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Sample records for sirolimus-eluting coronary stents

  1. Sirolimus-eluting coronary stents: a review

    PubMed Central

    Abizaid, Alexandre

    2007-01-01

    The sirolimus-eluting coronary stent received CE Mark approval in Europe in April 2002. In the US, FDA approval followed in April 2003. Since the preliminary results from the First-in-Man feasibility study were presented, several randomized, controlled trials have documented the profound antiproliferative effects of sirolimus, a macrolide antibiotic and potent cytostatic inhibitor of smooth muscle cell proliferation. Subsequently, the body of clinical evidence was increased by the second wave of evidence from trials in more complex lesions (such as in-stent restenosis, small vessels, chronic total occlusions) and “high-risk” patients such as those with diabetes. More recently we have had the opportunity to compare the two commercially available drug-eluting stents following the presentation of data from six head-to-head trials. As a result of numerous single and multi-center, national and international studies in which the safety and efficacy of sirolimus-eluting coronary stents have been subjected to close scrutiny, the global interventional cardiology community now has a wealth of evidence in support of the use of this technology resulting in dramatically improved patient outcomes after percutaneous intervention. PMID:17580729

  2. Economic evaluation of sirolimus-eluting stents

    PubMed Central

    Shrive, Fiona M.; Manns, Braden J.; Galbraith, P. Diane; Knudtson, Merril L.; Ghali, William A.

    2005-01-01

    Background Sirolimus-eluting stents have recently been shown to reduce the risk of restenosis among patients who undergo percutaneous coronary intervention (PCI). Given that sirolimus-eluting stents cost about 4 times as much as conventional stents, and considering the volume of PCI procedures, the decision to use sirolimus-eluting stents has large economic implications. Methods We performed an economic evaluation comparing treatment with sirolimus-eluting and conventional stents in patients undergoing PCI and in subgroups based on age and diabetes mellitus status. The probabilities of transition between clinical states and estimates of resource use and health-related quality of life were derived from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) database. Information on effectiveness was based on a meta-analysis of randomized controlled clinical trials (RCTs) comparing sirolimus-eluting and conventional stents. Results Cost per quality-adjusted life year (QALY) gained in the baseline analysis was Can$58 721. Sirolimus-eluting stents were more cost-effective in patients with diabetes and in those over 75 years of age, the costs per QALY gained being $44 135 and $40 129, respectively. The results were sensitive to plausible variations in the cost of stents, the estimate of the effectiveness of sirolimus-eluting stents and the assumption that sirolimus-eluting stents would prevent the need for cardiac catheterizations in the subsequent year when no revascularization procedure was performed to treat restenosis. Interpretation The use of sirolimus-eluting stents is associated with a cost per QALY that is similar to or higher than that of other accepted medical forms of therapy and is associated with a significant incremental cost. Sirolimus-eluting stents are more economically attractive for patients who are at higher risk of restenosis or at a high risk of death if a second revascularization procedure were to be required

  3. 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.

  4. Safety and efficacy of the Yukon Choice Flex sirolimus-eluting coronary stent in an all-comers population cohort

    PubMed Central

    Xhepa, E.; Tada, T.; Cassese, S.; King, L.; Ott, I.; Fusaro, M.; Kastrati, A.; Byrne, R.A.

    2014-01-01

    Aims The use of biodegradable-polymer drug-eluting stents has been shown to provide favorable results when compared with durable polymer drug-eluting stents and long-term follow up data have recently shown significant reductions in terms of very late stent thrombosis. Aim of the present study was to assess the safety and efficacy profile of a novel biodegradable polymer DES, the Yukon Choice Flex sirolimus-eluting stent. Methods We report here the one-year clinical outcomes associated with the use of the Yukon Choice Flex sirolimus-eluting stent in an all-comers patient population. The present stent represents a further refinement of the stent platform tested in the ISAR TEST 3 and 4 randomized clinical trials. A total of 778 consecutive patients undergoing implantation of this stent were enrolled in the present observational study and prospectively followed for one year. Results The use of the Yukon Choice Flex stent in a patient population with complex coronary lesion morphology was associated with optimal immediate angiographic results. At one year follow up the rates of death, myocardial infarction, definite stent thrombosis and ischemia-driven target lesion revascularization were respectively 2.4%, 1.9%, 0.3% and 11.3%. Conclusions The use of the sirolimus-eluting biodegradable polymer Yukon Choice Flex stent in an all-comers population of patients with complex coronary artery disease is associated with a favorable safety and efficacy profile up to one year follow up. PMID:24973842

  5. Experience with Biodegradable Polymer Coated Sirolimus-Eluting Coronary Stent System in “Real-Life” Percutaneous Coronary Intervention: 24-Month Data from the Manipal-S Registry

    PubMed Central

    Shetty, Ranjan; Vivek, G.; Thakkar, Ashok; Mishra, Supriya Sunder; Joseph, Vivek; Devraj, Mithun Gopal; Tumkur, Anil; Pai, Umesh

    2013-01-01

    Introduction: Despite the undeniable clinical efficacy of drug-eluting stents with durable polymers, concerns regarding their long-term safety have been raised, especially in more complex subsets. The Manipal-S Registry was designed to evaluate the safety and effectiveness of the biodegradable polymer coated Supralimus® Sirolimus-Eluting Coronary Stent for the treatment of coronary artery disease, across a wide range of patients who are treated in real-life clinical practice. Methods: All the consecutive 116 patients who underwent single-vessel or multiple vessel percutaneous coronary interventions with the use of Supralimus® sirolimus-eluting stents between September 2009 and December 2010, were included in this study. Patients were clinically followed-up at 1, 9, 12 and 24 months post-procedure. All clinical, procedural, and follow-up information were collected and analysed. Results: In total 116 patients, 126 lesions were implanted with 144 stents which had an average stent length of 25.8±8.0 mm. The incidences of any major adverse cardiac and cerebral events at 1, 9, 12 and 24 months were 0, 5 (4.3%), 8 (6.9%), and 10 (8.6%) respectively. Conclusion: These 24-month results clearly provide evidence for safety and effectiveness of the Supralimus® Sirolimus-eluting coronary stent system with the biodegradable polymer in real-life patients, even in those with acute myocardial infarctions. PMID:24179909

  6. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

    PubMed

    Kandzari, David E; Mauri, Laura; Koolen, Jacques J; Massaro, Joseph M; Doros, Gheorghe; Garcia-Garcia, Hector M; Bennett, Johan; Roguin, Ariel; Gharib, Elie G; Cutlip, Donald E; Waksman, Ron

    2017-08-25

    The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of

  7. ISR II study: a long-term evaluation of sirolimus-eluting stent in the treatment of patients with in-stent restenotic native coronary artery lesions.

    PubMed

    Commeau, Philippe; Barragan, Paul T; Roquebert, Pierre O; Siméoni, Jean B

    2005-10-01

    The aim of this pilot study was to determine the safety and long-term efficacy of treating intrastent restenosis (ISR) with the slow-release sirolimus-eluting stent Bx Velocity (Cypher stent) without intravascular ultrasound (IVUS) guidance. Of patients who received a bare metal stent implantation and presented an ISR, 30-80% of the patients will develop a second restenosis within the stent, at the stent edges or both. To date, intravascular brachytherapy using beta- and gamma-radiation has been the only effective treatment for ISR. Twenty-three patients with ISR and evidence of ischemia were treated with Cypher stent. Clinical information was collected 1, 8, 12, and 24 months after stent implantation. During the first 8 months of the study, in-stent lumen diameter remained essentially unchanged from postprocedure in 80% of the case. The target lesion repeat revascularization (TLR) was 17%, of which 50% were oculostenotic reflexes. Only one patient presented a restenosis greater than 70%. During the 2-year study period, the TLR rate was 17%; the major adverse coronary event rate was 26%, and the non-Q-wave myocardial infarction (MI) rate was 9%. There were no reports of death, coronary artery bypass grafting, or Q-wave MI during the study. This study demonstrates the feasibility of using sirolimus-eluting stents without IVUS guidance for the treatment of ISR, providing long-term stability of immediate results.

  8. One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial

    PubMed Central

    van Hout, B A; Serruys, P W; Lemos, P A; van den Brand, M J B M; Es, G-A van; Lindeboom, W K; Morice, M-C

    2005-01-01

    Objective: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. Design: Multicentre, double blind, randomised trial Setting: Percutaneous coronary intervention for single de novo coronary lesions Patients: 238 patients with stable or unstable angina. Interventions: Randomisation to sirolimus eluting stent or bare stent implantation. Main outcome measures: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. Results: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of €1286. At one year, however, the estimated additional cost difference had decreased to €54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at €166. Conclusions: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined. PMID:15772214

  9. Sirolimus-Eluting Stents vs Uncoated Stents for the Treatment of Proximal Left Anterior Descending Coronary Artery Stenosis

    PubMed Central

    Valencia, José; Mainar, Vicente; Bordes, Pascual; Berenguer, Alberto; Ruiz-Nodar, Juan Miguel; Pineda, Javier; Gomez, Silvia; Sogorb, Francisco; Caturla, Juan

    2007-01-01

    Sirolimus-eluting stents (SES) have demonstrated low incidence of target vessel revascularizations in several anatomic scenarios, including proximal left anterior descending coronary artery (pLAD) lesions. The aim of present study was to compare the efficacy of SES with bare metal stents (BMS) for the treatment of such lesions. 96 patients with severe pLAD stenosis treated with SES were included. Clinical follow-up were performed during a 24 month period. A 98 patient sample with pLAD lesions treated with BMS was taken as control group. Death, angiographic restenosis, new target lesion revascularization (TLR) and target vessel failure (TVF) were registered. Clinical, angiographic and procedural variables were analysed to identify predictors of TVF and TLR. Angiographic procedural success was 100% in SES group vs 99% in BMS group (p=1.0). At 2.5 years, the cumulative rate of TVF was 9.4% in SES group vs 16.3% in BMS group (p=0.15), and the rate of TLR was 5.2% in SES group vs 12.2% in control group (p=0.08). The probabilities of cumulative TVF and TLR free survival were in BMS group 83.7% and 87.8%, and in SES group 90.6% and 94.8%, respectively. After multivariate analysis only SES utilization was found as independent protective factor against TVF and TLR (HR 0.38, 95%CI [0.15-0.94] p=0.037 and HR 0.21, 95%CI [0.06-0.66] p=0.008, respectively), and diabetes as independent predictor of TFV and TLR (HR 2.37, 95%CI [1.07-5.24] p=0.034 and HR 3.57, 95%CI [1.29-9.87] p=0.014, respectively). This study demonstrates that SES utilization is safe and effective in the tretament of pLAD lesions with a better clinical outcome than BMS in a long-term follow-up. PMID:23675052

  10. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation.

    PubMed

    Koppara, Tobias; Joner, Michael; Bayer, Gerd; Steigerwald, Kristin; Diener, Tobias; Wittchow, Eric

    2012-06-01

    Biodegradable stent coatings were recently introduced as a potential solution to overcome sustained inflammatory responses observed with permanent polymer-based drug-eluting stents. In a preliminary study, selected biodegradable or permanent polymer-based sirolimus-eluting stent (SES) formulations were screened for effectiveness in comparison to bare metal stents (BMS) at 28 days. Subsequently, the most favourable SES formulation was compared to commercially available SES (Cypher™) at 28, 90 and 180 days to investigate the histopathologic response as well as tissue, blood and organ pharmacokinetics. Overlapping SES implantation was conducted to evaluate vascular healing at 28 days in this particular setting. SES with biodegradable poly (L-lactide) polymer (PLLA) or poly(lactide-co-glycolide) showed the most favourable outcome with regards to reductions in neointimal area in comparison to BMS at 28 days. The PLLA SES showed a similar reduction in neointimal area compared to Cypher™ at 28 days, with significant greater reductions at 90 and 180 days (1.7 ± 0.7 mm² vs. 3.1 ± 1.5 mm², p=0.03 and 1.8 ± 1.2 mm² vs. 3.0 ± 1.5 mm², p=0.01, respectively). Sirolimus vascular tissue concentrations were detectable up to 90 days following implantation. Overlapping stented segments showed favourable histopathologic results with respect to fibrin deposition and endothelialisation at 28 days. In conclusion, the use of PLLA as drug-eluting matrix resulted in mild inflammatory responses in the presence of effective sirolimus tissue concentrations. The greater efficacy observed at long-term follow-up in PLLA SES compared to Cypher™ may be a multifactorial result of stent design, polymer biocompatibility and improved release kinetics.

  11. Late-acquired stent malapposition after sirolimus-eluting stent implantation following acute coronary syndrome: angiographic, IVUS, OCT and coronary angioscopic observation.

    PubMed

    Rathore, Sudhir; Terashima, Mitsuyasu; Suzuki, Takahiko

    2009-12-01

    Drug-eluting stents (DES) have been shown to significantly reduce the incidence of restenosis and target lesion revascularization in a wide variety of clinical situations. DES have also been shown to significantly reduce neointimal hyperplasia as compared to bare-metal stents. However, the antiproliferative properties of DES also delay vascular healing and have been associated with stent malapposition, hypersensitivity reactions and late stent thrombosis. Stent thrombosis could result in myocardial infarction or death. We describe here a case report of late stent malapposition following sirolimus-eluting stent implantation observed by angiography, intravascular ultrasound, optical coherence tomography and angioscopy.

  12. Initial experience with the novel BioMime 60mm-long sirolimus-eluting tapered stent system in long coronary lesions.

    PubMed

    Valero, Ernesto; Consuegra-Sánchez, Luciano; Miñana, Gema; García-Blas, Sergio; Rodríguez, Juan Carlos; Moyano, Patricia; Sanchis, Juan; Núñez, Julio

    2017-09-05

    To describe our initial experience with the novel BioMime™ 60mm-long sirolimus-eluting tapered coronary stent system in patients with long coronary lesions. We included 50 consecutive patients in whom a 60mm-long drug- eluting stent (DES) implantation was attempted due to the presence of coronary lesions longer than 48mm. The 60mm-long DES was successfully implanted in 46 (92%) patients. In 4 patients stent deployment failed due to the impossibility of crossing completely the lesions. During a median follow-up of 275 days [IQR (166-386)], no clinical adverse events (death, myocardial infarction or target lesion revascularization) were observed. The use of the novel BioMime™ 60mm-long DES for the treatment of long coronary lesions exhibits promising results in a relatively short-intermediate follow-up.

  13. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study

    PubMed Central

    Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran

    2016-01-01

    Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58 ± 11 years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18 ± 0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent. PMID:27597929

  14. Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.

    PubMed

    Zbinden, Rainer; Piccolo, Raffaele; Heg, Dik; Roffi, Marco; Kurz, David J; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Franzone, Anna; Eberli, Franz; Jüni, Peter; Windecker, Stephan; Pilgrim, Thomas

    2016-03-15

    No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026). Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by

  15. Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial.

    PubMed

    Christiansen, Evald Høj; Jensen, Lisette Okkels; Thayssen, Per; Tilsted, Hans-Henrik; Krusell, Lars Romer; Hansen, Knud Nørregaard; Kaltoft, Anne; Maeng, Michael; Kristensen, Steen Dalby; Bøtker, Hans Erik; Terkelsen, Christian Juhl; Villadsen, Anton Boel; Ravkilde, Jan; Aarøe, Jens; Madsen, Morten; Thuesen, Leif; Lassen, Jens Flensted

    2013-02-23

    Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting. This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov, number NCT01254981. From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk

  16. The real world experience of the biodegradable polymer-coated sirolimus-eluting coronary stent system: Results From an "All-Comers" Clinical Experience.

    PubMed

    Rajasekhar, D; Vanajakshamma, V; Shashank, C; Srinivasakumar, M L; Sivasankara, C

    2016-09-01

    This INDOLIMUS Registry sought to evaluate the safety and efficacy of the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent for the treatment of coronary artery disease across a wide range of patients treated in routine clinical practice, including those with high-risk characteristics and complex lesions. First-generation drug-eluting stents utilize nonbiodegradable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events in an unselected patient population. All 530 consecutive unselected patients (415 males and 115 females) included who underwent percutaneous coronary intervention at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India between August 2012 and March 2013, with an in-hospital, at 30-days and at 6-months follow-up. Retrospective analysis of those data had been done. A total of 617 lesions were treated in 530 enrolled patients (mean age 54.9 ± 10.8 years) with average stent length of 18.8 ± 6.0 mm. An average of 1.18 stents was implanted per patient. The patients' characteristics are noted as having 169 (31.9%) patients of diabetics and 215 (40.6%) hypertension. Smoking, alcoholism and tobacco chewing were found in 273 (51.5%), 130 (24.5%) and 17 (3.2%), respectively. The indications for intervention were unstable angina in 77 (14.5%) and previous myocardial infarction in 56 (10.6%) of the patients. Lesions were of type B2 in 264 (42.7%) and type C in 127 (20.6%). Stent delivery was successful in all cases and in-hospital, 30-days and 6-months follow-up of all 530 patients was obtained. The incidence of any major adverse cardiac events at in-hospital, at 30-days and at 6-months were 5 (0.94%), 8 (1.52%), and 18 (3.40%), respectively. Long term follow-up of

  17. A current problem in cardiology: very late thrombosis after implantation of sirolimus eluting stent.

    PubMed

    Sharifkazemi, Mohammad Bagher; Zamirian, Mahmood; Aslani, Amir

    2007-01-01

    Discontinuation of antiplatelet medications has been strongly associated with coronary stent thrombosis. The first reported cases have been documented at 6 h to 6 weeks after stent implantation. This article presents a case of very late stent thrombosis 24 months after sirolimus eluting stent implantation and 18 months after clopidogrel discontinuation, despite aspirin continuation, and argues in favor of prolonging dual antiplatelet medication including clopidogrel in this setting, at least until data from randomized trials address this important issue.

  18. Late-term clinical outcomes with zotarolimus- and sirolimus-eluting stents. 5-year follow-up of the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).

    PubMed

    Kandzari, David E; Mauri, Laura; Popma, Jeffrey J; Turco, Mark A; Gurbel, Paul A; Fitzgerald, Peter J; Leon, Martin B

    2011-05-01

    This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES). Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES

  19. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): a randomised, single-blind, non-inferiority trial.

    PubMed

    Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Muller, Olivier; Vuilliomenet, André; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Fahrni, Therese; Moschovitis, Aris; Noble, Stéphane; Eberli, Franz R; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2014-12-13

    Refinements in stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-eluting stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-eluting stent. We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-eluting stents or durable polymer everolimus-eluting stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-eluting stents (1063 patients, 1594 lesions) or everolimus-eluting stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-eluting stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-eluting stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one

  20. A case of active peri-stent inflammation after sirolimus-eluting stent implantation.

    PubMed

    Kurosawa, Takafumi; Kotani, Jun-Ichi; Matsuyama, Taka-aki; Ishibashi-Ueda, Hatsue

    2015-03-01

    We report an autopsy case of a coronary aneurysm with massive adventitial inflammation post-percutaneous coronary intervention with sirolimus-eluting stent (SES) insertion in the left circumflex (LCX) coronary artery for ischemic heart disease 3 years prior to death. The internal elastic membrane was disrupted opposite the site of the eccentric LCX plaque due to injury during stenting, and the adventitia showed massive inflammatory cell infiltration, mainly consisting of eosinophils. The LCX showed aneurysmal dilatation with inflammatory cell infiltration. Inappropriate SES implantation attracted chronic inflammation. Chronic inflammation can lead to the development of coronary artery aneurysms.

  1. 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

  2. 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

  3. Functional comparison between BuMA Supreme biodegradable polymer sirolimus-eluting and durable polymer zotarolimus-eluting coronary stents using Quantitative Flow Ratio: PIONEER QFR substudy.

    PubMed

    Asano, Taku; Katagiri, Yuki; Collet, Carlos; Tenekecioglu, Erhan; Miyazaki, Yosuke; Sotomi, Yohei; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter; Wykrzykowska, Joanna J; Ribeiro, Vasco Gama; Periera, Helder; da Silva, Pedro Canas; Piek, Jan J; Reiber, Johan H C; von Birgelen, Clemens; Sabaté, Manel; Onuma, Yoshinobu; Serruys, Patrick W

    2017-10-10

    Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES). The current post-hoc analysis was performed in the PIONEER randomized trial (1:1 randomization to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at pre-procedural, post-procedural and 9-month angiography without pharmacologically induced hyperemia (contrast QFR). At 9 months, both the values of QFR distal to the stent (B-SES: 0.89±0.10 vs. 0.89±0.11, p=0.97) and the numbers of the vessels with QFR ≤0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% versus 3.5%, P=1.00). QFR gradient across the device (∆QFR) at 9 months was also similar between both groups (B-SES: 0.03±0.04 vs. 0.03±0.07, p=0.95). Quantitative flow assessment 9 months after stenting did not differ between B-SES and R-ZES, despite of a significant difference in in-stent late lumen loss.

  4. Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents

    PubMed Central

    Zhang, Haijun; Wang, Xiangfei; Deng, Wei; Wang, Shenguo; Ge, Junbo; Toft, Egon

    2016-01-01

    Abstract Background: The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimax—a novel abluminal biodegradable polymer SES and Cypher Select—a durable polymer SES, at 9 months angiographic and 5-year clinical follow-up. Methods: We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up. Results: Cordimax was noninferior to Cypher select for in-stent LLL (0.25 ± 0.47 vs 0.18 ± 0.49 mm; P = 0.587) and in-stent mean diameter stenosis (22.19 ± 12.21% vs 19.89 ± 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039). Conclusion: Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group. PMID:27661023

  5. Late stent thrombosis after implantation of a sirolimus-eluting stent.

    PubMed

    Kerner, Arthur; Gruberg, Luis; Kapeliovich, Michael; Grenadier, Ehud

    2003-12-01

    Late stent thrombosis in the era of routine high-pressure stent deployment and combined antiplatelet therapy with thienopyridines and aspirin has become a rare but feared complication. We describe a patient with acute myocardial infarction due to late stent thrombosis 6 weeks after deployment of a sirolimus-eluting stent and 2 weeks after the discontinuation of clopidogrel. This is the first report of late thrombosis of a sirolimus-eluting stent.

  6. A new generation of biodegradable polymer-coated sirolimus-eluting stents for the treatment of coronary artery disease: final 5-year clinical outcomes from the CREATE study.

    PubMed

    Han, Ya-Ling; Zhang, Lei; Yang, Li-Xia; Liu, Hui-Liang; Qu, Peng; Li, Wei-Min; Jiang, Tie-Min; Li, Shu-Mei; Jing, Quan-Min; Zhang, Quan-Yu; Xu, Bo; Li, Yi; Gao, Run-Lin

    2012-11-22

    The aim of the present study was to evaluate the five-year safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent with six months dual antiplatelet therapy in daily practice. Two thousand and seventy-seven daily practice patients, exclusively treated with biodegradable polymer-coated sirolimus-eluting stents (EXCEL; JW Medical Systems, Weihai, China), were prospectively enrolled in the multicentre CREATE study. Clinical follow-up was completed in 1,982 patients (95.4%) at five-year follow-up. The rates of cardiac death, non-fatal myocardial infarction (MI), target lesion revascularisation and overall major adverse cardiac events (MACE) at five-year follow-up were 3.0%, 1.5%, 3.7% and 7.4%, respectively. The rates of definite or probable stent thrombosis (ST) at five years and definite ST from one to five years were 1.1% and 0.3%, respectively. Heart failure (hazard ratio [HR]: 3.324, 95% confidence interval [CI]: 1.729-6.391, p<0.001) and prior MI (HR: 2.664, 95% CI: 1.358-5.227, p=0.004) were independent predictors of ST. Landmark analysis of a propensity score matched patient cohort showed that patients with or without clopidogrel treatment after six months had similar clinical outcomes. The present study demonstrates satisfactory and sustained five-year clinical safety and efficacy profiles as evidenced by the low rates of MACE and ST for the EXCEL, a biodegradable polymer-based sirolimus-eluting stent, when patients were treated with six months dual antiplatelet therapy in daily practice.

  7. Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial.

    PubMed

    von Birgelen, Clemens; Kok, Marlies M; van der Heijden, Liefke C; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Gin, R Melvyn Tjon Joe; Somi, Samer; van Houwelingen, K G; Stoel, M G; de Man, Frits H A F; Louwerenburg, J Hans W; Hartmann, Marc; Zocca, Paolo; Linssen, Gerard C M; van der Palen, Job; Doggen, Carine J M; Löwik, Marije M

    2016-11-26

    In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers. The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised, BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged 18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with drug-eluting stent implantation according to clinical guidelines or the operators' judgment. Exclusion criteria were: participation in another randomised drug or device study before reaching the primary endpoint of that study; planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance to components of the investigational product or medication required; uncertainty about the adherence to follow-up procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents (which differ substantially in type, amount, distribution, and resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months of follow up with a

  8. Long-term coronary arterial response to biodegradable polymer biolimus-eluting stents in comparison with durable polymer sirolimus-eluting stents and bare-metal stents: five-year follow-up optical coherence tomography study.

    PubMed

    Kuramitsu, Shoichi; Sonoda, Shinjo; Yokoi, Hiroyoshi; Iwabuchi, Masashi; Nishizaki, Yuji; Shinozaki, Tomohiro; Domei, Takenori; Hyodo, Makoto; Inoue, Katsumi; Shirai, Shinichi; Ando, Kenji; Nobuyoshi, Masakiyo

    2014-11-01

    The long-term coronary arterial response of biodegradable polymer biolimus-eluting stents (BES) remains unclear. We sought to evaluate the coronary arterial response of biodegradable polymer BES at 5 years after stent implantation using optical coherence tomography (OCT) as compared with that of durable polymer sirolimus-eluting stents (SES) and bare-metal stents (BMS). Five-year follow-up OCT was performed in 30 patients with 33 stents (10 with 12 BES; 10 with 11 SES; 10 with 10 BMS). Quantitative parameters and qualitative characteristics of the neointima were evaluated. A total of 5178 struts (BES, n = 2056; SES, n = 1410; BMS, n = 1712) were analyzed. Uncovered struts were found in 15 out of 2055 struts in the BES (weighted estimate 0.01%, 95% confidence intervals [CI]: 0.00-0.33%) and 54 out of 1410 struts in the SES (0.11%, 95% CI: 0.00-3.33%) (odds ratio [OR] 0.12, 95% CI: 0.01-1.95, p = 0.13). None of 1712 struts were uncovered in the BMS. Cross-sectional qualitative analysis of neointimal tissue showed that the frequency of lipid-laden neointima tended to be lower in the BES (2.26%, 95% CI: 0.38-12.3%) compared with the SES (9.90%, 95% CI: 4.37-20.9%; OR 0.21, 95% CI 0.03-1.16, p = 0.07), and was similar to the BMS (2.23%, 95% CI: 0.54-8.74%; OR 0.98, 95% CI 0.13-7.14, p = 0.98). Biodegradable polymer BES shows a favorable coronary arterial response compared with SES, but different response with BMS at 5 years follow-up. The observed frequency of in-stent neoatherosclerosis within BES was similar to BMS and tended to be lower than SES. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  9. The Ultimaster Biodegradable-Polymer Sirolimus-Eluting Stent: An Updated Review of Clinical Evidence

    PubMed Central

    Chisari, Alberto; Pistritto, Anna Maria; Piccolo, Raffaele; La Manna, Alessio; Danzi, Gian Battista

    2016-01-01

    The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES. PMID:27608017

  10. The Ultimaster Biodegradable-Polymer Sirolimus-Eluting Stent: An Updated Review of Clinical Evidence.

    PubMed

    Chisari, Alberto; Pistritto, Anna Maria; Piccolo, Raffaele; La Manna, Alessio; Danzi, Gian Battista

    2016-09-06

    The Ultimaster coronary stent system (Terumo Corporation, Tokyo, Japan) represents a new iteration in drug-eluting stent (DES) technology that has recently received the Conformité Européenne (CE) mark approval for clinical use. The Ultimaster is a thin-strut, cobalt chromium, biodegradable-polymer, sirolimus-eluting coronary stent. The high elasticity of the biodegradable-polymer (PDLLA-PCL) and the abluminal gradient coating technology are additional novel features of this coronary device. The Ultimaster DES has undergone extensive clinical evaluation in two studies: The CENTURY I and II trials. Results from these two landmark studies suggested an excellent efficacy and safety profile of the Ultimaster DES across several lesion and patient subsets, with similar clinical outcomes to contemporary, new-generation DES. The aim of this review is to summarize the rationale behind this novel DES technology and to provide an update of available evidence about the clinical performance of the Ultimaster DES.

  11. First-in-man randomized comparison of BuMA Supreme biodegradable polymer sirolimus-eluting versus durable polymer zotarolimus-eluting coronary stents: The PIONEER trial.

    PubMed

    von Birgelen, Clemens; Asano, Taku; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter C; Wykrzykowska, Joanna J; Ribeiro, Vasco Gama; Periera, Helder; Canas da Silva, Pedro; Piek, Jan J; Onuma, Yoshinobu; Serruys, Patrick W; Sabaté, Manel

    2017-09-19

    A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA-polymer coating with electrografting base layer on a thin-strut (80µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial assessed the efficacy and safety of the novel device. This randomized, multi-center, single-blinded, non-inferiority trial compared BuMA Supreme SES versus contemporary durable polymer zotarolimus-eluting stents (ZES) in terms of angiographic in-stent late lumen loss (LLL) at 9-months follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with SES (n=83) or ZES (n=87). At 9-month angiographic follow-up, in-stent LLL was 0.29±0.33mm in SES and 0.14±0.37mm in ZES (Pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, P=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to a device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at 9-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

  12. Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study.

    PubMed

    Estévez-Loureiro, Rodrigo; Pérez de Prado, Armando; Pérez-Martínez, Claudia; Cuellas-Ramón, Carlos; Regueiro-Purriños, Marta; Gonzalo-Orden, José M; López-Benito, María; Molina-Crisol, María; Duocastella-Codina, Luis; Fernández-Vázquez, Felipe

    2015-12-01

    Initial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary arteries. Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later. The stents were implanted at a stent/artery ratio of 1.34±0.15, with no significant differences between groups. The new stents showed less late loss and angiographic restenosis than conventional stents (P=.006 and P<.001, respectively). Histologically, restenosis and neointimal area were lower with all the new platforms than with the conventional stents (P<.001 for each variable), and no differences were found vs the drug-eluting stents on the market. Safety data showed that endothelialization was lower with drug-eluting stents than with conventional stents, except for drug-eluting stent 3 (P=.084). Likewise, inflammation was lower with drug-eluting stent 3 than with other stents. The new drug-eluting stent platforms studied are associated with less restenosis than conventional stents and showed no significant differences in safety or efficacy vs commercialized drug-eluting stents. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  13. Evaluation of the Svelte Medical systems SLENDER IDS Sirolimus-eluting coronary stent-on-a-wire integrated delivery system for the treatment of coronary artery disease.

    PubMed

    Verheye, Stefan

    2017-09-01

    The SLENDER Integrated Delivery System (IDS™) is an 'all-in-one' fixed-wire coronary stenting device designed for direct stenting, precluding the need for conventional guidewires and predilatation balloons. It achieves ultra-low profiles (crossing profiles as low as 0.031" / 0.79), enabling the downsizing of catheters to facilitate TRI across wider subsets of patients. Areas covered: This paper aims to evaluate the SLENDER IDS for the treatment of coronary artery disease. Expert commentary: The system represents the first advance in coronary stent delivery since the introduction of rapid-exchange stent delivery systems more than 20 years ago. SLENDER IDS has demonstrated non-inferiority compared with commercial DES, excellent long-term safety and a potentially more efficient approach to PCI where patient comfort is enhanced, procedures are streamlined and resource consumption is reduced.

  14. Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents: Nine months angiographic and 5-year clinical outcomes.

    PubMed

    Zhang, Haijun; Wang, Xiangfei; Deng, Wei; Wang, Shenguo; Ge, Junbo; Toft, Egon

    2016-09-01

    The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimax-a novel abluminal biodegradable polymer SES and Cypher Select-a durable polymer SES, at 9 months angiographic and 5-year clinical follow-up. We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up. Cordimax was noninferior to Cypher select for in-stent LLL (0.25 ± 0.47 vs 0.18 ± 0.49 mm; P = 0.587) and in-stent mean diameter stenosis (22.19 ± 12.21% vs 19.89 ± 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039). Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group.

  15. Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent.

    PubMed

    Zhu, Jinzhou; Liu, Huizhu; Cui, Haipo; Tang, Zhirong; Song, Chengli; Zhang, Ruiyan

    2017-03-01

    Late stent thrombosis (LST) following drug-eluting stent (DES) implantation in patients with coronary artery disease (CAD) is often associated with delayed vascular healing, resulting from vascular inflammation and hypersensitivity to durable polymers and drugs. Therefore, DES design, materials, and coatings have been technologically revolutionized. Herein, we designed a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (AGF-BP-SES), with a sirolimus content of only about one-third of traditional DES. The mechanical performances of AGF-BP-SES during compression and expansion were investigated. The pharmacokinetic (PK) profile of sirolimus was studied in the swine model. The in vivo efficacy of AGF-BP-SES was compared with that of Xience PRIME(®) stent. The results showed that AGF-BP-SES exhibited mechanical properties similar to traditional DES, including the rebound ratio of radial contraction/direction, rebound ratio of axial contraction/direction, and inhomogeneity of compression/expansion. Despite utilizing a reduced dose of sirolimus, AGF-BP-SES delivered sirolimus to the coronary artery in a controlled and efficient manner. The stent maintained a safe and effective local drug concentration without local or systemic risks. In the swine model, histopathological indicators predicted safety and biocompatibility of AGF-BP-SES. In conclusion, AGF-BP-SES maintained similar mechanical properties as other stents while reducing the drug-loading capacity, and showed a favorable safety and efficacy profile of the targeted DES.

  16. 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.

  17. The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.

    PubMed

    Abizaid, Alexandre; Costa, J Ribamar; Banning, Adrian; Bartorelli, Antonio L; Dzavik, Vladimir; Ellis, Stephen; Gao, Runlin; Holmes, David R; Jeong, Muyng Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Orlick, Amy; Spaulding, Christian; Worthley, Stephen; Urban, Philip M

    2012-01-01

    This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.

    PubMed

    Urban, Philip; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio L; Baux, Ana Cebrian; Džavík, Vladimír; Ellis, Stephen; Gao, Runlin; Holmes, David; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Spaulding, Christian; Worthley, Stephen

    2011-03-29

    The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry.

    PubMed

    Roleder, Tomasz; Smolka, Grzegorz; Podolecka, Ewa; Chudek, Jolanta; Dworowy, Sebastian; Żelazowska, Katarzyna; Wojakowski, Wojciech; Ochała, Andrzej

    Data from clinical trials suggested that biodegradable-polymer-based drug-eluting stents (DES) might improve long-term clinical outcomes. PROLIM (Balton, Warsaw, Poland) DES is based on a stainless steel platform with a closed cell design releasing sirolimus from biodegradable copolymer (lactic and glycolic acid) in eight weeks. In the present study the safety and the efficacy of a PROLIM stent was assessed in patients with de novo coronary lesions in 12-month clinical follow-up. It was a single-centre, observational, prospective registry to assess the safety and efficacy of a PROLIM stent implantation in all consecutive patients with de novo coronary artery lesions treated with percutaneous coronary intervention (PCI). The primary study endpoint was a composite safety (cardiac death, non-fatal myocardial infarction), and the second study endpoint was the efficacy of PROLIM implantation-clinically driven target vessel revascularisation (TVR) assessed at 12-month follow-up. One hundred patients were enrolled into the study and 118 PROLIM stents were implanted. Thirty-two (32%) patients had diabetes, 46 (46%) patients were prior PCI, and 17 (17%) patients had coronary artery bypass grafting. 67% of stented lesions were complex ones (B2/C) and 17% were bifurcations. During the 12-month follow-up primary study endpoints occurred in five (5%) patients. Two (2%) cardiac deaths were reported and three (3%) TVRs were performed, of which one was related to in-PROLIM stent restenosis. PCI with biodegradable-polymer PROLIM DES seems to be safe and effective in 12-month follow-up. A larger trial is warranted to assess clinical outcomes post PROLIM stent implantation.

  20. Neointimal hyperplasia persists at six months after sirolimus-eluting stent implantation in diabetic porcine

    PubMed Central

    Zhang, Qi; Lu, Lin; Pu, LiJin; Zhang, RuiYan; Shen, Jie; Zhu, ZhengBing; Hu, Jian; Yang, ZhenKun; Chen, QiuJin; Shen, WeiFeng

    2007-01-01

    Background Observational clinical studies have shown that patients with diabetes have less favorable results after percutaneous coronary intervention compared with the non-diabetic counterparts, but its mechanism remains unclear. The aim of this study was to examine the changes of neointimal hyperplasia after sirolimus-eluting stent (SES) implantation in a diabetic porcine model, and to evaluate the impact of aortic inflammation on this proliferative process. Methods Diabetic porcine model was created with an intravenous administration of a single dose of streptozotocin in 15 Chinese Guizhou minipigs (diabetic group); each of them received 2 SES (Firebird, Microport Co, China) implanted into 2 separated major epicardial coronary arteries. Fifteen non-diabetic minipigs with SES implantation served as controls (control group). At 6 months, the degree of neointimal hyperplasia was determined by repeat coronary angiography, intravascular ultrasound (IVUS) and histological examination. Tumor necrosis factor (TNF)-α protein level in the aortic intima was evaluated by Western blotting, and TNF-α, interleukin (IL)-1β and IL-6 mRNA levels were assayed by reverse transcription and polymerase chain reaction. Results The distribution of stented vessels, diameter of reference vessels, and post-procedural minimal lumen diameter were comparable between the two groups. At 6-month follow-up, the degree of in-stent restenosis (40.4 ± 24.0% vs. 20.2 ± 17.7%, p < 0.05), late lumen loss (0.33 ± 0.19 mm vs. 0.10 ± 0.09 mm, p < 0.001) by quantitative angiography, percentage of intimal hyperplasia in the stented area (26.7 ± 19.2% vs. 7.3 ± 6.1%, p < 0.001) by IVUS, and neointimal area (1.59 ± 0.76 mm2 vs. 0.41 ± 0.18 mm2, p < 0.05) by histological examination were significantly exacerbated in the diabetic group than those in the controls. Significant increases in TNF-α protein and TNF-α, IL-1β and IL-6 mRNA levels were observed in aortic intima in the diabetic group

  1. Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model.

    PubMed

    Pérez de Prado, Armando; Pérez Martínez, Claudia; Cuellas Ramón, Carlos; Regueiro Purriños, Marta; López Benito, María; Gonzalo Orden, José Manuel; Rodríguez Altónaga, José Antonio; Estévez Loureiro, Rodrigo; Benito González, Tomás; Viñuela Baragaño, David; Molina Crisol, María; Amorós Aguilar, Marc; Pérez Serranos, Isabel; Vidal Parreu, Arnau; Benavides Montegordo, Ana; Duocastella Codina, Luis; Fernández Vázquez, Felipe

    2017-06-21

    New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  2. Randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus: the LIPSIA Yukon trial.

    PubMed

    Desch, Steffen; Schloma, Denis; Möbius-Winkler, Sven; Erbs, Sandra; Gielen, Stephan; Linke, Axel; Yu, Jiangtao; Lauer, Bernward; Kleinertz, Klaus; Dänschel, Wilfried; Schuler, Gerhard; Thiele, Holger

    2011-04-01

    The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus. The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus. Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent. A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization. Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV.

    PubMed

    Jensen, Lisette Okkels; Thayssen, Per; Christiansen, Evald Høj; Maeng, Michael; Ravkilde, Jan; Hansen, Knud Nørregaard; Hansen, Henrik Steen; Krusell, Lars; Kaltoft, Anne; Tilsted, Hans Henrik; Berencsi, Klara; Junker, Anders; Lassen, Jens Flensted

    2016-02-23

    Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown. This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial. Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis. At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72). At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. Angioscopic assessment of arterial repair following biodegradable polymer-coated biolimus A9-eluting stent implantation. - Comparison with durable polymer-coated sirolimus-eluting stent-.

    PubMed

    Awata, Masaki; Uematsu, Masaaki; Sera, Fusako; Ishihara, Takayuki; Watanabe, Tetsuya; Fujita, Masashi; Onishi, Toshinari; Iida, Osamu; Ishida, Yoshio; Nanto, Shinsuke; Nagata, Seiki

    2011-01-01

    Second-generation drug-eluting stents (DES) are expected to show better arterial repair than older DES. We angioscopically compared the biodegradable polymer-coated biolimus A9-eluting stent (BES) and durable polymer-coated sirolimus-eluting stent (SES) to explore differences in arterial repair. Angioscopy was performed 9 ± 1 months after 15 BES and 16 SES were implanted initially in the native coronary artery. Heterogeneity of neointimal coverage (NIC) as well as the dominant NIC grade was examined. NIC was defined as: grade 0 = fully visible struts; grade 1 = struts bulging into the lumen, but covered; grade 2 = embedded, but translucent struts; grade 3 = invisible struts. Heterogeneity was judged when the NIC grade varied ≥ 1. In-stent late loss (0.06 ± 0.23 vs. 0.07 ± 0.18 mm, P = 0.80), and dominant NIC grade (1.5 ± 0.8 vs. 1.3 ± 0.7, P = 0.45) were similar for BES and SES. Within the stents, NIC was more heterogeneous in SES than in BES (P = 0.035). 80% of BES showed homogeneous NIC, while 56% of SES had heterogeneous NIC. BES showed limited late loss similar to that for SES. Nonetheless, the NIC with BES was more homogeneous than that with SES. Biodegradable polymer-coated BES may have an advantage in homogeneous NIC.

  5. 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.

  6. Sirolimus-eluting, bioabsorbable polymer-coated constant stent (Cura) in acute ST-elevation myocardial infarction: a clinical and angiographic study (CURAMI Registry).

    PubMed

    Lee, Chi-Hang; Lim, Jimmy; Low, Adrian; Zhang, Xiao-Ling; Kyaing, Than-Than; Chan, Mark Y; Wong, Hwee-Bee; Lim, Yean-Teng; Tan, Huay-Cheem

    2007-04-01

    There are safety concerns over the current polymer-based drug-eluting stents (DES) on the possible delayed healing process and adverse reactions to the polymer when drug elution is completed. Cura (Orbus Neich) is a sirolimus-eluting, bioabsorbable, polymer-coated constant stent. From March 1 to June 30, 2005, Cura stent implantation was instituted as the default strategy for percutaneous coronary intervention in 49 consecutive ST-Elevation Myocardial Infarction (STEMI) patients (male 86%; average age 55 +/- 10 years; diabetes 31%). The angiographic success rate was 100%. In-hospital adverse events consisted of 1 in-hospital death (2% heart failure). A total of 27 patients (56%) underwent 8-month angiographic follow up. Binary restenosis occurred in 6 patients (22%), and late loss was 0.74 +/- 0.89 mm. At 9-month follow up, a total of 5 patients had 6 major adverse events (1 death, 1 reinfarction, and 4 target lesion revascularizations). There was no incidence of stent thrombosis. Cura stent implantation appears to be feasible and safe in the treatment of STEMI. However, the binary restenosis rate and late loss at angiographic follow up were similar to that of bare-metal stents, and therefore compare unfavorably with other proven benchmark DES.

  7. Long-term efficacy of sirolimus-eluting stent for small vessel disease--subanalysis of Cypher Stent Japan Post-Marketing Surveillance Registry.

    PubMed

    Fujimoto, Hajime; Ikari, Yuji; Nakamura, Masato

    2013-01-01

    Percutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting stents reduce the risk of restenosis, the long-term efficacy of drug-eluting stent implantation in small vessels is unclear. We reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting stent (SES) implantation in vessels with diameter less than 2.5mm (small vessel group) compared to that with diameter of 2.5mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p=0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p=0.004). The rate of stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5mm was not an independent risk factor for MACE. SES implantation for vessels with diameter less than 2.5mm is safe and provides good long-term outcomes. Copyright © 2012 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  8. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial.

    PubMed

    Serruys, Patrick W; Farooq, Vasim; Kalesan, Bindu; de Vries, Ton; Buszman, Pawel; Linke, Axel; Ischinger, Thomas; Klauss, Volker; Eberli, Franz; Wijns, William; Morice, Marie Claude; Di Mario, Carlo; Corti, Roberto; Antoni, Diethmar; Sohn, Hae Y; Eerdmans, Pedro; Rademaker-Havinga, Tessa; van Es, Gerrit-Anne; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

    2013-08-01

    This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From

  9. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial.

    PubMed

    Xu, Bo; Gao, Runlin; Yang, Yuejin; Cao, Xuebin; Qin, Lei; Li, Yi; Li, Zhanquan; Li, Xueqi; Lin, Hailong; Guo, Yong; Ma, Yitong; Wang, Jian'an; Nie, Shaoping; Xu, Liang; Cao, Eric; Guan, Changdong; Stone, Gregg W

    2016-05-17

    Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics. The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population. PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048). The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275). Copyright

  10. Five-year outcomes of ST-elevation myocardial infarction versus non-ST-elevation acute coronary syndrome treated with biodegradable polymer-coated sirolimus-eluting stents: Insights from the CREATE trial.

    PubMed

    Liu, Hui-Liang; Jin, Zhi-Geng; Yang, Sheng-Li; Han, Wei; Jing, Quan-Min; Zhang, Lei; Luo, Jian-Ping; Ma, Dong-Xing; Liu, Ying; Yang, Li-Xia; Jiang, Tie-Min; Qu, Peng; Li, Wei-Min; Li, Shu-Mei; Xu, Bo; Gao, Run-Lin; Han, Ya-Ling

    2017-01-01

    Long-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS. We explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended. STEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1). STEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  11. Peri-stent contrast staining and very late stent thrombosis after sirolimus-eluting stent implantation: an observation from the RESTART (REgistry of Stent Thrombosis for review And Re-evaluaTion) angiographic substudy.

    PubMed

    Kozuma, Ken; Kimura, Takeshi; Suzuki, Nobuaki; Miyazawa, Akiyoshi; Waseda, Katsuhisa; Honda, Yasuhiro; Morimoto, Takeshi; Aizawa, Tadanori; Mitsudo, Kazuaki; Miyazaki, Shunichi; Yamaguchi, Tetsu; Isshiki, Takaaki

    2013-11-01

    The aim of the study was to clarify the angiographic characteristics of stent thrombosis (ST) in relation to sirolimus-eluting stents (SES). RESTART is a Japanese registry of SES-associated ST. As an angiographic substudy, coronary angiograms at baseline, at six to 12 months and at the time of ST were analysed. Angiograms of 313 patients (early ST [EST] 169 patients, late ST [LST] 59 patients, and very late ST [VLST] 85 patients) were investigated. Residual dissection post procedure was more frequently seen in the EST group. Stent fracture was more frequently seen in the VLST group than in the EST and LST groups (16.5%, 3.0%, and 3.4%, respectively; p<0.001). Peri-stent contrast staining (PSS), defined as contrast staining outside the stent contour extending to ≥20% of the stent diameter, was remarkably more prevalent in the VLST group than in the EST and LST groups (34.1%, 4.7%, and 6.8%, respectively; p<0.001). Abnormal angiographic findings such as PSS and stent fracture were found significantly more frequently in lesions with VLST than in lesions with EST and LST.

  12. Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT).

    PubMed

    Nakamura, Masato; Muramatsu, Toshiya; Yokoi, Hiroyoshi; Okada, Hisayuki; Ochiai, Masahiko; Suwa, Satoru; Hozawa, Hidenari; Kawai, Kazuya; Awata, Masaki; Mukawa, Hiroaki; Fujita, Hiroshi; Shiode, Nobuo; Asano, Ryuta; Tsukamoto, Yoshiaki; Yamada, Takahisa; Yasumura, Yoshio; Ohira, Hiroshi; Miyamoto, Akira; Takashima, Hiroaki; Ogawa, Takayuki; Matsuyama, Yutaka; Nanto, Shinsuke

    2015-04-01

    The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES. Stratification was based on the presence or absence of DM. PES target vessel failure (TVF) non-inferiority at 8 months (primary endpoint) was not demonstrated when compared to SES (SES 4.5 % vs. PES 6.4 %, p = 0.23). In addition, PES TVF superiority at 8 months in the DM subset (secondary endpoint) was not shown (SES 5.6 % vs. PES 7.6 %, p = 0.10). Insulin treatment was associated with increased TVF rates, however, this was less pronounced in the PES group. At 8 months, the similar TVF rates for SES and PES up to that point diverged significantly, favoring SES out to 12 months. Patients undergoing routine angiographic follow-up demonstrated lower TVF prior to the 8-month point, and higher TVF after 8 months, as compared to those followed clinically. In conclusion, the current study failed to demonstrate the proposed superiority of PES for DM patients. In addition, the diversion of TVF at 8 months may reflect an "oculo-stenotic reflex" bias (the tendency to treat lesions found during routine, rather than clinically driven, angiographic follow-up), which could constitute an obstacle for evaluating the true clinical effect of new devices.

  13. Preclinical evaluation of a novel abluminal surface coated sirolimus eluting stent with biodegradable polymer matrix

    PubMed Central

    Doshi, Manish; Galloni, Marco; Vignolini, Christina; Vyas, Ashwin; Chevli, Bhavesh; Sheiban, Imad

    2015-01-01

    Background Second generation of drug eluting stents (DES) has attempted to improve safety using abluminal sirolimus drug delivery with biodegradable polymers matrix. The present preclinical study was designed to investigate the safety and efficacy profile of Abluminus™ stents (SES). This is a new coronary stent with sirolimus and biodegradable polymer matrix coated on abluminal stent and balloon surface. Methods SES were compared with two controls: bare metal stent (BMS) and BMS + polymer coated stents (PC). All devices (40 stents) were implanted in porcine coronary arteries with primary endpoint of endothelialization at 7 days and subsequent histological and morphometric evaluations at 7, 30 and 90 days. Results Early endothelialization at seven days was complete in all stents. Histology at 30 days revealed minimum inflammation in all groups and increased at 90 days in PC group while it was absent at 180 days. Thirty day morphometry showed significantly reduction of neointimal area in Abluminus™ (SES 0.96±0.48 mm2; BMS 1.83±0.34 mm2; PC 1.76±0.55 mm2; P<0.05); after 90 days neointimal area was 1.10±0.54 mm2 for SES; 1.92±0.36 mm2 for BMS; and 1.94±0.48 mm2 for PC; P<0.05). Neointimal thickness at 30 and 90 days respectively was 0.15±0.07 and 0.18±0.10 mm for SES, 0.57±0.08 and 0.61±0.09 mm for BMS and 0.52±0.09 and 0.59±0.08 mm, P<0.001 for PC group. Conclusions The most significant experimental evidence appears to be earlier endothelialization at 7 days for SES which led to safety of the device. Efficacy of the device was also observed by a reduced neointimal thickness and minimized inflammatory score at all follow-ups. Termination of antiplatelet at 30 days has not shown any further complications. Polymer thickness was almost in negligible amount at 180 days with no inflammation. PMID:26331109

  14. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

    PubMed Central

    Lemos, Pedro A; Chandwani, Prakash; Saxena, Sudheer; Ramachandran, Padma Kumar; Abhyankar, Atul; Campos, Carlos M; Marchini, Julio Flavio; Galon, Micheli Zanotti; Verma, Puneet; Sandhu, Manjinder Singh; Parikh, Nikhil; Bhupali, Ashok; Jain, Sharad; Prajapati, Jayesh

    2016-01-01

    Objectives To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up. Interventions Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures The primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months. Results At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm. Conclusions The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up. PMID:26888727

  15. Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry.

    PubMed

    Ohlow, Marc-Alexander; von Korn, Hubertus; Gunkel, Oliver; Farah, Ahmed; Fuhrmann, Joerg T; Lauer, Bernward

    2014-12-01

    Drug-eluting stents (DES) constitute a major achievement in preventing re-stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer-free sirolimus-eluting stent system YUKON-Choice (Yukon-DES, Translumina, Germany). From 01/2006-09/2008 all patients receiving Yukon-DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long-term major adverse cardiac events (MACE). 701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6-months angiographic follow-up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between "on-label" and "off-label" indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%. Our data suggests that the implantation of the sirolimus-coated polymer-free YUKON-DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels. © 2013 Wiley Periodicals, Inc.

  16. Polymer-free sirolimus-eluting stents in a large-scale all-comers population

    PubMed Central

    Krackhardt, Florian; Kočka, Viktor; Waliszewski, Matthias W.; Utech, Andreas; Lustermann, Meik; Hudec, Martin; Studenčan, Martin; Schwefer, Markus; Yu, Jiangtao; Jeong, Myung Ho; Ahn, Taehoon; Wan Ahmad, Wan Azman; Boxberger, Michael; Schneider, André; Leschke, Matthias

    2017-01-01

    Objective The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied. Methods Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, ‘all comers’ observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated. Results A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001). Conclusions PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575). Trial registration number NCT02629575. PMID:28761678

  17. Polymer-free sirolimus-eluting stents in a large-scale all-comers population.

    PubMed

    Krackhardt, Florian; Kočka, Viktor; Waliszewski, Matthias W; Utech, Andreas; Lustermann, Meik; Hudec, Martin; Studenčan, Martin; Schwefer, Markus; Yu, Jiangtao; Jeong, Myung Ho; Ahn, Taehoon; Wan Ahmad, Wan Azman; Boxberger, Michael; Schneider, André; Leschke, Matthias

    2017-01-01

    The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied. Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated. A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001). PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575). NCT02629575.

  18. Angioscopy study from a large patient population comparing sirolimus-eluting stent with biodegradable versus durable polymer.

    PubMed

    Chen, Shao-Liang; Xu, Tian; Zhang, Jun-Jie; Ye, Fei; Hu, Zuo-Ying; Tian, Nai-Liang; Zhang, Yao-Jun; Kotani, Junichi; Zhang, Jun-Xia

    2012-09-01

    This study aimed to compare the neointimal coverage (NIC), subclinical thrombus, color of plaque underneath the stent at 9-month after implantation of sirolimus-eluting stent (SES) either with durable or with biodegradable polymer (BDPM). A total of 175 patients were assigned as Cypher (n = 81, 97 stents with durable polymer) and Excel (n = 94, 112 stents with BDPM) stent at 9-month after indexed procedure. NIC was classified from grade 0-3. Color of plaque was divided into white, light-yellow, yellow, and dark yellow. Thrombus was diagnosed as white or red material with cotton-like or ragged appearance. Incomplete NIC (grade 0/1) circled by a blush was termed by "inflaming." There were significant differences in unstable angina (90.5 vs. 52.4%, P = 0.015), previous myocardial infarction (33.3 vs. 4.0%, P = 0.045) and left ventricular eject fraction (55.2 ± 7.8 vs. 62.6 ± 6.3%, P = 0.021) between the Excel and Cypher groups. The minimal- and maximal-NIC grades in the Cypher group were 0.67 ± 0.58 and 2.29 ± 0.46, respectively, when compared with 1.45 ± 0.67 (P < 0.001) and 2.64 ± 0.49 (P = 0.023) in the Excel group. The percentage of yellow plaque, thrombus, "inflaming" and NIC grade of 0 in the Excel and Cypher groups, respectively, were as follows: 8.0 vs. 26.8% (P = 0.031), 9.8 vs. 32.9% (P = 0.024), 8.0 vs. 38.1% (P = 0.017), and 38.1 vs. 0% (P < 0.001). Of the stents with "inflaming," 63.6% had thrombus when compared with 20.1% of the non-erosion stents (P < 0.001). Overlapping segments had the lowest NIC grades and more "inflaming" demonstrating a significant difference between Cypher vs. Excel stents. NIC grade was positively correlated with thrombus. SES with BDPM has improved NIC resulting in less yellow plaque, thrombus, and "inflaming." Overlapping segments had the lowest NIC grade and more "inflaming." Copyright © 2011 Wiley Periodicals, Inc.

  19. Impact of statin therapy on late target lesion revascularization after sirolimus-eluting stent implantation (from the CREDO-Kyoto Registry Cohort-2).

    PubMed

    Natsuaki, Masahiro; Nakagawa, Yoshihisa; Morimoto, Takeshi; Ono, Koh; Shizuta, Satoshi; Furukawa, Yutaka; Kadota, Kazushige; Iwabuchi, Masashi; Kato, Yoshihiro; Suwa, Satoru; Inada, Tsukasa; Doi, Osamu; Takizawa, Akinori; Nobuyoshi, Masakiyo; Kita, Toru; Kimura, Takeshi

    2012-05-15

    Therapeutic strategies preventing late target lesion revascularization (TLR) after drug-eluting stent implantation have not been yet adequately investigated. In 13,087 consecutive patients undergoing first percutaneous coronary intervention in the CREDO-Kyoto Registry Cohort-2, we identified 10,221 patients who were discharged alive after implantation of sirolimus-eluting stents (SESs) only (SES stratum 5,029) or bare-metal stents (BMSs) only (BMS stratum 5,192). Impact of statin therapy at time of discharge from the index hospitalization on early (within the first year) and late (1 year to 4 years) TLR, was assessed in the SES stratum (statin group 2,735; nonstatin group 2,294) and in the BMS stratum (statin group 2,576; nonstatin group 2,616). Despite a significantly lower incidence of early TLR (7.8% vs 22.2%, p <0.0001), SES use compared to BMS use was associated with a significantly higher incidence of late TLR (7.7% vs 3.0%, p <0.0001). In the SES and BMS strata, the incidence of early TLR was similar regardless of statin use. In the SES stratum, the incidence of late TLR was significantly lower in the statin group than in the nonstatin group (6.1% vs 9.6%, p = 0.002), whereas no significant difference was found in the BMS stratum (2.6% vs 3.3%, p = 0.38). After adjusting confounders, risk for late TLR significantly favored statin use in the SES stratum (hazard ratio 0.73, 95% confidence interval 0.54 to 0.98, p = 0.04), whereas the risk decrease was not significant in the BMS stratum (hazard ratio 0.74, 95% confidence interval 0.46 to 1.20, p = 0.23). In conclusion, statin therapy at hospital discharge was associated with a significantly lower risk for late TLR after SES implantation.

  20. Stent thrombosis with biodegradable polymer drug-eluting stents versus durable polymer sirolimus-eluting stents: an update meta-analysis.

    PubMed

    Zhu, Lin; Lv, Yi Ning; Wang, Li Yu

    2015-01-01

    Durable polymer sirolimus-eluting stents (DP-SES) are associated with a low risk of stent thrombosis; biodegradable polymer drug-eluting stents (BP-DES) were designed to reduce these risks. However, their benefits are still variable. We undertook a meta-analysis of randomized trials identified by systematic searches of Medline, Embase, and the Cochrane Database. Eleven studies (9,676 patients) with a mean follow-up of 22.6 months were included. Overall, compared with DP-SES, BP-DES significantly lowered the rate of definite or probable stent thrombosis (RR, 0.73; 95% CI, 0.55-0.97; p = 0.03; I(2) = 0.0%) due to a decreased risk of very late stent thrombosis (RR, 0.26; 95% CI, 0.11-0.63; p = 0.00; I(2) = 0.0%). However, BP-DES were associated with a comparable rate of early and late stent thrombosis. Meanwhile, BP-DES were associated with a broadly equivalent risk of target vessel revascularization (RR, 0.90; 95% CI, 0.78-1.03; p = 0.13; I(2) = 0.0%), cardiac death (RR, 0.89; 95% CI, 0.72-1.09; p = 0.24; I(2) = 0.0%), myocardial infarction (RR, 1.03; 95% CI, 0.84-1.26; p = 0.79; I(2) = 0.0%), and major adverse cardiac events (MACE; RR, 0.91; 95% CI, 0.83-1.0; p = 0.08; I(2) = 0.0%). Furthermore, angiographic data showed that in-stent and in-segment late luminal loss were similar between the two groups. Compared with DP-SES, BP-DES were associated with a lower rate of very late stent thrombosis and an equivalent risk of MACE. Larger randomized studies are needed to confirm this finding.

  1. Comparison of acute and long-term results and underlying mechanisms from sirolimus-eluting stent implantation for the treatment of in-stent restenosis and recurrent in-stent restenosis in patients in whom intracoronary radiation failed as assessed by intravascular ultrasound.

    PubMed

    Schiele, Thomas M; Rieber, Johannes; König, Andreas; Leibig, Marcus; Erhard, Isabelle; Theisen, Karl; Siebert, Uwe; Klauss, Volker

    2004-10-01

    In-stent restenosis (ISR), especially after vascular brachytherapy, is a therapeutic challenge. Sirolimus-eluting stent implantation is a promising new option for the treatment of patients with ISR. The efficacy of sirolimus-eluting stent implantation for the treatment of patients with their first episodes of ISR and with recurrent ISR due to the failure of vascular brachytherapy was compared using intravascular ultrasound imaging.

  2. Impact of the clinical syntax score on 5-year clinical outcomes after sirolimus-eluting stents implantation.

    PubMed

    Hara, Hironori; Aoki, Jiro; Tanabe, Kengo; Nishi, Akihiro; Tanimoto, Shuzou; Nakajima, Yoshifumi; Yahagi, Kazuyuki; Nakashima, Makoto; Hashimoto, Takuya; Asami, Masahiko; Watanabe, Mika; Yoshida, Eri; Nakajima, Hiroyoshi; Hara, Kazuhiro

    2013-07-01

    The SYNTAX score stratifies risk among drug-eluting stent-treated patients and is based on lesion characteristics alone. The Clinical SYNTAX Score (CSS) combines the SYNTAX score with age, ejection fraction, and creatinine clearance. We assessed its ability to stratify long-term outcomes in sirolimus-eluting stents (SES)-treated patients. Between August 2004 and March 2005, 249 patients were treated with SES. Clinical follow-up was evaluated at more than 5 years. The CSS was available for 206 patients. More than 5-year clinical follow-up data (mean 2114 ± 107 days) and CSS (range 1-322, mean 35.3 ± 49.9, median 17.5) were available for 201 patients. We divided these scores into tertiles: CSS-LOW ≤ 9.5, 9.5 < CSS-MID ≤ 28, and CSS-HIGH > 28. CSS-HIGH was associated with a higher death rate (CSS-LOW 9.0 %, CSS-MID 11.9 %, CSS-HIGH 41.8 %; log-rank p < 0.001) and major adverse cardiovascular events (MACE) (CSS-LOW 29.8 %, CSS-MID 35.8 %, CSS-HIGH 61.2 %; log-rank p = 0.004). Independent predictors for death were hemodialysis [hazard ratio (HR) 3.82; p < 0.001], age (HR 1.67; p = 0.003), ejection fraction (HR 0.98, p = 0.012) and CSS (HR 1.73, p = 0.028), and those for MACE were hemodialysis (HR 2.53, p = 0.002) and CSS (HR 1.40, p = 0.028). Areas under the curve for the SYNTAX score and CSS for death were 0.60 and 0.78 (p < 0.001), whereas those for MACE were 0.58 and 0.68 (p < 0.001), respectively. The CSS predicts long-term outcomes among SES-treated patients better than the SYNTAX score.

  3. Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies).

    PubMed

    Lansky, Alexandra J; Kastrati, Adnan; Edelman, Elazer R; Parise, Helen; Ng, Vivian G; Ormiston, John; Wijns, William; Byrne, Robert A

    2016-02-15

    We compared the outcomes of a novel, thin-strut, cobalt-chromium, absorbable, polymer sirolimus-eluting stent (APSES; MiStent) to the durable polymer cobalt-chromium everolimus-eluting stent (EES; Xience). A propensity-matched analysis was performed comparing data from the DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries (DESSOLVE) I and II studies, evaluating the APSES to the EES arm of the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4 study. Target lesion failure (TLF) and its components were evaluated at 12 months and annually to 3 years; 805 patients (APSES = 153; EES = 652) were included with propensity matching in 204 patients (APSES = 102; EES = 102). APSES compared with EES had lower TLF at 1 year (3.0% vs 8.0%, p = 0.12) driven by a difference in target lesion revascularization (TLR; 1% vs 6%, p = 0.05), with no difference in target vessel myocardial infarction (p = 0.56) or stent thrombosis (p = 0.31). At 3 years, TLF (5.0% vs 12.5%, p = 0.07) and TLR (2.0% vs 8.4%, p = 0.04) remained lower with APSES. By landmark analysis, there was no significant difference in TLF between 1 and 3 years (p = 0.36). In conclusion, in a propensity-matched analysis, the APSES demonstrated reduced clinically indicated TLR rates at 1 and 3 years compared with the durable polymer EES, with minimal accrual of events between 1 and 3 years.

  4. Clinical outcomes according to diabetic status in patients treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: prespecified subgroup analysis of the BIOSCIENCE trial.

    PubMed

    Franzone, Anna; Pilgrim, Thomas; Heg, Dik; Roffi, Marco; Tüller, David; Vuilliomenet, André; Muller, Olivier; Cook, Stéphane; Weilenmann, Daniel; Kaiser, Christoph; Jamshidi, Peiman; Räber, Lorenz; Stortecky, Stefan; Wenaweser, Peter; Jüni, Peter; Windecker, Stephan

    2015-06-01

    Ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) proved noninferior to durable polymer everolimus-eluting stents (DP-EES) for a composite clinical end point in a population with minimal exclusion criteria. We performed a prespecified subgroup analysis of the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation (BIOSCIENCE) trial to compare the performance of BP-SES and DP-EES in patients with diabetes mellitus. BIOSCIENCE trial was an investigator-initiated, single-blind, multicentre, randomized, noninferiority trial comparing BP-SES versus DP-EES. The primary end point, target lesion failure, was a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months. Among a total of 2119 patients enrolled between February 2012 and May 2013, 486 (22.9%) had diabetes mellitus. Overall diabetic patients experienced a significantly higher risk of target lesion failure compared with patients without diabetes mellitus (10.1% versus 5.7%; hazard ratio [HR], 1.80; 95% confidence interval [CI], 1.27-2.56; P=0.001). At 1 year, there were no differences between BP-SES versus DP-EES in terms of the primary end point in both diabetic (10.9% versus 9.3%; HR, 1.19; 95% CI, 0.67-2.10; P=0.56) and nondiabetic patients (5.3% versus 6.0%; HR, 0.88; 95% CI, 0.58-1.33; P=0.55). Similarly, no significant differences in the risk of definite or probable stent thrombosis were recorded according to treatment arm in both study groups (4.0% versus 3.1%; HR, 1.30; 95% CI, 0.49-3.41; P=0.60 for diabetic patients and 2.4% versus 3.4%; HR, 0.70; 95% CI, 0.39-1.25; P=0.23, in nondiabetics). In the prespecified subgroup analysis of the BIOSCIENCE trial, clinical outcomes among diabetic patients treated with BP-SES or DP-EES were comparable at 1 year. URL: http://www.clinicaltrials.gov. Unique identifier

  5. Long-term effectiveness and safety of the sirolimus-eluting BiOSS LIM® dedicated bifurcation stent in the treatment of distal left main stenosis: an international registry.

    PubMed

    Gil, Robert J; Bil, Jacek; Grundeken, Maik J; Iñigo Garcia, Luis A; Vassilev, Dobrin; Kern, Adam; Pawłowski, Tomasz; Wykrzykowska, Joanna J; Serruys, Patrick W

    2016-11-20

    The aim of this study was to assess prospectively the effectiveness and safety of a new version of the dedicated bifurcation BiOSS stent, the sirolimus-eluting BiOSS LIM, for the treatment of distal left main (LM) stenosis. This was a prospective international registry which enrolled patients with NSTE-ACS or stable angina. Provisional T-stenting was the mandated strategy. The primary endpoint was the cumulative rate of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR) at 12 months. Twelve-month quantitative coronary angiography endpoints included late lumen loss and percent diameter stenosis. A total of 74 patients with distal LM stenosis were enrolled. Seventy-three of the 74 patients (aged 67±9 years, 23% women, 20.3% NSTE-ACS, SYNTAX score 22.4±4.4) were successfully treated with the BiOSS LIM stent, with additional side branch placement of regular DES in 11 patients (14.9%). Periprocedural MI occurred in one (1.4%) patient. The 12-month MACE rate was 9.5% without cardiac death or definite stent thrombosis. TLR and MI rates were 6.8% (n=5) and 2.7% (n=2), respectively. The use of the BiOSS LIM dedicated bifurcation stent for the treatment of distal LM stenosis was feasible and safe, with promising long-term clinical effectiveness.

  6. Antiplatelet therapy discontinuation and stent thrombosis after sirolimus-eluting stent implantation: five-year outcome of the j-Cypher Registry.

    PubMed

    Yano, Mariko; Natsuaki, Masahiro; 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; Mitsudo, Kazuaki; Kimura, Takeshi

    2015-11-15

    The influence of antiplatelet therapy discontinuation on the incidence of stent thrombosis, especially very late stent thrombosis, after drug-eluting stent implantation has not been yet fully addressed. Relationship between antiplatelet therapy discontinuation and stent thrombosis up to 5years was evaluated in 12,812 consecutive patients undergoing sirolimus-eluting stents (SES) implantation in the j-Cypher registry. Data on status of antiplatelet therapy during follow-up were collected prospectively. Median follow-up interval was 1699days (interquartile range, 1184-1928days). Incidences of definite stent thrombosis were 0.34% at 30days, 0.55% at 1year, and 1.6% at 5years. Dual antiplatelet therapy was maintained in 97.4%, 63%, and 43.9% of patients at 30days, 1year, and 5years, respectively. The rates of stent thrombosis in patients who discontinued both thienopyridine and aspirin were significantly higher in the time intervals of 31-365days, 2-3years and 3-4years, and tended to be higher in the time intervals of 1-2years and 4-5years than those in patients who continued both (31-365days: 1.26% versus 0.2%, P<0.001; 1-2years: 0.59% versus 0.15%, P=0.06; 2-3years: 1.35% versus 0.2%, P=0.004; 3-4years: 1.09% versus 0.25%, P=0.0496; 4-5years: 1.35% versus 0.43%, P=0.17). Patients who discontinued either thienopyridine or aspirin only did not have an excess of stent thrombosis in any time intervals. In conclusion, discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine or aspirin only, was associated with an increased incidence of late and very late stent thrombosis up to 5years after SES implantation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial).

    PubMed

    Stiermaier, Thomas; Heinz, Anja; Schloma, Denis; Kleinertz, Klaus; Dänschel, Wilfried; Erbs, Sandra; Linke, Axel; Boudriot, Enno; Lauer, Bernward; Schuler, Gerhard; Thiele, Holger; Desch, Steffen

    2014-02-15

    The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected. The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent. At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent. Copyright © 2013 Wiley Periodicals, Inc.

  8. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study.

    PubMed

    Han, Yaling; Jing, Quanmin; Li, Yi; Yang, Lixia; Liu, Huiliang; Shang, Xiaoming; Jiang, Tiemin; Li, Zhanquan; Zhang, Hua; Yan, Gaoliang

    2012-02-01

    The CREATE is a post-marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus-eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice. To evaluate the three-year clinical safety and efficacy outcomes in patients enrolled in the CREATE study. A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months. Clinical follow-up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053). This study demonstrates sustained three-year clinical safety and efficacy of biodegradable polymer-based sirolimus-eluting stents when used with six months of dual antiplatelet therapy in a "real-world" setting. Copyright © 2011 Wiley Periodicals, Inc.

  9. Comparison of long-term in-stent vascular response between abluminal groove-filled biodegradable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent: 3-year OCT follow-up from the TARGET I trial.

    PubMed

    Xu, Bo; Zhang, Yao-Jun; Sun, Zhong-Wei; Qiao, Shu-Bin; Chen, Shao-Liang; Zhang, Rui-Yan; Pan, Dao-Rong; Pang, Si; Zhang, Qi; Xu, Liang; Yang, Yue-Jin; Leon, Martin B; Gao, Run-Lin

    2015-12-01

    The study sought to compare long-term optical coherence tomography (OCT)-based in-stent vascular response between the abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) and the durable polymer everolimus-eluting stent (EES) in the TARGET I trial. The TARGET I trial was a prospective, multicenter, randomized clinical trial which enrolled 458 patients with single de novo lesions treated by abluminal groove-filled biodegradable polymer SES and EES. A subset of 43 patients underwent angiography and OCT examinations at 3 years. All OCT images were analyzed at 0.4 mm intervals. A similar increase in angiographic late lumen loss was observed in SES and EES (from 0.05 ± 0.05 vs. 0.05 ± 0.05 mm [p = 0.84] at 9 months to 0.25 ± 0.37 vs. 0.26 ± 0.19 mm [p = 0.99] at 3 years, respectively), without significant differences at 3 years in mean neointimal thickness of stent struts (SES: 0.13 ± 0.02 mm vs. EES: 0.13 ± 0.02 mm, p = 0.80); mean percentage of covered struts (SES: 99.2 % vs. EES: 99.3 %, p = 0.53), or malapposed strut rates (SES: 0.08 % vs. EES: 0.06 %, p = 0.15). The OCT-based in-stent vascular response evaluation found similar vascular healing for the two studied devices, indicating that the luminal loss in EES from 9 months to 3 years cannot be imputed on its coated biocompatible polymer.

  10. Long-term outcome of the unrestricted use of everolimus-eluting stents compared to sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients: the Bern-Rotterdam diabetes cohort study.

    PubMed

    Simsek, C; Räber, L; Magro, M; Boersma, E; Onuma, Y; Stefanini, G G; Zanchin, T; Kalesan, B; Wenaweser, P; Jüni, P; van Geuns, R J; van Domburg, R T; Windecker, S; Serruys, P W J C

    2013-12-05

    Newer generation everolimus-eluting stents (EES) improve clinical outcome compared to early generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). We investigated whether the advantage in safety and efficacy also holds among the high-risk population of diabetic patients during long-term follow-up. Between 2002 and 2009, a total of 1963 consecutive diabetic patients treated with the unrestricted use of EES (n=804), SES (n=612) and PES (n=547) were followed throughout three years for the occurrence of cardiac events at two academic institutions. The primary end point was the occurrence of definite stent thrombosis. The primary outcome occurred in 1.0% of EES, 3.7% of SES and 3.8% of PES treated patients ([EES vs. SES] adjusted HR=0.58, 95% CI 0.39-0.88; [EES vs. PES] adjusted HR=0.29, 95% CI 0.13-0.67). Similarly, patients treated with EES had a lower risk of target-lesion revascularization (TLR) compared to patients treated with SES and PES ([EES vs. SES], 5.6% vs. 11.5%, adjusted HR=0.68, 95% CI: 0.55-0.83; [EES vs. PES], 5.6% vs. 11.3%, adjusted HR=0.51, 95% CI: 0.33-0.77). There were no differences in other safety end points, such as all-cause mortality, cardiac mortality, myocardial infarction (MI) and MACE. In diabetic patients, the unrestricted use of EES appears to be associated with improved outcomes, specifically a significant decrease in the need for TLR and ST compared to early generation SES and PES throughout 3-year follow-up. © 2013.

  11. First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial.

    PubMed

    Ribeiro, Expedito E; Campos, Carlos M; Ribeiro, Henrique B; Lopes, Augusto C; Esper, Rodrigo B; Meirelles, George X; Perin, Marco A; Abizaid, Alexandre; Lemos, Pedro A

    2014-01-01

    The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

  12. Five-year clinical outcomes of a polymer-free sirolimus-eluting stent versus a permanent polymer paclitaxel-eluting stent: final results of the intracoronary stenting and angiographic restenosis - test equivalence between two drug-eluting stents (ISAR-TEST) trial.

    PubMed

    King, Lamin; Byrne, Robert A; Mehilli, Julinda; Schömig, Albert; Kastrati, Adnan; Pache, Jurgen

    2013-01-01

    Limited evidence exists regarding the long-term performance of polymer-free (PF) drug-eluting stents (DES) in comparison to permanent polymer DES. This study investigated the 5-year efficacy and safety of a PF sirolimus-eluting stent (PF-SES) versus a permanent polymer paclitaxel-eluting stent (PES) in the setting of the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between Two Drug-Eluting Stents (ISAR-TEST) randomized trial. A total of 450 patients undergoing percutaneous coronary intervention were randomized to receive either PF-SES (Yukon, Translumina; n = 225) or PES (Taxus, Boston Scientific; n = 225). Clinical follow-up was performed to 5 years after enrollment. The endpoints were major adverse cardiac events (MACE), target lesion revascularization (TLR), the composite of death or any myocardial infarction (MI) and stent thrombosis (ST). The incidence of MACE at 5 years was 27.3% (57 patients) in the PF-SES group and 31.7% (65 patients) in the PES group [hazard ratio (HR) = 0.87 [95% confidence interval (95% CI) = 0.61-1.24]; P = 0.40]. The combined incidence of death or MI was 16.6% (34 patients) in the PF-SES group and 20.0% (39 patients) in the PES group (HR = 0.86 [95% CI = 0.54-1.36]; P = 0.52). The incidence of TLR was 16.5% (34 patients) in the PF-SES group and 16.4% (33 patients) in the PES group (HR = 1.03 [95% CI = 0.64-1.66]; P = 0.89). ST occurred in 0.5% (one patient) in the PF-SES group and 1.6% (three patients) in the PES group (HR = 0.33 [95% CI = 0.03-3.14]; P = 0.32). Overall there was no significant difference in clinical outcomes between PF-SES and PES to 5 years. Extended follow-up supports the durability of efficacy and safety of PF-SES. Copyright © 2012 Wiley Periodicals, Inc.

  13. Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial

    PubMed Central

    Oliveira, Marcos Danillo Peixoto; Ribeiro, Expedito E.; Campos, Carlos M.; Ribeiro, Henrique B.; Faillace, Bruno L. R.; Lopes, Augusto C.; Esper, Rodrigo B.; Meirelles, George X.; Perin, Marco A.; Abizaid, Alexandre

    2015-01-01

    Background The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391). Methods A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years. Results Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11). The rate of death/MI was similar between the groups, but there was a significant decrease in the risk of repeat revascularization in the Inspiron group compared to the control arm TLR (0.0% vs. 23.5% respectively, P=0.02). There were no stent thromboses in the study population. Conclusions The novel Inspiron™ SES showed a sustained safe and effective clinical profile after 4-year of follow-up, with very low adverse events and null stent thrombosis (ST) occurrence. PMID:26331110

  14. Long-term performance of the second-generation cobalt-chromium sirolimus-eluting stents in real-world clinical practice: 3-year clinical outcomes from the prospective multicenter FOCUS registry

    PubMed Central

    Zhang, Feng; Yang, Ji’e; Qian, Juying; Ge, Lei; Zhou, Jun

    2016-01-01

    Background The short- and mid-term outcomes of the second-generation cobalt-chromium sirolimus-eluting stent (CoCr-SES) in real-world patients had been reported previously, but the long-term performance remained unclear. The objective of this analysis was to evaluate the long-term safety and efficacy of the second-generation CoCr-SES from the FOCUS registry. Methods The FOCUS registry (ClinicalTrials.gov Identifier: NCT00868829) enrolled all-comers eligible to receive Firebird-2 CoCr-SES. Follow-up was continued to 3 years to evaluate long-term safety and effectiveness of the second-generation CoCr-SES in real-world practice. Results of the extended-use group and standard-use group are compared to explore performance of CoCr-SES in more severe patients with more complex lesions. Results The rate of 3-year MACE was 7.37%, consisting of 84 cases (1.78%) of cardiac death, 166 cases (3.52%) of MI and 98 cases (2.08%) of TVR. ARC definite/probable stent thrombosis happened in 34 (0.72%) patients, only 3 new cases (<0.1%) of very late stent thrombosis was reported in the third year. Meanwhile, the difference of MACE (7.77% vs. 6.06%; P=0.058), TLF (4.71% vs. 3.49%; P=0.085) and ARC definite/probable stent thrombosis (0.83% vs. 0.37%; P=0.116) between extended-use group and standard-use group showed no significance. Conclusions The second-generation CoCr-SES was associated with continued low rates of 3-year MACE, TLF and stent thrombosis in a broad spectrum of patients. PMID:27499948

  15. Role of new sirolimus self-apposing stent in coronary interventions.

    PubMed

    Giustino, G; Mehran, R

    2015-02-01

    Device technology in interventional cardiology is continuously evolving. Self-expandable (SE) coronary artery stents were the first device to be implanted within a human coronary artery. However, because of their initial limitations, balloon-expandable (BE) stents were predominantly developed and used in the last 30 years. Unfortunately, in challenging anatomical settings such as bifurcation lesions, large, ectatic or aneurysmal vessels, tapered vessels or vasoconstricted arteries, outcomes with BE stents are not always optimal. The Stentys (Stentys SA, Paris, France) SE nitinol stents were initially developed for the treatment of coronary bifurcation lesions. The understanding of the underlying mechanism involved in incomplete stent apposition and subsequent stent thrombosis led to the introduction of self-apposing stents in the treatment of acute coronary syndrome in order to overcome the limitations of drug-eluting stents in presence of high thrombus burden. In this regard, Stentys allows a progressive stent expansion which could reduce the rates of incomplete stent apposition by conforming to vascular remodeling. Enhancing the advantages of this technology by adding the release of an antiproliferative drug to prevent restenosis is even more attractive and potentially effective. Recently, the results of the new Stentys sirolimus-eluting stent have been reported. This article provides an overview of the pathobiological rational, device characteristics and results of the new Stentys self-expandable sirolimus-eluting stent.

  16. Coronary aneurysm and stent fracture following stenting of a myocardial bridge.

    PubMed

    Lu, Hao; Ge, Lei; Ge, Junbo

    2016-01-01

    Myocardial bridge is the most common congenital coronary anomaly. We represent an extremely rare case of stent fracture combination with coronary aneurysm following stenting of a myocardial bridge. This 60-years-old male patient underwent coronary angiography in the local hospital four years ago. Coronary angiography revealed a myocardial bridge in the distal left anterior descending coronary artery (LAD). A 3.0 mm × 29 mm sirolimus eluting stent was deployed in the distal LAD. Three years later, repeat coronary angiography showed a large coronary aneurysm in the mid segment of the stent. The patient subsequently underwent coronary artery bypass grafting with left internal mammary artery (LIMA) to the distal segment of the LAD. But six months later, another coronary angiography showed a stent fracture in mid portion of the stent associated with a large coronary aneurysm, and the LIMA graft was totally occluded. A possible mechanism of stent fracture was long-standing and cyclic mechanical stress on the stent by myocardium. These forces over a period of time may lead to metal fatigue and eventually fracture. Based on the observation of fracture and aneurysm in this study, we recommend that myocardial bridge should not be treated with intracoronary stenting. © 2015 Wiley Periodicals, Inc.

  17. Assessment of vascular response to BiOSS LIM C(®) stents vs Orsiro(®) stents in the porcine coronary artery model.

    PubMed

    Bil, Jacek; Gil, Robert J; Pawlowski, Tomasz; Milewski, Krzysztof P

    2017-08-01

    The optimal treatment strategy for coronary bifurcation lesions is still unknown. The aim of the study was to assess applicability of the new cobalt-chromium version of the sirolimus-eluting dedicated bifurcation BiOSS(®) LIM C stent in comparison with regular sirolimus-eluting Orsiro(®)  stent in a porcine coronary model. A total of 13 BiOSS(®) LIM C stents and 6 Orsiro(®) stents were implanted in normal nonatherosclerotic porcine straight coronary arteries of six animals using 1.2:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imaging. Vascular response was assessed by quantitative coronary angiography (QCA), optical coherence tomography (OCT), and histological analyses. OCT performed at 28 days confirmed that all stents were patent with no signs of thrombus. In morphometric analysis, no differences between groups regarding stent diameter (P=.141), neointima area (P=.247), % area stenosis (P=.293), or % diameter stenosis (P=.069) were observed. Also, no significant differences were noted between groups regarding their histopathology scores. The injury and inflammation scores were low (mean grade<1) in all groups. The novel BiOSS(®) LIM C stent demonstrates good short-term vascular effects in a porcine coronary bifurcation model which are comparable with Orsiro(®) stents. © 2017 John Wiley & Sons Ltd.

  18. 6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold: The FANTOM II Study.

    PubMed

    Abizaid, Alexandre; Carrié, Didier; Frey, Norbert; Lutz, Matthias; Weber-Albers, Joachim; Dudek, Darius; Chevalier, Bernard; Weng, Shu-Chuan; Costa, Ricardo A; Anderson, Jeffrey; Stone, Gregg W

    2017-09-25

    The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%). The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease. Copyright © 2017. Published by Elsevier Inc.

  19. Sirolimus-Versus Zotarolimus-Eluting Stents in Acute Coronary Syndromes With C Type Left Anterior Descending Artery Lesions: A Three-Year Clinical Follow-Up

    PubMed Central

    Gokay, Seher; Cicek, Davran; Muderrisoglu, Haldun

    2012-01-01

    Background Drug-eluting stents have improved the efficacy of percutaneous coronary intervention and made it the preferred therapy in the treatment of ischemic heart diseases including acute coronary syndromes. The objective of the study was to compare the clinical efficacy and safety of sirolimus-eluting stent with that of zotarolimus-eluting stent following percutaneous coronary intervention for acute coronary syndrome patients with C-type left anterior descending stenosis. Methods A total of 154 acute coronary syndrome patients with C-type lesions in the left anterior descending artery, requiring a stent > 28 mm in length, were randomized into two groups to receive either sirolimus- (n = 74) or zotarolimus-eluting stent (n = 80). The follow-up period after stent implantation was approximately 36 months. The primary endpoint was a major cardiac event (a composite of cardiac death, myocardial infarction, or ischemia-related target vessel revascularization), and the secondary endpoint included these individual end points plus stent thrombosis. Results After 3 years follow-up, the rate of the primary end point (major cardiac event: cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was 16% in the sirolimus group (n = 12) versus 11.2% in the zotarolimus group (n = 9) (P = 0.2). Although there were four cases of stent thrombosis with sirolimus-eluting stent and one with zotarolimus-eluting stent (4.0% sirolimus vs. 1.25% zotarolimus; P = 0.2), neither non-Q myocardial infarction (4.0%sirolimus vs. 1.25% zotarolimus; P = 0.2) nor stent thrombosis, differed significantly. Conclusions Although zotarolimus-eluting stent implantation showed more favorable results with respect to stent thrombosis and major adverse cardiac event rates compared to sirolimus-eluting stent implantation, statistically, both stent groups have nearly similar clinical safety and efficacy in the treatment of acute coronary syndromes with C-type lesions in the left

  20. Effect of solvent on drug release and a spray-coated matrix of a sirolimus-eluting stent coated with poly(lactic-co-glycolic acid).

    PubMed

    Choi, Jiyeon; Jang, Bu Nam; Park, Bang Ju; Joung, Yoon Ki; Han, Dong Keun

    2014-08-26

    Sirolimus (SRL) release from the biodegradable poly(l-lactic-co-glycolic acid) (PLGA) matrix was investigated for the application of drug-eluting stents (DES). In particular, this study focused on whether various organic solvents affect the interaction between SRL and PLGA and the formation of microstructures during ultrasonic coating. The SRL-loaded PLGA coated by tetrahydrofuran or acetone showed a significant initial burst, whereas that from acetonitrile was constantly released during a period of 21 days. On the basis of these results, the interactions at the molecular level of SRL with the polymer matrix were estimated according to various organic solvents. Although the topographies of the coated surface were obviously different, the correlation between surface roughness and SRL release was very poor. Irrespective of organic solvents, FT-IR data showed significantly weak SRL-PLGA interactions. From the result of wide-angle X-ray diffraction, it was confirmed that SRL was dispersed in an amorphous state in the polymer matrix after ultrasonic coating. The glass-transition temperature was also influenced by organic solvents, resulting in a plasticizing effect. The particle size of SRL appeared to determine the release profile from the PLGA matrix, which was the combination of diffusion and polymer degradation at an SRL size of more than 800 nm and the Fickian release at that of less than 300 nm. Therefore, organic solvents can lead to a heterogeneous microstructure in the SRL-loaded PLGA matrix, which is at or near the surface, consisting of aggregated drug- and polymer-rich regions. It is expected that the drug release can be controlled by physicochemical properties of organic solvents, and this study can be used effectively for localized drug release in biomedical devices such as drug-eluting stents.

  1. Impact of insulin-treated diabetes and hemodialysis on long-term clinical outcomes following sirolimus-eluting stent deployment. Insights from a sub-study of the Cypher Stent Japan Post-Marketing Surveillance(Cypher J-PMS) Registry.

    PubMed

    Nakamura, Masato; Yokoi, Hiroyoshi; Hamazaki, Yuji; Watarai, Masato; Kijima, Mikihiro; Mitsudo, Kazuaki

    2010-11-01

    Long-term clinical outcomes of diabetes mellitus (DM) patients who underwent drug-eluting stent deployment has not well investigated. A total of 2,050 cases were enrolled consecutively from 50 sites in Japan into the Cypher stent Japan Post-Marketing Surveillance (Cypher J-PMS) registry, and the 3-year outcomes of DM patients were analyzed. Subjects were divided into 2 groups based on the treatment of DM (insulin-treated diabetes (IT) group, n=207; and non insulin-treated diabetes (NIT) group, n=682). Major adverse cardiac event (MACE) rates in the IT group and the NIT group were 26.0% and 14.5% at 3 years, respectively (P<0.001). There were no significant differences in stent thrombosis rates (definite and probable by Academic Research Consortium (ARC) definition) (0% and 1.08%, respectively). Multivariate analysis suggested that hemodialysis and insulin-treated DM were independent predictors for MACE, and insulin-treated DM, hemodialysis and long lesions were strong independent predictors for target-lesion revascularization (TLR). Hemodialysis and insulin-treated DM were strong independent predictors of mortality and TLR in DM patients. These results might suggest that special attention to patients with hemodialysis and insulin-treated DM is warranted in the setting of sirolimus-eluting stent deployment for DM patients.

  2. Angioscopic Evaluation of Neointimal Coverage of Coronary Stents.

    PubMed

    Uchida, Yasumi; Uchida, Yasuto

    2010-10-01

    Drug-eluting stents (DES) reduce coronary restenosis significantly; however, late stent thrombosis (LST) occurs, which requires long-term antiplatelet therapy. Angioscopic grading of neointimal coverage of coronary stent struts was established, and it was revealed that neointimal formation is incomplete and prevalence of LST is higher in DES when compared to bare-metal stents. It was also observed that the neointima is thicker and LST is less frequent in paclitaxel-eluting and zotarolimus-eluting stents than in sirolimus-eluting stents. Many new stents were devised and they are now under experimental or clinical investigations to overcome the shortcomings of the stents that have been employed clinically. Endothelial cells are highly anti-thrombotic. Neo-endothelial cell damage is considered to be caused by friction between the cells and stent struts due to the thin neointima between them which might act as a cushion. Therefore, development of a DES that causes an appropriate thickness (around 100 μm) of the neointima is a potential option with which to prevent neo-endothelial cell damage and consequent LST while preventing restenosis.

  3. A randomized, open-label clinical trial using optical coherence tomography to compare two sirolimus-eluting stents, one with a biodegradable polymer and the other with a permanent polymer.

    PubMed

    Tian, Feng; Chen, Yundai; Liu, Changfu; Jin, Qinhua; Chen, Lian; Sun, Zhijun; Liu, Hongbin; Guo, Jun; Gai, Luyue

    2013-04-01

    Intimal hyperplasia appears to differ after implanting a drug-eluting stent (DES) with a biodegradable or a permanent polymer. The aim of the present study was to compare biodegradable with permanent polymer DES, since the available data are limited. One hundred patients with de novo coronary artery stenosis were included in this study. The patients were classified into 2 groups: DES with a biodegradable polymer (n=50) and DES with a permanent polymer (n=50). Optical coherence tomography (OCT) examination was performed before and after stent implantation. A follow‑up OCT, performed 1 year after stent implantation, compared the morphologies of intimal hyperplasia in the 2 groups. The frequencies of uncovered stent struts (2.27 vs. 1.87%, P=0.145) and stent strut malapposition (1.9 vs. 2.02%, P=0.655) upon the first-year follow-up were not significantly different. Average neointimal thickness was lower in the biodegradable compared with the permanent polymer group (106.12±80.65 vs. 181.20±146.96 µm, P<0.001). The frequencies of neointimal thickness <100 µm were significantly higher in the biodegradable compared with the permanent polymer group (62.1 vs. 35.9%, P<0.001). The average intimal thickness was also lower in the biodegradable compared with the permanent polymer group (57.7±24.6 vs. 67.6±22.4 µm, P<0.001). In conclusion, biodegradable polymer DES resulted in significantly lower intimal hyperplasia and had well-proportioned intimal coverage compared with permanent polymer DES.

  4. Nanoporous CREG-Eluting Stent Attenuates In-Stent Neointimal Formation in Porcine Coronary Arteries

    PubMed Central

    Sun, Mingyu; Tao, Jie; Yan, Chenghui; Kang, Jian; Li, Shaohua

    2013-01-01

    Background The goal of this study was to evaluate the efficacy of a nanoporous CREG-eluting stent (CREGES) in inhibiting neointimal formation in a porcine coronary model. Methods In vitro proliferation assays were performed using isolated human endothelial and smooth muscle cells to investigate the cell-specific pharmacokinetic effects of CREG and sirolimus. We implanted CREGES, control sirolimus-eluting stents (SES) or bare metal stents (BMS) into pig coronary arteries. Histology and immunohistochemistry were performed to assess the efficacy of CREGES in inhibiting neointimal formation. Results CREG and sirolimus inhibited in vitro vascular smooth muscle cell proliferation to a similar degree. Interestingly, human endothelial cell proliferation was only significantly inhibited by sirolimus and was increased by CREG. CREGES attenuated neointimal formation after 4 weeks in porcine coronary model compared with BMS. No differences were found in the injury and inflammation scores among the groups. Scanning electron microscopy and CD31 staining by immunohistochemistry demonstrated an accelerated reendothelialization in the CREGES group compared with the SES or BMS control groups. Conclusions The current study suggests that CREGES reduces neointimal formation, promotes reendothelialization in porcine coronary stent model. PMID:23573278

  5. 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

  6. Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial.

    PubMed

    Teeuwen, Koen; van der Schaaf, René J; Adriaenssens, Tom; Koolen, Jacques J; Smits, Pieter C; Henriques, José P S; Vermeersch, Paul H M J; Tjon Joe Gin, R Melvyn; Schölzel, Bastiaan E; Kelder, Johannes C; Tijssen, Jan G P; Agostoni, Pierfrancesco; Suttorp, Maarten J

    2017-01-23

    The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss

  7. Pitavastatin-incorporated nanoparticle-eluting stents attenuate in-stent stenosis without delayed endothelial healing effects in a porcine coronary artery model.

    PubMed

    Tsukie, Noriaki; Nakano, Kaku; Matoba, Tetsuya; Masuda, Seigo; Iwata, Eiko; Miyagawa, Miho; Zhao, Gang; Meng, Wei; Kishimoto, Junji; Sunagawa, Kenji; Egashira, Kensuke

    2013-01-01

    The use of currently marketed drug-eluting stents presents safety concerns including increased late thrombosis, which is thought to result mainly from delayed endothelial healing effects (impaired re-endothelialization resulting in abnormal inflammation and fibrin deposition). We recently developed a bioabsorbable polymeric nanoparticle (NP)-eluting stent using a novel cationic electrodeposition technology. Statins are known to inhibit the proliferation of vascular smooth muscle cells (VSMC) and to promote vascular healing. We therefore hypothesized that statin-incorporated NP-eluting stents would attenuate in-stent stenosis without delayed endothelial healing effects. Among six marketed statins, pitavastatin (Pitava) was found to have the most potent effects on VSMC proliferation and endothelial regeneration in vitro. We thus formulated a Pitava-NP-eluting stent (20µg Pitava per stent). In a pig coronary artery model, Pitava-NP-eluting stents attenuated in-stent stenosis as effectively as polymer-coated sirolimus-eluting stents (SES). At SES sites, delayed endothelial healing effects were noted, whereas no such effects were observed in Pitava-NP-eluting stent sites. Pitava-NP-eluting stents attenuated in-stent stenosis as effectively as SES without the delayed endothelial healing effects of SES in a porcine coronary artery model. This nanotechnology platform could be developed into a safer and more effective device in the future.

  8. Activation of matrix metalloproteinase-9 is associated with mobilization of bone marrow-derived cells after coronary stent implantation.

    PubMed

    Inoue, Teruo; Taguchi, Isao; Abe, Shichiro; Toyoda, Shigeru; Nakajima, Kohsuke; Sakuma, Masashi; Node, Koichi

    2011-11-03

    After stent-related vascular injury, an inflammatory response triggers the mobilization of bone marrow-derived stem cells, including both endothelial and smooth muscle progenitors, leading to re-endothelialization as well as restenosis. It has been postulated that neutrophil-released matrix metalloproteinase-9 (MMP-9) induces stem cell mobilization. To elucidate the mechanistic link between inflammation and stem cell mobilization after coronary stenting. In 31 patients undergoing coronary stenting, we serially measured activated Mac-1 on the surface of neutrophils and active MMP-9 levels in the coronary sinus blood plasma, and the number of circulating CD34-positive cells in the peripheral blood. After bare-metal stent implantation (n=21), significant increases in the numbers of CD34-positive cells (maximum on post-procedure day 7, P<0.001), activated Mac-1 (at 48 h, P<0.001), and active MMP-9 levels (at 24h, P<0.001) were observed. However, these changes were absent after sirolimus-eluting stent implantation (n=10). In overall patients, the numbers of CD34-positive cells on day 7 (R=0.58, P<0.01) and activated Mac-1 at 48 h (R=0.58, P<0.01) were both correlated with active MMP-9 levels at 24h. Stimulation of activated Mac-1 on the surface of isolated human neutrophils produced active MMP-9 release in vitro. These results suggest that stent-induced activation of Mac-1 on the surface of neutrophils might trigger their MMP-9 release, possibly leading to the mobilization of bone marrow-derived stem cells. These reactions were substantially inhibited by sirolimus-eluting stents. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  9. Histopathological heterogeneity of in-stent restenosis in four coronary endarterectomy specimens.

    PubMed

    Takashima, Akira; Shimabukuro, Michio; Tabata, Minoru; Fukuda, Daiju; Uematsu, Etsuko; Ishibashi-Ueda, Hatsue; Takanashi, Shuichiro; Sata, Masataka

    2015-01-01

    Here, we histopathologically compare four patients undergoing coronary artery bypass with coronary endarterectomy and onlay patch grafting for in-stent restenosis (ISR) after the implantation of a bare-metal stent (BMS), sirolimus-eluting stent (SES), or paclitaxel-eluting stent (PES) in an everolimus-eluting stent (EES). Heterogeneity of ISR was noted histopathologically. In ISR for BMS, restenosis is likely caused by so-called neoatherosclerosis that occurred which altered the healing process of BMS implantation. Two ISR cases for SES showed a histopathological heterogeneity: one showed nodular calcified thrombus around stent strut protruding into the lumen, and the other showed concentric neointima composed of CD68-positive foam cell proliferation. In the ISR lesion for PES in EES, infiltrations with foam cells macrophages, particularly numerous eosinophilic cell infiltrations, suggest a peristent strut hypersensitivity reaction. We found a remarkable histopathological heterogeneity of ISR. The study using coronary endarterectomy specimens can give us pivotal information about the histopathological heterogeneity of ISR. Copyright © 2014 Elsevier Inc. All rights reserved.

  10. Specific coronary drug-eluting stents interfere with distal microvascular function after single stent implantation in pigs.

    PubMed

    van den Heuvel, Mieke; Sorop, Oana; Batenburg, Wendy W; Bakker, Charlotte L; de Vries, René; Koopmans, Sietse Jan; van Beusekom, Heleen M M; Duncker, Dirk J; Danser, A H Jan; van der Giessen, Willem J

    2010-07-01

    The aim of this study was to compare the effects of single drug-eluting stents (DES) on porcine coronary function distal to the stent in vivo and in vitro. The mechanism of endothelial dysfunction occurring in human coronary conduit arteries up to 9 months after DES implantation is unknown. A sirolimus-eluting stent (SES), paclitaxel-eluting stent (PES), and a bare-metal stent (BMS) were implanted in the 3 coronary arteries of 11 pigs. After 5 weeks, in vivo responses in distal coronary flow to different doses of bradykinin (BK) and nitrates were measured. In vitro, vasodilation to BK and nitrates, as well as vasoconstriction to endothelin (ET)-1 were assessed in both distal coronary conduit and small arteries. In addition, contributions of nitric oxide (NO) and endothelium-derived hyperpolarizing factors (EDHFs) and cyclic guanosine monophosphate (cGMP) responses to BK-stimulation were determined in vitro. Both DES did not alter in vivo distal vasomotion. In vitro distal conduit and small arterial responses to BK were also unaltered; DES did not alter the BK-induced increase in cGMP. However, after NO synthase blockade, PES showed a reduced BK-response in distal small arteries as compared with BMS and SES (p < 0.05). The ET-1-induced vasoconstriction and vascular smooth muscle cell function were unaltered. In this study of single stenting in healthy porcine coronaries for 5 weeks, SES did not affect distal coronary vascular function, whereas PES altered distal endothelial function of small arteries under conditions of reduced NO bioavailability. Therefore, specifically the EDHF component of microvascular function seems affected by PES. Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. Comparison of two biodegradable-polymer-based sirolimus-eluting stents with varying elution and absorption kinetics in patients with acute myocardial infarction: A subgroup analysis of the PANDA III trial.

    PubMed

    Guan, Changdong; Xu, Bo; Qiao, Shubin; Qin, Lei; Li, Yi; Li, Zhanquan; Guo, Yong; Sun, Zhongwei; Song, Lei; Gao, Runlin

    2017-03-01

    Implantation of early-generation metallic drug-eluting stents (DES) in patients with acute myocardial infarction (AMI) is associated with poor vessel wall healing. Use of biodegradable polymer (BP) DES might improve safety outcomes; however, the impact of varying drug elution and polymer absorption kinetics of BP-DES on clinical outcomes in the AMI population is unknown. This subgroup analysis of the randomized PANDA III trial included 732 patients (366 in each group) presenting with recent (<1 month) AMI. Primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), or ischemia-driven target lesion revascularization. Secondary endpoints included a patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization; individual TLF and PoCE components; and definite/probable stent thrombosis (ST). There were no significant differences between-groups in baseline clinical, angiographic, or procedural characteristics other than the proportion of post-dilatation, which was performed more frequently with the BuMA stent (53.9% vs. 44.5%; P = 0.004). After 1 year, compared to Excel SES implantation in patients with AMI, BuMA was associated with similar incidences of TLF and PoCE (5.5% vs. 8.3%, P = 0.14; 8.8% vs. 9.9%, P = 0.61, respectively) but lower incidences of MI (2.5% vs. 6.1%, P = 0.02), target vessel MI (2.2% vs. 5.8%, P = 0.01), and definite/probable ST (0.3% vs. 2.2%, P = 0.04). BuMA SES, with faster drug elution rate and polymer absorption kinetics, might improve safety outcomes compared to Excel SES in the high-risk AMI population. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  12. Long-term outcomes of routine versus provisional T-stenting for de novo coronary bifurcation lesions: five-year results of the Bifurcations Bad Krozingen I study.

    PubMed

    Ferenc, Miroslaw; Ayoub, Mohamed; Büttner, Hans-Joachim; Gick, Michael; Comberg, Thomas; Rothe, Jürgen; Valina, Christian M; Hochholzer, Willibald; Neumann, Franz-Josef

    2015-12-01

    Previously, we reported that the nine-month angiographic result after treatment of coronary bifurcation lesions with provisional T-stenting was not significantly different from that with routine T-stenting. To compare long-term clinical outcomes of the two stenting strategies, we extended the follow-up of our study on bifurcation stenting. One hundred and one patients with coronary bifurcation lesions had been randomly assigned to provisional T-stenting and 101 to routine T-stenting, using sirolimus-eluting stents. We performed complete five-year follow-up. The primary efficacy endpoint was the incidence of target lesion revascularisation (TLR), and the primary safety endpoint was the incidence of definite/probable stent thrombosis (ST). We also monitored death, myocardial infarction (MI) and MACE (composite of death, MI and TLR). The cumulative five-year incidence of TLR in the provisional T-stenting arm was not significantly different from that in the routine T-stenting arm (16.2% vs. 16.3%, p=0.97). The same was true for MACE (22.8% vs. 22.9%, p=0.91), the composite of death and MI (9.9% vs. 13.9%, p=0.40), and ST (2.0% vs. 5.1%; p=0.25). During five-year follow-up, routine T-stenting offered no advantage over provisional T-stenting with respect to TLR or MACE. ClinicalTrials.gov Identifier: NCT00288535

  13. Coronary covered stents.

    PubMed

    Kilic, Ismail Dogu; Fabris, Enrico; Serdoz, Roberta; Caiazzo, Gianluca; Foin, Nicolas; Abou-Sherif, Sara; Di Mario, Carlo

    2016-11-20

    Covered stents offer an effective bail-out strategy in vessel perforations, are an alternative to surgery for the exclusion of coronary aneurysms, and have a potential role in the treatment of friable embolisation-prone plaques. The aim of this manuscript is to offer an overview of currently available platforms and to report results obtained in prior studies.

  14. 10-Year Clinical Outcome After Randomization to Treatment by Sirolimus- or Paclitaxel-Eluting Coronary Stents.

    PubMed

    Galløe, Anders M; Kelbæk, Henning; Thuesen, Leif; Hansen, Henrik S; Ravkilde, Jan; Hansen, Peter R; Christiansen, Evald H; Abildgaard, Ulrik; Stephansen, Ghita; Lassen, Jens F; Engstrøm, Thomas; Jensen, Jan Skov; Jeppesen, Jørgen L; Bligaard, Niels

    2017-02-14

    First-generation drug-eluting coronary stents (DES) were introduced in 2003 to 2004, and their use resulted in a considerable reduction in the development of in-stent restenosis at the cost of an increased risk of late stent thromboses. This study followed clinical outcomes of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention. A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES implanted. This study recorded the occurrence of a major adverse cardiac event (MACE) assessed as the composite of cardiac death, myocardial infarction, and target vessel revascularization. Stent thromboses were also assessed. Of the 2,098 unselected patients, 73.1% were still alive after 10 years. During the follow-up period, MACE occurred in 346 (32.5%) in the group receiving a sirolimus-eluting stent and in 342 (33.1%) in the group receiving a paclitaxel-eluting stent (hazard ratio: 0.96; 95% confidence interval: 0.83 to 1.11; p = 0.60), with a steady annual rate of 2.6% after the first year. Definite, probable, and possible stent thrombosis appeared in 279 patients (13.3%), with no difference between stent types and with a steady annual rate of 1.3% after the first year. Among the surviving patients, the long-term annual MACE rate and the stent thrombosis rate appeared constant for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT00388934). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  15. A Report of Successful Procedural, Clinical, and Angiographic Outcomes with a Tapered Stent of a Patient in Naturally Tapered Coronary Vessel

    PubMed Central

    Kumar, Yerra Shiv

    2017-01-01

    In cases involving stenosis or occlusions in major parts of a long vessel, natural tapering of coronary vessels may create dilemma in deciding the optimal stent size during percutaneous coronary intervention. In this regard, tapered stents have been developed recently. Herein, we present a case of 67-year-old male patient with triple vessel disease including two tandem lesions in naturally tapered Left Anterior Descending (LAD) artery. The patient received a 3.0–2.5x60 mm Sirolimus-eluting BioMime Morph stent (Meril life Sciences, Gujarat, India) in the mid-distal LAD lesion along with conventional stent implantations in other two lesions. The procedure was successful and good coronary flow was obtained after revascularization. The patient remained asymptomatic thereafter. At one year, angiographic follow-up revealed good flow and no restenosis in the LAD vessel. We are of opinion that using tapered stents with decremented diameter may offer the advantages of excellent adaptation to vessel size, vessel tapering, and good apposition in patients with long coronary lesions in tapered vessels. PMID:28273994

  16. Everolimus-eluting stents: update on current clinical studies.

    PubMed

    Allocco, Dominic J; Joshi, Anita A; Dawkins, Keith D

    2011-01-01

    Everolimus-eluting stents (EES) have become the most commonly implanted coronary stents worldwide. This review describes and analyzes the clinical data supporting the use of EES, focusing primarily on published, randomized, controlled trials. Everolimus-eluting stents have been shown to have less restenosis, stent thrombosis, and periprocedural myocardial infarction compared with earlier generation paclitaxel-eluting stents (PES). Lower rates of adverse events for EES compared with PES were generally seen in all subgroups, with the notable exception of patients with diabetes mellitus. There have been fewer, randomized, clinical trials comparing EES with either sirolimus-eluting stents or zotarolimus-eluting stents, although very good results with EES have been observed in the trials that have been performed. Recent clinical trial data suggest that this excellent safety and efficacy profile is maintained in a next-generation EES designed to have improved mechanical properties and radiopacity.

  17. Drug-eluting stents: some first-generation problems.

    PubMed

    Murphy, Bruce E

    2004-01-01

    The recent fervor surrounding the introduction of drug-eluting stents into the practice of cardiology has proven to be problematic. The experience with the Cypher Sirolimus-Eluting Coronary Stent (Cordis Corp., Miami Lakes, FL) at Arkansas Heart Hospital progressed from anxious anticipation to complete removal of the stent from inventory in a 6-month period. Several cases involving edge dissection and subacute thrombosis were the catalyst for the decision to cease use of the device. While new products may entice, each new modality must be approached with measured enthusiasm. Drug-eluting stents are first-generation devices that may have unexposed flaws when used as first-line treatment in routine practice. The first-generation Cypher stent, as with many new devices, offers treatment-not a cure-for coronary atherosclerosis and enhances the desire for an evolved product.

  18. Drug-eluting stents in percutaneous coronary intervention: a benefit-risk assessment.

    PubMed

    Byrne, Robert A; Sarafoff, Nikolaus; Kastrati, Adnan; Schömig, Albert

    2009-01-01

    Drug-eluting stent (DES) therapy has represented a very significant milestone in the evolution of percutaneous coronary intervention (PCI) therapy. This review attempts to provide a balanced overview of the unprecedented wealth of data generated on this new technology, by examining the evidence bases for anti-restenotic efficacy, safety and cost effectiveness. The performance of a DES may be related to each of its three components: stent backbone; carrier polymer (to control drug-release kinetics); and active drug. In terms of anti-restenotic efficacy, the most appropriate parameters to examine are target lesion revascularization, angiographic restenosis and late luminal loss. The principal safety parameters are overall mortality, myocardial infarction (MI) and stent thrombosis. Anti-restenotic superiority of DES over bare metal stents (BMS) has been demonstrated across a spectrum of disease from straightforward 'vanilla lesions' through higher disease complexity in pivotal clinical trials to phase IV studies of efficacy in 'off-label' populations. The treatment effect of DES versus BMS is consistent in terms of a reduction in the need for repeat intervention of the order of 35-70%. Regarding differential efficacy of first-generation DES, a benefit may exist in favour of the Cypher (sirolimus-eluting) stent over Taxus (paclitaxel-eluting), particularly in high-risk lesion subsets. The second-generation approved devices are the Endeavor (zotarolimus-eluting) and Xience (everolimus-eluting) DES. While all four of these stents are permanent polymer-based, the current focus of development is towards DES platforms that are devoid of durable polymer, the presence of which has been implicated in late adverse events. In terms of safety concerns raised in relation to DES therapy, it is reasonable to conclude the following at 4- to 5-year post-stent implantation: (i) that there is no increased risk of death or MI with DES (neither is there a general signal of mortality

  19. Coronary Stent Infection Presented as Recurrent Stent Thrombosis

    PubMed Central

    Lai, Chih-Hung; Lin, Yung-Kai; Lee, Wen-Lieng

    2017-01-01

    Percutaneous transluminal coronary angioplasty with metal stent placement has become a well-developed treatment modality for coronary stenotic lesions. Although infection involving implanted stents is rare, it can, however, occur with high morbidity and mortality. We describe herein a case of an inserted coronary stent that was infected and complicated with recurrent stent thrombosis, pseudoaneurysm formation and severe sepsis. Despite repeated intervention and bypass surgery, the patient died from severe sepsis. PMID:28120580

  20. Antiplatelet therapy in patients undergoing coronary stenting

    PubMed Central

    ten Berg, J.M.; van Werkum, J.W.; Heestermans, A.A.C.M.; Jaarsma, W.; Hautvast, R.M.A.; den Heijer, P.; de Boer, M.J.

    2006-01-01

    Background Anticoagulation after coronary stenting is essential to prevent stent thrombosis. Drug-eluting stents, which are the preferred therapy, may be associated with a higher tendency for stent thrombosis. Methods Patients who underwent coronary stent placement and presented with late stent thrombosis are described. Results Eight patients with stent thrombosis are presented. Early discontinuation of the antithrombotic medication is associated with the occurrence of these complications. Conclusion Long-term antithrombotic therapy seems essential to prevent stent thrombosis, especially for patients treated with drug-eluting stents. PMID:25696663

  1. 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.

  2. Balancing Long-Term Risks of Ischemic and Bleeding Complications after Percutaneous Coronary Intervention with Drug-Eluting Stents

    PubMed Central

    Matteau, Alexis; Yeh, Robert; Camenzind, Edoardo; Steg, Ph. Gabriel; Wijns, William; Mills, Joseph; Gershlick, Anthony; de Belder, Mark; Ducrocq, Gregory; Mauri, Laura

    2015-01-01

    Introduction While trials comparing antiplatelet strategies after coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond one year after treatment. Methods Patient-level data from PROTECT, a broadly inclusive trial enrolling 8709 subjects treated with drug-eluting stents (sirolimus vs. zotarolimus-eluting stent), and PROTECT US, a single arm study including 1018 subjects treated with a zotarolimus-eluting stent were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis and the risk of bleeding events, GUSTO moderate or severe bleed were predicted using logistic regression, and the correlation between predicted ischemic and bleeding risks within individual patients was estimated. Results At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%), and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were: older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p<0.05). Ischemic events shared all of the same predictors with bleeding events as well as: sex, BMI, prior MI, prior CABG, STEMI on presentation, stent length and sirolimus-eluting stent use (all p<0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated (ρ=0.76, p<0.001). 97% of subjects had a greater risk of ischemic events than bleeding. Conclusions Individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up. PMID:26187674

  3. Heparin-Coated Coronary Stents.

    PubMed

    van Der Giessen WJ; van Beusekom HM; Larsson; Serruys

    1999-09-01

    The development of the heparin-coated (HC)-stent should be viewed against the backdrop of the early unfavorable results with noncoated stents in the pre-intravascular ultrasound and pre-ticlopidine era. Notwithstanding, results of pilot and randomized trials show a surprisingly low incidence of (sub)acute stent thrombosis under challenging circumstances, such as acute coronary syndromes. Considering the quite low incidence of early complications with noncoated second-generation stents, it may require large trials to prove the clinical efficacy of the heparin- coating against noncoated devices. However, even if the "added value" of the heparin-coating will never be clinically proven, it has helped to enhance the penetration of stent therapy in interventional cardiology. Unlike the situation in 1992, very few cardiologists will now disagree with the statement that stents contribute to the state-of-the-art treatment of patients with angina pectoris or acute myocardial infarction. A preliminary comparison of available trials also suggests that the heparin-coated Palmaz-Schatz stent (Cordis Corp., Waterloo, Belgium) is as effective as the noncoated stent plus abciximab treatment.

  4. 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.

  5. Rescue coronary stenting in acute myocardial infarction

    NASA Astrophysics Data System (ADS)

    Barbieri, Enrico; Meneghetti, Paolo; Molinari, Gionata; Zardini, Piero

    1996-01-01

    Failed rescue coronary angioplasty is a high risk situation because of high mortality. Coronary stent has given us the chance of improving and maintaining the patency of the artery. We report our preliminary experience of rescue stenting after unsuccessful coronary angioplasty.

  6. Randomized Comparison of Absorb Bioresorbable Vascular Scaffold and Mirage Microfiber Sirolimus-Eluting Scaffold Using Multimodality Imaging.

    PubMed

    Tenekecioglu, Erhan; Serruys, Patrick W; Onuma, Yoshinobu; Costa, Ricardo; Chamié, Daniel; Sotomi, Yohei; Yu, Ting-Bin; Abizaid, Alexander; Liew, Houng-Bang; Santoso, Teguh

    2017-06-12

    The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device. The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns. In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months. Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0

  7. Risks of noncardiac surgery after coronary stenting.

    PubMed

    Reddy, Proddutur R; Vaitkus, Paul T

    2005-03-15

    An increased risk of major complications for noncardiac surgery after coronary stenting has been suggested. We retrospectively reviewed all cases of coronary stents from 1999 to 2003 with subsequent surgery to assess major adverse cardiovascular events (MACEs), including myocardial infarction, stent thrombosis, major bleeding, and death. Among the 56 patients identified, 8 developed MACEs; 38% underwent surgery < or =14 days after stenting, and 62% underwent surgery 15 to 42 days after stenting. No patient developed MACEs if surgery occurred >42 days after stenting. Among patients who developed MACEs, 77% of surgeries were elective, 19% were urgent, and only 4% were emergency. Noncardiac surgery 6 weeks after coronary stenting is associated with a high risk of MACEs.

  8. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis

    PubMed Central

    Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

    2013-01-01

    Objective To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Design Mixed treatment comparison meta-analysis of 258 544 patient years of follow-up from randomized trials. Data sources and study selection PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Outcomes Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. Results From 126 randomized trials and 258 544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased

  9. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis.

    PubMed

    Bangalore, Sripal; Toklu, Bora; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Hannan, Edward L; Faxon, David P; Feit, Frederick

    2013-11-08

    To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents. Mixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials. PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents. Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents. From 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1

  10. [Absorbable coronary stents. New promising technology].

    PubMed

    Erbel, Raimund; Böse, Dirk; Haude, Michael; Kordish, Igor; Churzidze, Sofia; Malyar, Nasser; Konorza, Thomas; Sack, Stefan

    2007-06-01

    Coronary stent implantation started in Germany 20 years ago. In the beginning, the progress was very slow and accelerated 10 years later. Meanwhile, coronary stent implantation is a standard procedure in interventional cardiology. From the beginning of permanent stent implantation, research started to provide temporary stenting of coronary arteries, first with catheter-based systems, later with stent-alone technology. Stents were produced from polymers or metal. The first polymer stent implantation failed except the Igaki-Tamai stent in Japan. Newly developed absorbable polymer stents seem to be very promising, as intravascular ultrasound (IVUS) and optical coherence tomography have demonstrated. Temporary metal stents were developed based on iron and magnesium. Currently, the iron stent is tested in peripheral arteries. The absorbable magnesium stent (Biotronik, Berlin, Germany) was tested in peripheral arteries below the knee and meanwhile in the multicenter international PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) study. The first magnesium stent implantation was performed on July 30, 2004 after extended experimental testing in Essen. The magnesium stent behaved like a bare-metal stent with low recoil of 5-7%. The stent struts were absorbed when tested with IVUS. Stent struts were not visible by fluoroscopy or computed tomography (CT) as well as magnetic resonance imaging (MRI). That means, that the magnesium stent is invisible and therefore CT and MRI can be used for imaging of interventions. Only using micro-CT the stent struts were visible. The absorption process could be demonstrated in a patient 18 days after implantation due to suspected acute coronary syndrome, which was excluded. IVUS showed a nice open lumen. Stent struts were no longer visible, but replaced by tissue indicating the previous stent location. Coronary angiography after 4 months showed an ischemia-driven target lesion

  11. Stent-based percutaneous coronary interventions in small coronary arteries.

    PubMed

    Roguin, Ariel; Grenadier, Ehud

    2006-01-01

    A third to half of all percutaneous coronary interventions involve small diameter vessels of less than 3 mm. Small vessel size is a predictor of restenosis after balloon angioplasty, as well as after stent placement. Stents deployed in small arteries, have a higher metal-to-artery ratio; this may increase the risk of sub-acute thrombosis or restenosis. Various studies have shown that stent design, stent coating, and stent strut thickness may determine event-free survival. Dedicated stents for small vessels with less amount of metal, appropriate expansion to the vessel size with correct radial force and cells morphology, and less prothrombotic properties, may further improve the results of stenting in this setting (thinner struts, fewer cells, or loops per circumference). This review provides an update on the current status, review the major trials and define the clinical utility of small vessel stenting, particularly in the era of drug-eluting stents.

  12. StentBoost Visualization for the Evaluation of Coronary Stent Expansion During Percutaneous Coronary Interventions.

    PubMed

    Cura, Fernando; Albertal, Mariano; Candiello, Alfonsina; Nau, Gerardo; Bonvini, Victor; Tricherri, Hernan; Padilla, Lucio T; Belardi, Jorge A

    2013-12-01

    Inadequate stent implantation is associated with stent thrombosis and restenosis. StentBoost can enhance stent visualization and evaluate stent expansion. Currently, there are limited comparison studies between StentBoost and intravascular ultrasound (IVUS). We aimed to test the correlation and agreement between IVUS and StentBoost measurements. From December 2010 to December 2011, 38 patients (54 stents) were analyzed using IVUS and StentBoost. Minimal stent diameter and proximal and distal edge stent diameter were compared between imaging techniques using Pearson correlation and Bland-Altman scatter plot. There was good correlation between StentBoost and IVUS measurements regarding minimal stent diameter (p < 0.001 in all stent portions) and an optimal agreement between IVUS and StentBoost, while lesser agreement was found between IVUS and quantitative coronary angiography. The assessment of stent implantation using StentBoost showed an adequate correlation and agreement with IVUS. This easily applicable angiographic technique can be used to guide stent implantation.

  13. Improved image guidance of coronary stent deployment

    NASA Astrophysics Data System (ADS)

    Close, Robert A.; Abbey, Craig K.; Whiting, James S.

    2000-04-01

    Accurate placement and expansion of coronary stents is hindered by the fact that most stents are only slightly radiopaque, and hence difficult to see in a typical coronary x-rays. We propose a new technique for improved image guidance of multiple coronary stents deployment using layer decomposition of cine x-ray images of stented coronary arteries. Layer decomposition models the cone-beam x-ray projections through the chest as a set of superposed layers moving with translation, rotation, and scaling. Radiopaque markers affixed to the guidewire or delivery balloon provide a trackable feature so that the correct vessel motion can be measured for layer decomposition. In addition to the time- averaged layer image, we also derive a background-subtracted image sequence which removes moving background structures. Layer decomposition of contrast-free vessels can be used to guide placement of multiple stents and to assess uniformity of stent expansion. Layer decomposition of contrast-filled vessels can be used to measure residual stenosis to determine the adequacy of stent expansion. We demonstrate that layer decomposition of a clinical cine x-ray image sequence greatly improves the visibility of a previously deployed stent. We show that layer decomposition of contrast-filled vessels removes background structures and reduces noise.

  14. Role of Animal Models in Coronary Stenting.

    PubMed

    Iqbal, Javaid; Chamberlain, Janet; Francis, Sheila E; Gunn, Julian

    2016-02-01

    Coronary angioplasty initially employed balloon dilatation only. This technique revolutionized the treatment of coronary artery disease, although outcomes were compromised by acute vessel closure, late constrictive remodeling, and restenosis due to neointimal proliferation. These processes were studied in animal models, which contributed to understanding the biology of endovascular arterial injury. Coronary stents overcome acute recoil, with improvements in the design and metallurgy since then, leading to the development of drug-eluting stents and bioresorbable scaffolds. These devices now undergo computer modeling and benchtop and animal testing before evaluation in clinical trials. Animal models, including rabbit, sheep, dog and pig are available, all with individual benefits and limitations. In smaller mammals, such as mouse and rabbit, the target for stenting is generally the aorta; whereas in larger animals, such as the pig, it is generally the coronary artery. The pig coronary stenting model is a gold-standard for evaluating safety; but insights into biomechanical properties, the biology of stenting, and efficacy in controlling neointimal proliferation can also be gained. Intra-coronary imaging modalities such as intravascular ultrasound and optical coherence tomography allow precise serial evaluation in vivo, and recent developments in genetically modified animal models of atherosclerosis provide realistic test beds for future stents and scaffolds.

  15. Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

    PubMed

    Lai, Chao-Lun; Wu, Ching-Fen; Kuo, Raymond Nien-Chen; Yang, Yen-Yun; Chen, Ming-Fong; Chan, K Arnold; Lai, Mei-Shu

    2015-01-01

    The clinical outcomes of different limus-based drug-eluting stents (DES) in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES), Endeavor zotarolimus-eluting stent (E-ZES) and everolimus-eluting stent (EES), using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES). After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group). Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

  16. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

    PubMed

    Lemos, Pedro A; Abizaid, Alexandre A C; Meireles, George C; Sarmento-Leite, Rogério; Prudente, Mauricio; Cantarelli, Marcelo; Dourado, Adriano D; Mariani, Jose; Perin, Marco A; Costantini, Costantino; Costa, Ricardo A; Costa, José Ribamar; Chamie, Daniel; Campos, Carlos A; Ribeiro, Expedito

    2015-12-01

    To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent. © 2015 John Wiley & Sons Ltd.

  17. Dose-dependent vascular response following delivery of sirolimus via fast releasing, biodegradable polymer stent matrix: an experimental study in the porcine coronary model of restenosis.

    PubMed

    Buszman, Piotr P; Orlik, Bartłomiej; Pająk, Jacek; Jelonek, Michał; Krauze, Agata; Janas, Adam; Legutko, Jacek; Wojakowski, Wojciech; Buszman, Paweł E; Milewski, Krzysztof

    2015-01-01

    Fast releasing, rapamycin-eluting stents, although safe, showed inferior results with regard to inhibition of restenosis. Therefore, we report vascular effects of a novel, biodegradable polymer stent matrix with elevated sirolimus dose and fast release kinetics (ed-frSES, Alex, Balton) in the porcine coronary in-stent restenosis model. A total of 19 stents were implanted with 120% overstretch in the coronary arteries of seven domestic pigs: seven ed-frSES with 1.3 μg/mm2 of sirolimus, eight frSES with 1 μg/mm2 of sirolimus, and eight bare metal stents (BMS). For the following 28 days, coronary angiography was performed, animals were sacrificed, and the stented segments harvested for histopathological evaluation. In angiography at 28 days the late lumen loss was lowest in the elevated dose sirolimus eluting stent (SES) (ed-frSES: 0.20 ± 0.2 vs. frSES: 0.80 ± 0.5 vs. BMS: 0.96 ± 0.5 mm, p < 0.01). This was confirmed in the morphometric evaluation in histopathology as represented by a significant and dose-dependent decrease in the percentage area of stenosis (ed-frSES: 22.4 ± 12.7% vs. frSES: 35 ± 10.7% vs. BMS: 47.5 ± 12.5%, p < 0.01). There was no peri-strut inflammation in any of the groups. However, the endothelialisation score was numerically not meaningfully decreased in ed-frSES (ed-frSES: 2.93 vs. frSES: 3. vs. BMS: 3, p = 0.05). Signs of fibrin were also noted in ed-frSES (ed-frSES: 0.4 vs. frSES: 0 vs. BMS: 0, p = 0.05). Sirolimus dose-dependent vascular response was reported. The elevated dose, fast releasing SES shows satisfactory vascular healing, similar to regular dose, fast release SES, with improved efficacy in restenosis inhibition.

  18. Three-year follow-up of patients with bifurcation lesions treated with sirolimus- or everolimus-eluting stents: SEAside and CORpal cooperative study.

    PubMed

    Pan, Manuel; Burzotta, Francesco; Trani, Carlo; Medina, Alfonso; Suárez de Lezo, Jose; Niccoli, Giampaolo; Romero, Miguel; Porto, Italo; Mazuelos, Francisco; Leone, Antonio Maria; Martín, Pedro; Coluccia, Valentina; Suárez de Lezo, Javier; Ojeda, Soledad; Crea, Filippo

    2014-10-01

    To compare the 3-year incidence of major events in patients with bifurcation lesions treated with provisional sirolimus-eluting stents vs everolimus-eluting stents. A pooled analysis of 2 prospective randomized trials with similar methodology (SEAside and CORpal) was performed. In these trials, 443 patients with bifurcation lesions were randomly assigned to treatment with either sirolimus-eluting stents or everolimus-eluting stents. The clinical follow-up was extended up to 3 years to assess major adverse cardiovascular events (death or acute myocardial infarction or target vessel revascularization). At 3 years, survival free of major adverse cardiovascular events was 93.2% vs 91.3% in the everolimus-eluting stent group vs the sirolimus-eluting stent group (P = .16). Exploratory land-mark analysis for late events (occurring after 12 months) showed significantly fewer major adverse cardiovascular events in the everolimus-eluting stent group: 1.4% vs 5.4% in the sirolimus-eluting stent group (P = .02). Provisional stenting with either sirolimus-eluting stents or everolimus-eluting stents in bifurcation lesions is associated with low rates of major adverse events at 3-years' follow-up. The results of a subanalysis of events beyond 1 year, showing a lower event rate with everolimus-eluting stents than with sirolimus-eluting stents, suggest that studies exploring the long-term clinical benefit of the latest generation of drug-eluting stents are warranted. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  19. Percutaneous transradial artery approach for coronary stent implantation.

    PubMed

    Kiemeneij, F; Laarman, G J

    1993-10-01

    A new approach for implantation of Palmaz Schatz coronary stents is reported. We describe the technique and rationale of coronary stenting with miniaturized angioplasty equipment via the radial artery. This technique is illustrated in three patients. One patient underwent Palmaz Schatz stent implantation for a saphenous vene coronary bypass graft stenosis, the second patient for a restenosis in the anterior descending coronary artery after atherectomy, and the third patient for a second restenosis after balloon angioplasty in the circumflex coronary artery.

  20. [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?

  1. Vessel healings after stenting with different polymers in STEMI patients

    PubMed Central

    Jin, Qin-Hua; Chen, Yun-Dai; Tian, Feng; Guo, Jun; Jing, Jing; Sun, Zhi-Jun

    2016-01-01

    Background Different stents implantation in ST-segment elevation myocardial infarction (STEMI) patients may influence the long term prognosis by affecting vessel healings after stenting. The aim of this study was to evaluate the vessel healings after implantation of drug eluting stents (DES) with biodegradable or durable polymer or of bare-metal stents (BMS) in patients with acute STEMI. Methods This study included 50 patients, who underwent follow up angiogram and optical coherence tomography (OCT) assessment about one year after percutaneous coronary intervention (PCI) for STEMI. According to the initial stents types, these patients were classified to durable (n = 19) or biodegradable polymer sirolimus-eluting stents (n = 15), or BMS (n = 16) groups. The conditions of stent struts coverage and malapposition were analyzed with OCT technique. Results A total of 9003 struts were analyzed: 3299, 3202 and 2502 from durable or biodegradable polymer DES, or BMS, respectively. Strut coverage rate (89.0%, 94.9% and 99.3%, respectively), malapposition presence (1.7%, 0.03% and 0 of struts, respectively) and average intimal thickness over struts (76 ± 12 µm, 161 ± 30 µm and 292 ± 29 µm, respectively) were significantly different among different stent groups (all P < 0.001). Conclusions Vessel healing status in STEMI patients is superior after implantation of biodegradable polymer DES than durable polymer DES, while both are inferior to BMS. PMID:27403139

  2. Antiplatelet therapy discontinuation and the risk of serious cardiovascular events after coronary stenting: observations from the CREDO-Kyoto Registry Cohort-2.

    PubMed

    Watanabe, Hirotoshi; Morimoto, Takeshi; Natsuaki, Masahiro; 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; Kastrati, Adnan; Kimura, Takeshi

    2015-01-01

    Relation of antiplatelet therapy (APT) discontinuation with the risk of serious cardiovascular events has not been fully addressed yet. This study is aimed to evaluate the risk of ischemic event after APT discontinuation based on long-term APT status of large cohort. In the CREDO-Kyoto Registry Cohort-2 enrolling 15939 consecutive patients undergoing first coronary revascularization, 10470 patients underwent percutaneous coronary intervention either with bare-metal stents (BMS) only (N=5392) or sirolimus-eluting stents (SES) only (N=5078). Proportions of patients taking dual-APT were 67.3% versus 33.4% at 1-year, and 48.7% versus 24.3% at 5-year in the SES and BMS strata, respectively. We evaluated daily APT status (dual-, single- and no-APT) and linked the adverse events to the APT status just 1-day before the events. No-APT as compared with dual- or single-APT was associated with significantly higher risk for stent thrombosis (ST) beyond 1-month after SES implantation (cumulative incidence rates beyond 1-month: 1.23 versus 0.15/0.29, P<0.001/P<0.001), while higher risk of no-APT for ST was evident only until 6-month after BMS implantation (incidence rates between 1- and 6-month: 8.43 versus 0.71/1.20, P<0.001/P<0.001, and cumulative incidence rates beyond 6-month: 0.31 versus 0.11/0.08, P=0.16/P=0.08). No-APT as compared with dual- or single-APT was also associated with significantly higher risk for spontaneous myocardial infarction (MI) and stroke regardless of the types of stents implanted. Single-APT as compared with dual-APT was not associated with higher risk for serious adverse events, except for the marginally higher risk for ST in the SES stratum. In conclusion, discontinuation of both aspirin and thienopyridines was associated with increased risk for serious cardiovascular events including ST, spontaneous MI and stroke beyond 1-month after coronary stenting.

  3. Antiplatelet Therapy Discontinuation and the Risk of Serious Cardiovascular Events after Coronary Stenting: Observations from the CREDO-Kyoto Registry Cohort-2

    PubMed Central

    Watanabe, Hirotoshi; Morimoto, Takeshi; Natsuaki, Masahiro; 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; Kastrati, Adnan; Kimura, Takeshi

    2015-01-01

    Relation of antiplatelet therapy (APT) discontinuation with the risk of serious cardiovascular events has not been fully addressed yet. This study is aimed to evaluate the risk of ischemic event after APT discontinuation based on long-term APT status of large cohort. In the CREDO-Kyoto Registry Cohort-2 enrolling 15939 consecutive patients undergoing first coronary revascularization, 10470 patients underwent percutaneous coronary intervention either with bare-metal stents (BMS) only (N=5392) or sirolimus-eluting stents (SES) only (N=5078). Proportions of patients taking dual-APT were 67.3% versus 33.4% at 1-year, and 48.7% versus 24.3% at 5-year in the SES and BMS strata, respectively. We evaluated daily APT status (dual-, single- and no-APT) and linked the adverse events to the APT status just 1-day before the events. No-APT as compared with dual- or single-APT was associated with significantly higher risk for stent thrombosis (ST) beyond 1-month after SES implantation (cumulative incidence rates beyond 1-month: 1.23 versus 0.15/0.29, P<0.001/P<0.001), while higher risk of no-APT for ST was evident only until 6-month after BMS implantation (incidence rates between 1- and 6-month: 8.43 versus 0.71/1.20, P<0.001/P<0.001, and cumulative incidence rates beyond 6-month: 0.31 versus 0.11/0.08, P=0.16/P=0.08). No-APT as compared with dual- or single-APT was also associated with significantly higher risk for spontaneous myocardial infarction (MI) and stroke regardless of the types of stents implanted. Single-APT as compared with dual-APT was not associated with higher risk for serious adverse events, except for the marginally higher risk for ST in the SES stratum. In conclusion, discontinuation of both aspirin and thienopyridines was associated with increased risk for serious cardiovascular events including ST, spontaneous MI and stroke beyond 1-month after coronary stenting. PMID:25853836

  4. Residual stresses in coronary artery stents.

    PubMed

    Möller, D; Reimers, W; Pyzalla, A; Fischer, A

    2001-01-01

    In western industrial countries, coronary heart disease is the most common cause of death. The reason is a coronary sclerosis, which by the generation of plaques narrows the inner lumen of an artery and, thus, deteriorates the blood supply. This leads to symptoms like burning pain or increased pressure in the chest, and finally to an under supply and damage of the heart muscle. In order to keep those portions of arteries that are covered by a plaque open, the stent technique was developed in the 1980s and is increasingly used since about 13 years. These stents are usually made of wires or of a slotted tube and are of two kinds: self-expanding and balloon expanding. Both types are implanted after being mounted on a catheter and expanded in the desired position. Self-expanding stents make use of the elastic deformation, while the other group of stents are expanded by a balloon, which brings about a plastic deformation of certain regions of the stent structure. Thus, after implantation, parts of these stents undergo two steps of distinct plastic deformation. First during compression, which is necessary for the mounting procedure on the catheter (crimping), and second during expansion for implantation. In this article, the residual stresses generated during crimping and expansion are presented and discussed. These stresses are stored in the structure of a portion of a stent after implantation and are superimposed on those stresses generated by the more than 700 million cyclic heart beats during the patient's life. This work is a part of several interdisciplinary research projects by the authors in order to gain reliable fail-safe criteria for the static and cyclic mechanical properties of coronary stents.

  5. Coronary angioscopy before and after stent deployment

    NASA Astrophysics Data System (ADS)

    Denardo, Scott J.; Schatz, Richard A.; Rocha-Singh, Krishna J.; Wong, S. Chiu; Morris, Nancy A.; Strumpf, Robert K.; Heuser, Richard R.; Teirstein, Paul

    1993-09-01

    Coronary angioscopy was used in an attempt to visualize the internal architecture of cardiac vessels before and after deployment of Palmaz-Schatz stents in 50 patients. The vessel was successfully visualized in 48 (96%) of these patients. In 24 patients, angioscopy was performed both after preliminary balloon angioplasty and then again after stent deployment. In all 24 patients the diameter of the lumen appeared larger after stent deployment as compared to after balloon angioplasty. In 16 of these 24 patients a dissection was documented by angioscopy after balloon angioplasty. The dissection was absent after stent deployment in all 16 patients. In seven patients, thrombus that was not apparent by angiography was visualized by angioscopy. Moreover, in four patients, thrombus that was suggested by angiography could not be confirmed by angioscopy.

  6. Coronary stenting: A matter of revascularization

    PubMed Central

    Bonaventura, Aldo; Montecucco, Fabrizio; Liberale, Luca

    2017-01-01

    In the last few decades, the recommended treatment for coronary artery disease has been dramatically improved by percutaneous coronary intervention (PCI) and the use of balloon catheters, bare metal stents (BMSs), and drug-eluting stents (DESs). Catheter balloons were burdened by acute vessel occlusion or target-lesion re-stenosis. BMSs greatly reduced those problems holding up the vessel structure, but showed high rates of in-stent re-stenosis, which is characterized by neo-intimal hyperplasia and vessel remodeling leading to a re-narrowing of the vessel diameter. This challenge was overtaken by first-generation DESs, which reduced re-stenosis rates to nearly 5%, but demonstrated delayed arterial healing and risk for late in-stent thrombosis, with inflammatory cells playing a pivotal role. Finally, new-generation DESs, characterized by innovations in design, metal composition, surface polymers, and anti-proliferative drugs, finally reduced the risk for stent thrombosis and greatly improved revascularization outcomes. New advances include bioresorbable stents potentially changing the future of revascularization techniques as the concept bases upon the degradation of the stent scaffold to inert particles after its function expired, thus theoretically eliminating risks linked with both stent thrombosis and re-stenosis. Talking about DESs also dictates to consider dual antiplatelet therapy (DAPT), which is a fundamental moment in view of the good outcome duration, but also deals with bleeding complications. The better management of patients undergoing PCI should include the use of DESs and a DAPT finely tailored in consideration of the potentially developing bleeding risk in accordance with the indications from last updated guidelines. PMID:28400917

  7. Assessment of coronary stents by 64-slice computed tomography: in-stent lumen visibility and patency.

    PubMed

    Kong, Ling-Yan; Jin, Zheng-Yu; Zhang, Shu-Yang; Zhang, Zhu-Hua; Wang, Yi-Ning; Song, Lan; Zhang, Xiao-Na; Zhang, Yun-Qing

    2009-09-01

    To assess lumen visibility of coronary stents by 64-slice computed tomography (CT) coronary angiography, and determine the value of 64-slice CT in non-invasive detecting of in-stent restenosis after coronary artery stent implantation. Totally, 60 patients (54 males, aged 57.0+/-12.7 years) and 105 stents were investigated by 64-slice CT at a mean interval of 20.0+/-16.6 months after coronary stents implantation. Axial multi-planar reconstruction images of the stents and curved-planar reconstruction images through the median of the stents were reconstructed for evaluating stent image quality on a 5-point scale (1=excellent, 5=non-assessable), and stent lumen diameter was detected. Conventional coronary angiography was performed in 18 patients, and 32 stents were evaluated. Image quality was good to excellent on average (score 1.71+/-0.76). Stent image quality score was correlated to heart rate (r=0.281, P<0.01) and stent diameter (r=-0.480, P<0.001). All the stents were assessable in lumen visibility with an average visible lumen diameter percentage of 60.7%+/-13.6%. Visible lumen diameter percentage was correlated to heart rate (r=-0.193, P<0.05), stent diameter (r=0.403, P<0.001), and stent image quality score (r=-0.500, P<0.001). Visible lumen diameter percentage also varied depending on the stent type. In comparison with the conventional coronary angiography, 4 of 6 in-stent stenoses were correctly detected. The sensitivity and specificity for the detection of in-stent stenosis were 66.7% and 84.6%, respectively. Using a 64-slice CT, the stent lumen is partly visible in most of the stents. And 64-slice CT may be useful in the assessment of stent patency.

  8. Successful Coronary Stent Retrieval From a Pedal Artery

    SciTech Connect

    Mariano, Enrica Versaci, Francesco; Gandini, Roberto; Simonetti, Giovanni; Di Vito, Livio; Romeo, Francesco

    2008-05-15

    The purpose of this article is to report complications from a coronary drug-eluting stent lost in the peripheral circulation. We report the case of successful retrieval of a sirolimus coronary stent from a pedal artery in a young patient who underwent coronary angiography for previous anterior myocardial infarction. Recognition of stent embolization requires adequate removal of the device to avoid unwelcome clinical sequelae.

  9. Intravascular ultrasound evaluation of optimal drug-eluting stent expansion after poststent balloon dilation using a noncompliant balloon versus a semicompliant balloon (from the Poststent Optimal Stent Expansion Trial [POET]).

    PubMed

    Kim, Jung-Sun; Moon, Jae-Youn; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Kang, Woong Chol; Ahn, Taehoon; Kim, Byoung-Keuk; Oh, Seong Jin; Jeon, Dong Woon; Yang, Joo-Young

    2008-08-01

    The impact of type of balloon such as noncompliant (NC; Quantum) or semicompliant (SC; Maverick(2)) used after stent dilation on optimal stent expansion (OSE) has not been established for drug-eluting stents (DESs). We conducted a prospective multicenter, randomized study to compare NC with SC balloons after stent balloon dilatation. A total of 301 patients (127 men, 83 women, 62 +/- 9 years of age) treated with a DES (sirolimus-eluting stent [SES], n = 152; paclitaxel-eluting stent, n = 149) were included. OSE followed the definition of the Multicenter Ultrasound Stenting in Coronaries (MUSIC) study. The primary end point was the incidence of OSE using intravascular ultrasound according to type of balloon. Baseline characteristics of each group showed no significant differences. OSE in the SC balloon group was achieved at higher rates than the NC balloon group (53 +/- 35%, vs 73 +/- 48%, p = 0.022 in all stents; 25 +/- 33%, vs 36, 48%, p = 0.051 in SESs). However, any differences in the achievement of OSE between the NC and SC balloon groups were not present in paclitaxel-eluting stents. In conclusion, despite postadjuvant balloon inflations with high pressures, underexpansion of the DES was seen commonly. Between the 2 types of balloon for adjuvant dilation after DES implantation, same-size SC balloons could be more useful for obtaining OSE than NC balloons, especially in SESs.

  10. [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.

  11. Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.

    PubMed

    Urban, Philip; Valdés, Mariano; Menown, Ian; Eberli, Franz; Alhaddad, Imad; Hildick-Smith, David; Iosseliani, David; Roffi, Marco; Oldroyd, Keith; Kalloudi, Erifyli; Eerdmans, Pedro; Berland, Jacques; Kleber, Franz Xaver

    2015-12-01

    To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice. The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent. 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years. Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST. This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents. © 2015 Wiley Periodicals, Inc.

  12. 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.

  13. CT Imaging of Coronary Stents: Past, Present, and Future

    PubMed Central

    Mahnken, Andreas H.

    2012-01-01

    Coronary stenting became a mainstay in coronary revascularization therapy. Despite tremendous advances in therapy, in-stent restenosis (ISR) remains a key problem after coronary stenting. Coronary CT angiography evolved as a valuable tool in the diagnostic workup of patients after coronary revascularization therapy. It has a negative predictive value in the range of 98% for ruling out significant ISR. As CT imaging of coronary stents depends on patient and stent characteristics, patient selection is crucial for success. Ideal candidates have stents with a diameter of 3 mm and more. Nevertheless, even with most recent CT scanners, about 8% of stents are not accessible mostly due to blooming or motion artifacts. While the diagnosis of ISR is currently based on the visual assessment of the stent lumen, functional information on the hemodynamic significance of in-stent stenosis became available with the most recent generation of dual source CT scanners. This paper provides a comprehensive overview on previous developments, current techniques, and clinical evidence for cardiac CT in patients with coronary artery stents. PMID:22997590

  14. A Nuclear Magnetic Resonance Spectroscopy as a Method for Evaluation of In Vivo Poly-l-Lactide Biodegradation Kinetics From Stent-Polymer Matrices: An Experimental Study Utilizing Porcine Model of In-Stent Restenosis.

    PubMed

    Orlik, Bartłomiej; Buszman, Piotr P; Krauze, Agata; Gąsior, Paweł; Desperak, Piotr; Pająk, Jacek; Kasperczyk, Janusz; Janas, Adam; Jelonek, Michał; Handzlik-Orlik, Gabriela; Buszman, Paweł E; Milewski, Krzysztof

    2016-01-01

    We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method. In 22 domestic swine, 18 biodegradable polymer-only coated stents (BPSs) and 36 biodegradable polymer-coated sirolimus-eluting stents (BP-SES) were implanted in coronary arteries with 115% overstretch. The animals were sacrificed at 1, 3, 7, 14, 28, and 56 days following baseline procedures. Vessel segments with BPS were harvested to evaluate polymer degradation with a NMR method, whereas BP-SES to analyze sirolimus tissue uptake and retention. Additionally, 8 BP-SES were implanted for histological analysis for 90 days of follow-up. The NMR showed a gradual absorption of the polymer over the 6 consecutive time points, from 5.48 µg of the polymer on the stent at 1-day follow-up, through 4.33 µg at 3 days, 3.16 µg at 7 days, 2.42 µg at 14 days, 1.92 µg at 28 days to 1.24 µg in the last day of the study. The curve of polymer degradation corresponds well with the pharmacokinetic profile of sirolimus eluted from its surface and measured at identical time points. In histopathology, at 90 days, complete healing and biocompatibility were reported. The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution. © The Author(s) 2015.

  15. Fully biodegradable coronary stents : progress to date.

    PubMed

    Ramcharitar, Steve; Serruys, Patrick W

    2008-01-01

    The limitations of currently available metallic drug-eluting stents have renewed interest in biodegradable stents (BDS). Apart from removing the (offending) foreign material that may potentiate a thrombotic event, BDS have the advantage of avoiding 'full metal jackets,' and thus can preclude subsequent coronary surgery. In addition, they do not interfere with the diagnostic evaluation of non-invasive imaging such as cardiac magnetic resonance and CT. There are now several BDS in development or in clinical trials that incorporate a variety of biodegradable polymer technologies. Two broad categories of materials are generally used: those made from organic biopolymers and those made from corrodible metals. However, to date, none of the materials/stents tested have been able to establish a perfect balance between biocompatibility, the kinetics of degradation needed to maintain mechanical strength to limit recoil, and inflammation. However, studies, such as the ABSORB trial with the everolimus eluting poly-L-lactide stent, which demonstrated comparable restenotic rates with bare metallic stents and a low incidence of major adverse cardiac events (MACE) at 12 months of 3.3%, with only one patient having a non-Q-wave myocardial infarction and no target lesion revascularization, suggest that there has been significant progress with respect to the earlier prototypes. The acute recoil observed could potentially be addressed with the polytyrosine REVA stent currently being evaluated in the RESORB trial, which incorporates a novel locking mechanism within its design. Alternative BDS designs include the combination of an antiproliferative drug with endothelial progenitor cell capturing antibodies to facilitate epithelialization and/or dual eluting having, in addition to the antiproliferative drug, polymeric salicyclic acid to limit inflammation. Compared with biodegradable polymers, there are fewer metals used in the manufacture of BDS. The only metal BDS in trials is the

  16. 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

  17. Coronary perforation and covered stents: an update and review.

    PubMed

    Al-Mukhaini, Mohammed; Panduranga, Prashanth; Sulaiman, Kadhim; Riyami, Abdulla Amour; Deeb, Mohammed; Riyami, Mohamed Barkat

    2011-04-01

    Coronary perforation is a rare complication of percutaneous coronary intervention. We present two different types of coronary intervention, but both ending with coronary perforation. However, these perforations were tackled successfully by covered stents. This article reviews the incidence, causes, presentation, and management of coronary perforation in the present era of aggressive interventional cardiology. Coronary perforations are classified as type I (extraluminal crater), II (myocardial or pericardial blushing), and III (contrast streaming or cavity spilling). Types I and II coronary perforations are caused by stiff or hydrophilic guidewires. Type I has a benign prognosis, whereas type II coronary perforations have the potential to progress to tamponade. Type III coronary perforations are caused by balloons, stents, or other intracoronary devices and commonly lead to cardiac tamponade necessitating pericardial drainage. However, type III perforations can be managed with covered stents without need for surgical intervention.

  18. Coronary Perforation and Covered Stents: An Update and Review

    PubMed Central

    Al-Mukhaini, Mohammed; Panduranga, Prashanth; Sulaiman, Kadhim; Riyami, Abdulla Amour; Deeb, Mohammed; Riyami, Mohamed Barkat

    2011-01-01

    Coronary perforation is a rare complication of percutaneous coronary intervention. We present two different types of coronary intervention, but both ending with coronary perforation. However, these perforations were tackled successfully by covered stents. This article reviews the incidence, causes, presentation, and management of coronary perforation in the present era of aggressive interventional cardiology. Coronary perforations are classified as type I (extraluminal crater), II (myocardial or pericardial blushing), and III (contrast streaming or cavity spilling). Types I and II coronary perforations are caused by stiff or hydrophilic guidewires. Type I has a benign prognosis, whereas type II coronary perforations have the potential to progress to tamponade. Type III coronary perforations are caused by balloons, stents, or other intracoronary devices and commonly lead to cardiac tamponade necessitating pericardial drainage. However, type III perforations can be managed with covered stents without need for surgical intervention. PMID:22121463

  19. Stent sizing by coronary computed tomographic angiography: comparison with conventional coronary angiography in an experienced setting.

    PubMed

    de Silva, Ramesh; Mussap, Christian J; Hecht, Harvey S; van Mieghem, Nicolas M; Matarazzo, Thomas J; Roubin, Gary S; Panagopoulos, Georgia

    2011-11-01

    The goal was to compare stent sizing by coronary computed tomographic angiography (CCTA) with that deployed in an experienced setting based upon conventional coronary angiography (CA). Stent sizing is currently performed by visual estimation, with infrequent guidance by intravascular ultrasound. CCTA permits quantitative determination of stent length (Stent L) and diameter (Stent D). Projected L (CTA-Stent L) and D (CTA-Stent D) were determined from CCTA obtained in 248 patients with 352 lesions undergoing percutaneous coronary intervention within 4 months of the CCTA, and were compared to the Stent-L and Stent-D of the actually deployed stents. The effects of lesion modification and calcified plaque were also evaluated. There were significant correlations between CTA-Stent L and Stent L (r = 0.656, P < 0.0001) and between CTA-Stent D and Stent D (r = 0.40, P < 0.001). Median predicted CTA-Stent L was slightly longer (20 mm vs. 18 mm, P < 0.0001) and predicted CTA-Stent D was slightly smaller (3.0 mm vs. 3.2 mm, P < 0.0001) than Stent-L and Stent-D, respectively. The differences were unchanged in stents with lesion modification by pre-dilation or intracoronary nitroglycerin. CTA Stent-L and CTA Stent-D increased significantly with increasing calcium (P < 0.0001 and P = 0.019, respectively). (1) There are significant correlations between CCTA and CA based stent sizing in an experienced setting. (2) CCTA projects slightly longer and slightly smaller diameter stents than those deployed during PCI irrespective of lesion modification; the small differences are unlikely to have clinical significance. (3) CCTA may offer a noninvasive alternative to intravascular ultrasound for stent planning. Copyright © 2011 Wiley-Liss, Inc.

  20. Design Optimisation of Coronary Artery Stent Systems.

    PubMed

    Bressloff, Neil W; Ragkousis, Giorgos; Curzen, Nick

    2016-02-01

    In recent years, advances in computing power and computational methods have made it possible to perform detailed simulations of the coronary artery stenting procedure and of related virtual tests of performance (including fatigue resistance, corrosion and haemodynamic disturbance). Simultaneously, there has been a growth in systematic computational optimisation studies, largely exploiting the suitability of surrogate modelling methods to time-consuming simulations. To date, systematic optimisation has focussed on stent shape optimisation and has re-affirmed the complexity of the multi-disciplinary, multi-objective problem at hand. Also, surrogate modelling has predominantly involved the method of Kriging. Interestingly, though, optimisation tools, particularly those associated with Kriging, haven't been used as efficiently as they could have been. This has especially been the case with the way that Kriging predictor functions have been updated during the search for optimal designs. Nonetheless, the potential for future, carefully posed, optimisation strategies has been suitably demonstrated, as described in this review.

  1. Celiac artery stent placement for coronary ischemia.

    PubMed

    Madden, Nicholas J; Piccolo, Carmen; Kunasani, Ratna; Mohan, Chittur; Khoobehi, Ali; Sohn, Richard

    2015-08-01

    The use of endovascular technology for mesenteric interventions has become an increasingly accepted treatment modality. We present an unusual case of celiac artery stent placement for coronary ischemia. A 66-year-old male with a history most notable for coronary artery disease and coronary artery bypass grafting (CABG) x 3 utilizing left internal mammary artery to left anterior descending, radial artery to first diagonal and his right gastroepiploic artery (GEA) to posterior descending artery presented with chest pain. His work-up included a cardiac catheterization that revealed a 90% stenosis at the origin of the celiac axis. A subsequent computerized tomography angiogram confirmed this and noted moderate stenosis of his superior mesenteric artery (SMA) as well as severe inferior mesenteric artery (IMA) stenosis. The patient was taken for mesenteric angiography by vascular surgery at which time he underwent balloon-expandable stent placement in the celiac axis. The patient tolerated this procedure well and was noted to have an improvement in his symptoms postoperatively. Use of arterial conduits for CABG have proven to be superior to vein. Long-term viability of the GEA as a conduit is dependent in part on the patency of mesenteric circulation. Our findings demonstrate a viable endovascular treatment option for angina pectoris secondary to mesenteric stenosis in this unique patient population. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. 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.

  3. Stabilization of Coronary Stents Using the Floating-Wire Technique.

    PubMed

    Li, Yue; Xue, Jingyi; Li, Shuang; Sheng, Li; Sun, Danghui; Li, Weimin; Gong, Yongtai

    2015-11-01

    Excessive movement of coronary stents within the artery can make accurate stent placement difficult. This study assessed the use of the floating-wire technique to reduce stent motion to improve placement accuracy. During percutaneous coronary intervention, if excessive stent movement prevented accurate stent placement, the floating-wire technique was performed to reduce stent motion within the coronary artery during both stent positioning and deployment. Postprocedural angiograms were analyzed by two independent operators to measure the motion length of the stent delivery system relative to the coronary artery before and after using the floating-wire technique. The floating-wire technique was considered necessary in 19 patients. No procedural complications occurred. The extent of motion was markedly reduced by using the floating-wire technique (4.04 ± 1.25 mm to 1.11 ± 0.81 mm; P<.001). The floating-wire technique is an effective and safe method to reduce stent movement and facilitate accurate stent deployment. This simple technique can be easily applied in any interventional cardiac catheterization laboratory without the need for additional training or equipment.

  4. 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.

  5. Elastic recoil of coronary stents: a comparative analysis.

    PubMed

    Barragan, P; Rieu, R; Garitey, V; Roquebert, P O; Sainsous, J; Silvestri, M; Bayet, G

    2000-05-01

    Minimum elastic recoil (ER) has became an essential feature of new coronary stents when deployed in artheromatous lesions of various morphologies. The ER of coronary stent might be an important component of 6-month restenosis rate by minimizing the luminal loss. We evaluated the intrinsic ER of 23 coronary stents with a mechanical test bench. The amount of ER for one size of stent (3.0 mm) was quantified using a 3D optical contactless machine (Smartscope MVP, Rochester, NY). The stents were expanded on their own balloon for the precrimped stents; the uncrimped stents were expended using identical 3.0-mm balloons. Two types of measurements were done without exterior stress and with a 0.2-bar exterior stress, directly on the stent at the end of balloon expansion, immediately after balloon deflation, and then 30 min, 60 min, and 120 min after. ER ranged from 1.54%+/-0.81% (Bestent BES 15) to 16.51%+/-2.89% (Paragon stent) without stress (P<0.01) and from 2.35%+/-1.14% (Bestent BES 15) to 18.34%+/-2.41% (Cook GR2) under 0.2-bar pressure (P<0.0001). Furthermore, there was a significant reduction between the mean result of tubular stents (TS) and coil stents (CS). The results of in vitro mechanical tests may confirm strongly the interest of a minimum ER in the prevention of the 6-month restenosis.

  6. The use of drug eluting stents in single and multivessel disease: results from a single centre experience

    PubMed Central

    Mikhail, G W; Airoldi, F; Tavano, D; Chieffo, A; Rogacka, R; Carlino, M; Montorfano, M; Sangiorgi, G; Corvaja, N; Michev, I; Orlic, D; Di Mario, C; Colombo, A

    2004-01-01

    Objective: Drug eluting stents have been shown to reduce the rate of in-stent restenosis in cases where single lesions are treated. The performance of these stents, in patients with multivessel disease and complex lesions, however, remains unknown. Our experience with sirolimus eluting stents in such patients is presented. Design and patients: This study includes all consecutive patients treated at San Raffaele Hospital and EMO Centro Cuore Columbus, Milan, Italy treated with sirolimus eluting stents. Results: Between April 2002 and March 2003, 486 patients with 1027 lesions were treated (437 males, 49 females) with a mean (SD) age of 62.2 (10.5) years. Of all patients studied, 19.1% had single vessel disease, 33.8% had two vessel disease, and 47.1% had three vessel disease. Of the whole study group, 20.3% of patients had diabetes mellitus. A mean (SD) of 2.3 (0.4) stents per patient and 1.1 (0.2) stents per lesion were implanted. The baseline mean reference diameter was 2.7 (0.6) mm with a mean minimal luminal diameter of 0.9 (0.5) mm. Post-stenting, the acute gain was 1.8 (0.6) mm. During hospital stay one patient died (0.2%) and 13 (2.7%) patients had in-hospital myocardial infarction (MI). One patient required urgent repeat percutaneous coronary intervention. Six months clinical follow up was performed in all 347 eligible patients. Six months mortality was 2.0% (n  =  7) and acute MI occurred in 0.3% (n  =  1). Target lesion revascularisation occurred in 9.5% (n  =  33) of the patients and target vessel revascularisation (TVR) in 11.5% (n  =  40) of the patients. Major adverse cardiac event rate was 13.8% (n  =  48). TVR was 4.5% for single vessel disease and 13.2% for multivessel disease. Diabetes mellitus was the only significant predictor for TVR. Conclusion: The use of drug eluting stents in single and multivessel coronary disease produces good short and medium term results with a low rate of revascularisation. Longer term follow-up is

  7. Clinical outcomes of compromised side branch (stent jail) after coronary stenting with the NIR stent.

    PubMed

    Bhargava, B; Waksman, R; Lansky, A J; Kornowski, R; Mehran, R; Leon, M B

    2001-11-01

    Acute side-branch (SB) compromise or occlusion stent jail after native coronary stenting is a matter of concern. Attempts at maintaining SB patency can be a technical challenge. The purpose of this study was to determine the clinical impact of SB compromise or occlusion in patients undergoing stenting of parent vessel lesions. We evaluated in-hospital and long-term clinical outcomes (death, Q-wave myocardial infarction, and repeat revascularization rates at 6 months) in 318 consecutive patients undergoing NIR stent implantation across an SB. Based on independent angiographic analysis, 218 (68.6%) patients had no poststent SB compromise, 85 (26.7%) patients had narrowed SB (> 70% narrowing, without total occlusion), and 15 (4.7%) patients had an occluded SB after stent implantation. The baseline patient and lesion characteristics were similar between the groups. Procedural success was 100%. Patients with SB occlusion had a higher stents/lesion ratio (P < 0.006). Side-branch occlusion was associated with higher in-hospital ischemic complications (Q-wave myocardial infarction, 7%; non-Q-wave myocardial infarction, 20%; P < 0.05) compared to patients with SB compromise or normal SB. At 6-month follow-up, there was a trend for more myocardial infarctions in the group with SB occlusion during the index procedure (Q-wave myocardial infarction, 7% vs. 1% in the narrowed and 0% in normal SB; P = 0.09). However, late target lesion revascularization and mortality were similar in the three groups (P = 0.91). SB occlusion after parent vessel stenting is associated with more frequent in-hospital Q-wave and non-Q-wave myocardial infarctions. However, with the NIR stent, side-branch compromise or occlusion does not influence late (6 month) major adverse events, including death, myocardial infarction, or need for repeat revascularization.

  8. The MGuard coronary stent: safety, efficacy, and clinical utility

    PubMed Central

    Gracida, Montserrat; Romaguera, Rafael; Jacobi, Francisco; Gómez-Hospital, Joan A; Cequier, Angel

    2015-01-01

    Atheromatous and thrombotic embolization during percutaneous coronary revascularization is a feared complication that may cause impaired myocardial reperfusion even with a patent epicardial vessel. The MGuard stent is a cobalt chromium bare metal stent with a porous net attached to its outer surface that has been designed to prevent thrombus fragmentation and distal embolization during stent implantation. This review summarizes the available evidence supporting the use of the MGuard stent in different scenarios such as lesions with high thrombus burden, saphenous vein graft interventions, coronary perforations, or carotid lesions. PMID:26425097

  9. Methotrexate loaded SAE coated coronary stents reduce neointimal hyperplasia in a porcine coronary model

    PubMed Central

    Huang, Y; Salu, K; Liu, X; Li, S; Wang, L; Verbeken, E; Bosmans, J; De Scheerder, I

    2004-01-01

    Objective: To evaluate the effect of stent based methotrexate delivery on neointimal hyperplasia. Methods: Stainless steel coronary stents and biological polymer coated (SAE) stents were randomly implanted in coronary arteries of pigs with a stent to artery ratio of 1.1:1. The pigs were killed after five days (10 stents) or four weeks (20 stents). Second, stainless steel coronary stents were dip coated in a 10 mg/ml methotrexate–SAE polymer solution, resulting in a total load of 150 μg methotrexate/stent. SAE coated stents and methotrexate loaded stents were randomly implanted in porcine coronary arteries with a stent to artery ratio of 1.2:1 and followed up to four weeks. Results: SAE coated stents and bare stents elicited a similar tissue response at five days. At four weeks, neointimal hyperplasia induced by the coated stents was less pronounced than with the bare stents (1.32 (0.66) v 1.73 (0.93) mm2, p > 0.05). In vitro drug release studies showed that 50% of the methotrexate was released in 24 hours, and all drug was released within four weeks. No impact on vascular smooth muscle cell proliferation or viability was observed in in vitro cell cultures. At four weeks the arteries with methotrexate loaded stents had decreased peristrut inflammation and neointimal hyperplasia (1.22 (0.34) v 2.25 (1.28) mm2, p < 0.01). Conclusions: SAE coating had an excellent biocompatibility with vascular tissue. Stent based delivery of methotrexate in the SAE coating effectively reduced neointimal hyperplasia in a porcine coronary stent model, potentially due to reduced peristrut inflammation. PMID:14729797

  10. Dissimilar relevance given to diseases by medical literature, and the potential to create biases in the clinical decision-making process: the case of late stent thrombosis.

    PubMed

    Agostoni, Pierfrancesco; Kedhi, Elvin; Verheye, Stefan; Vermeersch, Paul; Van Langenhove, Glenn

    2007-01-08

    We discuss two cases of non-occlusive sub-acute/late stent thrombosis, one correctly diagnosed (with the help of intravascular ultrasound) 12 days after implantation of a sirolimus eluting stent, the other erroneously non recognized 17 days after implantation of a bare metal stent and evolving 6 weeks later in total thrombotic occlusion of the stent itself. We believe that our clinical judgment, accurate in case of sirolimus eluting stent thrombosis, but wrong in case of bare metal stent thrombosis, was largely influenced by the recent literature giving overwhelming attention, in the drug-eluting stent era, to an issue (late stent thrombosis) that was already present but under-considered, also in the bare metal stent era.

  11. 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.

  12. [Biodegradable coronary stents: history of application and own experience].

    PubMed

    Furkalo, S N; Khasianov, I V; Vlasenko, E A

    2014-10-01

    Experience of application of a new generation coronary stents--biodegradable stent--platforms--was summarized, in 46 patients, suffering an ischemic heart disease, 60 stents "Absorb" were implanted. Unstable course of the disease was noted in 6 (13.0%) patients, coronary angina of functional class II--III--in 40 (87%). Early stenting was accomplished in 10, aortocoronary shunting--in 4 patients, and abdominal aorta endoprosthesis--in 1. One stent "Absorb" was implanted to 33 patients, two stents--to 11, four biodegradable stents--1. In one observation the stenting of coronary arteries and a. carotis interna was conducted. In all the patients the immediate postoperative period course was uneventful, unfaithful implantation or an acute thrombosis of stent were not observed. The investigation results witnesses the possibility of application of this technology in various clinical and angiographic situations. For wide introduction of biodegradable stents into practice of interventional cardiology departments it is necessary to proceed with the immediate and late follow-up results studying.

  13. 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

  14. Coronary artery bypass is superior to drug-eluting stents in multivessel coronary artery disease.

    PubMed

    Guyton, Robert A

    2006-06-01

    Percutaneous intervention for the treatment of multivessel coronary artery disease continues to displace coronary artery bypass graft surgery. But controlled trials of percutaneous intervention versus coronary bypass, in meta-analysis, have shown a significant survival advantage for coronary bypass. Studies of bare metal stents have not presented any data to prompt reversal of this conclusion for all but the small portion of patients most suited for stenting. Drug-eluting stents have no survival advantage compared with bare metal stents. Data from real-world registries have shown that the current therapy of multivessel disease patients has resulted in a relative excess mortality of as much as 46% in patients with initial stenting compared with patients with initial coronary bypass. Ethical considerations demand that patients with multivessel disease be informed of the documented mortality benefit of coronary bypass graft surgery.

  15. Recent developments in drug-eluting coronary stents.

    PubMed

    Yildiz, Mustafa; Yildiz, Banu Sahin; Gursoy, Mustafa Ozan; Akin, Ibrahim

    2014-01-01

    The interventional treatment of coronary artery disease was introduced in 1970`s by Andreas Grüntzig. The initial treatment strategy with plain old balloon angioplasty (POBA) was associated with high restenosis rates. The introduction of coronary stents, especially drug-eluting stents (DES) in 2002 has improved the results by lowering the rate of in-stent restenosis from 20-40% in the era of bare-metal stent (BMS) to 6-8%. However, in 2006 with the observation of late stent thrombosis the reputations of DES have decreased. However, improvements in stent design especially antiproliferative agents, polymeric agents as well as stent platforms improved newer generation DES. In controlled trials as well as registries the use of second-generation DES as compared to bare-metal stents (BMS) was associated with better clinical and angiographic results. A further development of these stents with use of biodegradable polymers, polymer-free stents, and biodegradable stents on the basis of poly L-lactide (PLLA) or magnesium resulted in third-generation DES and has been evaluated in preclinical and first clinical trials. However, to date, there is a lack of data comparing these third-generation DES with first- and second-generatrion DES in a large scale.

  16. Emergency coronary stenting with the Palmaz-Schatz stent for failed transluminal coronary angioplasty: results of a learning phase.

    PubMed

    Kiemeneij, F; Laarman, G J; van der Wieken, R; Suwarganda, J

    1993-07-01

    This study describes initial results of Palmaz-Schatz stent implantation in our department to restore and maintain vessel patency in 52 patients with obstructive dissection, defined as an intraluminal filling defect with coronary flow impairment after percutaneous transluminal coronary angioplasty (PTCA). The majority of patients (62%) underwent PTCA for unstable angina (n = 28), defined as angina at rest with documented ST segment changes resistant to nitrates, or acute myocardial infarction (n = 4). In six patients (11%) the stent could not be delivered. Seven of the remaining 46 patients (15%) had coronary artery bypass surgery performed because of increased risk for subacute stent occlusion, residual thrombosis, residual obstruction near the stent, coronary artery diameter less than 3.0 mm, or multiple and overlapping stents. One patient (3%) died in hospital from intracranial bleeding. Nine patients (23%) had subacute stent occlusion, retrospectively unpredictable in four patients. Nine of 29 patients (29%) with an uncomplicated clinical course after stenting had angiographic restenosis at a mean follow-up of 6.0 +/- 1.4 months (range 12 days to 8.3 months). Two patients (7%) died 3 months after successful stenting: one patient because of stent thrombosis after stopping warfarin before an abdominal operation and one patient after acute vascular surgery for late traumatic groin bleeding. Of the 39 medically treated patients with a stent, three (8%) had major bleeding complications. It is concluded that stent implantation is feasible in most patients with obstructive dissection after PTCA. After successful stent delivery, coronary flow is temporarily restored.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. Tips and tricks for stenting of bifurcation coronary lesions.

    PubMed

    Kwan, Tak W; Vales, Lori; Liou, Michael; Kanei, Yumiko; Chen, Shao-Liang

    2010-09-01

    Although the provisional stenting technique to treat coronary bifurcation lesions is the preferred method, many bifurcation lesions still require a two-stent technique to optimize the result and clinical outcome. This manuscript summarizes the tips and tricks of bifurcation stenting with cases illustrations. As interventionists are encountering more complex and difficult cases, one may find the tips and tricks in this manuscript helpful in daily practice.

  18. Direct coronary stenting by transradial approach: rationale and technical issues.

    PubMed

    Burzotta, Francesco; Hamon, Martial; Trani, Carlo; Kiemeneij, Ferdinand

    2004-10-01

    Direct stent implantation using radial approach represents to date the less invasive, less traumatic strategy to perform a percutaneous coronary intervention, rendering its adoption an attraction for many interventional cardiologists. A growing series of reports suggests the feasibility of transradial direct stenting in a variety of clinical situations. Here we discuss the main advantages of the adoption of this technique. Moreover, a detailed analysis of the technical issues specifically related with each phase of transradial direct stenting procedures is reported.

  19. [Safety of magnetic resonance imaging after coronary stenting].

    PubMed

    Sinitsyn, V E; Stukalova, O V; Kupriianova, O M; Ternovoĭ, S K

    2007-01-01

    Magnetic resonance imaging (MRI) is contraindicated to some patients with certain types of metallic devices and implants (e.g. cerebral surgical clips, defibrillators). There are some controversies concerning safety of MRI in patients with metallic coronary stents in cases when MRI examination is performed earlier then one month after stent implantation. Analysis of published data has shown that MRI performed with systems having field strength up to 3 Tesla does not cause migration and heating of both bare and coated stent and is not associated with increased risk of coronary artery thrombosis. MRI can be performed safely in first days after coronary stent implantation. Small local artifacts on MRI images do not influence interpretation of the data (except for cases of coronary magnetic resonance angiography).

  20. Breakthrough: NETL's Research Saving Lives with Coronary Stents

    ScienceCinema

    Turner, Paul

    2016-07-12

    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.

  1. Breakthrough: NETL's Research Saving Lives with Coronary Stents

    SciTech Connect

    Turner, Paul

    2012-11-26

    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.

  2. Stent dislodgement induced by a vasodilator used for severe coronary artery spasm caused by Kounis syndrome.

    PubMed

    Nishi, Masahiro; Zen, Kan; Kambayashi, Daisuke; Asada, Satoshi; Yamaguchi, Shinichiro; Tatsukawa, Hirotaka

    2016-01-01

    Coronary stent dislodgement is a rare but critical complication of percutaneous coronary intervention. It can potentially result in serious consequences, such as stent embolization and emergent coronary artery bypass graft surgery. Here, we describe the successful retrieval of an extracoronary dislodged stent, where dislodgement was induced by a vasodilator used for severe coronary artery spasm caused by Kounis syndrome.

  3. Direct coronary stent implantation: safety, feasibility, and predictors of success of the strategy of direct coronary stent implantation.

    PubMed

    Laarman, G; Muthusamy, T S; Swart, H; Westendorp, I; Kiemeneij, F; Slagboom, T; van der Wieken, R

    2001-04-01

    This prospective study was designed to evaluate the feasibility, safety, predictive factors of success, and 6-month follow-up of stent implantation without balloon predilatation (direct stenting) in 250 patients undergoing elective stent implantation. Balloon dilatation prior to stent implantation was a prerequisite to facilitate passage and deployment of the stent. Stent technology has changed tremendously, resulting in stents with improved properties, which may allow stent placement without prior balloon dilatation. Patients with coronary lesions suitable for elective stent implantation were included in this trial. Coronary interventions were undertaken predominantly via the transradial route using 6 Fr guiding catheters. Direct stent implantation was attempted using AVE GFX II coronary stent delivery systems. Upon failure, predilatation was undertaken before reattempting stent implantation. Patient data and ECGs were obtained from case records and from personal or telephone interviews 6 months after the procedure. Values were presented as mean +/- standard deviation. Student's t-test, two-tailed at 5% level of significance, was used to compare the difference of two means. Multivariate logistic regression analysis was performed to establish predictive factors for failure of direct stenting. Two hundred and sixty-six direct stent implantations were attempted in 250 patients. Direct stenting was successful in 226 (85%) cases. Out of 40(15%) cases where direct stenting failed, balloon predilatation facilitated stent implantation in 39. In one lesion, stent implantation was not possible despite adequate predilatation. Predictive factors for failure of direct stenting on multivariate analysis were LCx lesions (P < 0.01), complex lesions (P < 0.01), and longer stents (P < 0.001). Minimal luminal diameter and percentage diameter stenosis of lesions in the successful and the failure group were not significantly different (0.94 +/- 0.39 mm vs. 0.84 +/- 0.41 mm, P = NS

  4. Safety, efficacy and costs associated with direct coronary stenting compared with stenting after predilatation

    PubMed Central

    IJsselmuiden, A.; Serruys, P.W.; Tangelder, G.J.; Slagboom, T.; van der Wieken, R.; Kiemeneij, F.; Laarman, G.J.

    2004-01-01

    Objectives Comparison of the in-hospital success rates, procedural costs and short-term clinical outcomes of direct stenting versus stenting after balloon predilatation. Methods Altogether, 400 patients with angina pectoris and/or myocardial ischaemia due to coronary stenoses in a single native vessel were randomised to either direct stenting or stenting after predilatation. Baseline characteristics were evenly distributed between the two groups. Results Procedural success rates were similar (96.0% direct stenting group vs. 94.5% predilatation) as well as final successful stent implantation (98.3 vs. 97.8%), while the primary success rate of direct stenting alone was 88.3%, p=0.01. In multivariate analysis, angiographic lesion calcification was an independent predictor of unsuccessful direct stenting (odds ratio 7.1, 95% confidence interval 2.8-18.2, p<0.0001). Rates of troponin I rises >0.15 μg/l, used as a measure of distal embolisation, were similar in both groups (17.8 vs. 17.1%). Rates of major adverse cardiac events at 30 days were 4.5% in the direct stenting group versus 5.5% in the predilated group (ns). Direct stenting was associated with savings in fluoroscopy time, and angiographic contrast agent use, and a reduction in utilisation of angioplasty balloons (0.4 vs. 1.17 balloons per patient, p<0.001). Mean per patient procedural costs associated with direct stenting versus predilatation were €2545±914 versus €2763±842 (p=0.01), despite the implantation of more stents in the directly stented group. Conclusion Compared with a strategy of stenting preceded by balloon predilatation, direct stenting was equally safe and effective, with similar in-hospital and 30-day clinical outcomes, and modest procedural cost-savings. A calcified lesion predicted unsuccessful direct stenting. PMID:25696356

  5. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.

    PubMed

    Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis; Erglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco; Cornelis, Kristoff; Janssens, Luc; Maeng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F; Stella, Pieter

    2017-09-19

    The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Risk Factors and Clinical Impacts of Peri-Stent Contrast Staining After Second-Generation Drug-Eluting Stent Implantation.

    PubMed

    Tokuda, Takahiro; Yamawaki, Masahiro; Mori, Shinsuke; Takimura, Hideyuki; Sakamoto, Yasunari; Kobayashi, Norihiro; Araki, Motoharu; Hirano, Keisuke; Ito, Yoshiaki

    2016-04-01

    Peri-stent contrast staining (PSS) after sirolimus-eluting stent implantation is associated with target lesion revascularization (TLR) and very late stent thrombosis. However, the risk factors and clinical sequelae of PSS after second-generation DES implantation remain unclear. This study comprised 2,090 patients with 2,883 lesions treated with second-generation DES from April 2009 to February 2013. Angiographic findings and clinical outcomes were compared between PSS and non-PSS groups. Follow-up angiography was available for 2,411 lesions. PSS was observed in 23 lesions: 4 in biolimus-eluting stents, 4 in zotarolimus-eluting stents (ZES), and 15 in everolimus-eluting stents (EES). Right coronary artery lesions, chronic total occlusion (CTO), and lesions with severe angulation (>90°) were more frequent in the PSS group compared with the non-PSS group. Lesions were longer and the cumulative TLR incidence at 3 years was higher in the PSS group than those in the non-PSS group (27.9 mm vs. 19.4 mm, P < 0.0001; 27.4% vs. 8.6%, P = 0.0002). There was no significant difference in stent thrombosis between the two groups. Multivariable analysis identified CTO [odds ratio (OR) 3.75, 95%CI 1.52-8.88, P = 0.005] as an independent predictor of PSS. PSS after second-generation DES implantation was associated with an increased risk of subsequent TLR. CTO was the independent predictor of PSS. © 2016, Wiley Periodicals, Inc.

  7. Late coronary thrombosis in paclitaxel-eluting stents. Case reports.

    PubMed

    Cassin, Matteo; De Biasio, Marzia; Macor, Franco; Burelli, Claudio; Vendrametto, Fauzia; Driussi, Mauro; Nicolosi, Gian Luigi

    2007-04-01

    Drug-eluting stent (DES) implantation has reduced angiographic and clinical restenosis that actually develops in less than 10% of treated patients. DESs also tend to delay the endothelialisation process increasing the risk of stent thrombosis. Subacute stent thrombosis may complicate long-term success of coronary angioplasty; it is a sudden event and usually causes acute myocardial infarction or sudden cardiac death. Patients undergoing DES implantation should be treated with dual antiplatelet therapy for at least 3-6 months. We describe two cases presenting with ST-elevation acute myocardial infarction due to stent thrombosis that occurred late after deployment of a paclitaxel-eluting stent, after discontinuation of antiplatelet therapy. It is important, for clinical cardiologists and general practitioners, to know the potential risk of late thrombosis of DES patients and, consequently, the implications regarding management of antiplatelet therapy.

  8. 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.

  9. A mixed treatment comparison for short- and long-term outcomes of bare-metal and drug-eluting coronary stents.

    PubMed

    Petrou, Panagiotis; Dias, Sofia

    2016-01-01

    The increasing use of drug eluting stents in interventional cardiology calls for assessment of their efficacy and safety, both among drug-eluting and bare-metal stents, in the context of rational decision making. We searched for papers that compared any of the sirolimus-eluting stent, paclitaxel-eluting stent, drug- eluting stent, biodegradable stent, everolimus-eluting stent, zotarolimus-resolute eluting stent, biolimus- eluting stent, bare-metal stent and zotarolimus-eluting stent. The search was contacted through Medline, the Cochrane database, Embase, TCTMD, ClinicalTrials.gov, Clinical Trial Results, CardioSource, abstracts and presentations from major cardiovascular meetings. We also searched for further articles cited by selected papers. Furthermore, important conferences and relevant proceedings and abstracts, such as the American Heart Association, American College of Cardiology, Transcatheter Cardiovascular Therapeutics, Society of Cardiovascular Angiography and Intervention, European Society of Cardiology, and Euro-PCR, were also searched. Inclusion criteria were: randomised controlled trials (RCTs), size of study (≥100 patients), duration more than 6 months and definition of reported endpoints (target vessel revascularization, thrombosis, myocardial infarction and cardiac death). Analysis of the data was performed for short-term (less than a year) and long-term outcomes (more than a year). A mixed treatment comparison approach was utilised for the data analysis. Based on the rankings of each treatment, a distinct difference between the 2nd and 1st generation stents was identified. We can conclude that everolimus, zotarolimus-resolute and biolimus eluting stents carry the highest probabilities of being superior for all endpoints. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Outcomes of Coronary Artery Bypass and Stents for Unprotected Left Main Coronary Stenosis.

    PubMed

    Chang, Yin-Shu; Wang, Jia-Xiang; Chang, Da-Wei

    2017-08-01

    This study assessed the short-, medium-, and long-term outcomes of coronary artery bypass grafting vs stenting for patients with unprotected left main coronary artery disease through a meta-analysis of randomized controlled trials. PubMed, Embase, Scopus, Web of Science, Cochrane Library, and major conference proceedings databases were systematically searched for randomized controlled trials of coronary artery bypass grafting compared with stents in unprotected left main coronary artery disease. End points assessed were all-cause death, myocardial infarction, major adverse cardiac and cerebrovascular events, target vessel revascularization, and cerebral stroke. A meta-analysis was conducted according to predefined clinical end points. All-cause death and stroke were similar between stenting and coronary artery bypass grafting at 1 year and at follow-up beyond 1 year. The incidence of myocardial infarction was similar between stenting and coronary artery bypass grafting at each separate time point. The incidence of repeat revascularization was similar between the two groups at 30 days but was higher for stenting at 1 year and beyond. There was a trend toward fewer major adverse cardiac and cerebrovascular events after stenting compared with coronary artery bypass grafting at 30 days, but this difference was no longer significant at 1 year and reversed at follow-up beyond 1 year. The early advantages of stenting over coronary artery bypass grafting have been shown to progressively shift to coronary artery bypass grafting over time. Further larger sample randomized controlled trials are warranted to confirm the results. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  11. Emergency Coronary Stenting with Wiktor Stent Ñ Immediate and Late Results.

    PubMed

    Bertrand; Legrand; Bilodeau; Martinez; Kulbertus

    1997-01-01

    In case of failed angioplasty, coronary stenting has gradually emerged as a non-surgical method to restore vessel patency and optimize coronary blood flow. There is still little clinical and angiographic information on the use of radiopaque single loose interdigitating wire stents in angioplasty complicated by threatened or acute closure. Seventy-one patients received Wiktor stents after threatened vessel closure in 53 cases and acute closure in 18 cases. Stent delivery was successful in 98%. In-hospital death occurred in 1 case (1.4%). Stents occlusion were faced in 10 cases (14%), of which 6 presented early and 4 late after the procedure. Urgent bypass surgery was needed in 9 cases (12%) and 7 patients (10%) developed acute myocardial infarction. Serious bleeding complications occurred in 7 cases (10%) and vascular repair was performed in 4 patients (5%). During a follow-up of 20 +/- 10 months, 2 patients died, no myocardial infarction was observed and recurrence of angina was noted in 17 patients (24%). Angiographic analysis showed an acute gain in minimal lumen diameter of 1.71 +/- 0.22 mm and a late loss of 0.63 +/- 0.17 mm. Angiographic restenosis (diameter stenosis > 50%) presented in 20% of patients. Therefore, Wiktor stenting yields similar results than currently used stents in acute closure and strictly defined threatened vessel closure following angioplasty.

  12. Coronary Stent Materials and Coatings: A Technology and Performance Update.

    PubMed

    O'Brien, Barry; Zafar, Haroon; Ibrahim, Ahmad; Zafar, Junaid; Sharif, Faisal

    2016-02-01

    This paper reviews the current state of the art for coronary stent materials and surface coatings, with an emphasis on new technologies that followed on from first-generation bare metal and drug-eluting stents. These developments have been driven mainly by the need to improve long term outcomes, including late stent thrombosis. Biodegradable drug-eluting coatings aim to address the long term effects of residual durable polymer after drug elution; the SYNERGY, BioMatrix, and Nobori stents are all promising devices in this category, with minimal polymer through the use of abluminal coatings. Textured stent surfaces have been used to attached drug directly, without polymer; the Yukon Choice and BioFreedom stents have some promising data in this category, while a hydroxyapatite textured surface has had less success. The use of drug-filled reservoirs looked promising initially but the NEVO device has experienced both technical and commercial set-backs. However this approach may eventually make it to market if trials with the Drug-Filled Stent prove to be successful. Non-pharmacological coatings such as silicon carbide, carbon, and titanium-nitride-oxide are also proving to have potential to provide better performance than BMS, without some of the longer term issues associated with DES. In terms of biological coatings, the Genous stent which promotes attachment of endothelial progenitor cells has made good progress while gene-eluting stents still have some practical challenges to overcome. Perhaps the most advancement has been in the field of biodegradable stents. The BVS PLLA device is now seeing increasing clinical use in many complex indications while magnesium stents continue to make steady advancements.

  13. Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry).

    PubMed

    Godino, Cosmo; Furuichi, Shinichi; Latib, Azeem; Morici, Nuccia; Chieffo, Alaide; Romagnoli, Enrico; Tamburino, Corrado; Barbagallo, Rossella; Cera, Michela; Antoniucci, David; Goktekin, Omer; Di Mario, Carlo; Reimers, Bernard; Grube, Eberhard; Airoldi, Flavio; Sangiorgi, Giuseppe M; Colombo, Antonio

    2008-10-15

    Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.

  14. 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

  15. 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

  16. Angiographic restenosis in ephesos coronary stents: experience from a large medical center in Ankara, Turkey.

    PubMed

    Altin, Timucin; Berkalp, Berkten; Ozdol, Cagdas; Akyurek, Omer; Sayin, Tamer; Kervancioglu, Celal; Oral, Dervis; Erol, Cetin

    2008-01-01

    Coronary stent restenosis, which emerges in late periods after implantation, has not been completely abolished. Our aim was to investigate the restenosis rates of Ephesos coronary stents. In all, 96 patients (66 men) with 135 Ephesos coronary stents were included. Control angiograms were performed after 160 +/- 60 days. Quantitative coronary analysis was performed during the procedure and control angiogram. The stents were divided into 2 groups according to the presence or absence of restenosis. Groups were compared with clinical and angiographic variables. Restenosis was observed in 31 (23%) of 135 stents. Preprocedure percent diameter stenosis was higher (P = .02), whereas minimum lumen diameter ( P = .02), mean age (P < .001), and hypertension incidence ( P = .043) was less, and there was a trend toward smaller stent size ( P = .054) in the restenosis group. By multivariate analysis, age <50 years (P < .001) and stent size <3.0 mm (P = .016) were independent predictors of restenosis. Ephesos coronary stents seems to have acceptable restenosis rates.

  17. In-stent restenosis after revascularization of myocardium with drug-eluting stents is accompanied by elevated level of blood plasma eosinophil cationic protein.

    PubMed

    Gabbasov, Zufar A; Kozlov, Sergei G; Imaeva, Asiya E; Saburova, Olga S; Zykov, Kirill A; Masenko, Valery P; Smirnov, Vladimir N

    2011-06-01

    The aim of this study was to assess the involvement of eosinophil cationic protein, a marker of eosinophil activation, in the development of in-stent restenosis after drug-eluting stent implantation. Follow-up angiography at 6 to 12 months was performed in 32 patients who were treated with percutaneous coronary intervention and implantation of sirolimus-eluting stents. Blood plasma levels of eosinophil cationic protein (ECP) and total immunoglobulin E (IgE) were measured by enzyme-linked immunosorbent assay and the level of C-reactive protein (hs-CRP) by high-sensitivity nephelometry. According to angiography data, in-stent restenosis occurred in 13 patients, while 19 patients did not develop it. There were no differences between the hs-CRP and IgE levels in patients with or without restenosis. In contrast, ECP level was higher in patients with restenosis compared with that in patients without restenosis [17.7 ng/mL (11.2-24.0) vs. 9.0 ng/mL (6.4-12.9), p = 0.017]. The incidence of in-stent restenoses was 63% in patients with ECP level higher than or equal to 11 ng/mL, and 19% in patients with an ECP level lower than 11 ng/mL (p = 0.019). These findings suggest that elevated eosinophil activation may play an important role in the pathogenesis of in-stent restenosis after implantation of drug-eluting stents.

  18. 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.

  19. No country for old stents? Improving long-term patient outcomes with biodegradable polymer drug-eluting stents.

    PubMed

    Byrne, Robert A; Kastrati, Adnan

    2012-04-01

    Biodegradable polymer-coated drug-eluting stents (DESs) represent an attractive approach to improve vascular healing after coronary intervention. The proof-of-concept chain of investigation includes preclinical safety assessment, surrogate end point clinical efficacy studies and large-scale clinical outcome studies, in which noninferiority against benchmark devices is assessed at 12 months, with adjudication of hypothesized clinical advantage at long-term follow-up. The 4-year outcome data from large-scale trials such as the LEADERS study represents a final link in this process. Data from this trial show maintenance of noninferiority and an overall improvement in the composite of death, myocardial infarction and revascularization with biodegradable polymer DESs versus durable polymer sirolimus-eluting stents that is statistically significant and perhaps also clinically important (risk ratio: 0.81; 95% CI: 0.66-1.00; p-value for superiority = 0.05). Furthermore, although reductions in the incidence of stent thrombosis with biodegradable polymer stents at 4 years did not reach statistical significance, in keeping with the hypothesized mechanism of benefit, the observed risk differences seemed to be driven by a reduction in very late events beyond 1 year after intervention. These findings are backed up by those from a pooled analysis of the three largest biodegradable polymer DES randomized trials. With the availability of high-quality biodegradable polymer devices and the phasing out of earlier generation devices, the next 5 years will see increasing uptake of this therapy in routine practice. Whether improvements in outcomes with biodegradable polymer DESs can also be demonstrated against second-generation durable polymer stents is the subject of a number of ongoing clinical trials.

  20. Biocompatibility of phosphorylcholine coated stents in normal porcine coronary arteries

    PubMed Central

    Whelan, D; van der Giessen, W J; Krabbendam, S; van Vliet, E A; Verdouw, P; Serruys, P; van Beusekom, H M M

    2000-01-01

    OBJECTIVE—To improve the biocompatibility of stents using a phosphorylcholine coated stent as a form of biomimicry.
INTERVENTIONS—Implantation of phosphorylcholine coated (n = 20) and non-coated (n = 21) stents was performed in the coronary arteries of 25 pigs. The animals were killed after five days (n = 6), four weeks (n = 7), and 12 weeks (n = 8), and the vessels harvested for histology, scanning electron microscopy, and morphometry.
MAIN OUTCOME MEASURES—Stent performance was assessed by studying early endothelialisation, neointima formation, and vessel wall reaction to the synthetic coating.
RESULTS—Stent thrombosis did not occur in either group. Morphometry showed no significant differences between the two study groups at any time point. At five days both the coated and non-coated stents were equally well endothelialised (91% v 92%, respectively). At four and 12 weeks there was no difference in intimal thickness between the coated and non-coated stents. Up to 12 weeks postimplant the phosphorylcholine coating was still discernible in the stent strut voids, and did not appear to elicit an adverse inflammatory response.
CONCLUSION—In this animal model the phosphorylcholine coating showed excellent blood and tissue compatibility, unlike a number of other polymers tested in a similar setting. Given that the coating was present up to 12 weeks postimplant with no adverse tissue reaction, it may be a potential candidate polymer for local drug delivery.


Keywords: phosphorylcholine; stents; coatings; biocompatible materials PMID:10677417

  1. Influence of metal alloy and the profile of coronary stents in patients with multivessel coronary disease

    PubMed Central

    Maurício de Abreu Filho, Luciano; da Cruz Forte, Antonio Artur; Kiyoshi Sumita, Marcos; Favarato, Desidério; César Ximenes Meireles, George

    2011-01-01

    BACKGROUND: In Brazil, despite the recommendations of the Brazilian Society of Hemodynamics and Interventional Cardiology, the National Health System has not yet approved the use of drug-eluting stents. In percutaneous coronary interventions performed in the public and part of the private health care system, bare metal stents are used as the only option. Therefore, new information on bare metal stents is of great importance. The primary endpoint was to evaluate the influence of the alloy and the profile of coronary stents on late loss and restenosis rates 6 months after implantation in patients with multivessel coronary disease. METHODS: Single center, randomized and prospective study comparison of cobalt–chromium versus stainless steel stent implantation in 187 patients with multivessel coronary disease. At least one cobalt–chromium and one stainless steel stent were implanted per patient. RESULTS: Mean age of patients was 59.5±10.1 years with a prevalence of males (66.3%) and patients with acute coronary syndrome (56%). Baseline clinical characteristics were similar with hypertension in 146 (78%), dyslipidemia in 85 (45.5%) and diabetes in 68 (36.4%). Two hundred and twenty-nine cobalt–chromium and 284 stainless steel stents were implanted. Angiographic variables showed no statistically significant difference. Angiographic follow-up to 6 months after implantation showed similar late loss and restenosis rates. CONCLUSION: The use of two different alloys, stainless steel and cobalt–chrome stents, in the same patient and in the same vessel produced similar 6-month restenosis and late loss rates. PMID:21808863

  2. Drug-eluting stents versus bare-metal stents for acute coronary syndrome.

    PubMed

    Feinberg, Joshua; Nielsen, Emil Eik; Greenhalgh, Janette; Hounsome, Juliet; Sethi, Naqash J; Safi, Sanam; Gluud, Christian; Jakobsen, Janus C

    2017-08-23

    Approximately 3.7 million people died from acute coronary syndrome worldwide in 2012. Acute coronary syndrome, also known as myocardial infarction or unstable angina pectoris, is caused by a sudden blockage of the blood supplied to the heart muscle. Percutaneous coronary intervention is often used for acute coronary syndrome, but previous systematic reviews on the effects of drug-eluting stents compared with bare-metal stents have shown conflicting results with regard to myocardial infarction; have not fully taken account of the risk of random and systematic errors; and have not included all relevant randomised clinical trials. To assess the benefits and harms of drug-eluting stents versus bare-metal stents in people with acute coronary syndrome. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, SCI-EXPANDED, and BIOSIS from their inception to January 2017. We also searched two clinical trials registers, the European Medicines Agency and the US Food and Drug Administration databases, and pharmaceutical company websites. In addition, we searched the reference lists of review articles and relevant trials. Randomised clinical trials assessing the effects of drug-eluting stents versus bare-metal stents for acute coronary syndrome. We included trials irrespective of publication type, status, date, or language. We followed our published protocol and the methodological recommendations of Cochrane. Two review authors independently extracted data. We assessed the risks of systematic error by bias domains. We conducted Trial Sequential Analyses to control the risks of random errors. Our primary outcomes were all-cause mortality, major cardiovascular events, serious adverse events, and quality of life. Our secondary outcomes were angina, cardiovascular mortality, and myocardial infarction. Our primary assessment time point was at maximum follow-up. We assessed the quality of the evidence by the GRADE approach. We included 25

  3. Coronary stenting during burn shock: diagnostic and treatment considerations.

    PubMed

    Gregg, Shea C; Fidler, Philip E; Atweh, Nabil A

    2006-01-01

    Myocardial injury is known to occur in victims of both thermal and electrical burns. A variety of mechanisms have been ascribed to the pathogenesis of cardiac damage during burn shock. However, limited evidence exists that coronary artery thrombosis plays a frequent role. Distinguishing between acute coronary syndrome (impending myocardial infarction from coronary artery occlusion) vs global cardiac injury is essential; the care diverges drastically. The following case describes a patient who was angiographically proven to have acute coronary thrombosis amidst burn shock ftera 50% TBSA electrical flash burn. Managing the patient's burn shock, myocardial injury, and multiple surgical procedures while considering antiplatelet medications for a newly placed coronary artery stent presented a number of challenges not previously reported.

  4. Comparison of real-world clinical outcomes between Cypher- and Taxus-eluting stents: the GARA-GARA study.

    PubMed

    Fukumoto, Atsushi; Otsuji, Satoru; Takiuchi, Shin; Ikushima, Masashi; Asano, Katsuaki; Terasoma, Kunihiko; Hasegawa, Katsuyuki; Yabuki, Masanori; Higashino, Yorihiko

    2011-09-01

    To evaluate real-world outcomes of PCI in unselected individuals using sirolimus-eluting (SESs) or paclitaxel-eluting stents (PESs) in a single-center randomized trial. Eight hundred consecutive patients (919 lesions) with coronary artery disease were randomized to receive SES or PES implantation. In-hospital, mid-term, and 1-year clinical and angiographical outcomes in both groups were compared. MACEs were defined as cardiac death, myocardial infarction, CABG and target vessel revascularization (TLR). Follow-up angiography was performed in 80.7% of patients. The baseline clinical characteristics were similar in both groups. Pre- and postprocedural reference vessel diameter, minimum length diameter, and diameter stenosis (%DS) were similar in both groups, as was incidence of in-hospital and mid-term MACEs. SESs significantly reduced the risk of TLR, compared with PESs (SES = 5.5%, PES = 10.5%). The superiority of SESs for TLR was also demonstrated with regard to small vessel lesions (stent diameter <2.5 mm) (SES = 6.0%, PES = 15.9%), whereas larger vessel (stent diameter >2.5 mm) lesions did not differ between groups (SES = 5.3%, PES = 8.4%). The safety and efficacy of both DESs were nearly equivalent. SESs, however, were superior to PESs in reducing mid-term TLR, particularly in the small vessel lesion subsets.

  5. Behaviour of implantable coronary stents during magnetic resonance imaging.

    PubMed

    Friedrich, Matthias G; Strohm, Oliver; Kivelitz, Dietmar; Gross, Werner; Wagner, Anja; Schulz-Menger, Jeanette; Liu, Xiaomeng; Hamm, Bernd

    1999-01-01

    BACKGROUND: Magnetic resonance imaging (MRI) becomes more and more a routine diagnostic tool in clinical cardiology. In patients undergoing MRI, metallic implants may be harmful by motion or heating under certain circumstances. Many cardiac patients have implanted intracoronary stents. However, the safety of these metallic implants and especially their temperature behaviour during MRI has not been sufficiently tested. METHODS: This study investigated motion and temperature changes of 14 different stents for intracoronary application in two clinical scanners at field strengths of 1.0 and 1.5 T. At 1.5 T these studies were repeated after implantation of the stents into the coronary arteries of excised porcine hearts. Furthermore, the clinical status of 33 patients was assessed after a cardiac MR study and compared with a group of 33 patients matched for age, sex and risk factors for restenosis. RESULTS: No visible motion of the stents was observed. Furthermore, using a highly sensitive infrared camera any significant heating of the stents during MRI could be excluded. The rate of clinical events was not different in patients after MRI as compared with the control group. CONCLUSION: It is concluded that MRI is safe in patients with the currently available intracoronary stents.

  6. 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).

  7. Insulin-treated diabetes mellitus: An important, actionable risk marker after coronary stenting.

    PubMed

    Hillegass, William B

    2016-01-01

    Insulin treatment for diabetes is a simple but important risk marker for doubled adjusted death and myocardial infarction rates and tripled stent thrombosis risk after coronary stenting. Insulin treatment does not predict meaningfully increased major bleeding or additional revascularization procedures after drug eluting coronary stent implantation. Third generation P2 Y12 receptor antagonists substantially lower risk of events in diabetics after stenting with insulin treated diabetics having twice the magnitude of benefit of diabetics not needing insulin.

  8. Update on multidetector coronary CT angiography of coronary stents: in vitro evaluation of 29 different stent types with dual-source CT.

    PubMed

    Maintz, David; Burg, Matthias C; Seifarth, Harald; Bunck, Alexander C; Ozgün, Murat; Fischbach, Roman; Jürgens, Kai Uwe; Heindel, Walter

    2009-01-01

    The aim of this study was to test a large sample of the latest coronary artery stents using four image reconstruction approaches with respect to lumen visualization, lumen attenuation, and image noise in dual-source multidetector row CT (DSCT) in vitro and to provide a CT catalogue of currently used coronary artery stents. Twenty-nine different coronary artery stents (19 steel, 6 cobalt-chromium, 2 tantalum, 1 iron, 1 magnesium) were examined in a coronary artery phantom (vessel diameter 3 mm, intravascular attenuation 250 HU, extravascular density -70 HU). Stents were imaged in axial orientation with standard parameters: 32 x 0.6 collimation, pitch 0.24, 400 mAs, 120 kV, rotation time 0.33 s. Image reconstructions were obtained with four different convolution kernels (soft, medium-soft, standard high-resolution, stent-dedicated). To evaluate visualization characteristics of the stent, the lumen diameter, intraluminal density, and noise were measured. The stent-dedicated kernel offered best average lumen visualization (54 +/- 8.3%) and most realistic lumen attenuation (222 +/- 44 HU) at the expense of increased noise (23.9 +/- 1.9 HU) compared with standard CTA protocols (p < 0.001 for all). The magnesium stent showed the least artifacts with a lumen visibility of 90%. The majority of stents (79%) exhibited a lumen visibility of 50-59%. Less than half of the stent lumen was visible in only six stents. Stent lumen visibility largely varies depending on the stent type. Magnesium is by far more favorable a stent material with regard to CT imaging when compared with the more common materials steel, cobalt-chromium, or tantalum. The magnesium stent exhibits a lumen visibility of 90%, whereas the majority of the other stents exhibit a lumen visibility of 50-59%.

  9. Efficacy of drug-eluting stents for treating in-stent restenosis of drug-eluting stents (from the Korean DES ISR multicenter registry study [KISS]).

    PubMed

    Ko, Young-Guk; Kim, Jung-Sun; Kim, Byeong-Keuk; Choi, Donghoon; Hong, Myeong-Ki; Jeon, Dong Woon; Yang, Joo-Young; Ahn, Young Keun; Jeong, Myung Ho; Yu, Cheol Woong; Yun, Kyeong-Ho; Lim, Do-Sun; Jang, Yangsoo

    2012-03-01

    There is currently no established standard treatment for in-stent restenosis (ISR) after the implantation of a drug-eluting stent (DES). The aim of this study was to investigate the efficacy of DES versus balloon angioplasty (BA) for the treatment of DES ISR in a multicenter registry cohort. After matching propensity scores of 805 patients with DES ISR treated with either DES (n = 422) or BA (n = 383), 268 matched pairs were selected and analyzed for major adverse cardiac events, a composite of death, myocardial infarction, and target-vessel revascularization, as the primary end point. Baseline clinical and lesion characteristics of the matched pairs were similar. Survival free of major adverse cardiac events at 2 years was higher with DES compared to BA (88.9% vs 78.7%, p <0.001), mainly because of higher TVR-free survival (92.4% vs 81.0%, p <0.001). Among various baseline variables, BA (hazard ratio 2.546, 95% confidence interval 1.412 to 4.593, p = 0.002) was the most important independent risk factor for recurrent target vessel revascularization, followed by acute coronary syndromes as the clinical presentation of DES ISR, and previous implantation of a sirolimus-eluting stent. Survival free of death, myocardial infarction, or stent thrombosis did not differ between the 2 groups. Whereas there was no significant difference in survival free of target vessel revascularization between DES and BA for focal ISR lesions, DES was superior to BA in diffuse ISR lesions (94.3% vs 75.2% at 2 years, p <0.001). In conclusion, compared to BA, the implantation of DES was safe and more effective in the treatment of DES ISR.

  10. Comparison of long-term clinical outcomes between sirolimus- and paclitaxel-eluting stents in real-world clinical practice.

    PubMed

    Naito, Ryo; Miyauchi, Katsumi; Konishi, Hirokazu; Tsuboi, Shuta; Ogita, Manabu; Kasai, Takatoshi; Tamura, Hiroshi; Okazaki, Shinya; Daida, Hiroyuki

    2015-11-01

    Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan-Meier curves for the primary endpoint did not significantly differ between the two groups (p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively (p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups.

  11. Anticoagulation in patients with atrial fibrillation undergoing coronary stent implantation.

    PubMed

    Bernard, A; Fauchier, L; Pellegrin, C; Clementy, N; Saint Etienne, C; Banerjee, A; Naudin, D; Angoulvant, D

    2013-09-01

    In patients with atrial fibrillation (AF) undergoing coronary stent implantation, the optimal antithrombotic strategy is unclear. We evaluated whether use of oral anticoagulation (OAC) was associated with any benefit in morbidity or mortality in patients with AF, high risk of thromboembolism (TE) (CHA2DS2-VASC score ≥ 2) and coronary stent implantation. Among 8,962 unselected patients with AF seen between 2000 and 2010, a total of 2,709 (30%) had coronary artery disease and 417/2,709 (15%) underwent stent implantation while having CHA2DS2-VASC score ≥ 2. During follow-up (median=650 days), all TE, bleeding episodes, and major adverse cardiac events (i.e. death, acute myocardial infarction, target lesion revascularisation) were recorded. At discharge, 97/417 patients (23%) received OAC, which was more likely to be prescribed in patients with permanent AF and in those treated for elective stent implantation. The incidence of outcome event rates was not significantly different in patients treated and those not treated with OAC. However, in multivariate analysis, the lack of OAC at discharge was independently associated with increased risk of death/stroke/systemic TE (relative risk [RR] =2.18, 95% confidence interval [CI] 1.02-4.67, p=0.04), with older age (RR =1.12, 1.04-1.20, p=0.003), heart failure (RR =3.26, 1.18-9.01, p=0.02), and history of stroke (RR =18.87, 3.11-111.11, p=0.001). In conclusion, in patients with AF and high thromboembolic risk after stent implantation, use of OAC was independently associated with decreased risk of subsequent death/stroke/systemic TE, suggesting that OAC should be systematically used in this patient population.

  12. Geometry parameterization and multidisciplinary constrained optimization of coronary stents.

    PubMed

    Pant, Sanjay; Bressloff, Neil W; Limbert, Georges

    2012-01-01

    Coronary stents are tubular type scaffolds that are deployed, using an inflatable balloon on a catheter, most commonly to recover the lumen size of narrowed (diseased) arterial segments. A common differentiating factor between the numerous stents used in clinical practice today is their geometric design. An ideal stent should have high radial strength to provide good arterial support post-expansion, have high flexibility for easy manoeuvrability during deployment, cause minimal injury to the artery when being expanded and, for drug eluting stents, should provide adequate drug in the arterial tissue. Often, with any stent design, these objectives are in competition such that improvement in one objective is a result of trade-off in others. This study proposes a technique to parameterize stent geometry, by varying the shape of circumferential rings and the links, and assess performance by modelling the processes of balloon expansion and drug diffusion. Finite element analysis is used to expand each stent (through balloon inflation) into contact with a representative diseased coronary artery model, followed by a drug release simulation. Also, a separate model is constructed to measure stent flexibility. Since the computational simulation time for each design is very high (approximately 24 h), a Gaussian process modelling approach is used to analyse the design space corresponding to the proposed parameterization. Four objectives to assess recoil, stress distribution, drug distribution and flexibility are set up to perform optimization studies. In particular, single objective constrained optimization problems are set up to improve the design relative to the baseline geometry-i.e. to improve one objective without compromising the others. Improvements of 8, 6 and 15% are obtained individually for stress, drug and flexibility metrics, respectively. The relative influence of the design features on each objective is quantified in terms of main effects, thereby suggesting the

  13. 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

  14. 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

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

    NASA Astrophysics Data System (ADS)

    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 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.

  16. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study.

    PubMed

    Rahel, Braim M; Suttorp, Maarten J; Laarman, Gert J; Kiemeneij, Ferdinand; Bal, Egbert T; Rensing, Benno J; Ernst, Sjef M P G; ten Berg, Jurriën M; Kelder, Johannes C; Plokker, H W Thijs

    2004-05-01

    Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions may decrease the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. In a prospective, randomized trial, balloon angioplasty was compared with stent implantation for the treatment of chronic total occlusions. Patients were followed for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis was performed by an independent core lab. A total of 200 patients were enrolled. Baseline characteristics were evenly distributed. After the procedure the mean minimal luminal diameter in the conventional group was 2.34 +/- 0.46 mm versus 2.90 +/- 0.41 mm in the stented group (P <.0001). The 6-month angiographic follow-up showed a mean minimal luminal diameter of 1.57 +/- 0.74 mm in the conventional group versus 1.93 +/- 0.85 mm in the stented group (P =.009) and a mean diameter stenosis of 44.7% +/- 25.0% versus 35.5% +/- 26.5% (P =.036). Binary angiographic restenosis (>50% diameter stenosis) was seen in 33% in the conventional group versus 22% in the stented group (P =.137). The reocclusion rates were 7.3% and 8.2%, respectively (P = 1.00). At 12 month follow-up, the rate of target lesion revascularization was significantly higher in the conventional group (29% versus 13%, P <.0001). These data demonstrate that stenting of chronic total occlusions is superior to balloon angioplasty alone with a statistically significant reduction in the need for target lesion revascularization and a lower, but not significant, restenosis rate.

  17. Heterogeneous Intravascular Ultrasound Findings of Stent Thrombosis

    PubMed Central

    Morofuji, Toru; Inaba, Shinji; Aisu, Hiroe; Takahashi, Kayo; Saito, Makoto; Higashi, Haruhiko; Yoshii, Toyofumi; Sumimoto, Takumi

    2017-01-01

    Objective The underlying mechanisms of stent thrombosis are not completely understood. Methods We experienced 12 definite stent thrombosis cases (1 early, 1 late, and 10 very late) at our hospital from July 2011 to April 2016 and evaluated the possible causes of stent thrombosis by intravascular ultrasound (IVUS). Results Five different potential morphological causes of stent thrombosis (neoatherosclerosis, stent malapposition, stent fracture, edge dissection, and stent underexpansion) were detected by IVUS in 10 cases (83.3%); in 1 of the remaining 2 cases, the discontinuation of antithrombotic drugs resulted in early stent thrombosis without abnormal IVUS findings. Of the 12 stent thrombosis cases, 4 occurred at a bare-metal stent (average time from stent implantation, 106 months); in all 12, significant neointimal hyperplasia was observed on IVUS, and 2 had plaque ruptures at an in-stent or proximal reference. Malapposed stent struts were observed in three very-late stent thromboses, and all of these underwent sirolimus-eluting stent implantation. Stent thrombosis due to mechanical (stent fracture) or procedure-related complications (edge dissection and stent underexpansion) was observed in three cases. Conclusion In patients with stent thrombosis, heterogeneous findings were observed in IVUS. This IVUS case series illustrates the possible mechanisms of stent thrombosis. PMID:28154268

  18. Delayed aortic regurgitation caused by a right coronary stent protruding into the aorta.

    PubMed

    Quintana, Eduard; Mestres, Carlos A; Congiu, Stefano; Josa, Miguel; Cartañá, Ramon

    2009-11-01

    Aortic valve perforation is an extremely rare complication after percutaneous coronary intervention. The case is presented of a 49-year-old male with aortic valve regurgitation secondary to the intra-aortic protrusion of a right coronary stent. The patient had undergone an apparently successful rescue percutaneous transluminal coronary angioplasty with a drug-eluting stent following failed fibrinolysis, but one month later was readmitted for acute pulmonary edema. Further investigations demonstrated new-onset aortic regurgitation. Medical stabilization was achieved and an elective aortic valve replacement and coronary revascularization performed. Intraoperatively, the stent was found to be partially deployed within the aortic lumen, causing perforation to the non-coronary cusp.

  19. Clinical utility of platinum chromium bare-metal stents in coronary heart disease

    PubMed Central

    Jorge, Claudia; Dubois, Christophe

    2015-01-01

    Coronary stents represent a key development for the treatment of obstructive coronary artery disease since the introduction of percutaneous coronary intervention. While drug-eluting stents gained wide acceptance in contemporary percutaneous coronary intervention practice, further developments in bare-metal stents remain crucial for patients who are not candidates for drug-eluting stents, or to improve metallic platforms for drug elution. Initially, stent platforms used biologically inert stainless steel, restricting stent performance due to limitations in flexibility and strut thickness. Later, cobalt chromium stent alloys outperformed steel as the material of choice for stents, allowing latest generation stents to be designed with significantly thinner struts, while maintaining corrosion resistance and radial strength. Most recently, the introduction of the platinum chromium alloy refined stent architecture with thin struts, high radial strength, conformability, and improved radiopacity. This review will provide an overview of the novel platinum chromium bare-metal stent platforms available for coronary intervention. Mechanical properties, clinical utility, and device limitations will be summarized and put into perspective. PMID:26345228

  20. Fibrin-film stenting in a porcine coronary injury model: efficacy and safety compared with uncoated stents.

    PubMed

    McKenna, C J; Camrud, A R; Sangiorgi, G; Kwon, H M; Edwards, W D; Holmes, D R; Schwartz, R S

    1998-05-01

    This study was designed to test the efficacy and safety of a fibrin-film-covered stent compared with that of a bare metal stent in the porcine coronary injury model. Biodegradable stents are a potential method of achieving total lesion coverage and delivering local, lesion-specific drug therapy. Two coronary arteries in each pig were randomly assigned to deployment of either a fibrin-film or a bare tantalum wire-coil stent. An oversized balloon injury, 1.15 to 1.30 times the reference vessel diameter, was induced in each coronary segment before stenting to simulate angioplasty injury. Thirty pigs were studied: group 1 for 28 days (15 pigs); group 2 for 90 days (5 pigs); group 3 for 6 months (5 pigs); group 4 for 1 year (5 pigs). Two pigs died of occlusion of the bare stent and one of occlusion of the fibrin stent (p > 0.99). There were no significant differences between the fibrin-stented and bare-stented coronary segments with regard to arterial injury. In group 1 (28 days, 14 pigs), the mean neointimal thicknesses in the fibrin-stented and bare-stented groups were 0.57+/-0.31 and 0.57+/-0.27 mm, respectively (p=0.89). In groups 2 to 4 (90 days, four pigs; 6 months, four pigs; 1 year, five pigs), the mean neointimal thicknesses for fibrin- and bare-stented coronary segments at the times studied were 0.48+/-0.26 versus 0.50+/-0.22 mm at 90 days; 035+/-0.04 versus 0.35+/-0.16 mm at 6 months; and 0.33+/-0.14 versus 0.30+/-0.14 mm at 1 year (p=0.98). Fibrin-film stents appear to be an excellent candidate for local drug delivery because they can completely and safely cover the stented coronary segment while degrading slowly over 1 to 3 months. This result is important when compared with the poor results of previous studies of synthetic polymer stents.

  1. A randomized optical coherence tomography study of coronary stent strut coverage and luminal protrusion with rapamycin-eluting stents.

    PubMed

    Moore, Philip; Barlis, Peter; Spiro, Jonathan; Ghimire, Gopal; Roughton, Michael; Di Mario, Carlo; Wallis, William; Ilsley, Charles; Mitchell, Andrew; Mason, Mark; Kharbanda, Rajesh; Vincent, Peter; Sherwin, Spencer; Dalby, Miles

    2009-05-01

    We used optical coherence tomography, which has a resolution of <20 microm, to analyze thin layers of neointima in rapamycin-eluting coronary stents. Lack of neointimal coverage has been implicated in the pathogenesis of drug-eluting coronary stent thrombosis. Angiography and intracoronary ultrasound lack the resolution to examine this. We conducted a randomized trial in patients receiving polymer-coated rapamycin-eluting stents (Cypher, Cordis, Johnson & Johnson, Miami, Florida) and nonpolymer rapamycin-eluting stents (Yukon, Translumina, Hechingen, Germany) to examine neointimal thickness, stent strut coverage, and protrusion at 90 days. Twenty-four patients (n = 12 for each group) underwent stent deployment and invasive follow-up at 90 days with optical coherence tomography. The primary end point was binary stent strut coverage. Coprimary end points were neointimal thickness and stent strut luminal protrusion. No patient had angiographic restenosis. For polymer-coated and nonpolymer rapamycin-eluting stents, respectively, mean (SD), neointimal thickness was 77.2 (25.6) microm versus 191.2 (86.7) mum (p < 0.001). Binary stent strut coverage was 88.3% (11.8) versus 97.2% (6.1) (p = 0.030). Binary stent strut protrusion was 26.5% (17.5) versus 4.8% (8.6) (p = 0.001). Mean neointimal thickness for the polymer-coated rapamycin-eluting stent was significantly less than the nonpolymer rapamycin-eluting stent but as a result coverage was not homogenous, with >10% of struts being uncovered. High-resolution imaging allowed development of the concept of the protrusion index, and >25% of struts protruded into the vessel lumen with the polymer-coated rapamycin-eluting stent compared with <5% with the nonpolymer rapamycin-eluting stent. These findings may have important implications for the risk of stent thrombosis and, therefore, future stent design. (An optical coherence tomography study to determine stent coverage in polymer coated versus bare metal rapamycin eluting

  2. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial.

    PubMed

    Duda, Stephan H; Bosiers, Marc; Lammer, Johannes; Scheinert, Dierk; Zeller, Thomas; Oliva, Vincent; Tielbeek, Alexander; Anderson, John; Wiesinger, Benjamin; Tepe, Gunnar; Lansky, Alexandra; Jaff, Michael R; Mudde, Catharina; Tielemans, Hans; Beregi, Jean-Paul

    2006-12-01

    To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents. Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months. Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups. These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.

  3. 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.

  4. Biomechanical Modeling to Improve Coronary Artery Bifurcation Stenting: Expert Review Document on Techniques and Clinical Implementation.

    PubMed

    Antoniadis, Antonios P; Mortier, Peter; Kassab, Ghassan; Dubini, Gabriele; Foin, Nicolas; Murasato, Yoshinobu; Giannopoulos, Andreas A; Tu, Shengxian; Iwasaki, Kiyotaka; Hikichi, Yutaka; Migliavacca, Francesco; Chiastra, Claudio; Wentzel, Jolanda J; Gijsen, Frank; Reiber, Johan H C; Barlis, Peter; Serruys, Patrick W; Bhatt, Deepak L; Stankovic, Goran; Edelman, Elazer R; Giannoglou, George D; Louvard, Yves; Chatzizisis, Yiannis S

    2015-08-24

    Treatment of coronary bifurcation lesions remains an ongoing challenge for interventional cardiologists. Stenting of coronary bifurcations carries higher risk for in-stent restenosis, stent thrombosis, and recurrent clinical events. This review summarizes the current evidence regarding application and use of biomechanical modeling in the study of stent properties, local flow dynamics, and outcomes after percutaneous coronary interventions in bifurcation lesions. Biomechanical modeling of bifurcation stenting involves computational simulations and in vitro bench testing using subject-specific arterial geometries obtained from in vivo imaging. Biomechanical modeling has the potential to optimize stenting strategies and stent design, thereby reducing adverse outcomes. Large-scale clinical studies are needed to establish the translation of pre-clinical findings to the clinical arena.

  5. Automatic detection of coronary stent struts in intravascular OCT imaging

    NASA Astrophysics Data System (ADS)

    Tung, Kai Pin; Shi, Wen Zhe; Pizarro, Luis; Tsujioka, Hiroto; Wang, Hai-Yan; Guerrero, Ricardo; De Silva, Ranil; Edwards, Philip E.; Rueckert, Daniel

    2012-03-01

    Optical coherence tomography (OCT) is a light-based, high resolution imaging technique to guide stent deployment procedure for stenosis. OCT can accurately differentiate the most superficial layers of the vessel wall as well as stent struts and the vascular tissue surrounding them. In this paper, we automatically detect the struts of coronary stents present in OCT sequences. We propose a novel method to detect the strut shadow zone and accurately segment and reconstruct the strut in 3D. The estimation of the position of the strut shadow zone is the key requirement which enables the strut segmentation. After identification of the shadow zone we use probability map to estimate stent strut positions. This method can be applied to cross-sectional OCT images to detect the struts. Validation is performed using simulated data as well as in four in-vivo OCT sequences and the accuracy of strut detection is over 90%. The comparison against manual expert segmentation demonstrates that the proposed strut identification is robust and accurate.

  6. Evaluation of the biocompatibility of two new diamond-like stent coatings (Dylyn) in a porcine coronary stent model.

    PubMed

    De Scheerder, I; Szilard, M; Yanming, H; Ping, X B; Verbeken, E; Neerinck, D; Demeyere, E; Coppens, W; Van de Werf, F

    2000-08-01

    Hydrogenated diamond-like carbon films (DLC, a-C:H), deposited using plasma-assisted or ion beam-assisted techniques, offer great potential as self-lubricating coatings in many tribological applications. Additionally, studies on biocompatibility have shown that DLC is an inert, impervious hydrocarbon with properties suitable for use in the biomedical field. One particular class of modified DLC coatings are diamond-like nanocomposite coatings (DLN or Dylyn , Bekaert, Kortrijk, Belgium), which offer promising solutions for many industrial applications. In this study, the biocompatibility of two diamond-like stent coatings are evaluated in a porcine coronary stent model. Either coated or non-coated stents were randomly implanted in two coronary arteries of 20 pigs so that each group contained 13 stented arteries. Pigs underwent a control angiogram at 6 weeks and were then sacrificed. Quantitative coronary analysis before, immediately after stent implantation, and at 6 weeks was performed using the semi-automated Polytron 1000 system (Siemens, Erlangen, Germany). Morphometry was performed using a computerized morphometric program. Angiographic analysis showed similar baseline selected arteries and post-stenting diameters. At 6-week follow-up, there was no significant difference in minimal stent diameter. Histopathology revealed a similar injury score in the 3 groups. Inflammation was significantly increased in the DLN-DLC coating group. Thrombus formation was significantly decreased in both coated stent groups. Neointimal hyperplasia was decreased in both coated stent groups; however, the difference with the non-coated stents was not statistically significant. Area stenosis was lower in the DLN-coated stent group than in the control group (41 +/- 17% vs. 54 +/- 15%; p = 0.06). The results indicate that the diamond-like nanocomposite stent coatings are compatible, resulting in decreased thrombogenicity and decreased neointimal hyperplasia. Covering this coating with

  7. Emergency Stenting of Unprotected Left Main Coronary Artery after Acute Catheter-Induced Occlusive Dissection

    PubMed Central

    Akgul, Ferit; Batyraliev, Talantbek; Besnili, Fikret; Karben, Zarema

    2006-01-01

    Left main coronary artery dissection occurs very rarely during selective coronary angiography, but it generally progresses to complete coronary occlusion. The traditional treatment of occlusive dissection of the unprotected left main coronary artery has been surgical. Percutaneous treatment has been sporadic and controversial. We report a case of iatrogenic occlusive dissection of the unprotected left main coronary artery during diagnostic coronary angiography, followed by successful stenting of the lesion. PMID:17215985

  8. Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis

    PubMed Central

    Stettler, Christoph; Allemann, Sabin; Wandel, Simon; Kastrati, Adnan; Morice, Marie Claude; Schömig, Albert; Pfisterer, Matthias E; Stone, Gregg W; Leon, Martin B; de Lezo, José Suárez; Goy, Jean-Jacques; Park, Seung-Jung; Sabaté, Manel; Suttorp, Maarten J; Kelbaek, Henning; Spaulding, Christian; Menichelli, Maurizio; Vermeersch, Paul; Dirksen, Maurits T; Cervinka, Pavel; Carlo, Marco De; Erglis, Andrejs; Chechi, Tania; Ortolani, Paolo; Schalij, Martin J; Diem, Peter; Meier, Bernhard; Windecker, Stephan

    2008-01-01

    Objective To compare the effectiveness and safety of three types of stents (sirolimus eluting, paclitaxel eluting, and bare metal) in people with and without diabetes mellitus. Design Collaborative network meta-analysis. Data sources Electronic databases (Medline, Embase, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, book chapters, and proceedings of advisory panels for the US Food and Drug Administration. Manufacturers and trialists provided additional data. Review methods Network meta-analysis with a mixed treatment comparison method to combine direct within trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. Overall mortality was the primary safety end point, target lesion revascularisation the effectiveness end point. Results 35 trials in 3852 people with diabetes and 10 947 people without diabetes contributed to the analyses. Inconsistency of the network was substantial for overall mortality in people with diabetes and seemed to be related to the duration of dual antiplatelet therapy (P value for interaction 0.02). Restricting the analysis to trials with a duration of dual antiplatelet therapy of six months or more, inconsistency was reduced considerably and hazard ratios for overall mortality were near one for all comparisons in people with diabetes: sirolimus eluting stents compared with bare metal stents 0.88 (95% credibility interval 0.55 to 1.30), paclitaxel eluting stents compared with bare metal stents 0.91 (0.60 to 1.38), and sirolimus eluting stents compared with paclitaxel eluting stents 0.95 (0.63 to 1.43). In people without diabetes, hazard ratios were unaffected by the restriction. Both drug eluting stents were associated with a decrease in revascularisation rates compared with bare metal stents in people both with and without diabetes. Conclusion In trials that specified a duration of dual antiplatelet therapy of six

  9. Impact of Coronary Plaque Characteristics on Late Stent Malapposition after Drug-Eluting Stent Implantation

    PubMed Central

    Hong, Sung-Jin; Kim, Byeong-Keuk; Shin, Dong-Ho; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2015-01-01

    Purpose To evaluate the impact of pre-procedural coronary plaque composition assessed by virtual histology intravascular ultrasound (VH-IVUS) on late stent malapposition assessed by optical coherence tomography (OCT) following drug-eluting stent (DES) implantation. Materials and Methods The study population consisted of 121 patients (121 lesions) who underwent both pre-procedural VH-IVUS and follow-up OCT after DES implantation. The association between pre-procedural plaque composition [necrotic core (NC), dense calcium (DC), fibrotic (FT), and fibro-fatty (FF) volumes] assessed by VH-IVUS and late stent malapposition (percent malapposed struts) or strut coverage (percent uncovered struts) assessed by follow-up OCT was evaluated. Results Pre-procedural absolute total NC, DC, FT, and FF plaque volumes were 22.9±19.0, 7.9±9.6, 63.8±33.8, and 16.5±12.4 mm3, respectively. At 6.3±3.1 months post-intervention, percent malapposed and uncovered struts were 0.8±2.5% and 15.3±16.7%, respectively. Pre-procedural absolute total NC and DC plaque volumes were positively correlated with percent malapposed struts (r=0.44, p<0.001 and r=0.45, p<0.001, respectively), while pre-procedural absolute total FT plaque volume was weakly associated with percent malapposed struts (r=0.220, p=0.015). Pre-procedural absolute total DC plaque volume was the only independent predictor of late stent malapposition on multivariate analysis (β=1.12, p=0.002). There were no significant correlations between pre-intervention plaque composition and percent uncovered struts. Conclusion Pre-procedural plaque composition was associated with late stent malapposition but not strut coverage after DES implantation. Larger pre-procedural absolute total DC plaque volumes were associated with greater late stent malapposition. PMID:26446634

  10. [Coronary stenting and surgery: perioperative management of antiplatelet therapy in patients undergoing surgery after coronary stent implantation].

    PubMed

    Rossini, Roberta; Bramucci, Ezio; Castiglioni, Battistina; De Servi, Stefano; Lettieri, Corrado; Lettino, Maddalena; Musumeci, Giuseppe; Visconti, Luigi Oltrona; Piccaluga, Emanuela; Savonitto, Stefano; Trabattoni, Daniela; Buffoli, Francesca; Angiolillo, Dominick J; Bovenzi, Francesco; Cremonesi, Alberto; Scherillo, Marino; Guagliumi, Giulio

    2012-01-01

    The management of antiplatelet therapy in patients with coronary stents undergoing surgery is a growing clinical problem and often represents a matter of debate between cardiologists and surgeons. It has been estimated that about 4-8% of patients undergoing coronary stenting need to undergo surgery within the next year. 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. In addition, surgery confers an additional risk of perioperative cardiac ischemic events, being high in these patients because of the pro-inflammatory and pro-thrombotic effects of surgery. Current international guidelines recommend to postpone non-urgent surgery for at least 6 weeks after bare metal stent implantation and for 6-12 months after drug-eluting stent implantation. However, these recommendations provide little support with regard to managing antiplatelet therapy in the perioperative phase in case of urgent operations and/or high hemorrhagic risk. Furthermore, ischemic and hemorrhagic risk is not defined in detail on the basis of clinical and procedural characteristics. Finally, guidelines shared with cardiologists and surgeons are lacking. The present consensus document provides practical recommendations on the management of antiplatelet therapy in the perioperative period in patients with coronary stents undergoing surgery. Cardiologists and surgeons contributed equally to its creation. An ischemic risk stratification has been provided on the basis of clinical and procedural data. All surgical interventions have been defined on the basis of the hemorrhagic risk. A consensus on the most appropriate antiplatelet regimen in the perioperative phase has been reached on the basis of the ischemic and hemorrhagic risk. Dual antiplatelet therapy should not be withdrawn for surgery at low bleeding risk, whereas aspirin

  11. Longitudinal compression behaviour of coronary stents: a bench-top comparative study.

    PubMed

    Barragan, Paul; Garitey, Vincent; Mouneimne, Karim; Rieu, Régis

    2014-01-01

    The aim of this study was to characterise the coronary stent longitudinal resistance of new coronary stents under worst case clinical crossing simulated configurations. Six coronary balloon-expandable stents were evaluated using two different tests. The first was a direct parallel plates longitudinal crush resistance test: it was conducted on stents deployed to 3 mm diameter, and three samples of each model were used. The second was performed by tracking over the wire and deploying the stents in two types of coronary model: good and malapposition models. Two samples of each model were used for this test. After deployment, a PTCA balloon was advanced over the wire. For each stent, the force required for balloon tracking and the stent shortening were recorded. In the first crush test, three out of six stent models demonstrated higher longitudinal crush rates compared to the Resolute Integrity (Medtronic, Minneapolis, MN, USA): PROMUS Element™ (Boston Scientific, Natick, MA, USA) p<0.0001, Coroflex® Blue (B. Braun, Melsungen, Germany) p<0.0001, and Orsiro (Biotronik, Berlin, Germany) p=0.038. In the simulation test, there were no statistical differences when comparing all good and malapposition groups. Lower resistance to mechanical longitudinal compression of some stents did not correlate to significantly higher crush rates in simulated clinical conditions. Nevertheless, it would be useful for cardiologists to be aware of the actual mechanical characteristics of new stents to take them into account and thus minimise longitudinal compression during difficult stent implantations.

  12. 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

  13. [Exrercise tolerance in patients with coronary artery disease after coronary artery stenting].

    PubMed

    Tseluyko, V; Kreyndel, K; Vashakidze, Z

    2014-01-01

    The aim of the research is to investigate the impact of coronary stenting on exercise tolerance after 4-8 week and after 12-15 months. The study involved total 90 patients with coronary artery disease, who underwent coronary stenting. All patients underwent clinical examination, including an assessment of their condition, the frequency of angina attacks, echocardioscopy, resting ECG was recorded in all the patients in the standard 12 -lead veloergometry. Statistical processing was performed using Statistica 6.0 for Windows, the method of Wald - Wolfowitz . Data are presented as arithmetic means and error average M ± m. We used a statistical method of calculation - the median ranks (with the median calculated by the usual rules of statistics - the arithmetic mean of the central members of the ordered series). Significant differences were assessed by t-test . The level of significance was considered significant when p <0,05. According to the monitoring data of patients have a significant increase in exercise tolerance: threshold power increased by 63% and in 12-15 months by 58 % compared with the original. The duration of the test conducted after stenting increased by almost 2 -fold. In addition, significantly reduced the proportion of patients whose test results were evaluated as positive. Stenting of the coronary arteries after 4-8 weeks promotes the significant increase in exercise tolerance that persists after 12-15 months. The factors of associated with insufficient increase in exercise tolerance after stenting according veloergometry are: female gender, diabetes, smoking cessation further contributes to the increase in the threshold of physical activity.

  14. In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry.

    PubMed

    Rubboli, Andrea; Sciahbasi, Alessandro; Briguori, Carlo; Saia, Francesco; Palmieri, Cataldo; Moroni, Luigi Andrea; Calabrò, Paolo; Leone, Antonio Maria; Franco, Nicoletta; Valgimigli, Marco; Varani, Elisabetta; Santi, Michela; Pasqualini, Paola; Capecchi, Alessandro; Piccalò, Giacomo; Margheri, Massimo; di Pasquale, Giuseppe; Galvani, Marcello; Bolognese, Leonardo; Gonzini, Lucio; Maggioni, Aldo Pietro

    2013-04-01

    The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.

  15. Does Coronary Stenting Following Balloon Angioplasty Improve Myocardial Fractional Flow Reserve?

    SciTech Connect

    Takeuchi, Masaaki; Himeno, Etsuro

    1998-11-15

    Purpose: Suboptimal distal coronary flow reserve after successful balloon angioplasty has been attributed to angiographically unrecognized inadequate lumen expansion, and adjunct coronary stenting has been shown to improve coronary flow reserve. The aim of this study was to investigate whether myocardial fractional flow reserve (FFRmyo) would increase further after coronary stenting compared with balloon angioplasty alone in the same patient group. Methods: FFRmyo and quantitative coronary angiography were obtained before and after pre-stent balloon dilation, and again after stent placement in 11 patients (7 left anterior descending artery, 3 right coronary artery and 1 left circumflex artery). FFRmyo was calculated as the ratio of Pd/Pa during intracoronary adenosine 5'-triphosphate (50 {mu}g and 20 {mu}g in the left and right coronary arteries, respectively)-induced maximum hyperemia, where Pd represents mean distal coronary pressure measured by a 2.1 Fr infusion catheter and Pa represents mean aortic pressure measured by the guiding catheter. Results: Percent diameter stenosis significantly decreased after balloon angioplasty (74% {+-} 15% vs 37% {+-} 17%, p < 0.001), and decreased further after stent placement (18% {+-} 10%, p < 0.001 vs baseline and balloon angioplasty). FFRmyo after coronary stenting (0.85 {+-} 0.09) was significantly higher than that at baseline (0.51 {+-} 0.16, p < 0.001) and after balloon angioplasty (0.77 {+-} 0.11, p < 0.05). There was a significant correlation between angiographic variables and FFRmyo. The increase in lumen dimensions after coronary stenting was followed by a further significant improvement of FFRmyo. Conclusion: These results suggest that coronary stenting may provide a more favorable functional status and lumen geometry of residual coronary stenosis compared with balloon angioplasty alone.

  16. Peri-stent contrast staining, major evaginations and severe malapposition after biolimus-eluting stent implantation: a case report based on coronary optical frequency domain imaging.

    PubMed

    Antonsen, Lisbeth; Thayssen, Per; Jensen, Lisette Okkels

    2014-01-01

    Peri-stent contrast staining and late acquired malapposition represent pathological vessel wall healing patterns following percutaneous coronary intervention with stent implantation. Earlier studies have described these abnormal vessel wall responses commonly present after implantation of first-generation drug-eluting stents. These coronary vascular changes can cause flow disturbance and thereby dispose for later thrombotic events. This case report, based on coronary optical frequency domain imaging, describes peri-stent contrast staining, major evaginations and severe malapposition occurring 18months after third-generation biolimus-eluting stent implantation. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Computational fluid dynamic simulations of image-based stented coronary bifurcation models

    PubMed Central

    Chiastra, Claudio; Morlacchi, Stefano; Gallo, Diego; Morbiducci, Umberto; Cárdenes, Rubén; Larrabide, Ignacio; Migliavacca, Francesco

    2013-01-01

    One of the relevant phenomenon associated with in-stent restenosis in coronary arteries is an altered haemodynamics in the stented region. Computational fluid dynamics (CFD) offers the possibility to investigate the haemodynamics at a level of detail not always accessible within experimental techniques. CFD can quantify and correlate the local haemodynamics structures which might lead to in-stent restenosis. The aim of this work is to study the fluid dynamics of realistic stented coronary artery models which replicate the complete clinical procedure of stent implantation. Two cases of pathologic left anterior descending coronary arteries with their bifurcations are reconstructed from computed tomography angiography and conventional coronary angiography images. Results of wall shear stress and relative residence time show that the wall regions more prone to the risk of restenosis are located next to stent struts, to the bifurcations and to the stent overlapping zone for both investigated cases. Considering a bulk flow analysis, helical flow structures are generated by the curvature of the zone upstream from the stent and by the bifurcation regions. Helical recirculating microstructures are also visible downstream from the stent struts. This study demonstrates the feasibility to virtually investigate the haemodynamics of patient-specific coronary bifurcation geometries. PMID:23676893

  18. 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.

  19. Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis.

    PubMed

    Martin, David; Boyle, Fergal

    2015-09-01

    Several clinical studies have identified a strong correlation between neointimal hyperplasia following coronary stent deployment and both stent-induced arterial injury and altered vessel hemodynamics. As such, the sequential structural and fluid dynamics analysis of balloon-expandable stent deployment should provide a comprehensive indication of stent performance. Despite this observation, very few numerical studies of balloon-expandable coronary stents have considered both the mechanical and hemodynamic impact of stent deployment. Furthermore, in the few studies that have considered both phenomena, only a small number of stents have been considered. In this study, a sequential structural and fluid dynamics analysis methodology was employed to compare both the mechanical and hemodynamic impact of six balloon-expandable coronary stents. To investigate the relationship between stent design and performance, several common stent design properties were then identified and the dependence between these properties and both the mechanical and hemodynamic variables of interest was evaluated using statistical measures of correlation. Following the completion of the numerical analyses, stent strut thickness was identified as the only common design property that demonstrated a strong dependence with either the mean equivalent stress predicted in the artery wall or the mean relative residence time predicted on the luminal surface of the artery. These results corroborate the findings of the large-scale ISAR-STEREO clinical studies and highlight the crucial role of strut thickness in coronary stent design. The sequential structural and fluid dynamics analysis methodology and the multivariable statistical treatment of the results described in this study should prove useful in the design of future balloon-expandable coronary stents.

  20. Diagnostic accuracy of 64-slice CT in the assessment of coronary stents.

    PubMed

    Cademartiri, F; Palumbo, A; Maffei, E; La Grutta, L; Runza, G; Pugliese, F; Midiri, M; Mollet, N R A; Meijboom, W B; Menozzi, A; Vignali, L; Reverberi, C; Ardissino, D; Krestin, G P

    2007-06-01

    The purpose of this study was to assess the diagnostic accuracy of 64-slice computed tomography (64-CT) coronary angiography in the detection of coronary in-stent restenosis. Ninety-five patients (72 men and 23 women, mean age 58+/-8 years) with previous percutaneous coronary intervention with stenting and suspected restenosis underwent 64-CT (Sensation 64, Siemens). The mean time between stent deployment and 64-CT was 6.1+/-4.2 months. The scan parameters were: slices 32 x 2, individual detector width 0.6 mm, rotation time 0.33 s, feed 3.84 mm/rotation, 120 kV, 900 mAs. After the intravenous administration of iodinated contrast material (Iomeprol 400 mgI/ml, Iomeron, Bracco) and a bolus chaser (40 ml of saline), the scan was completed in <12 s. All coronary segments with a stent were assessed on 64-CT by two observers in consensus and judged as: patent, with intimal hyperplasia (lumen reduction of <50%), with in-stent restenosis (> or =50%), or with in-stent occlusion (100%). The consensus reading was compared with conventional coronary angiography. Four patients were excluded because of insufficient image quality. In the remaining 91, we assessed 102 stents (31 RCA; 10 LM; 54 LAD; 7 CX). In 14 (13.7%) stents, in-stent restenosis (n=8) or in-stent occlusion (n=6) was found. Intimal hyperplasia was detected in 11 (10.8%) stents. The sensitivity and negative predictive value of 64-CT for in-stent occlusion were 100% and 100%, respectively, whereas for all stenoses, >50% they were 92.9% and 98.7%, respectively. We found that 64-CT has a high diagnostic accuracy for the detection of in-stent restenosis in a selected patient population.

  1. Exercise training is safe after coronary stenting: a prospective multicentre study.

    PubMed

    Iliou, Marie-Christine; Pavy, Bruno; Martinez, Jimena; Corone, Sonia; Meurin, Philippe; Tuppin, Philippe

    2015-01-01

    Data on the safety of exercise training after coronary stenting are scarce. This is a prospective cohort study of 3132 patients with coronary stenting within the last 12 months, recruited by 44 cardiac rehabilitation centres; patients were included in a cardiac rehabilitation programme with training sessions 3-5 days a week. Cardiac rehabilitation was defined as early rehabilitation when starting <1 month after coronary stenting and as late rehabilitation when starting later. Rate of acute coronary syndrome (ACS) after coronary stenting was estimated according to time to training session. ACS was defined as related to exercise when it occurs during or within the hour after an exercise stress test or a training session. All ACS were documented by an angiographic control. Overall 5016 stents (41.4% drug-eluting stents) were implanted in 3132 patients aged 56.5 ± 12.9 years (84.7% men) with a median of 1 stent (range 1-8) per patient. Indication of coronary senting was ACS (86.4%), angina pectoris (8.6%), and silent ischaemia (5%). Combined antiplatelet treatment was used in 97.2% of the patients. Overall rate of ACS after coronary stenting was 2.9/1000 patients, corresponding to 1.7 complications out of 10(6) patient-hours of exercise. There were four stent thromboses related to exercise (1.2/1000 patients, 0.8/10(6) patient-hours of exercise): two in the early rehabilitation group (days 9 and 11), and two in the late rehabilitation group (days 77 and 228). Exercise training seems safe and there is no justification to delay cardiac rehabilitation after coronary stenting. © The European Society of Cardiology 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  2. Clinical and economic studies of eptifibatide in coronary stenting.

    PubMed

    Pasala, Tilak; Sattayaprasert, Prasongchai; Bhat, Pradeep K; Athappan, Ganesh; Gandhi, Sanjay

    2014-01-01

    Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin), who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant), routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications). Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access) is unknown. This review provides an overview of key clinical and economic studies of eptifibatide well into the current era of potent antiplatelet agents, novel safer anticoagulants, and contemporary percutaneous coronary intervention.

  3. Good visibility of TITAN-2 coronary stents demonstrable on cardiac computer tomographic angiography: a report of 2 cases.

    PubMed

    Ong, Paul Jau; Jau, Ong Paul; Ho, Hee Hwa; Hwa, Ho Hee; Jafary, Fahim Haider; Haider, Jafary Fahim; Loh, Kwok Kong; Kong, Loh Kwok; Ooi, Yau Wei; Wei, Ooi Yau; Wong, Chun Pong; Pong, Wong Chun; Foo, David; David, Foo

    2011-09-01

    Numerous studies have sought to assess stent patency by cardiac computer tomographic angiography (CCTA) in comparison with invasive coronary angiography in patients who had undergone percutaneous coronary stenting. Even with newer generation scanners, CCTA has been of limited value in the assessment of the revascularized patient. The main reason being blooming artifact from metallic stents often obscures stent luminal dimension, making the stented segment unassessable. We report on a novel finding of good visibility of TITAN-2 coronary stents demonstrable on CCTA for 2 patients and discuss the possible mechanism and potential implications of this observation.

  4. Long-term outcomes of biodegradable polymer versus durable polymer drug-eluting stents in patients with diabetes a pooled analysis of individual patient data from 3 randomized trials.

    PubMed

    de Waha, Antoinette; Stefanini, Giulio G; King, Lamin A; Byrne, Robert A; Serruys, Patrick W; Kufner, Sebastian; Meier, Bernhard; Jüni, Peter; Kastrati, Adnan; Windecker, Stephan

    2013-10-15

    There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES). We pooled individual patient-level data from 3 randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4 and LEADERS) comparing biodegradable polymer DES with durable polymer SES. Clinical outcomes out to 4 years were assessed. The primary end point was the composite of cardiac death, myocardial infarction and target-lesion revascularization. Secondary end points were target lesion revascularization and definite or probable stent thrombosis. Of 1094 patients with diabetes included in the present analysis, 657 received biodegradable polymer DES and 437 durable polymer SES. At 4 years, the incidence of the primary end point was similar with BP-DES versus SES (hazard ratio = 0.95, 95% CI = 0.74-1.21, P = 0.67). Target lesion revascularization was also comparable between the groups (hazard ratio = 0.89, 95% CI = 0.65-1.22, P = 0.47). Definite or probable stent thrombosis was significantly reduced among patients treated with BP-DES (hazard ratio = 0.52, 95% CI = 0.28-0.96, P = 0.04), a difference driven by significantly lower stent thrombosis rates with BP-DES between 1 and 4 years (hazard ratio = 0.15, 95% CI = 0.03-0.70, P = 0.02). In patients with diabetes, biodegradable polymer DES, compared to durable polymer SES, were associated with comparable overall clinical outcomes during follow-up to 4 years. Rates of stent thrombosis were significantly lower with BP-DES. © 2013.

  5. [Drug-eluting stents do they make the difference? ].

    PubMed

    Presbitero, P; Asioli, M

    2002-10-01

    The main limitation to further expansion of PTCI (percutaneous transluminal coronary intervention) is restenosis that occurs in 30% of the patients within 6-months after the procedure. Coronary stenting decreases the percent of restenosis due to arterial remodeling after PTCI but proliferation of smooth muscle cells due to vascular injury still remains. A mechanical approach the only treatment up to now (further balloon expansion, plaque removal with rotablator or directional atherectomy) failed. Because the restenotic process is due to a complex series of biological events which start with platelet aggregation, grow-factors and cytochine release, the use of antiflammatory, antithrombotic and antiproliferative drugs were attempted. Cortisone and heparin showed low benefits in clinical trial. New drugs (rapamycin, taxol, actinomycin D, tacrolimus, estradiol, dexamethazone) with antiproliferative and antiflammatory activities are under evaluation. They act as inhibitors of the cell migration and of the cell cicle progression with different specific molecular mechanisms. The first pilot study performed in 45 patients with sirolimus-eluting stents has shown a sustained suppression (25% in the fast release group and 23% in the slow release group) of neointimal formation at 12 months after procedure with absence of restenosis. The Ravel study, a randomized trial, has enrolled 238 patients treated with sirolimus coated stent vs a control group: the results confirm the previous data with a complete suppression of intimal hyperproliferation and restenosis at six months follow-up. The first 400 patients treated in the Sirius trial a similar study which will randomize 1100 pts show a low, but not a complete inhibition of the restenotic process probably due to a more complexity of the lesions treated in comparison to Ravel trial (9.2% of restenosis). Another very promising drug is taxol (paclitaxel). It is an antiproliferative and antinflammatory molecule tested in a series of

  6. Refractory coronary artery spasm with superimposed thrombosis: successful treatment with Palmaz-Schatz stent.

    PubMed

    Sganzerla, P; Child, M; Savasta, C; Passaretti, B; Tavasci, E

    1999-03-01

    Prinzmetal variant angina due to epicardial coronary artery spasm is a disease usually treated with drug therapy with successful results. A case of variant angina, refractory to conventional pharmacological treatment, and complicated by coronary artery thrombosis, was treated with percutaneous transluminal coronary angioplasty and stenting with good immediate and late clinical results.

  7. Comparison of Drug-eluting Coronary Stents, Bare Coronary Stents and Self-expanding Stents in Angioplasty of Middle Cerebral Artery Stenoses

    PubMed Central

    Lee, Jong-Hyeog; Jo, Sung-Min; Jo, Kwang-Deog; Kim, Moon-Kyu; Lee, Sang-Youl

    2013-01-01

    Objective The purpose of this study is to investigate the results of treatment using stent-angioplasty for symptomatic middle cerebral arterial (MCA) stenosis and comparison of in-stent restenosis between drug-eluting stents (DES), bare metal coronary stents (BMS) and self-expanding stents (SES). Materials and Methods From Jan. 2007 to June. 2012, 34 patients (mean age ± standard deviation: 62.9 ± 13.6 years) with MCA stenosis were treated. Inclusion criteria were acute infarction or transient ischemic attacks (TIAs) and angiographically proven symptom related severe stenosis. Stents used for treatment were DES (n = 8), BMS (n = 13) and SES (n = 13). National Institutes of Health Stroke Scale (NIHSS) at admission was 2.5 ± 3.1 and mean stenosis rate was 79.0 ± 8.2%. Assessment of clinical and angiographic results was performed retrospectively. Results Among 34 patients, periprocedural complications occurred in four cases (11.8%), however, only two cases (6.0%) were symptomatic. All patients were followed clinically (mean follow-up period; 40.7 ± 17.7 months) and 31 were followed angiographically (91.2%. 13.4 ± 8.5 months). There was no occurrence of repeat stroke in all patients; however, mild TIAs related to restenosis occurred in three of 34 patients (8.8%). The mean NIHSS after stent-angioplasty was 1.7 ± 2.9 and 0.8 ± 1.1 at discharge. The modified Rankin score (mRS) at discharge was 0.5 ± 0.9 and 0.3 ± 0.8 at the last clinical follow-up. In-stent restenosis over 50% occurred in five of 31 angiographically followed cases (16.1%), however, all of these events occurred only in patients who were treated with BMS or SES. Restenosis rate was 0.0% in the DES group and 20.8% in the other group (p = 0.562); it did not differ between BMS and SES (2/11 18.2%, 3/13 23.1%, p = 1.000). Conclusion Stent-angioplasty appears to be effective for symptomatic MCA stenosis. As for restenosis, in our study, DES was presumed to be more effective than BMS and SES; meanwhile

  8. Finite Element Simulation of Mechanical Behaviors of Coronary Stent in a Vessel with Plaque

    NASA Astrophysics Data System (ADS)

    Imani, M.; Hojjati, M. H.; Eshghi, N.; Goudarzi, A. M.

    2011-12-01

    The paper presents results of the finite element analysis of a coronary stent used in a treatment of blood vessel stenosis. This analysis is an efficient way to modify the design of stent and its performance. The work focuses on the Medtronic AVE Modular stent S7. A nonlinear model that contains balloon, stent, and vessel with plaque was used. A bi-linear elasto-plastic material model for stent and hyper-elastic material models for balloon, artery, and plaque were assumed for material modeling. Stress distribution, outer diameter changes and bending behavior were investigated.

  9. Computational fluid dynamics study of commercially available stents inside an idealised curved coronary artery

    NASA Astrophysics Data System (ADS)

    Chen, Winson Xiao; Ooi, Andrew; Hutchins, Nicholas; Poon, Eric; Thondapu, Vikas; Barlis, Peter

    2015-11-01

    Stent placement restores blood flow in diseased coronary arteries and is the standard treatment for obstructive coronary atherosclerosis. Analysis of the hemodynamic characteristics of stented arteries is essential for better understanding of the relationship between key fluid dynamic variables and stent designs. Previous computational studies have been limited to idealised stents in curved arterial segments or more realistic stents in straight segments. In clinical practice, however, it is often necessary to place stents in geometrically complex arterial curvatures. Thus, numerical simulations of the incompressible Navier-Stokes equations are carried out to investigate the effects of curvature on hemodynamics using detailed, commercially available coronary stents. The computational domain is a 3mm curved coronary artery model and simulations are conducted using a physiologically realistic inlet condition. The averaged flow rate is about 80 mL/min, similar to the normal human resting condition. The examination of hemodynamic parameters will assess the performance of several commercially available stents in curved arteries and identify regions that may be at risk for restenosis. It is anticipated that this information will lead to improvements in future stent design and deployment.

  10. Development and characterization of a coronary polylactic acid stent prototype generated by selective laser melting.

    PubMed

    Flege, Christian; Vogt, Felix; Höges, Simon; Jauer, Lucas; Borinski, Mauricio; Schulte, Vera A; Hoffmann, Rainer; Poprawe, Reinhart; Meiners, Wilhelm; Jobmann, Monika; Wissenbach, Konrad; Blindt, Rüdiger

    2013-01-01

    In-stent restenosis is still an important issue and stent thrombosis is an unresolved risk after coronary intervention. Biodegradable stents would provide initial scaffolding of the stenosed segment and disappear subsequently. The additive manufacturing technology Selective Laser Melting (SLM) enables rapid, parallel, and raw material saving generation of complex 3- dimensional structures with extensive geometric freedom and is currently in use in orthopedic or dental applications. Here, SLM process parameters were adapted for poly-L-lactid acid (PLLA) and PLLA-co-poly-ε-caprolactone (PCL) powders to generate degradable coronary stent prototypes. Biocompatibility of both polymers was evidenced by assessment of cell morphology and of metabolic and adhesive activity at direct and indirect contact with human coronary artery smooth muscle cells, umbilical vein endothelial cells, and endothelial progenitor cells. γ-sterilization was demonstrated to guarantee safety of SLM-processed parts. From PLLA and PCL, stent prototypes were successfully generated and post-processing by spray- and dip-coating proved to thoroughly smoothen stent surfaces. In conclusion, for the first time, biodegradable polymers and the SLM technique were combined for the manufacturing of customized biodegradable coronary artery stent prototypes. SLM is advocated for the development of biodegradable coronary PLLA and PCL stents, potentially optimized for future bifurcation applications.

  11. Effect of force-induced mechanical stress at the coronary artery bifurcation stenting: Relation to in-stent restenosis

    NASA Astrophysics Data System (ADS)

    Lee, Cheng-Hung; Jhong, Guan-Heng; Hsu, Ming-Yi; Liu, Shih-Jung; Wang, Chao-Jan; Hung, Kuo-Chun

    2014-05-01

    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 following 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.

  12. Effect of force-induced mechanical stress at the coronary artery bifurcation stenting: Relation to in-stent restenosis

    SciTech Connect

    Lee, Cheng-Hung; Jhong, Guan-Heng; Hsu, Ming-Yi; Wang, Chao-Jan; Liu, Shih-Jung; Hung, Kuo-Chun

    2014-05-28

    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 following 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.

  13. In-vitro assessment of coronary artery stents in 256-multislice computed tomography angiography

    PubMed Central

    2014-01-01

    Background The important detection of in-stent restenosis in cardiovascular computed tomography (CT) is still challenging. The first study assessing the in-vitro stent lumen visualization of the state of the art 256-multislice CT (256-MSCT), which was performed by our research group, yielded promising results. As the applied technical approach is not suitable for daily routine, we assessed the capability of the 256-MSCT and its different reconstruction kernels for the coronary stent lumen visualization employing a clinically applicable technique in a phantom study. Results The XCD kernel showed significantly lower artificial lumen narrowing (ALN) values (overall ALN < 40%) than the other reconstruction kernels (CC, CD, XCB) irrespective of the stent caliber. The ALN of coronary stents with a diameter >3 mm was significantly lower than of stents with a smaller caliber. The ALN difference between stents with a diameter of 3 mm and smaller ones was not statistically significant. Yet, the lumen visualization of the smaller stents was impaired by a halo effect. The XCD kernel showed more constant attenuation values throughout the different stent diameters than the other reconstruction kernels. Conclusions The 256-MSCT provides a good lumen visualization of coronary stents with a diameter >3 mm. The assessment of stents with a diameter of 3 mm seems feasible but has to be validated in further studies. The clinical evaluation of smaller stents cannot be recommended so far. The XCD kernel showed the best lumen visualization and should therefore be applied in addition to the standard cardiac reconstruction kernels when assessing coronary artery stents using 256-MSCT. PMID:24423187

  14. Polymeric stent materials dysregulate macrophage and endothelial cell functions: implications for coronary artery stent.

    PubMed

    Wang, Xintong; Zachman, Angela L; Chun, Young Wook; Shen, Fang-Wen; Hwang, Yu-Shik; Sung, Hak-Joon

    2014-07-01

    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. 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. We demonstrated that 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 (VCAM)-1 along with decreased nitric oxide production, indicating that ECs were activated and lost their capacity to maintain homeostasis. The activation of both cell types induced the release of elastase or elastase-like protease, which further accelerated polymer degradation. 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 that 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. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. Impact of myocardial bridge on clinical outcome after coronary stent placement.

    PubMed

    Tsujita, Kenichi; Maehara, Akiko; Mintz, Gary S; Doi, Hiroshi; Kubo, Takashi; Castellanos, Celia; Liu, Jian; Yang, Junqing; Oviedo, Carlos; Franklin-Bond, Theresa; Sugirtharaj, Dorcas Deborah; Dangas, George D; Lansky, Alexandra J; Stone, Gregg W; Moses, Jeffrey W; Leon, Martin B; Mehran, Roxana

    2009-05-15

    Most intravascular ultrasound (IVUS)-identifiable myocardial bridges (MBs) were not appreciated angiographically, especially when they occurred adjacent to fixed proximal obstructive disease. The impact of MB stent placement on clinical outcome was determined in 317 consecutive patients with obstructive left anterior descending coronary artery lesions undergoing coronary stent placement. In these patients, IVUS identified 70 MBs, defined as a segment of coronary artery with both systolic compression and perivascular echolucent muscle. IVUS showed that the stent extended into the MB segment beyond the obstructive lesion in 24 patients (34%; MB stent group), although significant plaque was not observed within any MB segment. In the remaining 46 patients, the left anterior descending artery stent was implanted in only the obstructive lesion, avoiding the distal MB segment (non-MB stent group). Minimum stent area was significantly smaller in the MB stent group than non-MB stent group (4.8 +/- 1.1 vs 5.8 +/- 1.8 mm(2); p = 0.02). Rates of target-lesion revascularization, target-vessel revascularization, and composite end point (death/myocardial infarction/target-lesion revascularization/target-vessel revascularization, evaluated at a mean follow-up of 358 +/- 252 days) were more common in patients with versus without MB stent placement. Specifically, target-lesion revascularization rates were 24% versus 3%, respectively (log-rank p = 0.003). In-stent restenosis occurred within the stented MB segment in 3 of 5 MB stent group patients who required target-lesion revascularization (60%). In conclusion, inadvertent MB stent placement in left anterior descending artery lesions occurred commonly and may have been associated with an increased incidence of late events.

  16. High incidence of inaccurate stent placement in the treatment of coronary aorto-ostial disease.

    PubMed

    Dishmon, Dwight A; Elhaddi, Adam; Packard, Kevin; Gupta, Vishal; Fischell, Tim A

    2011-08-01

    The purpose of this study was to evaluate the incidence of inaccurate stent positioning in the treatment of coronary aorto-ostial lesions. The percutaneous treatment of aorto-ostial disease is challenging, with a paucity of data describing the incidence of stent mispositioning. We retrospectively reviewed the accuracy of stent positioning in 100 consecutive coronary aorto-ostial lesions. Using careful angiographic review, each stent placement was classified as "missed" (> 1 mm distal or proximal to the angiographically determined ostium) or "accurately" positioned. The true ostium was missed during stent placement in 54% of cases. In 52% of the misses, the stent was placed too proximally. This proximal miss was associated with an inability to coaxially re-engage the treated vessel in 93% of the cases. The stent was placed too distally in 48% of missed cases, resulting in a placement of one or more additional overlapping stents in 38% of those cases. Clinical follow-up (mean, 24.5 ± 12.9 months) was obtained in 98% of cases. Angiographic follow-up prompted by recurrent chest pain or ischemia was performed in 45/100 cases. There was a three-fold increase in restenosis and target lesion revascularization (TLR) among the cohort of patients with stent misplacement (26% and 23%, respectively) compared to those with accurate stent placement (9% and 6%, respectively; p = 0.02 for both restenosis and TLR). Angiographically-guided stenting for coronary aorto-ostial disease leads to a high incidence of proximal and distal stent misplacement. Stent mispositioning is associated with significantly higher restenosis and clinically driven TLR compared to patients with accurate stent placement.

  17. [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,

  18. 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

  19. Drug-eluting stents and the future of coronary artery bypass surgery: facts and fiction.

    PubMed

    Raja, Shahzad G

    2006-03-01

    The treatment of patients with coronary artery disease continues to evolve. Recent, exciting data on the use of drug-eluting stents in diseased coronary vessels has generated immense enthusiasm within the interventional community leading to claims that "drug-eluting stents will put bypass surgeons out of business." However, despite promising short-term and midterm outcomes of this revolutionary new technology, valid concerns regarding long-term safety and efficacy of drug-eluting stents persist. This review article evaluates current status of drug-eluting stents with special emphasis on real and potential drawbacks of this emerging percutaneous coronary interventional modality and its impact on the practice of coronary artery bypass surgery.

  20. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials.

    PubMed

    Stefanini, Giulio G; Byrne, Robert A; Serruys, Patrick W; de Waha, Antoinette; Meier, Bernhard; Massberg, Steffen; Jüni, Peter; Schömig, Albert; Windecker, Stephan; Kastrati, Adnan

    2012-05-01

    The efficacy of durable polymer drug-eluting stents (DES) is delivered at the expense of delayed healing of the stented vessel. Biodegradable polymer DES aim to avoid this shortcoming and may potentially improve long-term clinical outcomes, with benefit expected to accrue over time. We sought to compare long-term outcomes in patients treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES). We pooled individual patient data from three large-scale multicentre randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing biodegradable polymer DES with durable polymer SES and assessed clinical outcomes during follow-up through 4 years. The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. Out of 4062 patients included in the present analysis, 2358 were randomly assigned to treatment with biodegradable polymer DES (sirolimus-eluting, n= 1501; biolimus-eluting, n= 857) and 1704 patients to durable polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, the risk of target lesion revascularization was significantly lower among patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.82, 95% CI 0.68-0.98, P= 0.029). In addition, the risk of stent thrombosis was significantly reduced with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.56, 95% CI 0.35-0.90, P= 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio 0.22, 95% CI 0.08-0.61, P= 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.59, 95% CI 0.73-0.95, P= 0.031). Biodegradable polymer DES improve safety and efficacy compared with durable polymer SES during long-term follow-up to 4 years.

  1. [Coronary stents. From a simple idea to a medical high-tech device].

    PubMed

    Wieneke, Heinrich; Böse, Dirk; Haude, Michael; Eggebrecht, Holger; Konorza, Thomas; Naber, Christoph; Erbel, Raimund

    2005-08-15

    Coronary stents were introduced in clinical cardiology in the middle of the 1980s, as balloon angioplasty was associated with a high incidence of acute vessel closure and restenosis. However, primarily designed to counteract elastic recoil after angioplasty, initial results were complicated by acute and subacute stent thrombosis. With the introduction of drugs effectively inhibiting platelet aggregation like ticlopidine and clopidogrel, stent could exhibit its superiority in comparison to angioplasty. Although the incidence of restenosis could be decreased significantly by coronary stents, restenosis remained a major drawback of this interventional technique. Several modifications of stent design and stent material had been tested, but without a real breakthrough. The introduction of active stent coating with anti-inflammatory and antiproliferative drugs marks a milestone in the development of this technology. With this approach the restenosis problem could be, even though not solved, but essentially mitigated. Current developments address bioabsorbable materials to make stents compatible with new upcoming noninvasive imaging techniques. Introduced 20 years ago as a simple wire mesh, modified by new designs and materials, and coated by highly effective drugs, coronary stents have advanced to medical high-tech devices in interventional cardiology.

  2. Percutaneous closure of iatrogenic femoral arteriovenous fistula using a covered coronary stent.

    PubMed

    Rama-Merchan, Juan Carlos; Cruz-González, Ignacio; Martín-Moreiras, Javier; Diego-Nieto, Alejandro; Rodríguez-Collado, Javier; Sánchez, Pedro Luis

    2017-02-25

    We present the case of a patient with a high-output fistula between the right superficial femoral artery and femoral vein after left atrial appendage closure successfully treated with a PK-Papyrus covered coronary stent using a 6F guiding catheter. To the best of our knowledge this is the first time a PK-Papyrus coronary stent has been used in this setting.

  3. Stenting of partial and total coronary occlusions in Trinidad and Tobago.

    PubMed

    Thomas, C N; Williams, D H; Hinds, A; Daniel, S; Ryan, F; Ramroop, C; Nath, C F; Crosby, D

    2001-03-01

    In order to evaluate the efficacy and safety of coronary stenting, we reviewed the first 32 consecutive patients (34 vessels) who underwent elective coronary stenting during the period August 1999 to August 2000 inclusive at the Digital Lab installed at the Eric Williams Medical Sciences Complex, Trinidad and Tobago. Aspirin, heparin and ticlopidine were used routinely. Abciximab was used in selected cases (38%). The mean age of patients was 55 +/- 10 years. Eighty-one per cent were male, 52% were hypertensive and 21% were diabetic. Sixty-five per cent had severe angina. Prior Coronary Artery Bypass Grafting (CABG) was performed in 3% and previous Percutaneous Transluminal Coronary Angioplasty (PTCA) in 3%. Multivessel disease was present in 43%. The mean left ventricular ejection fraction was 53 +/- 12%. The culprit lesion was located in either the native left anterior descending (LAD) coronary artery (53%), right coronary artery (RCA) (31%), circumflex artery 13% and saphenous vein graft (3%). The mean baseline diameter stenosis was 91 +/- 9% and this was reduced to 13 +/- 33% after stenting. Procedural success was 100% for 26 partially occluded vs 50% for 8 totally occluded vessels. For the total occlusions, procedural success was inversely related to the duration of the occlusion. There were no cases of death, acute vessel closure, Q-wave myocardial infarction, repeat PTCA or emergent Coronary Artery Bypass Graft (CABG) during and following the procedure. Distal embolization occurred in one patient. The mean duration of hospital stay was one day (for 30 outpatient cases). One patient had recurrence of symptoms with a negative stress test. No patient underwent repeat angiography during the first year of follow-up. Coronary stents were successfully implanted at a tertiary care facility in the Caribbean with low in-hospital morbidity and mortality. Stents markedly reduced the diameter stenosis of the coronary lesion during PTCA. The incidence of clinical

  4. Second- and third-generation drug-eluting coronary stents: progress and safety.

    PubMed

    Akin, I; Schneider, H; Ince, H; Kische, S; Rehders, T C; Chatterjee, T; Nienaber, C A

    2011-05-01

    Drug-eluting stents (DES) have revolutionized the treatment of coronary artery disease by reducing the rate of in-stent restenosis from 20-40% with bare-metal stent (BMS) to 6-8% with DES. However, with widespread use of DES, safety concerns have risen due to the observation of late stent thrombosis. With this in mind and better understanding of mechanism and pathophysiology of stent thrombosis, the technological platform, especially innovative anti-restenotic agents, polymeric coatings, and stent platforms, improved with newer DES. Two second-generation DES, the Endeavor zotarolimus-eluting stent (ZES) and the Xience-V everolimus-eluting stent (EES), have provided promising results in both randomized controlled trials (SPIRIT and ENDEAVOR) and registries (E-Five, COMPARE) compared with bare-metal stents (BMS) and first-generation DES. Newer third-generation stent technology, especially biodegradable polymers, polymer-free stents, and biodegradable stents on the basis of poly-L-lactide (PLLA) or magnesium, has been evaluated in preclinical and initial clinical trials. However, despite encouraging initial results, long-term data of large-scale randomized trials as well as registries comparing them to currently approved first- and second-generation DES are still lacking.

  5. Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-to-stent era.

    PubMed

    Mercado, N; Boersma, E; Wijns, W; Gersh, B J; Morillo, C A; de Valk, V; van Es, G A; Grobbee, D E; Serruys, P W

    2001-09-01

    We sought to assess whether coronary stents have modified the predictive value of demographic, clinical and quantitative coronary angiographic (QCA) predictors of coronary restenosis. A systematic analysis in a large cohort of registries and randomized trials of the percutaneous transluminal coronary angioplasty (PTCA) and stent era has never been performed. A total of 9,120 treated lesions in 8,156 patients included in nine randomized trials and 10 registries, with baseline, post-procedural and six-month follow-up QCA analyses, were included in this study. Predictors of restenosis were identified with univariate and multivariate logistic regression analyses. Interaction terms were introduced in the regression equation to evaluate whether the predictors of restenosis were common to both eras or specific for either one of the revascularization techniques. The restenosis rate was 35% after PTCA and 19% after angioplasty with additional stenting. In the univariate analysis, favorable predictors were previous coronary artery bypass graft surgery (CABG), stent use, stent length and a large pre-procedural minimal lumen diameter (pre-MLD); unfavorable predictors were weight, body mass index, diabetes mellitus, multi-vessel disease, lesion length and a high residual post-procedural diameter stenosis (post-DS). Predictors specific for the PTCA population were a large post-procedural MLD (post-MLD) as favorable and a severe pre-procedural DS (pre-DS) as unfavorable. Favorable predictors specific for the stent population were a large post-MLD and a large pre-procedural reference diameter (pre-RD). In the multivariate analysis, the best model included the following favorable predictors: stent use, a large post-MLD, previous CABG and the interaction term between stent use and a large post-MLD; unfavorable predictors were lesion length and diabetes mellitus. There are no major differences in demographic and clinical predictors of coronary restenosis between PTCA and stent

  6. Association between cholesterol efflux capacity and coronary restenosis after successful stent implantation.

    PubMed

    Imaizumi, Satoshi; Miura, Shin-Ichiro; Takata, Kohei; Takamiya, Yosuke; Kuwano, Takashi; Sugihara, Makoto; Ike, Amane; Iwata, Atsushi; Nishikawa, Hiroaki; Saku, Keijiro

    2016-08-01

    The measurement of high-density lipoprotein (HDL) functionality could be useful for identifying patients who have an increased risk of coronary restenosis after stent implantation. In the present study, we elucidates whether HDL functionality can predict restenosis. The participants included 48 consecutive patients who had stable angina and were successfully implanted with a drug-eluting stent (DES) or bare-metal stent. Follow-up coronary angiography was performed after 6-8 months of stenting. Cholesterol efflux and the anti-inflammatory capacity of HDL were measured before stenting (at baseline) and at follow-up. The mean age was 64 ± 11 years and the body mass index was 24 ± 3 kg/m(2). While HDL cholesterol (HDL-C) significantly increased from baseline to follow-up, there was no significant association between HDL-C level at baseline and in-stent late loss. Cholesterol efflux capacity was significantly increased from baseline to follow-up. The efflux capacity at baseline was negatively correlated with in-stent late loss, whereas the anti-oxidative activity of HDL at baseline was not associated with in-stent late loss. We analyzed the predictors of in-stent late loss using independent variables (efflux capacity and anti-oxidative capacity at baseline in addition to age, gender, HDL-C and low-density lipoprotein cholesterol at baseline, hypertension, diabetes mellitus, smoking, lesion length and DES implantation, history of myocardial infarction and prior percutaneous coronary intervention) by a multiple regression analysis. The efflux capacity at baseline was only independently associated with in-stent late loss. In conclusion, cholesterol efflux capacity at baseline could predict coronary restenosis in patients with successful stent implantation.

  7. Effect of stent implantation on upstream coronary artery compliance--a cause of late plaque rupture?

    PubMed

    Ward, Michael R; Hibi, Kiyoshi; Shaw, James A; Furukawa, Eri; Resnic, Frederic S; Kimura, Kazuo

    2005-09-01

    Stent implantation in the rabbit aorta has been shown to increase vessel wall compliance at the inflow to the stent, but it is uncertain whether similar effects might be seen in the coronary arteries of humans and whether this would have any significant clinical consequences. First, we measured vessel compliance (systolic lumen area--diastolic lumen area/pulse pressure) before, immediately after, and at the 6-month follow-up visit at a site 5 mm upstream of the proximal edge of an implanted coronary stent in patients undergoing coronary intervention using motorized pull-back intravascular ultrasound recordings. Compliance in the upstream segment increased significantly immediately after stenting (before 7.13 +/- 1.49 vs after 10.73 +/- 1.36 mm2/mm Hg, p = 0.03), an effect that was unchanged at 6 months of follow-up (11.84 +/- 2.11 mm2/mm Hg, p = 0.08 vs before stenting). Second, we examined the site of plaque rupture in all patients presenting with an acute coronary syndrome in whom the culprit lesion was in a vessel that had had a stent implanted >12 months previously (n = 31). Plaque rupture was statistically more likely at the inflow to the stent (n = 22) than at other sites within the culprit vessel (n = 9, p <0.01). We conclude that stenting causes an increase in vessel compliance immediately proximal to the stent, and that when a vessel has been previously stented, plaque rupture is most likely to occur at the stent inflow site.

  8. 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.

  9. Stent thrombosis and optimal duration of dual antiplatelet therapy after coronary stenting in contemporary practice

    PubMed Central

    Cho, Min Soo; Park, Duk-Woo

    2017-01-01

    The introduction of drug-eluting stents (DES) in the practice of percutaneous coronary intervention (PCI) has substantially reduced angiographic and clinical restenosis but is associated with an increasing propensity for very late stent thrombosis (ST). Among several clinical, lesion, or procedure-related predictors of ST, early discontinuation of dual antiplatelet therapy (DAPT) is the most important factor for DES-associated late thrombosis; therefore, the optimal duration of DAPT is a major issue to be critically considered in the current DES era. Given that the benefit and risk of longer duration DAPT should be simultaneously considered, the optimal DAPT period following DES implantation has been controversial. Several small-to-medium sized randomized clinical trials and observational registries have indicated that short-term DAPT (< 6 months) is not inferior to 12-month DAPT with fewer bleeding events, whereas prolonged duration of DAPT (> 12 months) failed to prove its superiority. However, compelling evidence from a landmark DAPT trial has clearly demonstrated the efficacy of prolonged DAPT up to 30 months in terms of preventing ST and major cardiovascular adverse events at the expense of major bleeding. In addition, coupled with various risk algorithms, a more individualized approach to balance the efficacy and safety of optimal DAPT duration has been emphasized. In this review article, we systematically summarize the cumulative evidence from key clinical studies and try to help the physician make decisions on the optimal duration of DAPT in contemporary PCI practice. PMID:28823143

  10. Clinical usefulness of red cell distribution width to angiographic severity and coronary stent thrombosis

    PubMed Central

    Erdem, Aysun; Ceylan, Ufuk Sadik; Esen, Aycan; Zencirci, Ertugrul; Topcu, Birol; Ozden, Kivilcim; Yazici, Selcuk; Terzi, Sait; Emre, Ayse; Yesilcimen, Kemal

    2016-01-01

    Background Red cell distribution width (RDW) is a quantitative measurement and shows heterogeneity of red blood cell size in peripheral blood. RDW has recently been associated with cardiovascular events and cardiovascular diseases, and it is a novel predictor of mortality. In this study, we aimed to evaluate the clinical usefulness of measuring RDW in patients with coronary stent thrombosis. Patients and methods We retrospectively reviewed 3,925 consecutive patients who presented with acute coronary syndrome and who underwent coronary angiography at the Siyami Ersek Hospital between May 2011 and December 2013. Of the 3,925 patients, 73 patients (55 males, mean age 59±11 years, 55 with ST elevated myocardial infarction) with stent thrombosis formed group 1. Another 54 consecutive patients who presented with acute coronary syndrome (without coronary stent thrombosis, 22 patients with ST elevated myocardial infarction, 44 males, mean age 54±2 years) and underwent percutaneous coronary intervention in May 2011 formed group 2. Data were collected from all groups for 2 years. The RDW values were calculated from patients 1 month later at follow-up. Syntax scores were calculated for all the patients. The patients were also divided as low syntax score group and moderate–high syntax score group. Results The patients in group 1 with stent thrombosis had significantly higher RDW level (13.85) than the patients in group 2 without stent thrombosis (12) (P<0.001). In addition, in all study patients, the moderate–high syntax score group had significantly higher RDW level (13.6) than the low syntax score group (12.9) (P=0.009). A positive correlation was determined between RDW and syntax scores (r=0.204). Conclusion RDW is a new marker of poor prognosis in coronary artery disease. Increased RDW level is correlated with angiographic severity of coronary artery disease, and RDW may be an important clinical marker of coronary stent thrombosis in patients undergoing coronary

  11. Reproducibility of grayscale and radiofrequency IVUS data acquisition in stented coronary arteries.

    PubMed

    Madssen, Erik; Jakala, Jacek; Proniewska, Klaudia; Kulaga, Tomasz; Hegbom, Knut; Wiseth, Rune

    2014-10-01

    Variability in data acquisition from intervened coronary arteries could represent a source of error that has implications for the design of serial stent studies. We assessed inter-pullback reproducibility of volumetric grayscale and radiofrequency intravascular ultrasound (IVUS) data in stented coronary arteries. Fifteen patients with coronary artery lesions treated with stent implantation were included and examined with two separate pullbacks using the Eagle Eye Gold-phased array 20 MHz IVUS catheter (Volcano). The arteries were divided into five segments, giving a total of 150 sub-segments for analyses. Matching of frames was performed using landmarks that were clearly visible in coronary angiography and intravascular pullbacks. Data were analyzed off-line at an independent Corelab. The inter-pullback reproducibility of geometrical data was very good for non-stented segments with relative differences less than 5% between pullbacks for lumen-, vessel-, and plaque volumes. For stented segments reproducibility was poorer with relative differences between pullbacks in the range of 5-10%. The inter-pullback reproducibility of compositional data demonstrated large standard deviations of relative differences, indicating a weaker agreement. Agreements between pullbacks were weaker in stented than those in non-stented segments. Based on our data, future longitudinal IVUS studies in intervened vessels should account for a variability of 5-10% attributed to the acquisition of images.

  12. 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.

  13. Cost comparison between two modes of Palmaz Schatz coronary stent implantation: transradial bare stent technique vs. transfemoral sheath-protected stent technique.

    PubMed

    Kiemeneij, F; Hofland, J; Laarman, G J; van der Elst, D H; van der Lubbe, H

    1995-08-01

    Coronary Palmaz Schatz stent implantation is usually performed by using the sheath protected stent delivery system (SDS) via the percutaneous transfemoral route. However, downsizing of PTCA equipment made transradial coronary stenting feasible. Bare stent implantation, 6F technique, increased patient mobility, reduced vascular complications and reduced hospital stay may increase cost effectiveness of this novel technique. Two well-documented patient groups selected for elective single vessel and single lesion Palmaz Schatz stent implantation were retrospectively compared. Group A (transradial stenting; n = 35) was compared to Group B (transfemoral stenting; n = 25) derived from the Benestent population, included in our hospital. A comparison was made for three areas of interest: (1) procedural consumption of material (the number of guiding catheters, guidewires, balloon catheters and stents), (2) postprocedural need for diagnostic and therapeutic procedures for stent-related complications, and (3) duration of hospital stay. Differences between these subjects in Group A and B were translated to hospital costs. Although more guiding catheters were used in group A (1.69 +/- 0.87 vs. 1.08 +/- 0.28; P = 0.001), the use of the SDS contributed importantly to higher material costs in group B (cost reduction in group A; 13%). Less patients in group A required diagnostic (2 vs. 7; P = 0.027) and therapeutic (0 vs. 5; P = 0.01) procedures for bleeding complications (cost reduction; 93%). Hospitalization in Group A was shorter (6.4 +/- 4.7 vs. 11.6 +/- 9.9 days; P = 0.005), caused by early and safe mobilization, less vascular complications, and preprocedural adjustment on coumadin (cost reduction; 45%).(ABSTRACT TRUNCATED AT 250 WORDS)

  14. Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study.

    PubMed

    Sabatier, Rémi; Hamon, Martial; Zhao, Quan Ming; Burzotta, Francesco; Lecluse, Emmanuel; Valette, Benoit; Grollier, Gilles

    2002-06-01

    Recently, direct stenting has been shown in retrospective and randomized studies to be feasible and safe in highly selected patients, with a potential interest to reduce the cost of the procedure and the rate of no-reflow. This randomized pilot study was designed to compare the incidence of no-reflow after direct stenting or conventional stenting after balloon predilation in acute coronary syndrome-related lesions. Between December 1998 and October 1999, 130 patients in our center with acute coronary syndromes were included in this study and randomized in 2 groups. In group A (n = 65), direct stent implantation was performed without balloon predilation. In group B (n = 65), conventional balloon predilation was carried out before stent implantation. Baseline clinical and angiographic characteristics before the procedure were similar in the 2 groups of patients. No-reflow was observed in 7.7% after direct stenting and in 6.1% after conventional stent implantation (P = not significant). The immediate clinical success rate was similar in the 2 groups. Among the procedural data, only duration of the procedure (shorter in the direct stenting group), the number of balloons used, and the quantity of contrast agent (lower in the direct stenting group) were significantly different between the 2 groups (P <.05). The 6-month clinical outcome was similar in the 2 groups. This randomized study confirms the promising results of previous studies that show the feasibility and the safety of direct coronary stenting in highly selected acute coronary syndrome-related lesions. The major impact of this strategy is the improvement of the cost-benefit ratio, with no major influence on the acute complications and especially on the occurrence of no-reflow in this high-risk population.

  15. Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.

    PubMed

    Kaul, Upendra; Bangalore, Sripal; Seth, Ashok; Arambam, Priyadarshini; Abhaichand, Rajpal K; Abhaychand, Rajpal K; Patel, Tejas M; Banker, Darshan; Abhyankar, Atul; Mullasari, Ajit S; Shah, Sanjay; Jain, Rajneesh; Kumar, Premchand R; Bahuleyan, C G

    2015-10-29

    The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002). In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target

  16. Minimally invasive coronary artery bypass grafting versus stenting for patients with proximal left anterior descending coronary artery disease.

    PubMed

    Shirai, Kazuyuki; Lansky, Alexandra J; Mehran, Roxana; Dangas, George D; Costantini, Costantino O; Fahy, Martin; Slack, Steven; Mintz, Gary S; Stone, Gregg W; Leon, Martin B

    2004-04-15

    The purpose of this study was to compare the clinical outcomes of stenting and minimally invasive coronary artery bypass grafting (MIDCAB) in patients with proximal left anterior descending (LAD) coronary artery disease. The Patency, Outcome, Economics of Minimally invasive direct coronary bypass (POEM) study demonstrated that MIDCAB had similar safety and long-term efficacy for LAD revascularization compared with conventional coronary artery bypass grafting. Although LAD stenting is superior to conventional balloon angioplasty, whether it is comparable to MIDCAB is not known. We identified a matched population of 429 consecutive patients with 1-vessel disease who underwent elective proximal LAD stenting and compared their clinical outcomes with those of the 152 patients in the MIDCAB group of the POEM study. The in-hospital event rate was similar in both groups, except for a shorter length of hospital stay with LAD stenting compared with MIDCAB (2.68 vs 4.07 days, p <0.0001). At 6-month follow-up, the incidence of death and Q-wave myocardial infarction or that of cerebrovascular accident was not significantly different between these 2 groups. However, target vessel revascularization was significantly higher with LAD stenting than MIDCAB (13.3% vs 6.6%, p = 0.045). In the subgroup of patients without diabetes, all clinical events were similar in both groups, and the benefit of a shorter hospital stay associated with stenting was maintained. Compared with MIDCAB, LAD stenting is associated with higher repeat revascularization rates but offers the advantage of shorter hospitalization. For nondiabetics with proximal LAD disease, stenting may be the revascularization strategy of choice.

  17. A complete metal jacket case using ten paclitaxel-eluting stents for multiple de novo coronary artery lesions.

    PubMed

    Suh, Soon Yong; Rha, Seung-Woon; Choi, Cheol Ung; Kim, Jin Won; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog; Oh, Dong Joo

    2007-02-07

    Although full metal jacket using drug-eluting stent (DES) for a single coronary artery disease has sparsely been described before, there is no report of safety and efficacy of complete metal jacket from left main (LM) to three major coronary arteries. We report a complete metal jacket case using 10 paclitaxel-eluting stents (PES; Taxus, Boston Scientific) for a triple vessel diffuse de novo coronary diseases who refused coronary artery bypass graft.

  18. Optimal kissing balloon inflation after single-stent deployment in a coronary bifurcation model.

    PubMed

    Murasato, Yoshinobu; Iwasaki, Kiyotaka; Yamamoto, Tadashi; Yagi, Takanobu; Hikichi, Yutaka; Suematsu, Yasunori; Yamamoto, Tomohiko

    2014-12-01

    To define the optimal kissing balloon inflation (KBI) after single-stent deployment in a coronary bifurcation model. We deployed stents in main vessels (MV) followed by KBI in various conditions and compared the stent configurations. A) KBI at the operator's discretion vs. under the guidelines of minimal balloon overlapping (MBO). Various stent configurations were observed after the former option, whereas similar maximal dilation points were observed under the MBO guidelines. B) Long balloon overlapping (LBO) vs. MBO with proximal MV dilated by a large balloon. The proximal MV was dilated to an ideal round shape with MBO versus an oval shape with LBO. C) Two-link vs. 3-link stents. Although the 2-link stent was advantageous to open the side branch, it incurred a risk of overdilatation of the proximal struts, whereas the 3-link stent preserved its structure. Computed simulations of coronary flow were analysed in the following left main coronary models: circle with a diameter of 4 and 5.5 mm, ellipse with longitudinal direction and tilt position. They revealed that the overdilated side was exposed to low shear stress regardless of its shape. Optimal KBI can be achieved with MBO and proximal dilatation by an optimally sized balloon.

  19. Non-polymeric coatings to control drug release from metallic coronary stents

    NASA Astrophysics Data System (ADS)

    Gupta, Celia Edith Macias

    Percutaneous transluminal coronary angiography (PTCA) is a procedure used to re-open narrowed coronary arteries. During PTCA, a coronary stent is expanded inside a diseased vessel and serves as a scaffold to keep the artery open. The major drawback of stenting is restenosis---a re-narrowing of the vessel resulting from the hyperproliferation of smooth muscle cells. Drug eluting stents (DES) reduce the rate of restenosis compared to bare metal stents. Paclitaxel (PAT) is commonly used in DES for its ability to prevent restenosis. However, DES have been associated with thrombosis due to the polymer carrier that controls drug delivery. Therefore, there is a need to change the drug delivery mechanisms to eliminate the need of polymers. The goal of this dissertation is to develop a novel polymer-free drug eluting stent that controls drug release using nanoscale metal coatings. The coating was designed to release PAT as the metal slowly degrades in biological conditions. Once all the Paclitaxel has eluted from the surface, the coating will continue to degrade until the final result is a bare metal stent. The results of this study include a novel non-polymeric drug delivery system using nanoscale coatings that release Paclitaxel at a rate similar to commercial stents, as well as the biocompatibility and efficacy of these coatings. The non-polymeric drug delivery system described here achieved a Paclitaxel release profile equivalent to clinically available Paclitaxel-eluting stents and effectively inhibits smooth muscle cell proliferation, thereby completely eliminating the need for polymers to control drug release from coronary stents.

  20. Provisional stenting in the real world: results in 1058 consecutive patients undergoing percutaneous coronary angioplasty.

    PubMed

    Ten Berg, Jurriën M; Kelder, Johannes C; Suttorp, Maarten Jan; Plokker, Thijs HW

    2001-09-01

    OBJECTIVE: To study a strategy of aggressive coronary balloon angioplasty with provisional stenting in allcomers. In randomized trials, stenting has improved the outcome of patients undergoing coronary intervention. However, whether these results hold up in clinical practice is largely unknown. Furthermore, the results of balloon angioplasty have also improved dramatically. It is therefore essential to evaluate the current results of balloon angioplasty and to assess whether stents are required in all patients. METHODS: The authors prospectively studied the occurrence of death, myocardial infarction (MI) and target lesion revascularization (TLR) of a large consecutive group of patients undergoing aggressive balloon angioplasty with provisional stenting. None of the patients received a platelet glycoprotein IIb/IIIa receptor blocker. The results were compared with the outcome of routine stenting in recent randomized trials. RESULTS: Angioplasty was performed in 1058 patients of whom 369 (34.9%) received a stent. The angiographic success rate was 98.9%. During hospital stay, 4.8% of the patients suffered any cardiac event. At one-year follow-up, death occurred in 1.1%, MI in 3.3%, TLR in 12.4% and any event in 16.7% of the patients. Event-free survival at one-year was 82.3%. These results compare favorably with routine stenting in recent trials. CONCLUSIONS: Aggressive balloon angioplasty with provisional stenting yields excellent results in a general patient population.

  1. Experimental Comparison of the Hemodynamic Effects of Bifurcating Coronary Stent Implantation Techniques

    NASA Astrophysics Data System (ADS)

    Brindise, Melissa; Vlachos, Pavlos; AETheR Lab Team

    2015-11-01

    Stent implantation in coronary bifurcations imposes unique effects to the blood flow patterns and currently there is no universally accepted stent deployment approach. Despite the fact that stent-induced changes can greatly alter clinical outcomes, no concrete understanding exists regarding the hemodynamic effects of each implantation method. This work presents an experimental evaluation of the hemodynamic differences between implantation techniques. We used four common stent implantation methods including the currently preferred one-stent provisional side branch (PSB) technique and the crush (CRU), Culotte (CUL), and T-stenting (T-PR) two-stent techniques, all deployed by a cardiologist in coronary models. Particle image velocimetry was used to obtain velocity and pressure fields. Wall shear stress (WSS), oscillatory shear index, residence times, and drag and compliance metrics were evaluated and compared against an un-stented case. The results of this study demonstrate that while PSB is preferred, both it and T-PR yielded detrimental hemodynamic effects such as low WSS values. CRU provided polarizing and unbalanced results. CUL demonstrated a symmetric flow field, balanced WSS distribution, and ultimately the most favorable hemodynamic environment.

  2. High coronary calcium score and post-procedural CK-MB are noninvasive predictors of coronary stent restenosis

    PubMed Central

    Lee, Jae-Beom; Choi, Yun-Seok; Chung, Woo-Baek; Kwon, Ami; Park, Chul-Soo; Lee, Man-Young

    2017-01-01

    Purpose High coronary calcium score (CCS) and post-procedural cardiac enzyme may be related with poor outcomes in patients with coronary stent implantation. Methods A total of 1,072 patients (63.2% male, mean age: 61.7±10.3 years) who underwent coronary multi-detect computed tomography at index procedure and follow-up coronary angiography (CAG) after drug-eluting stent (DES) were divided into two groups: those with and without target lesion revascularization (TLR; >50% reduction in luminal stent diameter or angina symptoms on follow-up CAG). The CCSs for predicting stent revascularization were elucidated. Results There were no significant differences between the two groups with regard to risk factors. The initial CCS was significantly higher in the TLR group (1,102.4±743.7 vs 345.8±51.05, P=0.04). After adjustment of significant factors for TLR, only CCS and post-procedural creatine kinase MB form (CK-MB) elevation were significant predictors of coronary artery TLR. Receiver operation curve revealed that >800 in CCS had 69% in sensitivity and 88% in specificity about predicting the TLR. Conclusion High CCS with post-procedural CK-MB might be the useful predictors for TLR after DES implantation. PMID:28255235

  3. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials.

    PubMed

    Tanimoto, Shuzou; Serruys, Patrick W; Thuesen, Leif; Dudek, Dariusz; de Bruyne, Bernard; Chevalier, Bernard; Ormiston, John A

    2007-10-01

    This study sought to evaluate and compare in vivo acute stent recoil of a novel bioabsorbable stent and a metallic stent. The bioabsorbable everolimus-eluting coronary stent (BVS) is composed of a poly-L-lactic acid backbone, coated with a bioabsorbable polymer containing the antiproliferative drug, everolimus, and expected to be totally metabolized and absorbed in the human body. Because the BVS is made from polymer, it may have more acute recoil than metallic stents in vivo. A total of 54 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: 27 patients treated with the BVS and 27 patients treated with the everolimus-eluting cobalt chromium stent (EES). Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage. Acute absolute recoil of the BVS and EES was 0.20 +/- 0.21 mm and 0.13 +/- 0.21 mm, respectively (P = 0.32). Acute percent recoil was 6.9% +/- 7.0% in the BVS group and 4.3% +/- 7.1% in the EES group (P = 0.25). In vivo acute stent recoil of the BVS is slightly larger but insignificantly different from that of the EES, implying that the BVS may have good radial strength similar to the metallic stent. (c) 2007 Wiley-Liss, Inc.

  4. Towards a self-reporting coronary artery stent--measuring neointimal growth associated with in-stent restenosis using electrical impedance techniques.

    PubMed

    Shedden, Laurie; Kennedy, Simon; Wadsworth, Roger; Connolly, Patricia

    2010-10-15

    Implantable medical devices have become the standard method for treating a variety of cardiovascular diseases (NICE, 2003, 2009), such as coronary artery disease, where coronary artery stents are the device of choice (Fischman et al., 1994; Babapulle et al., 2004). One post-operative problem with these devices is the long-term monitoring of the device-tissue interface, with respect to the complications that often arise from in-stent restenosis. This monitoring, where it is available, is currently performed using imaging techniques such as contrast angiography, IVUS, CT and MRI. In this study we propose an alternative method for the non-invasive monitoring of restenosis in coronary artery stents. This preliminary study uses impedance spectroscopy to measure the electrical impedance of cells and tissues associated with the neointimal growth that characterises in-stent restenosis in coronary artery stents. An in vitro organ culture model, using a stent implanted in a section of pig coronary artery, simulated tissue growth inside a stent. Impedance measurements were made regularly over a 28-day culture period. In a novel step, the stent itself was employed as an electrode. Differences in electrical impedance could be seen between control (stent alone) and artery-embedded stents in culture, which were associated with the presence of biological tissue. This method could potentially be developed to produce a stent that was capable of self-reporting in-stent restenosis. The advantages of such a device would be that monitoring could be non-invasively and easily carried out, allowing more routine follow-ups and the early identification and management of any device complications.

  5. Performance of dual-source CT with high pitch spiral mode for coronary stent patency compared with invasive coronary angiography.

    PubMed

    Yang, Xia; Yu, Qiang; Dong, Wei; Fu, Zhen-Hong; Yang, Jun-Jue; Guo, Jun; Chen, Yun-Dai

    2016-10-01

    To investigate the performance of dual-source computed tomography (DSCT) using high-pitch spiral (HPS) mode for coronary stents patency. We conducted a prospective study on 120 patients with 260 previous stents implanted due to recurred suspicious symptoms of angina scheduled for invasive coronary angiography (ICA), while DSCT were conducted using HPS mode. There was no significant impact of age, body mass index or heat rate (HR) on image quality (P > 0.05), while HR variability had a slight impact on that (P < 0.05). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of DSCT in detection of in-stent restenosis (ISR) based per-patient were 92.3%, 96.7%, 88.9%, and 97.8%, respectively. And those based per-stent were 87%, 96.8%, 83.3%, and 97.7% with un-assessment stents, 97.4%, 99.5%, 97.4%, and 99.5% without un-assessment stents. There was significant difference on sensitivity, specificity, PPV and NPV between diameter ≥ 3.0 mm group (93.3%, 97.9%, 87.5%, and 98.9%) and diameter < 3.0 mm group (80%, 93.3%, 80.0%, and 93.3%) (P < 0.05), and that between stent number ≥ 3 group (82.3%, 77.8%, 66.7%, and 60%) with < 3 group (97.3%, 80%, 96.5%, and 75%). The effective dose of DSCT (1.4 ± 0.5 mSv) is significantly less than that by invasive coronary angiography [4.0 ± 0.8 mSv (P < 0.01)]. DSCT using HPS mode provides good diagnostic performance on stent patency with lower effective dose in patients with HR < 65 beats/min.

  6. Performance of dual-source CT with high pitch spiral mode for coronary stent patency compared with invasive coronary angiography

    PubMed Central

    Yang, Xia; Yu, Qiang; Dong, Wei; Fu, Zhen-Hong; Yang, Jun-Jue; Guo, Jun; Chen, Yun-Dai

    2016-01-01

    Objective To investigate the performance of dual-source computed tomography (DSCT) using high-pitch spiral (HPS) mode for coronary stents patency. Methods We conducted a prospective study on 120 patients with 260 previous stents implanted due to recurred suspicious symptoms of angina scheduled for invasive coronary angiography (ICA), while DSCT were conducted using HPS mode. Results There was no significant impact of age, body mass index or heat rate (HR) on image quality (P > 0.05), while HR variability had a slight impact on that (P < 0.05). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of DSCT in detection of in-stent restenosis (ISR) based per-patient were 92.3%, 96.7%, 88.9%, and 97.8%, respectively. And those based per-stent were 87%, 96.8%, 83.3%, and 97.7% with un-assessment stents, 97.4%, 99.5%, 97.4%, and 99.5% without un-assessment stents. There was significant difference on sensitivity, specificity, PPV and NPV between diameter ≥ 3.0 mm group (93.3%, 97.9%, 87.5%, and 98.9%) and diameter < 3.0 mm group (80%, 93.3%, 80.0%, and 93.3%) (P < 0.05), and that between stent number ≥ 3 group (82.3%, 77.8%, 66.7%, and 60%) with < 3 group (97.3%, 80%, 96.5%, and 75%). The effective dose of DSCT (1.4 ± 0.5 mSv) is significantly less than that by invasive coronary angiography [4.0 ± 0.8 mSv (P < 0.01)]. Conclusion DSCT using HPS mode provides good diagnostic performance on stent patency with lower effective dose in patients with HR < 65 beats/min. PMID:27928222

  7. Rescue AVE Stent Placement for Left Anterior Descending Coronary Artery Occlusion During Diagnostic Angiography.

    PubMed

    van Dijk D; Ernst; Six; Plokker

    1996-06-01

    In a 65-year-old male with coronary artery disease a proximal occlusion of the left anterior descending coronary artery occurred during diagnostic coronary angiography. The most likely cause was an occlusive dissection. This resulted in acute myocardial ischemia and immediate cardiogenic shock. The decision was made to proceed to emergency percutaneous transluminal coronary angioplasty (PTCA). After balloon dilatation, a 3.5 mm AVE stent was deployed successfully at the site of the lesion. This resulted in a satisfactory angiographic result and an immediate improvement of the clinical picture. We conclude that placement of an AVE stent can provide a means for restoring flow in case of acute occlusive dissection during coronary angiography.

  8. A rare case of stenting of spontaneous dissection of Shepherd's Crook right coronary artery.

    PubMed

    Dubey, Laxman

    2014-03-01

    Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome (ACS) and sudden death. It usually occurs in young women during the peripartum period; however, it had also been reported in older aged males having risk factors for atherosclerotic coronary artery disease. This case describes a 69-year-old male patient who presented with manifestations of ACS due to a spontaneous dissection of the Shepherd's Crook right coronary artery (RCA), which was successfully managed with percutaneous coronary intervention (PCI) and stenting. At the 6th month follow-up, the patient remained chest pain free. Patients with SCAD in the presence of ongoing ischemia can be treated with PCI and stenting.

  9. 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.

  10. Effects of bifurcation-specific and conventional stents on coronary bifurcation flow. An experimental and numerical study.

    PubMed

    García García, J; García Carrascal, P; Castro Ruiz, F; Manuel Martín, F; Fernández, J A

    2017-02-07

    Our paper builds on existing research into conventional bare metal stents in order to assess new devices specifically designed for coronary bifurcation angioplasty. The first aim is to validate the numerical model against data from in vitro experiments on stented coronary phantoms. A surface mesh was built in accordance with micro-computed tomography images obtained from coronary stents implanted in silicone models and used for numerical analysis. Computational simulations for steady and unsteady cases generally agreed with their experimental counterparts. A second objective is to compare the hemodynamic performance of one of these new devices (Stentys) to that of conventional devices and stenting techniques in a simplified coronary bifurcation model. Four different coronary bifurcation stenting techniques were analyzed. We have focused on factors contributing to restenosis, such as wall shear stress (WSS), oscillatory shear index (OSI), pressure loss, and local normalized helicity (LNH). It was found that bifurcation-specific stents implanted in the side branch led to increased malapposition. This effect has proved to be more important than stent specific design characteristics such as strut size (different for conventional and Stentys stent). This conclusion is confirmed by means of drop in pressure and mechanical energy loss rate calculation; for the latter, the increase ranged from 9% to 17%, depending on the stenting technique, when dedicated stents were implanted in the side branch. The behavior patterns presented in this study should be double-checked against those obtained in more realistic geometries.

  11. Stent mal-apposition with resorption of intramural hematoma with spontaneous coronary artery dissection

    PubMed Central

    Lempereur, Mathieu; Fung, Anthony

    2015-01-01

    Spontaneous coronary artery dissection (SCAD) is an infrequent cause of acute coronary syndrome (ACS). Conservative management is typically recommended but revascularization may be necessary if ongoing ischemia or adverse anatomical characteristics are present. Percutaneous coronary intervention (PCI) of SCAD can be fraught with challenges, and intracoronary imaging with optical coherence tomography (OCT) may provide insights on optimizing the acute results and identify long-term stent-related adverse events. We report three cases of SCAD treated with drug-eluting stents (DES) with OCT follow-up showing stent mal-apposition at different stages of follow-up. The clinical significance of these OCT findings and management options are discussed. PMID:26331116

  12. Surface chemical and physical modification in stent technology for the treatment of coronary artery disease.

    PubMed

    Nazneen, Feroze; Herzog, Grégoire; Arrigan, Damien W M; Caplice, Noel; Benvenuto, Pasquale; Galvin, Paul; Thompson, Michael

    2012-10-01

    Coronary artery disease (CAD) kills millions of people every year. It results from a narrowing of the arteries (stenosis) supplying blood to the heart. This review discusses the merits and limitations of balloon angioplasty and stent implantation, the most common treatment options for CAD, and the pathophysiology associated with these treatments. The focus of the review is heavily placed on research efforts geared toward the modification of stent surfaces for the improvement of stent-vascular compatibility and the reduction in the occurrence of related pathophysiologies. Such modifications may be chemical or physical, both of which are surveyed here. Chemical modifications may be passive or active, while physical modification of stent surfaces can also provide suitable substrates to manipulate the responses of vascular cells (endothelial, smooth muscle, and fibroblast). The influence of micro- and nanostructured surfaces on the in vitro cell response is discussed. Finally, future perspectives on the combination of chemical and physical modifications of stent surfaces are also presented.

  13. Successful recanalization of a left circumflex artery jailed with a polytetrafluoroethylene-covered stent after coronary perforation during stent implantation in the left main bifurcation.

    PubMed

    Taniguchi, Norimasa; Takahashi, Akihiko; Mizuguchi, Yukio; Yamada, Takeshi; Hata, Tetsuya; Nakajima, Shunsuke

    2015-01-01

    An 88-year-old woman underwent emergency percutaneous coronary intervention (PCI) to treat circulatory collapse with severe stenosis in the distal left main coronary artery (LMCA). After 3.5/18-mm stent deployment from the LMCA to the left anterior descending artery (LAD), coronary perforation occurred in the LAD ostium. Therefore, we implanted a polytetrafluoroethylene (PTFE)-covered stent crossing over the left circumflex artery (LCX), and achieved successful hemostasis. Additional PCI was undertaken to recanalize the LCX. A Confienza 8-20 guidewire was able to penetrate the wall of the PTFE-covered stent, and coronary flow was successfully recovered after deployment of a 2.5/8-mm stent in the proximal LCX.

  14. Use of a tacrolimus-eluting stent to inhibit neointimal hyperplasia in a porcine coronary model.

    PubMed

    Huang, Yanming; Salu, Koen; Wang, Lan; Liu, Xiaoshun; Li, Shengqiao; Lorenz, Gunter; Wnendt, Stephan; Verbeken, Eric; Bosmans, Johan; Van de Werf, Frans; De Scheerder, Ivan

    2005-03-01

    In-stent restenosis remains an unresolved problem which occurs in 5-20% of patients undergoing coronary stenting within the first 3-6 months. Neointimal formation is the main contributor to in-stent restenosis. Stent-induced arterial injury and peri-strut inflammation are involved in the process of neointimal formation by activating cytokines and growth factors which induce smooth muscle cell dedifferentiation, migration, and proliferation. Histopathological studies found that neointimal hyperplasia is principally composed of smooth muscle cells, inflammatory cells, and extracellular matrix. Stent-based delivery of anti-proliferative and/or anti-inflammatory agents have shown beneficial effects on neointimal hyperplasia in experimental studies and clinical trials. Tacrolimus (FK506) is a water-insoluble macrolide immunosuppressant discovered in 1984. It has been widely used in reducing the incidence and severity of allograft rejection after organ transplantation. It has also been used to treat other inflammatory conditions such as atopic dermatitis. In this study, we evaluated the efficacy of stent-based delivery of tacrolimus on inflammation and neointimal formation in an overstretched coronary stent model.

  15. Development of a Rabbit Model for a Preclinical Comparison of Coronary Stent Types In-Vivo

    PubMed Central

    Lee, Joo Myung; Lee, Jaewon; Jeong, Heewon; Choe, Won Seok; Seo, Won-Woo; Lim, Woo-Hyun; Kim, Young-Chan; Hur, Jin; Lee, Sang Eun; Yang, Han-Mo; Cho, Hyun-Jai

    2013-01-01

    Along with the development of innovative stent designs, preclinical trials in animal models are essential. Many animal models have been used and appear to yield comparable results to clinical trials despite substantial criticisms about their validity. Among the animal models, porcine coronary artery models have been the standard models for the preclinical evaluation of endovascular devices. However, rapid growth rate, high body weight potential, and the propensity to develop granulomatous inflammatory reactions are major limitations of the porcine coronary artery model. Compared with porcine coronary artery models, the comparative rabbit iliac artery model has the advantages of being small and easy to handle and relatively inexpensive. Furthermore, the rabbit model has been known to reliably reflect human restenosis histopathologically and have major advantages such as pairwise comparison, which makes each animal serve as its own control subject, therefore, maximizing its statistical power for comparative testing. However, despite the widespread use of this model, a systematic description of the procedure and harvest protocols has never been published. This article describes the surgical procedure, stent implantation procedure, method for tissue harvesting, and how measurements are performed. Although the results of animal models may not perfectly extrapolate to humans, the comparative rabbit iliac artery model may be a useful tool for assessing and comparing the efficacy of new coronary stents with conventional stent systems. This thorough description of the techniques required for vascular access, stent implantation, tissue preparation, and measurement, should aid investigators wishing to begin using the comparative rabbit iliac artery model. PMID:24363745

  16. Development of a rabbit model for a preclinical comparison of coronary stent types in-vivo.

    PubMed

    Lee, Joo Myung; Lee, Jaewon; Jeong, Heewon; Choe, Won Seok; Seo, Won-Woo; Lim, Woo-Hyun; Kim, Young-Chan; Hur, Jin; Lee, Sang Eun; Yang, Han-Mo; Cho, Hyun-Jai; Kim, Hyo-Soo

    2013-11-01

    Along with the development of innovative stent designs, preclinical trials in animal models are essential. Many animal models have been used and appear to yield comparable results to clinical trials despite substantial criticisms about their validity. Among the animal models, porcine coronary artery models have been the standard models for the preclinical evaluation of endovascular devices. However, rapid growth rate, high body weight potential, and the propensity to develop granulomatous inflammatory reactions are major limitations of the porcine coronary artery model. Compared with porcine coronary artery models, the comparative rabbit iliac artery model has the advantages of being small and easy to handle and relatively inexpensive. Furthermore, the rabbit model has been known to reliably reflect human restenosis histopathologically and have major advantages such as pairwise comparison, which makes each animal serve as its own control subject, therefore, maximizing its statistical power for comparative testing. However, despite the widespread use of this model, a systematic description of the procedure and harvest protocols has never been published. This article describes the surgical procedure, stent implantation procedure, method for tissue harvesting, and how measurements are performed. Although the results of animal models may not perfectly extrapolate to humans, the comparative rabbit iliac artery model may be a useful tool for assessing and comparing the efficacy of new coronary stents with conventional stent systems. This thorough description of the techniques required for vascular access, stent implantation, tissue preparation, and measurement, should aid investigators wishing to begin using the comparative rabbit iliac artery model.

  17. Transradial artery Palmaz-Schatz coronary stent implantation: results of a single-center feasibility study.

    PubMed

    Kiemeneij, F; Laarman, G J

    1995-07-01

    The purpose of this study was to evaluate the feasibility and safety of implantation of unsheathed Palmaz-Schatz coronary stents introduced via the radial artery. Anticoagulation after coronary stenting carries the risk of vascular complications if large-bore guiding catheters are introduced via the femoral artery. These complications have serious local sequelae and lead to suboptimal anticoagulation and prolonged hospitalization. By combining 6F guiding catheters and low-profile dilatation catheters mounted with Palmaz-Schatz stents, smaller vessels such as the radial artery can be selected as the entry site. It is hypothesized that with this technique major puncture site-related complications rarely occur because hemostasis is easily achieved and because no veins and nerves are near this artery. With the double blood supply to the hand, radial artery occlusion is well tolerated. In 100 consecutive patients, stent implantation was attempted for 122 lesions in 104 vessels. Immediately after stent implantation and final angiography, the introducer sheath was withdrawn and intense anticoagulation and mobilization initiated. The radial artery puncture site was studied by two-dimensional and Doppler ultrasound. Successful stent implantation via the radial artery was achieved in 96 patients. In 2 patients, arterial puncture failed but was followed by successful stenting via another entry site. In 1 patient, stent implantation was achieved with a stent delivery system via the femoral artery after a failed attempt to cross the lesion with a bare stent via the radial approach, complicated by groin bleeding requiring transfusions and vascular surgery.(ABSTRACT TRUNCATED AT 250 WORDS)

  18. Nine-year clinical outcomes of drug-eluting stents vs. bare metal stents for large coronary vessel lesions

    PubMed Central

    Yin, Dong; Li, Jia; Yang, Yue-Jin; Wang, Yang; Zhao, Yan-Yan; You, Shi-Jie; Qiao, Shu-Bin; Xu, Bo; Dou, Ke-Fei

    2017-01-01

    Objectives To evaluate the very long-term safety and effectiveness of drug-eluting stents (DES) compared to bare-metal stents (BMS) for patients with large coronary vessels. Methods From April 2004 to October 2006, 2407 consecutive patients undergoing de novo lesion percutaneous coronary intervention with reference vessel diameter greater than or equal to 3.5 mm at Fu Wai Hospital in Beijing, China, were prospectively enrolled into this study. We obtained 9-year clinical outcomes including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We performed Cox's proportional-hazards models to assess relative risks of all the outcome measures after propensity match. Results After propensity scoring, 514 DES-treated patients were matched to 514 BMS-treated patients. The patients treated with BMS were associated with higher risk of TLR (HR: 2.55, 95%CI: 1.520–4.277, P = 0.0004) and TVR (HR: 1.889, 95%CI: 1.185–3.011, P = 0.0075), but the rates of death/MI and MACE were not statistically different. All Academic Research Consortium definition stent thrombosis at 9-year were comparable in the two groups. Conclusions During long-term follow-up through nine years, use of DES in patients with large coronary arteries was still associated with significant reductions in the risks of TLR and TVR.

  19. Stent fracture and longitudinal compression detected on coronary CT angiography in the first- and new-generation drug-eluting stents.

    PubMed

    Chung, Mi Sun; Yang, Dong Hyun; Kim, Young-Hak; Roh, Jae-Hyung; Song, Jihyun; Kang, Joon-Won; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Lee, Cheol Whan; Park, Seong-Wook; Park, Seung-Jung; Lim, Tae-Hwan

    2016-04-01

    To evaluated prevalence and clinical implication of stent fracture and longitudinal compression in first- and new-generation drug-eluting stents (DES) using coronary computed tomography angiography (CCTA). The incidence of stent fracture and longitudinal compression were compared between first- and new-generation DES in 374 patients who underwent coronary stenting using DES and follow-up CCTA due to recurrent angina. 235 and 139 patients received 322 first- and 213 new-generation DES, respectively. The crude per-stent incidence of longitudinal compression (6.1 vs. 0.3 %, p < 0.001) was higher after new- than first-generation DES implantation using CCTA and the incidence of stent fracture (11.3 vs. 8.1 %, p = 0.23) was comparable. On follow-up coronary angiography for 347 stents, stent fracture (3.2 %) and longitudinal compression (0.9 %) were less detected than those on CCTA. Ostial stenting was a risk factor of longitudinal compression (p < 0.001). Stent fracture was associated with younger patients (p = 0.03), longer stent (p = 0.010), and excessively tortuous lesions (p = 0.001). The presence of stent fracture or longitudinal compression was not associated with poor clinical outcomes. The longitudinal compression more frequently occurred after new-generation DES implantation. The stent fracture was comparable between two DES. However, the occurrence of such mechanical deformities did not translate into a poor clinical outcome.

  20. Novel drug-eluting stents in the treatment of de novo coronary lesions

    PubMed Central

    Capodanno, Davide; Dipasqua, Fabio; Tamburino, Corrado

    2011-01-01

    Due to safety concerns in recent years, much effort has been devoted to improving the outcomes associated with drug-eluting stents (DESs). This review summarizes the current status of methodological and technical achievements reported in second-generation DES. Novel stents are described based on the component (the platform, the polymer, and the drug) that has undergone the most significant changes compared to earlier generation DES. An overview of the currently available evidence on the use of novel coronary devices in patients undergoing coronary revascularization is also reviewed. PMID:21415924

  1. Recommendations for management of antiplatelet therapy in patients undergoing elective noncardiac surgery after coronary stent implantation.

    PubMed

    Huang, Pei-Hsiu; Croce, Kevin J; Bhatt, Deepak L; Resnic, Frederic S

    2012-12-01

    Patients commonly undergo noncardiac surgical procedures after implantation of a coronary stent. In the case where surgery cannot be deferred until completing the minimum duration of dual antiplatelet therapy, the Brigham and Women's Hospital Cardiac Catheterization Laboratory recommends using a glycoprotein IIb/IIIa bridging protocol to minimize the risk of perioperative ischemic events. We discuss our algorithm for managing antiplatelet agents, including the newer agents, prasugrel and ticagrelor, in patients undergoing noncardiac surgery after coronary stenting and present our glycoprotein IIb/IIIa bridging strategy along with a review of the relevant pharmacodynamic and clinical evidence.

  2. Percutaneous Coronary Interventions for the Treatment of Stenoses in Small Coronary Arteries: A Network Meta-Analysis.

    PubMed

    Siontis, George C M; Piccolo, Raffaele; Praz, Fabien; Valgimigli, Marco; Räber, Lorenz; Mavridis, Dimitris; Jüni, Peter; Windecker, Stephan

    2016-07-11

    This study evaluated the most appropriate percutaneous coronary intervention (PCI) for the treatment of stenoses in small coronary arteries. PCI in small coronary arteries is associated with an increased risk of lesion failure and restenosis. Randomized trials comparing different PCI strategies were identified through a broad search of published reports. Primary angiographic outcome was %DS (%DS). A pairwise meta-analysis was performed by using random effects model, followed by a network meta-analysis synthesizing direct and indirect evidence. Overall, 19 trials were eligible, which included 5,072 patients comprising a network without closed loops among 5 identified interventions (early generation sirolimus-eluting stents [SES], paclitaxel-eluting stents [PES], drug-coated balloons [DCB], bare-metal stents [BMS], and balloon angioplasty [BA]). No dedicated trial was identified evaluating new generation drug-eluting stents. Early generation SES yielded the best angiographic results according to %DS. For %DS, SES was ranked as the most effective treatment, followed by PES (standardized mean differences [SMD]: -0.44; 95% confidence interval [CI]: -0.92 to 0.05 vs. SES) and DCB (SMD: -0.89; 95% CI: -1.53 to -0.25 vs. SES). In terms of absolute differences, SES yielded a reduction of 18% in diameter stenosis compared to DCB. SES significantly reduced the risk of target-lesion revascularization compared to PES (odds ratio [OR]: 0.39; 95% CI: 0.16 to 0.93), DCB (OR: 0.34; 95% CI: 0.10 to 0.97), BMS (OR: 0.21; 95% CI: 0.13 to 0.36), and BA (OR: 0.16; 95% CI: 0.09 to 0.29). Early generation SES yielded the most favorable angiographic and clinical outcomes for the treatment of stenoses in small coronary arteries. New generation DES need to be evaluated against this standard in future randomized trials. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Photon-Counting CT: High-Resolution Imaging of Coronary Stents.

    PubMed

    Mannil, Manoj; Hickethier, Tilman; von Spiczak, Jochen; Baer, Matthias; Henning, André; Hertel, Madeleine; Schmidt, Bernhard; Flohr, Thomas; Maintz, David; Alkadhi, Hatem

    2017-09-23

    The aim of this study was to investigate computed tomography (CT) imaging characteristics of coronary stents using a novel photon-counting detector (PCD) in comparison with a conventional energy-integrating detector (EID). In this in vitro study, 18 different coronary stents were expanded in plastic tubes of 3 mm diameter, were filled with contrast agent (diluted to an attenuation of 250 Hounsfield units [HU] at 120 kVp), and were sealed. Stents were placed in an oil-filled custom phantom calibrated to an attenuation of -100 HU at 120 kVp for resembling pericardial fat. The phantom was positioned in the gantry at 2 different angles at 0 degree and 90 degrees relative to the z axis, and was imaged in a research dual-source PCD-CT scanner. Detector subsystem "A" used a standard 64-row EID, while detector subsystem "B" used a PCD, allowing high-resolution scanning (detector pixel-size 0.250 × 0.250 mm in the isocenter). Images were obtained from both detector systems at identical tube voltage (100 kVp) and tube current-time product (100 mA), and were both reconstructed using a typical convolution kernel for stent imaging (B46f) and using the same reconstruction parameters. Two independent, blinded readers evaluated in-stent visibility and measured noise, intraluminal stent diameter, and in-stent attenuation for each detector subsystem. Differences in noise, intraluminal stent diameter, and in-stent attenuation where tested using a paired t test; differences in subjective in-stent visibility were evaluated using a Wilcoxon signed-rank test. Best results for in-stent visibility, noise, intraluminal stent diameter, and in-stent attenuation in EID and PCD were observed at 0-degree phantom position along the z axis, suggesting higher in-plane compared with through-plane resolution. Subjective in-stent visibility was superior in coronary stent images obtained from PCD compared with EID (P < 0.001). Mean in-stent diameter was 28.8% and 8.4% greater in PCD (0.85 ± 0.24 mm

  4. Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

    PubMed

    Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

    2014-04-01

    To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

  5. 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

  6. Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries.

    PubMed

    Baim, D S; Cutlip, D E; O'Shaughnessy, C D; Hermiller, J B; Kereiakes, D J; Giambartolomei, A; Katz, S; Lansky, A J; Fitzpatrick, M; Popma, J J; Ho, K K; Leon, M B; Kuntz, R E

    2001-01-15

    The NIR stent is a novel second generation tubular stent that was designed to overcome some of the limitations of the earlier Palmaz-Schatz (PS) stent design. The NIR Vascular Advanced North American (NIRVANA) trial randomized 849 patients with single coronary lesions to treatment with the NIR stent or the PS stent. The study was an "equivalency" trial, designed to demonstrate that the NIR stent was not inferior to (i.e., equivalent or better than) the PS stent, for the primary end point of target vessel failure (defined as death, myocardial infarction, or target vessel revascularization) by 9 months. Successful stent delivery was achieved in 100% versus 98.8%, respectively, with a slightly lower postprocedural diameter stenosis (7% vs. 9%, p = 0.04) after NIR and PS stent placement, respectively. Major adverse cardiac events (death, myocardial infarction, repeat target lesion revascularization) were not different at 30 days (4.3% vs. 4.4%). The primary end point of target vessel failure at 9 months was seen in 16.0% of NIR versus 17.2% of PS patients, with the NIR proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). Angiographic restudy in 71% of a prespecified cohort showed no significant difference in restenosis (19.3% vs 22.4%). Thus, the NIR stent showed excellent deliverability with slightly better acute angiographic results and equivalent or better 9-month target vessel failure rate when compared with the PS stent.

  7. Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation.

    PubMed

    Kaya, Mehmet Gungor; Okyay, Kaan; Yazici, Huseyin; Sen, Nihat; Tavil, Yusuf; Turkoglu, Sedat; Timurkaynak, Timur; Ozdemir, Murat; Cemri, Mustafa; Yalcin, Ridvan; Cengel, Atiye

    2009-03-01

    We sought to investigate the early and late effects of magnetic resonance imaging (MRI) on stent thrombosis and major adverse coronary events after coronary artery stent (CAS) implantation at a long-term follow-up period. Forty-three patients (28 men, mean age 63+/-10 years) who underwent CAS implantation before MRI examination were included. MRI was performed on a 1.5-T MR-system with a phased array multicoil. An average of 1.3 stents per patient were implanted (1-4 stents). More than one MRI was performed for two patients. Patients who underwent MRI within 8 weeks after the procedure were included in the early-term group (17 patients), and those who underwent MRI after 8 weeks were included in the late-term group (26 patients). Mean follow-up period was 36+/-15 months. There was no acute or subacute stent thrombosis. Late stent thrombosis that resulted in acute myocardial infarction was observed in a patient from the early group after an operation for prostate hyperplasia 5 months after MRI, and the patient underwent percutaneous coronary artery angioplasty. De-nova lesion was observed in four patients in the early group and two patients in the late group (P=0.14). In-stent restenosis was recorded in two patients in the early group and three patients in the late group (P=0.98). Composite major adverse cardiac events (acute coronary syndrome, myocardial infarction, death, and cerebrovascular event) were observed in seven of the early-group patients (41%), and in six of the late-group patients (23%) (P=0.20). MRI can be safely performed in patients with CAS implantation both in the early and late course, and is not associated with an increased risk of major adverse clinical cardiac events at long-term follow-up.

  8. 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.

  9. 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

  10. Solely abluminal drug release from coronary stents could possibly improve reendothelialization.

    PubMed

    Zhang, Haijun; Deng, Wei; Wang, Xiangfei; Wang, Shenguo; Ge, Junbo; Toft, Egon

    2016-09-01

    To compare a new stent with an asymmetric coating, eluting the drug to the abluminal surface, to a stent with a conventional coating eluting the drug both to the luminal and the abluminal side. Stents with asymmetric coating, eluting the drug to the vessel wall (BPSES-A), could potentially give faster reendothelialization after percutaneous coronary interventions (PCI) and decrease in in-stent thrombosis and late restenosis. BPSES-A, conventional coated stents (BPSES-C), biodegradable polymer stents without drug (BPS, for control), and bare metal stents (BMS, for control) were implanted into the coronary arteries of 38 pigs (75 stents). Pigs were sacrificed after 4, 12, and 24 weeks. Quantitative coronary angiography was used to compare in-stent late lumen loss (LLL) and electron microscopy was used to reveal levels of reendothelialization. The stents were all successfully implanted. LLL of BPSES-A, BPSES-C, BMS, and BPS were 0.56 ± 0.51, 0.60 ± 0.58, 0.89 ± 0.43, and 1.68 ± 0.30 mm, respectively, after 4 weeks. LLL of BPSES-A and BPSES-C were 0.63 ± 0.53 and 0.69 ± 0.24 mm, respectively, after 12 weeks. LLL of BPSES-A, BPSES-C, and BMS were 0.42 ± 0.15 m, 0.56 ± 0.28 mm, and 0.99 ± 0.13 mm, respectively, after 24 weeks. The scaling of reendothelialization was as follows: after 4 weeks BMS > = BPS > BPSES-A > BPSES-C, after 12 weeks BPSES-A > BPSES-C, and after 24 weeks BMS > BPSES-A > BPSES-C. Reendothelialization was better in BPSES-A than BPSES-C (P < 0.05). There was no correlation between LLL and reendothelialization (P = 0.42). Asymmetric coating of coronary stents might be helpful to improve reendothelialization. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  11. The impact of industry representative's visits on utilization of coronary stents.

    PubMed

    Sudarsky, Doron; Charania, Jahangir; Inman, Alexandra; D'Alfonso, Sabrina; Lavi, Shahar

    2013-08-01

    The interaction between physicians and industry is complex and essential for improvement of medical care. However, conflict of interests may affect decision process. Our aim was to test if promotional visits by industry representatives affect treatment patterns and the use of various stents during percutaneous coronary interventions. Medical records of 1,145 consecutive patients who underwent percutaneous coronary intervention in an academic institution over 1-year period were retrospectively reviewed and linked to presence or absence of industry representative. We compared use of bare-metal stents, drug-eluting stents (DES), and balloon catheters according to company presence. A total of 1,785 stents were implanted in 1,145 patients; 60.8% were DES. More DES per case were implanted when a representative was present (1.71 ± 0.9 vs 1.60 ± 0.93, P = .023). There was no difference in the utilization of balloons and bare-metal stents between groups. Stent cost per case was higher when a representative was present (Can $1,703.5 ± 1,314.4 vs 1,468.9 ± 1,273.3, P < .001). For all companies marketing DES, there was increase in the use of the company's DES when their sale representative was present with less use of the competitors' stents. Sale representative presence was associated with increased use of the representative company's stents during percutaneous coronary interventions. The effect was more pronounced on use of the company's DES and resulted in higher procedural cost. Copyright © 2013 Mosby, Inc. All rights reserved.

  12. On the necessity of modelling fluid-structure interaction for stented coronary arteries.

    PubMed

    Chiastra, Claudio; Migliavacca, Francesco; Martínez, Miguel Ángel; Malvè, Mauro

    2014-06-01

    Although stenting is the most commonly performed procedure for the treatment of coronary atherosclerotic lesions, in-stent restenosis (ISR) remains one of the most serious clinical complications. An important stimulus to ISR is the altered hemodynamics with abnormal shear stresses on endothelial cells generated by the stent presence. Computational fluid dynamics is a valid tool for studying the local hemodynamics of stented vessels, allowing the calculation of the wall shear stress (WSS), which is otherwise not directly possible to be measured in vivo. However, in these numerical simulations the arterial wall and the stent are considered rigid and fixed, an assumption that may influence the WSS and flow patterns. Therefore, the aim of this work is to perform fluid-structure interaction (FSI) analyses of a stented coronary artery in order to understand the effects of the wall compliance on the hemodynamic quantities. Two different materials are considered for the stent: cobalt-chromium (CoCr) and poly-l-lactide (PLLA). The results of the FSI and the corresponding rigid-wall models are compared, focusing in particular on the analysis of the WSS distribution. Results showed similar trends in terms of instantaneous and time-averaged WSS between compliant and rigid-wall cases. In particular, the difference of percentage area exposed to TAWSS lower than 0.4Pa between the CoCr FSI and the rigid-wall cases was about 1.5% while between the PLLA cases 1.0%. The results indicate that, for idealized models of a stented coronary artery, the rigid-wall assumption for fluid dynamic simulations appears adequate when the aim of the study is the analysis of near-wall quantities like WSS. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. [Perioperative management of patients with coronary stents in non-cardiac surgery].

    PubMed

    Jámbor, C; Spannagl, M; Zwissler, B

    2009-10-01

    In patients with coronary stents scheduled for surgery the question arises whether and how antiplatelet therapy should be continued. Risks of perioperative bleeding and of acute stent thrombosis have to be considered simultaneously. The bleeding risk depends primarily on the kind of surgery and on patient comorbidity. The risk of stent thrombosis is increased in these patients due to the thrombogenic surface of the stents. The main determinants are hereby the time duration after stent implantation, the kind of the stent [uncoated (bare-metal stent, BMS) or coated (drug-eluting stent, DES)], as well as angiographic and clinical patient factors. Therefore, perioperative antiplatelet therapy has to be individually adapted for each patient. Bridging with heparin is ineffective. Bridging with intravenous antiplatelet drugs during the perioperative interruption of oral antiplatelet therapy might be a potential procedure in high-risk patients. Whether bedside monitoring of antiplatelet therapy improves the perioperative management of these patients and reduces adverse outcome is object of current studies.

  14. Effect of Stents Coated with Artemisinin or Dihydroartemisinin in a Porcine Coronary Restenosis Model

    PubMed Central

    Jang, Suyoung; Lim, Kyung Seob; Bae, In Ho; Park, Jun-Kyu; Park, Dae Sung; Shim, Jae Won; Kim, Jung Ha; Kim, Hyun Kuk; Sim, Doo Sun; Hong, Young Joon; Ahn, Youngkeun; Kang, Jung Chaee

    2017-01-01

    Background and Objectives Artemisinin and dihydroartemisinin are drugs used to treat malaria. These drugs suppress inflammatory reactions. The aim of this study was to examine the anti-intima hyperplasia effect of a novel drug-eluting stent with artemisinin or dihydroartemisinin in a porcine coronary restenosis model. Materials and Methods Pigs were randomized into four groups; in the first, the coronary arteries (20 pigs, a total of 40 coronary arteries, with 10 coronary arteries in each group) was implanted with bare metal stents (BMS, n=10); the second group was given polymer-coated stents (PCS, n=10); the third group was treated with artemisinin-eluting stents (AES, n=10); and the fourth group was given dihydroartemisinin-eluting stents (DAES, n=10). Histopathologic analysis was performed 28 days after stenting. Results The injury and fibrin scores among the four groups were not significantly different. However, the internal elastic lamina, lumen area, and neointima area were significantly different. Moreover, the percent area of stenosis (46.2±18.66% in BMS vs. 89.4±10.92% in PCS vs. 83.3±17.07% in AES vs. 36.7±11.20% in DAES, p<0.0001) and inflammation score (1.0 [range: 1.0-1.0] vs. 3.0 [range: 2.25-3.0] vs. 3.0 [range: 1.0-3.0] vs. 2.0 [range: 1.75-3.0] in BMS, PCS, AES, and DAES, respectively; p<0.001) were markedly decreased in the DAES group compared to the PCS group. Conclusion DES, which uses a natural substance, dihydroartemisinin, showed a neointima and inflammatory suppressive effect in a porcine coronary restenosis model. PMID:28154599

  15. First-in-man use of polymer-free valsartan-eluting stents in small coronary vessels: a comparison to polymer-free rapamycin (2%)-eluting stents.

    PubMed

    Peters, Stefan; Behnisch, Boris; Heilmann, Torsten; Richter, Christian

    2009-06-01

    Orally administered angiotensin receptor antagonists administered after bare-metal stent implantation and even after drug-eluting stent implantation seem to lower in-stent restenosis rates.Whether valsartan-eluting stents are similarly effective was tested here in a first-in-man trial. The efficacy of a polymer-free drug-eluting stent coated with 300 mcg valsartan was compared to a coating with a 2% rapamycin solution in small (coronary vessels with and without oral valsartan on the basis of the YUKON Choice stent system (Translumina GmbH, Hechingen, Germany). Fifteen patients (eight males, mean age 64.4+/-7.7 years) were treated with YUKON Choice valsartan-eluting stents and 30 patients (24 males, mean age 65.7+/-8.4 years) received YUKON Choice rapamycin-eluting stents. Clopidogrel was given for six months in all patients. Within the first 30 days, no adverse events occurred in either group. Binary in-stent restenosis rate was 30.8% (four in 13 angiographic controls) in the valsartan-eluting stent group and 35.0% (eight in 20 angiographic controls) in the rapamycin-eluting YUKON Choice stent group. Mean late lumen loss was 0.78+/-0.53 mm and 0.79+/-0.58 mm, respectively. Target lesion and target vessel revascularisation rate was 26.6% and 25.0%, respectively. No restenoses in rapamycin-eluting YUKON Choice stents appeared in 12 patients with adjunct oral valsartan administration. If polymer-free YUKON Choice stents are used in small vessels, valsartan-eluting stents show an identical efficacy as rapamycin-loaded stents. In patients with rapamycin-eluting YUKON Choice stents it seems that the efficacy can be increased by oral valsartan administration.

  16. Reduction of Late In-Stent Stenosis in a Porcine Coronary Artery Model by Cobalt Chromium Stents with a Nanocoat of Polyphosphazene (Polyzene-F)

    SciTech Connect

    Stampfl, Ulrike; Sommer, Christof-Matthias; Thierjung, Heidi; Stampfl, Sibylle; Lopez-Benitez, Ruben; Radeleff, Boris; Berger, Irina; Richter, Goetz M.

    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 alpha (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.

  17. Antiplatelet therapy and outcome in patients undergoing surgery following coronary stenting: Results of the surgery after stenting registry.

    PubMed

    Rossini, Roberta; Angiolillo, Dominick J; Musumeci, Giuseppe; Capodanno, Davide; Lettino, Maddalena; Trabattoni, Daniela; Pilleri, Annarita; Calabria, Paolo; Colombo, Paola; Bernabò, Paola; Ferlini, Marco; Ferri, Marco; Tarantini, Giuseppe; De Servi, Stefano; Savonitto, Stefano

    2017-01-01

    The aim of the present study was to define the feasibility and clinical impact of complying with national consensus recommendations on perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and noncardiac surgery. There are limited evidence-based recommendations on the perioperative management of antiplatelet therapy in stented patients undergoing surgery. The recommendations provided by the national consensus document were applied in a multicenter, prospective registry of consecutive patients with prior coronary stenting undergoing any type of surgery at 19 hospitals in Italy. The primary end-point was in-hospital net adverse clinical events (NACE) represented by the composite of all-cause death, myocardial infarction, probable/definite stent thrombosis and Bleeding Academic Research Consortium (BARC) grade ≥3 bleeding. Patients were followed for 30 days. A total of 1,082 patients were enrolled. Adherence to consensus recommendations occurred in 85% of the cases. Perioperative aspirin and dual antiplatelet therapy were maintained in 69.7 and 10.5% of the cases, respectively. In-hospital NACE rate was 12.7%, being significantly higher in patients undergoing cardiac surgery (36.3% vs. 7.3%, P < 0.01), mainly due to BARC 3 bleeding events (32.3%). At 30 days, MACE rates were similar (3.5% vs. 3.5%, P = NS) in patients undergoing cardiac and noncardiac surgery, whereas BARC ≥3 bleeding events were significantly higher with cardiac surgery (36.3% vs. 5.6%, P < 0.01). The results of this registry demonstrate the safety and feasibility of applying a national consensus document on the perioperative management of antiplatelet therapy in stented patients undergoing surgery. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  18. Influence of plaque calcifications on coronary stent fracture: a numerical fatigue life analysis including cardiac wall movement.

    PubMed

    Morlacchi, Stefano; Pennati, Giancarlo; Petrini, Lorenza; Dubini, Gabriele; Migliavacca, Francesco

    2014-03-03

    Coronary stent fracture is still an unresolved issue in the field of minimally invasive cardiovascular interventions due to its high rate of incidence and uncertain clinical consequences. Recent studies, based on clinical data, proved that there are several factors which can be identified as independently responsible of coronary stent fracture. Among these, calcifications, which increase the local stiffness and heterogeneity of atherosclerotic plaques, seem to play a major role. From a mechanical point of view, stent fracture in coronary arteries is triggered by the cyclic loading of pulsatile blood pressure combined with the movement of cardiac wall. In this context, this study aims at simulating the stent expansion in a model of epicardial atherosclerotic coronary artery and correlating the effects of cyclic blood pressure and cardiac wall movement on the stent fatigue resistance. Two ideal cases of atherosclerotic plaques were modelled: the first one included a localised plaque calcification; the latter one did not include such calcification. Results of stress/strain and fatigue analyses confirmed the influence of the plaque calcification on potential fracture of the devices. In addition, the effects of cardiac wall movement were quantified as more dangerous causes of the stent fatigue fracture with respect to the internal blood pressure oscillations. In conclusion, this study demonstrates the increased risk of coronary stent fracture associated to the presence of localised plaque calcifications. This work also suggests the necessity of more realistic biomechanical models which takes into account the heterogeneity of atherosclerotic plaques in order to assess the mechanical performances of coronary stents.

  19. Miniaturized Self-Expanding Drug-Eluting Stent in Small Coronary Arteries: Late Effectiveness

    PubMed Central

    de Oliveira, Flavio Roberto Azevedo; Mattos, Luiz Alberto Piva e; Abizaid, Alexandre; Abizaid, Andrea S.; Costa, J. Ribamar; Costa, Ricardo; Staico, Rodolfo; Botelho, Roberto; Sousa, J. Eduardo; Sousa, Amanda

    2013-01-01

    Background Small vessels represent a risk factor for restenosis in percutaneous coronary angioplasty (PCA). The Sparrow® self-expanding drug-eluting stent, which has a lower profile than the current systems, has never been tested in this scenario. Objectives To evaluate the late effectiveness of the Sparrow® drug-eluting stent, regarding in-stent late lumen loss (LLL). Methods Patients with ischemia, symptomatic or documented, were submitted to PCA in vessels with reference diameter < 2.75 mm, divided into two groups regarding Sparrow® stent type: group 1: Sparrow® drug-eluting stent (DES), group 2: Sparrow® bare metal stent (BMS). Clinical follow-up duration was 12 months. Evaluation using quantitative coronary angiography (QCA) was performed immediately and at 8 months. A decrease of over 65% of in-stent LLL with DES was estimated to calculate sample size. IBM® SPSS software, release 19 (Chicago, Illinois, USA) was used for the statistical analysis. Results A total of 24 patients were randomized, 12 in each group. The DES and BMS groups were similar in age (63.25 ± 10.01 vs. 64.58 ± 11.54, p = 0.765), male gender (58.3% vs. 33.3%, p = 0.412), risk factors and all angiographs aspects. Immediate results were satisfactory in both groups. At 8 months in-stent late lumen loss was significantly lower in DES than in BMS group (DES vs. BMS 0.25 ± 0.16 0.97 ± 0.76, p = 0.008). Conclusion In small-vessel PCA, the Sparrow® DES determined significant reduction in in-stent LLL, when compared to Sparrow® BMS. PMID:24100691

  20. Comparison of Full Lesion Coverage versus Spot Drug-Eluting Stent Implantation for Coronary Artery Stenoses

    PubMed Central

    Kim, Seunghwan; Yun, Kyeong Ho; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2014-01-01

    Purpose The aim of this study was to evaluate and compare the long-term clinical outcomes of the spot drug-eluting stent (DES) implantation strategy, which is used to minimize implanted stent length and the number of stents, versus full lesion coverage for treatment of coronary artery stenoses. Materials and Methods We evaluated 1-year clinical outcomes of 1619 patients with stent implantation for a single coronary lesion. They were divided into two groups: those treated by full lesion coverage (n=1200) and those treated with the spot stenting strategy (n=419). The combined occurrence of 1-year target vessel failure (TVF), including cardiac death, target-vessel related myocardial infarction, or ischemia-driven target-vessel revascularization was evaluated. Results The spot DES implantation group had a shorter stent length (23.14±9.70 mm vs. 25.44±13.24 mm, respectively; p<0.001) and a fewer number of stents (1.09±0.30 vs. 1.16±0.41, respectively; p<0.001), even though the average lesion length was similar to the full lesion coverage group (21.36±10.30 mm vs. 20.58±10.97 mm, respectively; p=0.206). Spot DES implantation was superior to full DES coverage with respect to 1-year TVF (1.4% vs. 3.3%, p=0.044). Cox proportional hazard model analysis showed that the risk for 1-year TVF was almost 60% lower among patients who received spot DESs compared to those who received full DES coverage after adjustment for other risk factors (HR=0.40, 95% confidence interval=0.17-0.98; p=0.046). Conclusion Minimizing stent length and the number of stents with overlapping by spot DES implantation may result in reduced rates of 1-year TVF, compared with full DES coverage. PMID:24719123

  1. Chemico-physical characterisation and in vivo biocompatibility assessment of DLC-coated coronary stents.

    PubMed

    Castellino, Micaela; Stolojan, Vlad; Virga, Alessandro; Rovere, Massimo; Cabiale, Karine; Galloni, Marco R; Tagliaferro, Alberto

    2013-01-01

    The vast majority of stent thrombosis occurs in the acute and sub-acute phases and is more common in patients with acute coronary syndromes, due to the thrombotic milieu where stent struts are positioned. Stent thrombosis is likely due to incomplete tissue coverage of metallic stents as the contact between metallic stents and blood elements may lead to platelet adhesion and trigger vessel thrombosis. If a stent is covered after 7 days, the risk that it will be found uncovered at later stages is very low (<1%). In this article, we demonstrate that diamond-like carbon (DLC) coatings, deposited by physical vapour deposition, promote rapid endothelisation of coronary stent devices, with very low platelets activation, reducing thrombotic clots. We relate these behaviours to the surface and bulk material properties of the DLC films, subjected to a comprehensive chemico-physical characterisation using several techniques (X-ray photoelectron spectroscopy, atomic force microscopy, field-emission scanning electron microscope, transmission electron microscopy combined with electron energy loss spectroscopy, Raman and dispersive X-ray spectroscopy). In vivo studies, conducted on 24 pigs, have shown complete endothelisation after 7 days, with no fibrin mesh and with only rare monocytes scattered on the endothelial layer while 30 and 180 days tests have shown reduced inflammatory activation and a complete stabilisation of the vessel healing, with a minimal neointimal proliferation. The integral and permanent DLC film coating improves haemo- and bio-compatibility and leads to an excellent early vessel healing of the stent whilst the extremely thin strut thickness reduces the amount of late neointima and consequently the risk of late restenosis. These data should translate into a reduced acute and sub-acute stent thrombosis.

  2. Successful Coronary Stent Retrieval from the Saphenous Vein Graft to Right Coronary Artery

    PubMed Central

    Aydin, Mustafa; Sayin, Muhammet Rasit

    2009-01-01

    Stent dislodgement and migration is a rare but serious complication of stent usage. For extraction of unexpanded stents different techniques have been described previously. We describe a case which used small baloon catheter for retrieval of a stent from the SVG-RCA. PMID:19902010

  3. Stent overlapping and geometric curvature influence the structural integrity and surface characteristics of coronary nitinol stents.

    PubMed

    Kapnisis, Konstantinos K; Halwani, Dina O; Brott, Brigitta C; Anderson, Peter G; Lemons, Jack E; Anayiotos, Andreas S

    2013-04-01

    Preliminary studies have revealed that some stents undergo corrosion and fatigue-induced fracture in vivo, with significant release of metallic ions into surrounding tissues. A direct link between corrosion and in-stent restenosis has not been clearly established; nonetheless in vitro studies have shown that relatively high concentrations of heavy metal ions can stimulate both inflammatory and fibrotic reactions, which are the main steps in the process of restenosis. To isolate the mechanical effects from the local biochemical effects, accelerated biomechanical testing was performed on single and overlapping Nickel-Titanium (NiTi) stents subjected to various degrees of curvature. Post testing, stents were evaluated using Scanning Electron Microscopy (SEM) to identify the type of surface alterations. Fretting wear was observed in overlapping cases, in both straight and curved configurations. Stent strut fractures occurred in the presence of geometric curvature. Fretting wear and fatigue fractures observed on stents following mechanical simulation were similar to those from previously reported human stent explants. It has been shown that biomechanical factors such as arterial curvature combined with stent overlapping enhance the incidence and degree of wear and fatigue fracture when compared to single stents in a straight tube configuration.

  4. Finite element analysis of balloon-expandable coronary stent deployment: influence of angioplasty balloon configuration.

    PubMed

    Martin, David; Boyle, Fergal

    2013-11-01

    Today, the majority of coronary stents are balloon-expandable and are deployed using a balloon-tipped catheter. To improve deliverability, the membrane of the angioplasty balloon is typically folded about the catheter in a pleated configuration. As such, the deployment of the angioplasty balloon is governed by the material properties of the balloon membrane, its folded configuration and its attachment to the catheter. Despite this observation, however, an optimum strategy for modelling the configuration of the angioplasty balloon in finite element studies of coronary stent deployment has not been identified, and idealised models of the angioplasty balloon are commonly employed in the literature. These idealised models often neglect complex geometrical features, such as the folded configuration of the balloon membrane and its attachment to the catheter, which may have a significant influence on the deployment of a stent. In this study, three increasingly sophisticated models of a typical semi-compliant angioplasty balloon were employed to determine the influence of angioplasty balloon configuration on the deployment of a stent. The results of this study indicate that angioplasty balloon configuration has a significant influence on both the transient behaviour of the stent and its impact on the mechanical environment of the coronary artery.

  5. Use of Drug-Eluting Stents in Patients With Coronary Artery Disease and Renal Insufficiency

    PubMed Central

    El-Menyar, Ayman A.; Al Suwaidi, Jassim; Holmes, David R.

    2010-01-01

    Renal insufficiency (RI) has been shown to be associated with increased major adverse cardiovascular events after percutaneous coronary intervention. We reviewed the impact of RI on the pathogenesis of coronary artery disease and outcomes after percutaneous coronary intervention in the form of drug-eluting stent (DES) implantation in these high-risk patients. We searched the English-language literature indexed in MEDLINE, Scopus, and EBSCO Host research databases from 1990 through January 2009, using as search terms coronary revascularization, drug-eluting stent, and renal insufficiency. Studies that assessed DES implantation in patients with various degrees of RI were selected for review. Most of the available data were extracted from observational studies, and data from randomized trials formed the basis of a post hoc analysis. The outcomes after coronary revascularization were less favorable in patients with RI than in those with normal renal function. In patients with RI, DES implantation yielded better outcomes than did use of bare-metal stents. Randomized trials are needed to define optimal treatment of these high-risk patients with coronary artery disease. PMID:20118392

  6. Incidence and significance of the pseudo stent strut in optical coherence tomography analysis for coronary artery stents

    NASA Astrophysics Data System (ADS)

    Suzuki, Nobuaki; Kozuma, Ken; Hatsuno, Taketo; Takada, Kaoru; Iino, Ryu; Maeno, Yoshio; Yamamoto, Hirosada; Shiratori, Yoshitaka; Ishikawa, Shuichi; Miyazawa, Akiyoshi; Isshiki, Takaaki

    2010-02-01

    Introduction: Quantitative optical coherence tomography (OCT) analysis is about to be relevant for the correct assessment of incomplete stent apposition which can result to late stent thrombosis. Nevertheless, the pseudo stent struts (PS), which show the strong signal same as the true strut, are sometimes seen at odd positions in the lumen and locate at the same distance from the image wire as a true strut. PS may be produced by the distorted beam and interfere accurate analysis. Our aim was to investigate the incidence of PS. Methods: We created a simple phantom model (2.5 mm-coronary artery stent apposed in 2.5-mm silicon tube). OCT pullback images at 1 mm/sec were obtained with an eccentric imagewire position for 5 times with different 5 pieces of imagewire. The strut location was recognized by the strong signal. Of these, PS was defined as: an irregularity of the alignment of strut locations; the difference in the strut-wire distance with one of the adjacent struts is within 20 micron. Strut contour with and without PS were delineated by semi-automated dedicated software with cubic spline interpolation, and symmetry index (= Min/Max diameter) was calculated. Results: In the phantom with Cypher stent and Tsunami stent, a pseudo strut reflection was observed in 71 of 7112 (1%) frames and 43 of 10302 (0.4%) frames, respectively. The PS incidence was the highest at fifth pull-back images. The symmetry index was significantly higher in strut contours without pseudo strut (0.95+/-0.02 versus 0.83+/-0.07, p<0.001). Conclusion: PS may mislead to the wrong data of clinical OCT analysis, in spite of the infrequency. When one starts to use the new image modality, one should be careful if there is some artifact which can affect on the data of the clinical investigations.

  7. Coronary stent strut size dependent stress-strain response investigated using micromechanical finite element models.

    PubMed

    Savage, P; O'Donnell, B P; McHugh, P E; Murphy, B P; Quinn, D F

    2004-02-01

    Cardiovascular stents are metal scaffolds that are used in the treatment of atherosclerosis. These devices are typically composed of very thin struts (< or = 100 microm thickness, for coronary applications). At this size-scale the question arises as to the suitability of using bulk material properties in stent design. This paper investigates the use of finite element analysis to predict the mechanical failure of stent struts, typical of the strut size used in coronary stents. 316 L stainless steel in uniaxial loading was considered. To accurately represent the constitutive behavior of the material at this size-scale, a computational micromechanics approach was taken involving an explicit representation of the grain structure in the steel struts, and the use of crystal plasticity theory to represent the constitutive behavior of the individual grains. The development of the finite element models is discussed and results are presented for the predictions of tensile mechanical behavior as a function of strut thickness. The results showed that using this modelling approach, a size effect, already seen experimentally, is produced. This has significant implications for stent design, especially in the context of the desire to produce smaller stents for small bore neurovascular and peripheral artery applications.

  8. Clinical Outcome of Double Kissing Crush Versus Provisional Stenting of Coronary Artery Bifurcation Lesions

    PubMed Central

    Santoso, Teguh; Zhang, Jun-Jie; Ye, Fei; Xu, Ya-Wei; Fu, Qiang; Kan, Jing; Zhang, Feng-Fu; Zhou, Yong; Xie, Du-Jiang; Kwan, Tak W.

    2017-01-01

    Background— Provisional stenting is effective for anatomic simple bifurcation lesions. Double kissing crush stenting reduces the 1-year rate of target lesion revascularization. This study aimed to investigate the 5-year clinical results of the DKCRUSH-II study (Randomized Study on Double Kissing Crush Technique Versus Provisional Stenting Technique for Coronary Artery Bifurcation Lesions). Methods and Results— A total of 370 patients with coronary bifurcation lesions who were randomly assigned to either the double kissing crush or provisional stenting group in the DKCRUSH-II study were followed for 5 years. The primary end point was the occurrence of a major adverse cardiac event at 5 years. Patients were classified by simple and complex bifurcation lesions according to the DEFINITION criteria (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents). At 5 years, the major adverse cardiac event rate (23.8%) in the provisional stenting group was insignificantly different to that of the double kissing group (15.7%; P=0.051). However, the difference in the target lesion revascularization rate between 2 groups was sustained through the 5-year follow-up (16.2% versus 8.6%; P=0.027). The definite and probable stent thrombosis rate was 2.7% in each group (P=1.0). Complex bifurcation was associated with a higher rate of target lesion revascularization (21.6%) at 5 years compared with 11.1% in patients with a simple bifurcation (P=0.037), with an extremely high rate in the provisional stenting group (36.8% versus 12.5%, P=0.005) mainly because of final kissing balloon inflation (19.4% versus 5.2%; P=0.036). Conclusions— The double kissing crush stenting technique for coronary bifurcation lesions is associated with a lower rate of target lesion revascularization. The optimal stenting approach based on the lesions’ complexity may improve the revascularization for patients with

  9. In vivo volumetric analysis of coronary stent using optical coherence tomography with a novel balloon occlusion-flushing catheter: a comparison with intravascular ultrasound.

    PubMed

    Kawase, Yoshiaki; Hoshino, Kozo; Yoneyama, Ryuichi; McGregor, Jennifer; Hajjar, Roger J; Jang, Ik-Kyung; Hayase, Motoya

    2005-10-01

    Optical coherence tomography (OCT) is limited as an intravascular imaging tool because of interference with blood. This study tested a new balloon occlusion-flushing catheter for OCT scanning of stented coronary arteries and compared stent measurements between OCT and intravascular ultrasound (IVUS). Motorized pullback with OCT and IVUS was examined in coronary stents deployed in swine. Quantitative measurements were obtained and compared between both groups. In addition, stent strut thickness was compared among OCT, IVUS and actual measurement. The occlusion catheter successfully provided motorized pullback OCT images in the stented coronary arteries without any complications. There were no differences in calculated lumen volume. However, stent volumes were significantly smaller with OCT than with IVUS (p < 0.05). OCT significantly underestimated the stent strut thickness compared with the actual measurement. Although OCT underestimates the stent strut thickness, motorized pullback OCT imaging with the occlusion catheter can provide appropriate in-stent images in the porcine coronary arteries.

  10. Shrinking the Supply Chain for Implantable Coronary Stent Devices.

    PubMed

    Moore, Sean S; O'Sullivan, Kevin J; Verdecchia, Francesco

    2016-02-01

    Stenting treatments for the management of disease in the heart, arterial and venous systems, biliary ducts, urethras, ureters, oesophageal tract and prostate have made enormous technical advances since their introduction into clinical use. The progression from metallic to polymer based bio-absorbable stents, coupled with the advances in additive manufacturing techniques, present a unique opportunity to completely re-envision the design, manufacture, and supply chain of stents. This paper looks at current stenting trends and proposes a future where the stent supply chain is condensed from ~150 days to ~20 min. The Cardiologist therefore has the opportunity to become a designer, manufacturer and user with patients receiving custom stents specific to their unique pathology that will be generated, delivered and deployed in the Cath-lab. The paper will outline this potentially revolutionary development and consider the technical challenges that will need to be overcome in order to achieve these ambitious goals. A high level overview of the generating eluting stents in situ program-GENESIS-is outlined including some early experimental work.

  11. [A long term accelerating corrosion fatigue texting of coronary stents in vitro].

    PubMed

    Wang, Jianyu; Li, Jiage; Tang, Jinglong; Lu, Songfang; Xi, Tingfei

    2008-04-01

    According to the related standards, an in vitro corrosion fatigue testing of coronary stents was designed. The stents were fixed in the latex tubes, which were full of 0.9% saline solution, and radial stress was produced for simulating natural vessel. The accelerated fatigue test was performed with 4 x 10(8) cycles at a frequency of 60 Hz, which was equal to 10 years in vivo implantation. Twelve coronary stents made from stainless steel were adopted in the experiment. The bulk structure and surface morphology before and after testing were analysed by scanning electron microscopy. The structure damage and surface change caused by corrosion fatigue were identified and the probable reasons were proposed.

  12. Coronary artery aneurysm formation following implantation of a bioresorbable vascular scaffold for in-stent restenosis.

    PubMed

    García-Guimaraes, Marcos; Cuesta, Javier; Alvarado, Teresa; Rivero, Fernando; Bastante, Teresa; Benedicto, Amparo; Alfonso, Fernando

    2017-06-01

    Coronary artery aneurysm (CAA) formation is a rare complication of coronary intervention that may develop after implantation of bare-metal or drug-eluting stents. The etiology of this entity appears to be multifactorial and its prognosis is poorly understood, but it has been associated with an increased risk of stent thrombosis. To date few cases of CAAs related to bioresorbable vascular scaffold (BVS) implantation have been reported, and the development of CAA after BVS implantation for the treatment of in-stent restenosis (ISR) has not been previously described. Here we present two cases of CAA formation after BVS, which represent the first demonstration of CAA formation after the use of BVS for ISR. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  13. High-Definition Computed Tomography for Coronary Artery Stent Imaging: a Phantom Study

    PubMed Central

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

    2012-01-01

    Objective 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). Materials and Methods 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 (AVin-stent) and the in-vessel extra-stent attenuation value (AVin-vessel) were measured by two observers. The artificial lumen narrowing (ALN = [ISD - ISDmeasured]/ISD) and artificial attenuation increase between in-stent and in-vessel (AAI = AVin-stent - AVin-vessel) were calculated. All data was analyzed by intraclass correlation and ANOVA-test. Results The correlation coefficient of ISD, AVin-vessel and AVin-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). Conclusion 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). PMID:22247632

  14. Successful outcome of emergency coronary artery bypass grafting and retrieval of entrapped stent, angioplasty balloon, and guidewire.

    PubMed

    Karthik, Shishir; Silverton, Paul; Blaxill, Jonathan A; O'Regan, David J

    2005-03-01

    A 42-year-old man presented with worsening of angina after a recent angioplasty and stenting. Repeat angiography revealed further untreated lesions in the left anterior descending coronary artery. The patient underwent re-angioplasty and stenting. After stent deployment, the guidewire and balloon got entrapped in the left anterior descending coronary artery, which was associated with hypotension and ischemic changes of the anterolateral wall on electrocardiogram. The patient was stabilized with the insertion of an intraaortic balloon pump, and he underwent emergency coronary artery bypass grafting and removal of the entrapped equipment. He had an uneventful postoperative recovery.

  15. Adenosine triphosphate stress 99mTc-methoxyisobutylisonitrile gated myocardial perfusion imaging efficacy in diagnosing stent restenosis following coronary stent implantation

    PubMed Central

    Zhang, Pengfei; Chen, Song; Li, Yang; Du, Qiuhong; Wang, Lijuan; Sun, Yingxian; Li, Yaming

    2016-01-01

    Coronary stent restenosis rate following implantation is considerably high. The adenosine stress gated myocardial perfusion imaging (G-MPI) method has been widely used in the diagnosis, risk stratification and prognosis evaluation of coronary heart disease; however, the high cost of adenosine limits its clinical application. The aim of the present study was to investigate the efficacy of adenosine triphosphate (ATP) stress 99mTc-methoxyisobutylisonitrile (99mTc-MIBI) G-MPI for diagnosis in-stent restenosis following coronary stent implantation. Data from 66 patients with typical angina pectoris symptoms who had undergone percutaneous coronary stent implantation >3 months prior to participation in the study were analyzed. All the patients underwent ATP stress 99mTc-MIBI G-MPI and coronary artery angiography as the criterion diagnostic standard within 1 month. The sensitivity, specificity, and accuracy of ATP stress 99mTc-MIBI G-MPI in the assessment of in-stent restenosis were calculated. In addition, Fisher's exact probability methods were used to compare differences between experimental groups. Among 66 patients with a total of 99 implanted coronary arterial branches, 39 patients (59%) with 45 coronary arteries (45%) presented in-stent restenosis. The diagnostic sensitivity, specificity, accuracy, positive predictive and negative predictive value of ATP stress 99mTc-MIBI G-MPI for assessing stent restenosis in all patients were 85, 89, 86, 92 and 80%, respectively. Similarly, these values in patients with myocardial infarction were 79, 88, 83, 88 and 78%, respectively, while in patients without myocardial infarction the values were 90, 91, 90, 95 and 83%, respectively. Therefore, the diagnostic efficacy of ATP stress 99mTc-MIBI G-MPI in patients without myocardial infarction was higher compared with those with myocardial infarction; however, no significant difference was observed between the two groups. Furthermore, the sensitivity, specificity and accuracy for

  16. Adenosine triphosphate stress (99m)Tc-methoxyisobutylisonitrile gated myocardial perfusion imaging efficacy in diagnosing stent restenosis following coronary stent implantation.

    PubMed

    Zhang, Pengfei; Chen, Song; Li, Yang; Du, Qiuhong; Wang, Lijuan; Sun, Yingxian; Li, Yaming

    2016-12-01

    Coronary stent restenosis rate following implantation is considerably high. The adenosine stress gated myocardial perfusion imaging (G-MPI) method has been widely used in the diagnosis, risk stratification and prognosis evaluation of coronary heart disease; however, the high cost of adenosine limits its clinical application. The aim of the present study was to investigate the efficacy of adenosine triphosphate (ATP) stress (99m)Tc-methoxyisobutylisonitrile ((99m)Tc-MIBI) G-MPI for diagnosis in-stent restenosis following coronary stent implantation. Data from 66 patients with typical angina pectoris symptoms who had undergone percutaneous coronary stent implantation >3 months prior to participation in the study were analyzed. All the patients underwent ATP stress (99m)Tc-MIBI G-MPI and coronary artery angiography as the criterion diagnostic standard within 1 month. The sensitivity, specificity, and accuracy of ATP stress (99m)Tc-MIBI G-MPI in the assessment of in-stent restenosis were calculated. In addition, Fisher's exact probability methods were used to compare differences between experimental groups. Among 66 patients with a total of 99 implanted coronary arterial branches, 39 patients (59%) with 45 coronary arteries (45%) presented in-stent restenosis. The diagnostic sensitivity, specificity, accuracy, positive predictive and negative predictive value of ATP stress (99m)Tc-MIBI G-MPI for assessing stent restenosis in all patients were 85, 89, 86, 92 and 80%, respectively. Similarly, these values in patients with myocardial infarction were 79, 88, 83, 88 and 78%, respectively, while in patients without myocardial infarction the values were 90, 91, 90, 95 and 83%, respectively. Therefore, the diagnostic efficacy of ATP stress (99m)Tc-MIBI G-MPI in patients without myocardial infarction was higher compared with those with myocardial infarction; however, no significant difference was observed between the two groups. Furthermore, the sensitivity, specificity and

  17. Percutaneous transradial artery approach for coronary Palmaz-Schatz stent implantation.

    PubMed

    Kiemeneij, F; Laarman, G J

    1994-07-01

    The purpose of this study was to evaluate feasibility, safety, and efficacy of implantation of unsheathed Palmaz-Schatz coronary stents via the radial artery. Anticoagulation after coronary stenting has the hazard of vascular complications if large-bore guiding catheters are introduced via the femoral artery. Such complications have serious local sequelae, are associated with suboptimal anticoagulation, and prolong hospitalization. By combining 6F guiding catheters and low-profile dilatation catheters with bare Palmaz-Schatz stents, smaller vessels such as the radial artery can be selected as the entry site. It is postulated that no major puncture site-related complications occur because hemostasis is easily achieved and no veins and nerves are near the radial artery. With double blood supply to the hand, radial artery occlusion is well tolerated. Twenty-five bare Palmaz-Schatz stents were implanted via the radial artery through 6F guiding catheters in 20 consecutive patients for venous bypass graft stenosis (n = 9; 45%), native coronary artery restenosis (n = 7; 35%) and suboptimal transradial artery PTCA (n = 4; 20%). Immediately after stent implantation and assessment of the result by means of computerized quantitative coronary analysis, the arterial sheath was withdrawn followed by intense anticoagulation and free ambulation of the patient. Radial artery function and anatomy were assessed by two-dimensional and Doppler ultrasound examination. Lesions (n = 24) were of type A (n = 13; 54%), B (n = 6; 25%) and C (n = 5; 21%). The reference diameter of the stented segments was 3.2 +/- 0.5 mm (2.2 to 4.2 mm).(ABSTRACT TRUNCATED AT 250 WORDS)

  18. In situ coronary stent paving by Pluronic F127-alginate gel blends: Formulation and erosion tests.

    PubMed

    Dalmoro, Annalisa; Barba, Anna Angela; Grassi, Mario; Grassi, Gabriele; Lamberti, Gaetano

    2016-07-01

    In this work the development of an experimental protocol to perform the in situ gel-paving of coronary stent is presented. Biocompatible aqueous blends of Pluronic F127 and sodium alginates are used as potential drug dosage system for pharmacological in situ treatment of coronary in-stent restenosis. Pluronic F127/alginate aqueous blend has the unique characteristic to be liquid at room condition and to form gel at physiological temperature. The proposed protocol is based on the blend injection on stent wall previously implanted in a flexible silicon pipe mimicking the coronary artery. Injected blend is warmed up until human body temperature achieving a soft gel, then it is reticulated by copper bivalent ions to obtain an hard gel. To test the gel paving resistance to erosion phenomena when it is exposed to fluid flux (i.e. blood flux) a dedicated device, (the Simulated Artery Device, SAD), was built to simulate the human circulatory apparatus. The SAD is an hydraulic circuit in which a buffer solution (at pH 7.4) was fluxed by a peristaltic pump through the pipe hosting the covered stent. Erosion tests were performed monitoring, by gravimetric and spectrophotometric methods, the residual mass anchored to stent mesh after given times. The obtained results showed that the in situ gel-paving developed protocol was efficacious and reliable. The gel-paving was completely eroded in a time of the same order of magnitude of the physiological period required to restore the coronary lesion (subsequent to the atheroma removal) and of a pharmacological therapy to inhibit the in-stent-restenosis pathology. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1013-1022, 2016. © 2015 Wiley Periodicals, Inc.

  19. Local Angiopeptin Delivery Using Coated Stents Reduces Neointimal Proliferation in Overstretched Porcine Coronary Arteries.

    PubMed

    De Scheerder I; Wilczek; Van Dorpe J; Verbeken; Cathapermal; Wang; Desmet; Schacht; Foegh; De Geest H; Piessens

    1996-06-01

    BACKGROUND: Systemic administration of angiopeptin has been shown to inhibit myointimal thickening after arterial injury in several animal species. METHODS AND RESULTS: To explore to what extent high and long-lasting local concentrations of angiopeptin influence the healing process after vascular injury, tantalum balloon-expandable stents were first coated with a polymer loaded with angiopeptin 250 µg. Implantation of these stents in porcine coronary arteries resulted in tissue concentrations of 10.7 pg/ml wet weight in the stented arterial segment 24 hours after stent implantation, gradually declining to 2.0 pg/ml wet weight at day 8. Finally, 20 pigs were randomly treated with either an angiopeptin-loaded or a blank-coated stent. At baseline, the angiographic parameters were similar between both groups but, after 6 weeks, the minimal luminal diameter of the stented arterial segment was larger in the angiopeptin-treated pigs when compared to controls (2.20 +/- 0.57 mm vs 1.57 +/- 0.68 mm, p < 0.01) This angiographic finding was confirmed by post-mortem morphometry where the respective lumen area values were 1.00 +/- 0.54 mm2 and 0.43 +/- 0.28 mm2 (p < 0.01). CONCLUSION: Polymer coated stents can be loaded with angiopeptin, which after implantation in porcine right coronary arteries result in high local tissue concentrations gradually declining over more than 8 days. These high local concentrations inhibit myointimal proliferation induced by poly(organo)phosphazene coated overstretched stents.

  20. Design Optimization of Coronary Stent Based on Finite Element Models

    PubMed Central

    Qiu, Tianshuang; Zhu, Bao; Wu, Jinying

    2013-01-01

    This paper presents an effective optimization method using the Kriging surrogate model combing with modified rectangular grid sampling to reduce the stent dogboning effect in the expansion process. An infilling sampling criterion named expected improvement (EI) is used to balance local and global searches in the optimization iteration. Four commonly used finite element models of stent dilation were used to investigate stent dogboning rate. Thrombosis models of three typical shapes are built to test the effectiveness of optimization results. Numerical results show that two finite element models dilated by pressure applied inside the balloon are available, one of which with the artery and plaque can give an optimal stent with better expansion behavior, while the artery and plaque unincluded model is more efficient and takes a smaller amount of computation. PMID:24222743

  1. Left main coronary artery stenosis treatment with two paclitaxel-eluting stents in a patient with cardiac allograft vasculopathy.

    PubMed

    Martínez-Ríos, Marco A; Méndez-Ortíz, Arturo; Gaspar, Jorge; Barragán-García, Rodolfo; Fernández-de-la-Reguera, Guillermo; González-Quesada, Carlos J

    2008-01-01

    Cardiac transplantation is a well defined therapy for end stage heart failure. After the first year of transplantation, allograft coronary artery disease (ACAD) is the second main cause of death. The ACAD is defined as a diffuse process affecting the entire length of epicardial vessels. Once ACAD has been established, treatments such as coronary angioplasty, coronary stenting, and coronary bypass are performed. We present a case of successful stenting of the left main coronary artery (LMCA) in a patient with ACAD. The patient's medical history was significant for heart transplantation due to ischemic heart failure. Four years after transplantation the patient was admitted again due to sudden worsening of New York Heart Association functional class and extreme fatigue. Coronary angiogram showed a severe stenosis in the proximal segment of the LMCA; we performed stenting with a paclitaxel-eluting stent (PES). Six months after the procedure, the patient had an elective angiogram, where we discovered a new severe occlusion distally to the former stent; a second PES was implanted. Fourteen months after the second stenting, a new elective angiogram was performed without evidence of in-stent restenosis. After a 8-year follow-up since transplantation, the patient is free from dyspnea, angina, and adverse cardiovascular events. Our report suggests the efficacy of PES as ACAD treatment of the unprotected LMCA.

  2. Nobori-Biolimus-Eluting Stents versus Resolute Zotarolimus-Eluting Stents in Patients Undergoing Coronary Intervention: A Propensity Score Matching

    PubMed Central

    Tantawy, Ayman; Ahn, Chul-Min; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo

    2017-01-01

    Purpose To compare the 1-year outcomes of a durable polymer Zotarolimus-eluting stent (ZES) versus a biodegradable polymer Biolimus-eluting stent (BES) in patients undergoing percutaneous coronary intervention. Materials and Methods A total of 2083 patients from 2 different registries, 1125 treated with BES in NOBORI registry and 858 received ZES in CONSTANT registry were included in this study. Clinical outcomes were compared with the use of propensity score matching (PSM). The primary endpoint was a composite of major adverse cardiovascular and cerebrovascular events (MACCEs) including cardiac death, myocardial infarction, clinically driven target lesion revascularization and stroke. Secondary end points were individual components of MACCEs as well as the incidence of stent thrombosis at 1-year follow-up. Results After PSM, 699 matched pairs of patients (n=1398) showed no significant difference between BES and ZES in the risk of composite MACCEs at 1 year (2.6% vs. 1.7%; p=0.36). Cardiac death was not statistically different between groups (0.7% vs. 0.4%, p=0.73). Target lesion revascularization rate was also similar between BES and ZES (1.1% vs. 0.7%, p=0.579). Non-Q wave myocardial infarction, as well as target-vessel revascularization rate, was similar between the two groups (0.14% for BES and 0.72% for ZES). Both stent types were excellent with no cases of stent thrombosis and rate of Q wave myocardial infarction reported during the follow-up period. Conclusion In this cohort of patients treated with BES or ZES, the rate of MACCEs at 1 year was low and significantly not different between both groups. PMID:28120558

  3. The SYNERGY biodegradable polymer everolimus eluting coronary stent: Porcine vascular compatibility and polymer safety study.

    PubMed

    Wilson, Gregory J; Marks, Angela; Berg, Kimberly J; Eppihimer, Michael; Sushkova, Natalia; Hawley, Steve P; Robertson, Kimberly A; Knapp, David; Pennington, Douglas E; Chen, Yen-Lane; Foss, Aaron; Huibregtse, Barbara; Dawkins, Keith D

    2015-11-15

    SYNERGY is a novel platinum chromium alloy stent that delivers abluminal everolimus from an ultrathin poly-lactide-co-glycide (PLGA) biodegradable polymer. This study evaluated the in vivo degradation of the polymer coating, everolimus release time course, and vascular compatibility of the SYNERGY stent. SYNERGY stents were implanted in arteries of domestic swine. Devices were explanted at predetermined time points (up to 120 days) and the extent of PLGA coating or everolimus remaining on the stents was quantified. Everolimus levels in the arterial tissue were also evaluated. A pathological analysis on coronary arteries of single and overlapping stents was performed at time points between 5 and 270 days. PLGA bioabsorption began immediately after implantation, and drug release was essentially complete by 90 days; PLGA absorption was substantially complete by 120 days (>90% of polymer was absorbed) leaving a bare metal SYNERGY stent. Vascular response was similar among SYNERGY and control stents (bare metal, polymer-only, and 3× polymer-only). Mild increases in para-strut fibrin were seen for SYNERGY at an early time point with no significant differences in all other morphological and morphometric parameters through 270 days or endothelial function (eNOS immunostaining) at 90 or 180 days. Inflammation was predominantly minimal to mild for all device types. In a swine model, everolimus was released by 90 days and PLGA bioabsorption was complete shortly thereafter. The SYNERGY stent and its biodegradable polymer, even at a 3× safety margin, demonstrated vascular compatibility similar to bare metal stent controls. © 2015 Wiley Periodicals, Inc.

  4. Outcomes with various drug-eluting or bare metal stents in patients with ST-segment-elevation myocardial infarction: a mixed treatment comparison analysis of trial level data from 34 068 patient-years of follow-up from randomized trials.

    PubMed

    Bangalore, Sripal; Amoroso, Nicholas; Fusaro, Mario; Kumar, Sunil; Feit, Frederick

    2013-08-01

    The efficacy and safety of drug-eluting stents (DES) in patients with ST-segment-elevation myocardial infarction (STEMI) is controversial. Consequently, DES implantation has a class IIa indication in the American College of Cardiology/American Heart Association and the European Society of Cardiology STEMI guidelines. PUBMED, EMBASE, and CENTRAL were searched for randomized clinical trials, until March 2013, comparing any of the 5 Food and Drug Administration-approved durable stent and polymer DES (sirolimus eluting stent, paclitaxel eluting stent, everolimus-eluting stent [EES], zotarolimus-eluting stent, and zotarolimus-eluting stent resolute), against each other or bare metal stents (BMS), and enrolling ≥ 50 patients with STEMI. Efficacy (target vessel revascularization) and safety (death, myocardial infarction, and stent thrombosis) outcomes at the longest reported follow-up times were evaluated. Twenty-eight randomized clinical trials with 34 068 patient-years of follow-up on subjects with STEMI fulfilled the inclusion criteria. When compared with BMS (reference rate ratio [RR] of 1), sirolimus eluting stent (RR, 0.46; 95% credibility interval [CrI], 0.36-0.56), paclitaxel eluting stent (RR, 0.69; 95% CrI, 0.53-0.87), and EES (RR, 0.42; 95% CrI, 0.26-0.62) were associated with a statistically significant reduction in rate of target vessel revascularization, with the point estimate for zotarolimus-eluting stent resolute trending in a similar direction. There was no increase in the risk of death, myocardial infarction, or stent thrombosis with any DES compared with BMS. Moreover, EES was associated with a statistically significant reduction in the rate of stent thrombosis when compared with sirolimus eluting stent (RR, 0.38; 95% CrI, 0.21-0.74), paclitaxel eluting stent (RR, 0.39; 95% CrI, 0.21-0.73), and even BMS (RR, 0.42; 95% CrI, 0.23-0.76). There was a 74% probability that EES had the lowest rate of any stent thrombosis when compared with all other stent

  5. A Novel Tram Stent Method in the Treatment of Coronary Bifurcation Lesions – Finite Element Study

    PubMed Central

    Arokiaraj, Mark C.; De Santis, Gianluca; De Beule, Matthieu; Palacios, Igor F.

    2016-01-01

    A novel stent was designed for the treatment of coronary bifurcation lesion, and it was investigated for its performance by finite element analysis. This study was performed in search of a novel method of treatment of bifurcation lesion with provisional stenting. A bifurcation model was created with the proximal vessel of 3.2 mm diameter, and the distal vessel after the side branch (2.3 mm) was 2.7 mm. A novel stent was designed with connection links that had a profile of a tram. Laser cutting and shape setting of the stent was performed, and thereafter it was crimped and deployed over a balloon. The contact pressure, stresses on the arterial wall, stresses on the stent, the maximal principal log strain of the main artery and the side-branch were studied. The study was performed in Abaqus, Simulia. The stresses on the main branch and the distal branch were minimally increased after deployment of this novel stent. The side branch was preserved, and the stresses on the side branch were lesser; and at the confluence of bifurcation on either side of the side branch origin the von-Mises stress was marginally increased. The stresses and strain at the bifurcation were significantly lesser than the stresses and strain of the currently existing techniques used in the treatment of bifurcation lesions though the study was primarily focused only on the utility of the new technology. There is a potential for a novel Tram-stent method in the treatment of coronary bifurcation lesions. PMID:26937643

  6. A Novel Tram Stent Method in the Treatment of Coronary Bifurcation Lesions - Finite Element Study.

    PubMed

    Arokiaraj, Mark C; De Santis, Gianluca; De Beule, Matthieu; Palacios, Igor F

    2016-01-01

    A novel stent was designed for the treatment of coronary bifurcation lesion, and it was investigated for its performance by finite element analysis. This study was performed in search of a novel method of treatment of bifurcation lesion with provisional stenting. A bifurcation model was created with the proximal vessel of 3.2 mm diameter, and the distal vessel after the side branch (2.3 mm) was 2.7 mm. A novel stent was designed with connection links that had a profile of a tram. Laser cutting and shape setting of the stent was performed, and thereafter it was crimped and deployed over a balloon. The contact pressure, stresses on the arterial wall, stresses on the stent, the maximal principal log strain of the main artery and the side-branch were studied. The study was performed in Abaqus, Simulia. The stresses on the main branch and the distal branch were minimally increased after deployment of this novel stent. The side branch was preserved, and the stresses on the side branch were lesser; and at the confluence of bifurcation on either side of the side branch origin the von-Mises stress was marginally increased. The stresses and strain at the bifurcation were significantly lesser than the stresses and strain of the currently existing techniques used in the treatment of bifurcation lesions though the study was primarily focused only on the utility of the new technology. There is a potential for a novel Tram-stent method in the treatment of coronary bifurcation lesions.

  7. Stenting of "unprotected" left main coronary artery stenoses: early and late results.

    PubMed

    Laruelle, C J; Brueren, G B; Ernst, S M; Bal, E T; Mast, G E; Suttorp, M J; Brutel de la Rivière, A; Plokker, T H

    1998-02-01

    To assess short and long term efficacy of coronary stent implantation for unprotected left main coronary artery stenosis. Retrospective follow up study. Tertiary referral centre for interventional cardiology and cardiac surgery. Eighteen consecutive patients (12 men; age 70.8 years) between May 1993 and July 1996. Ten patients presented with stable angina and underwent the procedure electively, eight patients presented either with unstable angina or myocardial infarction and underwent the procedure in emergency. Johnson and Johnson Palmaz-Schatz stents were used in 16 patients, and a Microstent and a Gianturco-Roubin in one patient each. An intra-aortic balloon pump was prophylactively used for two patients in the elective group. In the acute group, six required an intra-aortic balloon pump. Procedural success rate and major adverse cardiac events. Successful stent implantation was achieved in all patients. In the elective group, no major adverse cardiac event occurred during the procedure, but one patient had to undergo repeated angioplasty before discharge. All patients of the elective group were discharged alive and there has been one non-cardiac death during a follow up of (mean (SD)) 10 (4) months. In the emergency group, one patient died during the procedure, one patient developed a non Q-wave myocardial infarction, one patient underwent emergency coronary bypass surgery, while another patient died suddenly before hospital discharge. Six patients of the emergency group were discharged alive and there has been one non-cardiac death during a follow up of 7 (4) months. Elective stent implantation for unprotected left main coronary artery stenosis is safe and effective in selected stable patients. Urgent stent implantation, however, cannot be considered as a definitive procedure in emergency situation.

  8. 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).

  9. Angioplasty and stents in coronary artery disease: a systematic review and meta-analysis.

    PubMed

    Dündar, Yenal; Hill, Ruaraidh A; Bakhai, Ameet; Dickson, Rumona; Walley, Tom

    2004-08-01

    To undertake a systematic review of the clinical effectiveness of routine percutaneous transluminal coronary angioplasty (PTCA) plus stenting vs PTCA alone. MEDLINE; EMBASE; Science Citation Index; The Cochrane Library; cardiovascular journals and conference proceedings; Internet resources (including industry supported web pages); and reference lists of included studies and relevant reviews. Study selection included published and unpublished randomized controlled trials (RCTs) comparing the use of coronary stents to PTCA. Outcome measures assessed included death, acute myocardial infarction (AMI), event rate (such as major cardiac adverse events (MACE) or other composite measures), and binary restenosis (BR). Data extraction and quality assessment were conducted according to internationally recognized methods. Data synthesis included meta-analysis of assessed outcomes, reported as odds ratios (ORs). Fifty RCTs involving 16,500 patients met the inclusion criteria (39 full articles, 11 abstracts). Of these, 23 studies compared stenting with PTCA in patients with non-specific coronary artery disease (CAD), 11 compared stents with PTCA following AMI, 8 included patients with small coronary arteries and 8 included patients whose vessels had chronic total occlusion. There were no differences in rates of death or AMI. There were reductions in the rates of MACE (death, AMI or revascularization) with stents compared to PTCA (at 6 months, for non-specific group OR: 1.64, 95% CI 1.44-1.87; for AMI group OR: 2.36, 95% CI 1.92-2.89; for small vessel group OR: 1.38, 95% CI 1.10-1.74; at 12 months, for non-specific group OR: 1.31, 95% CI 1.11-1.55; for AMI OR: 2.26, 95% CI 1.47-3.46). Reporting of combined major adverse cardiac events was inconsistent across studies. Most events were revascularizations that may have been partly driven by protocol-required angiograms. Stents reduced BR rates at angiogram at 6 months compared to PTCA in all groups. We found no differences in

  10. Multi-objective optimization of coronary stent using Kriging surrogate model.

    PubMed

    Li, Hongxia; Gu, Junfeng; Wang, Minjie; Zhao, Danyang; Li, Zheng; Qiao, Aike; Zhu, Bao

    2016-12-28

    In stent design optimization, the functional relationship between design parameters and design goals is nonlinear, complex, and implicit and the multi-objective design of stents involves a number of potentially conflicting performance criteria. Therefore it is hard and time-consuming to find the optimal design of stent either by experiment or clinic test. Fortunately, computational methods have been developed to the point whereby optimization and simulation tools can be used to systematically design devices in a realistic time-scale. The aim of the present study is to propose an adaptive optimization method of stent design to improve its expansion performance. Multi-objective optimization method based on Kriging surrogate model was proposed to decrease the dogboning effect and the radial elastic recoil of stents to improve stent expansion properties and thus reduce the risk of vascular in-stent restenosis injury. Integrating design of experiment methods and Kriging surrogate model were employed to construct the relationship between measures of stent dilation performance and geometric design parameters. Expected improvement, an infilling sampling criterion, was employed to balance local and global search with the aim of finding the global optimal design. A typical diamond-shaped coronary stent-balloon system was taken as an example to test the effectiveness of the optimization method. Finite element method was used to analyze the stent expansion of each design. 27 iterations were needed to obtain the optimal solution. The absolute values of the dogboning ratio at 32 and 42 ms were reduced by 94.21 and 89.43%, respectively. The dogboning effect was almost eliminated after optimization. The average of elastic recoil was reduced by 15.17%. This article presents FEM based multi-objective optimization method combining with the Kriging surrogate model to decrease both the dogboning effect and radial elastic recoil of stents. The numerical results prove that the proposed

  11. Self-expanding intracoronary stents in the treatment of coronary artery disease: new developments and future directions.

    PubMed

    Lu, H; Grundeken, M J; Koch, K T; Wykrzykowska, J J

    2013-10-01

    The first stent implanted in the human coronary circulation was a self-expandable (SE) stent and was introduced almost simultaneously with the first balloon-expandable (BE) stents in the late 1980s. Nowadays, the majority of the available stents are delivered by balloon expansion. While BE stents reach their final size at the time of implantation, the SE stent continues to enlarge days to weeks after implantation. Potential advantages of the self-expandable and self-apposing properties of nitinol stents, a super-elastic metallic alloy of nickel and titanium, could be reduction of acute and late acquired stent malapposition with a subsequently decreased risk of target vessel restenosis. Several nitinol stents have been developed and clinically evaluated and are now in use in daily clinical practice. However, it is important to further improve and optimize the SE stent design and apply newer strategies to the development of next generation SE stents. The present review will provide an overview of the development of these devices and the currently available clinical evidence of the contemporary SE stents.

  12. Evaluation of coronary stents in vitro with CT angiography: effect of stent diameter, convolution kernel, and vessel orientation to the z-axis.

    PubMed

    Suzuki, Shigeru; Furui, Shigeru; Kaminaga, Tatsuro; Yamauchi, Teiyu; Kuwahara, Sadatoshi; Yokoyama, Naoyuki; Suzuki, Masatoshi; Isshiki, Takaaki

    2005-09-01

    The aims of the present study were to assess the effect of the stent diameter, convolution kernel, and vessel orientation to the z-axis on the evaluation of coronary stents, in vitro with computed tomography (CT) angiography. Seven vascular models (2 models without stenosis, 2 with obstruction, and 3 with stenosis) with an approximate inner diameter of 3 or 4 mm, filled with contrast material (79 or 330 HU) were scanned with a 16-detector CT. The diameter measurement of the stent lumen and stenosis evaluation were both done in an orientation parallel to the z-axis of the scanner using 4 convolution kernels. The measured diameters of the stented lumen were 47-57% and 36-45% smaller than the actual inner diameter of the 3- and 4-mm diameter models, respectively. The diameter measurement of the stent lumen and visualization of the in-stent stenosis were improved by using convolution kernels with higher spatial resolution. The in-stent artifacts were evaluated in 4 orientations (0 degrees , 30 degrees , 60 degrees , 90 degrees ) to the z-axis. The artifact was the minimum in 0 degrees to the z-axis, and the maximum in 90 degrees . Visualization of the lumen of a stent by CT is affected by its diameter, convolution kernel, and vessel orientation to the z-axis, and these factors should be taken into consideration in the stent evaluation.

  13. A Pilot Study on Culottes versus Crossover Single Stenting for True Coronary Bifurcation Lesions

    PubMed Central

    Zhang, Linlin; Zhong, Wenliang; Luo, Yukun; Chen, Lianglong

    2016-01-01

    Background The purpose of our study was to compare clinical and angiographic outcomes of planned culottes technique with that of provisional crossover single stenting in the treatment of true coronary bifurcation lesions (CBL) with drug-eluting stent (DES). Methods True CBL patients (n = 104) were randomly assigned to either the provisional stenting of the side branch (crossover group) or the culottes group. Additional side branch (SB) stenting in the crossover group was required if there was thrombolysis in myocardial infarction flow ≤ 1 flow). The primary end point was the occurrence of major adverse cardiac events (MACE) at nine months, including cardiac death, myocardial infarction, target lesion/vessel revascularization and in-stent thrombosis. The secondary end point was angiographic in-segment restenosis at nine months. Results The rate of MACE at nine months was similar between the crossover and culottes groups (7.7% vs. 7.7%, p = 1.000). Additional SB stenting in the crossover group was required in 3.8% of patients. There was one procedural occlusion of SB in the crossover group. At nine months, the rate of in-segment restenosis was similar in the parent main vessel (0% vs. 1.9%, p = 1.000), main branch (1.9% vs. 7.7%, p = 0.363) and SB (17.3% vs. 9.6%, p = 0.250) between the crossover and culottes groups, respectively. Conclusions This study demonstrated that there is no significant difference in cumulative MACE or in-segment restenosis between crossover and culottes groups. Larger randomized clinical trials are warranted to re-evaluate the outcomes of the provisional crossover stenting versus the culottes stenting techniques utilizing DES for true CBL. PMID:27471358

  14. Human recombinant activated protein C-coated stent for the prevention of restenosis in porcine coronary arteries.

    PubMed

    Lukovic, Dominika; Nyolczas, Noemi; Hemetsberger, Rayyan; Pavo, Imre J; Pósa, Aniko; Behnisch, Boris; Horak, Gerhard; Zlabinger, Katrin; Gyöngyösi, Mariann

    2015-10-01

    Activated protein C (APC), an endogenous protein, inhibits inflammation and thrombosis and interrupts the coagulation cascade. Here, we investigated the effect of human recombinant APC on the development of neointimal hyperplasia in porcine coronary arteries. Yukon Choice bare metal stents were coated with 2.6 µg APC/mm(2). Under general anesthesia, APC-coated and bare stents were implanted in the left anterior descending and circumflex coronary arteries of 10 domestic pigs. During the 4-week follow-up, animals were treated with dual antiplatelet therapy and neointimal hyperplasia was evaluated via histology. Scanning electron microscopy indicated successful but unequal coating of stents with APC; nearly complete drug release occurred within 4 h. Enzyme-linked immunosorbent assay revealed that intracoronary stent implantation rapidly increased the levels of monocyte chemoattractant protein-1, an effect that was inhibited by APC release from the coated stent. Fibrin deposition and adventitial inflammation were significantly decreased 1 month after implanting APC-coated stents versus bare stents, paralleled by significantly smaller neointimal area (0.98 ± 0.92 vs. 1.44 ± 0.91 mm(2), P = 0.028), higher lumen area (3.47 ± 0.94 vs. 3.06 ± 0.91 mm(2), P = 0.046), and lower stenosis area (22.2 ± 21.2% vs. 32.1 ± 20.1%, P = 0.034). Endothelialization was complete with APC-coated but not bare (90%) stents. P-selectin immunostaining revealed significantly fewer activated endothelial cells in the neointima in the APC group (4.6 ± 1.9 vs. 11.6 ± 4.1%, P < 0.001). Thus, short exposure of coronary arteries to APC reduced inflammatory responses, neointimal proliferation, and in-stent restenosis, offering a promising therapy to improve clinical outcomes of coronary stenting. However, coating stents with APC for prolonged, controlled drug release remains technically challenging.

  15. 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.

  16. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial.

    PubMed

    Kereiakes, Dean J; Meredith, Ian T; Windecker, Stephan; Lee Jobe, R; Mehta, Shamir R; Sarembock, Ian J; Feldman, Robert L; Stein, Bernardo; Dubois, Christophe; Grady, Timothy; Saito, Shigeru; Kimura, Takeshi; Christen, Thomas; Allocco, Dominic J; Dawkins, Keith D

    2015-04-01

    Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053. © 2015 American Heart Association, Inc.

  17. Diagnostic accuracy of 16-slice multidetector-row CT for detection of in-stent restenosis vs detection of stenosis in nonstented coronary arteries.

    PubMed

    Kefer, Joelle M; Coche, Emmanuel; Vanoverschelde, Jean-Louis J; Gerber, Bernhard L

    2007-01-01

    The purpose of this study was to assess the diagnostic accuracy of 16-slice multidetector-row computed tomography (MDCT) for detecting in-stent restenosis. Fifty patients with 69 previously implanted coronary stents underwent 16-slice MDCT before quantitative coronary angiography (QCA). Diagnostic accuracy of MDCT for detection of in-stent restenosis defined as >50% lumen diameter stenosis (DS) in stented and nonstented coronary segments >1.5-mm diameter was computed using QCA as reference. According to QCA, 18/69 (25%) stented segments had restenosis. In addition, 33/518 (6.4%) nonstented segments had >50% DS. In-stent restenosis was correctly identified on MDCT images in 12/18 stents, and absence of restenosis was correctly identified in 50/51 stents. Stenosis in native coronary arteries was correctly identified in 22/33 segments and correctly excluded in 482/485 segments. Thus, sensitivity (67% vs 67% p=1.0), specificity (98% vs 99%, p=0.96) and overall diagnostic accuracy (90% vs 97%, p=0.68) was similarly high for detecting in-stent restenosis as for detecting stenosis in nonstented coronary segments. MDCT has similarly high diagnostic accuracy for detecting in-stent restenosis as for detecting coronary artery disease in nonstented segments. This suggests that MDCT could be clinically useful for identification of restenosis in patients after coronary stenting.

  18. The evolution and investigation of native coronary arteries in patients after coronary stent implantation: a study by 320-detector CT angiography.

    PubMed

    Juan, Yu-Hsiang; Huang, Yu-Chieh; Sun, Zhonghua; Hsieh, I-Chang; Chan, Wen-Hui; Chen, Chun-Chi; Hung, Kuo-Chun; Wen, Ming-Shien; Wan, Yung-Liang

    2014-06-01

    To study the role of 320-detector coronary computed tomography angiography (CTA) in assessing native coronary arteries in patients treated with coronary stents. 123 patients with coronary stenting received both CTA and conventional coronary angiography (CCA) within 1 day. The clinical parameters, coronary calcium scoring, CTA and CCA were analyzed to determine the prevalence of significant stenosis of native coronary arteries (SSNCA), the predictive value of CTA and the factors correlating with SSNCA and newly developed SSNCA after stenting (NDSSNCAS), with CCA as the standard of reference, using both vessel-based analysis (VBA) and patient-based analysis (PBA). Both the source and the reconstructed images were analyzed by CTA. All native coronary arteries were interpretable independent of cardiac motion. CTA showed a sensitivity/specificity of 93.5%/97.3% and 92.5%/92.5% in diagnosing SSNCA in VBA and PBA, respectively. The significant factors related to SSNCA were higher calcium scores (P = 0.003), a higher serum glucose level (P = 0.048), a greater number of vessels without previous stent placement (P = 0.003) and fewer stents implanted within the vessels (P = 0.003). The risk factors showed no significant correlation from PBA on SSNCA or from NDSSNCAS on either VBA or PBA. CTA demonstrates excellent correlation with CCA. The prevalence of SSNCA is significantly correlated with the presence of higher calcium scores in the arteries, a higher serum glucose level, a greater number of vessels without previous stent placement and fewer stents implanted within the vessels; PBA on SSNCA and NDSSNCAS on both VBA and PBA showed no significance.

  19. 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; ...

  20. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk.

    PubMed

    Urban, Philip; Meredith, Ian T; Abizaid, Alexandre; Pocock, Stuart J; Carrié, Didier; Naber, Christoph; Lipiecki, Janusz; Richardt, Gert; Iñiguez, Andres; Brunel, Philippe; Valdes-Chavarri, Mariano; Garot, Philippe; Talwar, Suneel; Berland, Jacques; Abdellaoui, Mohamed; Eberli, Franz; Oldroyd, Keith; Zambahari, Robaayah; Gregson, John; Greene, Samantha; Stoll, Hans-Peter; Morice, Marie-Claude

    2015-11-19

    Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month. In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization. We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001). Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).

  1. Stenting of "unprotected" left main coronary artery stenoses: early and late results

    PubMed Central

    Laruelle, C; Brueren, G; Ernst, S; Bal, E; Mast, G; Suttorp, M; de la Riviere, A B.; Plokker, T

    1998-01-01

    Objective—To assess short and long term efficacy of coronary stent implantation for unprotected left main coronary artery stenosis.
Design—Retrospective follow up study.
Setting—Tertiary referral centre for interventional cardiology and cardiac surgery.
Patients—Eighteen consecutive patients (12 men; age 70.8 years) between May 1993 and July 1996. Ten patients presented with stable angina and underwent the procedure electively, eight patients presented either with unstable angina or myocardial infarction and underwent the procedure in emergency.
Intervention—Johnson and Johnson Palmaz-Schatz stents were used in 16 patients, and a Microstent and a Gianturco-Roubin in one patient each. An intra-aortic balloon pump was prophylactively used for two patients in the elective group. In the acute group, six required an intra-aortic balloon pump.
Main outcome measures—Procedural success rate and major adverse cardiac events.
Results—Successful stent implantation was achieved in all patients. In the elective group, no major adverse cardiac event occurred during the procedure, but one patient had to undergo repeated angioplasty before discharge. All patients of the elective group were discharged alive and there has been one non-cardiac death during a follow up of (mean (SD)) 10 (4) months. In the emergency group, one patient died during the procedure, one patient developed a non Q-wave myocardial infarction, one patient underwent emergency coronary bypass surgery, while another patient died suddenly before hospital discharge. Six patients of the emergency group were discharged alive and there has been one non-cardiac death during a follow up of 7 (4) months.
Conclusions—Elective stent implantation for unprotected left main coronary artery stenosis is safe and effective in selected stable patients. Urgent stent implantation, however, cannot be considered as a definitive procedure in emergency situation.

 Keywords: stent;  left main

  2. Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries.

    PubMed

    Wu, Chao; Qiu, Hong; Hu, Xiao-Ying; Ruan, Ying-Mao; Tian, Yi; Chu, Yan; Xu, Xin-Lin; Xu, Liang; Tang, Yue; Gao, Run-Lin

    2013-01-01

    To overcome the drawbacks of permanent stents, biodegradable stents have been studied in recent years. The bioabsorbable polymer vascular scaffold (BVS) was the first bioabsorbable stent to undergo clinical trials, demonstrating safety and feasibility in the ABSORB studies. Iron can potentially serve as the biomaterial for biodegradable stents. This study aimed to assess the short-term safety and efficacy of a biodegradable iron stent in mini-swine coronary arteries. Eight iron stents and eight cobalt chromium alloy (VISION) control stents were randomly implanted into the LAD and RCA of eight healthy mini-swine, respectively. Two stents of the same metal base were implanted into one animal. At 28 days the animals were sacrificed after coronary angiography, and histopathological examinations were performed. Histomorphometric measurements showed that mean neointimal thickness ((0.46 ± 0.17) mm vs. (0.45 ± 0.18) mm, P = 0.878), neointimal area ((2.55 ± 0.91) mm(2) vs. (3.04 ± 1.15) mm(2), P = 0.360) and percentage of area stenosis ((44.50 ± 11.40)% vs. (46.00 ± 17.95)%, P = 0.845) were not significantly different between the iron stents and VISION stents. There was no inflammation, thrombosis or necrosis in either group. The scanning electron microscopy (SEM) intimal injury scores (0.75 ± 1.04 vs. 0.88 ± 0.99, P = 0.809) and number of proliferating cell nuclear antigen (PCNA) positive staining cells were not significantly different between the two groups. The percentage of neointimal coverage by SEM examination was numerically higher in iron stents than in VISION stents ((84.38 ± 14.50)% vs. (65.00 ± 22.04)%, P = 0.057), but the difference was not statistically significant. Iron staining in the tissue surrounding the iron stents at 28 days was positive and the vascular wall adjacent to the iron stent had a brownish tinge, consistent with iron degradation. No abnormal histopathological changes were detected in coronary arteries or major organs. The

  3. Drug-eluting stents in unprotected left main coronary artery disease.

    PubMed

    Bernelli, Chiara

    2014-11-01

    Though coronary bypass graft surgery (CABG) has traditionally been the cornerstone of therapy in patients with unprotected left main coronary artery (ULMCA) disease, recent evidence supports the use of percutaneous coronary intervention in appropriate patients. Indeed in patients with ULMCA disease, drug-eluting stents (DES) have shown similar incidence of hard end points, fewer periprocedural complications and lower stroke rates compared with CABG, though at the cost of increased revascularization with time. Furthermore, the availability of newer efficacious and safer DES as well as improvements in diagnostic tools, percutaneous techniques and, importantly, a better patient selection, allowed percutaneous coronary intervention a viable alternative to CABG of left main-patients with low disease complexity; however, even in this interventional era characterized by efficacious DES, patients with ULMCA disease remain a challenging high-risk population where outcomes strongly depend on clinical characteristics, anatomical disease complexity and extension and operator's experience. This review summarizes the role of DES in ULMCA disease patients.

  4. Refractory coronary vasospasm following drug-eluting stent placement treated with cyproheptadine.

    PubMed

    El-Bialy, Adel; Shenoda, Michael; Caraang, Chris

    2006-02-01

    Serotonin (5-hydroxytryptamine) has been recently shown to be an important mediator of coronary vasospasm. Its divergent effect on normal and atherosclerosed arteries has been demonstrated in both animal and human studies. We present a case of coronary vasospasm in a 55-year-old man with repeated episodes of chest pain following coronary percutaneous intervention. Repeat angiography demonstrated no reocclusion or complication. The patient's symptoms were resistant to treatment with maximum doses of two calcium channel antagonists and oral and intravenous nitrates, but responded to cyproheptadine, a nonselective serotonin antagonist. Currently, there are only two reported cases of coronary vasospasm following balloon angioplasty responding to treatment with serotonin antagonists. This is the first case reported case following drug-eluting stent deployment.

  5. 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°.

  6. Impact of StentBoost subtract imaging on patient radiation exposure during percutaneous coronary intervention.

    PubMed

    Jin, Zhigeng; Yang, Shengli; Jing, Limin; Liu, Huiliang

    2013-08-01

    The purpose of this study was to assess the impact of StentBoost Subtract (SBS) imaging on patient radiation dose during percutaneous coronary intervention. Data were prospectively collected between February 2010 and November 2012 at a tertiary cardiac catheterization. All patients who had scheduled for coronary stent implantation performed by one expert interventional cardiologist with sufficient experience in SBS imaging and radiation protection, were included. The patients were divided into groups with or without SBS. A multiple linear regression analysis was used to determine the impact of SBS imaging on patient radiation dose. Of 712 patients screened, 414 patients were enrolled in the study (with SBS: n = 177, without SBS: n = 237). Although the DAP, fluoroscopy time and cine frames used in the group with SBS were significantly increased when compared with those used in the group without SBS (P < 0.05), multiple linear regression shows SBS imaging has no significant impact on patient radiation dose (P > 0.05). Multivariate predictors of patient radiation dose were the patients' BMI, B2/C lesions, number of stents placed and bifurcation stenting (P < 0.05). In selected patients, SBS imaging can be performed with comparable patient radiation dose, compared with plain fluoroscopic imaging. This may attribute to the operator's sufficient experience in SBS imaging and radiation protection.

  7. 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

  8. Management of radial artery perforation during transradial catheterization using a polytetrafluoroethylene-covered coronary stent.

    PubMed

    Chatterjee, Arka; White, Jeremy S; Leesar, Massoud A

    2017-03-01

    An 88-year-old woman underwent attempted percutaneous coronary intervention (PCI) through a right radial approach. Catheterization was complicated by radial artery perforation. Conservative therapeutic options including external compression, advancement of a diagnostic catheter distal to the perforation, and balloon tamponade failed to control the bleeding requiring deployment of a Polytetrafluoroethylene (PTFE)-covered stent to seal the perforation. We describe the stepwise approach advocated for managing a radial perforation and summarize relevant literature available for the same.

  9. 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.

  10. Picosecond laser micromachining of nitinol and platinum-iridium alloy for coronary stent applications

    NASA Astrophysics Data System (ADS)

    Muhammad, N.; Whitehead, D.; Boor, A.; Oppenlander, W.; Liu, Z.; Li, L.

    2012-03-01

    The demand for micromachining of coronary stents by means of industrial lasers rises quickly for treating coronary artery diseases, which cause more than one million deaths each year. The most widely used types of laser for stent manufacturing are Nd:YAG laser systems with a wavelength of 1064 nm with pulse lengths of 10-3-10-2 seconds. Considerable post-processing is required to remove heat-affected zones (HAZ), and to improve surface finishes and geometry. Using a third harmonic laser radiation of picosecond laser (6×10-12 s pulse duration) in UV range, the capability of the picosecond laser micromachining of nitinol and platinum-iridium alloy for coronary stent applications are presented. In this study dross-free cut of nitinol and platinum-iridium alloy tubes are demonstrated and topography analysis of the cut surface is carried out. The HAZ characteristics have been investigated by means of microscopic examinations and measurement of micro-hardness distribution near the cut zones.

  11. Successful technical and clinical outcome using a second generation balloon expandable coronary stent for transplant renal artery stenosis: Our experience

    PubMed Central

    Salsamendi, Jason; Pereira, Keith; Baker, Reginald; Bhatia, Shivank S; Narayanan, Govindarajan

    2015-01-01

    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. PMID:26629289

  12. Comparison of Clinical Outcomes in Patients Undergoing Coronary Intervention with Drug-Eluting Stents or Bare-Metal Stents: A Nationwide Population Study

    PubMed Central

    Sung, Shih-Hsien; Chen, Tzu-Ching; Cheng, Hao-Min; Lee, Jia-Chun; Lang, Hui-Chu; Chen, Chen-Huan

    2017-01-01

    Background The aim of this propensity score-matched cohort study was to investigate the prognostic impacts of drug-eluting stents (DES) and bare-metal stents (BMS) in patients undergoing percutaneous coronary intervention (PCI). Methods We conducted a retrospective cohort study based on the National Health Insurance program. Patients who had undergone coronary stenting between Jan. 2007 and Dec. 2008 were recruited and monitored until the end of 2010. Subjects with either BMS or DES were matched 2:1 by propensity score, which adjusted for age, sex, stent number and Charlson comorbidity index (CCI). The Kaplan-Meier method and Cox regression models were used for prognostic analyses. Results Among a total of 966 patients with a mean age of 66 years, 644 subjects had BMS and 322 subjects had DES. The incidence of myocardial infarction (MI) and death were significantly lower in the DES group as compared with the BMS group for the three-year follow-up duration. With adjustments for age, sex, premium-based monthly salary, levels of hospital care, stent number, CCI, medications, and acute coronary syndrome presentation in the index hospitalization, use of DES rather than BMS was associated with reduced adverse coronary events (hazard ratio and 95% confidence interval: 0.55, 0.38-0.81 in the whole population, and 0.44, 0.26-0.73 in the subgroup patients with stable coronary artery disease). Conclusions Implantation of DES was related to better outcomes than for BMS, in terms of reducing MI and mortality after PCI. The survival benefit for patients with DES was even greater in patients with stable coronary artery disease. PMID:28115802

  13. The Relationship Between Lymphocyte-to-Monocyte Ratio and Bare-Metal Stent In-Stent Restenosis in Patients With Stable Coronary Artery Disease.

    PubMed

    Murat, Sani Namik; Yarlioglues, Mikail; Celik, Ibrahim Etem; Kurtul, Alparslan; Duran, Mustafa; Kilic, Alparslan; Oksuz, Fatih

    2017-04-01

    In-stent restenosis (ISR) is a common clinical problem in patients with coronary artery disease treated with percutaneous coronary intervention. Inflammatory process plays a pivotal role in the development of ISR. Both lymphocytes and monocytes are associated with inflammatory status. Recently, it has been shown that the lymphocyte-to-monocyte ratio (LMR) is a novel inflammatory marker. We aimed to investigate the association of serum LMR levels and ISR in patients undergoing bare-metal stent (BMS) implantation. The study included 273 patients (aged 61 ± 11 years, 66.5% men) with a history of BMS implantation and a further control coronary angiography due to stable angina pectoris. Patients were divided into 2 groups: patients with and without ISR. The LMR levels were significantly lower in patients with ISR than in those without ISR (2.50 ± 0.95 vs 3.87 ± 1.51, respectively, P < .001). On multivariate logistic regression analysis, the LMR was independently associated with ISR (odds ratio [OR]: 0.310, 95% confidence interval: 0.166-0.579, P < .001) together with high-sensitivity C-reactive protein (OR: 1.244, P = .008), reason for stent implantation (OR: 6.566, P = .003), stent diameter (OR: 0.015, P < .001), and stent length (OR: 1.137, P = .007). In conclusion, LMR levels are inversely related to ISR in patients treated with BMS implantation.

  14. Influence of increased epicardial adipose tissue volume on 1-year in-stent restenosis in patients who received coronary stent implantation

    PubMed Central

    Zhou, Ying; Zhang, Hua-Wei; Tian, Feng; Chen, Jin-Song; Han, Tian-Wen; Tan, Ya-Hang; Zhou, Jia; Zhang, Tao; Jing, Jing; Chen, Yun-Dai

    2016-01-01

    Background Epicardial adipose tissue (EAT) is significantly associated with the formation and composition of coronary atherosclerotic plaque, cardiac events and the clinical prognosis of coronary heart disease. But, whether increased EAT deposition may affect the incidence of in-stent restenosis (ISR) is currently unclear. This study used coronary computed tomography angiography (CCTA) as a mean to investigate whether increased EAT volume was associated with ISR. Methods A total of 364 patients who underwent 64-slice CCTA examination for the evaluation of suspected coronary artery disease, and subsequently underwent percutaneous coronary intervention (PCI) for the first time, and then accepted coronary angiography (CA) follow-up for ISR examination in one year, were retrospectively included in this study. EAT volume was measured by CCTA examination. CA follow-up was obtained between 9 and 15 months. ISR was defined as ≥ 50% luminal diameter narrowing of the stent segment or peri-stent segment. EAT volume was compared between patients with and without ISR and additional well-known predictors of ISR were compared. Results EAT volume was significantly increased in patients with ISR compared with those without ISR (154.5 ± 74.6 mL vs. 131.0 ± 52.2 mL, P < 0.001). The relation between ISR and EAT volume remained significant after adjustment for conventional cardiovascular risk factors and angiographic parameters. Conclusions EAT volume was related with ISR and may provide additional information for future ISR. PMID:27899941

  15. Levels of circulating CD34+/KDR+ cells do not predict coronary in-stent restenosis.

    PubMed

    Haine, Steven E; Van Craenenbroeck, Emeline M; Hoymans, Vicky Y; Miljoen, Hielko P; Vandendriessche, Tom R; Claeys, Marc J; Frederix, Geert; Conraads, Viviane M; Bosmans, Johan M; Vrints, Christiaan J

    2014-01-01

    Angiographic and clinical parameters are poor predictors of in-stent restenosis. Bone marrow-derived CD34(+) cells that coexpress a receptor for vascular endothelial growth factor (kinase insert domain receptor [KDR]) are committed to endothelial lineage. Mobilization and infusion of CD34(+)/KDR(+) cells accelerates re-endothelialization and reduces neointimal thickness in vascular injury models. Bioengineered stents capturing CD34(+) cells also show expedited re-endothelialization. We examined whether circulating CD34(+)/KDR(+) cell counts can be used to predict restenosis in a bare-metal stent (BMS). CD34(+)/KDR(+) cells were counted by flow cytometry in 124 nondiabetic patients before BMS implantation and the relation to in-stent late luminal loss (LLL) was examined by angiography at 6 months (primary end point). Neointima was also quantified as the maximum percentage area stenosis (M%AS) and percentage volume intima hyperplasia (%VIH) on intravascular ultrasonography (secondary end points). Multiple linear regression analysis, taking into account implanted stent length and diameter, revealed no relation between CD34(+)/KDR(+) cell counts and LLL (partial regression coefficient b = 0.11; 95% confidence interval [CI], -0.19-0.42; P = 0.46). Similarly, no relation between CD34(+)/KDR(+) cell counts and M%AS or %VIH could be demonstrated. Moreover, the increase in CD34(+)/KDR(+) cell counts over 6 months was unrelated to LLL (b = -0.15; 95% CI, -0.42-0.12; P = 0.28), M%AS, and %VIH. Although our study does not exclude a pathophysiologic role for CD34(+)/KDR(+) cells in the formation of neointima, cell counts before percutaneous coronary intervention proved to be unrelated to LLL or intravascular ultrasonographically derived restenosis parameters in coronary BMSs at 6 months. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  16. Risks and Benefits of Dual Antiplatelet Therapy Beyond 12 Months After Coronary Stenting

    PubMed Central

    Dadjou, Yahya; Safavi, Salar; Kojuri, Javad

    2016-01-01

    Abstract The optimal duration of dual antiplatelet therapy (DAT) after coronary stenting remains poorly define. The aim of this study was to evaluate the impact of longer than 24 months DAT in patients who received drug-eluting and bare-metal stents. A total of 1010 individuals who underwent elective, urgent or emergency coronary angioplasty with intended stent implantation at reference or specialized cardiac hospitals were randomized to receive long-term and short-term DAT to determine the benefits and adverse effects of long-term DAT. Total of 508 patients were randomized to long-term and 502 patients to <1 year DAT, and all of them were followed for more than 36 months for major adverse cardiac and cerebvascular events and bleeding major adverse cardiac and cerebvascular events (MACCE) Mean age of the 1010 patients (364 women and 646 men) was 60 years. Stent reocclusion occurred in 15 patients. Mean Syntax score was 23.00 ± 5.08 for whole samples, 25.00 ± 5.27 in 28 patients with MACCE and 23 ± 5.00 in 982 patients without MACCE (P = 0.057). According to all specified bleeding definitions, clopidogrel therapy for >12 months was not associated with a greater risk of hemorrhage. A regimen of >12 months of clopidogrel therapy in patients who had received drug-eluting or bare-metal stents did not differ significantly from a regimen of <12 months on clopidogrel with regard to MACCE. Long-term DAT might not significantly affect the reduction in the risk of death from any cause, myocardial infarction, or stroke, and not associated with minor or major bleeding events. PMID:27258494

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

    PubMed Central

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

    2016-01-01

    Objective 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. Methods 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. Results 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. Conclusions 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. PMID:27621830

  18. Sequential vs. kissing balloon angioplasty for stenting of bifurcation coronary lesions.

    PubMed

    Brueck, Martin; Scheinert, Dierk; Flachskampf, Frank A; Daniel, Werner G; Ludwig, Josef

    2002-04-01

    Coronary angioplasty of bifurcation lesions remains a technical challenge and is believed to result in low procedural success associated with the risk of side-branch occlusion. Furthermore, long-term results are associated with a high rate of reintervention. The aim of the study was to evaluate the immediate and long-term clinical and angiographic results of sequential vs. simultaneous balloon angioplasty (kissing balloon technique) for stenting of bifurcation coronary lesions. Between December 1999 and January 2001, 59 patients underwent coronary angioplasty because of symptomatic bifurcation lesions type III (i.e., side branch originates from within the target lesion of the main vessel, and both main and side branch are angiographically narrowed more than 50%). Twenty-six patients were treated with simultaneous and 33 patients with sequential balloon angioplasty. Main-vessel stent placement was mandatory; side-branch stenting and platelet IIb/IIIa antagonists were allowed at the discretion of the operator. Kissing balloon technique offered no advantage in terms of procedural success or need for repeat target vessel revascularization due to restenosis at 6-month follow-up. Using sequential balloon angioplasty, permanent or transient side-branch compromise rate (TIMI flow < 3) was significantly higher than after kissing balloon technique (33% vs. 0%, respectively; P = 0.003). Major clinical events in-hospital or at 6-month follow-up, however, showed no significant differences. Kissing balloon angioplasty reduces the rate of transient side-branch occlusion compared to sequential PTCA but does not improve immediate or long-term outcome compared to sequential PTCA for stenting of bifurcation lesions.

  19. Impact of Incomplete Revascularization on Long-Term Mortality Following Coronary Stenting

    PubMed Central

    Wu, Chuntao; Dyer, Anne-Marie; King, Spencer B.; Walford, Gary; Holmes, David R.; Stamato, Nicholas J.; Venditti, Ferdinand J.; Sharma, Samin; Fergus, Icilma; Jacobs, Alice K.; Hannan, Edward L.

    2011-01-01

    Background The impact of incomplete revascularization (IR) on adverse outcomes following percutaneous coronary intervention (PCI) remains inconclusive; and few studies have examined mortality during follow-ups longer than 5 years. The objective of this study is to test the hypothesis that IR is associated with higher risk of long-term (8-year) mortality following stenting for multivessel coronary disease. Methods and Results A total of 13,016 patients with multivessel disease who had undergone stenting procedures with bare-metal stents (BMS) in 1999–2000 were identified in the New York State’s Percutaneous Coronary Intervention Reporting System. A logistic regression model was fit to predict the probability of achieving complete revascularization (CR) in these patients using baseline risk factors; then, the CR patients were matched to the IR patients with similar likelihoods of achieving CR. Each patient’s vital status was followed through 2007 using the National Death Index, and the difference in long-term mortality between IR and CR was compared. It was found that CR was achieved in 29.2% (3,803) of the patients. For the 3,803 pair-matched patients, the respective 8-year survival rates were 80.8% and 78.5% for CR and IR (P=0.04). The risk of death was marginally significantly higher for IR (hazard ratio = 1.12, 95% confidence interval (CI): 1.01–1.26, P=0.04). The 95% bootstrap CI for the hazard ratio was 0.98–1.32. Conclusions IR may be associated with higher risk of long-term mortality following stenting with BMS in patients with multivessel disease. More prospective studies are needed to further test this association. PMID:21972405

  20. Real World Application of Stenting of Unprotected Left Main Coronary Stenosis: A Single-Center Experience

    PubMed Central

    Leung, Calvin C.; Ball, Timothy C.; Sidhu, Mandeep S.; DeVries, James T.; Jayne, John E.; Robb, John F.; Kaplan, Aaron V.; Brown, Jeremiah R.; Malenka, David J.; Thompson, Craig A.

    2012-01-01

    Background The aim of this study was to summarize our single-center real-world experience with percutaneous coronary intervention (PCI) stenting of unprotected left main coronary artery (ULMCA). PCI-stenting of the ULMCA, while controversial, is emerging as an alternative to coronary artery bypass graft (CABG) surgery in select patients and clinical situations. Methods Between January 2005 and December 2008, PCI-stenting was performed on 125 patients with ULMCA lesions at our institution. Clinical and procedural data were recorded at the time of procedure, and patients were followed prospectively (mean 1.7 years; range 1 day-4.1 years) for outcomes, including death, myocardial infarction (MI), and target vessel revascularization (TVR). Results The majority of cases were urgent or emergent (82.5%), 50.4% of patients were non-surgical candidates, and 63.2% had 3 vessel disease. Many emergent patients presented in shock (62.1%), were not surgical candidates (89.7%), and had high mortality (20.7% in-hospital, 44.8% long-term). Mortality in the elective group was 6.3%. Cumulative death and TVR rates were 28.8% and 13.6%, respectively. Independent predictors of mortality were ejection fraction (EF) ≤ 35% (HR 2.4, CI 1.1 - 5.4) and left main bifurcation (HR 2.7, CI 1.2 - 5.7). Conclusions PCI-stenting is a viable option in patients with LMCA disease and extends options to patients who are poor candidates for CABG. Elective PCI in low-risk CABG patients results in good long-term survival. Cumulative TVR is 13.6%. EF ≤ 35% and left main bifurcation are independently associated with increased mortality.

  1. Microstructural changes within similar coronary stents produced from two different austenitic steels.

    PubMed

    Weiss, Sabine; Meissner, Andreas; Fischer, Alfons

    2009-04-01

    Coronary heart disease has become the most common source for death in western industrial countries. Since 1986, a metal vessel scaffold (stent) is inserted to prevent the vessel wall from collapsing [Puel, J., Joffre, F., Rousseau, H., Guermonprez, B., Lancelin, B., Valeix, B., Imbert, G., Bounhoure, J.P, 1987. Endo-prothéses coronariennes autoexpansives dans la Préevention des resténoses apés angioplastie transluminale. Archives des Maladies du Coeur et des Vaisseaux, 1311--1312]. Most of these coronary stents are made from CrNiMo-steel (AISI 316L). Due to its austenitic structure, the material shows strength and ductility combined with corrosion resistance and a satisfactory biocompatibility. However, recent studies indicate that Nickel is under discussion as to its allergenic potential. Other typically used materials like Co-Base L605 or Tantalum alloys are relatively expensive and are not used so often. Newly developed austenitic high-nitrogen CrMnMoN-steels (AHNS) may offer an alternative. Traditional material tests revealed that strength and ductility, as well as corrosion resistance and biocompatibility, are as good as or even better than those of 316L [Vogt, J.B., Degallaix, S., Foct J., 1984. Low cycle fatigue life enhancement of 316L stainless steel by nitrogen alloying. International Journal of Fatigue 6 (4), 211-215, Menzel, J., Stein, G., 1996. High nitrogen containing Ni-free austenitic steels for medical applications. ISIJ Intern 36 (7), 893-900, Gavriljuk, V.G., Berns, H., 1999. High nitrogen steels, Springer Verlag, Berlin, Heidelberg]. However, because of a strut diameter of about 100 microm, the cross section consists of about five to ten crystal grains (oligo-crystalline). Thus very few, or even just one, grain can be responsible for the success or failure of the whole stent. During implantation, the structure of coronary artery stents is subjected to distinct inhomogeneous plastic deformation due to crimping and dilation.

  2. One-year outcomes of coronary artery bypass graft surgery versus percutaneous coronary intervention with multiple stenting for multisystem disease: a meta-analysis of individual patient data from randomized clinical trials.

    PubMed

    Mercado, Nestor; Wijns, William; Serruys, Patrick W; Sigwart, Ulrich; Flather, Marcus D; Stables, Rodney H; O'Neill, William W; Rodriguez, Alfredo; Lemos, Pedro A; Hueb, Whady A; Gersh, Bernard J; Booth, Jean; Boersma, Eric

    2005-08-01

    We aimed to provide a quantitative analysis of the 1-year clinical outcomes of patients with multisystem coronary artery disease who were included in recent randomized trials of percutaneous coronary intervention with multiple stenting versus coronary artery bypass graft surgery. An individual patient database was composed of 4 trials (Arterial Revascularization Therapies Study, Stent or Surgery Trial, Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease 2, and Medicine, Angioplasty, or Surgery Study 2) that compared percutaneous coronary intervention with multiple stenting (N = 1518) versus coronary artery bypass graft surgery (N = 1533). The primary clinical end point of this study was the combined incidence of death, myocardial infarction, and stroke at 1 year after randomization. Secondary combined end points included the incidence of repeat revascularization at 1 year. All analyses were based on the intention-to-treat principle. After 1 year of follow-up, 8.7% of patients randomized to percutaneous coronary intervention with multiple stenting versus 9.1% of patients randomized to coronary artery bypass graft surgery reached the primary clinical end point (hazard ratio 0.95 and 95% confidence interval 0.74-1.2). Repeat revascularization procedures occurred more frequently in patients allocated to percutaneous coronary intervention with multiple stenting compared with coronary artery bypass graft surgery (18% vs 4.4%; hazard ratio 4.4 and 95% confidence interval 3.3-5.9). The percentage of patients who were free from angina was slightly lower after percutaneous coronary intervention with multiple stenting than after coronary artery bypass graft surgery (77% vs 82%; P = .002). One year after the initial procedure, percutaneous coronary intervention with multiple stenting and coronary artery bypass graft surgery provided a similar degree of protection against death, myocardial

  3. 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 stent lumen noise decreased by approximately 14.2% ± 19.2% in medium kernel (P stent struts and in-stent lumen than that with medium kernel. Iterative reconstruction in image space reconstruction can effectively reduce the image noise and improve image quality. The sharp kernel images constructed with iterative reconstruction are considered the optimal images to observe coronary stents in this study.

  4. Full Metal Jacket With Drug-Eluting Stents for Coronary Chronic Total Occlusion.

    PubMed

    Lee, Pil Hyung; Lee, Seung-Whan; Yun, Sung-Cheol; Bae, Jaeseok; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Kim, Young-Hak; Lee, Cheol Whan; Park, Seong-Wook; Park, Seung-Jung

    2017-07-24

    The aim of this study was to evaluate the long-term outcomes and predictors of adverse events following successful "full metal jacket" (FMJ) (stent length ≥60 mm without gap) procedures using drug-eluting stents to treat coronary chronic total occlusions (CTOs). The FMJ stenting procedure is often required to treat CTOs, but its clinical efficacy and safety remain unknown. In total, 1,126 successful CTO procedures (1,107 consecutive patients) performed between May 2003 and March 2015 were studied. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization or reocclusion. Overall, 406 patients (36.7%) underwent the FMJ procedure, increasing in frequency over time (28.5% from 2003 to 2006 and 41.7% after 2011). The mean stent length was 76.8 ± 14.6 mm (range 60 to 122 mm), and the average number of stent overlaps was 2.5 ± 0.6 (range 2 to 4). A total of 127 patients (31.3%) had persistent luminal narrowing at the distal reference segment after stenting. During the median follow-up period of 5.1 years, target lesion failure occurred in 16.0% of patients. There were 17 cases of total reocclusion and 5 cases of stent thrombosis. Multivariate analysis confirmed that the number of implanted stents (hazard ratio: 1.72; 95% confidence interval: 1.16 to 2.54; p = 0.006) and persistent distal luminal narrowing (hazard ratio: 2.73; 95% confidence interval: 1.66 to 4.47; p < 0.001) were predictors of increased risk for target lesion failure. The FMJ procedure using drug-eluting stents for CTOs provides acceptable long-term clinical results. Persistent distal luminal narrowing increases the future likelihood of adverse events despite procedural success. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings.

    PubMed

    Eric Jones, John; Chen, Meng; Yu, Qingsong

    2014-10-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20-25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH₃/O₂ plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O- and N-contents on the surfaces were substantially increased after NH₃/O₂ plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH₃/O₂ plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electrochemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream.

  6. Corrosion resistance improvement for 316L stainless steel coronary artery stents by trimethylsilane plasma nanocoatings

    PubMed Central

    Jones, John Eric; Chen, Meng; Yu, Qingsong

    2015-01-01

    To improve their corrosion resistance and thus long-term biocompatibility, 316L stainless steel coronary artery stents were coated with trimethylsilane (TMS) plasma coatings of 20–25 nm in thickness. Both direct current (DC) and radio-frequency (RF) glow discharges were utilized for TMS plasma coatings and additional NH3/O2 plasma treatment to tailor the surface properties. X-ray photoelectron spectroscopy (XPS) was used to characterize the coating surface chemistry. It was found that both DC and RF TMS plasma coatings had Si- and C-rich composition, and the O-and N-contents on the surfaces were substantially increased after NH3/O2 plasma treatment. Surface contact angle measurements showed that DC TMS plasma nanocoating with NH3/O2 plasma treatment generated very hydrophilic surface. The corrosion resistance of TMS plasma coated stents was evaluated through potentiodynamic polarization and electro-chemical impedance spectroscopy (EIS) techniques. The potentiodynamic polarization demonstrated that the TMS plasma coated stents imparted higher corrosion potential and pitting potential, as well as lower corrosion current densities as compared with uncoated controls. The surface morphology of stents before and after potentiodynamic polarization testing was analyzed with scanning electron microscopy, which indicated less corrosion on coated stents than uncoated controls. It was also noted that, from EIS data, the hydrophobic TMS plasma nanocoatings showed stable impedance modulus at 0.1 Hz after 21 day immersion in an electrolyte solution. These results suggest improved corrosion resistance of the 316L stainless steel stents by TMS plasma nanocoatings and great promise in reducing and blocking metallic ions releasing into the bloodstream. PMID:24500866

  7. Association of Coronary Perivascular Adipose Tissue Inflammation and Drug-Eluting Stent-Induced Coronary Hyperconstricting Responses in Pigs: (18)F-Fluorodeoxyglucose Positron Emission Tomography Imaging Study.

    PubMed

    Ohyama, Kazuma; Matsumoto, Yasuharu; Amamizu, Hirokazu; Uzuka, Hironori; Nishimiya, Kensuke; Morosawa, Susumu; Hirano, Michinori; Watabe, Hiroshi; Funaki, Yoshihito; Miyata, Satoshi; Takahashi, Jun; Ito, Kenta; Shimokawa, Hiroaki

    2017-09-01

    Although coronary perivascular adipose tissue (PVAT) may play important roles as a source of inflammation, the association of coronary PVAT inflammation and coronary hyperconstricting responses remains to be examined. We addressed this important issue in a porcine model of coronary hyperconstricting responses after drug-eluting stent implantation with (18)F-fluorodeoxyglucose ((18)F-FDG) positron emission tomographic imaging. An everolimus-eluting stent (EES) was randomly implanted in pigs into the left anterior descending or the left circumflex coronary artery while nonstented coronary artery was used as a control. After 1 month, coronary vasoconstricting responses to intracoronary serotonin (10 and 100 μg/kg) were examined by coronary angiography in vivo, followed by in vivo and ex vivo (18)F-FDG positron emission tomographic/computed tomographic imaging. Coronary vasoconstricting responses to serotonin were significantly enhanced at the EES edges compared with the control site (P<0.01; n=40). Notably, in vivo and ex vivo (18)F-FDG positron emission tomographic/computed tomographic imaging and autoradiography showed enhanced (18)F-FDG uptake and its accumulation in PVAT at the EES edges compared with the control site, respectively (both P<0.05). Furthermore, histological and reverse transcription polymerase chain reaction analysis showed that inflammatory changes of coronary PVAT were significantly enhanced at the EES edges compared with the control site (all P<0.01). Importantly, Rho-kinase expressions (ROCK1/ROCK2) and Rho-kinase activity (phosphorylated myosin phosphatase target subunit-1) at the EES edges were significantly enhanced compared with the control site. These results indicate for the first time that inflammatory changes of coronary PVAT are associated with drug-eluting stent-induced coronary hyperconstricting responses in pigs in vivo and that (18)F-FDG positron emission tomographic imaging is useful for assessment of coronary PVAT inflammation.

  8. Frequency and prognostic value of cardiac troponin I elevation after coronary stenting.

    PubMed

    Garbarz, E; Iung, B; Lefevre, G; Makita, Y; Farah, B; Michaud, P; Graine, H; Vahanian, A

    1999-09-01

    Mild myocardial injuries after coronary angioplasty are associated with adverse late outcomes. The incidence and prognostic value of this phenomenon when using cardiac troponin I (cTnI) after stent implantation is unknown. We studied cTnI and creatine kinase (CK) release in 109 patients after stenting. Clinical success was achieved in 103 patients (94%). In-hospital major adverse coronary events were: death in 1 patient, Q-wave myocardial infarction in 1 patient, and non-Q-wave myocardial infarction in 2 patients. Twenty-nine patients (27%) had postprocedural cTnI increase, 16 (15%) had CK elevation. No preprocedural variables predicted marker elevation. Marker release was related to the occurrence of in-lab complications (59% vs 29% [p = 0.004 for cTnI] and 69% vs 32% [p = 0.011 for CK]). In 34% no explanation was found for cTnI increase. Success was more frequent in patients without cTnI elevation (100% vs 86%, p <0.001). The negative predictive value of cTnI increase was 100% for in-hospital major adverse coronary events (MACE), whereas its positive predictive value was 14%. cTnI and CK concordant elevation was associated with more intra- and postprocedural adverse events. During a mean follow-up of 8+/-3 months, major adverse coronary events were: death in 2 patients, myocardial infarction in 2 patients, and repeat PTCA in 8 patients. cTnI elevation was not predictive of these late MACE. cTnI elevation is common after stenting, and is related to the occurrence of in-lab complications. Its isolated elevation is not a good predictor of MACE. Patients with concordant cTnI and CK elevation seem to be at higher risk of in-hospital MACE.

  9. Effects of genetic factors to stent thrombosis due to clopidogrel resistance after coronary stent placement.

    PubMed

    Kirac, D; Erdem, A; Avcilar, T; Yesilcimen, K; Guney, A I; Emre, A; Yazici, S; Terzi, S; Kaspar, E C; Cetin, S E; Isbir, T

    2016-01-19

    Stent thrombosis (ST) is considered as a multifactorial problem which is mostly occurs due to clopidogrel resistance. It may be due to some CYP450 enzyme deficiencies which play role in clopidogrel metabolism. Therefore the aim of this study is to detect the mutations in CYP2C19 and CYP2C9 genes which may cause ST, and to investigate the relation between other risk factors and ST. 50 individuals who have stent thrombosis and 50 individuals who haven't got any complication were enrolled as patient and control group respectively. *2,*3,*4,*5,*17 mutations in CYP2C19 gene and *2 ve *3 mutations in CYP2C9 gene were investigated with RT-PCR. Clopidogrel and aspirin resistance were investigated with multiple electrode platelet aggregometry. Results were evaluated statistically. CYP2C19*2 mutation was found statistically higher in patients (% 18), whereas CYP2C19*17 was found statistically higher in controls (% 36)(p<0.05). Additionally, it was found that patients who have clopidogrel and/or aspirin resistance also have CYP2C19*1/*2 or CYPC19*2/*2 genotype. These relations were also found statistically significant. (p=0,000005 for clopidogrel resistance and p=0,000059 for aspirin resistance). In conclusion, it was suggested that there is a relation between CYP2C19*2 mutations and ST due to clopidogrel resistance, and CYP2C19*17 may have a protective role in this process. The use of novel and more potent drug or high clopidogrel maintenance dosing before stent implantation may be beneficial treatment options for antiplatelet therapy in CYP2C19*2 carriers.

  10. Health technology diffusion rates. Statins, coronary stents, and MRI in England.

    PubMed

    Booth-Clibborn, N; Packer, C; Stevens, A

    2000-01-01

    To analyze the rates and influences on the adoption of three selected health technologies: statins, coronary stents, and magnetic resonance imaging (MRI). A retrospective diffusion study using primary care prescribing data and questionnaire responses from acute hospital trusts in the West Midlands region (population 5.3 million or 10% of England). The selected technologies had markedly different diffusion curves. Statins diffused rapidly soon after launch. Coronary stents were initially used 6 years after first availability, but within 2 years all responding hospitals reported using them. MRI scanners were initially purchased 6 years after first availability with a subsequently slow rate of diffusion, and are still absent from some hospitals. Influences on the adoption of each technology were different. Commercial marketing was reported as a major influence on the diffusion of statins but not at all on MRIs. Cost impact was a major negative influence on the diffusion of MRI scanners and statins, whereas enthusiastic individuals were key to the diffusion of stents. Influences on adoption and consequent diffusion rates are very different for different health technologies. It is not at all clear that such diffusion patterns relate well to an optimum timing rate. This has important implications for technology gatekeepers in health care.

  11. Underwater femtosecond laser micromachining of thin nitinol tubes for medical coronary stent manufacture

    NASA Astrophysics Data System (ADS)

    Muhammad, Noorhafiza; Li, Lin

    2012-06-01

    Microprofiling of medical coronary stents has been dominated by the use of Nd:YAG lasers with pulse lengths in the range of a few milliseconds, and material removal is based on the melt ejection with a high-pressure gas. As a result, recast and heat-affected zones are produced, and various post-processing procedures are required to remove these defects. This paper reports a new approach of machining stents in submerged conditions using a 100-fs pulsed laser. A comparison is given of dry and underwater femtosecond laser micromachining techniques of nickel-titanium alloy (nitinol) typically used as the material for coronary stents. The characteristics of laser interactions with the material have been studied. A femtosecond Ti:sapphire laser system (wavelength of 800 nm, pulse duration of 100 fs, repetition rate of 1 kHz) was used to perform the cutting process. It is observed that machining under a thin water film resulted in no presence of heat-affected zone, debris, spatter or recast with fine-cut surface quality. At the optimum parameters, the results obtained with dry cutting showed nearly the same cut surface quality as with cutting under water. However, debris and recast formation still appeared on the dry cut, which is based on material vaporization. Physical processes involved during the cutting process in a thin water film, i.e. bubble formation and shock waves, are discussed.

  12. In-stent thrombosis when switching ticagrelor to clopidogrel after percutaneous coronary intervention.

    PubMed

    Brice, Aaron E; Hernandez, Gabriel A; Sanchez, Mariluz; Haynick, Marshall; Mendoza, Cesar E

    2017-05-01

    Dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker has been proven to reduce subsequent cardiovascular events and in-stent thrombosis in patients undergoing percutaneous coronary intervention. Newer P2Y12 antagonists with faster onset and greater inhibition of platelet activity have improved cardiovascular outcomes but have created uncertainty with the appropriate dosing when switching between agents. Currently, there are no evidence-based guidelines to aid clinicians when switching between P2Y12 receptor blockers. Here we describe two patients that developed in-stent thrombosis when switching from ticagrelor to clopidogrel using a 300 mg clopidogrel loading dose. Both patients presented with ST elevation myocardial infarction and underwent stent placement but then developed in-stent thrombosis 48 hours after switching from ticagrelor to clopidogrel. These cases illustrate the severe consequences of suboptimal platelet inhibition and the need for prospective trials thoroughly powered to assess clinical outcomes in order to determine the most appropriate strategy when switching from ticagrelor to clopidogrel.

  13. Immediate and long-term results of a modified simultaneous kissing stenting for percutaneous coronary intervention of coronary artery bifurcation lesions.

    PubMed

    Isaaz, Karl; Bayle, Sandrine; Lamaud, Michel; Robin, Christophe; Cerisier, Alexis; Mayaud, Norbert; Richard, Laure; Sabry, Mohamed Hassan; Khamis, Hazem; Abd-Alaziz, Ahmad; Da Costa, Antoine

    2013-03-01

    We propose a modified simultaneous kissing stenting technique (MSKS) based on systematic implantation of a protective stent in the proximal main vessel (PMV) proximally to the bifurcation before simultaneous kissing stenting (SKS). SKS has been proposed in large-size coronary vessel bifurcation lesions (BLs) when the PMV can accommodate two stents. SKS implies, however, low-pressure simultaneous final balloon inflations to avoid retrograde PMV dissection or rupture and therefore may not ensure optimal final stent apposition. From January 2005 to May 2008, a total of 97 patients with 100 BLs (true bifurcation in 92%) who underwent MSKS were enrolled in a prospective registry. Drug-eluting stents were used for distal main vessel and side branch. Drug-eluting or large-size bare-metal stents were used as proximal protective stents. Immediate procedural success rate was 100%. Global restenosis rate was 10% (5% in the main vessel and 8% in the side branch) at follow-up angiogram performed at 7 months in all patients (100%). No patient had early or late stent thrombosis. Two cases of non-fatal very late stent thrombosis occurred at 46 and 64 months. Over a mean 4.5-year follow-up period, target lesion revascularization rate was 11%, with only 3% driven by clinical ischemia. Protective stent systematic implantation in the PMV represents a newly modified SKS technique that allows safe finalization of the procedure by high-pressure kissing balloon final inflation, ensuring optimal stent apposition with high immediate procedural success and low rates of long-term events.

  14. Retroperitoneal Bleeding and Arteriovenous Fistula after Percutaneous Coronary Intervention Successfully Treated with Intravascular Ultrasound-guided Covered Stent Implantation.

    PubMed

    Mogi, Satoshi; Maekawa, Yuichiro; Fukuda, Keiichi; Noma, Shigetaka

    2016-01-01

    The major puncture-site complications of the transfemoral approach are retroperitoneal bleeding (RPB), arteriovenous (AV) fistula, and arterial pseudoaneurysm. Although the management of RPB and AV fistula depends on individual cases, our experience shows that the use of a covered stent with intravascular ultrasound (IVUS) guidance can successfully manage percutaneous coronary intervention-associated RPB and AV fistula. IVUS guidance can therefore make it easy to use an optimal-size covered stent.

  15. CFD analysis of strut influence on blood flow in stent-implanted left main coronary artery bifurcation.

    PubMed

    Yamada, Yuya; Tsukahara, Takahiro; Motosuke, Masahiro; Fujino, Yusuke

    2016-08-01

    We numerically studied blood flows in a simulated branching pipe of coronary artery bifurcation, which is affected by stent implantation. We found that stent struts provide effects as guide vanes and blockages on the flow into circumflex branch. The former effect increases the flow rate and shear stress on the arteriosclerosis-prone site. The blockage effect may overwhelm the guide effect depending on a strut position against the inflow.

  16. Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with second-generation drug-eluting stents for patients with multivessel and unprotected left main coronary artery disease

    PubMed Central

    Papadopoulos, Kyriacos; Lekakis, Ioannis; Nicolaides, Evagoras

    2017-01-01

    Objectives: To compare the efficacy and safety of percutaneous coronary intervention using second-generation drug-eluting stents with those of coronary artery bypass grafting among patients with multivessel disease and/or unprotected left main coronary artery disease in terms of mortality, myocardial infarction, repeat revascularization, and angina. Background: Although coronary artery disease is a leading cause of death in the Western world and in many developing countries, its optimal treatment is still a matter of controversy. Several studies have examined the clinical safety and efficacy of percutaneous coronary intervention using first-generation drug-eluting stents over coronary artery bypass grafting in patients with multivessel disease and/or unprotected left main coronary artery disease. However, this study compared the efficacy of percutaneous coronary intervention using second-generation drug-eluting stents to that of coronary artery bypass grafting for multivessel disease and/or unprotected left main coronary artery disease. Methods: This was a prospective single-center cohort study conducted from September 2012 to November 2014 at the Nicosia General Hospital. In total, 140 patients (94% men and 6% women) with chronic coronary artery disease undergoing revascularization with either percutaneous coronary intervention using second-generation drug-eluting stents or coronary artery bypass grafting were evaluated. We examined the differences in clinical outcomes between coronary artery bypass grafting and percutaneous coronary intervention at 1-year follow-up. Results: Percutaneous coronary intervention with second-generation drug-eluting stents as opposed to coronary artery bypass grafting resulted in similar rates of mortality (5.7% vs 11.4%, respectively; p = 0.135), myocardial infarction (0% vs 4.3%, respectively), repeat revascularization (4.3% vs 8.6%, respectively; p = 0.115) and angina (10% vs 18.6%, respectively; p = 0.153). Conclusion

  17. In-vivo iMap IVUS comparison of in-stent neointima and native coronary atherosclerosis.

    PubMed

    Trusinskis, Karlis; Strenge, Karlis; Juhnevica, Dace; Erglis, Andrejs

    2015-06-01

    The purpose of this study was to compare plaque characteristics of native coronary atherosclerosis and in-stent neointima ten months after ST elevation myocardial infarction (STEMI) using iMap intravascular ultrasound (IVUS). In 49 patients in-stent neointima and the coronary segment proximal to the stent were analyzed with iMap intravascular ultrasound (IVUS) ten months after primary PCI for STEMI. A higher percentage of necrotic tissue was observed in the proximal coronary segment compared to the in-stent neointima by iMap IVUS (25.5% ± 12.8% vs 12.3% ± 3.3%, p < 0.0001) ten months after STEMI. The proportion of fibrotic tissue in the proximal segment was lower (63.6% ± 14.8% vs 72.0% ± 5.7%, p = 0.002) and the proportion of the lipidic tissue was higher (8.8% ± 3.0% vs 5.9% ± 2.0%, p < 0.0001) than in-stent neointima. In patients ten months after STEMI, in-stent neointima contained a higher proportion of fibrotic tissue and lower proportion of necrotic and lipidic tissue compared the native atherosclerotic lesion. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary artery stenting: hovering among bleeding risk, thromboembolic events, and stent thrombosis

    PubMed Central

    2012-01-01

    Dual antiplatelet treatment with aspirin and clopidogrel is the antithrombotic treatment recommended after an acute coronary syndrome and/or coronary artery stenting. The evidence for optimal antiplatelet therapy for patients, in whom long-term treatment oral anticoagulation is mandatory, is however scarce. To evaluate the safety and efficacy of the various antithrombotic strategies adopted in this population, we reviewed the available evidence on the management of patients receiving oral anticoagulation, such as a vitamin-k-antagonists, referred for coronary artery stenting. Atrial fibrillation is the most frequent indication for oral anticoagulation. The need of starting antiplatelet therapy in this clinical scenario raises concerns about the combination to choose: triple therapy with warfarin, aspirin, and a thienopyridine being the most frequent and advised. The safety of this regimen appeared suboptimal because of an increased risk in hemorrhagic complications. On the other hand, the combination of oral anticoagulation and an antiplatelet agent is suboptimal in preventing thromboembolic events and stent thrombosis; dual antiplatelet therapy may be considered only when a high hemorrhagic risk and low thromboembolic risk are perceived. Indeed, the need for prolonged multiple-drug antithrombotic therapy increases the bleeding risks when drug eluting stents are used. Since current evidence derives mainly from small, single-center and retrospective studies, large-scale prospective multicenter studies are urgently needed. PMID:23075316

  19. The management of patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation: in-hospital-data from the Atrial Fibrillation undergoing Coronary Artery Stenting study.

    PubMed

    Schlitt, Axel; Rubboli, Andrea; Lip, Gregory Y H; Lahtela, Heli; Valencia, Josè; Karjalainen, Pasi P; Weber, Michael; Laine, Mika; Kirchhof, Paulus; Niemelä, Matti; Vikman, Saila; Buerke, Michael; Airaksinen, K E Juhani

    2013-12-01

    Current recommendations on the management of patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent (PCI-S) essentially derive from small, single-center, retrospective datasets. To obtain larger and better quality data, we carried out the prospective, multicenter Atrial Fibrillation undergoing Coronary Artery Stenting (AFCAS) study. Therefore, consecutive patients with history of or ongoing AF undergoing PCI-S were enrolled, and occurrence of adverse ischemic and bleeding events recorded during 12 months follow-up. In this article, we report the in-hospital observations. Out of the 963 patients, in the majority of cases (49.1%) AF was permanent. The associated risk of stroke, as defined by a CHADS2 -score ≥2, was in 70% of patients moderate to high. Upon enrollment in the registry, 69.3% of patients were on VKA therapy. Overall occurrence of in-hospital major adverse cardiac events was 4.5% (cardiovascular death 1.9%, urgent revascularization in 1.5%, and stroke/arterial thromboembolism in 0.6%). Bleeding complications occurred in 7.1% of patients, being severe in 2.5%. In a logistic regression analysis, no risk factor was independently associated with bleeding events, whereas Clopidogrel treatment decreased and female gender/treatment with gpIIb/IIIa-antagonists, respectively increased the risk for the combined ischemic endpoint. The majority of AF patients undergoing PCI-S are at high stroke risk, and therefore VKA treatment should not be withdrawn and combined anticoagulant and antiplatelet treatment is warranted. Current management appears largely in accordance with current recommendations, whereby accounting for the limited occurrence of in-hospital adverse ischemic and bleeding events.

  20. High platelet reactivity after P2Y12-inhibition in patients with atrial fibrillation and coronary stenting.

    PubMed

    Rilinger, Jonathan; Meyer, Melanie; Schnabel, Katharina; Weik, Patrick; Charlet, Anne; Esser, Jennifer S; Zhou, Qian; Bode, Christoph; Moser, Martin; Diehl, Philipp; Olivier, Christoph B

    2016-11-01

    High platelet reactivity (HPR) after P2Y12-inhibition in patients undergoing coronary stenting is associated with an increased risk for thromboembolic events and coronary death. So far it is not known how HPR affects the clinical outcome of different treatment strategies in patients with atrial fibrillation (AF) undergoing coronary stenting. In this single centre, observational study the antiplatelet effect of P2Y12-inhibitors in AF patients undergoing coronary stenting was investigated using impedance aggregometry. Patients received either dual antiplatelet therapy (DAPT) or triple therapy (TT). HPR was defined as the ratio of ADP-to TRAP-induced aggregation (r-ADP-agg) ≥50 %. Thromboembolic and bleeding events were assessed within the first 30 days after stenting. Out of 910 screened patients 167 patients were available for the present analysis. HPR was found in 5 of 43 (12 %) patients treated with DAPT and in 18 of 124 (15 %) patients treated with TT. In patients receiving TT, HPR was not a risk factor for thromboembolic events compared to patients with adequate response to P2Y12-inhibitors (6 vs. 8 %, p = 0.712). There was a trend for less bleeding events in patients with HPR compared to r-ADP-agg <50 % in the TT group (0 vs. 16 %, p = 0.077). Our data suggest that HPR after P2Y12-antagonism in patients receiving TT due to AF and coronary stenting might protect from bleeding without increasing thromboembolic risk. Future studies will need to investigate if patients with AF receiving coronary stenting benefit from a reduction of antithrombotic therapy.

  1. Use of drug-eluting versus bare-metal stents after an acute coronary syndrome in Portugal: the EURHOBOP study.

    PubMed

    Barros, Vítor; Pereira, Marta; Araújo, Carla; Braga, Pedro; Azevedo, Ana

    2015-01-01

    The interventional cardiologist chooses a specific stent type based on the risk-benefit profile for each case. In general, drug-eluting stents should be considered in all clinical conditions, except if there are concerns or contraindications for prolonged dual antiplatelet therapy. The aim of this work was to describe the use of bare-metal vs. drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI) after an acute coronary syndrome in Portuguese hospitals, according to patients' demographic and clinical characteristics and institutional characteristics. Within the EURopean Hospital Benchmarking Processes (EURHOBOP) study, we retrospectively assessed 3009 consecutive patients in 10 Portuguese hospitals in 2009. Only patients with stents implanted during PCI (n=1194) were analyzed. A total of 425 patients (36%) received a bare-metal stent and 769 patients (64%) received a drug-eluting stent. A history of previous PCI, current non-ST-elevation myocardial infarction, anterior descending artery as the infarct-related artery and being initially admitted to a hospital with a catheterization laboratory were associated with drug-eluting stent implantation. Age under 45 or over 80, anemia and previous anticoagulation and/or atrial fibrillation were associated with bare-metal stent use. Approximately two-thirds of patients received drug-eluting stents, which were less frequently implanted in patients with ST-elevation myocardial infarction, aged over 80 years, female, with a previous history of stroke, anticoagulation and/or atrial fibrillation and anemia. Patients who had previously undergone PCI and those with the anterior descending artery as the infarct-related artery were more likely to receive a drug-eluting stent. Copyright © 2013 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  2. Reconstruction of stented coronary arteries from optical coherence tomography images: Feasibility, validation, and repeatability of a segmentation method

    PubMed Central

    Bologna, Marco; Migliori, Susanna; Aurigemma, Cristina; Burzotta, Francesco; Celi, Simona; Dubini, Gabriele; Migliavacca, Francesco; Mainardi, Luca

    2017-01-01

    Optical coherence tomography (OCT) is an established catheter-based imaging modality for the assessment of coronary artery disease and the guidance of stent placement during percutaneous coronary intervention. Manual analysis of large OCT datasets for vessel contours or stent struts detection is time-consuming and unsuitable for real-time applications. In this study, a fully automatic method was developed for detection of both vessel contours and stent struts. The method was applied to in vitro OCT scans of eight stented silicone bifurcation phantoms for validation purposes. The proposed algorithm comprised four main steps, namely pre-processing, lumen border detection, stent strut detection, and three-dimensional point cloud creation. The algorithm was validated against manual segmentation performed by two independent image readers. Linear regression showed good agreement between automatic and manual segmentations in terms of lumen area (r>0.99). No statistically significant differences in the number of detected struts were found between the segmentations. Mean values of similarity indexes were >95% and >85% for the lumen and stent detection, respectively. Stent point clouds of two selected cases, obtained after OCT image processing, were compared to the centerline points of the corresponding stent reconstructions from micro computed tomography, used as ground-truth. Quantitative comparison between the corresponding stent points resulted in median values of ~150 μm and ~40 μm for the total and radial distances of both cases, respectively. The repeatability of the detection method was investigated by calculating the lumen volume and the mean number of detected struts per frame for seven repeated OCT scans of one selected case. Results showed low deviation of values from the median for both analyzed quantities. In conclusion, this study presents a robust automatic method for detection of lumen contours and stent struts from OCT as supported by focused validation

  3. Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stenting

    PubMed Central

    Albertal, M; Van Langenhove, G; Regar, E; Kay, I; Foley, D; Sianos, G; Kozuma, K; Beijsterveldt, T; Carlier, S; Belardi, J; Boersma, E; Sousa, J; de Bruyne, B; Serruys, P

    2001-01-01

    OBJECTIVE—To study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome.
METHODS—523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection.
RESULTS—Following balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%) v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603 v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was < 2.5 or ⩾ 2.5 after balloon angioplasty.
CONCLUSIONS—Moderate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome.


Keywords: coronary dissection; intracoronary Doppler; angioplasty PMID:11454840

  4. Extended Outcomes of Complex Coronary Disease in the Drug Eluting Stent Era

    PubMed Central

    Desrosiers, Kevin P.; Brown, Jeremiah R.; Langner, Craig A.; Sidhu, Mandeep S.; Robb, John F.; Hearne, Michael J.; Lee, Peter M. Ver; Kellett, Mirle A.; Ryan, Thomas J.; O’Meara, John R.; Dauerman, Harold L.; Silver, M. Theodore; Thompson, Craig A.; Malenka, David J.

    2011-01-01

    Background Several randomized trials comparing bare-metal stents to Drug-Eluting Stents (DES) have demonstrated a significant reduction in Target Vessel Revascularization (TVR) and Target Lesion Revascularization (TLR) exists with the use of drug-eluting stents, without compromising survival. These conclusions are based on restricted inclusion criteria for patients and lesion. It is unknown if these results can be generalized to an unselected patient population and more complex disease. The objective of this study was to determine to what extent the availability of DES has impacted survival, TVR, and TLR in a large regional experience without the restriction of on-label indications. Methods Patients registered with the Northern New England Cardiovascular Disease Study Group’s PCI registry with single vessel coronary disease undergoing a first PCI were sorted according to the Bare-Metal stent (BMS) era (2001 - 2002) or the Drug-Eluting stent (DES) era (2004 - 2005) based on the time period their first PCI took place. Totally, 6,093 BMS and 5,651 DES patients were identified. Outcomes of survival, TLR and TVR were measured after one year. Results After 1 year, survival was comparable, TLR was reduced by 4.9% (absolute) and TVR was reduced by 5.4% (absolute) in the DES era compared to the BMS era. The TLR/TVR differences remained significant after propensity matching in the DES era vs BMS era (Mortality: HR 1.00, 95% CI: 0.83 - 1.28; TLR: HR 0.40, 95% CI 0.32 - 0.46; TVR: HR 0.44, 95% CI 0.38 - 0.51). Conclusions In large regional experience with a consecutive series of patients representing the contemporary practice of PCI, including both on and off label use, the frequent use of DES reduces the risk of TVR and TLR without compromising survival.

  5. [Role of eosinophil granulocytes in the occurrence of restenosis in patients after coronary stenting with drug-eluting stents].

    PubMed

    Gabbasov, Z A; Kozlov, S G; Imaeva, A É; Saburova, O S; Masenko, V P

    2014-01-01

    To study the role of eosinophil granulocytes in the development of restenosis after drug-eluting stent (DES) implantation. The blood levels of eosinophils, eosinophil cationic protein (ECP), immunoglobulin E (IgE), and C-reactive protein (CRP) were compared in 170 patients with coronary heart disease (CHD) and stable angina who had undergone recoronarography within the first year after endovascular myocardial revascularization using DES. The blood level of eosinophils was determined by the results obtained employing the FACS Calibur flow cytofluorometer (Becton Dickinson, USA). That of ECP, IgE, and CRP was estimated by enzyme immunoassay by means of an Immulite-100 analyzer (Siemens, Germany). The data were presented as median (25th percentile and 75th percentile). The blood eosinophil level was 272 (234; 292) cells/μl in patients with restenosis while that was 134 (85; 156) cells/μl in those without restenosis (p = 0.002). The plasma ECP level proved to be greater in the patients who had developed restenosis after DES implantation than in those who had not [17.7 (11.2; 24) and 9 (6.4; 12.9) ng/ml, respectively (p = 0.017). At 6 months after DES implantation, the level of ECP was significantly higher (8.6 (7.3; 9.7) ng/ml) than the baseline level (p = 0.04). Later on, there was an even greater increase in ECP levels. No significant changes were noted in blood ECP levels after bare stent implantation. The findings suggest that there is a relationship between the occurrence of restenosis and the enhanced activity of eosinophil granulocytes in CHD patents after DES implantation.

  6. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System.

    PubMed

    Cutlip, Donald E; Garratt, Kirk N; Novack, Victor; Barakat, Mark; Meraj, Perwaiz; Maillard, Luc; Erglis, Andrejs; Jauhar, Rajiv; Popma, Jeffrey J; Stoler, Robert; Silber, Sigmund

    2017-01-23

    The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. Polyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. The association of red cell distribution width with in-stent restenosis in patients with stable coronary artery disease.

    PubMed

    Kurtul, Alparslan; Murat, Sani Namik; Yarlioglues, Mikail; Duran, Mustafa; Karadeniz, Muhammed; Ergun, Gokhan; Akyel, Ahmet; Mendi, Mehmet Ali; Oksuz, Fatih

    2015-01-01

    Increased red cell distribution width (RDW) is closely related to the poor prognosis and adverse events of cardiovascular diseases. We aimed to investigate the association of serum RDW levels and in-stent restenosis (ISR) after coronary stenting with bare-metal stent in patients with stable coronary artery disease. A total of 251 patients (age 62 ± 11 years, 69% male) with a history of coronary stenting who underwent control coronary angiography (128 with ISR and 123 without ISR) were enrolled into the study. Laboratory parameters were measured before angiography. ISR was defined as luminal stenosis ≥50% within the stent or within 5 mm of its edges by the quantitative coronary analysis. The patients were divided into the two groups: ISR group and no-ISR group. Baseline characteristics of the patients were similar. The ISR group had significantly higher RDW levels compared with patients in no-ISR group (14.47 ± 1.37 vs. 13.59 ± 0.88, p < 0.001). Furthermore, the ISR group had significantly longer stent length and lower stent diameter when compared to no-ISR group (p = 0.001 and p = 0.004, respectively). In a multivariate analysis, RDW levels >13.75%, high-sensitivity C-reactive protein levels, stent diameter and stent length were independently associated with ISR [odds ratio (OR) = 2.12, 95% confidence interval (CI) = 1.71-3.15, OR = 2.80, 95% CI = (1.34-4.61), OR = -2.60, 95% CI = -(1.19-4.51), OR = 2.02, 95% CI = 1.99-3.76, p = 0.001, respectively]. We concluded that increased serum RDW levels were independently associated with bare-metal ISR in patients with stable coronary artery disease.

  8. Current understanding of coronary in-stent restenosis. Pathophysiology, clinical presentation, diagnostic work-up, and management.

    PubMed

    Schiele, T M

    2005-11-01

    In-stent restenosis is the limiting entity following coronary stent implantation. It is associated with significant morbidity and cost and thus represents a major clinical and economical problem. Worldwide, approximately 250 000 in-stent restenotic lesions per year have to be dealt with. The pathophysiology of instent restenosis is multifactorial and comprises inflammation, smooth muscle cell migration and proliferation and extracellular matrix formation, all mediated by distinct molecular pathways. Instent restenosis has been recognised as very difficult to manage, with a repeat restenosis rate of 50% regardless of the mechanical angioplasty device used. Much more favourable results were reported for the adjunctive irradiation of the in-stent restenotic lesion, with a consistent reduction of the incidence of repeat in-stent restenosis by 50%. Data from the first clinical trials on drug-eluting stents for the treatment of in-stent restenosis have shown very much promise yielding this strategy likely to become the treatment of choice. This review outlines the histological and molecular findings of the pathophysiology, the epidemiology, the predictors and the diagnostic work-up of in-stent restenosis and puts emphasis on the various treatment options for its prevention and therapy.

  9. Preparation and surface characterization of HMDI-activated 316L stainless steel for coronary artery stents.

    PubMed

    Chuang, T-W; Chen, M-H; Lin, F-H

    2008-06-01

    Poor compatibility between blood and metallic coronary artery stents is one reason for arterial restenosis. Immobilization of anticoagulant agents on the stent's surface is feasible for improving compatibility. We examined possible surface-coupling agents for anticoagulant agent immobilization. Hexamethylene diisocyanate (HMDI) and 3-aminopropyl-triethoxysilane (APTS) were examined as surface-coupling agents to activate 316L stainless steel (e.g., stent material). The activated surface was characterized using Fourier transformation infrared spectroscopy (FTIR), atomic force microscope (AFM), surface plasmon resonance (SPR), and trinitrobenzene sulfonic acid (TNBS) assay. In FTIR analysis, HMDI and APTS were both covalently linked to 316L stainless steel. In AFM analysis, it was found that the HMDI-activated surface was smoother than the APTS-activated one. In SPR test, the shift of SPR angle for the APTS-activated surface was much higher than that for the HMDI-activated surface after being challenged with acidic solution. TNBS assay was used to determine the amount of immobilized primary amine groups. The HMDI-activated surface was found to consist of about 1.32 micromol/cm(2) amine group, whereas the APTS-activated surface consisted of only 0.89 micromol/cm(2) amine group. We conclude that the HMDI-activated surface has more desirable surface characteristics than the APTS-activated surface has, such as chemical stability and the amount of active amine groups.

  10. Drug-eluting stent thrombosis: the Kounis hypersensitivity-associated acute coronary syndrome revisited.

    PubMed

    Chen, Jack P; Hou, Dongming; Pendyala, Lakshmana; Goudevenos, John A; Kounis, Nicholas G

    2009-07-01

    The advent of drug-eluting stents (DES) has revolutionized the field of interventional cardiology. Their dramatic and persistent restenotic and target lesion revascularization advantages are unquestioned. However, concerns over the rare but potentially catastrophic risk of stent thrombosis (ST) have tempered universal acceptance of these devices. Although the precise mechanism of DES ST is undoubtedly multifactorial and as yet not fully elucidated, delayed or incomplete endothelial healing clearly plays a pivotal role. Detailed histopathological data have implicated a contributory allergic or hypersensitivity component, as verified by the Food and Drug Administration's Manufacturer and User Device Experience Center and the Research on Adverse Drug/device events And Reports (RADAR) project. These findings thus suggest a potential connection with the Kounis syndrome, the concurrence of acute coronary events with allergic, hypersensitivity, anaphylactic, or anaphylactoid reactions. Potential culprits responsible for this phenomenon include: arachidonic acid metabolites such as leukotrienes and thromboxane, proteolytic enzymes such as chymase and tryptase, histamine, cytokines, and chemokines. Additionally, inflammatory cells such as macrophages, T-lymphocytes, and mast cells are probably also contributory. Autopsy-confirmed infiltrates of various inflammatory cells including lymphocytes, plasma cells, macrophages, and eosinophils have been reported in all 3 vascular wall layers and are reminiscent of those associated with the Kounis syndrome. Although the concurrence of acute coronary syndromes with hypersensitivity reactions has been long established, the specific association with DES ST remains unproven. Potential incorporation of hypersensitivity suppressive agents might represent a promising paradigm shift from efficacy to safety in future DES designs.

  11. Zotarolimus-eluting stent utilization in small-vessel coronary artery disease (ZEUS).

    PubMed

    Jim, Man-Hong; Yiu, Kai-Hang; Fung, Raymond Chi-Yan; Ho, Hee-Hwa; Ng, Andrew Kei-Yan; Siu, Chung-Wah; Chow, Wing-Hing

    2014-01-01

    The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

  12. Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

    PubMed

    Weinfurt, Kevin P; Seils, Damon M; Tzeng, Janice P; Lin, Li; Schulman, Kevin A; Califf, Robert M

    2008-05-07

    Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006. We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote. In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.

  13. Stenting of the left main coronary artery. Local experience in Liège.

    PubMed

    Ghavami, A; Boland, J; Legrand, V; Materne, P

    2000-06-01

    We examined the immediate and long-term outcome after stenting of the left main coronary artery (LMCA) in 41 consecutive patients who had been considered unsuitable for coronary artery bypass graft surgery (CABG). The procedure was elective in thirty-two patients (78%) with a protected LMCA in 24 patients and non-protected LMCA in 8 patients; the procedure was acute in the setting of myocardial infarction or complication of a diagnostic angiography in 9 patients (22%). The mean follow-up duration was 19 +/- 13 months. There were 5 in-hospital and 3 late deaths; repeat angioplasty was performed in 5 cases, but only one for LMCA restenosis. Results varied considerably depending on the clinical presentation. For acute patients, technical success was achieved in 89%, survival at hospital discharge was 44% and there was no cardiac event at the late follow-up. For elective patients, technical success was achieved in 100%, survival at hospital discharge was 96% and 90% at follow-up. The results of our study suggest that when patients have surgical risks, elective LMCA stenting either protected or unprotected may be undertaken with a high procedural success rate and a favourable clinical late follow-up.

  14. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial.

    PubMed

    Grundeken, Maik J; Wykrzykowska, Joanna J; Ishibashi, Yuki; Garg, Scot; de Vries, Ton; Garcia-Garcia, Hector M; Onuma, Yoshinobu; de Winter, Robbert J; Buszman, Pawel; Linke, Axel; Ischinger, Thomas; Klauss, Volker; Eberli, Franz; Corti, Roberto; Wijns, William; Morice, Marie-Claude; di Mario, Carlo; Meier, Bernhard; Jüni, Peter; Yazdani, Ashkan; Copt, Samuel; Windecker, Stephan; Serruys, Patrick W

    2016-06-01

    Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI. The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/prob