society on Thrombosis and Haemostasis.

Extended Duration Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Peripheral Arterial Disease: A Meta-Analysis.

PubMed

Ling, Hua; Andrews, Ebony; Ombengi, David; Li, Fang

2018-06-01

Patients with peripheral arterial disease (PAD) undergoing percutaneous coronary intervention (PCI) are at elevated risk of ischemic and bleeding events. However, the optimal duration of dual antiplatelet therapy (DAPT) after PCI in patients with PAD remains unclear. A systematic literature search was performed through June 2017 using PubMed, EMBASE and Cochrane databases with the following key terms: "dual antiplatelet therapy", "P2Y12 inhibitor", "myocardial infarction", "percutaneous coronary intervention", "stent", "peripheral arterial disease", and "ankle-brachial index". The analysis was restricted to randomized trials published in English in patients with PAD receiving extended DAPT (> 12-month) after PCI. Overall analysis was performed using Review Manager 5.3 with the Mantel-Haenszel method. Two randomized controlled trials involving 895 patients were included in this review. Compared to the placebo group, there was no statistical significance in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients receiving extended DAPT (odds ratio (OR) 0.76, 95% confidence interval (CI) 0.37 - 1.57; P = 0.46). The results were associated with substantial heterogeneity (I 2 = 71%, P = 0.07). Extended DAPT was not significantly associated with increased moderate/severe bleeding events (OR 1.63, 95% CI 0.84 - 3.18; P = 0.15; I 2 = 0%, P = 0.59). The extended DAPT was associated with 82% relative risk reduction in the events of definite/probably stent thrombosis. Among patients with PAD, extended DAPT after PCI resulted in a non-significant difference in ischemic and bleeding events compared to placebo, respectively. The routine use of extended DAPT in this cohort should be carefully evaluated.

A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial.

PubMed

Romaguera, Rafael; Gómez-Hospital, Joan A; Gomez-Lara, Josep; Brugaletta, Salvatore; Pinar, Eduardo; Jiménez-Quevedo, Pilar; Gracida, Montserrat; Roura, Gerard; Ferreiro, Jose L; Teruel, Luis; Montanya, Eduard; Fernandez-Ortiz, Antonio; Alfonso, Fernando; Valgimigli, Marco; Sabate, Manel; Cequier, Angel

2016-01-11

The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM). The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM. This was a multicenter, randomized, noninferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin and de novo coronary lesions were randomized in a 1:1 fashion to AES or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up. A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm for EES (p = 0.27), with a larger minimal lumen diameter at follow-up for AES (p = 0.02), mainly driven by 2 cases of occlusive restenosis in the EES group. AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter.

PubMed

Price, Matthew J; Saito, Shigeru; Shlofmitz, Richard A; Spriggs, Douglas J; Attubato, Michael; McLaurin, Brent; Popma Almonacid, Alexandra; Brar, Sandeep; Liu, Minglei; Moe, Elizabeth; Mehran, Roxana

2017-07-24

The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD). Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation. This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure. A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%. In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501). Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

[Effects of control-releasing arsenic trioxide-eluting stent on intimal smooth muscle cells and type III collagen in canine coronary artery post-stent model].

PubMed

Zhao, Jun-Li; Sun, Bao-Gui; Wen, Qin-Zhu

2010-06-01

To study the safety and efficacy of control-releasing arsenic trioxide (As2O3)-eluting stent on intimal smooth muscle cells (SMC) and type III collagen (CIII) in canine coronary artery post-stent model. Twenty-four experimental canines were equally divided into 4 groups, the three tested groups were deployed by stents with different dosage of As2O3 (1.6 microg/mm2, 2.4 microg/mm2 and 3.2 microg/mm2 in low, median and high dose groups, respectively) and coated with polybutyl methacrylate/nano silica and poly-lactide-coglycolide in mild oversizing (stent/vessel ratio of 1.3:1) in left anterior descending (LAD) or circumflex coronary arteries (LCX), while the control group only by simple coated stent without As2O3. The effect was assessed 4 weeks after stent implantation in terms of vascular histomorphology, and changes of SMC and C III expressions were detected using immunohistochemical analysis. Subintimal hemorrhage, medial/adventitial necrosis, thrombosis and inflammatory cell infiltration were not found and integral endothelium could be seen under screening electron microscopy in all groups. Positive expression of SMC and CIII in the tested groups, especial in the high dose As2O3 group, was more weaker than that in control group. Histo-morphological analysis showed that the neo-genetic intimal area and vascular stenosis were lower, but the mean luminal diameter was larger in the three tested groups than that in the control group (P < 0.01). Comparisons of various indices between tested groups treated by different doses of As2O3 showed that the difference between high/median dose vs. low dose was significant (P < 0.01), but that between high dose vs. median dose was insignificant (P > 0.05). Control-releasing As2O3-eluting stent shows a reliable and safe effect in preventing and treating post-stent restenosis by its dose-dependent inhibition on expressions of SMC and CIII to suppress the neo-genesis of intimal hyperplasia.

Structural Mechanics Predictions Relating to Clinical Coronary Stent Fracture in a 5 Year Period in FDA MAUDE Database

PubMed Central

Everett, Kay D.; Conway, Claire; Desany, Gerard J.; Baker, Brian L.; Choi, Gilwoo; Taylor, Charles A.; Edelman, Elazer R.

2016-01-01

Endovascular stents are the mainstay of interventional cardiovascular medicine. Technological advances have reduced biological and clinical complications but not mechanical failure. Stent strut fracture is increasingly recognized as of paramount clinical importance. Though consensus reigns that fractures can result from material fatigue, how fracture is induced and the mechanisms underlying its clinical sequelae remain ill-defined. In this study, strut fractures were identified in the prospectively maintained Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), covering years 2006–2011, and differentiated based on specific coronary artery implantation site and device configuration. These data, and knowledge of the extent of dynamic arterial deformations obtained from patient CT images and published data, were used to define boundary conditions for 3D finite element models incorporating multimodal, multi-cycle deformation. The structural response for a range of stent designs and configurations was predicted by computational models and included estimation of maximum principal, minimum principal and equivalent plastic strains. Fatigue assessment was performed with Goodman diagrams and safe/unsafe regions defined for different stent designs. Von Mises stress and maximum principal strain increased with multimodal, fully reversed deformation. Spatial maps of unsafe locations corresponded to the identified locations of fracture in different coronary arteries in the clinical database. These findings, for the first time, provide insight into a potential link between patient adverse events and computational modeling of stent deformation. Understanding of the mechanical forces imposed under different implantation conditions may assist in rational design and optimal placement of these devices. PMID:26467552

Structural Mechanics Predictions Relating to Clinical Coronary Stent Fracture in a 5 Year Period in FDA MAUDE Database.

PubMed

Everett, Kay D; Conway, Claire; Desany, Gerard J; Baker, Brian L; Choi, Gilwoo; Taylor, Charles A; Edelman, Elazer R

2016-02-01

Endovascular stents are the mainstay of interventional cardiovascular medicine. Technological advances have reduced biological and clinical complications but not mechanical failure. Stent strut fracture is increasingly recognized as of paramount clinical importance. Though consensus reigns that fractures can result from material fatigue, how fracture is induced and the mechanisms underlying its clinical sequelae remain ill-defined. In this study, strut fractures were identified in the prospectively maintained Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), covering years 2006-2011, and differentiated based on specific coronary artery implantation site and device configuration. These data, and knowledge of the extent of dynamic arterial deformations obtained from patient CT images and published data, were used to define boundary conditions for 3D finite element models incorporating multimodal, multi-cycle deformation. The structural response for a range of stent designs and configurations was predicted by computational models and included estimation of maximum principal, minimum principal and equivalent plastic strains. Fatigue assessment was performed with Goodman diagrams and safe/unsafe regions defined for different stent designs. Von Mises stress and maximum principal strain increased with multimodal, fully reversed deformation. Spatial maps of unsafe locations corresponded to the identified locations of fracture in different coronary arteries in the clinical database. These findings, for the first time, provide insight into a potential link between patient adverse events and computational modeling of stent deformation. Understanding of the mechanical forces imposed under different implantation conditions may assist in rational design and optimal placement of these devices.

Best way to revascularize patients with main stem and three vessel lesions: patients should undergo PCI!

PubMed

Schächinger, Volker; Herdeg, Christian; Scheller, Bruno

2010-09-01

The optimal revascularization strategy for multivessel disease is under controversial discussion for long time. Until now, technical innovations have been faster than performance of clinical trials, making results of randomized studies outdated at the time of appearance. Recently, the SYNTAX trial has been published, which compared drug elutings stents (DES) implantation with Coronary artery bypass graft (CABG) patients with multivessel or left main disease in a clinically stable population. Overall, CABG was superior with respect to the clinical endpoint of death, myocardial infarction, stroke, or revascularization. However, the difference is driven by the "weakest" end point, namely repeated revascularization, whereas combined "hard" events did not demonstrate a difference. More detailed analysis demonstrates that only patients with most complex coronary anatomy gain definite benefit from CABG. In addition, SYNTAX demonstrated that left main disease is no longer a domain of CABG, since DES implantation revealed comparable results, as long as there is no concomitant multivessel disease. Regardless the results of SYNTAX, one should not forget that SYNTAX represents only a minority of daily patients in a catheterization laboratory, excluding patients with one- or two-vessel disease and those with an acute coronary syndrome. Especially in the latter, percutaneous coronary intervention has demonstrated to improve prognosis.

The History of Primary Angioplasty and Stenting for Acute Myocardial Infarction.

PubMed

Smilowitz, Nathaniel R; Feit, Frederick

2016-01-01

The evolution of the management of acute myocardial infarction (MI) has been one of the crowning achievements of modern medicine. At the turn of the twentieth century, MI was an often-fatal condition. Prolonged bed rest served as the principal treatment modality. Over the past century, insights into the pathophysiology of MI revolutionized approaches to management, with the sequential use of surgical coronary artery revascularization, thrombolytic therapy, and percutaneous coronary intervention (PCI) with primary coronary angioplasty, and placement of intracoronary stents. The benefits of prompt revascularization inspired systems of care to provide rapid access to PCI. This review provides a historical context for our current approach to primary PCI for acute MI.

Development of AISI 316L stainless steel coronary stent

NASA Astrophysics Data System (ADS)

García-López, Erika; Siller, Héctor R.; Rodríguez, Ciro A.

2018-02-01

Coronary stents are manufactured through a sequence of processes and each step demands the process control to assure surface quality. This study is focused on the influence of laser cutting parameters and electropolishing on average surface roughness and back wall dross percentage for fiber laser cutting of AISI 316L coronary struts. A preliminary test and a design of experiments (DOE) were implemented to determine the limiting cutting conditions and the effect of these parameters on quality indicators. Preliminary results identify four cutting zones from a non-cut zone to a burned zone, in a frequency range between 1000 and 1500 Hz and a peak power between 160 to 180 W for clean cuts. From the DOE results, several interactions between factors were observed; however, a laser frequency of 1000 to 1500 Hz and a cutting speed of 250 mm/min minimize the backwall dross percentage and the surface roughness to values less than 2% and 0.9 μm, respectively. After the laser conditions selection, coronary stents were manufactured and electropolished to reduce the surface roughness on the strut edge. Electropolishing results indicate a surface roughness reduction from 0.9 μm to 0.3 μm after 300 s of electropolishing time.

A novel side branch protection technique in coronary stent implantation: Jailed Corsair technique.

PubMed

Numasawa, Yohei; Sakakura, Kenichi; Yamamoto, Kei; Yamamoto, Shingo; Taniguchi, Yousuke; Fujita, Hideo; Momomura, Shin-Ichi

2017-06-01

Side branch occlusion, which was one of the common complications in percutaneous coronary interventions, was closely associated with cardiac death and myocardial infarction. Clinical guidelines also support the importance of preservation of physiologic blood flow in SB during PCI to bifurcation lesions. In order to avoid side branch occlusion during stent implantation, we often performed the jailed wire technique, in which a conventional guide wire was inserted to the side branch before stent implantation to the main vessel. However, the jailed wire technique could not always prevent side branch occlusion. In this case report, we described a case of 72-year-old male suffering from angina pectoris. Coronary angiography revealed the diffuse calcified stenosis in the proximal and middle of left anterior descending coronary artery, and the large diagonal branch originated from the middle of the stenosis. To prevent side branch occlusion, we performed a novel side branch protection technique by using the Corsair microcatheter (Asahi Intecc, Nagoya, Japan). In this case report, we illustrated this "Jailed Corsair technique", and discussed the advantage compared to other side branch protection techniques such as the jailed balloon technique. Copyright © 2017 Elsevier Inc. All rights reserved.

Percutaneous coronary intervention with second-generation paclitaxel-eluting stents versus everolimus-eluting stents in United States contemporary practice (REWARDS TLX Trial).

PubMed

Waksman, Ron; Ghali, Magdi; Goodroe, Randy; Ryan, Thomas; Turco, Mark; Ring, Michael; McGarry, Thomas; Dobies, David; Shammas, Nicolas; Steinberg, Daniel H; Swymelar, Stacy; Kaneshige, Kimberly; Torguson, Rebecca

2012-10-15

Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study's primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs. Copyright © 2012 Elsevier Inc. All rights reserved.

New stent surface materials: the impact of polymer-dependent interactions of human endothelial cells, smooth muscle cells, and platelets.

PubMed

Busch, Raila; Strohbach, Anne; Rethfeldt, Stefanie; Walz, Simon; Busch, Mathias; Petersen, Svea; Felix, Stephan; Sternberg, Katrin

2014-02-01

Despite the development of new coronary stent technologies, in-stent restenosis and stent thrombosis are still clinically relevant. Interactions of blood and tissue cells with the implanted material may represent an important cause of these side effects. We hypothesize material-dependent interaction of blood and tissue cells. The aim of this study is accordingly to investigate the impact of vascular endothelial cells, smooth muscle cells and platelets with various biodegradable polymers to identify a stent coating or platform material that demonstrates excellent endothelial-cell-supportive and non-thrombogenic properties. Human umbilical venous endothelial cells, human coronary arterial endothelial cells and human coronary arterial smooth muscle cells were cultivated on the surfaces of two established biostable polymers used for drug-eluting stents, namely poly(ethylene-co-vinylacetate) (PEVA) and poly(butyl methacrylate) (PBMA). We compared these polymers to new biodegradable polyesters poly(l-lactide) (PLLA), poly(3-hydroxybutyrate) (P(3HB)), poly(4-hydroxybutyrate) (P(4HB)) and a polymeric blend of PLLA/P(4HB) in a ratio of 78/22% (w/w). Biocompatibility tests were performed under static and dynamic conditions. Measurement of cell proliferation, viability, glycocalix width, eNOS and PECAM-1 mRNA expression revealed strong material dependency among the six polymer samples investigated. Only the polymeric blend of PLLA/P(4HB) achieved excellent endothelial markers of biocompatibility. Data show that PLLA and P(4HB) tend to a more thrombotic response, whereas the polymer blend is characterized by a lower thrombotic potential. These data demonstrate material-dependent endothelialization, smooth muscle cell growth and thrombogenicity. Although polymers such as PEVA and PBMA are already commonly used for vascular implants, they did not sufficiently meet the criteria for biocompatibility. The investigated biodegradable polymeric blend PLLA/P(4HB) evidently represents a promising material for vascular stents and stent coatings. Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Interventional cardiology audit report for 2011.

PubMed

Baker, L

2012-10-01

In 2011 there were 658 percutaneous coronary intervention cases performed with more than 60% of the patients presenting to the hospital as an acute coronary syndrome. Most procedures consisted of balloon dilatation followed by stent deployment, and 93% of these stents were drug-eluting stents. Procedural success was achieved in 93.3% of cases and an overall major adverse cardiac events rate of 3.6%. This includes a mortality rate of (0.5%). In addition, there were 25 Core Valve procedures carried out. This is more than twice the amount of patients who had a transcatheter aortic valve implantation in 2010, reflecting the changing direction of the management of structural heart disease. © 2012 The Author; Internal Medicine Journal © 2012 Royal Australasian College of Physicians.

Simulation of blood flow using extended Boltzmann kinetic approach

NASA Astrophysics Data System (ADS)

Chen, Caixia; Chen, Hudong; Freed, David; Shock, Richard; Staroselsky, Ilya; Zhang, Raoyang; Ümit Coşkun, A.; Stone, Peter H.; Feldman, Charles L.

2006-03-01

Lattice Boltzmann (LB) simulations are conducted to obtain the detailed hydrodynamics in a variety of blood vessel setups, including a prototype stented channel and four human coronary artery geometries based on the images obtained from real patients. For a model of stented flow involving an S-shape stent, a pulsatile flow rate is applied as the inlet boundary condition, and the time- and space-dependent flow field is computed. The LB simulation is found to reproduce the analytical solutions for the velocity profiles and wall shear stress distributions for the pulsatile channel flow. For the coronary arteries, the distributions of wall shear stress, which is important for clinical diagnostic purposes, are in good agreement with the conventional CFD predictions.

Does the novel delivery system for the STENTYS self-apposing coronary stent increase the risk of stent edge dissections? Optical coherence tomography post stent findings.

PubMed

Lu, Huangling; Kalkman, Deborah N; Grundeken, Maik J; Tijssen, Jan G P; Wykrzykowska, Joanna J; de Winter, Robbert J; Koch, Karel T

2018-02-01

With optical coherence tomography (OCT), details of arterial injuries during percutaneous coronary intervention can be assessed accurately. There might be an increased risk of stent edge dissections with the novel delivery system for the STENTYS stent. We evaluated the prevalence of stent edge dissections using the novel Xposition delivery device as compared with the conventional delivery device. A total of 38 patients who were treated with the self-apposing STENTYS stent and with OCT assessment at our center were retrospectively analysed. Twenty patients were treated using the Xposition- and 18 using the conventional delivery device. OCT was performed according to study protocol. Frames with poor quality were excluded. A total of 12(18%) dissections were detected, 7(20%) in the Xposition delivery device group, and 5(15%) in the conventional group (p = 1). Using the Xposition delivery device 4(33%) dissections were found proximally, using the conventional delivery device 3(25%) (p = ns). Mean longitudinal dissection length was 2.07 ± 1.80mm, 8(67%) appeared as flaps, 4(33%) as cavities. Morphometric parameters were comparable in both groups. Detailed OCT assessment of stent edge dissections was possible, which revealed no large differences using the Xposition delivery device as compared with conventional delivery device, however large studies are warranted.

In vitro and in vivo cell-capture strategies using cardiac stent technology - A review.

PubMed

Ravindranath, Rohan R; Romaschin, Alexander; Thompson, Michael

2016-01-01

Stenosis is a symptom of coronary artery disease (CAD), and is caused by narrowing of arteries in the heart. Over the last several decades, medical implants such as cardiac stents have been developed to counter stenosis. Upon implantation of a stent to open up a restricted artery, narrowing of the artery can reoccur (restenosis), due to an immune response launched by the body towards the stent. Currently, restenosis is a major health concern for patients who have undergone heart surgery for coronary artery disease. Recently, there have been new methods developed to combat restenosis, which have shown potential signs of success. One proposed method is the use of stents to capture cells, thereby reducing immune response. This review will explore the different methods for cell capture both in vitro and in vivo. Biological modifications of the stent will be surveyed, as well as the use of surface science to immobilize biological probes. Immobilization of proteins and nucleotides, as well as use of magnetic field are all methods that will be further discussed. Finally, concluding remarks and future prospects will be presented. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Percutaneous coronary angioscopy and stents

NASA Astrophysics Data System (ADS)

Heuser, Richard R.

1994-05-01

With the expanding array of therapies available for coronary intervention, the invasive cardiologist has many choices for treating a specific lesion in an individual patient. Certain types of lesions might respond more effectively with stents, particularly the rigid Palmax- Schatz device. Thrombus and dissection immediately following stent placement are associated with early occlusion, and the interventionist must be able to assess their presence pre- and post-stenting. Angiography is deficient in quantifying minimal disease and in defining lesion architecture and composition, as well as the plaque rupture and thrombosis associated with unstable angina. It is also imprecise in detecting dissection and thrombus. Intravascular ultrasound (IVUS) provides high-resolution images that delineate irregularities and other structures inside the lumen and within the vessel wall and surrounding tissues. Like angiography, IVUS has limited specificity for thrombus differentiation. Angioscopy is superior to angiography and IVUS in detecting thrombus and dissection. Angioscopy allows the clinician to assess the appearance of stent struts after deployment and at follow-up. This may aid in reducing acute complications as well as restenosis. Follow-up angioscopy of stents to detect thrombus or exposed struts may guide therapy in a patient who has clinical symptoms of restenosis.

The impact of a 600-mg loading dose of clopidogrel in diabetic and non-diabetic patients undergoing elective PCI.

PubMed

Mohareb, Mina W; Abd Elghany, Mohamed; Sabry, Nirmeen A; Farid, Samar F

2016-08-01

High platelet reactivity (HPR) and suboptimal response to dual antiplatelet therapy (DAPT) may explain high recurrent rates of ischemic events in type 1 and 2 diabetes mellitus (DM) patients undergoing percutaneous coronary intervention (PCI). The aim of this study was to determine the effect of diabetes mellitus on clopidogrel activity in cardiac patients undergoing PCI. This is an observational study. Patients were categorized according to DM status into diabetic group (N.=30) and non-diabetic group (N.=33). All patients received clopidogrel in a loading dose of 600 mg before PCI. Platelet function was assessed using light transmittance aggregometry (LTA) technique at baseline (before clopidogrel administration), 24 hour after clopidogrel loading dose administration and 7-10 days after PCI. All patients were followed up for at least one year after PCI for recurrence of acute cardiac events. There was no statistically significant difference between the two groups with respect to 10 µm adenosine diphosphate (ADP)-induced platelet aggregation measured at baseline (P=0.64), 24 hours after PCI (P=0.874), and 7-10 days after PCI (0.643). Diabetics were not significantly different from non-diabetics in terms of post-PCI acute stent thrombosis (P=0.945), sub-acute stent thrombosis (P=0.945), unstable angina (P=0.29) and cardiac death (P=0.64). There was a statistically significant difference between patients with and without post-PCI acute events regarding ADP aggregation measured 24 hours and 7-10 days after PCI. The use of a high loading dose of clopidogrel (600 mg) in patients undergoing elective PCI can overcome the significant increase in post-PCI platelet aggregation and rate of acute cardiac events induced by diabetes mellitus as co-morbidity in those patients.

Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial.

PubMed

Han, Yaling; Guo, Jincheng; Zheng, Yang; Zang, Hongyun; Su, Xi; Wang, Yu; Chen, Shaoliang; Jiang, Tiemin; Yang, Ping; Chen, Jiyan; Jiang, Dongju; Jing, Quanmin; Liang, Zhenyang; Liu, Haiwei; Zhao, Xin; Li, Jing; Li, Yi; Xu, Bo; Stone, Gregg W

2015-04-07

The safety and efficacy of bivalirudin compared with heparin with or without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention (PCI) are uncertain. To determine if bivalirudin is superior to heparin alone and to heparin plus tirofiban during primary PCI. Multicenter, open-label trial involving 2194 patients with AMI undergoing primary PCI at 82 centers in China between August 2012 and June 2013. Patients were randomly assigned to receive bivalirudin with a post-PCI infusion (n = 735), heparin alone (n = 729), or heparin plus tirofiban with a post-PCI infusion (n = 730). Among patients treated with bivalirudin, a postprocedure 1.75 mg/kg/h infusion was administered for a median of 180 minutes (IQR, 148-240 minutes). The primary end point was 30-day net adverse clinical events, a composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or bleeding. Additional prespecified safety end points included the rates of acquired thrombocytopenia at 30 days, and stent thrombosis at 30 days and 1 year. Net adverse clinical events at 30 days occurred in 65 patients (8.8%) of 735 who were treated with bivalirudin compared with 96 patients (13.2%) of 729 treated with heparin (relative risk [RR], 0.67; 95% CI, 0.50-0.90; difference, -4.3%, 95% CI, -7.5% to -1.1%; P = .008); and 124 patients (17.0%) of 730 treated with heparin plus tirofiban (RR for bivalirudin vs heparin plus tirofiban, 0.52; 95% CI, 0.39-0.69; difference, -8.1%, 95% CI, -11.6% to -4.7%; P < .001). The 30-day bleeding rate was 4.1% for bivalirudin, 7.5% for heparin, and 12.3% for heparin plus tirofiban (P < .001). There were no statistically significant differences between treatments in the 30-day rates of major adverse cardiac or cerebral events (5.0% for bivalirudin, 5.8% for heparin, and 4.9% for heparin plus tirofiban, P = .74), stent thrombosis (0.6% vs 0.9% vs 0.7%, respectively, P = .77), acquired thrombocytopenia (0.1% vs 0.7% vs 1.1%; P = .07), or in acute (<24-hour) stent thrombosis (0.3% in each group). At the 1-year follow-up, the results remained similar. Among patients with AMI undergoing primary PCI, the use of bivalirudin with a median 3-hour postprocedure PCI-dose infusion resulted in a decrease in net adverse clinical events compared with both heparin alone and heparin plus tirofiban. This finding was primarily due to a reduction in bleeding events with bivalirudin, without significant differences in major adverse cardiac or cerebral events or stent thrombosis. clinicaltrials.gov Identifier: NCT01696110.

42 CFR 410.49 - Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage.

Code of Federal Regulations, 2012 CFR

2012-10-01

... rehabilitation treatment, and psychosocial evaluation of the individual's response to and rate of progress under... coronary artery bypass surgery; (iii) Current stable angina pectoris; (iv) Heart valve repair or replacement; (v) Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; (vi) A heart or...

42 CFR 410.49 - Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage.

Code of Federal Regulations, 2013 CFR

2013-10-01

... rehabilitation treatment, and psychosocial evaluation of the individual's response to and rate of progress under... coronary artery bypass surgery; (iii) Current stable angina pectoris; (iv) Heart valve repair or replacement; (v) Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; (vi) A heart or...

42 CFR 410.49 - Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage.

Code of Federal Regulations, 2014 CFR

2014-10-01

... rehabilitation treatment, and psychosocial evaluation of the individual's response to and rate of progress under... coronary artery bypass surgery; (iii) Current stable angina pectoris; (iv) Heart valve repair or replacement; (v) Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; (vi) A heart or...

Bypassing Bypass Surgery and Other Success Stories from the National Institutes of Health

PubMed Central

Nijhara, Ruchika; Tidwell, J. Lille; Ferguson, Steven; Balakrishnan, Krishna

2009-01-01

After a heart attack, patients often undergo a procedure to open up the clogged artery and install a tiny meshlike device called a stent to keep the artery propped open. In most cases, the body reacts to this foreign object with scar-tissue formation, and the artery narrows again. To combat this re-clogging process, National Institutes of Health inventors developed paclitaxel-coated stents and later licensed it to Angiotech. Approved by the Food and Drug Administration in March 2004, these stents are expected to substantially reduce the use of coronary artery bypass surgery, an expensive operation now performed annually on 350,000-plus Americans. This and three other examples of NIH licensing success stories are described in this paper: (a) Kepivance, which improves the quality of life for cancer patients by eliminating mouth sores, (b) AIDS drug ddI, an important component of many combination drug therapies, and (c) Vitravene, the first and only antisense drug to be approved by FDA. These four examples will illustrate the success not only of the NIH licensing program, but also the innovative approaches taken by NIH inventors and the persistence of its commercial partners. This paper also highlights the business and legal lessons learned from these four cases. PMID:23730679

When Not to Go SOLO? Contraindications Based on Implant Experience.

PubMed

Wollersheim, Laurens W; Li, Wilson W; Kaya, Abdullah; van Boven, Wim J; van der Meulen, Jan; de Mol, Bas A

2016-11-01

Because of the design and specific implantation technique of the stentless Freedom SOLO bioprosthesis, patient selection is crucial. The aim of the study was to discuss the contraindications to this prosthesis based on the authors' implant experience. Between April 2005 and February 2015, one surgeon at the authors' center performed 292 aortic valve replacements using a bioprosthesis, with the initial intention of implanting a SOLO valve in every patient. A search was conducted for all of these patients and data collected on whether a SOLO valve was used, or not. A SOLO valve was implanted in 238 patients (82%), and a stented bioprosthesis in 54 (18%). The predominant reasons not to implant a SOLO valve were asymmetric commissures (26%) and a large aortic annulus (24%). Only one patient had structural valve deterioration, and none of the patients had to undergo reoperation because of aortic valve insufficiency or paravalvular leakage. Asymmetric commissures, large aortic annulus (>27 mm), calcified aortic sinuses, dilated sinotubular junction, aberrant location of coronary ostia and whenever the stent of a stented bioprosthesis is useful, were contraindications to implant a SOLO valve. When these contraindications were taken into account, a very good durability could be achieved with the SOLO valve during mid-term follow up.

Heart imaging: the accuracy of the 64-MSCT in the detection of coronary artery disease.

PubMed

Alessandri, N; Di Matteo, A; Rondoni, G; Petrassi, M; Tufani, F; Ferrari, R; Laghi, A

2009-01-01

At present, coronary angiography represents the gold standard technique for the diagnosis of coronary artery disease. Our aim is to compare the conventional coronary angiography to the coronary 64-multislice spiral computed tomography (64-MSCT), a new and non-invasive cardiac imaging technique. The last generation of MSCT scanners show a better imaging quality, due to a greater spatial and temporal resolution. Four expert observers (two cardiologists and two radiologists) have compared the angiographic data with the accuracy of the 64-MSCT in the detection and evaluation of coronary vessels stenoses. From the data obtained, the sensibility, the specificity and the accuracy of the coronary 64-MSCT have been defined. We have enrolled 75 patients (57 male, 18 female, mean age 61.83 +/- 10.38; range 30-80 years) with known or suspected coronary artery disease. The above population has been divided into 3 groups: Group A (Gr. A) with 40 patients (mean age 60.7 +/- 12.5) affected by both non-significant and significant coronary artery disease; Group B (Gr. B) with 25 patients (mean age 60.3 +/- 14.6) who underwent to percutaneous coronary intervention (PCI); Group C (Gr. C) with 10 patients (mean age 54.20 +/- 13.7) without any coronary angiographic stenoses. All the patients underwent non-invasive exams, conventional coronary angiography and coronary 64-MSCT. The comparison of the data obtained has been carried out according to a per group analysis, per patient analysis and per segment analysis. Moreover, the accuracy of the 64-MSCT has been defined for the detection of >75%, 50-75% and <50% coronary stenoses. Coronary angiography has identified significant coronary artery disease in 75% of the patients in the Gr. A and in 73% of the patients in the Gr. B. No coronary stenoses have been detected in Gr. C. According to a per segment analysis, in Gr. A, 36% of the segments analysed have shown a coronary stenosis (37% stenoses >75%, 32% stenoses 50-75% and 31% stenoses <50%). In Gr. B, 32% of the segments have shown a coronary stenosis (33% stenoses >75%, 29% stenoses 50-75% and 38% stenoses <50%). In-stent disease has been shown in only 4 of the 29 coronary stents identified. In Gr. A, coronary 64-MSCT has confirmed the angiographic results in the 93% of cases (sensibility 93%, specificity 100%, positive predictive value 100% and negative predictive value 83%) while, in Gr. B, this confirm has been obtained only in 64% of cases (sensibility 64%, specificity 100%, positive predictive value 100% and negative predictive value 50%). In Gr. C, we have observed a complete agreement between angiographic and CT data (sensibility, specificity, positive predictive value and negative predictive value 100%). According to a per segment analysis, the angiographic results have been confirmed in 98% of cases in Gr. A (sensibility 98%, specificity 94%, positive predictive value 90% and negative predictive value 94%) but only in 55% of cases in Gr. B (sensibility 55%, specificity 90%, positive predictive value 71% and negative predictive value 81%). Moreover, only 1 of the 4 in-stent restenoses has been detected (sensibility 25%, specificity 100%, positive predictive value 100% and negative predictive value 77%). Coronary angiography has detected a greater number of coronary stenoses than the 64-MSCT. 64-MSCT has demonstrated better accuracy in the study of coronary vessels wider than 2 mm, while its accuracy is lower for smaller vessels (diameter < 2.5 mm) and for the identification of in-stent restenosis, because there is a reduced image quality for these vessels and therefore a lower accuracy in the coronary stenosis detection. Nevertheless, 64-MSCT shows high accuracy and it can be considered a comparative but not a substitutive exam of the coronary angiography. Several technical limitations of the 64-MSCT are responsible of its lower accuracy versus the conventional coronary angiography, but solving these technical problems could give us a new non-invasive imaging technique for the study of coronary stents.

Longitudinal Deformation of Distal Edge in a New-Generation Stent Caused by Guidewire Entrapment

PubMed Central

Taleb, Adam; Parikh, Gaurav

2018-01-01

Longitudinal stent deformation, described in some older stent geometries, prompted design modifications such as reinforcing struts on the proximal end. However, distal edges of stents—also subject to longitudinal force—have not been reinforced. We report a case of guidewire entrapment that deformed the distal edge of a new-generation stent during percutaneous coronary intervention, and we describe our efforts to restore the stent to its initial length. This case highlights the risk of manipulating equipment beyond the position of a newly deployed stent, the ongoing potential for deformation of distal edges in newer stent platforms, and the advisability of treating distal lesions before proximal ones. PMID:29556153

First report of atretic coronary sinus stenting in a 5-kg infant resulting in dramatic improvement of ventricular function in functional single ventricle.

PubMed

El-Said, Howaida; Hegde, Sanjeet; Moore, John

2014-01-01

The patient was a male infant with L-transposition of great arteries (L-TGA), Ebstein's anomaly of the tricuspid valve, subvalvar aortic stenosis, ventricular septal defect (VSD), hypoplastic right ventricle, arch hypoplasia, and congenital complete heart block. He underwent a Norwood procedure, aortic arch repair, permanent pacemaker implantation, and a 3.5-mm aortopulmonary shunt at 4 days of age. At the time of his surgery, left ventricular function was in the normal range (ejection fraction [EF] = 67%). However by 3 months of age, he was noted to have developed moderate-severe biventricular dysfunction (left ventricular ejection fraction [LVEF] = 34%). Atresia of the coronary sinus with a small left superior venacava (LSVC) and a bridging vein was discovered during cardiac catheterization at this time. The coronary sinus mean pressure was 17 mm Hg, and the common atrial mean pressure was 6 mmHg. We opened the atretic coronary sinus ostium using radiofrequency ablation and stent placement. There was dramatic improvement in ventricular function observed over a 2-month period. Follow-up cardiac catheterization 5 months later revealed the stent in the coronary sinus to be widely patent with no intimal buildup, and the ventricular function was normal (LVEF = 58%). The patient had a bidirectional Glenn procedure with an uncomplicated postoperative course and is currently awaiting Fontan completion. © 2013 Wiley Periodicals, Inc.

Cost-effectiveness of measuring fractional flow reserve to guide coronary interventions.

PubMed

Fearon, William F; Yeung, Alan C; Lee, David P; Yock, Paul G; Heidenreich, Paul A

2003-05-01

Most patients come to the catheterization laboratory without prior functional tests, which makes the cost-effective treatment of patients with intermediate coronary lesions a practical challenge. We developed a decision model to compare the long-term costs and benefits of 3 strategies for treating patients with an intermediate coronary lesion and no prior functional study: 1) deferring the decision for percutaneous coronary intervention (PCI) to obtain a nuclear stress imaging study (NUC strategy); 2) measuring fractional flow reserve (FFR) at the time of angiography to help guide the decision for PCI (FFR strategy); and 3) stenting all intermediate lesions (STENT strategy). On the basis of the literature, we estimated that 40% of intermediate lesions would produce ischemia, 70% of patients treated with PCI and 30% of patients treated medically would be free of angina after 4 years, and the quality-of-life adjustment for living with angina was 0.9 (1.0 = perfect health). We estimated the cost of FFR to be 761 dollars, the cost of nuclear stress imaging to be 1093 dollars, and the cost of medical treatment for angina to be 1775 dollars per year. The extra cost of splitting the angiogram and PCI as dictated by the NUC strategy was 3886 dollars by use of hospital cost-accounting data. Sensitivity and threshold analyses were performed to determine which variables affected our results. The FFR strategy saved 1795 dollars per patient compared with the NUC strategy and 3830 dollars compared with the STENT strategy. Quality-adjusted life expectancy was similar among the 3 strategies (NUC-FFR = 0.8 quality-adjusted days, FFR-STENT = 6 quality-adjusted life days). Compared with the FFR strategy, the NUC strategy was expensive (>800,000 dollars per quality-adjusted life year gained). Both screening strategies were superior to (less cost, better outcomes) the STENT strategy. Sensitivity analysis indicated that the NUC strategy would only become attractive (<50,000 dollars/quality-adjusted life years compared with FFR) if the specificity of nuclear stress imaging was >25% better than FFR. Our results were not altered significantly by changing the other assumptions. In patients with an intermediate coronary lesion and no prior functional study, measuring FFR to guide the decision to perform PCI may lead to significant cost savings compared with performing nuclear stress imaging or with simply stenting lesions in all patients.

Polymeric stent materials dysregulate macrophage and endothelial cell functions: implications for coronary artery stent

PubMed Central

Wang, Xintong; Zachman, Angela L.; Chun, Young Wook; Shen, Fang-Wen; Hwang, Yu-Shik; Sung, Hak-Joon

2014-01-01

Background Biodegradable polymers have been applied as bulk or coating materials for coronary artery stents. The degradation of polymers, however, could induce endothelial dysfunction and aggravate neointimal formation. Here we use polymeric microparticles to simulate and demonstrate the effects of degraded stent materials on phagocytic activity, cell death and dysfunction of macrophages and endothelial cells. Methods Microparticles made of low molecular weight polyesters were incubated with human macrophages and coronary artery endothelial cells (ECs). Microparticle-induced phagocytosis, cytotoxicity, apoptosis, cytokine release and surface marker expression were determined by immunostaining or ELISA. Elastase expression was analyzed by ELISA and the elastase-mediated polymer degradation was assessed by mass spectrometry. Results We demonstrated poly(D,L-lactic acid) (PLLA) and polycaprolactone (PCL) microparticles induced cytotoxicity in macrophages and ECs, partially through cell apoptosis. The particle treatment alleviated EC phagocytosis, as opposed to macrophages, but enhanced the expression of vascular cell adhesion molecule-1 (VCAM) along with decreased nitric oxide production, indicating ECs were activated and lost their capacity to maintain homeostasis. The activation of both cell types induced release of elastase or elastase-like protease, which further accelerated polymer degradation. Conclusions This study revealed that low molecule weight PLLA and PCL microparticles increased cytotoxicity and dysregulated endothelial cell function, which in turn enhanced elastase release and polymer degradation. These indicate polymer or polymer-coated stents impose a risk of endothelial dysfunction after deployment which can potentially lead to delayed endothelialization, neointimal hyperplasia and late thrombosis. PMID:24820736

Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial.

PubMed

de Waha, Suzanne; Allali, Abdelhakim; Büttner, Heinz-Joachim; Toelg, Ralph; Geist, Volker; Neumann, Franz-Josef; Khattab, Ahmed A; Richardt, Gert; Abdel-Wahab, Mohamed

2016-03-01

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel-eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long-term data of prospective head-to-head comparisons between both treatment strategies have been reported. ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2-year follow-up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2-year follow-up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.

Computer Simulations of Coronary Blood Flow Through a Constriction

DTIC Science & Technology

2014-03-01

interventional procedures (e.g., stent deployment). Building off previous models that have been partially validated with experimental data, this thesis... stent deployment). Building off previous models that have been partially validated with experimental data, this thesis continues to develop the...the artery and increase blood flow. Generally a stent , or a mesh wire tube, is permanently inserted in order to scaffold open the artery wall

Stenting of long coronary artery lesions: initial angiographic results and 6-month clinical outcome of the micro stent II-XL.

PubMed

Schalij, M J; Udayachalerm, W; Oemrawsingh, P; Jukema, J W; Reiber, J H; Bruschke, A V

1999-09-01

To evaluate the results of long Micro Stent II (MS-XL) implantations, 119 MS-XLs were implanted in 102 patients (age, 62.83 years). Nineteen stents (16%) were implanted in saphenous vein grafts; 100 stents (84%) were implanted in native coronary arteries. Twenty-five patients (25%) were treated because of acute myocardial infarction (AMI); 30 patients (29%) because of unstable angina or angina class IV, and 47 patients (46%) because of stable angina. Eighty-six de novo lesions (84%) and 16 restenotic lesions (16%) were treated. Indications for stent implantation include elective, 61 patients (60%); suboptimal balloon angioplasty result, 22 patients (21%); and bailout after balloon angioplasty, 19 patients (19%). Because of residual thrombus after stenting, 27 patients (26%) received abciximab. All patients received ticlopidin for 28 days and acetylsalicylic acid. One hundred and seventeen MS-XLs (98%) were implanted successfully. Additional (shorter) MS-II were implanted in 40 patients (39%). The stented segment length was 45 +/- 20 mm. The minimum lumen diameter increased from 0.5 +/- 0.5 mm before to 2.7 +/- 0.5 mm after stent implantation. The acute gain was 2.2 +/- 0.4 mm. Early clinical events (<4 weeks) include death, 3 (3%); subacute stent thrombosis, 1 (1%); non-Q-wave infarction, 2 (2%); CABG, 1 (1%); vascular complications, 2 (2%). Late clinical events (<6 months) include acute myocardial infarction, 5 (5%); reintervention, 6 (6%); CABG, 1 (1%). The procedural success rate was 88%, and the event free survival at 6 months was 76%. Stenting of long lesions with the MS-XL was successful and associated with an acceptable complication rate. Cathet. Cardiovasc. Intervent. 48:105-112, 1999. Copyright 1999 Wiley-Liss, Inc.

The impact of precise robotic lesion length measurement on stent length selection: ramifications for stent savings.

PubMed

Campbell, Paul T; Kruse, Kevin R; Kroll, Christopher R; Patterson, Janet Y; Esposito, Michele J

2015-09-01

Coronary stent deployment outcomes can be negatively impacted by inaccurate lesion measurement and inappropriate stent length selection (SLS). We compared visual estimate of these parameters to those provided by the CorPath 200® Robotic PCI System. Sixty consecutive patients who underwent coronary stent placement utilizing the CorPath System were evaluated. The treating physician assessed orthogonal images and provided visual estimates of lesion length and SLS. The robotic system was then used for the same measures. SLS was considered to be accurate when visual estimate and robotic measures were in agreement. Visual estimate SLSs were considered to be "short" or "long" if they were below or above the robotic-selected stents, respectively. Only 35% (21/60) of visually estimated lesions resulted in accurate SLS, whereas 33% (20/60) and 32% (19/60) of the visually estimated SLSs were long and short, respectively. In 5 cases (8.3%), 1 less stent was placed based on the robotic lesion measurement being shorter than the visual estimate. Visual estimate assessment of lesion length and SLS is highly variable with 65% of the cases being inaccurately measured when compared to objective measures obtained from the robotic system. The 32% of the cases where lesions were visually estimated to be short represents cases that often require the use of extra stents after the full lesion is not covered by 1 stent [longitudinal geographic miss (LGM)]. Further, these data showed that the use of the robotic system prevented the use of extra stents in 8.3% of the cases. Measurement of lesions with robotic PCI may reduce measurement errors, need for extra stents, and LGM. Copyright © 2015 Elsevier Inc. All rights reserved.

Tracking delivery of a drug surrogate in the porcine heart using photoacoustic imaging and spectroscopy

NASA Astrophysics Data System (ADS)

Furdella, Kenneth J.; Witte, Russell S.; Vande Geest, Jonathan P.

2017-04-01

Although the drug-eluting stent (DES) has dramatically reduced the rate of coronary restenosis, it still occurs in up to 20% of patients with a DES. Monitoring drug delivery could be one way to decrease restenosis rates. We demonstrate real-time photoacoustic imaging and spectroscopy (PAIS) using a wavelength-tunable visible laser and clinical ultrasound scanner to track cardiac drug delivery. The photoacoustic signal was initially calibrated using porcine myocardial samples soaked with a known concentration of a drug surrogate (DiI). Next, an in situ coronary artery was perfused with DiI for 20 min and imaged to monitor dye transport in the tissue. Finally, a partially DiI-coated stent was inserted into the porcine brachiocephalic trunk for imaging. The photoacoustic signal was proportional to the DiI concentration between 2.4 and 120 μg/ml, and the dye was detected over 1.5 mm from the targeted coronary vessel. Photoacoustic imaging was also able to differentiate the DiI-coated portion of the stent from the uncoated region. These results suggest that PAIS can track drug delivery to cardiac tissue and detect drugs loaded onto a stent with sub-mm precision. Future work using PAIS may help improve DES design and reduce the probability of restenosis.

Double bifurcation optimization stent system technique for left main stenosis.

PubMed

Vassilev, D; Mateev, H; Alexandrov, A; Karamfiloff, K; Gil, R J

2014-12-01

We present a first-in-man case with implantation in culottes' fashion of two dedicated coronary bifurcation stents (BiOSS Lim) in distal left main stenosis. The immediate procedural and very short-term result was excellent. © 2014, Wiley Periodicals, Inc.

Comparative cath-lab assessment of coronary stenosis by radiology technician, junior and senior interventional cardiologist in patients treated with coronary angioplasty.

PubMed

Brunetti, Natale Daniele; Delli Carri, Felice; Ruggiero, Maria Assunta; Cuculo, Andrea; Ruggiero, Antonio; Ziccardi, Luigi; De Gennaro, Luisa; Di Biase, Matteo

2014-03-01

Exact quantification of plaque extension during coronary angioplasty (PCI) usually falls on interventional cardiologist (IC). Quantitative coronary stenosis assessment (QCA) may be possibly committed to the radiology technician (RT), who usually supports cath-lab nurse and IC during PCI. We therefore sought to investigate the reliability of QCA performed by RT in comparison with IC. Forty-four consecutive patients with acute coronary syndrome underwent PCI; target coronary vessel size beneath target coronary lesion (S) and target coronary lesion length (L) were assessed by the RT, junior IC (JIC), and senior IC (SIC) and then compared. SIC evaluation, which determined the final stent selection for coronary stenting, was considered as a reference benchmark. RT performance with QCA support in assessing target vessel size and target lesion length was not significantly different from SIC (r = 0.46, p < 0.01; r = 0.64, p < 0.001, respectively) as well as JIC (r = 0.79, r = 0.75, p < 0.001, respectively). JIC performance was significantly better than RT in assessing target vessel size (p < 0.05), while not significant when assessing target lesion length. RT may reliably assess target lesion by using adequate QCA software in the cath-lab in case of PCI; RT performance does not differ from SIC.

Reduction of atherothrombotic burden before stent deployment in non-ST elevation acute coronary syndromes: Reduction of myocardial necrosis achieved with nose-dive manual thrombus aspiration (REMNANT) trial. A volumetric intravascular ultrasound study.

PubMed

Zimarino, Marco; Angeramo, Francesca; Prasad, Abhiram; Ruggieri, Benedetta; Malatesta, Sara; Prati, Francesco; Buttitta, Fiamma; De Caterina, Raffaele

2016-11-01

To test whether thrombus aspiration (TA) reduces the atherosclerotic burden in culprit lesions and "facilitate" percutaneous coronary intervention with stent (S-PCI) among patients with non-ST elevation acute coronary syndromes (NSTE-ACS). Evidence on the effects of TA adjunctive to S-PCI in NSTE-ACS is limited and controversial. TA was defined "aggressive" when using 7F devices or a catheter/artery ratio >0.6, "conservative" with 6F, and a catheter/artery ratio ≤0.6. Angiography and intravascular ultrasound (IVUS) were performed at baseline, after TA and after stent deployment. TA was accomplished in 61/76 patients (80%) with NSTE-ACS. The aspirated material was red thrombus in 23% and plaque fragments in 49% of cases. Compared with baseline, TA was associated with an 82% increase in minimal lumen diameter and a 15% reduction in diameter stenosis (P < 0.001 for both). After TA, IVUS documented a 24 and 16% increase in minimal lumen area and lumen volume, respectively (P < 0.001 for both), a 7% decrease in area stenosis through an 11% reduction of plaque + media volume (P < 0.001). When compared with "conservative", an "aggressive" TA was associated with a more pronounced reduction in percent area stenosis (P < 0.05) and an increase in percent stent expansion (P < 0.001). The plaque + media volume reduction after TA was correlated with stent expansion (r = 0.261, P = 0.046). Manual TA reduces atherothrombotic burden in culprit lesions of NSTE-ACS patients before S-PCI and, when deep plaque removal is obtained, TA optimizes subsequent stent expansion. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

The experience of totally endoscopic coronary bypass grafting with the robotic system «Da Vinci» in Russia

NASA Astrophysics Data System (ADS)

Efendiev, V. U.; Alsov, S. A.; Ruzmatov, T. M.; Mikheenko, I. L.; Chernyavsky, A. M.; Malakhov, E. S.

2015-11-01

A new technology - a thoracoscopic coronary bypass grafting with the use of Da Vinci robotic system in Russia is represented by the experience of NRICP. The technology was introduced in Russia in 2011. Overall, one hundred endoscopic coronary artery bypass procedures were performed. We have compared and analyzed results of coronary artery stenting vs minimally invasive coronary artery bypass grafting. According to the results, totally endoscopic coronary artery bypass grafting has several advantages over alternative treatment strategies.

Clinical analysis of lectin-like oxidized low-density lipoprotein receptor-1 in patients with in-stent restenosis after percutaneous coronary intervention.

PubMed

Liu, Junfeng; Liu, Yunde; Jia, Kegang; Huo, Zhixiao; Huo, Qianyu; Liu, Zhili; Li, Yongshu; Han, Xuejing; Wang, Rong

2018-04-01

In-stent restenosis (ISR) is the most common complication associated with percutaneous coronary intervention (PCI). Although some studies have reported an association between lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) and ISR, not enough clinical validation data are available to support this link. Here, we report our cross-sectional study aimed at exploring the feasibility of LOX-1 as a biomarker for the prognostic diagnosis of patients undergoing PCI.Three groups were included: ISR group, including 99 patients with ISR diagnosed with coronary arteriography (CAG) after PCI; lesion group, comprising 87 patients with coronary artery stenosis (<50%) diagnosed with CAG after PCI; and control group, consisting of 96 volunteers with no coronary artery disease. The levels of LOX-1 were measured in each patient by using an enzyme-linked immunosorbent assay, and their general information as well as laboratory parameters were recorded and followed up during a period of 2 years.LOX-1 levels gradually increased after PCI along with the progression of the lesion in the 3 groups. The levels of LOX-1 were significantly higher in the ISR group than in the other 2 groups (P < .001). LOX-1 levels were correlated with the levels of uric acid (UA) (r = 0.289, P = .007), creatinine (CREA) (r = .316, P = .003), and high-density lipoprotein cholesterol (HDL-C) (r = -0.271, P = .012), whereas no statistically significant correlation was detected with the Gensini score (r = 0.157, P = .141). The sensitivity and specificity of LOX-1 were 81.5% and 55.7%, respectively, with the most optimal threshold (5.04 μg/L). The area under curve (AUC) of the receiver operator characteristic (ROC) curve of LOX-1 was 0.720, and LOX-1 had the highest AUC compared with CREA, UA, and HDL-C, both individually and in combination.A high level of LOX-1 in the early period after PCI has a certain predictive power and diagnostic value for ISR. However, the level of LOX-1 is not related to the Gensini score of coronary artery after PCI, and CREA and UA, which are weakly related to LOX-1, have no obvious synergy in the diagnosis of ISR with LOX-1.

From debulking to delivery: sequential use of rotational atherectomy and Guidezilla™ for complex saphenous vein grafts intervention.

PubMed

Pellicano, Mariano; Floré, Vincent; Barbato, Emanuele; De Bruyne, Bernard

2018-06-19

Percutaneous coronary interventions (PCI) of old calcified saphenous vein grafts (SVGs) is challenging and is associated with a considerably high risk of adverse ischemic events in the short- and long-term as compared to native coronary arteries. We report a case in which a non-dilatable, calcified SVG lesion is successfully treated with rotational atherectomy followed by PCI and stenting with local stent delivery (LSD) technique using the Guidezilla™ guide extension catheter (5-in-6 Fr) in the "child-in-mother" fashion. A 70 years-old man with a dilated ischemic cardiomyopathy, triple coronary artery bypass grafting (CABG) in 1990 and chronic renal failure (baseline GFR: 45 ml/min/1.73 m 2 ) underwent a coronary angiography for a Non-ST segment elevation myocardial infarction (NSTEMI). Native coronary circulation was completely occluded at the proximal segments. Grafts angiography showed a tandem calcified lesions of SVG on distal right coronary artery (RCA) and an ostial stenosis of the SVG on first obtuse marginal branch (OM1). Left internal mammary artery on the mid left anterior descending artery was patent. Ad Hoc PCI of SVG on RCA was attempted. The proximal calcified stenosis has been crossed with a 1.5 x 12 mm balloon only with the support of Guidezilla™, however the non-compliant (NC) balloon 2.5 x 15 mm was unable to break the hard and calcified plaque. After several attempts, the procedure was interrupted with a suboptimal result. An elective transradial PCI of SVG on RCA with rotational atherectomy was performed. Two runs with 1.25 mm burr and 2 runs with 1.5 mm burr were carried out. Then, the use of distal anchoring balloon warranted support and tracking, made as centring rail for the advance of the tip of the "mother-and-child" catheter into the SVG. During slow deflation of the balloon, the Guidezilla™ was advanced distal to the stenoses to be stented, thus allowing the placement of two long drug eluting stents according to a LSD technique. Rotational atherectomy is a feasible option for non-dilatable stenoses in old SVGs when there is no evidence of thrombus or vessel dissection and the subsequent use of "mother-and-child" catheter has a key role, especially in case of radial approach, for long stents delivery.

Transradial primary angioplasty and stenting in Indian patients with acute myocardial infarction: acute results and 6-month follow-up.

PubMed

Ranjan, Alok; Patel, Tejas M; Shah, Sanjay C; Malhotra, Hemant; Patel, Rajni; Vayada, Nishith; Pothiwala, Rasesh; Fonseca, Keith; Tanwar, Narendra S

2005-01-01

Coronary angioplasty and stent implantation is effective as primary intervention in acute myocardial infarction. Because of fewer puncture site complications and improved patient comfort, transradial access has been increasingly used as an alternative to transfemoral access for percutaneous coronary interventions. We studied 103 patients (94 men, 9 women: mean age 52.5 +/- 11.96 years) with a diagnosis of acute myocardial infarction (<12 hours after onset), who underwent primary percutaneous coronary intervention. Transradial access was used in all patients with a normal Allen's test and transfemoral access was used additionally only if intra-aortic balloon counterpulsation was required. Follow-up duration was 6 months. Transradial access was successfully achieved in all patients. Radial artery cannulation took <2 min in more than 85% patients. During percutaneous coronary intervention, cannulation to balloon inflation times and total procedure times were 11.3 +/- 5.2 min and 19.9 +/- 10.8 min, respectively. Stents were implanted in 99 (96.1%) patients andplain balloon angioplastywas performed in 3.9%. The primary success rate was 98.1%, with no major bleeding complications. Total length of hospitalization averaged 2.4 +/- 0.8 days. In-hospital major adverse clinical events rate was 5.9%. Six-month clinical follow-up was achieved for 84 (86.6%) patients. Six (7.1%) patients died during follow-up. Follow-up coronary angiography was performed in 22 (26.2%) patients. After 6 months, 7 patients required revascularizationof the target lesion. The rate of survival without myocardial infarction, bypass surgery or repeat coronary angioplasty was 88.5% at 6 months. Transradial access may represent a safe and feasible technique for performing primary percutaneous coronary intervention with good acute results and without major bleeding complications.

2013 Aerospace Medical Certification Statistical Handbook

DTIC Science & Technology

2014-12-01

etc.), rheumatoid arthritis, unstable knee (locked knee, herniated meniscus, no patella) † Excludes cardiomyopathy, pacemaker, cardiac stents , cardiac...angioplasty with a stent 881 (0.46) 478 (0.40) 2,939 (1.14) 4,298 (0.75) Coronary angioplasty procedure 159 (0.08) 126 (0.10) 559

Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study).

PubMed

Sumaya, Wael; Parker, William A E; Fretwell, Rebekah; Hall, Ian R; Barmby, David S; Richardson, James D; Iqbal, Javaid; Adam, Zulfiquar; Morgan, Kenneth P; Gunn, Julian P; Mason, Annah E; Judge, Heather M; Gale, Christopher P; Ajjan, Ramzi A; Storey, Robert F

2018-06-06

Delayed onset of action of oral P2Y 12 inhibitors in ST-elevation myocardial infarction (STEMI) patients may increase the risk of acute stent thrombosis. Available parenteral anti-thrombotic strategies, to deal with this issue, are limited by added cost and increased risk of bleeding. We investigated the pharmacodynamic effects of a novel regimen of enoxaparin in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). Twenty patients were recruited to receive 0.75 mg/kg bolus of enoxaparin (pre-PPCI) followed by infusion of enoxaparin 0.75 mg/kg/6 h. At four time points (pre-anti-coagulation, end of PPCI, 2-3 hours into infusion and at the end of infusion), anti-Xa levels were determined using chromogenic assays, fibrin clots were assessed by turbidimetric analysis and platelet P2Y 12 inhibition was determined by VerifyNow P2Y12 assay. Clinical outcomes were determined 14 hours after enoxaparin initiation. Nineteen of 20 patients completed the enoxaparin regimen; one patient, who developed no-reflow phenomenon, was switched to tirofiban after the enoxaparin bolus. All received ticagrelor 180 mg before angiography. Mean (± standard error of the mean) anti-Xa levels were sustained during enoxaparin infusion (1.17 ± 0.06 IU/mL at the end of PPCI and 1.003 ± 0.06 IU/mL at 6 hours), resulting in prolonged fibrin clot lag time and increased lysis potential. Onset of platelet P2Y 12 inhibition was delayed in opiate-treated patients. No patients had thrombotic or bleeding complications. In conclusion, enoxaparin 0.75 mg/kg bolus followed by 0.75 mg/kg/6 h provides sustained anti-Xa levels in PPCI patients. This may protect from acute stent thrombosis in opiate-treated PPCI patients who frequently have delayed onset of oral P2Y 12 inhibition. Schattauer GmbH Stuttgart.

High-dose, single-bolus eptifibatide: a safe and cost-effective alternative to conventional glycoprotein IIb/IIIa inhibitor use for elective coronary interventions.

PubMed

Fischell, Tim A; Attia, Tamer; Rane, Santosh; Salman, Waddah

2006-10-01

Adjunctive pharmacotherapy with eptifibatide, a glycoprotein (GP) IIb/IIIa inhibitor, as an intravenous bolus followed by infusion has been shown to improve outcomes in elective coronary interventions (PCI). However, bleeding complications and costs have limited the routine adoption of this regimen. The goal of this study was to examine the safety, efficacy and cost-effectiveness of high-dose, single-bolus eptifibatide, without post-intervention infusion, in "real-world" patients undergoing elective PCI. We studied 401 patients with stable and unstable angina who were treated with a high-dose (20 mg), single bolus of eptifibatide plus heparin prior to the start of elective PCI. Exclusion criteria included recent MI, stenting of bypass graft(s), rotational atherectomy and/or brachytherapy. The primary study endpoints were major adverse clinical events (MACE), defined as the in-hospital and 30-day incidence of death from any cause, Q-wave or non-Q-wave MI, repeat target vessel revascularization and/or major bleeding complications. Relevant demographic and procedural characteristics included mean age: 66.4 +/- 11.2; male gender: 242/401 (61%); number of vessels treated per patient: 1.46 +/- 0.42; and number of stents deployed per patient: 1.82 +/- 0.65. In-hospital non-Q-wave MI (CPK and/or CPK-MB > 3 times the upper limit of normal) occurred in 7/401 patients (1.75%) and MACE was 2.25%. Major bleeding complications were seen in 2/401 patients (0.49%). There were 4 additional MACE events at 30-day follow up (total MACE and bleeding = 3.25%). The average anticoagulation cost was 66 dollars/patient. Intravenous eptifibatide, administered as a high-dose (20 mg) single-vial bolus, is a safe, effective and highly cost-effective alternative to the conventional regimens of bolus plus prolonged intravenous GP IIb/IIIa inhibitor infusion for patients undergoing elective PCI.

Effect of postprocedural full-dose infusion of bivalirudin on acute stent thrombosis in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: Outcomes in a large real-world population.

PubMed

Wang, Heyang; Liang, Zhenyang; Li, Yi; Li, Bin; Liu, Junming; Hong, Xueyi; Lu, Xin; Wu, Jiansheng; Zhao, Wei; Liu, Qiang; An, Jian; Li, Linfeng; Pu, Fanli; Ming, Qiang; Han, Yaling

2017-06-01

This study aimed to evaluate the effect of prolonged full-dose bivalirudin infusion in real-world population with ST-elevation myocardial infarction (STEMI). Subgroup data as well as meta-analysis from randomized clinical trials have shown the potency of postprocedural full-dose infusion (1.75 mg/kg/h) of bivalirudin on attenuating acute stent thrombosis (ST) after primary percutaneous coronary intervention (PCI). In this multicenter retrospective observational study, 2047 consecutive STEMI patients treated with bivalirudin during primary PCI were enrolled in 65 Chinese centers between July 2013 and May 2016. The primary outcome was acute ST defined as ARC definite/probable within 24 hours after the index procedure, and the secondary endpoints included total ST, major adverse cardiac or cerebral events (MACCE, defined as death, reinfarction, stroke, and target vessel revascularization), and any bleeding at 30 days. Among 2047 STEMI patients, 1123 (54.9%) were treated with postprocedural bivalirudin full-dose infusion (median 120 minutes) while the other 924 (45.1%) received low-dose (0.25 mg/kg/h) or null postprocedural infusion. A total of three acute ST (0.3%) occurred in STEMI patients with none or low-dose prolonged infusion of bivalirudin, but none was observed in those treated with post-PCI full-dose infusion (0.3% vs 0.0%, P=.092). Outcomes on MACCE (2.1% vs 2.7%, P=.402) and total bleeding (2.1% vs 1.4%, P=.217) at 30 days showed no significant difference between the two groups, and no subacute ST was observed. Post-PCI full-dose bivalirudin infusion is safe and has a trend to protect against acute ST in STEMI patients undergoing primary PCI in real-world settings. © 2017 John Wiley & Sons Ltd.

Airway complications after covered stent placement for malignant esophageal stricture: special reference to radiation therapy.

PubMed

Park, Ji Yeon; Shin, Ji Hoon; Song, Ho-Young; Yi, Seong Yoon; Kim, Jin Hyoung

2012-02-01

The purpose of this study was to evaluate the characteristics of airway complications and survival with special reference to radiation therapy in the care of patients undergoing covered stent placement for malignant esophageal strictures. A total of 208 patients who underwent stent placement with or without palliative radiation therapy for inoperable esophageal cancer were included. The endpoints were frequency, type, and management of airway complications; association between occurrence of airway complications and radiation therapy history; and differences in stent-to-complication interval and survival period after esophageal stenting between patients who underwent radiation therapy before and those who underwent radiation therapy after stent placement. Airway complications occurred in 23 patients (11.1%): 18 (78.3%) had esophagorespiratory fistula, three (13.0%) had airway narrowing, and two (8.7%) had both complications. The frequency of airway complications was significantly greater among patients who underwent RT than those who did not (p = 0.005) but was not significantly different between the radiation before stenting and radiation after stenting groups (p = 0.158). The median stent-to-complication interval and survival period after esophageal stenting were significantly shorter in the radiation before stenting group than in the radiation after stenting group (p = 0.002, p = 0.001). Esophagorespiratory fistula is much more common than airway narrowing as an airway complication. The rate of complications increases significantly in association with radiation therapy among patients with malignant esophageal stricture. Clinicians need to be aware of earlier airway complications and poorer prognosis among patients who undergo radiation therapy before placement of an esophageal stent than in patients who undergo radiation after stent placement.

B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease: Analysis from the EXCEL Trial.

PubMed

Redfors, Björn; Chen, Shmuel; Crowley, Aaron; Ben-Yehuda, Ori; Gersh, Bernard J; Lembo, Nicholas J; Brown, W Morris; Banning, Adrian P; Taggart, David P; Serruys, Patrick W; Kappetein, Arie Pieter; Sabik, Joseph F; Stone, Gregg W

2018-04-17

Background -Elevated B-type natriuretic peptide (BNP) is reflective of impaired cardiac function and is associated with worse prognosis among patients with coronary artery disease (CAD). We sought to assess the association between baseline BNP, adverse outcomes, and the relative efficacy of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with left main (LM) CAD. Methods -The EXCEL trial randomized patients with LMCAD and low or intermediate SYNTAX scores to PCI with everolimus-eluting stents versus CABG. The primary endpoint was the composite of all-cause death, myocardial infarction (MI) or stroke. We used multivariable Cox proportional hazards regression to assess the associations between normal versus elevated BNP (≥100 pg/mL), randomized treatment, and the 3-year risk of adverse events. Results -BNP at baseline was elevated in 410 of 1037 (39.5%) patients enrolled in EXCEL. Patients with elevated BNP levels were older and more frequently had additional cardiovascular risk factors and lower LVEF than those with normal BNP, but had similar SYNTAX scores. Patients with elevated BNP had significantly higher 3-year rates of the primary endpoint (18.6% vs. 11.7%, adjusted HR 1.62, 95% CI 1.16-2.28, P=0.005), and higher mortality (11.5% vs. 3.9%, adjusted HR 2.49, 95% CI 1.48-4.19, P=0.0006), both from cardiovascular and non-cardiovascular causes. In contrast, there were no significant differences in the risks of MI, stroke, ischemia-driven revascularization, stent thrombosis, graft occlusion, or major bleeding. A significant interaction (P interaction =0.03) was present between elevated versus normal BNP and treatment with PCI versus CABG for the adjusted risk of the primary composite endpoint at 3 years among patients with elevated BNP (adjusted HR for PCI versus CABG 1.54, 95% CI 0.96-2.47) versus normal BNP (adjusted HR 0.74, 95% CI 0.46-1.20). This interaction was stronger when log(BNP) was modeled as a continuous variable (P interaction =0.002). Conclusions -In the EXCEL trial, elevated baseline BNP levels in patients with LMCAD undergoing revascularization were independently associated with long-term mortality but not non-fatal adverse ischemic or bleeding events. The relative long-term outcomes after PCI vs. CABG for revascularization of LMCAD may be conditioned by the baseline BNP level. Clinical Trial Registration -URL: http://www.clinicaltrials.gov. Unique identifier: NCT01205776.

Local delivery of sirolimus nanoparticles for the treatment of in-stent restenosis.

PubMed

Zago, Alexandre C; Raudales, José C; Attizzani, Guilherme; Matte, Bruno S; Yamamoto, German I; Balvedi, Julise A; Nascimento, Ludmila; Kosachenco, Beatriz G; Centeno, Paulo R; Zago, Alcides J

2013-02-01

To test the local delivery of sirolimus nanoparticles following percutaneous transluminal coronary angioplasty (PTCA) to treat in-stent restenosis (ISR) in a swine model. Coronary bare-metal stent (BMS) implantation reduces major adverse cardiac events when compared with PTCA; however, ISR rates remain high. Eighteen swine underwent BMS deployment guided by intravascular ultrasound (IVUS). Of these, 16 developed ISR (1 stent/swine) and underwent angioplasty with a noncompliant balloon (PTCA-NC). The animals were then randomized into four groups for local infusion of sirolimus nanoparticles through a porous balloon catheter, as follows: (1) PTCA-NC alone (control); (2) PTCA-NC + (polylactic acid)-based nanoparticle formulation (anionic 1); (3) PTCA-NC + (polylactic-co-glycolic acid)-based nanoparticle formulation (anionic 2); and (4) PTCA-NC + Eudragit RS nanoparticle formulation (cationic). Coronary angiography and IVUS follow-up were performed 28 days after ISR treatment. There was one episode of acute coronary occlusion with the cationic formulation. Late area loss was similar in all groups at 28 days according to IVUS. However, luminal volume loss (control = 20.7%, anionic 1 = 4.0%, anionic 2 = 6.7%, cationic = 9.6%; P = 0.01) and neointimal volume gain (control = 68.7%, anionic 1 = 17.4%, anionic 2 = 29.5%, cationic = 31.2%; P = 0.019) were significantly reduced in all treatment groups, especially in anionic 1. PTCA-NC followed by local infusion of sirolimus nanoparticles was safe and efficacious to reduce neointima in this model, and this strategy may be a promising treatment for BMS ISR. Further studies are required to validate this method in humans. Copyright © 2012 Wiley Periodicals, Inc.

The impact of generic clopidogrel bisulfate on platelet inhibition in patients with coronary artery stents: results of the ACCEL-GENERIC study.

PubMed

Jeong, Young-Hoon; Koh, Jin-Sin; Kang, Min-Kyung; Ahn, Yeon-Jeong; Kim, In-Suk; Park, Yongwhi; Hwang, Seok-Jae; Kwak, Choong Hwan; Hwang, Jin-Yong

2010-06-01

In patients with coronary artery stents, the cost of clopidogrel has been cited as a factor in the premature discontinuation of therapy. Thus, the introduction of lower-cost generic clopidogrel may increase patient compliance. However, platelet inhibition by generic clopidogrel has not been compared to the original clopidogrel formulation in patients with coronary artery stents. We prospectively enrolled 20 patients receiving chronic therapy with the original clopidogrel bisulfate (Plavix). After assessing patient compliance with Plavix, maintenance therapy was switched to generic clopidogrel bisulfate (Plavitor). Platelet reactivity was assessed at baseline and 30-day after the switch using conventional aggregometry and the VerifyNow P2Y12 assay. All patients completed maintenance therapy with Plavitor. Before and after switching therapy maximal (36.5 +/- 7.9% vs. 39.8 +/- 16.2%, p = 0.280) and late platelet aggregation (23.5 +/- 10.9% vs. 29.1 +/- 18.3%, p = 0.156) with 5 micromol/L adenosine diphosphate (ADP) stimulus did not differ. Likewise, 20 micromol/L ADP-induced platelet aggregation and P2Y12 reaction unit in patients on Plavitor therapy was comparable to that in patients on Plavix therapy. However, Bland-Altman analysis showed wide limits of agreement between measured platelet reactivity on Plavix vs. Plavitor therapies. Among patients on Plavix maintenance therapy with coronary stents, replacement with Plavitor shows a comparable inhibition of ADP-induced platelet aggregation. However, due to poor inter-therapy agreement, between two regimens, physicians may be cautious when introducing generic clopidogrel bisulfate.

Diagnostic accuracy of dual-source computed tomography angiography for the detection of coronary in-stent restenosis: A systematic review and meta-analysis.

PubMed

Liu, Wen-Jun; Li, Gui-Zhen; Liu, Hai-Feng; Lei, Jun-Qiang

2018-04-01

We sought to perform a meta-analysis to comprehensively evaluate the diagnostic accuracy of dual-source computed tomography angiography (DSCTA) in detecting coronary in-stent restenosis (CISR) when compared to invasive coronary angiography. The stent-based research studies in which DSCTA was used as diagnostic tool for CISR, as recent as of October 2017, from several reputed scientific libraries (PubMed, Embase, Scopus, The Cochrane Library, and Web of Science) were evaluated. Study inclusion, data extraction, and risk bias assessment were conducted by two researchers independently. Pooled sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under summary receiver operator characteristics (SROC) curve (AUC) were calculated to assess the diagnostic value. In addition, heterogeneity and subgroup analysis were also carried out. A total of 13 studies with a total of 894 patients and 1384 assessable stents were included. The pooled results of DSCTA diagnosing CISR were as follows: SEN 0.92 (95% confidence interval [CI] 0.87-0.96), SPE 0.91 (95% CI 0.87-0.94), PLR 9.83 (95% CI 6.93-13.94), NLR 0.09 (95% CI 0.05-0.15), DOR 114.73 (95% CI 64.12-205.28), and AUC 0.97 (95% CI 0.95-0.98), respectively. The subgroup analysis result suggested that DSTCA performed significantly better in CISR detection when the stent diameter was ≥3 mm compared with the stent diameter <3 mm: (0.98 [0.97-0.99] vs 0.82 [0.79-0.86]) with P < .05. This study revealed that DSCTA has excellent diagnostic performance for detecting CISR and may serve as an alternative for further patient evaluation with CISR, especially for stent diameter ≥3 mm. © 2018 Wiley Periodicals, Inc.

Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: two-year insights from the APPOSITION III (A Post-Market registry to assess the STENTYS self-exPanding COronary Stent In AcuTe MyocardIal InfarctiON) registry.

PubMed

Lu, Huangling; Grundeken, Maik J; Vos, Nicola S; IJsselmuiden, Alexander J J; van Geuns, Robert-Jan; Wessely, Rainer; Dengler, Thomas; La Manna, Alessio; Silvain, Johanne; Montalescot, Gilles; Spaargaren, René; Tijssen, Jan G P; Amoroso, Giovanni; de Winter, Robbert J; Koch, Karel T

2017-08-04

The APPOSITION III registry evaluated the feasibility and performance of the STENTYS self-apposing stent in an ST-segment elevation myocardial infarction (STEMI) population. This novel self-apposing stent device lowers stent strut malapposition rates and therefore carries the potential to prevent stent undersizing during primary percutaneous coronary intervention (PCI) in STEMI patients. To date, no long-term data are available using this device in the setting of STEMI. We aimed to evaluate the long-term clinical outcomes of the APPOSITION III registry. This was an international, prospective, multicentre post-marketing registry. The study population consisted of 965 STEMI patients. The primary endpoint, major adverse cardiac events (MACE), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR). At two years, MACE occurred in 11.2%, cardiac death occurred in 2.3%, TV-MI occurred in 2.3% and CD-TLR in 9.2% of patients. The two-year definite stent thrombosis (ST) rate was 3.3%. Incremental event rates between one- and two-year follow-up were 1.0% for TV-MI, 1.8% for CD-TLR, and 0.5% for definite ST. Post-dilation resulted in significantly reduced CD-TLR and ST rates at 30-day landmark analyses. Results were equivalent between the BMS and PES STENTYS subgroups. This registry revealed low rates of adverse events at two-year follow-up, with an incremental ST rate as low as 0.5% in the second year, demonstrating that the self-apposing technique is feasible in STEMI patients on long-term follow-up while using post-dilatation.

Biomimicry, vascular restenosis and coronary stents.

PubMed

Schwartz, R S; van der Giessen, W J; Holmes, D R

1998-01-01

Biomimicry is in its earliest stages and is being considered in the realm of tissue engineering. If arterial implants are to limit neointimal thickening, purely passive structures cannot succeed. Bioactivity must be present, either by pharmacologic intervention or by fabricating a 'living stent' that contains active cellular material. As tissue engineering evolves, useful solutions will emerge from applying this knowledge directly to vascular biologic problems resulting from angioplasty, stenting, and vascular prosthesis research.

Nitric Oxide Releasing Coronary Stent: A New Approach Using Layer-by-Layer Coating and Liposomal Encapsulation.

PubMed

Elnaggar, Mahmoud A; Seo, Seong Ho; Gobaa, Samy; Lim, Kyung Seob; Bae, In-Ho; Jeong, Myung Ho; Han, Dong Keun; Joung, Yoon Ki

2016-11-01

The sustained or controlled release of nitric oxide (NO) can be the most promising approach for the suppression or prevention of restenosis and thrombosis caused by stent implantation. The aim of this study is to investigate the feasibility in the potential use of layer-by-layer (LBL) coating with a NO donor-containing liposomes to control the release rate of NO from a metallic stent. Microscopic observation and surface characterizations of LBL-modified stents demonstrate successful LBL coating with liposomes on a stent. Release profiles of NO show that the release rate is sustained up to 5 d. In vitro cell study demonstrates that NO release significantly enhances endothelial cell proliferation, whereas it markedly inhibits smooth muscle cell proliferation. Finally, in vivo study conducted with a porcine coronary injury model proves the therapeutic efficacy of the NO-releasing stents coated by liposomal LBL technique, supported by improved results in luminal healing, inflammation, and neointimal thickening except thrombo-resistant effect. As a result, all these results demonstrate that highly optimized release rate and therapeutic dose of NO can be achieved by LBL coating and liposomal encapsulation, followed by significantly efficacious outcome in vivo. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology.

PubMed

Räber, Lorenz; Mintz, Gary S; Koskinas, Konstantinos C; Johnson, Thomas W; Holm, Niels R; Onuma, Yoshinubo; Radu, Maria D; Joner, Michael; Yu, Bo; Jia, Haibo; Menevau, Nicolas; de la Torre Hernandez, Jose M; Escaned, Javier; Hill, Jonathan; Prati, Francesco; Colombo, Antonio; di Mario, Carlo; Regar, Evelyn; Capodanno, Davide; Wijns, William; Byrne, Robert A; Guagliumi, Giulio

2018-05-22

This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.

Neuropsychological outcome after percutaneous coronary intervention or coronary artery bypass grafting: results from the Stent or Surgery (SoS) Trial.

PubMed

Währborg, Peter; Booth, Jean E; Clayton, Tim; Nugara, Fiona; Pepper, John; Weintraub, William S; Sigwart, Ulrich; Stables, Rod H

2004-11-30

Coronary artery bypass surgery (CABG) has been associated with a range of neurological and neuropsychological complications from stroke to cognitive problems such as memory and problem solving disturbance. However, little is known about the impact of percutaneous coronary intervention (PCI) on neuropsychological outcome. In the Stent or Surgery Trial (SoS), 988 patients were randomized in equal proportions between PCI supported by stent implantation and CABG. As a substudy of this trial, we undertook an evaluation of neurological and neuropsychological outcomes after intervention. A clinical examination and neuropsychological assessment consisting of 5 tests (Digit Span Forwards and Backwards, Visual Reproduction, Bourdon, and Block Design) were performed at baseline and 6 and 12 months after the procedure. A total of 145 patients were included in the substudy analysis: 77 in the PCI group and 68 in the CABG group. One patient in the PCI arm had a stroke. There was no significant difference between treatment groups at 6 and 12 months for any of the 5 tests. The mean change from baseline was also similar in both groups. We were not able to demonstrate an important and significant difference in neuropsychological outcome in patients treated with different revascularization strategies. This important finding needs to be examined in further research.

Coronary Artery Bypass Surgery Versus Drug-Eluting Stent Implantation for Left Main or Multivessel Coronary Artery Disease: A Meta-Analysis of Individual Patient Data.

PubMed

Lee, Cheol Whan; Ahn, Jung-Min; Cavalcante, Rafael; Sotomi, Yohei; Onuma, Yoshinobu; Suwannasom, Pannipa; Tenekecioglu, Erhan; Yun, Sung-Cheol; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Serruys, Patrick W; Park, Seung-Jung

2016-12-26

The authors undertook a patient-level meta-analysis to compare long-term outcomes after coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in 3,280 patients with left main or multivessel coronary artery disease (CAD). The relative efficacy and safety of CABG versus PCI with DES for left main or multivessel CAD remain controversial. Data were pooled from the BEST (Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease), PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trials. The primary outcome was a composite of all-cause death, myocardial infarction, or stroke. The median follow-up was 60 months, and follow-up was completed for 96.2% of patients. The rate of primary outcome was significantly lower with CABG than with PCI (13.0% vs. 16.0%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.69 to 1.00; p = 0.046). The difference was mainly driven by reduction in myocardial infarction (HR: 0.46; 95% CI: 0.33 to 0.64; p < 0.001). There was significant interaction between treatment effect and types of CAD, showing CABG to be superior compared with PCI with DES in patients with multivessel CAD (p = 0.001), but no between-group difference in those with left main CAD (p = 0.427). The rates for all-cause death and stroke were similar between the 2 groups. By contrast, the need for repeat revascularization was significantly lower in the CABG group compared with the PCI group. CABG, as compared with PCI with DES, reduced long-term rates of the composite of all-cause death, myocardial infarction, or stroke in patients with left main or multivessel CAD. The advantage of CABG over PCI with DES was particularly pronounced in those with multivessel CAD. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.