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Sample records for paclitaxel-eluting stent implantation

  1. Late acute thrombosis after paclitaxel eluting stent implantation

    PubMed Central

    Liistro, F; Colombo, A

    2001-01-01

    Late (more than six months) total occlusion after coronary stenting is a progressive phenomenon occurring in approximately 4% of patients, leading to acute myocardial infarction in less than 0.5%. The process must be related to severe and progressive intimal hyperplasia. In patients receiving coronary stenting with simultaneous brachytherapy, late total occlusion has been reported at a higher rate and to be related to stent thrombosis rather than intimal hyperplasia. Late total occlusion presenting with an acute clinical event seven months after the implantation of a paclitaxel drug eluting stent is reported. The occlusion developed soon after the interruption of ticlopidine treatment, suggesting that the event had a thrombotic genesis and that the risk is not confined to the first six month period.


Keywords: paclitaxel eluting stent; late thrombosis PMID:11514475

  2. [A retrospective analysis of our paclitaxel-eluting stent (Genius TAXCOR I) implantations and follow-up results].

    PubMed

    Kabakcı, Giray; Canpolat, Uğur; Ateş, Ahmet Hakan; Yorgun, Hikmet; Sunman, Hamza; Kaya, Ergün Barış; Dural, Muhammed; Aytemir, Kudret; Tokgözoğlu, Lale; Oto, Ali

    2011-12-01

    We evaluated our paclitaxel-eluting stent (Genius TAXCOR I) implantations and follow-up results in patients with coronary artery disease. The study included 101 patients (75 men, 26 women; mean age 60±10 years) who underwent elective paclitaxel-eluting stent deployment for de novo native coronary artery lesions. Sixteen patients received two stents. Lesion types were as follows: type A (23.9%), type B1 (29.1%), type B2 (32.5%), and type C (14.5%). Twelve lesions (10.3%) exhibited mild tortuosity, 32 (27.4%) had mild calcification, 12 had (10.3%) an angulation of more than 45 degrees, while eight (7.7%) had thrombus. Following stent implantation, the patients were examined at 1, 6, and 12 months, and annually thereafter. The mean follow-up period was 48.9±5.7 months (range 35 to 60 months). Stent implantation was successful in all the patients. The mean diameter stenosis was 82.8±9.9%, the mean stent diameter was 3.1±0.6 mm, and the mean stent length was 16.0±5.2 mm. During the follow-up period, 46 patients (45.5%) required coronary angiography, of which eight (17.4%) received target vessel revascularization, and four (8.7%) received target lesion revascularization. One patient (1.0%) died from sudden cardiac death. The clinical and angiographic follow-up results of this study involving relatively low- and intermediate-risk patients indicate that the use of the Genius TAXCOR I stents is effective and beneficial for the prevention of stent thrombosis and restenosis.

  3. Patency of paclitaxel-eluting versus bare metal stents long term after implantation in acute ST-segment elevation myocardial infarction.

    PubMed

    Vink, Maarten A; Van Nooijen, Ferdinand C; Laarman, Gerrit J; Suttorp, Maarten J; Tijssen, Jan G; Slagboom, Ton; Patterson, Mark S; Van Der Schaaf, Rene J; Kiemeneij, Ferdinand; Amoroso, Giovanni; Dirksen, Maurits T

    2011-11-01

    Drug-eluting stents effectively inhibit neointimal hyperplasia within the first year, thereby reducing the need for repeat revascularization. However, a delayed pattern of restenosis might be more prominent in drug-eluting stents compared to bare metal stents (BMSs). The extent of restenosis of paclitaxel-eluting stents (PESs) long term after implantation in acute ST-segment elevation myocardial infarction is currently unknown. The present study was designed to evaluate very late luminal loss (VLLL) of PESs used in ST-segment elevation myocardial infarction compared to BMSs. A total of 116 patients (61 with PESs and 55 with BMSs) initially included in the Paclitaxel Eluting Stent Versus Conventional Stent in ST-segment Elevation Myocardial Infarction (PASSION) trial and who were free from previous lesion failure underwent angiographic follow-up. Off-line quantitative coronary analysis of the angiogram immediately after stent implantation and at follow-up was performed. The primary end point was VLLL within the stent. The presence of binary restenosis was defined as diameter stenosis >50% as a secondary end point. The mean interval between stent implantation and follow-up was 4.1 ± 0.5 years in both stent groups. In-stent VLLL was 0.12 mm (interquartile range -0.03 to 0.42) in the PES group versus 0.30 mm (interquartile range 0.08 to 0.69) in the BMS group (p = 0.011). In-segment binary restenosis was found in 4 patients (6.6%) with a PES and 6 patients (10.9%) with a BMS (p = 0.40). In conclusion, angiographic follow-up 4 years after implantation in ST-segment elevation myocardial infarction showed that in patients prospectively randomized to PESs or BMSs, VLLL was low in both stent groups. PESs were associated with lower VLLL than BMSs, and the observed rate of binary restenosis was not significantly different between the 2 stent groups.

  4. 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.

  5. Impact of stent diameter on vascular response after self-expanding paclitaxel-eluting stent implantation in the superficial femoral artery.

    PubMed

    Miki, Kojiro; Fujii, Kenichi; Shibuya, Masahiko; Fukunaga, Masashi; Imanaka, Takahiro; Kawai, Kenji; Tamaru, Hiroto; Sumiyoshi, Akinori; Nishimura, Machiko; Horimatsu, Tetsuo; Saita, Ten; Yoshihara, Nagataka; Kimura, Takumi; Honda, Yasuhiro; Fitzgerald, Peter J; Masuyama, Tohru; Ishihara, Masaharu

    2017-10-01

    The optimal sizing of self-expanding paclitaxel-eluting stents (PES) in the treatment for superficial femoral artery (SFA) lesions is unclear. This study sought to investigate the influence of PES diameter on stent patency in SFA lesions using optical frequency domain imaging (OFDI). A total of 20 de novo SFA lesions were randomized 1:1 to receive either self-expanding PES with a nominal diameter of 6mm or 8mm. Follow-up angiography and OFDI was scheduled six months after stent implantation, and volumetric OFDI analysis was performed to evaluate vascular response to the stents. Volume index (VI) was defined as the volume divided by the stent length. The primary end point was lumen VI at the 6-month follow-up. Secondary end point was minimum lumen diameter (MLD) by quantitative vascular angiography (QVA) at the follow-up. Stent length was 78.0±23.9mm in the 6-mm group and 70.0±23.6mm in the 8-mm group (p=0.46). Baseline QVA data were also similar between the two groups. MLD immediately after stent implantation was similar between the two groups (4.2±0.5mm in the 6-mm group and 3.9±0.5mm in the 8-mm group, p=NS). At the 6-month follow-up, MLD was greater in the 8-mm group compared to the 6-mm group (4.0±1.0mm vs. 3.2±0.4mm, p<0.05). Stent VI was larger in the 8-mm group (28.4±6.7mm(3)/mm vs. 22.2±1.2mm(3)/mm, p=0.01). Neointimal VI was similar between the two groups (5.8±2.9mm(3)/mm vs. 5.2±2.6mm(3)/mm, p=0.68). Lumen VI was greater in the 8-mm group (23.2±7.6mm(3)/mm vs. 17.3±2.6mm(3)/mm, p=0.04). Chronic stent enlargement resulted in greater lumen area after implantation of self-expanding PES with a large diameter at the mid-term follow-up. Stent diameter might be important for stent patency in procedure with PES for SFA lesions. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  6. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction.

    PubMed

    Stone, Gregg W; Lansky, Alexandra J; Pocock, Stuart J; Gersh, Bernard J; Dangas, George; Wong, S Chiu; Witzenbichler, Bernhard; Guagliumi, Giulio; Peruga, Jan Z; Brodie, Bruce R; Dudek, Dariusz; Möckel, Martin; Ochala, Andrzej; Kellock, Alison; Parise, Helen; Mehran, Roxana

    2009-05-07

    There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI). We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical bare-metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months. Patients who received paclitaxel-eluting stents, as compared with those who received bare-metal stents, had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio, 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P=0.006), with noninferior rates of the composite safety end point (8.1% vs. 8.0%; hazard ratio, 1.02; 95% CI, 0.76 to 1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1 to 2.4; P=0.01 for noninferiority; P=0.92 for superiority). Patients treated with paclitaxel-eluting stents and those treated with bare-metal stents had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; hazard ratio, 0.44; 95% CI, 0.33 to 0.57; P<0.001). In patients with ST-segment elevation myocardial infarction who were undergoing primary PCI, implantation of paclitaxel-eluting

  7. [Inhospital and 12-months results of percutaneous coronary interventions with implantation of Paclitaxel eluting stents in patients with long de novo coronary artery lesions].

    PubMed

    Batyraliev, T A; Fettser, D V; Sidorenko, B A; Preobrazhenskiĭ, D V; Niyazova-Karben, Z A; Abdramanov, K A; Belenkov, Iu N

    2010-01-01

    We implanted 59 paclitaxel eluting Apollo stents to 48 patients with ischemic heart disease (IHD) and long de novo coronary artery lesions in 2007 with 100% immediate success rate without inhospital major cardiac complications. One patient developed hematoma at femoral artery puncture site. There were no cases of restenosis among 18 patients subjected to control angiography after 6 months. One patient had acute myocardial infarction in area supplied by nontarget artery. Control angiography after 12 months was carried out in 81.3% of patients while 14.6% of patients who refused angiography were examined with stress tests. Restenosis of stented segments was found in 3 (5.3%) patients, diameter loss was 0.32+/-0.45 mm. All these patients were subjected to repeat PCI. During follow up myocardial infarctions were registered in 4.2% of patients, overall rate of serious cardiac complications was 11.6%. PCI with implantation of paclitaxel was safe and effective with acceptable rate of major cardiac complications. Our results evidence in favor of further use of these stents.

  8. Comparing the vascular response in implantation of self-expanding, bare metal nitinol stents or paclitaxel-eluting nitinol stents in superficial femoral artery lesions: a serial optical frequency domain imaging study.

    PubMed

    Miki, Kojiro; Fujii, Kenichi; Shibuya, Masahiko; Fukunaga, Masashi; Imanaka, Takahiro; Tamaru, Hiroto; Nishimura, Machiko; Horimatsu, Tetsuo; Honda, Yasuhiro; Fitzgerald, Peter J; Masuyama, Tohru; Ishihara, Masaharu

    2016-12-20

    This study sought to investigate differences in vascular response between self-expanding bare metal nitinol stents (BMS) and paclitaxel-eluting nitinol stents (PES), in superficial femoral artery (SFA) disease, using optical frequency domain imaging (OFDI). Six months after stent implantation, follow-up quantitative vascular angiography (QVA) and OFDI assessment were scheduled to evaluate vascular response. Volume index (VI) was defined as volume divided by stent length. The primary endpoint was OFDI-derived late lumen area loss, defined as lumen VI post stent implantation minus lumen VI at follow-up. A total of 28 SFA lesions were analysed, with cases randomised to receive either BMS or PES implantation. QVA-derived diameter stenosis at six-month follow-up was lower in the PES group than in the BMS group (28.5% vs. 39.7%, p=0.04). After six months, BMS VI increased by 33.8% (20.7±3.7 to 27.7±3.5 mm3/mm), whilst PES exhibited an increase of 32.1% (19.0±2.3 to 25.1±4.7 mm3/mm). Neointimal VI was smaller (7.4±2.6 mm3/mm vs. 10.5±3.2 mm3/mm, p<0.01) and late lumen area loss was lower (2.9±1.3 mm3/mm vs. 5.6±2.8 mm3/mm, p<0.01) in the PES group. Serial volumetric OFDI analyses confirmed significantly smaller amounts of neointimal tissue and lower late lumen area loss following PES implantation for SFA lesions at short-term follow-up.

  9. 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

  10. 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.

  11. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.

    PubMed

    Kedhi, Elvin; Joesoef, Kaiyum Sheik; McFadden, Eugene; Wassing, Jochem; van Mieghem, Carlos; Goedhart, Dick; Smits, Pieter Cornelis

    2010-01-16

    Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005. The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. Unrestricted grants from Abbott Vascular and Boston Scientific. Copyright 2010 Elsevier Ltd. All rights

  12. 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.

  13. Effect of a paclitaxel-eluting metallic stent on rabbit esophagus

    PubMed Central

    Zhang, Yin; Gao, Ying; Chen, Jianping; Ma, Limei; Liu, Li; Wang, Xiang; Fan, Zhining

    2016-01-01

    The use of self-expanding metallic stents (SEMS) is the current treatment of choice for malignant gastrointestinal obstructions. A paclitaxel-eluting metallic SEMS (PEMS) may have an antitumor effect on esophageal tissue. PEMS with 10% paclitaxel or conventional SEMS were inserted into the lower esophagus of rabbits. Following the insertion of the stents for 1, 2, 4 and 6 weeks, the rabbits were sacrificed and the status of the stent insertion was examined, as well as any macroscopic or microscopic mucosal changes in the esophageal tissue. All the rabbits survived until death without any complications. No migration following stent insertion occurred. The number of cases with proximal obstruction increased in a time-dependent manner, and no significant difference was observed between the two groups. Gross histological examination showed similar tissue reaction to the stents at 1, 2 and 4 weeks, and inflammatory cell infiltrating was higher in the SEMS group at 1 and 2 weeks. However, inflammatory cell infiltration was markedly higher in the PEMS group at 4 and 6 weeks. Food-intake and weight were similar in the two groups. The results of the present study demonstrated that PEMS may serve as a safe alternative treatment strategy for esophageal obstruction. Furthermore, PEMS may inhibit the tumor growth of the esophageal wall through inflammatory infiltration and targeted drug delivery. A tumor model will be required in the future for evaluating the prognosis of patients with advanced esophageal carcinoma. PMID:27882097

  14. 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.

  15. 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.

  16. Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial.

    PubMed

    Gouëffic, Yann; Kaladji, Adrien; Guyomarch, Béatrice; Montagne, Carine; Fairier, Damien; Gestin, Simon; Riche, Valéry-Pierre; Vent, Pierre Alexandre; Chaillou, Philippe; Costargent, Alain; Patra, Philippe

    2014-10-30

    Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm). A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease. This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the

  17. Polymer-based paclitaxel-eluting coronary stents. Clinical results in de novo lesions.

    PubMed

    Chieffo, Alaide; Colombo, Antonio

    2004-03-01

    Drug-eluting stents (DES) represent one of the fastest-growing fields in interventional cardiology today. Paclitaxel (Taxol) is a potent antiproliferative agent that shifts the microtubule equilibrium toward assembly, favoring the formation of abnormally stable microtubules with blockage of the cell cycle in G2/M phases. A series of clinical trials (TAXUS I through VI) have been designed to test the safety and the efficacy of polymer- based paclitaxel-eluting stents (Taxus, Boston Scientific, Natick, MA, USA) at the dosage 1 microg/mm(2) in a variety of clinical settings. Except for TAXUS III and TAXUS V-ISR, in the TAXUS program de novo lesions have been evaluated. Two different release kinetics were evaluated: slow-release (SR) and moderate- release (MR) formulation. Very encouraging preliminary results also come from the "real world" data on Taxus SR stent collected in the "Web-based taxus Intercontinental obServational Data TransitiOnal registry prograM" (the WISDOM Registry) and in the "Real Life Polymer-Based Paclitaxel Registry" (the Real Life PBPaclitaxel Registry). The remarkable positive results obtained from the randomized trials offer the interventional cardiologist another effective option (besides the Cypher stent, Cordis a J & J, Warren, NJ, USA) to treat patients with a DES. This fact may certainly drive the competition and, ultimately, lower the cost. The final answer will probably come from the ongoing registries and prospective trials versus coronary artery bypass grafting (CABG), which will reveal the real impact of this new technology on everyday practice.

  18. Dedicated paclitaxel-eluting bifurcation stent BiOSS® (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population.

    PubMed

    Gil, Robert J; Vassilev, Dobrin; Michalek, Aleksandra; Kern, Adam; Formuszewicz, Radosław; Dobrzycki, Sławomir; Wójcik, Jarosław; Lesiak, Maciej; Kardaszewicz, Piotr; Lekston, Andrzej

    2012-07-20

    Dedicated bifurcation stents seem to be the most promising solution for treating bifurcations. The aim of our study was to present the 12 months results of a new dedicated stent for coronary bifurcation lesions -the paclitaxel-eluting stent- BiOSS® Expert (Bifurcation Optimisation Stent System, Balton, Warsaw, Poland). Sixty-three patients with 65 lesions were enrolled in the registry. Forty-six % of the patients were classified as NSTEMI or unstable angina, 27% were diabetics, 30% had previous myocardial infarction and 48% had a history of previous revascularisation. In addition, hypertension and dyslipidaemia were the most common risk factors (58% and 40%). Sixty-five stents were successfully implanted (100% device success rate). The analysis of 30 days follow-up for 63 patients revealed good clinical results showing lack of death, target lesion revascularisation procedures (TLR) and target vessel revascularisation procedures (TVR). There were six (9,5%) cases of in-hospital raised troponin, however, only one showed an additional increase in CK-MB levels and was qualified as non-Q myocardial infarction (MI). There was a need for percutaneous coronary intervention (PCI) in a non-index vessel in one patient due to exertional angina. The analysis of 12-month follow-up for 63 patients revealed good clinical results. There were two (3.2%) cases of death (three and 10 months after index procedure). The first patient, in good physical shape, drowned, while the second was found dead by his family. There were no incidents of MI or stroke in the rest of the population. At 12 months there were seven (10.8% per lesion; 11.1% per patient) cases of TLR and nine (13.8% per lesion; 14.3% per patient) TVR. There were also 15 (23.8%) cases of PCI on vessels not related to BiOSS® Expert stent implantation. Our registry showed that bifurcation treatment with a single dedicated paclitaxel-eluting bifurcation stent, BiOSS® Expert is feasible and successful. The long-term clinical

  19. Clinical outcomes of chronic kidney disease patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES).

    PubMed

    Kitasato, Lisa; Shimohama, Takao; Ikeda, Yuki; Namba, Sayaka; Hashikata, Takehiro; Kameda, Ryo; Sato, Nobuhiro; Takeuchi, Ichiro; Yamaoka-Tojo, Minako; Tojo, Taiki; Ako, Junya

    2015-05-01

    The target lesion revascularization of paclitaxel-eluting stents (PES) has been reported to be lower than that of sirolimus-eluting stents in patients on hemodialysis (HD). However, the comparison of PES and second generation drug-eluting stents in CKD patients has not been fully investigated. We compared clinical outcomes of everolimus-eluting stents (EES) and PES in CKD patients. Hundred and forty seven CKD patients (eGFR<60mLmin(-1)1.73m(-2)) treated with PES (n=74, from May 2007 to December 2009) and EES (n=73, from January 2010 to January 2013) were enrolled in the study. Major adverse cardiac events (MACEs) were defined as death, non-fatal myocardial infarction, and ischemia driven target lesion revascularization. The incidence of 36-month MACE was significantly lower in EES, non-HD group compared to PES, non HD group (0% in EES group and 13.5% in PES group, respectively, P<0.01). There was no significant difference in MACE between EES and PES in HD patients (5.4% in PES group and 5.5% in EES group, P=0.98). In multivariate analysis, PES group and PES ISR were independent factors for worse incidence of MACE. In CKD patients, PES was associated with worse clinical outcomes in non-HD patients as compared with EES. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  20. The STENTYS® paclitaxel-eluting stent in the treatment of unprotected distal left main.

    PubMed

    Briguori, Carlo; Visconti, Gabriella; Donahue, Michael; Focaccio, Amelia; Mitomo, Satoru; Kawamoto, Hiroyoshi; Nakamura, Sunao

    2015-09-01

    Vessel tapering represents an important limitation of the balloon-expandable drug-eluting stent (DES) in the treatment of distal unprotected left main coronary artery (ULMCA) lesions. In this study, we assessed the suitability of the STENTYS DES((P)) , a self-apposing nitinol paclitaxel-eluting stent, for use in the treatment of distal ULMCA lesions. From February 2012 to September 2013, 75 consecutive patients with tapered (that is a >1 mm difference in the diameter from the proximal to the distal main vessel) distal ULMCA lesions were treated with the STENTYS DES((P)) (STENTYS-DES group) at the Clinica Mediterranea (Naples, Italy). A matched-group of 75 patients treated with second-generation DES in the same period (Control group) was selected from the database of New Tokyo Hospital (Chiba, Japan). The result was assessed by both quantitative coronary angiography and intravascular ultrasound (IVUS). Although the final balloon diameter was larger in the Control group (4.51 ± 0.51 vs. 3.62 ± 0.49 mm; P < 0.001), the IVUS analysis showed a larger final minimal lumen area in the STENTYS-DES group than in the Control group (left main: 17.45 ± 3.45 vs. 14.84 ± 3.45 mm(2) ; P < 0.001; polygon of confluence: 15.74 ± 3.28 vs. 12.55 ± 5.45 mm(2) ; P < 0.002; ostial left anterior descending artery: 11.73 ± 1.97 vs. 8.56 ± 1.80 mm(2) ; P < 0.001). At 12 ± 5 months, major adverse cardiac events (including death, myocardial infarction, and repeat revascularization) occurred in seven patients in both groups. This pilot study suggests that the self-apposing properties of the STENTYS DES((P)) offer a valid alternative for the treatment of the distal ULMCA lesions. © 2015 Wiley Periodicals, Inc.

  1. Two-year clinical outcomes of paclitaxel-eluting stents for in-stent restenosis in patients from the ARRIVE programme.

    PubMed

    Lee, Michael S; Yang, Tae; Lasala, John M; Cox, David A; Bowman, Thomas S; Starzyk, Ruth M; Dawkins, Keith D

    2011-07-01

    To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) for in-stent restenosis (ISR) in an unselected patient population. Implantation of bare metal stents in native coronary vessels can result in ISR rates exceeding 50%. PES significantly reduces ISR-lesion restenosis and improves event-free survival versus vascular brachytherapy. The 7,492-patient ARRIVE registry enrolled patients receiving ≥1 TAXUS Express stent at procedure initiation with no inclusion/exclusion criteria, including 489 patients with ISR. Endpoints were independently adjudicated. All major cardiac events were monitored plus a 10%-20% sample per site. ISR patient 2-year follow-up was 94% complete (462/489). Compared to simple-use patients undergoing native coronary intervention (N=2698) or other, non-ISR expanded-use cases (N=4305), ISR patients had significantly more baseline comorbidities/complex disease. They had higher 2-year rates for mortality (8.6% vs. 4.2%, P<0.001), myocardial infarction (5.0% vs. 2.2%, P<0.001), definite/probable stent thrombosis (4.0% vs. 1.4%, P<0.001), and target lesion revascularisation (12.3% vs. 5.4%, P<0.001) versus simple-use. Safety outcomes were comparable between the ISR and non-ISR expanded-use subgroups but target vessel revascularisation (TVR) was significantly higher for ISR (16.0% vs. 10.9%, P=0.003). ISR was independently associated with increased risk for TVR (1.4-fold). ARRIVE ISR, one of the largest studied cohorts of patients receiving DES for ISR, had higher risk for clinical events versus simple-use patients but comparable safety outcomes versus other expanded-use patients except for significantly higher revascularisation. ARRIVE provides a detailed estimate of 2-year outcomes in these real-world patients.

  2. Zotarolimus- and paclitaxel-eluting stents in an all-comer population in China: the RESOLUTE China randomized controlled trial.

    PubMed

    Xu, Bo; Yang, Yuejin; Yuan, Zuyi; Du, Zhimin; Wong, S Chiu; Généreux, Philippe; Lu, Shuzheng

    2013-07-01

    This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population. Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk. Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents. A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p < 0.001; 95% confidence interval [CI]: -0.26 to -0.08). The rates of clinically driven target lesion revascularization were 1.5% for R-ZES and 7.0% for PES (p = 0.011). The rate of target lesion failure was 5.6% for R-ZES and 11% for PES (p = 0.068). In an all-comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China [R-China RCT]; NCT01334268). Copyright © 2013 American College of Cardiology Foundation. Published by

  3. The effect of paclitaxel-eluting covered metal stents versus covered metal stents in a rabbit esophageal squamous carcinoma model

    PubMed Central

    Zhang, Yin; Ma, Limei; Huang, Jin; Shuang, Jinquan

    2017-01-01

    Background The use of self-expanding metallic stents (SEMSs) is the current treatment of choice for malignant gastrointestinal obstructions. However, these stents can promote only drainage and have no antitumor effect. Some studies have reported that drug-eluting SEMSs may have tumor inhibition potential. The aim of this study was to evaluate the efficiency and safety of paclitaxel-eluting SEMSs (PEMSs) in rabbit esophageal cancer models. Materials and methods A PEMS was covered with a paclitaxel-incorporated membrane, in which the concentration of paclitaxel was 10% (wt/vol). The rabbit models were created endoscopically. Then, a PEMS or SEMS was endoscopically inserted into the rabbit esophagus. Two weeks after stent placement, the rabbits were sacrificed, and we evaluated the tumor volume, area of the wall defect, area of the tumor under endoscopic ultrasound (EUS) before and after stent placement, status of the proximal esophageal obstruction, tumor metastasis food-intake and weight loss. Results A total of 26 rabbits received stent insertion and survived until sacrifice, and migration occurred in 4 cases, 3 in SEMS group and 1 in PEMS group. For the remaining 22 rabbits, at the sacrificed time, the average tumor volume was 7.00±4.30 cm3 in the SEMS group and 0.94±1.51 cm3 in the PEMS group (P<0.05). The area of the esophageal wall defect was 0.70±0.63 cm2 in the SEMS group and 0.17±0.16 cm2 in the PEMS group (P<0.05). The tumor area under EUS was 4.40±1.47 cm2 in the SEMS group and 1.30±1.06 cm2 in the PEMS group (P<0.05). At the time of stent placement, tumor area under EUS was comparable in the two groups. Other indices did not significantly differ between the two groups. Conclusions SEMS and PEMS are both safe and effective to relieve dysphagia in rabbit esophageal cancer models. A PEMS can serve as an alternative tool for advanced esophageal cancer that may inhibit tumor growth by serving as a drug sustained-release platform. Clinical trials of the

  4. Long-term follow-up (four years) of unprotected left main coronary artery disease treated with paclitaxel-eluting stents (from the TRUE Registry).

    PubMed

    Godino, Cosmo; Parodi, Guido; Furuichi, Shinichi; Latib, Azeem; Barbagallo, Rossella; Goktekin, Omer; Cera, Michela; Mueller, Ralf; Tamburino, Corrado; Grube, Eberhard; Di Mario, Carlo; Reimers, Bernard; Chieffo, Alaide; Antoniucci, David; Colombo, Antonio; Sangiorgi, Giuseppe M

    2010-04-01

    Limited data are available on the long-term outcome following PCI with paclitaxel-eluting stent (PES) implantation in patients with unprotected left main coronary artery (LMCA). The objective of this study was to evaluate "real world" long-term outcome following paclitaxel-eluting stent (PES) implantation for unprotected LMCA disease in patients enrolled in the TRUE registry. From March 2003 to October 2004, 93 consecutive patients (81.7% male) underwent PCI for unprotected LMCA disease. Surveillance angiography was performed at 6.8+/-3.3 months follow-up. The target lesion involved the distal LMCA in 68 (73.1%) patients. Double stenting techniques were performed in 46 (67.6%) distal LMCA, of these 50% were stented using the Crush technique. Clinical follow-up was complete in all patients with 85.8% angiographic follow-up rate. In-segment restenosis occurred in 16 (20.3%) patients and was focal in 72.4% of cases and significantly higher in patients with distal LMCA (36.8% vs. 13.6%, p<0.04). At a median follow-up of 1,450 days (IQR 1281-1595), the overall incidence of MACE was 35.5% and the TLR rate was 25.8% and significantly higher in patients with bifurcation stenting (32.3% vs. 8%, p<0.02). The estimated cardiac survival rate at one and four years was 96.7% and 93.3%, respectively. Total mortality rate was 14.1% and cardiac was 6.5%. There was one (1.1%) definite stent thrombosis (ST) and one (1.1%) probable ST. Treatment of unprotected LMCA disease with PES, after four years follow-up, appears to be safe and effective with a low rate of cardiac mortality and overall risk of ST. The need for target lesion revascularisation in 25.8% of patients highlights the need for more effective PCI especially in patients with distal LMCA disease.

  5. 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.

  6. Comparison of Long-Term Outcomes in Real-World Patients Between Resolute Zotarilumus-Eluting and Paclitaxel-Eluting Stents in Small Vessel.

    PubMed

    Kilickesmez, Kadriye Orta; Kocaş, Betül; Yildiz, Ahmet; Coskun, Ugur; Ersanli, Murat; Arat, Alev; Gürmen, Tevfik

    2016-05-01

    To compare the long-term clinical outcomes between Resolute zotarolimus-eluting stent (R-ZES) and paclitaxel-eluting stent (PES) in patients with small coronary artery disease. Patients with a small vessel diameter are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation. A cohort of 265 patients treated with R-ZES (185 patients with 211 lesions) or PES (80 patients with 100 lesions) in small vessel (≤2.5 mm) lesions were retrospectively analyzed. The primary end point of the study was the composite of major adverse cardiac events. The secondary end points included target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis at 3 years. The baseline characteristics were similar between the 2 groups. In the R-ZES group, the mean stent diameter was smaller and the total stent length per lesion was longer. Major adverse cardiac events occurred in 8 (10%) patients who had received PES and in 7 (3.8%) patients who had received R-ZES (P = .07). The rates of 3-year TLR (2.2% vs 2.5%; P = 1.00) and TVR (5.4% vs 10.0%; P = .17) showed no statistically significant difference between the R-ZES and PES groups. The rate of stent thrombosis was 0.5% in the R-ZES group and 2.5% in the PES group (P = .21). The rates of major adverse cardiac events and cardiac death were similar in the R-ZES-treated group compared with the PES-treated group. © The Author(s) 2015.

  7. Combined paclitaxel-eluting balloon and Genous cobalt-chromium alloy stent utilization in de novo coronary stenoses (PEGASUS).

    PubMed

    Jim, Man-Hong; Fung, Raymond Chi-Yan; Yiu, Kai-Hang; Ng, Andrew Kei-Yan; Siu, Chung-Wah; Fan, Katherine Yu-Yan

    2013-12-01

    The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel-eluting balloon (PEB) and Genous stent. This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis. From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis ≥ 50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow-up were intended at 6 and 9 months, respectively. The mean age of patients was 61 ± 11 years, with male predominance (83%). Diabetes mellitus and end-stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 ± 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 ± 0.46 mm and 28 ± 9 mm vs. 2.98 ± 0.36 mm and 23 ± 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 ± 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 ± 0.37 mm. At 9-month follow-up, no stent thrombosis was observed. The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis. © 2013, Wiley Periodicals, Inc.

  8. Fluorocopolymer-coated nitinol self-expanding paclitaxel-eluting stent: pharmacokinetics and vascular biology responses in a porcine iliofemoral model.

    PubMed

    Hou, Dongming; Huibregtse, Barbara A; Eppihimer, Michael; Stoffregen, William; Kocur, Gordon; Hitzman, Cory; Stejskal, Elizabeth; Heil, John; Dawkins, Keith D

    2016-08-20

    Our aim was to evaluate arterial responses to paclitaxel and a novel fluorocopolymer-coated nitinol low-dose paclitaxel-eluting stent (FP-PES). Human smooth muscle cell (SMC) migration was assessed after exposure to paclitaxel in vitro. For pharmacokinetics and vascular response, FP-PES or bare metal stents (BMS) were implanted in porcine iliofemoral arteries. Paclitaxel significantly inhibited human coronary and femoral artery SMC migration at doses as low as 1 pM. Inhibition was significantly greater for femoral compared with coronary artery SMCs from 1 pM to 1 μM. Pharmacokinetics showed consistent paclitaxel release from FP-PES over the study duration. The peak arterial wall paclitaxel level was 3.7 ng/mg at 10 days, with levels decreasing to 50% of peak at 60 days and 10% at 180 days. Paclitaxel was not detected in blood or remote organs. Arteriogram and histomorphometry analyses showed FP-PES significantly inhibits neointimal proliferation versus BMS at 30 and 90 days. Re-endothelialisation scores were not different between groups. Paclitaxel affected femoral artery SMC migration at lower concentrations and to a greater degree than it did coronary artery SMCs. The novel FP-PES used in this preclinical study demonstrated a vascular healing response similar to BMS, while significantly inhibiting neointimal formation up to 90 days.

  9. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial.

    PubMed

    Turco, Mark A; Ormiston, John A; Popma, Jeffrey J; Mandinov, Lazar; O'Shaughnessy, Charles D; Mann, Tift; McGarry, Thomas F; Wu, Chiung-Jen; Chan, Charles; Webster, Mark W I; Hall, Jack J; Mishkel, Gregory J; Cannon, Louis A; Baim, Donald S; Koglin, Joerg

    2007-04-24

    The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.). The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform. The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization. Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487). Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709).

  10. Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease

    PubMed Central

    Müller-Hülsbeck, Stefan; Keirse, Koen; Zeller, Thomas; Schroë, Herman; Diaz-Cartelle, Juan

    2016-01-01

    Purpose: To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions. Methods: The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months. Results: All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months. Conclusion: MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months. PMID:27193308

  11. Dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® in the treatment of distal left main stem stenosis.

    PubMed

    Bil, Jacek; Gil, Robert J; Vassilev, Dobrin; Rzezak, Jarosław; Kulawik, Tomasz; Pawlowski, Tomasz

    2014-06-01

    The aim of this study was to assess prospectively the effectiveness and safety profile of distal left main stem (LMS) stenosis treatment with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®. Angioplasty of distal LMS stenosis is always a high-risk procedure, and optimal treatment is uncertain. This was a prospective international 2-center study, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) or stable angina with distal left main stenosis. All patients were treated with the dedicated bifurcation stent BiOSS Expert®. Provisional T-stenting was the obligatory strategy. Angiographic control was performed after 12 months. The primary end-point was cumulative rate of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. Angiographic end-points included late lumen loss, percent diameter stenosis, and binary restenosis rate. A total of 54 patients with distal LMS stenosis were enrolled. Seven patients (13%) were enrolled during NSTE-ACS, 77.8% were hypertensive, 27.8% were diabetic, 51.9% had previous MI, 53.7% underwent prior percutaneous coronary intervention, and 16.7% coronary artery bypass graft. The mean SYNTAX score was 21.52 ± 6.50. The device success rate was 100%. The mean BiOSS Expert stent parameters were as follows: 4.07 ± 0.26 mm × 3.36 ± 0.26 mm × 16.61 ± 1.72 mm and in side branch the other stent (classical drug-eluting stent) was implanted in 25.9% of cases. The overall TLR was 9.3%. There were no death, stent thrombosis, or acute MI. In the univariate regression analysis, the only factor associated with higher risk for TLR was the SYNTAX score value. The dedicated bifurcation stent BiOSS Expert® proved to be a feasible device, with promising safety and long-term clinical effectiveness in the treatment of distal LMS stenosis. © 2014, Wiley Periodicals, Inc.

  12. Sirolimus- versus paclitaxel-eluting stents: numero uno, first among equals or equal?

    PubMed

    Kuchulakanti, Pramod K; Waksman, Ron

    2006-07-01

    Drug-eluting stents (DESs) have shown the ability to reduce restenosis and major adverse cardiac events in de novo lesions when compared with bare metal stents in randomized studies. Enthused by the results of these trials, DESs are being used in other difficult lesion subsets, such as bifurcation lesions, in-stent restenosis, vein graft lesions and chronic total occlusions. They are also being used in difficult patient subsets, such as diabetes and acute myocardial infarction. Not all DES are equal, however, and research is now focused on understanding the differences between these stents. This review discusses the DESs that are US FDA-approved and currently available in the USA, namely Cypher (Cordis Corporation) and Taxus (Boston Scientific), and whether they are comparable.

  13. A budget impact model for paclitaxel-eluting stent in femoropopliteal disease in France.

    PubMed

    De Cock, Erwin; Sapoval, Marc; Julia, Pierre; de Lissovoy, Greg; Lopes, Sandra

    2013-04-01

    The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. The model estimated a net cumulative 5-year budget reduction of 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

  14. A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in France

    SciTech Connect

    De Cock, Erwin; Sapoval, Marc; Julia, Pierre; Lissovoy, Greg de; Lopes, Sandra

    2013-04-15

    The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. The model estimated a net cumulative 5-year budget reduction of Euro-Sign 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

  15. Two-year clinical outcomes with paclitaxel-eluting coronary stents in patients with chronic total occlusions: analysis from the TAXUS ARRIVE program.

    PubMed

    Huang, Pei-Hsiu; Yeung, Michael; Lasala, John M; Cox, David A; Bowman, Thomas S; Starzyk, Ruth M; Dawkins, Keith D

    2011-06-01

    To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) in chronic total occlusions (CTO) in an unselected patient population. The TAXUS ARRIVE registries compiled data on 7,492 patients, including 113 patients with CTO (TIMI flow 0). Patients enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent end-point adjudication. Two-year follow-up was 89% (101/113) for CTO patients who had significantly more baseline comorbidities/complex disease than simple-use patients undergoing native coronary intervention (N = 2,698) and significantly longer lesions/smaller vessels than other expanded-use patients (N = 4,681 without CTO). Among CTO patients the rate of 2-year major cardiac events (MCE, including cardiac death, myocardial infarction, and target vessel revascularization) was 22.3%, significantly higher than in simple-use patients (10.3%, P < 0.001). CTO MCE was similar to that for other expanded-use patients (16.5%, P = 0.14) but target lesion revascularization was significantly higher in year 2 (6.9% vs. 2.7%, P = 0.02). Academic Research Consortium definite/probable stent thrombosis through 2 years was 5.7%, significantly higher than simple-use patients but similar to other expanded-use cases. In a "real-world" setting, PES use in CTO was associated with increased MCE compared to simple- use patients, but achieved long-term outcomes similar to that observed in other complex patient/lesion cases. ©2011, Wiley Periodicals, Inc.

  16. Three-Year Clinical Outcomes of a Polymer-Free Paclitaxel-Eluting Microporous Stent in Real-World Practice: Final Results of the Safety and Efficacy Registry of the Yinyi Stent (SERY-I)

    PubMed Central

    Zhu, Jinzhou; Zhang, Qi; Chen, Lianglong; Zhang, Chenyun; Zhou, Xuchen; Yuan, Yong; Zhang, Ruiyan

    2017-01-01

    Background The safety and efficacy of a China-made polymer-free paclitaxel-eluting microporous stent (Yinyi) at 1-year has been previously reported. However, limited evidence exists regarding the long-term performance of this novel drug-eluting stent (DES). This study investigated the 3-year efficacy and safety of the Yinyi stent in the setting of safety and efficacy registry of the Yinyi stent (SERY-I) clinical trial. Methods Between June 2008 and August 2009, a total of 1045 patients undergoing percutaneous coronary intervention (PCI) were implanted with ≥ 1 Yinyi stents at 27 medical centers in mainland China. Thereafter, clinical follow-up was performed for a period of 3 years after enrollment. The primary endpoint was the cumulative rate of composite major adverse cardiac events (MACE) including target lesion revascularization (TLR), the combined incidence of cardiac death, and non-fatal myocardial infarction; the second endpoint was the incidence of stent thrombosis. Results Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 (98.7%) patients received dual antiplatelet therapy for at least 12 months. At 3 years, a total of 13 (1.33%) patients had suffered cardiac death. The incidence of non-fatal myocardial infarction and TLR was 9 (0.92%) and 58 (5.92%) among the patients. Stent thrombosis occurred in 13 (1.33%) patients, and the rate of Academic Research Consortium (ARC) definite or probable stent thrombosis was 0.82%. Conclusions Given the limitations that SERY-I was a single arm, nonrandomized study and only telephone follow-up was performed without angiographic analysis, the safety and efficacy of Yinyi stent observed in this extended follow-up Registry needs further verification. PMID:28115804

  17. Safety and efficacy of different paclitaxel-eluting balloons in a porcine model.

    PubMed

    Pérez de Prado, Armando; Pérez-Martínez, Claudia; Cuellas Ramón, Carlos; Regueiro Purriños, Marta; Diego Nieto, Alejandro; Gonzalo-Orden, José M; Molina Crisol, María; Gómez Castel, Alex; Duocastella Codina, Luis; Fernández-Vázquez, Felipe

    2014-06-01

    Paclitaxel-eluting balloons have shown high antiproliferative efficacy in the treatment and prevention of restenosis. Nevertheless, not all available devices are equally effective, which makes it interesting to compare results in a preclinical model. Our objective was to assess the preclinical efficacy and safety of different devices. We implanted 51 metallic stents (Architect(®), iVascular) in 17 domestic swine (mean, 25 [3] kg), inserting 1 stent per major coronary artery. Stent postdilatation was performed with different control balloons (n=10) or paclitaxel-eluting balloons: paclitaxel-eluting balloon 1 (iVascular) (n=15); paclitaxel-eluting balloon 2 (iVascular) (n=16) and In.Pact Falcon(®) (Medtronic) (n=10). The restenosis rate (using angiography and histomorphometry) and vascular healing parameters (balloon-related vascular injury score, endothelialization rate, and fibrin and inflammation scores) were analyzed at 28 days. The distinct paclitaxel-eluting balloons showed a similar degree of stenosis at follow-up, which was significantly lower than that in the control group: diameter stenosis was 9% (12%) vs 34% (18%) by angiography (P<.0001) and was 22% (8%) vs 51% (18%) by histomorphometry (P<.0001). Scores for vascular injury (mean, 0.6 [0.5]) and inflammation (mean, 0.8 [0.3]) were uniformly low across all groups. Drug effect markers differed significantly between the paclitaxel-eluting balloons and control groups, with lower endothelialization rates (87% [10%] vs 99% [2%]; P=.0007) and higher fibrin scores (2.1 [0.7] vs 0.4 [0.5]; P<.0001) in the paclitaxel-eluting balloons groups. There were no differences between the different paclitaxel-eluting balloons. In this preclinical model, the paclitaxel-eluting balloons studied significantly reduced in-stent restenosis compared with the control balloons. Although there were no findings of persistent vascular injury or inflammation, delayed endothelialization and fibrin aggregate suggest a drug deposition

  18. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery

    PubMed Central

    Ansel, Gary M.; Jaff, Michael R.; Ohki, Takao; Saxon, Richard R.; Smouse, H. Bob; Machan, Lindsay S.; Snyder, Scott A.; O’Leary, Erin E.; Ragheb, Anthony O.; Zeller, Thomas

    2016-01-01

    Background— This randomized controlled trial evaluated clinical durability of Zilver PTX, a paclitaxel-coated drug-eluting stent (DES), for femoropopliteal artery lesions. Outcomes compare primary DES versus percutaneous transluminal angioplasty (PTA), overall DES (primary and provisional) versus standard care (PTA and provisional Zilver bare metal stent [BMS]), and provisional DES versus provisional BMS. Methods and Results— Patients with symptomatic femoropopliteal artery disease were randomly assigned to DES (n=236) or PTA (n=238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS (n=59) or DES (n=61). The 1-year primary end points of event-free survival and patency showed superiority of primary DES in comparison with PTA; these results were sustained through 5 years. Clinical benefit (freedom from persistent or worsening symptoms of ischemia; 79.8% versus 59.3%, P<0.01), patency (66.4% versus 43.4%, P<0.01), and freedom from reintervention (target lesion revascularization, 83.1% versus 67.6%, P<0.01) for the overall DES group were superior to standard care in nonrandomized comparisons. Similarly, clinical benefit (81.8% versus 63.8%, P=0.02), patency (72.4% versus 53.0%, P=0.03), and freedom from target lesion revascularization (84.9% versus 71.6%, P=0.06) with provisional DES were improved over provisional BMS. These results represent >40% relative risk reduction for restenosis and target lesion revascularization through 5 years for the overall DES in comparison with standard care and for provisional DES in comparison with provisional BMS. Conclusions— The 5-year results from this large study provide long-term information previously unavailable regarding endovascular treatment of femoropopliteal artery disease. The Zilver PTX DES provided sustained safety and clinical durability in comparison with standard endovascular treatments. Clinical Trial

  19. Two-Year outcomes after utilization of the TAXUS paclitaxel-eluting stent in bifurcations and multivessel stenting in the ARRIVE registries.

    PubMed

    Brilakis, Emmanouil S; Lasala, John M; Cox, David A; Bowman, Thomas S; Starzyk, Ruth M; Dawkins, Keith D

    2011-08-01

    Examine the incidence of clinical events after utilization of the TAXUS(®) Express(®) paclitaxel-eluting stent (PES) in multivessel and bifurcation coronary stenting in an unselected patient population. The ARRIVE Program compiled data on 7,492 patients receiving ≥1 TAXUS Express PES, including patients with multivessel stenting (MVS; n = 1,208) and bifurcation stenting (n = 575). Patients were enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent adjudication of end-points. Compared to simple use (single vessel/single stent) patients undergoing native intervention (N = 2,698), MVS patients had significantly more baseline comorbidities. Both groups had higher 2-year rates of mortality (7.3%[MVS] and 7.5%[bifurcation] vs. 4.2%[simple-use], P < 0.001), myocardial infarction (5.5% and 4.6% vs. 2.2%, P < 0.001 and P = 0.002), target vessel revascularization (15.5% and 14.8% vs. 7.7%, P < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.3% and 4.4% vs. 1.4%, P < 0.001) than the simple-use group. ARRIVE multivessel and bifurcation stenting patients have significantly higher clinical risk through 2 years compared to simple-use patients. In the absence of large randomized controlled trials in these populations, ARRIVE provides important insight into clinical outcomes over an extended period of time. (J Interven Cardiol 2011;24:342-350). ©2011, Wiley Periodicals, Inc.

  20. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    PubMed Central

    2010-01-01

    Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to <2.75 mm that compares TAXUS Element with a matched historical bare metal Express stent control. Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541. PMID:20059766

  1. One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE).

    PubMed

    Tamburino, Corrado; Capodanno, Davide; Erglis, Andrejs; Menown, Ian B A; Horváth, Iván G; Moreno, Raul; Gilbert, Timothy J; Crowley, James J; Calabria, Paolo; Allocco, Dominic J; Dawkins, Keith D

    2015-03-01

    To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinum-chromium TAXUS Element stent in a real-world setting. The PERSEUS Workhorse and Small Vessel studies showed positive results with the TAXUS Element stent in a clinical trial setting. TE-PROVE was a prospective, open-label, multicentre, "all-comers" study which enrolled 1,014 patients at 37 European sites. Follow-up was at 30 days, six months and one year, and will continue annually up to five years. The primary endpoint was overall and stent-related target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction (MI) and target vessel revascularisation (TVR) at one year post implantation. Secondary endpoints included the components of TVF, all-cause mortality, and ARC definite/probable stent thrombosis. Follow-up was available in 97.3% (987/1,014) of patients. Patients were 75.0% male (760/1,014), mean age was 65.1±10.8 years, 25.5% had medically treated diabetes (259/1,014), and 10.7% (109/1,014) were treated for STEMI. At baseline, mean lesion length among 1,299 treated lesions was 19.8±12.0 mm and mean reference vessel diameter was 3.1±0.5 mm. At one year, the rate of TVF (primary endpoint) was 6.0% (59/987) overall; 3.7% (37/987) of TVF events were stent-related. Cardiac death was 0.7% (7/987), target vessel-related MI was 1.1% (11/987), and TVR was 4.7% (46/987). All-cause death occurred in 1.2% (12/987) of patients and ARC definite/probable ST was 0.5% (5/987). The primary endpoint results from the TE-PROVE registry demonstrate good performance and safety for the TAXUS Element paclitaxel-eluting stent at one year in everyday clinical practice. NCT01242696.

  2. Propensity-matched patient-level comparison of the TAXUS Liberté and TAXUS element (ION) paclitaxel-eluting stents.

    PubMed

    Kereiakes, Dean J; Cannon, Louis A; Ormiston, John A; Turco, Mark A; Mann, Tift; Mishkel, Gregory J; McGarry, Thomas; Wang, Hong; Underwood, Paul; Dawkins, Keith D

    2011-09-15

    Stent design, metal alloy composition, and strut thickness may influence late lumen loss and clinical outcomes after bare metal stent deployment; however, their impact on outcomes after drug-eluting stent deployment is unknown. Although the TAXUS Liberté and ION paclitaxel-eluting stents use similar polymer and drug, the ION stent incorporates a novel thin-strut platinum chromium metal alloy and cell design. We therefore compared patient-level data from 2,298 subjects enrolled into the TAXUS ATLAS (TAXUS Liberté) and PERSEUS (ION) clinical trials. Propensity-score (1:1) matching was performed to adjust for covariate imbalance between stent types. Twelve-month major adverse cardiac events were less frequent after use of the ION compared to the TAXUS Liberté (12.7% vs 8.3%, p <0.001, unadjusted; 12.0% vs 7.5%, p = 0.007, propensity matched) largely because of decreased non-Q-wave myocardial infarction (MI; 2.9% vs 1.4%, p = 0.01, unadjusted; 3.2% vs 0.9%, p = 0.004, propensity matched). The MI difference was predominantly periprocedural and in patients treated with a single stent. In conclusion, this exploratory post hoc analysis demonstrated that the ION was associated with fewer adverse clinical events than the TAXUS Liberté because of decreased non-Q-wave MI. Stent platform-related variables may influence clinical outcomes after drug-eluting stent use despite similar polymer and drug elution. Differences in adjunctive pharmacotherapy and/or stenting technique may also be contributory. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Long-term (three-year) safety and efficacy of everolimus-eluting stents compared to paclitaxel-eluting stents (from the SPIRIT III Trial).

    PubMed

    Applegate, Robert J; Yaqub, Manejeh; Hermiller, James B; Sood, Poornima; Yu, Shui; Doostzadeh, Julie; Williams, Jerome E; Farhat, Naim; Caputo, Ronald; Lansky, Alexandra J; Cutlip, Donald E; Sudhir, Krishnankutty; Stone, Gregg W

    2011-03-15

    The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.

  4. 2-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial).

    PubMed

    Smits, Pieter C; Kedhi, Elvin; Royaards, Kees-Jan; Joesoef, Kaiyum Sheik; Wassing, Jochem; Rademaker-Havinga, Tessa A M; McFadden, Eugene

    2011-06-28

    The purpose of this study was to compare the safety and efficacy of the Xience V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the Taxus Liberté (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) at 2-year follow-up. COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial) demonstrated a superior clinical outcome of EES over PES at 1 year in all comers. Whether this superiority is maintained after discontinuation, at 12 months, of dual antiplatelet therapy is unclear. Patients undergoing percutaneous coronary intervention with limited exclusion criteria were randomly allocated to EES or PES. The 2-year pre-specified endpoints are composites of safety and efficacy and stent thrombosis. Follow-up was completed in 1,795 of 1,800 patients (99.7%). The groups had similar baseline characteristics. At 2 years, significantly fewer EES patients took dual antiplatelet therapy (11.4% vs. 15.4%, p = 0.02). The primary composite of all death, nonfatal myocardial infarction, and target vessel revascularization occurred in 9.0% of EES patients and 13.7% of PES patients (relative risk [RR]: 0.66; 95% confidence interval [CI]: 0.50 to 0.86) driven by a lower rate of myocardial infarction (3.9% vs. 7.5%; RR: 0.52; 95% CI: 0.35 to 0.77) and target vessel revascularization (3.2% vs. 8.0%; RR: 0.41; 95% CI: 0.27 to 0.62), in parallel with a lower rate of definite or probable stent thrombosis (0.9% vs. 3.9%; RR: 0.23; 95% CI: 0.11 to 0.49). Differences significantly increased between 1- and 2-year follow-up for the primary composite endpoint (p = 0.04), target vessel revascularization (p = 0.02), and definite or probable stent thrombosis (p = 0.02). The substantial clinical benefit of the EES over the PES with regard to measures of both safety and efficacy is maintained at 2 years in real-life practice with an increasing benefit in

  5. 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.

  6. Cost-effectiveness of everolimus- versus paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization (from the SPIRIT-IV Trial).

    PubMed

    Amin, Amit P; Reynolds, Matthew R; Lei, Yang; Magnuson, Elizabeth A; Vilain, Katherine; Durtschi, Amy J; Simonton, Charles A; Stone, Gregg W; Cohen, David J

    2012-09-15

    Although several drug-eluting stents (DESs) have been shown to be economically attractive compared to bare-metal stents in patients at moderate to high risk of restenosis, little is known about the cost-effectiveness of alternative DES designs, especially second-generation DESs. We therefore performed an economic substudy alongside the SPIRIT-IV trial, in which 3,687 patients undergoing single or multivessel percutaneous coronary intervention were randomized to receive second-generation everolimus-eluting stents (EESs; n = 2,458) or first-generation paclitaxel-eluting stents (PESs; n = 1,229). Costs through 2 years of follow-up were assessed from the perspective of the United States health care system. The primary cost-effectiveness end point was the incremental cost-effectiveness ratio assessed as cost per quality-adjusted life year gained. Over a 2-year period, use of EESs versus PESs led to a trend toward decreased overall repeat revascularization procedures (14.2 vs 16.2 per 100 subjects, p = 0.20) driven by a significant decrease in the number of target vessel revascularization procedures (8.2 vs 11.0 per 100 subjects, p = 0.02) but also a slight increase in the number of nontarget vessel revascularization procedures (6.0 vs 5.1 per 100 subjects, p = 0.37). Follow-up cardiovascular costs were decreased by $273/patient in the EES group (95% confidence interval for difference 1,048 less to 502 more, p = 0.49). Formal cost-effectiveness analysis based on these results demonstrated that the probability that EES was an economically attractive strategy (incremental cost-effectiveness ratio <$50,000/quality-adjusted life year gained) was 85.7%. These findings demonstrate that in patients undergoing percutaneous coronary intervention with DESs, use of EESs is economically attractive compared to PESs with improved clinical outcomes and lower overall medical care costs at 2 years.

  7. Efficacies of the new Paclitaxel-eluting Coroflex Please™ Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please™ and Taxus™ (ECO-PLEASANT) trial: study rationale and design

    PubMed Central

    Seo, Jae-Bin; Jeon, Hui-Kyung; Park, Kyung-Woo; Park, Jong-Seon; Bae, Jang-Ho; Kim, Sang-Wook; Moon, Keon-Woong; Choi, Jae-Woong; Lee, Sang-Gon; Chung, Woo-Young; Youn, Tae-Jin; Kim, Soo-Joong; Kim, Doo-Il; Kim, Byung-Ok; Hyon, Min-Su; Park, Keum-Soo; Cha, Tae-Joon; Hwang, Hweung-Kon; Hur, Seung-Ho; Kim, Hyo-Soo

    2009-01-01

    Background Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes. Coroflex Please™ stent is a newly developed drug eluting stent using the Coroflex™ stent platform combined with the drug paclitaxel contained in a polymer coating. PECOPS I trial, one-arm observational study, showed that the clinical and angiographic outcomes of Coroflex Please™ stent were within the range of those of Taxus, the 1st generation paclitaxel-eluting stent (PES). However, there have been no studies directly comparing the Coroflex Please™ stent with the Taxus Liberte™ stent that is the newest version of Taxus. Therefore, prospective, randomized trial is required to demonstrate the non-inferiority of Coroflex Please™ stent compared with Taxus Liberte™ stent in a head-to-head manner. Methods In the comparison of Efficacy between COroflex PLEASe™ ANd Taxus™ stent(ECO-PLEASANT) trial, approximately 900 patients are being prospectively and randomly assigned to the either type of Coroflex Please™ stent and Taxus Liberte™ stent via web-based randomization. The primary endpoint is clinically driven target vessel revascularization at 9 months. The secondary endpoints include major cardiac adverse events, target vessel failure, stent thrombosis and angiographic efficacy endpoints. Discussion The ECO-PLEASANT trial is the study not yet performed to directly compare the efficacy and safety of the Coroflex Please™ versus Taxus Liberte™ stent. On the basis of this trial, we will be able to find out whether the Coroflex Please™ stent is non-inferior to Taxus Liberte™ stent or not. Trial registration ClinicalTrials.gov number, NCT00699543. PMID:19849864

  8. 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.

  9. Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus.

    PubMed

    Ali, Rosli Mohd; Degenhardt, Ralf; Zambahari, Robaayah; Tresukosol, Damras; Ahmad, Wan Azman Wan; Kamar, Haizal bin Haron; Kui-Hian, Sim; Ong, Tiong Kiam; bin Ismail, Omar; bin Elis, Safari; Udychalerm, Wasan; Ackermann, Hanns; Boxberger, Michael; Unverdorben, Martin

    2011-05-01

    Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients. Eighty-four diabetic patients (60.8 ± 9.1 years, 76.2% male) were randomised to either the DEB SeQuent Please or the DES Taxus Liberté to compare the 9-month clinical and angiographic outcome of PCI in native coronary arteries. Comparing the DEB vs. the DES the 9-month results (follow-up DEB 39/45 [86.7%], DES 36/39 [92.3%]) are statistically not different at the 0.05 level for the primary endpoint of in-segment (0.37 ± 0.59 mm vs. 0.35 ± 0.63 mm) and in-stent (0.51 ± 0.61 mm vs. 0.53 ± 0.67 mm) late lumen loss, overall and cardiac deaths (2/45 [4.4%] and 3/45 [6.7%] vs. 0), target lesion revascularisation (3/45 [8.9%] vs. 4/39 [10.3%]), the total MACE rate (6/45 [13.3%] vs. 6/39 [15.4%]), and the event free survival after 10.2 ± 3.8 months (Kaplan-Meier analysis, p<0.80, log rank test). The clinical and angiographic outcome of the combination of the drug-eluting balloon SeQuent Please with a cobalt chromium stent compared to the drug eluting Taxus stent are similar.

  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. Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions.

    PubMed

    Ormiston, John A; Charles, O'Shaughnessy; Mann, Tift; Hall, Jack J; McGarry, Thomas; Cannon, Louis A; Webster, Mark W I; Mishkel, Gregory J; Underwood, Paul L; Dawkins, Keith D

    2013-01-01

    To report the final, cumulative, 5-year outcomes from the TAXUS ATLAS program, which studied the use of the TAXUS Liberté paclitaxel-eluting stent in de-novo coronary artery lesions. TAXUS ATLAS Workhorse, Small Vessel, and Long Lesion are nonrandomized studies comparing TAXUS Liberté (N=871), TAXUS Liberté 2.25 mm (N=261), and TAXUS Liberté 38 mm (N=150) stents, respectively, with case-matched TAXUS Express historical controls. In the unadjusted analysis, TAXUS Liberté showed comparable 5-year rates of major adverse cardiac events (27.1% TAXUS Express vs. 26.2% TAXUS Liberté, P=0.70) in workhorse lesions and greater 5-year cumulative freedom from target lesion revascularization (78.4 vs. 87.3%, P=0.03) in small vessels. In addition, a lower periprocedural myocardial infarction rate (MI, 4.1 vs. 0.0%; P=0.01) was observed in long lesions versus TAXUS Express. After propensity score adjustment, no statistically significant effect of TAXUS Liberté on the 5-year rates of TLR in small vessels (17.9 vs. 13.3%, P=0.36) or MI in long lesions (9.1 vs. 7.0%, P=0.53) was found, although the rates remained numerically lower with TAXUS Liberté. Cumulative 5-year results of the TAXUS ATLAS studies suggest that the TAXUS Liberté stent provides similar safety and effectiveness in workhorse lesions, and may provide lower revascularization rates in small vessels and lower periprocedural MI rates in long lesions compared with the TAXUS Express stent, although no statistically significant differences were found following propensity adjustment.

  12. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial.

    PubMed

    Kereiakes, Dean J; Cannon, Louis A; Feldman, Robert L; Popma, Jeffrey J; Magorien, Raymond; Whitbourn, Robert; Dauber, Ira M; Rabinowitz, Abram C; Ball, Michael W; Bertolet, Barry; Kabour, Ameer; Foster, Michael C; Wang, John C; Underwood, Paul; Dawkins, Keith D

    2010-07-20

    The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses. The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES. The PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesionsor=2.75 to stent treatments, and stent thrombosis was infrequent (0.3% Express, 0.4% Element). At 1 year, the TAXUS Element is comparable in efficacy to the TAXUS Express PES. Furthermore, no safety concerns related to the novel platinum

  13. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    PubMed

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. 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.

  15. 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.

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

    PubMed

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

    2013-06-01

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

  17. Randomized trial of Legflow(®) paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial.

    PubMed

    Karimi, Amine; de Boer, Sanne W; van den Heuvel, Daniël A F; Fioole, Bram; Vroegindeweij, Dammis; Heyligers, Jan M M; Lohle, Paul N M; Elgersma, Otto; Nolthenius, Rudolf P T; Vos, Jan Albert; de Vries, Jean-Paul P M

    2013-03-28

    Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm. A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention. The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated

  18. Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model

    PubMed Central

    Wang, Ting; Zhang, Jie; Wang, Juan; Pei, Ying-Hua; Qiu, Xiao-Jian; Wang, Yu-Ling

    2016-01-01

    Background: Currently available silicone and metallic stents for tracheal stenosis are associated with many problems. Granulation proliferation is one of the main complications. The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model, as well as the pharmacokinetic features and safety profiles of the coated drug. Methods: Eight beagles were randomly divided into a control group (bare-metal stent group, n = 4) and an experimental group (paclitaxel-eluting stent group, n = 4). The observation period was 5 months. One beagle in both groups was sacrificed at the end of the 1st and 3rd months, respectively. The last two beagles in both groups were sacrificed at the end of 5th month. The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups. Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent. The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent. Results: Compared with the control group, the proliferation of granulation tissue in the experimental group was significantly reduced. The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation (up to 70.9%). Then, the release slowed down gradually. By the 5th month, the release reached up to 98.5%. During the observation period, a high concentration of the drug in the trachea (in the stented and adjacent unstented areas) and lung tissue was not noted, and the blood test showed no side effect. Conclusions: The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future. PMID:27824004

  19. Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm. Methods/Design A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5–15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention. Discussion The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the

  20. IVUS-Guided Implantation of Bioresorbable Vascular Scaffolds for Very Late Paclitaxel Stent Thrombosis

    PubMed Central

    Lin, Zhe-Zhong; Chang, Wei-Ting; Chiang, Chun-Yen; Chen, Zhih-Cherng; Ku, Po-Ming

    2017-01-01

    Bioresorbable vascular scaffold (BVS) implantation has been shown to be safe in patients with stable coronary disease, and effective against the thrombotic lesion and the in-stent restenosis (ISR) of the drug-eluting stent (DES). BVSs have the advantages of a snow racket concept, positive vessel remodeling, and better conformability compared with DES in acute coronary syndrome (ACS). We report on a young patient with ST-elevation myocardial infarction (STEMI) who presented to our emergency department arising from very late stent thrombosis (VLST) of a 2.5 × 28 mm paclitaxel-eluting stent (Coroflex® Please) three years after its implantation. After the patient was treated with balloon dilation, intravascular ultrasound (IVUS) revealed a short segment of a guide wire outside the DES mesh. Two BVSs were implanted to prevent a DES recoil. Post-scaffold-implantation IVUS showed adequately expanded strut of BVSs. Six months later, optical coherence tomography (OCT) revealed that some segments of the scaffold had been absorbed and that there was no in-scaffold restenosis. The patient had not complained about angina during the out-patient clinic follow-up. This is the first report of successful BVS implantation for a STEMI patient attributable to DES VLST. PMID:28115812

  1. Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

    PubMed

    Ogawa, Yukihisa; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2017-05-09

    Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. Level 3, Post-Market Surveillance Study.

  2. [Larynx: implants and stents].

    PubMed

    Sittel, C

    2009-05-01

    There is a wide variety of devices and materials to be implanted into the human larynx. Some are intended to remain only for a period of time, like laryngeal stents. If removal is not intended the device meets the definition for a medical implant. The majority of implants is used for the treatment of unilateral vocal fold immobility. There a 2 types of implants serving this purpose: Implants in a stricter sense are devices of solid material, which are brought into the paraglottic space through a window in the laryngeal framework (medialization thyroplasty). Several different products are presented in this review. In contrast, there are different substances available for endoscopic injection into the paralyzed vocal fold (injection laryngoplasty). Since some of these substances show a corpuscular consistency and a high viscosity they need to be deposited into the lateral paraglottic space. Therefore, the term "injectable implants" has been coined for these materials. The different substances available are discussed in detail in this review. Laryngeal stents are primarily used in the early postoperative phase after open reconstruction of the larynx. The different devices available on the market are described with their specific characteristics and intended use.

  3. 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.

  4. The Control of Drug Release and Vascular Endothelialization after Hyaluronic Acid-Coated Paclitaxel Multi-Layer Coating Stent Implantation in Porcine Coronary Restenosis Model

    PubMed Central

    Bae, In-Ho; Jeong, Myung Ho; Park, Yong Hwan; Lim, Kyung Seob; Park, Dae Sung; Shim, Jae Won; Kim, Jung Ha; Ahn, Youngkeun; Hong, Young Joon; Sim, Doo Sun

    2017-01-01

    Background and Objectives Hyaluronic acid (HA) is highly biocompatible with cells and the extracellular matrix. In contrast to degradation products of a synthetic polymer, degradation products of HA do not acidify the local environment. The aim of this study was to fabricate an HA-coated paclitaxel (PTX)-eluting stent via simple ionic interactions and to evaluate its effects in vitro and in vivo. Materials and Methods HA and catechol were conjugated by means of an activation agent, and then the stent was immersed in this solution (resulting in a HA-coated stent). After that, PTX was immobilized on the HA-coated stent (resulting in a hyaluronic acid-coated paclitaxel-eluting stent [H-PTX stent]). Study groups were divided into 4 groups: bare metal stent (BMS), HA, H-PTX, and poly (L-lactide)-coated paclitaxel-eluting stent (P-PTX). Stents were randomly implanted in a porcine coronary artery. After 4 weeks, vessels surrounding the stents were isolated and subjected to various analyses. Results Smoothness of the surface was maintained after expansion of the stent. In contrast to a previous study on a PTX-eluting stent, in this study, the PTX was effectively released up to 14 days (a half amount of PTX in 4 days). The proliferation of smooth muscle cells was successfully inhibited (by 80.5±12.11% at 7 days of culture as compared to the control) by PTX released from the stent. Animal experiments showed that the H-PTX stent does not induce an obvious inflammatory response. Nevertheless, restenosis was clearly decreased in the H-PTX stent group (9.8±3.25%) compared to the bare-metal stent group (29.7±8.11%). Conclusion A stent was stably coated with PTX via simple ionic interactions with HA. Restenosis was decreased in the H-PTX group. These results suggest that HA, a natural polymer, is suitable for fabrication of drug-eluting stents (without inflammation) as an alternative to a synthetic polymer. PMID:28154600

  5. Intravascular Ultrasound-Derived Stent Dimensions as Predictors of Angiographic Restenosis Following Nitinol Stent Implantation in the Superficial Femoral Artery.

    PubMed

    Miki, Kojiro; Fujii, Kenichi; Kawasaki, Daizo; Shibuya, Masahiko; Fukunaga, Masashi; Imanaka, Takahiro; Tamaru, Hiroto; Sumiyoshi, Akinori; Nishimura, Machiko; Horimatsu, Tetsuo; Saita, Ten; Okada, Kozo; Kimura, Takumi; Honda, Yasuhiro; Fitzgerald, Peter J; Masuyama, Tohru; Ishihara, Masaharu

    2016-06-01

    To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions. A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI). At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769). Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency. © The Author(s) 2016.

  6. 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

  7. 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.

  8. Stent-induced tracheal stenosis can be predicted by IL-8 expression in rabbits.

    PubMed

    Arellano-Orden, Elena; Serrano, Carolina; Montes-Worboys, Ana; Sánchez-López, Verónica; Laborda, Alicia; Lostalé, Fernando; Lahuerta, Celia; Rodríguez-Panadero, Francisco; de Gregorio, Miguel Ángel

    2017-01-01

    Bare metal stents may cause complications like fibrous encapsulation, granulation and tracheal stenosis. We investigated the behaviour of three commercially available stents in vivo (rabbits) and in vitro (coculture of those stents with epithelial and fibroblast cell lines). Also, we investigated whether development of tracheal stenosis could be predicted by any biological marker. The tracheae of 30 rabbits were implanted with either nitinol stents, with or without paclitaxel elution, or a cobalt-based stent. An additional ten rabbits underwent mock implantation (controls). Serial peripheral venous blood samples were taken throughout the study, and several cytokines measured. Animals were euthanized on day 90, with immediate tracheal endoscopy and lavage performed, then necropsy. Rabbits with cobalt-based stent exhibited more inflammation and the highest stenosis incidence, with reduced survival. Both in vivo and in vitro, this stent induced higher IL-8 levels than nitinol stents. Most important, the presence of stent-induced tracheal stenosis was closely associated to increase in IL-8 expression in blood just 1 day after tracheal stent implantation: a 1·19-fold increase vs. baseline had 83% sensitivity, 83% specificity, 77% positive predictive value, 88% negative predictive value and 83% accuracy to predict development of stenosis. The cobalt-based stent had the highest incidence of tracheal inflammation and stenosis. On the other hand, the paclitaxel-eluting nitinol stent did not prevent those complications and provoked a marked reaction compared with the bare nitinol stent. Early increase in IL-8 expression in blood after stent implantation could predict development of tracheal stenosis in rabbits. © 2016 Stichting European Society for Clinical Investigation Journal Foundation.

  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. Trajectory surgical guide stent for implant placement.

    PubMed

    Adrian, E D; Ivanhoe, J R; Krantz, W A

    1992-05-01

    This article describes a new implant placement surgical guide that gives both implant location and trajectory to the surgeon. Radiopaque markers are placed on diagnostic dentures and a lateral cephalometric radiograph is made that shows the osseous anatomy at the symphysis and the anterior tooth location. The ideal implant location and trajectory data are transferred to a surgical stent that programs the angle and location of the fixtures at time of surgery. The stent has the additional benefit of acting as an occlusion rim, a mouth prop, and tongue retractor. Use of this stent has resulted in consistently programming the placement of implant fixtures that are prosthodontically ideal.

  11. 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

  12. Two Cases of Immediate Stent Fracture after Zotarolimus-Eluting Stent Implantation

    PubMed Central

    Lee, Pil Hyung; Lee, Seung-Whan; Lee, Jong-Young; Kim, Young-Hak; Lee, Cheol Whan; Park, Duk-Woo; Park, Seong-Wook

    2015-01-01

    Drug-eluting stent (DES) implantation is currently the standard treatment for various types of coronary artery disease. However, previous reports indicate that stent fractures, which usually occur after a period of time from the initial DES implantation, have increased during the DES era; stent fractures can contribute to unfavorable events such as in-stent restenosis and stent thrombosis. In our present report, we describe two cases of zotarolimus-eluting stent fracture: one that was detected six hours after implementation, and the other case that was detected immediately after deployment. Both anatomical and technical risk factors contributed to these unusual cases of immediate stent fracture. PMID:25653706

  13. Vascular pathology of drug-eluting stents.

    PubMed

    Nakazawa, Gaku; Finn, Aloke V; Virmani, Renu

    2007-06-01

    Polymer-based sirolimus- (Cypher) and paclitaxel-eluting stents (Taxus), so-called drug-eluting stents (DES), have become the treatment of choice for patients with symptomatic coronary artery disease undergoing percutaneous coronary revascularization (PCI). While these stents have reduced rates of restenosis and late lumen loss compared to bare-metal stents (BMS), late thrombosis, a life-threatening complication of this technology, has emerged as a major concern. Our understanding of the pathophysiology of late DES thrombosis is derived from animal and human pathologic samples taken after implantation of these devices. These data indicate that the DES cause substantial impairment in arterial healing characterized by lack of complete reendothelialization and persistence of fibrin when compared to BMS. This so-called delayed healing is "identified as" the primary substrate of an underlying cause of late DES thrombosis at autopsy. Several additional risk factors for late stent thrombosis include penetration of necrotic core, malapposition, overlapping stent placement, excessive stent length, and bifurcation lesions. These represent additional barriers to healing and should be avoided if DES are to be used in order to minimize the late thrombotic risks of these devices. Since the time course of complete healing with DES is unknown, the optimal duration of antiplatelet treatment remains to be determined.

  14. Role of surgical stents in determining the position of implants

    PubMed Central

    Pal, U. S.; Chand, Pooran; Dhiman, Neeraj Kumar; Singh, R. K.; Kumar, Vimlesh

    2010-01-01

    Aim: Demand from implant patients for quality and efficient treatment is increasing. Fortunately dental implant treatment is evolving with patients expectations. Materials and Methods: The study comprised of 45 patients for whom 89 implants were placed at different sites. Efficacy of the stents is evaluated in determining the position and diameter of the implants. Conclusion: this study shows the extreme accuracy of this surgical stents in implant installation in terms of position and diameter. PMID:22442544

  15. The need for stent-lesion matching to optimize outcomes of intracoronary stent implantation.

    PubMed

    Lanzer, Peter; Strupp, Gerhard; Schmidt, Wolfram; Topoleski, L D Timmie

    2013-11-01

    Intracoronary stents have markedly improved the outcomes of catheter-based coronary interventions. Intracoronary stent implantation rates of over 90% during coronary angioplasty are common. Stent implantations are associated with a small but statistically significant number of adverse outcomes including restenosis, thrombosis, strut malapposition, incomplete strut endothelialization, and various types of stenting failure. Better matching of biomechanical properties of stents and lesions could further improve the clinical outcome of intracoronary stenting. Thus, in this article, we assess the need for advanced intracoronary stent-lesion matching. We reviewed the data on biomechanics of coronary stents and lesions to develop knowledge-based rationale for optimum intracoronary stent selection. The available technical information on marketed intracoronary stents and the current understanding of the biomechanical properties of coronary lesions at rest and under stress are limited, preventing the development of knowledge-based rationale for optimum intracoronary stent selection at present. Development of knowledge-based selection of intracoronary stents requires standardization of mechanical stent testing, communication of the nonproprietary technical data on stents by the industry and dedicated research into procedural stent-lesion interactions.

  16. Comparison of paclitaxel and everolimus-eluting stents in ST-segment elevation myocardial infarction and influence of thrombectomy on outcomes. ESTROFA-IM study.

    PubMed

    de la Torre Hernández, José M; Alfonso, Fernando; Martin Yuste, Victoria; Sánchez Recalde, Angel; Jimenez Navarro, Manuel F; Pérez de Prado, Armando; Hernández, Felipe; Abdul-Jawad Altisent, Omar; Roura, Gerard; García Camarero, Tamara; Elizaga, Jaime; Calviño, Ramón; Moreu, Jose; Bosa, Francisco; Jimenez Mazuecos, Jesús; Ruiz-Arroyo, José R; Garcia Del Blanco, Bruno; Rumoso, José R

    2014-12-01

    We sought to compare the long-term clinical outcome of with ST-segment elevation myocardial infarction treated with paclitaxel-eluting stents or everolimus-eluting stents and the influence of thrombectomy on outcomes. The ESTROFA-IM is a multicenter retrospective registry collecting consecutive patients with infarction treated with these stents in 16 centers. Propensity-score matching was performed to select comparable stent groups and comparable groups with and without thrombectomy. After matching patients, 350 treated with everolimus-eluting stents and 350 with paclitaxel-eluting stents were included in the analysis. The clinical and angiographic characteristics were comparable in both groups. The 2-year incidence of death, infarction, and target lesion revascularization was 14.9% for paclitaxel-eluting stents and 11.5% for everolimus-eluting stents (P = .04) and the incidence of definite/probable thrombosis 4.3% and 1.4%, respectively (P = .01). The use of paclitaxel-eluting was an independent predictor for events (hazard ratio = 2.44, 95% confidence interval, 1.28-4.65; P = .006). The benefit of everolimus-eluting stents over paclitaxel-eluting stents regarding stent thrombosis was more evident in the nonthrombectomy subgroup (5.4% vs 1.4%; P = .01). A significant interaction was found in the subgroups with and without thombectomy in the comparison between paclitaxel-eluting stents and everolimus-eluting stents for the end-point of stent thrombosis (P = .039). The results of this multicenter registry suggest better clinical outcomes with the everolimus-eluting stents in ST-segment elevation myocardial infarction. The lower risk of thrombosis with these stents could be more relevant in the absence of thrombectomy. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  17. 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.

  18. Delivery of stents to target lesions: techniques of intraoperative stent implantation and intraoperative angiograms.

    PubMed

    Ing, F F

    2005-01-01

    Mullins et al. [6] reported the first use of stent implantation to treat stenotic branch pulmonary arteries in 1988. In the early to mid-1990s, numerous reports confirmed its safety and efficacy, but there were limited stent and balloon designs and stent implantations were performed using relatively large delivery systems (10- to 12-Fr sheaths) [7, 8]. The general accepted patient size was limited to those weighing 12 kg or greater. Intraoperative stent implantation for branch pulmonary artery stenosis was reported in the early to mid-1990s [1-3, 5, 9]. Indications in these early reports included small patient size or difficult anatomy or patients who had additional cardiac lesions and needed surgery independent of the branch stenosis. The idea was to take advantage of the open-heart exposure provided in the operating room to permit direct access to the stenotic segment. Hence, all intraoperative stent implants were performed under direct visualization on bypass. There were no discussions on advantages over the routine percutaneous approach. Currently, with advances in stent and balloon technology as well as increased operator experience, many of those reported cases probably would have undergone cardiac catheterization for a percutaneous stent implant rather than open-heart surgery. The purpose of this report is to review the current indications, advantages, and disadvantages of intraoperative stent implantation as well as to discuss the techniques that are helpful to optimize intraoperative stent positioning. The role and advantages of intraoperative angiography will also be presented.

  19. 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

  20. Pulmonary Arterial Stent Implantation in an Adult with Williams Syndrome

    SciTech Connect

    Reesink, Herre J.; Henneman, Onno D. F.; Delden, Otto M. van; Biervliet, Jules D.; Kloek, Jaap J.; Reekers, Jim A.; Bresser, Paul

    2007-07-15

    We report a 38-year-old patient who presented with pulmonary hypertension and right ventricular dysfunction due to pulmonary artery stenoses as a manifestation of Williams syndrome, mimicking chronic thromboembolic pulmonary hypertension. The patient was treated with balloon angioplasty and stent implantation. Short-term follow-up showed a good clinical result with excellent patency of the stents but early restenosis of the segments in which only balloon angioplasty was performed. These stenoses were subsequently also treated successfully by stent implantation. Stent patency was observed 3 years after the first procedure.

  1. Pulmonary arterial stent implantation in an adult with Williams syndrome.

    PubMed

    Reesink, Herre J; Henneman, Onno D F; van Delden, Otto M; Biervliet, Jules D; Kloek, Jaap J; Reekers, Jim A; Bresser, Paul

    2007-01-01

    We report a 38-year-old patient who presented with pulmonary hypertension and right ventricular dysfunction due to pulmonary artery stenoses as a manifestation of Williams syndrome, mimicking chronic thromboembolic pulmonary hypertension. The patient was treated with balloon angioplasty and stent implantation. Short-term follow-up showed a good clinical result with excellent patency of the stents but early restenosis of the segments in which only balloon angioplasty was performed. These stenoses were subsequently also treated successfully by stent implantation. Stent patency was observed 3 years after the first procedure.

  2. Stent graft implantation in an aortic pseudoaneurysm associated with a fractured Cheatham-Platinum stent in aortic coarctation.

    PubMed

    Kuhelj, Dimitrij; Berden, Pavel; Podnar, Tomaž

    2016-03-01

    We report a case of aortic pseudoaneurysm associated with a fractured bare Cheatham-Platinum stent following stenting for aortic coarctation. These complications were recognised 6 years after the implantation procedure and were successfully managed by percutaneous stent graft implantation. Staged approach for stent dilatation might prevent development of aortic pseudoaneurysms. In addition, careful follow-up is warranted after stenting for aortic coarctation, particularly in patients with recognised aortic wall injury.

  3. Stent Coating Integrity of Durable and Biodegradable Coated Drug Eluting Stents.

    PubMed

    Yazdani, Saami K; Sheehy, Alexander; Pacetti, Stephen; Rittlemeyer, Brandon; Kolodgie, Frank D; Virmani, Renu

    2016-10-01

    Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo. © 2016, Wiley Periodicals, Inc.

  4. Intravascular stent implantation for the management of pulmonary artery stenosis.

    PubMed

    Krisnanda, Charles; Menahem, Samuel; Lane, Geoffrey K

    2013-01-01

    Pulmonary artery stenosis is a challenging problem in the management of congenital heart disease. Untreated pulmonary artery stenosis may contribute to increased mortality and morbidity, and lead to suboptimal results following surgical repair of congenital heart disease. Intravascular stent implantation has emerged as one of the preferred treatment options for pulmonary artery stenosis. However, issues regarding the effectiveness and complications of stent implantation for pulmonary artery stenosis need to be identified. In addition, difficulties of stent implantation in the paediatric setting, as a consequence of small vessel size and subsequent vessel growth, are also important considerations. This review will evaluate the short and long-term effectiveness, the outcomes and complications, and discuss the potential problems of stent implantation for pulmonary artery stenosis. Copyright © 2012 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  5. Lethal Hemorrhage Caused by Aortoenteric Fistula Following Endovascular Stent Implantation

    SciTech Connect

    Kahlke, Volker; Brossmann, Joachim; Klomp, Hans-Juergen

    2002-06-15

    A 55-year-old women developed an aortointestinal fistula between the bifurcation of the aorta and the distal ileum following implantation of multiple endovascular stents into both common iliac arteries for treatment of aortoiliac occlusive disease. Ten months before the acute onset of the gastrointestinal hemorrhage two balloon-expandable steel stents had been implanted into both common iliac arteries. Due to restenosis and recurrent intermittent claudication, three balloon-expandable covered stents were implanted 4 months later on reintervention. The patient presented with abdominal pain and melena, and fell into hemorrhagic shock with signs of upper gastrointestinal bleeding. After transfer to our hospital, she again developed hemorrhagic shock with massive upper and lower gastrointestinal bleeding and died during emergency laparotomy. The development of aortoenteric fistulas following endovascular surgery/stent implantation is very rare and has to be considered in cases of acute gastrointestinal hemorrhage.

  6. Neoatherosclerosis after Drug-Eluting Stent Implantation: Roles and Mechanisms

    PubMed Central

    Cui, Yuanyuan; Shi, Dazhuo; Chen, Keji

    2016-01-01

    In-stent neoatherosclerosis (NA), characterized by a relatively thin fibrous cap and large volume of yellow-lipid accumulation after drug-eluting stents (DES) implantation, has attracted much attention owing to its close relationship with late complications, such as revascularization and late stent thrombosis (ST). Accumulating evidence has demonstrated that more than one-third of patients with first-generation DES present with NA. Even in the advent of second-generation DES, NA still occurs. It is indicated that endothelial dysfunction induced by DES plays a critical role in neoatherosclerotic development. Upregulation of reactive oxygen species (ROS) induced by DES implantation significantly affects endothelial cells healing and functioning, therefore rendering NA formation. In light of the role of ROS in suppression of endothelial healing, combining antioxidant therapies with stenting technology may facilitate reestablishing a functioning endothelium to improve clinical outcome for patients with stenting. PMID:27446509

  7. 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.

  8. Palliative stent implantation for coarctation in neonates and young infants

    PubMed Central

    Sreeram, Isabel; Sreeram, Narayanswami; Bennink, Gerardus

    2012-01-01

    Background: In selected neonates and infants, primary palliative stent implantation may be indicated for coarctation of the aorta. We describe our experience with this approach in five consecutive patients. Methods: Five neonates and infants (age range 6 to 68 days, gestation 33 to 38 weeks, weight range at procedure of between 1650 to 4000 g) underwent palliative stent implantation as primary therapy for coarctation of the aorta. Indications for primary stent implantation were varied. All procedures were performed by elective surgical cut down of the axillary artery. Standard coronary stents (diameter 4.5 to 5 mm, length 12 to 16 mm) were delivered via a 4F sheath. The axillary artery was repaired after removal of the sheath. Results: All procedures were acutely successful, and without procedural complications. All patients survived to hospital discharge. Four patients have subsequently undergone elective stent removal and surgical repair of the arch, at between 38 and 83 days following stent implantation. Complete stent removal was achieved in three patients. Over a follow-up ranging between 8 weeks and 36 months, none of the patients has had any further complications. Conclusions: This palliative approach is warranted in carefully selected patients. Long-term follow-up is required. PMID:23129903

  9. Effect of Atorvastatin-Eluting Stents in a Rabbit Iliac Artery Restenosis Model

    PubMed Central

    Lim, Kyung Seob; Bae, In Ho; Park, Jun-Kyu; Park, Dae Sung; Kim, Jong Min; Kim, Jung Ha; Cho, Dong Lyun; Sim, Doo Sun; Park, Keun-Ho; Hong, Young Joon; Ahn, Youngkeun

    2013-01-01

    Statins have pleiotropic effects, which include the inhibition of neointima hyperplasia, the inhibition of vascular inflammation, and platelet inhibition. The aim of this study was to examine the effect of an atorvastatin-eluting stent (AES) in a rabbit iliac artery overstretch restenosis model. Ten rabbits were used in this study (10 rabbits, 10 iliac arteries for each stent). An AES and paclitaxel-eluting stent (PES) were implanted in the left and right iliac arteries in a rabbit (2 stents in each rabbit). The stents were deployed with oversizing (stent/artery ratio 1.3:1), and histopathologic analysis was assessed at 28 days after stenting. There were no significant differences in the injury score, lumen area, or inflammation score. There were significant differences in the neointimal area (0.7±0.18 mm2 in the AES group vs. 0.4±0.25 mm2 in the PES group, p<0.01), in the percentage stenosis area (14.8±5.06% in the AES group vs. 10.5±6.80% in the PES group, p<0.05), and in the fibrin score (0.4±0.51 in the AES group vs. 2.7±0.48 in the PES group, p<0.001). Although the AES did not suppress neointimal hyperplasia compared with the PES, it showed a superior arterial healing effect in a rabbit iliac artery overstretch restenosis model. PMID:24400214

  10. Tricuspid valved stent implantation: novel stent with a self-expandable super-absorbent polymer.

    PubMed

    Iino, Kenji; Lozonschi, Lucian; Metzner, Anja; Marczynski-Bühlow, Martin; Renner, Jochen; Cremer, Jochen; Lutter, Georg

    2011-08-01

    Trans-catheter aortic and pulmonary valve replacement procedures can result in favorable outcomes in selected patients. The aim of this study was to investigate the functioning of a novel self-expanding valved stent with super-absorbent polymer (SAP) for minimally invasive replacement of the tricuspid valve. A newly designed nitinol stent with SAP was specially designed for the tricuspid annulus. This device was composed of right atrial anchoring elements, a left ventricular tubular stent, and a trileaflet bovine pericardial valve. The stent was coated with a waterproof material, and a pouch containing SAP for minimizing paravalvular leakage was placed beneath the atrial element. Seven pigs underwent minimally invasive off-pump tricuspid valved stent implantation. This was performed through a lower ministernotomy using a transventricular approach under transesophageal echocardiographic guidance. After 1 and 6h, a complete echocardiographic evaluation and hemodynamics (Swan-Ganz catheter) were performed. Six of seven pigs exhibited normal hemodynamics immediately after tricuspid valved stent implantation and maintained stability for the entire period of monitoring. In one pig, a part of the atrial stent elements was deployed into the right ventricle, leading to significant paravalvular leakage, and died very soon. All subsequent animals survived with good results in the observation period. Accurate positioning of the valved stent was documented in six of seven pigs. SAP expanded and filled the gap between the stent and the native annulus in all animals. Mild paravalvular leakage was found in two of the six animals. Nevertheless, the observed leakage decreased to trace levels 6h after implantation. In the additional four pigs, only trace tricuspid regurgitation was revealed. No right ventricular outflow tract obstruction was detected. Trans-apical off-pump tricuspid valved stent implantation is feasible in an acute experimental setting, and SAP may help to reduce

  11. 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.

  12. Stent implantation influence wall shear stress evolution

    NASA Astrophysics Data System (ADS)

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

    2016-06-01

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

  13. Intravascular brachytherapy with radioactive stents produced by ion implantation

    NASA Astrophysics Data System (ADS)

    Golombeck, M.-A.; Heise, S.; Schloesser, K.; Schuessler, B.; Schweickert, H.

    2003-05-01

    About 1 million patients are treated for stenosis of coronary arteries by percutaneous balloon angioplasty annually worldwide. In many cases a so called stent is inserted into the vessel to keep it mechanically open. Restenosis is observed in about 20-30% of these cases, which can be treated by irradiating the stented vessel segment. In our approach, we utilized the stent itself as radiation source by ion implanting 32P. Investigations of the surface properties were performed with special emphasis on activity retention. Clinical data of about 400 patients showed radioactive stents can suppress instent restenosis, but a so called edge effect appeared, which can be avoided by the new "drug eluting stents".

  14. Investigation of Stent Implant Mechanics Using Linear Analytical and Computational Approach.

    PubMed

    Yang, Hua; Fortier, Aleksandra; Horne, Kyle; Mohammad, Atif; Banerjee, Subhash; Han, Hai-Chao

    2017-03-01

    Stent implants are essential in restoring normal blood flow in atherosclerotic arteries. Recent studies have shown high failure rates of stent implants in superficial femoral artery (SFA) as a result of dynamic loading environment imposed on the stent implants by the diseased arterial wall and turbulent blood flow. There are variety of stent designs and materials currently on the market however, there is no clear understanding if specific stent design is suitable with the material that is manufactured from and if this combination can sustain the life-cycle that the stent implants need to undergo once inside the artery. Lack of studies have been presented that relate stent mechanical properties with stent geometry and material used. This study presents linear theoretical and computational modeling approach that determines stent mechanical properties with effective stiffness of the deployed stent. Effective stiffness of the stent has been accurately derived based on stent structure design and loading in axial and radial directions. A rhombus stent structure was selected for this study due to its more common use and produced by main stream manufacturers. The derived theoretical model was validated using numerical finite element modeling approach. Results from this study can lead to preliminary insight towards understanding of stent deformation based on stent geometry, material properties and artery wall pressure; and how to carefully match stent's geometry with suitable material for long life cycle, increased strength, and reliable performance of stent implants.

  15. Comparison of Self-Expanding Polyethylene Terephthalate and Metallic Stents Implanted in Porcine Iliac Arteries

    SciTech Connect

    Wilczek, Krzysztof; Scheerder, Ivan de; Wang Kai; Verbeken, Eric; Piessens, Jan

    1996-05-15

    Purpose: Comparison of the biocompatibility of self-expanding polyethylene terephthalate (PET) stents with self-expanding metallic stents (Wallstents). Methods: Diameter- and length-matched PET stents and Wallstents were symmetrically implanted in the paired iliac arteries of 13 crossbred domestic swine. Stent deployment was studied angiographically and with intravascular ultrasound immediately after stent implantation. The angiographic stented lumen diameter was measured using quantitative vessel analysis before, immediately after stenting, and at 6-week follow-up. Cross-section histopathology and area morphometry were performed. Results: Immediately poststenting, intravascular ultrasound revealed proximal dislocation of 5 of the 13 PET stents, whereas all metal stents were firmly embedded at the implantation site. At 6-week follow-up, three of the remaining PET stents were totally or subtotally occluded by organized thrombus, whereas all metal stents were patent. Compared with immediately poststenting, the angiographic lumen diameter within the five remaining PET stents was reduced by 30%, and that of the metallic stents was virtually unaltered (p < 0.02). This observation was confirmed by postmortem morphometry, wherein the PET-stented vessel segments a diameter stenosis of 40% was measured vs only 9% in the metallic stents (p < 0.0001). Conclusion: PET-stent deployment is difficult to control due to the lack of radiopacity of this stent. PET stents seem to be more thrombogenic and lead to significantly more neointimal proliferation than metallic stents.

  16. Rotational Atherectomy and Stent Implantation for Calcified Left Main Lesions

    PubMed Central

    Schwartz, Bryan G.; Mayeda, Guy S.; Economides, Christina; Kloner, Robert A.; Shavelle, David M.; Burstein, Steven

    2011-01-01

    Background Left main coronary artery (LMCA) bifurcation and heavily calcified lesions are common and challenging to treat percutaneously. Rotational atherectomy (RA) may be beneficial in this setting to facilitate stent placement though direct supporting evidence is lacking. This study sought to analyze patients who underwent RA of the LMCA. Methods Consecutive cases involving RA of the LMCA between 1/1/2004 and 12/31/2009 at a private, tertiary referral hospital were reviewed retrospectively. Medical records, angiograms and clinically driven follow-up were reviewed. Results Thirty-one cases were identified (20 protected, 11 unprotected), including 23 with stent implantation (21 drug-eluting, 2 bare metal). All 31 lesions had moderate to severe calcification, 84% involved the distal segment. Mean burr-to-vessel ratio was 0.43. Overall angiographic success was 90% (28/31) and was higher with a drug-eluting stent versus no stent (100% vs. 62%; P = 0.0153). In-hospital major adverse cardiovascular events (MACE) occurred in 1 patient (3%). Mid-term MACE occurred in 6 patients (26%) and tended to occur less frequently in patients with protected LMCAs (P = 0.0697). At final follow-up, patients were more likely to be alive and free from angina with a protected LMCA (94% vs. 57% unprotected; P = 0.0564) and with a drug-eluting stent (89% vs. 50% with no stent; P = 0.0281). Conclusions RA of the LMCA to facilitate stent implantation appears to be safe and effective with favorable mid-term outcomes. In the setting of severe calcification and distal LMCA involvement RA and drug-eluting stent implantation should be considered.

  17. Immediate outcomes of eptifibatide therapy during intracoronary stent implantation

    PubMed Central

    Shariati, Hooman; Sanei, Hamid; Pourmoghadas, Ali; Salehizadeh, Leila; Amirpour, Afshin

    2016-01-01

    Background: The objective of the present study was to assess the major immediate outcomes of eptifibatide therapy during intracoronary stent implantation. Materials and Methods: In an interventional study, patients undergoing percutaneous coronary intervention (PCI) were randomized into either the eptifibatide (n = 100) or the control (n = 107) group. In each group, demographic and clinical characteristics such as cardiac death, stent thrombosis (ST), myocardial infarction (MI), rates of target lesion and vessel revascularization, cerebral vascular accident (CVA), and emergency coronary artery bypass grafting (CABG) were recorded. Results: The overall rates of major adverse events such as mortality, Stent thrombosis (ST), Myocardial Infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), CVA, and emergency CABG within 24 h after stent implantation were low and comparable between the two groups; P > 0.05 considered significant for all comparisons. Conclusion: There were no statistical differences between the clinical outcomes of groups administered with single-dose intracoronary eptifibatide and control groups among patients undergoing PCI during stent implantation. PMID:28217642

  18. 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.

  19. Long-term follow-up of stent implantation versus stent-like angioplasty in unstable angina.

    PubMed

    Marzocchi, A; Ortolani, P; Piovaccari, G; Marrozzini, C; Palmerini, T; Marinucci, L; Saia, F; Bacchi-Reggiani, M L; Branzi, A; Magnani, B

    1999-03-01

    Stent-like plain old balloon angioplasty (POBA, < or = 30% residual diameter stenosis) in patients with stable angina resulted in a clinical and angiographic long-term outcome equivalent to stenting. In unstable angina POBA showed lower acute and long-term efficacy than in the stable setting. Data comparing stent-like POBA and coronary stenting in unstable angina are lacking in the literature. The aim of this retrospective single-center study was to compare the long-term effectiveness of stent-like POBA and coronary stenting in unstable angina. From January 1996 to December 1996 we retrospectively examined 187 consecutive patients with unstable angina who underwent coronary angioplasty on a native vessel: 135 had coronary stenting in addition to POBA and 50 achieved a stent-like result with POBA. Two patients, with major contraindication to coronary stenting, who did not reach a stent-like angiographic result, were also treated with only POBA but were excluded from the study. Stent implantation indications were: elective (54 stents, 30%), suboptimal angiographic result (104 stents, 58%), and bail-out situation (21 stents, 12%). Stent implantation showed high angiographic (98.5%) and clinical (95.5%) success. Stent thrombosis occurred only in 2 patients (1.5%). At quantitative coronary angiography the stent group showed a higher post-procedure minimal lumen diameter (2.74 +/- 1.25 vs 2.27 +/- 0.58 mm, p = 0.025), acute gain (1.95 +/- 1.28 vs 1.43 +/- 0.57 mm, p = 0.007) and lower residual stenosis diameter (13.89 +/- 7.43 vs 20.4 +/- 7.28%, p = 0.001) than the stent-like POBA group. At 1-year follow-up the stent group showed a higher event-free survival rate (77.9 vs 64.6%, p = 0.009) mainly due to lower recurrence of angina and repetition of percutaneous procedures. Stent-like POBA procedure and baseline lesion length > or = 10 mm proved to be the only independent predictors of long-term ischemic event occurrence. In conclusion, in unstable angina, stent

  20. 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

  1. 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.

  2. 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.

  3. The stone formation in the Memotherm urethral stent implantation area: Is it a rare complication?

    PubMed Central

    Karakose, Ayhan; Atesci, Yusuf Ziya; Aydogdu, Ozgu

    2014-01-01

    Recurrent urethral stricture is one of the biggest problems in urology. Urethral stents as an alternative treatment has been used since 1985. The stone formation in the Memotherm (Angiomed) urethral stent implantation area is a rare complication. We report the case of a 67-year-old man who had a stone in the Memotherm urethral stent implantation area 6 years after his urethral stent surgery. PMID:24678370

  4. [Stent implantation in the treatment of pharynx anastomotic stenosis after cervical esophageal resection: a case report].

    PubMed

    Zang, Chuanshan; Sun, Jian; Sun, Yan

    2016-03-01

    We report the treatment of one patient with pharynx anastomotic stenosis after cervical esophagealresection by stent implantation. The patient suffered from serious pharynx anastomotic stenosis after gastric-pha-ryngeal anastomosis. After balloon-dilatation,a domestic self-expanding Z-stents was implanted in the stricture ofthe esophagus under the X-rays. After stent implantation, the patient has been leading a normal life for threeyears. Balloon dilatation and stent implantation is an effective and safe method in the treatment of patients withpharynx anastomotic stenosis.

  5. Optimization of Drug Delivery by Drug-Eluting Stents

    PubMed Central

    Bozsak, Franz; Gonzalez-Rodriguez, David; Sternberger, Zachary; Belitz, Paul; Bewley, Thomas; Chomaz, Jean-Marc; Barakat, Abdul I.

    2015-01-01

    Drug-eluting stents (DES), which release anti-proliferative drugs into the arterial wall in a controlled manner, have drastically reduced the rate of in-stent restenosis and revolutionized the treatment of atherosclerosis. However, late stent thrombosis remains a safety concern in DES, mainly due to delayed healing of the endothelial wound inflicted during DES implantation. We present a framework to optimize DES design such that restenosis is inhibited without affecting the endothelial healing process. To this end, we have developed a computational model of fluid flow and drug transport in stented arteries and have used this model to establish a metric for quantifying DES performance. The model takes into account the multi-layered structure of the arterial wall and incorporates a reversible binding model to describe drug interaction with the cells of the arterial wall. The model is coupled to a novel optimization algorithm that allows identification of optimal DES designs. We show that optimizing the period of drug release from DES and the initial drug concentration within the coating has a drastic effect on DES performance. Paclitaxel-eluting stents perform optimally by releasing their drug either very rapidly (within a few hours) or very slowly (over periods of several months up to one year) at concentrations considerably lower than current DES. In contrast, sirolimus-eluting stents perform optimally only when drug release is slow. The results offer explanations for recent trends in the development of DES and demonstrate the potential for large improvements in DES design relative to the current state of commercial devices. PMID:26083626

  6. Black hole restenosis after drug-eluting stent implantation for in-stent restenosis: potential mechanism and optimal strategy.

    PubMed

    Otsuka, Yoritaka; Murata, Takashi; Kono, Michiaki; Imoto, Hiroki; Koyama, Taku; Nakamura, Keita; Kadama, Sunao; Noguchi, Hiroo; Saito, Taro

    2015-09-01

    In-stent restenosis (ISR) has long remained as the major limitation of coronary stenting. The use of drug-eluting stent (DES) reduces the risk of repeat revascularization without an increase of death and myocardial infarction, compared to the standard bare metal stents. DES has also demonstrated markedly to reduce ISR for complex lesions. However, ISR after DES implantation still occurs and optimal treatment for ISR after DES has not been established. Herein, we report 3 cases with black hole restenosis confirmed by intravascular ultrasound at the site of overlapped DES and discuss potential mechanism and optimal strategy for this phenomenon.

  7. Paradoxical Hypertension after Successful Cheatham Platinum Stent Implantation in an Adolescent with Coarctation of the Aorta

    PubMed Central

    Tan, Yin Ling; Chih, Wan-Ling; Wang, Jou-Kou; Chen, Chun-An

    2016-01-01

    Stent implantation using a Cheatham Platinum (CP) stent for coarctation of the aorta (CoA) is a promising treatment alternative to traditional surgical repair. However, there are no earlier reports in the literature focusing on use of this stent in a Taiwanese patient. Herein we report a 16-year-old boy with CoA presenting with heart murmur and exercise intolerance who underwent successful CP stent placement. However, severe hypertension with arterial blood pressure increasing to 207/104 mmHg occurred four hours after stent implantation. There was no abdominal pain, nausea or vomiting. The patient’s hypertension was controlled by intravenous nitroglycerin infusion, followed by an oral antihypertensitve agent for the following 7 days. Experience from this case highlighted the usefulness of CP stent implantation for native CoA, and the importance of early recognition and management of paradoxical hypertension after CoA stenting. PMID:27899866

  8. 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

  9. 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.

  10. Correlation between high perfusion syndrome and stent restenosis after stent implantation

    PubMed Central

    Li, Yingyi; Tang, Lingtao; Qi, Dong; Wang, Chunlei; Zhang, Suxia; Hu, Pengfei; Wang, Yun; Zhang, Bogang; Zhang, Kunxi

    2016-01-01

    The present study was conducted to determine the correlation between high perfusion syndrome and stent restenosis after cerebral vascular stent implantation. A total of 146 patients diagnosed with cerebral vascular stenosis and stent implantation were selected. A total of 55 cases (37.67%) of cerebral hyperperfusion syndrome patients were diagnosed by xenon-enhanced computer tomography (Xe-CT) examination and clinical symptoms within 3 days after surgery and were chosen as the observation group. A total of 91 cases were selected as the control group. After treatment, blood flow of the anterior cerebral artery, middle cerebral artery, posterior cerebral artery, anterior border zone, posterior border zone and the inner border zone of the two groups increased, with values in the observation group increasing more significantly, and the differences were statistically significant (P<0.05). The rate of restenosis and target lesion diameter one month and one year after operation in the observation group were significantly higher than those in the control group (P<0.05). Multivariate logistic regression analysis showed that the mean systolic blood pressure (mSBP), mean diastolic blood pressure (mDBP), stenosis rate of cerebral vascular diameter and high perfusion syndrome were independent risk factors for restenosis (P<0.05). The application of Xe-CT examination is important for early diagnosis of hyperperfusion syndrome. Hyperperfusion syndrome and the occurrence of stent restenosis are closely related. mSBP, mDBP, cerebral blood vessel diameter stenosis rate and high perfusion comprehensive syndrome are the independent risk factors of restenosis. PMID:28101162

  11. 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.

  12. 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.

  13. Can angiotensin receptor antagonists prevent restenosis after stent placement?

    PubMed

    Peters, Stefan

    2002-01-01

    Restenosis rates after coronary stent implantation in complex lesions are between 30 and 50%. Neointimal hyperplasia promoted by complex interaction between cellular and acellular elements, such as cytokines and growth factors, is thought to be the primary process responsible for restenosis. The risk of in-stent restenosis is increased in patients with a history of restenosis after percutaneous transluminal coronary angioplasty, in long lesions, in total occlusions, in patients with diabetes mellitus, in small vessels, in the proximal parts of the left anterior descending coronary artery and in cases of stent oversizing. In-stent restenosis represents a serious economic burden on society because treatment strategies include expensive approaches such as cutting-balloon angioplasty, rotational atherectomy and brachytherapy. A number of pharmacological agents, including ACE inhibitors, have been unsuccessful in preventing restenosis. Alternative procedures such as brachytherapy, radioactive stents and drug-eluting stents are under evaluation. Although sirolimus- or paclitaxel-eluting stents have been associated with very low restenosis rates over durations of 6 to 12 months, the long-term efficacy and tolerability of this approach is currently being investigated. Although ACE inhibitors have failed in reducing restenosis rates, the selective angiotensin II type 1 (AT(1)) receptor antagonist valsartan has shown encouraging results in the single-center Valsartan for Prevention of Restenosis after Stenting of Type B2/C lesions trial (ValPREST). The ValPREST trial is the first randomized, placebo-controlled study to have evaluated the effect of an angiotensin receptor antagonist on in-stent restenosis in a moderate number of patients. Compared with ACE inhibitors, angiotensin receptor blockers exert additional effects on the pathophysiological processes which lead to restenosis. Angiotensin receptor antagonists may affect several mechanisms involved in neointimal

  14. Angiographic and clinical outcomes after implantation of drug eluting stents in bifurcation lesions with crush or kissing stent technique.

    PubMed

    Cheema, Asim N; Jolly, Sanjit S; Burstein, Jason M; Sharieff, Waseem; Mohammad, Atif; Yeoh, Eunice; Mancini, G B John; Cantor, Warren J; Kutryk, Michael J B; Strauss, Bradley H; Chisholm, Robert J

    2013-04-01

    Long-term outcome after bifurcation stenting with drug-eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6-9-month angiographic follow-up and long-term clinical outcomes after implantation of drug-eluting stents by crush and kissing stent technique for coronary bifurcation lesions. Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow-up was obtained at 6-9 months and clinical follow-up completed for a median of 38 months. A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow-up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow-up was available for a median duration of 38 months. During follow-up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow-up. Bifurcation stenting with crush or kissing stent

  15. Cubic Hermite Bezier spline based reconstruction of implanted aortic valve stents from CT images.

    PubMed

    Gessat, Michael; Altwegg, Lukas; Frauenfelder, Thomas; Plass, André; Falk, Volkmar

    2011-01-01

    Mechanical forces and strain induced by transcatheter aortic valve implantation are usually named as origins for postoperative left ventricular arrhythmia associated with the technique. No quantitative data has been published so far to substantiate this common belief. As a first step towards quantitative analysis of the biomechanic situation at the aortic root after transapical aortic valve implantation, we present a spline-based method for reconstruction of the implanted stent from CT images and for locally measuring the deformation of the stent.

  16. Implantation study of a tissue-engineered self-expanding aortic stent graft (bio stent graft) in a beagle model.

    PubMed

    Kawajiri, Hidetake; Mizuno, Takeshi; Moriwaki, Takeshi; Iwai, Ryosuke; Ishibashi-Ueda, Hatsue; Yamanami, Masashi; Kanda, Keiichi; Yaku, Hitoshi; Nakayama, Yasuhide

    2015-03-01

    The use of stent grafts for endovascular aortic repair has become an important treatment option for aortic aneurysms requiring surgery. This treatment has achieved excellent outcomes; however, problems like type 1 endoleaks and stent graft migration remain. Bio stent grafts (BSGs), which are self-expanding stents covered with connective tissue, were previously developed using "in-body tissue architecture" technology. We assessed their early adaptation to the aorta after transcatheter implantation in a beagle model. BSGs were prepared by subcutaneous embedding of acryl rods mounted with self-expanding nitinol stents in three beagles for 4 weeks (n = 3/dog). The BSGs were implanted as allografts into infrarenal abdominal aortas via the femoral artery of three other beagles. After 1 month of implantation, aortography revealed no stenosis or aneurysmal changes. The luminal surface of the BSGs was completely covered with neointimal tissue, including endothelialization, without any thrombus formation. The cover tissue could fuse the luminal surface of the native aorta with tight conjunctions even at both ends of the stents, resulting in complete impregnation of the strut into the reconstructed vascular wall, which is expected to prevent endoleaks and migration in clinical applications.

  17. The underdilation of nitinol stents at TIPS implantation: Solution or illusion?

    PubMed

    Mollaiyan, Ashkan; Bettinger, Dominik; Rössle, Martin

    2017-04-01

    This study investigates the behaviour of self-expanding nitinol stents at the time of TIPS-implantation and thereafter. Hundred consecutive patients with cirrhosis receiving a TIPS revision were included. The smallest stent diameter was measured radiologically immediately after implantation and before shunt revision. Accuracy of the measurement was assessed by comparing the nominal stent diameter with the largest stent diameter measured at the time of revision. Pearson correlation between largest measured and nominal diameters was excellent (r=0.952, p<0.001) showing that measurements are accurate. At TIPS implantation all stents were markedly underdilated reaching only 76-92% of their nominal diameter. Smallest measured diameters were similar (8mm) irrespective of the nominal diameter (8, 9, 10mm) of the stent. In addition, smallest diameters of 10mm stents were similar irrespective whether 8, 9 or 10mm balloons were used. During a mean follow-up of 12.7±17.8months (median 3 months, range 1-81) stents expanded by 0.5-1.6mm dependent on the nominal stent size (8, 9, 10mm) and the grade of primary underdilation. No significant difference was found between Viatorr and bare stents. At TIPS-implantation, the compliance of the surrounding tissue predominantly determines the stent diameter. The nominal size of the stent or the dilatation balloon has little influence. Accurate adjustment of a desired pressure gradient is, therefore, not possible. During follow-up, stents expand towards their nominal diameter questioning the usefulness of underdilation. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Inadvertent intracoronary stent extraction 10 months after implantation complicating cutting balloon angioplasty for in-stent restenosis

    SciTech Connect

    Almeda, Francis Q.; Billhardt, Roger A

    2003-09-01

    We report the case of an unusual complication for Cutting Balloon Angioplasty (CBA) during treatment for instent restenosis (ISR), which resulted in inadvertent intracoronary stent extraction 10 months after implantation. In this case report, CBA was utilized to treat an ISR lesion in the distal right coronary artery (RCA). Due to difficulty in withdrawing the cutting balloon into the guide after treatment of the lesion, the entire system (guide, cutting balloon, and guidewire) was removed as a unit from the body. Upon examination of the system, the previously placed stent in the distal RCA was attached to the microtomes of the cutting balloon. Although the precise mechanisms for stent extraction in this case remain speculative, the initial stent used in the distal RCA may have been undersized, and this may have played a major role in this complication. Although there is limited data regarding the optimal strategy to treat the site of the inadvertent stent extraction, we opted to re-stent the area with a properly-sized coronary stent. Following the intervention, there was no residual stenosis with TIMI 3 flow through the vessel. The patient remained asymptomatic and a serum troponin drawn 18 hours after the procedure was normal, and he was discharged the next day. The interventionist must be vigilant about this rare but serious complication when applying CBA in the treatment of ISR, particularly when an undersized or underdeployed stent is suspected.

  19. 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)

  20. 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.

  1. Influence of Vessel Size and Tortuosity on In-stent Restenosis After Stent Implantation in the Vertebral Artery Ostium

    SciTech Connect

    Zhou Zhiming; Yin Qin; Xu Gelin; Yue Xuanye; Zhang Renliang; Zhu Wusheng; Fan Xiaobing; Ma Minmin; Liu Xinfeng

    2011-06-15

    Purpose: Percutaneous transluminal angioplasty and stenting is emerging as an alternative for treating atherosclerotic stenosis in the vertebral artery ostium. However, in-stent restenosis (ISR) still remains a critical issue to be addressed. Little is known about the relationship between anatomic characteristics of the artery and ISR after stent implantation. In this study, we have evaluated influential factors for ISR in a cohort of the patients with stenting in the vertebral artery ostium. Methods: Sixty-one patients with 63 symptomatic lesions in vertebral artery ostium treated with stenting were enrolled onto this study. An average of 12.5 months' clinical and angiographic follow-up results were analyzed retrospectively. The possible influential factors for ISR, including conventional risk factors of cerebrovascular diseases and morphological characteristics of target lesions, were evaluated by univariate and multivariate regression analysis. Results: Technical success was achieved in all 63 interventional procedures. Stenosis was reduced from (mean {+-} standard deviation) 75.5 {+-} 12% before to 1 {+-} 3.6% after the procedure. During the mean 12.5-month angiographic follow-up, ISR was detected in 17 treated vessels (27.0%), with 2 treated arteries (3.2%) resulting in occlusion, and a stent fracture in 1 case (1.6%). Multivariate Cox regression analysis showed that the tortuosity of V1 (hazard ratio 3.54, P = 0.01) and smaller diameter of the stent (hazard ratio 3.8, P = 0.04) were independent predictors of ISR. Conclusions: Angioplasty and stenting for symptomatic stenosis in the vertebral artery ostium stenosis seem to be feasible and effective. Tortuosity and smaller diameter may affect ISR after stent implantation.

  2. Atherosclerotic plaque behind the stent changes after bare-metal and drug-eluting stent implantation in humans: implications for late stent failure?

    PubMed Central

    Andreou, Ioannis; Takahashi, Saeko; Tsuda, Masaya; Shishido, Koki; Antoniadis, Antonios P.; Papafaklis, Michail I.; Mizuno, Shingo; Coskun, Ahmet U.; Saito, Shigeru; Feldman, Charles L.; Edelman, Elazer R.; Stone, Peter H.

    2016-01-01

    Background and aims The natural history and the role of atherosclerotic plaque located behind the stent (PBS) are still poorly understood. We evaluated the serial changes in PBS following bare-metal (BMS) compared to first-generation drug-eluting stent (DES) implantation and the impact of these changes on in-stent neointimal hyperplasia (NIH). Methods Three-dimensional coronary reconstruction by angiography and intravascular ultrasound was performed after intervention and at 6–10-month follow-up in 157 patients with 188 lesions treated with BMS (n=89) and DES (n=99). Results There was a significant decrease in PBS area (−7.2%; p<0.001) and vessel area (−1.7%; p<0.001) after BMS and a respective increase in both areas after DES implantation (6.1%; p<0.001 and 4.1%; p<0.001, respectively). The decrease in PBS area significantly predicted neointimal area at follow-up after BMS (β: 0.15; 95% confidence interval [CI]: 0.10–0.20, p<0.001) and DES (β: 0.09; 95% CI: 0.07–0.11; p<0.001) implantation. The decrease in PBS area was the most powerful predictor of significant NIH after BMS implantation (odds ratio: 1.13; 95% CI: 1.02–1.26; p=0.02). Conclusions The decrease in PBS area after stent implantation is significantly associated with the magnitude of NIH development at follow-up. This finding raises the possibility of a communication between the lesion within the stent and the underlying native atherosclerotic plaque, and may have important implications regarding the pathobiology of in-stent restenosis and late/very late stent thrombosis. PMID:27494445

  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. Image-based dosimetry of an implanted radioactive stent using intravascular ultrasound

    NASA Astrophysics Data System (ADS)

    Peterson, Stephen W.

    Angioplasty has become an increasingly popular and effective treatment for heart disease. Unfortunately, restenosis, a cellular and biological reaction to the procedure, has hindered its effectiveness. Two of the most successful methods of inhibiting restenosis are radiation and stents. The combination of these two components, radioactive stents, is not as common as some of the other methods, yet still has potential of slowing restenosis. Investigation into source characteristics and artery wall radiobiology may illuminate some possible solutions to the problems of restenosis. This work has developed a calculational method to look at in-vivo images of implanted stents and determine the dose to the artery walls in order to test different source characteristics. The images are Intravascular Ultrasound (IVUS) cross-sectional slices of the stent and the artery. From these images, it is possible to determine the implanted stent structure. The pieces of the stent are identified in the images and modeled in a Monte Carlo simulation, using MCNP4c3. The simulation results were combined with the images to give three-dimensional absolute dose contours of the stent. The absolute dose values were verified using radiochromic film and 198Au-plated stents. This work was able to successfully verify the dose results and create a three-dimensional dose map of the implanted stent.

  5. Is direct stent implantation without predilatation safe? Acute and long-term outcome.

    PubMed

    Rahel, Braim M; Suttorp, Maarten Jan; Ten Berg, Jurriën M; Bal, Egbert T; Ernst, Sjef M P G; Mast, E Gijs; Kelder, Johannes C; Plokker, H W Thijs

    2002-08-01

    Direct stenting could potentially lead to a reduction in dissections, time, and restenosis at 6-month follow-up. Using the premounted Palmaz-Schatz Crown stent elective stenting was performed without predilatation in 61 consecutive patients who were compared with a control group of provisional stenting. All patients underwent clinical and angiographic follow-up at 6 months. Direct stenting was successful in 81% of patients. In 16% of the patients predilatation was needed. In 3% the stent could not be implanted despite predilatation. Stent dislodgment occurred in 2% of patients, without embolization. Six-month angiographic follow-up was performed in 51 (84%) of 61 patients. In the direct stenting group the mean preprocedural minimal luminal diameter (MLD) increased from 0.96 +/- 0.47 to 3.09 +/- 0.54 mm directly after the procedure. At 6-month follow-up the MLD measured 2.32 +/- 0.79 mm. In the provisional stenting group the mean MLD increased from 0.92 +/- 0.51 to 2.44 +/- 0.58 mm and was 1.84 +/- 0.70 mm at 6-month follow-up. Restenosis, defined as a diameter stenosis > 50%, occurred in 8% of the direct stenting group compared with 28% in the provisional stenting group (P < 0.001). Direct coronary stent implantation can be attempted safely and efficaciously. The risk of stent loss is low. The initial and long-term angiographic results are significantly better as compared with provisional stenting. The risk of restenosis is significantly lower.

  6. 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.

  7. Ulcerated Radiodermatitis Induced after Fluoroscopically Guided Stent Implantation Angioplasty

    PubMed Central

    Herz-Ruelas, Maira Elizabeth; Gómez-Flores, Minerva; Moxica-del Angel, Joaquín; Miranda-Maldonado, Ivett; Gutiérrez-Villarreal, Ilse Marilú; Villarreal-Rodríguez, Adriana Orelia

    2014-01-01

    Cases of radiation-induced skin injury after fluoroscopically guided procedures have been reported since 1996, though the majority of them have been published in Radiology and Cardiology literature, less frequently in Dermatology journals. Chronic radiation dermatitis induced by fluoroscopy can be difficult to diagnose; a high grade of suspicion is required. We report a case of an obese 46-year-old man with hypertension, dyslipidemia, and severe coronary artery disease. He developed a pruritic and painful atrophic ulcerated skin plaque over his left scapula, six months after fluoroscopically guided stent implantation angioplasty. The diagnosis of radiodermatitis was confirmed histologically. We report this case to emphasize the importance of recognizing fluoroscopy as a cause of radiation dermatitis. A good clinical follow-up at regular intervals is important after long and complicated procedures, since the most prevalent factor for injury is long exposure time. PMID:25276441

  8. 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.

  9. Drug-eluting stenting for femoropopliteal lesions, followed by cilostazol treatment, reduces stent restenosis in patients with symptomatic peripheral artery disease.

    PubMed

    Zen, Kan; Takahara, Mitsuyoshi; Iida, Osamu; Soga, Yoshimitsu; Kawasaki, Daizo; Nanto, Shinsuke; Yokoi, Hiroyoshi; Matoba, Satoaki

    2017-03-01

    Cilostazol improves clinical endovascular therapy outcomes for femoropopliteal (FP) lesions in patients with symptomatic peripheral arterial disease, but whether it also has clinical benefits for patients after drug-eluting stent implantation remains unclear. This study is a subanalysis of the ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy (ZEPHYR) study, a prospective multicenter study investigating FP lesions treated with the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent. The present study analyzed 475 lesions in 459 limbs of 399 patients who maintained therapy with aspirin and thienopyridine, with or without cilostazol, during the 1-year follow-up period. Restenosis rates at 1 year were assessed with duplex ultrasound imaging (peak systolic velocity ratio >2.4) or angiography (≥50% diameter stenosis) and compared in the groups with and without cilostazol. Propensity score matching was performed to minimize intergroup differences in baseline characteristics. The present study included 93 cilostazol-treated and 382 cilostazol-free cases. Among the patients, 71% had diabetes mellitus and 31% were on dialysis. Critical limb ischemia accounted for 29% of cases. The prevalence of de novo lesions was 76%, and in-stent restenosis was present in 15%. Propensity score matching was performed in 91 pairs. The 1-year restenosis rate was 33% (95% confidence interval [CI], 23%-43%) in the cilostazol-treated group and 51% (95% CI, 41%-62%) in the cilostazol-free group (P = .008). The odds ratio was 0.5 (95% CI, 0.3-0.8). The propensity score-matching analysis demonstrated that additional cilostazol administration was associated with a significantly lower restenosis incidence 1 year after drug-eluting stent implantation for FP lesions. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  10. 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.

  11. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2016-04-01

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

  13. Laser-induced fluorescence identification of intimal hyperplasia after intravascular stent implantation

    NASA Astrophysics Data System (ADS)

    Lucas, Alexandra; Perk, Masis; Wen, Yue; Tio, Fermin O.; Schneider, Wolfgang

    1992-08-01

    Laser-induced fluorescence spectroscopy has been developed as a guidance system for laser angioplasty. We have investigated fluorescence spectroscopic detection of neo-intimal formation from the endoluminal surface of stent implanted arteries. Nine White Leghorn roosters had Palmaz-Schatz intra-abdominal aortic stent implantation, nine had aortic balloon angioplasty. Five roosters with stent implantation and four roosters with balloon angioplasty were on a high cholesterol diet and the remainder were on a normal diet. Roosters were sacrificed at intervals of 1, 2, 4, 8, and 12 weeks after intervention. Fluorescence emission spectra were recorded from aortic segments during excimer laser excitation at 308 nm (XeCl, 1.5 - 2.0 mJ/pulse, 5 Hertz). Spectra were then correlated with histology. Fluorescence emission intensity recorded from abdominal aortic segments with stent implantation was higher than that of adjacent segments (p < 0.002 at 440 - 460 nm). Abdominal aortic segments of roosters on normal diets with stent implantation and balloon angioplasty were similar (p equals NS). With cholesterol feeding, aortic spectra from roosters with stent implant had higher intensity at 440 - 460 nm than spectra from aortic segments with balloon angioplasty (p < 0.004). Morphometric analysis demonstrated a twofold increase in intimal thickness in stent segments from cholesterol fed roosters when compared to similar segments of roosters on normal diets (p < 0.005). Our conclusion is: (1) Fluorescence emission spectra can be used to detect native artery fluorescence in stent implant areas. (2) Neo-intimal thickening at the stet implant site can be distinguished from adjacent areas by fluorescence emission spectra. (3) Cholesterol feeding increased neo-intimal thickening.

  14. 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)

  15. 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

  16. A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis

    PubMed Central

    Simsekyilmaz, Sakine; Schreiber, Fabian; Weinandy, Stefan; Gremse, Felix; Sönmez, Tolga Taha; Liehn, Elisa A.

    2013-01-01

    Despite the considerable progress made in the stent development in the last decades, cardiovascular diseases remain the main cause of death in western countries. Beside the benefits offered by the development of different drug-eluting stents, the coronary revascularization bears also the life-threatening risks of in-stent thrombosis and restenosis. Research on new therapeutic strategies is impaired by the lack of appropriate methods to study stent implantation and restenosis processes. Here, we describe a rapid and accessible procedure of stent implantation in mouse carotid artery, which offers the possibility to study in a convenient way the molecular mechanisms of vessel remodeling and the effects of different drug coatings. PMID:23711999

  17. Late Pseudocoarctation Syndrome After Stent-Graft Implantation For Traumatic Aortic Rupture

    SciTech Connect

    Letocart, Vincent Fau, Georges Tirouvanziam, Ashok; Toquet, Claire; Al Habash, Oussama Guerin, Patrice; Rousseau, Herve; Crochet, Dominique

    2013-06-15

    The present observation illustrates an unusual complication occurring after stent-grafting (S-graft) for aortic isthmus rupture. A 22-year-old patient, treated by S-graft in the emergency department for traumatic aortic rupture, was readmitted 10 months later with pseudocoarctation syndrome. A membrane was found inside the stent-graft that had induced a pseudo-dissection, which caused the pseudocoarctation syndrome. Surgical treatment consisted of removing the stent-graft and membrane and replacing it with a vascular implant. The patient's clinical course was fair. The suggested mechanism was circumferential neoendothelialization of the stent-graft. Dehiscence caused the superior part of the membrane to drop into the lumen of the stent-graft creating a 'false channel' that compressed the 'true lumen' and induced 'pseudocoarctation' syndrome. The cause of the extensive neointimalization remains unexplained. Thoracic aortic stent-grafts require regular follow-up monitoring by angioscan or angio-magnetic resonance imaging.

  18. Late pseudocoarctation syndrome after stent-graft implantation for traumatic aortic rupture.

    PubMed

    Letocart, Vincent; Fau, Georges; Tirouvanziam, Ashok; Toquet, Claire; Al Habash, Oussama; Guerin, Patrice; Rousseau, Hervé; Crochet, Dominique

    2013-06-01

    The present observation illustrates an unusual complication occurring after stent-grafting (S-graft) for aortic isthmus rupture. A 22-year-old patient, treated by S-graft in the emergency department for traumatic aortic rupture, was readmitted 10 months later with pseudocoarctation syndrome. A membrane was found inside the stent-graft that had induced a pseudo-dissection, which caused the pseudocoarctation syndrome. Surgical treatment consisted of removing the stent-graft and membrane and replacing it with a vascular implant. The patient's clinical course was fair. The suggested mechanism was circumferential neoendothelialization of the stent-graft. Dehiscence caused the superior part of the membrane to drop into the lumen of the stent-graft creating a "false channel" that compressed the "true lumen" and induced "pseudocoarctation" syndrome. The cause of the extensive neointimalization remains unexplained. Thoracic aortic stent-grafts require regular follow-up monitoring by angioscan or angio-magnetic resonance imaging.

  19. 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.

  20. Risk factors for the development of restenosis following stent implantation of venous bypass grafts

    PubMed Central

    Heidland, U; Heintzen, M; Michel, C; Strauer, B

    2001-01-01

    OBJECTIVE—To analyse the variables involved in the high restenosis rate following stent implantation in coronary artery bypass grafts.
DESIGN—A retrospective analysis of a consecutive group of patients attending a tertiary centre.
PATIENTS—The long term angiographic outcome of 219 stent implantations for individual lesions performed in 191 patients was investigated. Multivariate analysis correlated clinical, procedural, and angiographic variables with the incidence of angiographic restenosis, defined as diameter stenosis > 50% at follow up.
RESULTS—Angiographic restenosis was observed in 34% of lesions treated. Multiple logistic regression analysis defined diabetes mellitus (odds ratio 6.91, 95% confidence interval (CI) 2.43 to 9.69), graft recanalisation (2.89, 95% CI 1.18 to 6.63), lesion at the aortic anastomosis (6.98, 95% CI 2.77 to 21.31), lesion at the coronary anastomosis (3.01, 95% CI 1.19 to 7.69), high diameter stenosis after stent placement (7.21, 95% CI 2.66 to 16.81), placement of long stents (2.73, 95% CI 1.09 to 7.39), and implantation of more than one stent (7.31, 95% CI 2.08 to 19.96) as independent predictors of graft in-stent restenosis.
CONCLUSIONS—There appears to be a specific risk factor constellation contributing to the high restenosis rate following stent implantation in venous bypass grafts. Critical consideration of these variables may help identify patients who are poor candidates for stent implantation and who may benefit from a different approach.


Keywords: coronary artery bypass graft; stent; restenosis PMID:11179274

  1. Combined Arterial Infusion and Stent Implantation Compared with Metal Stent Alone in Treatment of Malignant Gastroduodenal Obstruction

    SciTech Connect

    Wang Zhongmin; Chen Kemin; Gong Ju; Zheng Yunfeng; Wang Tianxiang

    2009-09-15

    Many patients with malignant gastroduodenal obstruction have an unresectable primary lesion and distant metastases, which may prompt palliative management to allow the patient to eat and to improve the quality of life. Intraluminal metallic stent implantation (MSI) under fluoroscopic guidance has been reported to be an effective option for symptomatic relief in these patients, with a good safety record. An alternative, dual interventional therapy (DIT), has been used during the last decade, in which prosthesis insertion is followed by intra-arterial chemotherapy via the tumor-feeding arteries. The aim of this study was to compare success rates, complication rates, and survival time between MSI and DIT in patients who presented with gastroduodenal obstruction from advanced upper gastrointestinal tract cancer. All consecutive patients with malignant gastroduodenal obstruction seen at our center between October 2002 and August 2007 were retrospectively studied. Patients were treated palliatively by either MSI or DIT by the patient's or the next of kin's decision. Outcomes included technical and clinical success, complication rates, and survival. Of the 164 patients with malignant gastric and duodenal outlet obstructions, 80 (49%) underwent stent insertion as the primary therapy, while the remaining 84 (51%) received DIT. Clinical characteristics were similar between the two groups. In the MSI cohort initial stent implantation was successful in 73 patients (91%), two stents were used in 5 patients, and delayed additional stent insertion for stent obstruction related to tumor overgrowth was required in 3 patients during follow-up. In the DIT cohort the technical success rate was 94%, 3 patients required two stents, and stent obstruction occurred in 2 patients after initial stent placement. Early postprocedural clinical success, indicated by average dysphagia score, improved significantly in both groups: MSI group, from 4.56 to 1.51 (P < 0.01); and DIT group, from 4

  2. Haemodynamic impact of stent implantation for lateral tunnel Fontan stenosis: a patient-specific computational assessment.

    PubMed

    Tang, Elaine; McElhinney, Doff B; Restrepo, Maria; Valente, Anne M; Yoganathan, Ajit P

    2016-01-01

    The physiological importance of the lateral tunnel stenosis in the Fontan pathway for children with single ventricle physiology can be difficult to determine. The impact of the stenosis and stent implantation on total cavopulmonary connection resistance has not been characterized, and there are no clear guidelines for intervention. Methods and results A computational framework for haemodynamic assessment of stent implantation in patients with lateral tunnel stenosis was developed. Cardiac magnetic resonances images were reconstructed to obtain total cavopulmonary connection anatomies before stent implantation. Stents with 2-mm diameter increments were virtually implanted in each patient to understand the impact of stent diameter. Numerical simulations were performed in all geometries with patient-specific flow rates. Exercise conditions were simulated by doubling and tripling the lateral tunnel flow rate. The resulting total cavopulmonary connection vascular resistances were computed. A total of six patients (age: 14.4 ± 3.1 years) with lateral tunnel stenosis were included for preliminary analysis. The mean baseline resistance was 1.54 ± 1.08 WU · m(2) and dependent on the stenosis diameter. It was further exacerbated during exercise. It was observed that utilising a stent with a larger diameter lowered the resistance, but the resistance reduction diminished at larger diameters. Using a computational framework to assess the severity of lateral tunnel stenosis and the haemodynamic impact of stent implantation, it was observed that stenosis in the lateral tunnel pathway was associated with higher total cavopulmonary connection resistance than unobstructed pathways, which was exacerbated during exercise. Stent implantation could reduce the resistance, but the improvement was specific to the minimum diameter.

  3. Safety and efficacy of AVE gfx stent implantation via 6 Fr guiding catheters.

    PubMed

    Kiemeneij, F; Laarman, G J; Odekerken, D; Slagboom, T; van der Wieken, R

    1999-08-01

    This prospective study was designed to determine the feasibility of AVE gfx premounted stent systems in combination with 6 Fr guides. Between 1 April and 12 August 1997, 230 patients underwent AVE gfx coronary stent implantation via 6 Fr guides. The radial approach was used in 146 patients (63.5%). In 230 procedures (293 lesions), 237 guiding catheters were used. A total of 331 AVE gfx stents were implanted, 1.4 per patient. Backup, opacification, and friction were considered good in 85.8%, 96.4%, and 76.7%, respectively. Slight and severe friction was felt during combined use of long (> or = 18 mm), large-sized (3.5 mm) stents and small-sized guiding catheters (inner diameter, 0.061-0.062"). The presence of a second protecting guidewire impaired passage of the AVE gfx stent, also in large 6 Fr guides (ID 0.064"). Of 331, 320 (96.7%) stents were successfully deployed at the initial attempt. Ten stents (3%) had to be retrieved. Six of these were successfully placed at a second attempt and three slipped off the balloon, all successfully retrieved from the patient's circulation. At 1 month, 217 patients (94.4%) were free of events. The AVE gfx stent is compatible with 6 Fr guiding catheters. Use of new-generation, large-bore 6 Fr gc (> or = 0.064") is recommended.

  4. Successful percutaneous stent implantation for isolated dismal transverse aortic arch kinking

    PubMed Central

    Zuo, Zhi-Liang; Tsauo, Jia-Yu; Chen, Mao; Feng, Yuan

    2017-01-01

    Abstract Rationale: Isolated dismal transverse aortic arch kinking in adults is rare, and there is no recommended therapy at present. Percutaneous stent implantation may be an effective method to correct it and could be considered. Patient concerns: We report a 46-year-old woman who suffered from recurrent migraine and refractory hypertension with a significant systolic blood pressure difference between upper limbs. Diagnoses: The woman was diagnosed with isolated dismal transverse aortic arch kinking with refractory hypertension. Interventions: Percutaneous stent implantation was performed. Due to the kinking nature of the diseased transverse aortic arch, the first covered stent moved forward to the proximal transverse aortic arch during deploying without the left common carotid artery occlusion. And then, a second stent was placed to cover the residual kinked part of the dismal transverse arch. Outcomes: Angiography and post-procedural computed tomography angiography revealed fully corrected of the diseased segment. At 6-month follow-up after procedure, the patient was free of any symptoms and had a normal blood pressure under antihypertensive treatment. Lessons: This case indicates that transverse aortic arch kinking in isolation can be well treated by percutaneous stent implantation in adult patients. Unlike pure aortic coarctation, elongation and bucking give the rise to the occurrence rate of stent sliding and migration and sometimes a second stent is needed. PMID:28272200

  5. Hemodynamic Alterations after Stent Implantation in 15 Cases of Intracranial Aneurysms

    PubMed Central

    Wang, Chao; Tian, Zhongbin; Liu, Jian; Jing, Linkai; Paliwal, Nikhil; Wang, Shengzhang; Zhang, Ying; Xiang, Jianping; Siddiqui, Adnan H; Meng, Hui; Yang, Xinjian

    2016-01-01

    Background Stent-assisted coiling technology has been widely used in the treatment of intracranial aneurysms. In current study, we investigated the intra-aneurysmal hemodynamic alterations after stent implantation and its association with aneurysm location. Methods We first retrospectively studied 15 aneurysm cases (8 internal carotid artery-ophthalmic artery (ICA-OphA) aneurysms and 7 posterior communicating artery (PcoA) aneurysms) treated with Enterprise stents and coils. Then based on patient-specific geometries before and after stenting, we built virtual stenting computational fluid dynamics (CFD) simulation models. Results Before and after stent deployment, the average Wall Shear Stress (WSS) on the aneurysmal sac at systolic peak changed from 7.04 Pa (4.14 Pa, 15.77 Pa) to 6.04 Pa (3.86 Pa, 11.13 Pa), P = 0.001; and the spatially averaged value of flow velocity in the perpendicular plane of aneurysm dropped from 0.5 m/s (0.28 m/s, 0.7 m/s) to 0.33 m/s (0.25 m/s, 0.49 m/s), P = 0.001, respectively. Post-stent implantation, WSS in ICA-OphA aneurysms and PcoA aneurysms decreased by 14.4% (P = 0.012) and 16.6% (P = 0.018) respectively, and flow velocity also reduced by 10.3% (P = 0.029) and 10.5% (P = 0.013), respectively. Changes in WSS, flow velocity, and pressure were not significantly different between ICA-OphA aneurysms and PcoA aneurysms (P > 0.05). Stent implantation did not significantly change the peak systolic pressure in both aneurysm types. Conclusion After stent implantation, intra-aneurysmal flow velocity and WSS decreased independent of aneurysm type (ICA-OphA and PcoA). Little change was observed on peak systolic pressure. PMID:26746828

  6. 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

  7. 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

  8. Elastic Deformation Properties of Implanted Endobronchial Wire Stents in Benign and Malignant Bronchial Disease: A Radiographic In Vivo Evaluation

    SciTech Connect

    Hautmann, Hubert; Rieger, Johannes; Huber, Rudolf M.; Pfeifer, Klaus J.

    1999-03-15

    Purpose: To evaluate the long-term mechanical behavior in vivo of expandable endobronchial wire stents, we imaged three different prostheses in the treatment of tracheobronchial disease. Methods: Six patients with bronchial stenoses (three benign, three malignant) underwent insertion of metallic stents. Two self-expandable Wallstents, two balloon-expandable tantalum Strecker stents and two self-expandable nitinol Accuflex stents were used. Measurements of deformation properties were performed during voluntary cough by means of fluoroscopy, at 1 month and 7-10 months after implantation. The procedures were videotaped, their images digitized and the narrowing of stent diameters calculated at intervals of 20 msec. Results: After stent implantation all patients improved with respect to ventilatory function. Radial stent narrowing during cough reached 53% (Wallstent), 59% (tantalum Strecker stent), and 52% (nitinol Accuflex stent) of the relaxed post-implantation diameter. Stent compression was more marked in benign compared with malignant stenoses. In the long term permanent deformation occurred with the tantalum Strecker stents; the other stents were unchanged. Conclusion: Endobronchial wire stents can be helpful in the treatment of major airway collapse and obstructing bronchial lesions. However, evidence of material fatigue as a possible effect of exposure to recurrent mechanical stress on the flexible mesh tube may limit their long-term use. This seems to be predominantly important in benign bronchial collapse.

  9. 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.

  10. 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

  11. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study.

    PubMed

    Calderas, Carlos; Condado, Jose Francisco; Condado, Jose Antonio; Flores, Alejandra; Mueller, Amy; Thomas, Jack; Nakatani, Daisaku; Honda, Yasuhiro; Waseda, Katsuhisa; Fitzgerald, Peter

    2014-01-01

    The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization. Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773). In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year. © 2014.

  12. Everolimus-induced Pneumonitis after Drug-eluting Stent Implantation: A Case Report

    SciTech Connect

    Sakamoto, Susumu Kikuchi, Naoshi; Ichikawa, Atsuo; Sano, Go; Satoh, Keita; Sugino, Keishi; Isobe, Kazutoshi; Takai, Yujiro; Shibuya, Kazutoshi; Homma, Sakae

    2013-08-01

    Despite the wide use of everolimus as an antineoplastic coating agent for coronary stents to reduce the rate of restenosis, little is known about the health hazards of everolimus-eluting stents (EES). We describe a case of pneumonitis that developed 2 months after EES implantation for angina. Lung pathology demonstrated an organizing pneumonia pattern that responded to corticosteroid therapy. Although the efficacy of EES for ischemic heart disease is well established, EES carries a risk of pneumonitis.

  13. 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.

  14. Bare metal or drug-eluting stent implantation in last remaining vessel PCI? A serious dilemma.

    PubMed

    Zhang, Lei; Zhu, Jianhua; Kiemeneij, Ferdinand

    2009-04-01

    This case report describes the treatment of an old male diabetic patient with last remaining vessel coronary artery disease and poor left ventricular function. In presence of an old occlusion of the left main coronary artery, a subtotal stenosis of a dominant right coronary artery required angioplasty. After ample consideration it was decided to implant a bare metal stent (BMS) instead of a drug-eluting stent (DES). The major reason was the fear for early discontinuation of clopidogrel in case a drug-eluting stent was placed. The procedure and follow-up are described followed by an overview of current literature concerning similar pathology.

  15. 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.

  16. Similarities and differences in coatings for magnesium-based stents and orthopaedic implants

    PubMed Central

    Ma, Jun; Thompson, Marc; Zhao, Nan; Zhu, Donghui

    2016-01-01

    Magnesium (Mg)-based biodegradable materials are promising candidates for the new generation of implantable medical devices, particularly cardiovascular stents and orthopaedic implants. Mg-based cardiovascular stents represent the most innovative stent technology to date. However, these products still do not fully meet clinical requirements with regards to fast degradation rates, late restenosis, and thrombosis. Thus various surface coatings have been introduced to protect Mg-based stents from rapid corrosion and to improve biocompatibility. Similarly, different coatings have been used for orthopaedic implants, e.g., plates and pins for bone fracture fixation or as an interference screw for tendon-bone or ligament-bone insertion, to improve biocompatibility and corrosion resistance. Metal coatings, nanoporous inorganic coatings and permanent polymers have been proved to enhance corrosion resistance; however, inflammation and foreign body reactions have also been reported. By contrast, biodegradable polymers are more biocompatible in general and are favoured over permanent materials. Drugs are also loaded with biodegradable polymers to improve their performance. The key similarities and differences in coatings for Mg-based stents and orthopaedic implants are summarized. PMID:27695671

  17. Malignant Gastric and Duodenal Stenosis: Palliation by Peroral Implantation of a Self-Expanding Metallic Stent

    SciTech Connect

    Pinto, Isabel T.

    1997-11-15

    Purpose: To assess the use of self-expanding metallic stents in patients with inoperable malignant antrum-pylorus-duodenal obstruction. Methods: Six patients underwent implantation of a Wallstent self-expanding metallic endoprosthesis (20 mm in five patients and 16 mm in one). In five patients a catheter (Berenstein) was introduced perorally into the stomach. A guidewire (Terumo) was introduced through the catheter and advanced through the antrum-pylorus-duodenal stenosis. The guidewire was removed and a 260-cm-long, 0.035'' superstiff guide (Amplatz) was introduced. After the catheter was removed the stent assembly was introduced. In the last patient the stent was implanted through a percutaneous gastrostomy. Results: Treatment of inoperable gastric outlet obstruction caused by tumor compression is difficult and unsatisfactory. Peroral implantation of self-expanding metallic stents resulted in successful palliative therapy of antrum-pylorus-duodenal stenosis in six patients in whom surgery was not possible because of advanced disease and poor general condition. On average, patients were able to eat during 41 days. One patient is tolerating oral intake at 3 months. Conclusion: Implantation of stents resulted in palliative relief of malignant antrum-pylorus-duodenal obstructions.

  18. Peri-stent aneurysm formation following a stent implant for stenotic intracranial vertebral artery dissection: a technical report of two cases successfully treated with coil embolization.

    PubMed

    Ishimaru, Hideki; Nakashima, Kazuaki; Takahata, Hideaki; Matsuoka, Yohjiro

    2013-02-01

    Although stenting for stenotic vertebral artery dissection (VAD) improves compromised blood flow, subsequent peri-stent aneurysm (PSA) formation is not well-known. We report two cases with PSA successfully treated with coil embolization. Three patients with stenotic intracranial VAD underwent endovascular angioplasty at our institution because they had acute infarction in posterior circulation territory and clinical evidence of hemodynamic insufficiency. In two of three patients balloon angioplasty at first session failed to relieve the stenosis, and a coronary stent was implanted. Angiography immediately after stenting showed no abnormality in case 1 and minimal slit-like projection at proximal portion of the stent in case 2. Angiography obtained 16 months after the stenting revealed PSA in case 1. In case 2, angiography performed 3 months later showed that the projection at proximal portion enlarged and formed an aneurysm outside the stent. Because follow-up angiographies showed growth of the aneurysm in both cases, endovascular aneurysmal embolization was performed. We advanced a microcatheter into the aneurysm through the strut of existing stent and delivered detachable coils into the aneurysm lumen successfully in both cases. The post-procedural course was uneventful, and complete obliteration of aneurysm was confirmed on angiography in both cases. Stenting for stenotic intracranial VAD may result in delayed PSA; therefore, follow-up angiographies would be necessary after stenting for stenotic intracranial arterial dissection. Coil embolization through the stent strut would be a solution for enlarging PSA.

  19. Bare Stent Implantation in Iatrogenic Dissecting Pseudoaneurysm of the Superior Mesenteric Artery

    SciTech Connect

    Kutlu, Ramazan Ara, Cengiz; Sarac, Kaya

    2007-02-15

    Iatrogenic arterial dissection leading to the development of dissecting pseudoaneurysms of the superior mesenteric artery (SMA) is a rare complication of angiography. Surgical and endovascular treatment options exist for this important condition. We report a case of bare stent implantation in dissecting pseudoaneurysm of the SMA that developed after angiography in a patient with acute mesenteric ischemia. Although it is rarely published, iatrogenic arterial dissection causing pseudoaneurysm can occur after diagnostic and interventional angiography. Bare stent implantation in dissecting pseudoaneurysm of the SMA could be an advantageous endovascular treatment option in selected cases due its to potential preservation of important side branches of the SMA.

  20. 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.

  1. 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.

  2. Percutaneous transradial coronary Palmaz-Schatz stent implantation, guided by intravascular ultrasound.

    PubMed

    Kiemeneij, F; Laarman, G J; Slagboom, T

    1995-02-01

    Intravascular ultrasound (IVUS) allows accurate assessment of stent deployment, its use being confined to the use of 8 French (F) guiding catheters. We evaluated the feasibility of combining transradial artery Palmaz-Schatz stent implantation through 6F guiding catheters with IVUS for assessment of stent diameter after delivery at moderate inflation pressures (10-12 atmospheres [atm]) with compliant balloons and after high pressure dilatations with balloons of intermediate compliance. In 8 consecutive patients, 12 stents were delivered with Scimed Express balloon catheters at 10-12 atm followed by IVUS (EndoSonics CathScanner; Visions FX 3.5F 20 MHz transducer). An ultrasound study was repeated after high pressure dilatations (16-20 atm) with Schneider Magical Speedy balloon catheters. The balloon diameters were derived from manufacturer provided specifications. In all patients the transducer could easily be advanced through the guiding catheters. Reference diameter of the stented segment was 3.7 +/- 0.5 mm (2.7-4.5) and the diameter of Scimed Express balloons during inflation was 4.0 +/- 0.3 mm (3.6-4.7). Stent diameter was 3.0 +/- 0.1 mm (2.8-3.2) (P < 0.001 compared to the reference and the balloon diameter). The diameter of the Schneider Magical Speedy balloons at secondary dilatations with 16 +/- 3 atm (14-20) was 4.1 +/- 0.4 mm (3.3-4.5) (P = 0.50 compared to the initial balloon diameter). Final stent diameter was 3.3 +/- 0.4 mm (2.9-4.1) (P = 0.02 compared to the initial stent diameter). All stents were symmetrically deployed and well apposed. No damage to vessel or stents was detected after passage of the transducer.(ABSTRACT TRUNCATED AT 250 WORDS)

  3. Preservation of keratinized mucosa around implants using a prefabricated implant-retained stent: a case-control study

    PubMed Central

    2016-01-01

    Purpose The aim of this study was to clinically assess the impact of a prefabricated implant-retained stent clipped over healing abutments on the preservation of keratinized mucosa around implants after implant surgery, and to compare it with horizontal external mattress sutures. Methods A total of 50 patients were enrolled in this study. In the test group, a prefabricated implant-retained stent was clipped on the healing abutment after implant surgery to replace the keratinized tissue bucco-apically. In the control group, horizontal external mattress sutures were applied instead of using a stent. After the surgical procedure, the width of the buccal keratinized mucosa was measured at the mesial, middle, and distal aspects of the healing abutment. The change in the width of the buccal keratinized mucosa was assessed at 1 and 3 months. Results Healing was uneventful in both groups. The difference of width between baseline and 1 month was −0.26±0.85 mm in the test group, without any statistical significance (P=0.137). Meanwhile, the corresponding difference in the control group was −0.74±0.73 mm and it showed statistical significance (P<0.001). The difference of width between baseline and 3 months was −0.57±0.97 mm in the test group and −0.86±0.71 mm in the control group. These reductions were statistically significant (P<0.05); however, there was no difference between the 2 groups. Conclusions Using a prefabricated implant-retained stent was shown to be effective in the preservation of the keratinized mucosa around implants and it was simple and straightforward in comparison to the horizontal external mattress suture technique. PMID:27800215

  4. Biodegradable nanocomposite magnetite stent for implant-assisted magnetic drug targeting

    NASA Astrophysics Data System (ADS)

    Mangual, Jan O.; Li, Shigeng; Ploehn, Harry J.; Ebner, Armin D.; Ritter, James A.

    2010-10-01

    This study shows, for the first time, the fabrication of a biodegradable polymer nanocomposite magnetic stent and the feasibility of its use in implant-assisted-magnetic drug targeting (IA-MDT). The nanocomposite magnetic stent was made from PLGA, a biodegradable copolymer, and iron oxide nanopowder via melt mixing and extrusion into fibers. Degradation and dynamic mechanical thermal analyses showed that the addition of the iron oxide nanopowder increased the polymer's glass transition temperature ( Tg) and its modulus but had no notable effect on its degradation rate in PBS buffer solution. IA-MDT in vitro experiments were carried out with the nanocomposite magnetic fiber molded into a stent coil. These stent prototypes were used in the presence of a homogeneous magnetic field of 0.3 T to capture 100 nm magnetic drug carrier particles (MDCPs) from an aqueous solution. Increasing the amount of magnetite in the stent nanocomposite (0, 10 and 40 w/w%) resulted in an increase in the MDCP capture efficiency (CE). Reducing the MDCP concentrations (0.75 and 1.5 mg/mL) in the flowing fluid and increasing the fluid velocities (20 and 40 mL/min) both resulted in decrease in the MDCP CE. These results show that the particle capture performance of PLGA-based, magnetic nanocomposite stents are similar to those exhibited by a variety of different non-polymeric magnetic stent materials studied previously.

  5. 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.

  6. [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

  7. Implantation of stents for postsurgical recoarctation of the aorta in adolescents and adults.

    PubMed

    Sulik-Gajda, Sylwia; Fiszer, Roland; Białkowski, Jacek; Chodór, Beata; Pawlak, Szymon; Szkutnik, Małgorzata

    2017-06-14

    Results of stent implantation (SI) of postsurgical recoarctation of the aorta (ReCoA) are not frequently published. This study sought to retrospectively evaluate results of SI in ReCoA in older children and adults. Twenty-eight SI were performed on 26 ReCoA patients with a median age of 23(10-65) years. Dependent upon availability, the following stents were applied -Palmaz, Cheatham Platinum (CP), Andrastents XL/XXL(AS), Covered CP (CVCP) stents and selfexpanding stents (Smart). Generally high pressure balloons were applied to dilate stents. The procedure was effective in 20/26 patients (77,7%). The mean peak systolic gradient reduced from 40,5+/- 18,7 mmHg to 13,1+/- 12,1 mm Hg (p<0,05) and the diameter of stenosed segment increased from 7,5+/- 3.02 mm to 13,1 +/- 3,32 mm (p<0,05). In 6 cases (including a patient treated with a Smart stent) transaortic pressure gradient after SI remained >20 mm Hg (stiff postsurgical lesion). For one patient (40 year old male), an acute dissection of the aorta occurred during balloon predilatation. Immediate CVCP implantation resolved this problem. Two more CVCP were used - one to close a small aortic aneurysm which appeared 5 years after a Palmaz SI and one other to stabilize a broken CP bare metal stent. There were no deaths nor the aortic dissection during follow-up and most patients were able to reduce or suspend their medication for systemic hypertension. Endovascular stenting of recoarctation of the aorta in adults and adolescents appears to be an acceptable method of treatment in experienced hands. However, for some patients the presence of a stiff lesion can provoke suboptimal results. Considering the serious complications which may occur after SI, following surgery all patients should have regular follow up (including an imaging study). Covered stents should always be available in the cathlab as a rescue device when implanting stents in CoA patients.

  8. Comparison of endothelium-dependent and -independent vasomotor response after abluminal biodegradable polymer biolimus-eluting stent and persistent polymer everolimus-eluting stent implantation (COMPARE-IT).

    PubMed

    Puricel, Serban; Kallinikou, Zacharenia; Espinola, Jaqueline; Arroyo, Diego; Goy, Jean-Jacques; Stauffer, Jean-Christophe; Baeriswyl, Gérard; Smits, Pieter Cornelis; Cook, Stéphane; Togni, Mario

    2016-01-01

    Drug-eluting stents (DES) have been associated with local endothelial dysfunction in the segments proximal and distal to the stent (peristent segments) and increased thrombotic risk in long term follow-up. Little data exists on endothelial function post-implantation of new DES with biodegradable polymer. The aim of our study was to compare the local endothelial function assessed by exercise induced coronary vasomotion after implantation of a biolimus A9-eluting stent with biodegradable polymer (BES) with an everolimus-eluting stent with durable polymer (EES). Coronary vasomotion was evaluated with quantitative coronary angiography at rest and during supine bicycle exercise in nine patients with EES and thirteen patients with BES, 16 months after stent implantation. Mean luminal diameter of the stent, peristent segments, and of a control vessel were determined at rest, during exercise, and after the administration of nitroglycerine. The control vessel showed exercise-induced vasodilatation in both groups (EES: +6.4±5.5%, p=0.07; BES: +7.8±10.1%, p=0.07). Vasomotion in the stented vessel segment was abolished. There was exercise-induced vasoconstriction in both groups in the segments proximal (EES: -9.6±4.5%; p=0.03; BES: -4.3±5.4%, p=0.02) and distal to the stent (EES: -3.2±9.3%; p=0.41, BES -8.6±8.0%, p<0.01). Sublingual nitroglycerin was associated with maximal vasodilatation of the peristent segments in both groups. Alike DES with durable polymer, stents with a biodegradable polymer are associated with exercise-induced paradoxical coronary vasoconstriction of the peristent segments. This data suggests that endothelial dysfunction after DES implantation is not primarily caused by the durability of the polymer coating. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  9. [Carotid stenosis: the technic for PTA and stent implantation].

    PubMed

    Thurnher, S

    2000-09-01

    Percutaneous transluminal angioplasty and stenting of carotid artery stenosis represents an innovative experimental modality which has been increasingly employed in high-risk patients. Currently, results from prospective randomized trials are not available; thus, guidelines with regard to indications and technique are preliminary. Numerous technical innovations to avoid associated complications have evolved in neurointerventional procedures. Dedicated guiding catheters and stents using a transfemoral approach have been introduced for treatment of carotid artery disease. Low-profile stent delivery systems may decrease risk of releasing embolic load when crossing high-grade stenosis or kinking of the vessel. The introduction of a cerebral protection with the use of temporary occlusion balloons or filter systems has resulted in a reduction of procedure-related neurological complications, and is strongly recommended by leading experts in the field.

  10. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage

    PubMed Central

    Hwang, Jae J.; Jeong, Yeon S.; Park, Young S.; Yoon, Hyuk; Shin, Cheol M.; Kim, Nayoung; Lee, Dong H.

    2016-01-01

    Abstract The aim of the present study was to evaluate the more effective therapy for the postsurgical gastroesophageal leakage by a head-to-head comparison of endoscopic vacuum therapy (EVT) and endoscopic stent implantation with self-expandable metal stent (E-SEMS). In this hospital-based, retrospective, observative study, the patients were classified into 2 groups. Those treated with EVT were assigned to the EVT group (n = 7), and those treated with E-SMS were assigned to the E-SEMS group (n = 11). We evaluated the clinical characteristics and treatment outcomes between the 2 groups. All 7 patients (100%) were treated with EVT, but only 7 of 11 patients (63.6%) in the stenting group were treated successfully. The median time to clinical success was 19.5 (5–21) days in the EVT group and 27.0 (3–84) days in the E-SEMS group. The median hospital stay was 37.1 (13–128) days in the EVT group and 87.3 (17–366) days in the E-SEMS group. The complicaion rate was lower in the EVT group (0/7, 0.0%) than that in the E-SEMS group (6/11, 54.5%) with statistically significant difference (P = 0.042). EVT is more effective and has fewer adverse effects than E-SMS therapy as a treatment for postsurgical gastroesophageal leakage. PMID:27100431

  11. Comparison of Endoscopic Vacuum Therapy and Endoscopic Stent Implantation With Self-Expandable Metal Stent in Treating Postsurgical Gastroesophageal Leakage.

    PubMed

    Hwang, Jae J; Jeong, Yeon S; Park, Young S; Yoon, Hyuk; Shin, Cheol M; Kim, Nayoung; Lee, Dong H

    2016-04-01

    The aim of the present study was to evaluate the more effective therapy for the postsurgical gastroesophageal leakage by a head-to-head comparison of endoscopic vacuum therapy (EVT) and endoscopic stent implantation with self-expandable metal stent (E-SEMS). In this hospital-based, retrospective, observative study, the patients were classified into 2 groups. Those treated with EVT were assigned to the EVT group (n = 7), and those treated with E-SMS were assigned to the E-SEMS group (n = 11). We evaluated the clinical characteristics and treatment outcomes between the 2 groups. All 7 patients (100%) were treated with EVT, but only 7 of 11 patients (63.6%) in the stenting group were treated successfully. The median time to clinical success was 19.5 (5-21) days in the EVT group and 27.0 (3-84) days in the E-SEMS group. The median hospital stay was 37.1 (13-128) days in the EVT group and 87.3 (17-366) days in the E-SEMS group. The complicaion rate was lower in the EVT group (0/7, 0.0%) than that in the E-SEMS group (6/11, 54.5%) with statistically significant difference (P = 0.042). EVT is more effective and has fewer adverse effects than E-SMS therapy as a treatment for postsurgical gastroesophageal leakage.

  12. 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)

  13. Clinical outcomes following stent implantation in internal mammary artery grafts.

    PubMed

    Sharma, Arvind K; McGlynn, Scott; Apple, Sue; Pinnow, Ellen; Canos, Daniel A; Gevorkian, Natalie; Tebeica, Mihaela; Gruberg, Luis; Pichard, Augusto D; Lindsay, Joseph

    2003-08-01

    We evaluated our experience with percutaneous coronary intervention (PCI) of internal mammary artery (IMA) grafts. From the institution's database we identified 288 patients with 311 IMA lesions. Of these, 82 (26.4%) had stents placed during PCI. Angiographic success was 92%. Mortality at 1 month was 1.7%, myocardial infarction (MI) 15.7%, and target lesion revascularization (TLR) 0.4%. Cumulative 1-year event rates were mortality 6.4%, MI 20.4%, and TLR 8.0%. TLR rates were significantly higher in the stented lesions than lesions treated with angioplasty alone (19.2% vs. 4.9%; P = 0.004). The higher TLR rate in stented lesions was most apparent at the anastomotic site (25.0% vs. 4.2%; P = 0.006). Percutaneous revascularization of IMA grafts can be performed safely with high procedural success and excellent short- and long-term results. Stenting, particularly at the anastomotic site, was associated with significantly greater rates of TLR than angioplasty alone.

  14. 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.

  15. Intravascular ultrasound-guided stenting of left main stem dissection after Medtronic Corevalve implantation.

    PubMed

    Van Mieghem, N M; de Jaegere, P P

    2013-08-01

    Transcatheter aortic valve implantation (TAVI) implies the introduction, positioning, and deployment of a stented bioprosthesis in the (calcified) native aortic valve. We report an at first glance uneventful TAVI with the Medtronic Corevalve System, which was followed by transient electrocardiographic changes suggesting acute left main stem disease. The diagnosis of acute left main stem dissection extending from the left coronary cusp was firmly established by intravascular ultrasound. The ostium of the left main stem was successfully treated with intravascular ultrasound-guided placement of a drug eluting stent. © 2013 Wiley Periodicals, Inc.

  16. Successful transfemoral aortic valve implantation through aortic stent graft after endovascular repair of abdominal aortic aneurysm.

    PubMed

    Kawashima, Hideyuki; Watanabe, Yusuke; Kozuma, Ken

    2017-04-01

    The patient was a 91-year-old woman presenting with severe aortic valve stenosis. Pre-procedural computed tomography scan revealed a 45-mm abdominal aortic aneurysm (AAA). Transfemoral transcatheter aortic valve implantation (TF-TAVI) was performed after endovascular aortic repair (EVAR) of the AAA. The 23-mm Edwards Sapien XT system passed through the aortic stent graft smoothly. This is the first case report showing that successful TF-TAVI can be performed through a prior abdominal aortic stent graft. TF-TAVI after EVAR of AAA is a feasible option for patients with extremely poor access.

  17. Aspirin intolerance and the need for dual antiplatelet therapy after stent implantation: a proposed alternative regimen.

    PubMed

    Latib, Azeem; Ielasi, Alfonso; Ferri, Luca; Chieffo, Alaide; Godino, Cosmo; Carlino, Mauro; Montorfano, Matteo; Colombo, Antonio

    2013-05-25

    Dual antiplatelet therapy (DAT, i.e. aspirin+thienopyridine) has been shown to reduce the risk of stent thrombosis (ST) and myocardial infarction (MI) after coronary stent implantation. Data regarding alternative antiplatelet therapy in patients with allergy or intolerance to aspirin are lacking. This study is a retrospective analysis of consecutive patients with adverse reactions to aspirin who received an alternative combination of DAT (indobufen, trapidil, or triflusal in association with a thienopyridine) after elective implantation of either drug-eluting (DES) or bare-metal stents (BMS). Endpoints analyzed were cardiac death, MI, ST and bleeding. A total of 127 patients undergoing stenting of 267 lesions (DES 84%, BMS 16%), were identified between June'99 and November'08. Reasons for not taking aspirin included gastrointestinal intolerance (53.5%), allergy (39.4%), non-gastrointestinal bleeding (5.5%) and others (1.6%). Aspirin was substituted with indobufen (64.6%), trapidil (26.8%), triflusal (6.3%), or a combination of indobufen+trapidil (2.4%). Median duration of DAT was 369 days [IQR 273-1053] after DES and 46.5 days [IQR 30-699] after BMS implantation. Only 3.1% of patients prematurely discontinued DAT. During a median follow-up of 1161 days [IQR 781-1538], rates of cardiac death and MI were 3.1% and minor bleeding occurred in 1.5%. There was 1 very late definite ST occurring 2 days after DAT discontinuation and no probable ST. In this cohort of patients with aspirin intolerance undergoing coronary stent implantation, the combination of a thienopyridine with indobufen, trapidil, or triflusal was associated with a low rate of cardiac death, ST and MI. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  18. Short- and long-term clinical outcome after various stent implantation: overview of the results of uni- and multicenter stent registries.

    PubMed

    Gyöngyösi, Mariann; Khorsand, Aliashgar; Sperker, Wolfgang; Strehblow, Christoph; Wexberg, Paul; Probst, Peter; Siostrzonek, Peter; Lang, Irene; Sochor, Heinz; Glogar, Dietmar

    2004-07-01

    The present study reports the results of the short- and long-term outcomes of prospective uni- and multicenter stent registries: Palmaz-Schatz (n = 140 patients), Ave-Micro and GFX (n = 280), Multilink Duet (n = 340), Multilink Tetra (n = 192), and Carbo (n = 140) Stent Registries, as well as the predictors and angiographic cutoff points predicting major adverse cardiac events (MACE) after different stent implantations. Significant decrease in subacute stent thrombosis (from 2.9% to 0) and MACE (from 35% to 8.3%) occurred as the improved stents, optimized stent implantation technique, and new postintervention drug therapy were introduced. The changes of angiographic cutoff values (postintervention minimal lumen diameter and preintervention reference diameter: from 2.9 and 3.1 mm for Palmaz-Schatz to 2.5 and 2.8 mm for Multilink Duet, Multilink Tetra, and Carbo stents) and clinical and angiographic factors predicting MACE indicated the change of traditional restenosis paradigm and that progress in clinical practice might be able to counterbalance unfavorable lesion and intervention-related characteristics. Copyright 2004 Wiley-Liss, Inc.

  19. 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

  20. 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

  1. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.

    PubMed

    Unverdorben, Martin; Vallbracht, Christian; Cremers, Bodo; Heuer, Hubertus; Hengstenberg, Christian; Maikowski, Christian; Werner, Gerald S; Antoni, Diethmar; Kleber, Franz X; Bocksch, Wolfgang; Leschke, Matthias; Ackermann, Hanns; Boxberger, Michael; Speck, Ulrich; Degenhardt, Ralf; Scheller, Bruno

    2015-12-01

    Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented. One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period. The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).

  2. Management of Biliary Neoplastic Obstruction with Two Different Metallic Stents Implanted in One Session

    SciTech Connect

    Gandini, Roberto; Fabiano, S. Pipitone, Vincenzo; Spinelli, Alessio; Reale, Carlo Andrea; Colangelo, Vittorio; Pampana, Enrico; Romagnoli, Andrea; Simonetti, Giovanni

    2005-01-15

    The efficacy of the 'one-step' technique using two different metallic stents (Wallstent and Ultraflex) and associated rate of complications was studied in 87 patients with jaundice secondary to malignant biliary obstruction, with bilirubin level less than 15 mg/dl and Bismuth type 1 or 2 strictures. The study group, composed of 40 men and 47 women with a mean age of 59.4 years (range 37-81 years), was treated with a 'one-step' percutaneous transhepatic implantation of self-expanding stents. The cause of the obstruction was pancreatic carcinoma in 38 patients (44%), lymph node metastasis in 20 patients (23%), gallbladder carcinoma in 13 patients (15%), cholangiocarcinoma in 12 patients (14%) and ampullary carcinoma in four patients (5%). A significant reduction in jaundice was obtained in all but one patient, with a drop of total serum bilirubin level from a mean of 13.7 mg/dl to 4.3 mg/dl within the first 4 days. The mean postprocedural hospitalization period was 5.4 days in the Wallstent group and 6.4 days in the Ultraflex group. Mean survival rate was 7.8 months (Wallstent group) and 7.1 months (Ultraflex group). The use of both stents did not reveal any significant difference in parameters tested. The implantation of these self-expandable stents in one session, in selected patients, is clinically effective, devoid of important complications and cost-effective due to the reduction in hospitalization.

  3. Use of rapid prototyping models in the planning of percutaneous pulmonary valved stent implantation.

    PubMed

    Armillotta, A; Bonhoeffer, P; Dubini, G; Ferragina, S; Migliavacca, F; Sala, G; Schievano, S

    2007-05-01

    Percutaneous replacement of the pulmonary valve is a recently developed interventional technique which involves the implantation of a valved stent in the pulmonary trunk. It relies upon careful consideration of patient anatomy for both stent design and detailed procedure planning. Medical imaging data in the form of two-dimensional scans and three-dimensional interactive graphics offer only limited support for these tasks. The paper reports the results of an experimental investigation on the use of arterial models built by rapid prototyping techniques. An analysis of clinical needs has helped to specify proper requirements for such model properties as cost, strength, accuracy, elastic compliance, and optical transparency. Two different process chains, based on the fused deposition modelling technique and on the vacuum casting of thermoset resins in rubber moulds, have been tested for prototype fabrication. The use of anatomical models has allowed the cardiologist's confidence in patient selection, prosthesis fabrication, and final implantation to be significantly improved.

  4. Experimental study of laminar blood flow through an artery treated by a stent implantation: characterisation of intra-stent wall shear stress.

    PubMed

    Benard, Nicolas; Coisne, Damien; Donal, Erwan; Perrault, Robert

    2003-07-01

    The stimulation of endothelial cells by arterial wall shear stress (WSS) plays a central role in restenosis. The fluid-structure interaction between stent wire and blood flow alters the WSS, particularly between stent struts. We have designed an in vitro model of struts of an intra-vascular prosthesis to study blood flow through a 'stented' section. The experimental artery consisted of a transparent square section test vein, which reproduced the strut design (100x magnifying power). A programmable pump was used to maintain a steady blood flow. Particle image velocimetry method was used to measure the flow between and over the stent branches, and to quantify WSS. Several prosthesis patterns that were representative of the total stent strut geometry were studied in a greater detail. We obtained WSS values of between -1.5 and 1.5Pa in a weak SS area which provided a source of endothelial stimulation propitious to restenosis. We also compared two similar patterns located in two different flow areas (one at the entry of the stent and one further downstream). We only detected a slight difference between the weakest SS levels at these two sites. As the endothelial proliferation is greatly influenced by the SS, knowledge of the SS modification induced by the stent implantation could be of importance for intra-vascular prostheses design optimisation and thus can help to reduce the restenosis incidence rate.

  5. 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.

  6. Stent Implantation for Superior Vena Cava Syndrome of Malignant Cause.

    PubMed

    Büstgens, Felix A; Loose, Reinhard; Ficker, Joachim H; Wucherer, Michael; Uder, Michael; Adamus, Ralf

    2017-02-02

    Purpose The purpose of this paper is the retrospective analysis of endovascular therapy for the treatment of superior vena cava syndrome (SVCS) of malignant cause. This study focuses on the effectiveness of the therapy regarding the duration of remission, symptom control and practicability. Materials and Methods From January 2003 to November 2012, therapeutic implantation of one or more stents was performed in 141 patients suffering from SVCS. The medical history was retrospectively researched using digitalized patient files. If those were incomplete, secondary research was conducted using the cancer registry of the General Hospital Nuremberg, the cancer registry of the tumor center at Friedrich-Alexander-University Erlangen-Nuremberg (FAU) or information given by physicians in private practice. This data was collected using Microsoft Office Excel(®) and statistically analyzed using IBM SPSS Statistics 22(®). Results 168 stents were implanted in 141 patients (median age: 64.6 years; range: 36 - 84), 86 being male and 55 being female. In 121 patients, SVCS was caused by lung cancer (85.8 %), in 9 patients by mediastinal metastasis of an extrathoracic carcinoma (6.4 %), in 3 patients by mesothelioma of the pleura (2.1 %) and in 1 patient by Hodgkin's disease (0.7 %). There was no histological diagnosis in 7 cases (4.9 %). The primary intervention was successful in 138 patients (97.9 %). Immediate thrombosis in the stent occurred in the remaining 3 cases. Recurrence of SVCS was observed in 22 patients (15.6 %), including 5 early and 17 late occlusions. Stent dislocation or breakage was not observed. As expected, the survival after implantation was poor. The median survival was 101 days, and the median occlusion-free survival was 80 days. Conclusion The symptomatic therapy of SVCS with endovascular stents is effective and safe. Despite effective symptom control and a low rate of recurrence, the patients' prognosis is poor. Key Points

  7. Clinical Study on Using (125)I Seeds Articles Combined with Biliary Stent Implantation in the Treatment of Malignant Obstructive Jaundice.

    PubMed

    Wang, Tao; Liu, Sheng; Zheng, Yan-Bo; Song, Xue-Peng; Sun, Bo-Lin; Jiang, Wen-Jin; Wang, Li-Gang

    2017-08-01

    Aim: To study the feasibility and curative effect of(125)I seeds articles combined with biliary stent implantation in the treatment of malignant obstructive jaundice. Patients and Methods: Fifty patients with malignant obstructive jaundice were included. Twenty-four were treated by biliary stent implantation combined with intraluminal brachytherapy by (125)I seeds articles as the experimental group, while the remaining 26 were treated by biliary stent implantation only as the control group. The goal of this study was to evaluate total bilirubin, direct bilirubin and tumor markers (cancer antigen (CA)-199, CA-242 and carcinoembryonic antigen (CEA)), as well as biliary stent patency status and survival time before and after surgery. Results: Jaundice improved greatly in both groups. The decreases of CA-199 and CA-242 had statistical significance (p=0.003 and p=0.004) in the experimental group. The ratio of biliary stent patency was 83.3% (20/24) in the experimental group and 57.7% (15/26) in the control group (p=0.048). The biliary stent patency time in the experimental group was 1~15.5 (mean=9.84) months. The biliary stent patency time in the control group was 0.8~9 (mean=5.57) months, which was statistically significant (p=0.018). The median survival time was 10.2 months in the experimental group, while 5.4 months in control group (p<0.05). Conclusion:(125)I seeds articles combined with biliary stent implantation significantly prolongs biliary stent patency time and survival time for patients with malignant obstructive jaundice possibly by inhibiting the proliferation of vascular endothelial cells and the growth of tumor. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  8. Accuracy of a cone beam computed tomography-guided surgical stent for orthodontic mini-implant placement.

    PubMed

    Yu, Jae-Jung; Kim, Gyu-Tae; Choi, Yong-Suk; Hwang, Eui-Hwan; Paek, Janghyun; Kim, Seong-Hun; Huang, John C

    2012-03-01

    To validate the accuracy of a cone-beam computed tomography (CBCT)-guided surgical stent for orthodontic mini-implant (OMI) placement by quantitatively evaluating the difference between CBCT-prescribed and actual position of mini-implants in preoperative and postoperative CBCT images. A surgical stent was fabricated using Teflon-Perfluoroalkoxy, which has appropriate biological x-ray attenuation properties. Polyvinylsiloxane impression material was used to secure the custom-made surgical stent onto swine mandibles. CBCT scanning was done with the stent in place to virtually plan mini-implants using a three-dimensional (3D) software program. An appropriate insertion point was determined using 3D reconstruction data, and the vertical and horizontal angulations were determined using four prescribed angles. A custom-designed surveyor was used to drill a guide hole within the surgical stent as prescribed on the CBCT images for insertion of 32 OMIs. The mandibles with a surgical stent in place were rescanned with CBCT to measure the deviations between the virtual planning data and surgical results. The difference between the prescribed and actual vertical angle was 1.01 ± 7.25, and the horizontal difference was 1.16 ± 6.08. The correlation coefficient confirms that there was no intrarater variability in either the horizontal (R  =  .97) or vertical (R  =  .74) vectors. The surgical stent in this study guides mini-implants to the prescribed position as planned in CBCT. Since the statistical difference was not significant, the surgical stent can be considered to be an accurate guide tool for mini-implant placement in clinical use.

  9. Impact of early versus late clopidogrel discontinuation on stent thrombosis following percutaneous coronary intervention with first- and second-generation drug-eluting stents.

    PubMed

    Loh, Joshua P; Torguson, Rebecca; Pendyala, Lakshmana K; Omar, Alfazir; Chen, Fang; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2014-06-15

    Premature antiplatelet therapy discontinuation (ATD) after drug-eluting stent (DES) implantation is known to predict stent thrombosis (ST). However, recent data suggest that a shorter antiplatelet therapy duration is safe with newer generation DESs. The study aimed to compare the impact of early and late clopidogrel ATDs on ST in a real-world registry of first- and second-generation DES use. A total of 6,236 patients who underwent DES implantation were analyzed retrospectively: 4,217 received first-generation DESs (sirolimus- and paclitaxel-eluting stents) and 2,019 received second-generation DESs (everolimus-eluting stents). Within each DES cohort, patients were categorized into timing of clopidogrel discontinuation within 1 year: early (<3 months), late (3 to 12 months), and continued. ST rates and clinical outcomes at 1 year were analyzed. There were 341 patients (8.1%) in the first-generation DES group and 126 patients (6.2%) in the second-generation DES group who discontinued clopidogrel within the first year. Definite and probable ST rates were 3.8% for early ATD, 2.5% for late ATD, and 0.5% for continued (p = 0.001) in the first-generation DES cohort, whereas there were no definite or probable ST events in early and late ATDs and 0.5% for continued in the second-generation DES cohort. Major adverse cardiac event rates were 9.9% for early ATD, 5.6% for late ATD, and 0.9% for continued (p <0.001) in the first-generation DES cohort and 5.5% for early ATD, 7.4% for late ATD, and 1.5% for continued (p <0.001) in the second-generation DES cohort. In conclusion, ATD within the first year is associated with increased ST events with first-generation DESs, whereas ATD appears safe with second-generation DESs with regard to ST. However, ATD is associated with greater mortality and major adverse cardiac events in both first- and second-generation DESs. Thus, this study supports ATD if required based on physician discretion with the use of second-generation DESs but

  10. Early restenosis following biodegradable stent implantation in an aortopulmonary collateral of a patient with pulmonary atresia and hypoplastic pulmonary arteries.

    PubMed

    McMahon, Colin J; Oslizlok, Paul; Walsh, Kevin P

    2007-04-01

    Traditionally, the implantation of stents in young children with small blood vessels has been avoided as the presence of a metallic or fixed stent structure limits the ability to further dilate the stent with vessel growth. Pulmonary atresia with ventricular septal defect and hypoplastic pulmonary arteries represents one such cohort where the placement of fixed nondegradable stents has been difficult. We report a 2-month-old girl with pulmonary atresia, VSD, and multiple aorto-pulmonary collaterals with severely hypoplastic pulmonary arteries who underwent placement of a biodegradable magnesium stent within a stenotic aorto-pulmonary collateral. Although there was an initial significant increase in vessel diameter, significant restenosis occurred 4 months after stent placement. This to our knowledge represents the first case of the use of biodegradable stents in a child with severely hypoplastic pulmonary arteries. Although further refinements in stent technology are required, this development will hopefully usher in a new era of potential intervention in children previously deemed unsuitable for stent placement.

  11. Modelling chemistry and biology after implantation of a drug-eluting stent. Part I: Drug transport.

    PubMed

    Vo, Tuoi; Lee, William; Peddle, Adam; Meere, Martin

    2017-04-01

    Drug-eluting stents have been used widely to prevent restenosis of arteries following percutaneous balloon angioplasty. Mathematical modelling plays an important role in optimising the design of these stents to maximise their efficiency. When designing a drug-eluting stent system, we expect to have a sufficient amount of drug being released into the artery wall for a sufficient period to prevent restenosis. In this paper, a simple model is considered to provide an elementary description of drug release into artery tissue from an implanted stent. From the model, we identified a parameter regime to optimise the system when preparing the polymer coating. The model provides some useful order of magnitude estimates for the key quantities of interest. From the model, we can identify the time scales over which the drug traverses the artery wall and empties from the polymer coating, as well as obtain approximate formulae for the total amount of drug in the artery tissue and the fraction of drug that has released from the polymer. The model was evaluated by comparing to in-vivo experimental data and good agreement was found.

  12. Dopplersonographic analysis of the flow field in femoral arteries with stent implants

    NASA Astrophysics Data System (ADS)

    Verius, Michael; Huttary, Ralf; Recheis, Wolfgang; zur Nedden, Dieter

    2004-04-01

    This study investigates the instationary flow field in human femoarl arteries. The flow fiel is measured before and after the implantaion of five different metal stent implants in elastic and scaled silicone models of femoral arteries. The pulsating flow field is investigated under physiological conditions within the silicone vessel. For the simulation of the physilogical hemodynamics a computer controlled pump for the reproducible generation of flow patterns and a fluid with flow properties similar to human blood is used. At significant positions distal, proximal and inside the stent dopplersonographic measurements are performed with stationary and pulsatile flow. Via fast fourier analysis the sampled doppler audio signal, gained from the ultrasound stereo output, is converted into velocity profiles and displayed as color coded 3D spectrograms. By subtracting the spectra of the unstented model of the stented models differential spectra are obtained and compared. These differential spectra are used for a semiquantitative analysis of the flow field change caused by stents and are easy to interpret for the examining physician.

  13. Establishing a rabbit model of malignant esophagostenosis using the endoscopic implantation technique for studies on stent innovation

    PubMed Central

    2014-01-01

    Background Stents are recommended in patients with dysphagia caused by esophageal stricture, but an ideal stent does not currently exist. Thus, studies on new esophageal stents are necessary, and suitable animal models are desperately needed for these studies. The aim of this study was to establish a model of malignant esophageal stricture in rabbit for studies on stent innovation. Methods A total of 38 New Zealand white rabbits were used in this study. Using the endoscopic submucosal injection technique, VX2 fragments were inoculated into the submucosal layer of the rabbit thoracic esophagus, and an endoscopic follow-up was subsequently performed to observe the tumor development and progression. The self-expandable metal stents were randomly deployed in rabbits with severe esophageal stricture to investigate the safety and feasibility of the animal models for stenting. Results An endoscopic implantation procedure for VX2 tumors was completed in 34/38 rabbits, and tumor development was confirmed in 30/34 animals. The success rate of the endoscopic implantation and tumor development were 89.4% (95% CI, 79.6% to 99.2%) and 88.2% (95% CI, 76.9% to 99.5%) respectively. During the endoscopic follow-up period, severe esophageal stricture occurred in 22/30 rabbits with a rate of 73.3% (95% CI, 57.5% to 89.1%), and 12/22 models received stent placement. During and after stent implantation, no severe stent-related complication or mortality occurred in the animal models. The rabbits that received stent placement survived longer than those without stent implantation (the mean survival time: 53.9 days versus 40.3 days, P = 0.016). Conclusion The endoscopic method is a safe and effective method for establishing a malignant esophagostenosis model in rabbits. This model can simulate the human body environment for stent deployment and is an excellent tool for the study of stent innovation for the treatment of esophageal cancer. PMID:24507720

  14. In-vitro study on the accuracy of a simple-design CT-guided stent for dental implants

    PubMed Central

    Huh, Young-June; Choi, Bo-Ram; Huh, Kyung-Hoe; Yi, Won-Jin; Heo, Min-Suk; Lee, Sam-Sun

    2012-01-01

    Purpose An individual surgical stent fabricated from computed tomography (CT) data, called a CT-guided stent, would be useful for accurate installation of implants. The purpose of the present study was to introduce a newly developed CT-guided stent with a simple design and evaluate the accuracy of the stent placement. Materials and Methods A resin template was fabricated from a hog mandible and a specially designed plastic plate, with 4 metal balls inserted in it for radiographic recognition, was attached to the occlusal surface of the template. With the surgical stent applied, CT images were taken, and virtual implants were placed using software. The spatial positions of the virtually positioned implants were acquired and implant guiding holes were drilled into the surgical stent using a specially designed 5-axis drilling machine. The surgical stent was placed on the mandible and CT images were taken again. The discrepancy between the central axis of the drilled holes on the second CT images and the virtually installed implants on the first CT images was evaluated. Results The deviation of the entry point and angulation of the central axis in the reference plane were 0.47±0.27 mm, 0.57±0.23 mm, and 0.64±0.16°, 0.57±0.15°, respectively. However, for the two different angulations in each group, the 20° angulation showed a greater error in the deviation of the entry point than did the 10° angulation. Conclusion The CT-guided template proposed in this study was highly accurate. It could replace existing implant guide systems to reduce costs and effort. PMID:23071963

  15. 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

  16. Stent valve implantation in conventional redo aortic valve surgery to prevent patient-prosthesis mismatch.

    PubMed

    Ferrari, Enrico; Franciosi, Giorgio; Clivio, Sara; Faletra, Francesco; Moccetti, Marco; Moccetti, Tiziano; Pedrazzini, Giovanni; Demertzis, Stefanos

    2017-03-01

    The goal was to show the technical details, feasibility and clinical results of balloon-expandable stent valve implantation in the aortic position during conventional redo open-heart surgery in selected obese patients with a small aortic prosthesis and severe patient-prosthesis mismatch. Two symptomatic overweight patients (body mass index of 31 and 38), each with a small aortic prosthesis (a 4-year-old, 21-mm Hancock II biological valve and a 29-year-old, 23-mm Duromedic mechanical valve), increased transvalvular gradients (59/31 and 74/44 mmHg) and a reduced indexed effective orifice area (0.50 and 0.43 cm 2 /m 2 ) underwent implantation of two 26-mm balloon-expandable Sapien 3 valves during standard on-pump redo valve surgery. Using full re-sternotomy, cardiopulmonary bypass and cardioplegic arrest, the two balloon-expandable stent valves were implanted under direct view using a standard aortotomy, after prosthesis removal and without annulus enlargement. Aortic cross-clamp times were 162 and 126 min; cardiopulmonary bypass times were 178 and 180 min; total surgical times were 360 and 318 min. At discharge, echocardiograms showed transvalvular peak and mean gradients of 13/9 and 23/13 mmHg and indexed effective orifice areas of 0.64 and 1.08 cm 2 /m 2 . The 3-month echocardiographic follow-up showed transvalvular peak and mean gradients of 18/9 and 19/11 mmHg and indexed effective orifice areas of 0.78 cm 2 /m 2 and 0.84 cm 2 /m 2 , with improved symptoms (New York Heart Association class 1). Implantation of a balloon-expandable stent valve during redo aortic valve surgery is feasible in selected cases and prevents patient-prosthesis mismatch in obese patients without need for aortic annulus enlargement. Moreover, in the case of stent valve degeneration, this approach permits additional valve-in-valve procedures with large stent valves and prevents re-redo surgery.

  17. Accelerated Recovery of Endothelium Function after Stent Implantation with the Use of a Novel Systemic Nanoparticle Curcumin

    PubMed Central

    Lu, Qi; Ye, Fang; Yang, Xiangjun; Gu, Qingqing; Wang, Peng; Zhu, Jianhua; Shen, Li; Gong, Feirong

    2015-01-01

    Curcumin was reported to exhibit a wide range of pharmacological effects including antioxidant, anti-inflammatory, and antiproliferative activities and significantly prevent smooth muscle cells migration. In the present study, a novel kind of curcumin loaded nanoparticles (Cur-NP) has been prepared and characterized with the aim of inhibiting inflammation formation and accelerating the healing process of the stented arteries. Cur-NP was administrated intravenously after stent implantation twice a week and detailed tissue responses were evaluated. The results demonstrated that intravenous administration of Cur-NP after stent implantation accelerated endothelial cells restoration and endothelium function recovery and may potentially be an effective therapeutic alternative to reduce adverse events for currently available drug eluting stents. PMID:26167481

  18. Transhepatic implant of a trimmed Melody™ valved stent in tricuspid position in a 1-year-old infant.

    PubMed

    Cools, Bjorn; Rega, Filip; Gewillig, Marc

    2017-02-15

    Percutaneous valved stent implantation is precluded in small infants because large delivery sheaths and large devices. We describe a procedure in a 1-year-old boy in whom a 19 mm Epic™ valve in tricuspid position had become dysfunctional. As the internal diameter of the prosthetic valve was about 16 mm, the only available valve was the Melody™ valved stent. Technical modifications were required to address issues like venous access, the bulky delivery system, and the length of the valved stent. The Melody™ valved stent was surgically trimmed and mounted on a 16 mm Tyshak balloon, access was provided transhepatically through a short 18 Fr sheath. After deployment, the intrahepatic route was sealed with two vascular plugs (8 and 10 mm) in tandem. The procedure was uncomplicated with perfect valve function 18 months after implant. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  19. Comparison of complete versus incomplete stent frame expansion after transcatheter aortic valve implantation with Medtronic CoreValve bioprosthesis.

    PubMed

    Jilaihawi, Hasan; Chin, Derek; Spyt, Tomasz; Jeilan, Mohamed; Vasa-Nicotera, Mariuca; Mohamed, Noor; Bence, Johan; Logtens, Elaine; Kovac, Jan

    2011-06-15

    We sought to determine the significance of incomplete stent frame expansion after transcatheter aortic valve implantation with the Medtronic-CoreValve device. Incomplete coronary stent expansion is a well-described phenomenon. Transcatheter valves are mounted on stents; however, the incidence of incomplete stent expansion after transcatheter aortic valve implantation, its sequelae and predictors are poorly elucidated. The 18Fr CoreValve revalving system was used to treat anatomically and clinically suitable patients with severe calcific aortic stenosis. The postdeployment stent dimensions were measured on fluoroscopic images at multiple levels of the stent frame. Incomplete expansion at each was defined as <100% expected and complete expansion as ≥100%. These parameters were correlated to the hemodynamic and clinical end points. A total of 50 consecutive patients underwent transcatheter aortic valve implantation with the Medtronic-CoreValve at a single center from January 2007 to December 2008. For the inflow portion, incomplete expansion was seen in 54% of patients and was unrelated to the aortic valve area, peak or mean aortic valve gradients, or measures of aortic regurgitation, although it was paradoxically associated with a lower incidence of prosthesis-patient mismatch. Incomplete expansion of the constrained portion was seen in 62% of the patients and displayed a trend toward a greater incidence of aortic regurgitation grade 2 or greater, although this was rare. Incomplete expansion of the Medtronic CoreValve stent frame is common. For the most part, valvular hemodynamic function was satisfactory, regardless of the degree of expansion of the stent frame that carries it and a strategy of reluctant postdilation in the context of incomplete stent frame expansion was supported. Copyright © 2011 Elsevier Inc. All rights reserved.

  20. Impending rupture of saphenous vein graft aneurysm with floating fractured bare metal stent treated by coil embolization and covered stent implantation.

    PubMed

    Kodama, Atsuko; Kurita, Tairo; Kato, Osamu; Suzuki, Takahiko

    2016-11-01

    Aneurysmal degeneration of a saphenous vein graft (SVG) is a rare, but potentially fatal complication of coronary artery bypass graft (CABG) surgery. In this case report, a patient that had undergone prior CABG surgery and bare metal stent (BMS) implantation at the site of a stenotic SVG lesion presented at our hospital with chest pain, and an SVG aneurysm was detected at the previous BMS implantation site. In addition, the implanted BMS was fractured and floating in the SVG aneurysm. The SVG aneurysm was successfully occluded by percutaneous intervention, using a combination of distal covered stent deployment at the site of the anastomosis between the native coronary artery and the SVG and proximal coil embolization of the aneurysm.

  1. 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.

  2. 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.

  3. Serial clinical and angiographic follow-up after phosphorylcholine-coated stent implantation.

    PubMed

    Habara, Seiji; Mitsudo, Kazuaki; Kadota, Kazushige; Goto, Tsuyoshi; Fujii, Satoki; Yamamoto, Hiroyuki; Katoh, Harumi; Oka, Naoki; Fuku, Yasushi; Hosogi, Shingo; Hirono, Akitoshi; Maruo, Takeshi; Tanaka, Hiroyuki; Shigemoto, Yoshikazu; Hasegawa, Daiji; Tasaka, Hiroshi; Kusunose, Mana; Otsuru, Suguru; Okamoto, Yoji; Saito, Naoki; Tsujimoto, Yuki

    2011-01-01

    The efficacy of drug-eluting stents (DES) has been proven, but concerns about late complications after DES have been raised. Polymers that do not increase inflammatory or hypersensitivity reactions which may contribute to late complications are needed for new generation DES. To evaluate the safety and efficacy of phosphorylcholine-polymer coating, we investigated serial clinical and angiographic outcomes after phosphorylcholine-coated stent placement. Seventy-five consecutive patients treated with a BiodivYsio phosphorylcholine-coated stent for de novo lesions at our institute between October 2001 and August 2002 were enrolled. Six-month follow-up angiography was performed in 71 lesions (94.7%), and angiographic restenosis was found in 19 lesions (26.8%). Target lesion revascularization (TLR) was performed in 10 lesions (14.1%). Eighteen-month follow-up angiography was performed in 58 (95.1%) of the remaining 61 lesions (excluding TLR lesions), and angiographic restenosis was found in only 3 lesions. The cumulative MACE-free survival rate was 86.3%, 83.6%, and 78.6% at 6-month, 18-month, and 8-year follow-up, respectively. There were no episodes of stent thrombosis. Late loss decreased significantly from 0.74 ± 0.40 mm (6-months) to 0.51 ± 0.46 mm (18-months) (P < 0.0001). Phosphorylcholine-coated stent implantation was associated with acceptable clinical and angiographic results. Phosphorylcholine-coating may be an ideal polymer for new generation DESs.

  4. Defining a new standard for IVUS optimized drug eluting stent implantation: the PRAVIO study.

    PubMed

    Gerber, R T; Latib, A; Ielasi, A; Cosgrave, J; Qasim, A; Airoldi, F; Chieffo, A; Montorfano, M; Carlino, M; Michev, I; Tobis, J; Colombo, A

    2009-08-01

    Preliminary Investigation to the Angiographic Versus IVUS Optimization Trial is a single center prospective observational intravascular ultrasound (IVUS) guided stent implantation study assessing new criteria for optimal drug eluting stent (DES) deployment. IVUS assessment of DES often reveals underexpansion and malapposition. Optimal stent deployment is currently poorly defined and previous criteria may not be suitable in long and complex lesions. Optimization was defined as achieving >/or 70% of the cross-sectional area (CSA) of the postdilation balloon. This criterion was applied in 113 complex lesions. The size of this balloon was calculated according to vessel media-to-media diameters at various sites inside the stented segment. The IVUS guided treated lesions were matched according to diabetes, vessel type, reference vessel diameter, minimum lumen diameter (MLD), and lesion length with a group of angiographic treated lesions to compare final MLD achieved. Mean minimum stent CSA according to the postdilation balloon utilized was 4.62 mm(2), 6.26 mm(2), 7.87 mm(2), and 9.87 mm(2) for 2.5 mm, 3.0 mm, 3.5 mm, and 4 mm balloons, respectively. Final MLD (mm) was significantly larger in the IVUS compared to the angiographic-guided group (3.09 +/- 0.50 vs. 2.67 +/- 0.54; P < 0.0001). There were no procedural complications related to IVUS use. We propose new IVUS criteria based on vessel remodeling that results in an increment in the final MLD, compared to angiographic guidance, which is much larger than any previously published study. This criterion seems to be safely achievable. A proposed randomized study (angiographic vs. IVUS optimization trial) has been launched to test these concepts. (c) 2008 Wiley-Liss, Inc.

  5. First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby.

    PubMed

    Zartner, Peter; Cesnjevar, Robert; Singer, Helmut; Weyand, Michael

    2005-12-01

    Stent implantation in the youngest patients with a congenital heart disease implicates limitations concerning further vessel growth, the need of staged redilation, and later surgical removal. The search to overcome these restrictions led to open stent designs, with a wide adaptability to the vessel growth and recently to the development of bioabsorbable stent materials. A preterm baby born at 26 weeks of gestation was referred to our clinic following inadvertent ligation of the left pulmonary artery. Despite efficient debanding, the left lung perfusion was absent. Implantation of a biodegradable 3 mm magnesium stent was performed in a hybrid procedure when the baby weighed 1.7 kg. Reperfusion of the left lung was established and persisted throughout the 4-month follow-up period during which the gradual degradation process of the stent completed. Additional interventions, should they become necessary, seem not to be limited. Despite the small size of the baby, the degradation process was clinically well tolerated. The mechanical and degradation characteristics of the magnesium stent proved to be adequate to secure reperfusion of the previously occluded left pulmonary artery. Bioabsorbable stents with different diameters may help develop new strategies in the therapy of vessel stenosis in pediatric patients.

  6. 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.

  7. Endothelial cell repopulation after stenting determines in-stent neointima formation: effects of bare-metal vs. drug-eluting stents and genetic endothelial cell modification

    PubMed Central

    Douglas, Gillian; Van Kampen, Erik; Hale, Ashley B.; McNeill, Eileen; Patel, Jyoti; Crabtree, Mark J.; Ali, Ziad; Hoerr, Robert A.; Alp, Nicholas J.; Channon, Keith M.

    2013-01-01

    Aims Understanding endothelial cell repopulation post-stenting and how this modulates in-stent restenosis is critical to improving arterial healing post-stenting. We used a novel murine stent model to investigate endothelial cell repopulation post-stenting, comparing the response of drug-eluting stents with a primary genetic modification to improve endothelial cell function. Methods and results Endothelial cell repopulation was assessed en face in stented arteries in ApoE−/− mice with endothelial-specific LacZ expression. Stent deployment resulted in near-complete denudation of endothelium, but was followed by endothelial cell repopulation, by cells originating from both bone marrow-derived endothelial progenitor cells and from the adjacent vasculature. Paclitaxel-eluting stents reduced neointima formation (0.423 ± 0.065 vs. 0.240 ± 0.040 mm2, P = 0.038), but decreased endothelial cell repopulation (238 ± 17 vs. 154 ± 22 nuclei/mm2, P = 0.018), despite complete strut coverage. To test the effects of selectively improving endothelial cell function, we used transgenic mice with endothelial-specific overexpression of GTP-cyclohydrolase 1 (GCH-Tg) as a model of enhanced endothelial cell function and increased NO production. GCH-Tg ApoE−/− mice had less neointima formation compared with ApoE−/− littermates (0.52 ± 0.08 vs. 0.26 ± 0.09 mm2, P = 0.039). In contrast to paclitaxel-eluting stents, reduced neointima formation in GCH-Tg mice was accompanied by increased endothelial cell coverage (156 ± 17 vs. 209 ± 23 nuclei/mm2, P = 0.043). Conclusion Drug-eluting stents reduce not only neointima formation but also endothelial cell repopulation, independent of strut coverage. In contrast, selective targeting of endothelial cell function is sufficient to improve endothelial cell repopulation and reduce neointima formation. Targeting endothelial cell function is a rational therapeutic strategy to improve vascular healing and decrease neointima formation

  8. Mode of deployment of coronary Palmaz-Schatz stents after implantation with the stent delivery system: an intravascular ultrasound study.

    PubMed

    Kiemeneij, F; Laarman, G; Slagboom, T

    1995-04-01

    The stent delivery system (SDS) is a sheath-covered Palmaz-Schatz stent mounted on a 3.0, 3.5, or 4.0 mm compliant polyethylene balloon catheter; the balloon resists maximal inflation pressures of 5.7, 6.2, or 6.0 atm, respectively. It is postulated that these pressures are too low to obtain optimal stent deployment. Because optimal stent deployment is a prerequisite for optimal short- and long-term outcome, we performed an intravascular ultrasound study to the mode of stent deployment after delivery with the SDS and after high-pressure dilatations with low-compliant, oversized balloon catheters. In 23 patients an intravascular ultrasound study (30 MHz, 4.3F transducer) was performed to the geometry of 29 stents immediately after delivery with the SDS and after successive high-pressure inflations with low-compliant balloons. After delivery with the SDS (3.3 +/- 0.4 mm), stent diameter was 3.0 +/- 0.4 mm. After high-pressure dilatations (12.4 +/- 1.4 atm) with low-compliant balloons (3.9 +/- 0.5 mm), stent diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Only 8 (28%) stents were completely and symmetrically expanded to the corresponding reference diameter with good apposition after delivery with the SDS. Diameter of incomplete deployed stents (n = 16) was 2.8 +/- 0.3 mm. After high-pressure dilatations with low-compliant balloons (3.9 +/- 0.5 mm), diameter increased to 3.4 +/- 0.4 mm (p < 0.001). Now 20 (69%) stents (p = 0.004) became completely and symmetrically expanded to a diameter corresponding to the reference diameter. In conclusion, most stents are suboptimally deployed after delivery with the stent delivery system.(ABSTRACT TRUNCATED AT 250 WORDS)

  9. [Migration of a stent implanted in the pulmonary artery of a patient with tetralogy of Fallot].

    PubMed

    Palomero Rodríguez, M A; Gabaldón Rivilla, M; Cabestrero Alonso, D; Gonzalez Cibrián, C; Abelleira Pardeiro, C; Centella Hernánez, T; Collado Gutierrez, R; Asuero de Lis, M S; Gómez González, R

    2014-05-01

    Tetralogy of Fallot is a congenital heart disease that accounts for 11-13% of the congenital cardiomyopathies. Stenosis and hyperplasia of the pulmonary arteries occur in a high proportion of them as this disease causes a native stenosis of the pulmonary branch, which can be surgically repaired with a stent. The use of balloon expandable intravascular stents is an alternative technique to further surgery in patients with congenital heart diseases. However, despite the gradual increase in their use, the limited number of procedures, combined with the wide anatomical variability and different characteristics of these patients, even in expert hands, stent implants are associated with a not inconsiderable incidence of complications. These are not always obvious and often require performing surgery in patients who have already had multiple interventions, thus increasing the complexity and the risk. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

  10. 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.

  11. Bridge therapy or standard treatment for urgent surgery after coronary stent implantation: Analysis of 314 patients.

    PubMed

    De Servi, Stefano; Morici, Nuccia; Boschetti, Enrico; Rossini, Roberta; Martina, Paola; Musumeci, Giuseppe; D'Urbano, Maurizio; Lazzari, Ludovico; La Vecchia, Carlo; Senni, Michele; Klugmann, Silvio; Savonitto, Stefano

    2016-05-01

    Intravenous administration of a short acting glycoprotein IIb/IIIa inhibitor has been proposed as a bridge to surgery in patients on dual antiplatelet treatment, but data in comparison with other treatment options are not available. We conducted a retrospective analysis of consecutive patients who underwent un-deferrable, non-emergency surgery after coronary stenting. The bridge therapy was performed after discontinuation of the oral P2Y12 inhibitor by using i.v. tirofiban infusion. Net Adverse Clinical Events (NACE) was the primary outcome. We analyzed 314 consecutive patients: the bridge strategy was performed in 87 patients, whereas 227 were treated with other treatment options and represent the control group. Thirty-day NACE occurred in 8% of patients in the bridge group and in 22.5% in the control group (p < 0.01). Bridge therapy was associated with decreased 30-day NACE rate [Odds ratio (OR) 0.30; 95% confidence interval (CI) 0.13-0.39; p < 0.01], particularly when the time interval between stenting and surgery was ≤ 60 days (OR 0.09, 95% CI 0.01-0.72; p = 0.02). There were no cases of stent thrombosis in the bridge group and 3 (1.3%) in the control group. Bridge therapy was associated with decreased events rates as compared to both patients with and without P2Y12 inhibitors discontinuation in the control group. After adjustment for the most relevant covariates, the favorable effect of the bridge therapy was not materially modified. In conclusion, perioperative bridge therapy using tirofiban was associated with reduced 30-day NACE rate, particularly when surgery was performed within 60 days after stent implantation.

  12. The "edge effect" after implantation of beta-emitting (55Co) stents with high initial activity.

    PubMed

    Cervinka, Pavel; St'ásek, Josef; Costa, Marco Aurelio; Stursa, Jan; Fiser, Miloslav; Vodnanský, Petr; Kocisová, Michaela; Veselka, Josef; Pleskot, Miloslav; Malý, Jaroslav

    2004-01-01

    The aim of this study was to evaluate the incidence and the cause of "edge restenosis" after implantation of high activity 41.1 microCi +/- 1.2 microCi = 1520 kBq +/- 44 kBq, beta-emitting (55Co) stents. Proton bombarding in cyclotron has brought the radioactivity. Intravascular ultrasound (IVUS) investigation has been completed in 10 patients. The angiographies performed at 6 month revealed restenosis >50% in 5 cases (50%). The analysis of edges (5 mm distally and proximally to the last stent struts) showed no significant changes in TVV (187.3 +/- 62.60 mm3 and 176.9 +/- 53.5 mm3) but PMV increase significantly (i.e. neointimal proliferation) from 61.9 +/- 31.2 mm3 to 82.2 +/- 43.4 mm3 (p<0.04) and was the major contributor (from 66%) to lumen volume loss (125.4 +/- 40.7 mm3 and 94.7 +/- 22.2 mm3, p<0.02). In conclusion, neither statistically significant positive nor negative remodelling at the "stent edges", were present. Statistically significant increase in plaque +/- media volume (i.e. neointimal hyperplasia) and reduction in lumen volume were found. The cause of "edge restenosis" was especially (from 66%) due to increase in plaque +/- media volume (i.e. neointimal hyperplasia). Probably, main reason for "edge effect"/neointimal hyperplasia was in this trial sharp fall-off in radiation at the edges of the stents.

  13. Similar Success Rates with Bivalirudin and Unfractionated Heparin in Bare-Metal Stent Implantation

    SciTech Connect

    Hallak, Omar; Shams, S. Ali; Broce, Mike; Lavigne, P. Scott; Lucas, B. Daniel; Elhabyan, Abdul-Karim; Reyes, Bernardo J.

    2007-09-15

    Background. Unfractionated heparin (UFH) is the traditional agent utilized during percutaneous peripheral interventions (PPIs) despite its well-known limitations. Bivalirudin, a thrombin-specific anticoagulant, overcomes many of the limitations of UFH and has consistently demonstrated comparable efficacy with significantly fewer bleeding complications. The purpose of this study was to compare procedural success in patients undergoing bare-metal stent implantation for atherosclerotic blockage of the renal, iliac, and femoral arteries and receiving either bivalirudin (0.75 mg/kg bolus/1.75 mg/kg/hr infusion) or UFH (50-70 U/kg/hr bolus) as the primary anticoagulant. Methods. This study was an open-label, nonrandomized retrospective registry with the primary endpoint of procedural success. Secondary endpoints included incidence of: death, myocardial infarction (MI), urgent revascularization, amputation, and major and minor bleeding. Results. One hundred and five consecutive patients were enrolled (bivalirudin = 53; heparin = 52). Baseline demographics were comparable between groups. Patients were pretreated with clopidogrel (approx. 71%) and aspirin (approx. 79%). Procedural success was achieved in 97% and 96% of patients in the bivalirudin- and heparin-treated groups, respectively. Event rates were low and similar between groups. Conclusion. Bivalirudin maintained an equal rate of procedural success in this cohort without sacrificing patient safety. Results of this study add to the growing body of evidence supporting the safety and efficacy of bivalirudin as a possible substitute for UFH in anticoagulation during peripheral vascular bare-metal stent implantation.

  14. Clinical and angiographic outcome of elective stent implantation in small coronary vessels: an analysis of the BENESTENT trial.

    PubMed

    Keane, D; Azar, A J; de Jaegere, P; Rutsch, W; de Bruyne, B; Legrand, V; Kiemeneij, F; de Feyter, P; van de Heuvel, P; Ozaki, Y; Morel, M A; Serruys, P W

    1996-12-01

    We examined the influence of vessel size using an intention-to-treat approach in 259 patients who underwent stent implantation and in 257 patients who underwent balloon angioplasty alone in the BENESTENT trial. In the stented population, smaller vessel size was associated with a higher stent:vessel ratio, a greater relative gain and a greater subsequent loss index, and a higher risk of adverse cardiac events. In the balloon angioplasty population small vessel size conveyed an increased requirement for revascularization but did not increase the risk of procedural failure or myocardial infarction during follow-up. Logistic regression indicated that decreasing vessel size (as a continous variable) was associated with an increasing risk of a cardiac event for both the stent and balloon angioplasty populations.

  15. [Application of (125)I seeds combined with biliary stent implantation in the treatment of malignant obstructive jaundice].

    PubMed

    Wang, T; Liu, S; Zheng, Y B; Song, X P; Jiang, W J; Sun, B L; Wang, L G

    2016-03-23

    To study the feasibility and therapeutic effect of the application of (125)I seeds combined with biliary stent implantation on the treatment of malignant obstructive jaundice. Fifty patients with malignant obstructive jaundice treated from September 2010 to February 2013 in Yantai Yuhuangding Hospital were included in this study. Among them, 24 patients received biliary stent implantation combined with (125)I seeds intraluminal brachytherapy as experimental group, and 26 were treated by biliary stent implantation as control group.The total bilirubin, direct bilirubin and tumor markers (CA-199, CA-242, CEA) before and after surgery, the biliary stent patency status was assessed, and the survival time was evaluated. The 24 patients in experimental group were implanted with 30 (125)I seeds successfully in a total of 450 seeds. Jaundice was improved greatly in both groups. The CA-199 and CA-242 after treatment in the experimental group were significantly decreased than that before treatment (P=0.003 and P=0.004). CEA was also decreased, but showed no statistical significance (P>0.05). There were no significant improvement comparing the CA-199, CA-242 and CEA before and 2 months after surgery in the control group (P>0.05). The rate of biliary stent patency was 83.3% (20/24) in the experimental group and 57.7% (15/26) in the control group (P=0.048). The mean biliary stent patency time in the experimental group was 9.84 months (range 1-15.5 months). The mean biliary stent patency time in the control group was 5.57 months (range 0.8-9 months). There was a significant difference between the two groups (P=0.018). The median survival time was 10.2 months in the experimental group and 5.4 months in the control group (P<0.05). (125)I seeds combined with biliary stent implantation can inhibit the proliferation of vascular endothelial cells and the growth of tumor effectively, and can prolong the biliary stent patency time and the survival time obviously for patients with

  16. 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.

  17. Long-term outcomes of intravascular ultrasound-guided implantation of bare metal stents versus drug-eluting stents in primary percutaneous coronary intervention

    PubMed Central

    Cho, Yun-Kyeong; Park, Nam-Hee; Choi, Sang-Woong; Sohn, Ji-Hyun; Cho, Hyun-Ok; Park, Hyoung-Seob; Yoon, Hyuck-Jun; Kim, Hyungseop; Nam, Chang-Wook; Kim, Yoon-Nyun; Kim, Kwon-Bae

    2014-01-01

    Background/Aims While drug-eluting stents (DESs) have shown favorable outcomes in ST-segment elevation myocardial infarction (STEMI) compared to bare metal stents (BMSs), there are concerns about the risk of stent thrombosis (ST) with DESs. Because intravascular ultrasound (IVUS) guidance may help optimize stent placement and improve outcomes in percutaneous coronary intervention (PCI) patients, we evaluated the impact of IVUS-guided BMS versus DES implantation on long-term outcomes in primary PCI. Methods In all, 239 STEMI patients received DES (n = 172) or BMS (n = 67) under IVUS guidance in primary PCI. The 3-year incidence of major adverse cardiac events (MACEs) including death, myocardial infarction (MI), target vessel revascularization (TVR), and ST was evaluated. Results There was no difference in all cause mortality or MI. However, the incidence of TVR was 23.9% with BMS versus 9.3% with DES (p = 0.005). Thus, the number of MACEs was significantly lower with DES (11.0% vs. 29.9%; p = 0.001). The incidence of definite or probable ST was not different (1.5% vs. 2.3%; p = 1.0). IVUS-guided DES implantation (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.08 to 0.78; p = 0.017), stent length (HR, 1.03; 95% CI, 1.00 to 1.06; p = 0.046), and multivessel disease (HR, 3.01; 95% CI, 1.11 to 8.15; p = 0.030) were independent predictors of MACE. Conclusions In patients treated with primary PCI under IVUS guidance, the use of DES reduced the incidence of 3-year TVR versus BMS. However, all cause mortality and MI were similar between the groups. The incidence of ST was low in both groups. PMID:24574835

  18. [In hospital and mid-term outcome of patients with NIR stent implantation: multicenter ESPORT-NIR registry].

    PubMed

    Iñiguez, A; García, E; Seabra, R; Bordes, P; Bethencourt, A; Rigla, J

    2001-05-01

    Despite improvements in the results and techniques of catheter-based revascularization, few studies have evaluated the clinical results of the application of new stent designs. We describe the in-hospital and mid-term outcome of patients undergoing a stent NIR implantation. At least 1 Stent NIR was implanted in 1.004 patients (1.136 lesions) recruited from 50 centers in an international, multicenter, prospective, registry (Spain and Portugal NIR stent registry). Inclusion criteria were objective coronary ischemia related to a severe de novo lesion or first restenosis in native vessels with a reference diameter >= 2.75 mm. The primary end-point was the incidence of major adverse cardiac events within the first 7 months of follow-up. The mean age of the patients was 60 years and 82% were male. Angioplasty was indicated due to unstable angina in 61% of the cases. Stent implantation was successfully achieved in 99.6%. Clinical success (angiographic success without in-hospital major events) was achieved in 98.6% of patients. The rate of angiographic restenosis (> 50% stenosis narrowing) was 16% (CI 95%; 11.7-21.2). The accumulated major cardiac adverse event rate at seven months of follow-up was 8.7%: death (0.9%), acute myocardial infarction (1.2%) and target lesion revascularization (6.6%). In the wide setting of the population included in the ESPORT-NIR registry, stent NIR implantation was a highly effective therapy with a good mid-term clinical and angiographic outcome.

  19. Clopidogrel Therapy Discontinuation Following Drug Eluting Stent Implantation in Real World Practice in Israel

    PubMed Central

    Blich, Miry; Shwiri, Tawfiq Zeidan; Petcherski, Sirouch; Osherov, Azriel B; Hammerman, Haim

    2012-01-01

    Background Incidence and predictors of clopidogrel discontinuation after drug eluting stent (DES) implantation, in real world practice, are poorly known. Methods Prospective study included all patients who underwent implantation of at least one DES between February 2006 and January 2007. Predictors of clopidogrel discontinuation were assessed by a multivariable analysis. Results In 269 patients, mean period for clopidogrel therapy was 13.2 ± 7.2 month. Twenty eight patients (10.4%) discontinued clolopidogrel prematurely (< 3 months). Early clopidogrel discontinuation was a predictor of late stent thrombosis (P = 0.005) and urgent target vessel revascularization (P = 0.05). There was a trend for higher cardiac mortality among that group (P = 0.07). By 12 months, 173 patients (64.3%) have discontinued clopidogrel therapy. The most frequent circumstance to stop clopidogrel before 12 months was recommendation of family physician. Patients that were followed by cardiologist were more encouraged to longer clopidogrel therapy. In multivariable analysis being non Jew (OR 19.2, 95% CI 2.4 to 142, P = 0.005), not followed by cardiologist (OR 4.7, 95% CI 1 to 23.1, P = 0.05) and lack of information regarding the importance of clopidogrel maintenance at discharge from hospital (OR 10.8, 95% CI 2.7 to 42.9, P = 0.001) were independent predictors of early clopidogrel discontinuation. Conclusions Clopidogrel discontinuation, in real world practice is not unusual and related to poor outcome. Education for general physicians, clear instructions about the importance of antiplatelet maintenance at discharge and follow up by an expert cardiologist are opportunities to improve adherence do antiplatelet therapy following DES implantation.

  20. Effect of Stent Implantation on the Deformations of the Superficial Femoral Artery and Popliteal Artery: In Vivo Three-Dimensional Deformational Analysis from Two-Dimensional Radiographs.

    PubMed

    Schumann, Steffen; Gökgöl, Can; Diehm, Nicolas; Büchler, Philippe; Zheng, Guoyan

    2017-01-01

    The objective of this work was to develop a system for three-dimensional (3D) reconstruction of the femoropopliteal artery from two angiographic views and to quantify the in vivo 3D deformations in 18 patients before balloon angioplasty and after primary stent implantation. The procedure had an insignificant effect on the bending behavior of the artery, as the average mean curvature change within the lesion remained constant before (0.04 cm(-1) ± 0.03) and after stent implantation (0.03 cm(-1) ± 0.04). A significant effect of stent implantation was measured in terms of a decrease in arterial shortening during leg flexion.

  1. Safety of implantable coronary stents during 1H-magnetic resonance imaging at 1.0 and 1.5 T.

    PubMed

    Strohm, O; Kivelitz, D; Gross, W; Schulz-Menger, J; Liu, X; Hamm, B; Dietz, R; Friedrich, M G

    1999-01-01

    The safety of most available implantable intracoronary stents during magnetic resonance imaging (MRI) has not been sufficiently tested. Minor, but possibly clinically significant, increases in temperature have not been excluded. We measured temperature changes of 14 different stents clinically in use or currently tested for release on the world market. Stents were examined in 1.0- and 1.5-T MR scanners with multiple sequences used in routine cardiac and thoracic MRI examinations ("clinical worst case") and after implantation of the stents into the coronary arteries of excised pig hearts (1.5-T scanner only). We used a highly sensitive infrared camera with a thermal resolution of 10 mK and did not see significant heating of any stent during the examinations. We conclude that MRI is safe in patients with the currently available intracoronary stents.

  2. 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.

  3. [Baloon angioplasty with stent implantation in recoarctation of the aorta: an attractive alternative].

    PubMed

    Saliba, Z; Aggoun, Y; Iserin, L; Massih, T A; Bonnet, D; Acar, P; Mousseaux, E; Sidi, D; Kachaner, J; Bonhoeffer, P

    2001-05-01

    The results of transcatheter balloon angioplasty in teenagers and adults with aortic recoarctation are uncertain. Therefore, there is a current trend to prefer a more complex procedure including the implantation of a stent. This study deals with 8 patients aged 7 to 25.3 years (median: 15 years), weighing 20 to 68 kg. (median: 57) and having undergone resection of an aortic coarctation during infancy (24 days to 4 years). All had their lower limb pulses diminished or abolished, elevated blood pressure at rest (and at exercise in the 5 tested patients), and left ventricular hypertrophy. MRI documented the lesion and helped to select seven patients whose stenosis was short and remote enough from the origin of the main aortic collateral. In one case, the decision to stent was taken as an emergent measure to treat an aortic dissection which appeared shortly after balloon dilatation. The effectiveness of the procedure was immediate in all patients with a 50% increase in diameter of the dilated area, total relief of the gradient, drop to normal values of the blood pressure. These good results persisted at follow-up (3-24 months) in 6 patients, with moderate hypertensive rebounds in the last 2. There were 2 technical problems (premature burst of the balloon, asymmetrical inflation of the stent like an "Eiffel Tower") that could finally be overcome and should no longer occur with the new specially designed so-called "BIB" balloons. Would long term follow-up confirm these early results, one should conclude that this method offers an attractive, safe and effective option to surgery for adolescents and adults with late recoarctation of the aorta.

  4. Ductal Stent Implantation in Tetralogy of Fallot with Aortic Arch Abnormality

    PubMed Central

    Ergul, Yakup; Saygi, Murat; Ozyilmaz, Isa; Guzeltas, Alper; Odemis, Ender

    2015-01-01

    Stenting of patent ductus arteriosus is an alternative to palliative cardiac surgery in newborns with duct-dependent or decreased pulmonary circulation; however, the use of this technique in patients with an aortic arch abnormality presents a challenge. Tetralogy of Fallot is a congenital heart defect that is frequently associated with anomalies of the aortic arch and its branches. The association is even more common in patients with chromosome 22q11 deletion. We present the case of an 18-day-old male infant who had cyanosis and a heart murmur. After an initial echocardiographic evaluation, the patient was diagnosed with tetralogy of Fallot and right-sided aortic arch. The pulmonary annulus and the main pulmonary artery and its branches were slightly hypoplastic; the ductus arteriosus was small. Conventional and computed tomographic angiograms revealed a double aortic arch and an aberrant left subclavian artery. The right aortic arch branched into the subclavian arteries and continued into the descending aorta, whereas the left aortic arch branched into the common carotid arteries and ended with the patent ductus arteriosus. After evaluation of the ductal anatomy, we implanted a 3.5 × 15-mm coronary stent in the duct. Follow-up injections showed augmented pulmonary flow and an increase in oxygen saturation from 65% to 94%. The patient was also found to have chromosome 22q11 deletion. PMID:26175649

  5. Physical Simulation of the Random Failure of Implanted Braided NiTi Stents

    NASA Astrophysics Data System (ADS)

    Hirmanová, Klára; Pilch, Jan; Racek, Jan; Heller, Luděk; Šittner, Petr; Recman, Lukáš; Petrenec, Martin; Sedlák, Petr

    2014-07-01

    A problem of random clinical failures of the braided esophageal NiTi stents has been addressed by performing physical simulation experiments on helical NiTi springs loaded in cyclic tension in air, water, and simulated biological fluid. Strains and stresses involved in spring deformation were analyzed through simulation by FEM implemented SMA model. It was found that the fatigue life of NiTi springs is significantly lower in fluids than in the air pointing toward the corrosion fatigue mechanism. There is, however, a fatigue limit roughly corresponding to the onset of martensitic transformation in the wire, which is not common for corrosion fatigue. It is proposed that surface TiO2 oxide cracking plays major role in that. Once the oxide layer on the NiTi wire surface fractures, typically during the first mechanical cycle, cracks in the oxide layer periodically open and close during subsequent mechanical cycling. This leads to the localization of mechanical and corrosion attacks under the oxide cracked regions. Microcracks within the surface oxide layer crossing over into the NiTi matrix were indeed revealed by scanning electron microscopy of FIB sections of fatigued wires. A corrosion assisted mechanism for fatigue crack nucleation at the interface between the surface oxide and NiTi matrix is proposed based on the available evidence. The approach opens a space for a better assessment of the corrosion fatigue performance of superelastic NiTi and ultimately for estimation of the lifetime of implanted braided NiTi stents.

  6. Ductal stent implantation in tetralogy of fallot with aortic arch abnormality.

    PubMed

    Tola, Hasan Tahsin; Ergul, Yakup; Saygi, Murat; Ozyilmaz, Isa; Guzeltas, Alper; Odemis, Ender

    2015-06-01

    Stenting of patent ductus arteriosus is an alternative to palliative cardiac surgery in newborns with duct-dependent or decreased pulmonary circulation; however, the use of this technique in patients with an aortic arch abnormality presents a challenge. Tetralogy of Fallot is a congenital heart defect that is frequently associated with anomalies of the aortic arch and its branches. The association is even more common in patients with chromosome 22q11 deletion. We present the case of an 18-day-old male infant who had cyanosis and a heart murmur. After an initial echocardiographic evaluation, the patient was diagnosed with tetralogy of Fallot and right-sided aortic arch. The pulmonary annulus and the main pulmonary artery and its branches were slightly hypoplastic; the ductus arteriosus was small. Conventional and computed tomographic angiograms revealed a double aortic arch and an aberrant left subclavian artery. The right aortic arch branched into the subclavian arteries and continued into the descending aorta, whereas the left aortic arch branched into the common carotid arteries and ended with the patent ductus arteriosus. After evaluation of the ductal anatomy, we implanted a 3.5 × 15-mm coronary stent in the duct. Follow-up injections showed augmented pulmonary flow and an increase in oxygen saturation from 65% to 94%. The patient was also found to have chromosome 22q11 deletion.

  7. Transcatheter double stent implantation for treatment of middle aortic coarctation syndrome.

    PubMed

    McMahon, Colin J; Lambert, Imelda; Walsh, Kevin P

    2013-10-01

    A 13-year-old boy presented with severe systemic hypertension. His upper limb blood pressure measured 190/100 mm Hg and lower limb blood pressure measured 98/64 mm Hg. The brachial pulses were bounding and femoral pulses were not palpable. Echocardiography and magnetic resonance angiography confirmed middle aortic syndrome. There was severe diffuse thoraco-abdominal coarctation with continuous Doppler run-off. Cardiac catheterization was undertaken and using a retrograde approach two Advanta V12 stents were implanted in the complex thoraco-abdominal coarctation. The gradient across the coarctation was reduced from 80 to 40 mm Hg gradient with a significant improvement in the luminal diameter of the aorta. His upper limb blood pressure reduced to 142/78 mm Hg six weeks later.

  8. Histopathological background data of the systemic organs of CLAWN miniature swine with coronary artery stent implantation

    PubMed Central

    Isobe, Atsushi; Tasaki, Masako; Inoue, Tomoki; Terao, Hisako; Souba, Junko; Nagano, Kasuke; Hagiwara, Hitomi

    2016-01-01

    The aim of this study was to identify potential changes that could occur during histological evaluations of CLAWN miniature swine, with potential consequences for subsequent experiments. The systemic organs from male and female CLAWN miniature swine (16.3–42.3 months old) that had been used in long-term studies of coronary stent implantation were examined histologically. Commonly observed histopathological findings were testicular/epididymal atrophy, cyst-like follicles in the ovaries, hemosiderin deposition in the spleen, lipofuscin deposition in the proximal tubular epithelia and presence of eosinophilic globules in the Bowman’s space and the lumen of the proximal tubules in the kidneys, and cellular infiltration in several organs, including the eyelids, respiratory organs, and digestive tract. However, none of these changes were serious enough to indicate a significant impact on research. In conclusion, this study identified CLAWN miniature swine as a suitable animal model for various experiments. PMID:28190922

  9. Primary Implantation of Polyester-Covered Stent-Grafts for Transjugular Intrahepatic Portosystemic Stent Shunts (TIPSS): A Pilot Study

    SciTech Connect

    Cejna, Manfred; Thurnher, Siegfried; Pidlich, Johann; Kaserer, Klaus; Schoder, Maria; Lammer, Johannes

    1999-07-15

    Purpose: To investigate whether placement of a polyester-covered stent-graft increases the primary patency of transjugular intrahepatic portosystemic stent shunts (TIPSS). Methods: Between 1995 and 1997 Cragg Endopro or Passager MIBS stent-grafts were used for the creation of TIPSS in eight male patients, 35-59 years of age (mean 48 years). All patients suffered from recurrent variceal bleeding and/or refractory ascites due to liver cirrhosis. Seven stent-grafts were dilated to a diameter of 10 mm, one to 12 mm. Follow-up was performed with duplex ultrasound, clinical assessment, and angiography. Results: The technical success rate for creation of a TIPSS was 100%. The mean portosystemic pressure gradient decreased from 25 mmHg to 12 mmHg. In seven of eight patients TIPSS dysfunction occurred between 2 days and 3 years after stent-graft placement. In one patient the TIPSS is still primarily patent (224 days after creation). The secondary patency rates are 31 days to 3 years. Conclusion: The primary use of polyester-covered stent-grafts for TIPSS did not increase primary patency rates in our small series.

  10. Assessment of implanted stent coverage of side-branches in intravascular optical coherence tomographic images

    NASA Astrophysics Data System (ADS)

    Wang, A.; Eggermont, J.; Reiber, J. H. C.; Dekker, N.; de Koning, P. J. H.; Dijkstra, J.

    2013-02-01

    Coronary stents improve the blood flow by keeping narrowed vessels open, but small stent cells that overlay a side branch may cause restenosis and obstruct the blood flow to the side branch. There are increasing demands for precise measurement of the stent coverage of side branches for outcome evaluation and clinical research. Capturing micrometerresolution images, intravascular optical coherence tomography (IVOCT) allows proper visualization of the stent struts, which subsequently can be used for the coverage measurement purpose. In this paper, a new approach to compute the stent coverage of side branches in IVOCT image sequences is presented. The amount of the stent coverage of a side branch is determined by the ostial area of the stent cells that cover this side branch. First, the stent struts and the guide wires are detected to reconstruct the irregular stent surface and the stent cell contours are generated to segment their coverage area on the stent surface. Next, the covered side branches are detected and their lumen contours are projected onto the stent surface to specify the side branch areas. By assessing the common parts between the stent cell areas and the side branch areas, the stent cell coverage of side branches can be computed. The evaluation based on a phantom data set demonstrated that the average error of the stent coverage of side branches is 8.9% +/- 7.0%. The utility of the presented approach for in-vivo data sets was also proved by the testing on 12 clinical IVOCT image sequences.

  11. Outcomes of Acute Myocardial Infarction Patients Implanted With Biodegradable Polymer Biolimus-Eluting Stents Versus New-Generation Durable Polymer Drug-Eluting Stents: A Retrospective Analysis.

    PubMed

    Choe, Jeong Cheon; Cha, Kwang Soo; Jang, Hye Yoon; Choi, Jong Hyun; Kim, Bo Won; Ahn, Jinhee; Park, Jin Sup; Lee, Hye Won; Oh, Jun-Hyok; Choi, Jung Hyun; Lee, Han Cheol; Hong, Taek Jong; Ahn, Youngkeun; Jeong, Myung Ho

    2017-09-01

    We compared outcomes between biodegradable polymer biolimus-eluting stent (BP-BES) and new-generation durable polymer drug-eluting stent (DP-DES) implantations in patients with acute myocardial infarction (MI). Among 13472 patients with acute MI in a nationwide registry, 557 (64.8%) were in the BP-BES and 303 (35.2%) in the new-generation DP-DES group following coronary reperfusion. The occurrence of major adverse cardiac events (MACE; death, MI, revascularization) and stent thrombosis was compared. Major adverse cardiac events occurred in 53 (6.2%) patients and showed similar rates between the BP-BES and new-generation DP-DES groups (all: 6.6% vs 5.9%, P = .652; propensity score [PS] matched: n = 380, 6.3% vs 5.3%, P = .623). Stent thrombosis did not differ between groups (all: 0.3% vs 0.4%, P = .892; PS matched: 0.5% vs 0.5%, P = 1.000). Major adverse cardiac event-free survival was comparable between groups (all: 93.4% vs 94.1%, log-rank P = .357; PS matched: 93.7% vs 94.7%, log-rank P = .445). Biodegradable polymer biolimus-eluting stent was not associated with MACE (all: hazard ratio [HR], 1.67; 95% confidence interval [CI], 0.75-3.74; P = 0.212; PS matched: HR, 1.05; 95% CI, 0.40-2.75; P = .915). In conclusion, in patients with acute MI, BP-BES was equivalent to the new-generation DP-DES in terms of outcomes.

  12. Stent thrombosis is not increased following percutaneous coronary intervention in patients with non-insulin dependent diabetes mellitus taking metformin.

    PubMed

    Lipinski, Michael J; Pendyala, Lakshmana K; Torguson, Rebecca; Chen, Fang; Waksman, Ron

    2014-08-01

    Recent studies have suggested that metformin may inhibit endothelialization following limus-eluting stent (LES) placement and may increase the risk of stent thrombosis. Therefore, we assessed the impact of metformin on stent thrombosis and major adverse cardiovascular events (MACE) in non-insulin-dependent diabetes mellitus (NIDDM) patients who receive drug-eluting stents (DES). We assessed the impact of metformin and stent type on stent thrombosis, MACE, and death in NIDDM patients following DES placement. Of the 1201 patients included, 74.8% received LES, 25.2% received paclitaxel-eluting stents (PES), and 55% were taking metformin. There was no difference in stent thrombosis, regardless of stent type or metformin use. While Kaplan-Meier curves demonstrated reduced MACE (p = 0.007) and death (p = 0.006) with metformin use, multivariate analysis demonstrated that stent type and metformin use were not associated with outcome. In NIDDM patients, metformin use or stent type following DES placement did not increase stent thrombosis and MACE rates. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Repeated stent thrombosis after DES implantation and localized hypersensitivity to a stent implanted in the distal portion of a coronary aneurysm thought to be a sequela of Kawasaki disease: autopsy report.

    PubMed

    Yokouchi, Yuki; Oharaseki, Toshiaki; Ihara, Fumie; Naoe, Shiro; Sugawara, Shigetada; Takahashi, Kei

    2010-02-01

    The patient was a 40-year-old Japanese woman. At 37 years of age she underwent stent implantation in LAD#7 for an acute myocardial infarction. Subsequently, coronary intervention was performed four times because of occlusion of the stent. Sudden death occurred at 40 years of age due to ventricular tachycardia. Clinically, the patient had had no history of collagen disease, anti-phospholipid antibody syndrome or coagulation disorder. The autopsy revealed only very mild atherosclerotic changes in the aorta and various other organs, but concentric thickening of the intima was observed in all three branches of the coronary arteries. Also, aneurysms accompanied by calcification were observed at each of LAD #6, LCx #11 and RCA #4PD. The stent was occluded with a thrombus, and the vascular walls showed infiltration by lymphocytes, plasma cells and numerous eosinophils. The eosinophil infiltration was confined to the site of the stent. It was surmised that the patient had experienced late stent thrombosis due to a hypersensitivity reaction to the DES on the basis of a development of a state of high susceptibility to thrombus formation because of a coronary aneurysm. The aneurysm was suspected of being a post-inflammatory change of Kawasaki disease.

  14. A modified approach for vestibuloplasty in severely resorbed mandible using an implant-retained postoperative stent: a case report.

    PubMed

    Melo, Luiz Gustavo N; Almeida, Ana Lúcia P F; Lopes, José Fernando Scarelli; Rezende, Maria Lúcia R; Neto, José Sérgio M; Ciporkin, Frederico; Nagata, Maria José Hitomi

    2008-10-01

    Severely resorbed mandibles often present a short band of keratinized tissue associated with a shallow vestibule. As a result, prominent muscle insertions are present, especially in the mental region of the mandible. This case report describes the deepening of the vestibular sulcus in an atrophic mandible by combining free gingival grafts harvested from the palate and a postoperative acrylic resin stent screwed on osseointegrated implants placed at the anterior region of the mandible. During the second-stage surgery, a split-thickness labial flap was reflected and apically sutured onto the periosteum. Two free gingival grafts were obtained and then sutured at this recipient site. A previously custom-made acrylic stent was then screwed onto the most distally positioned implants. To document the procedure's stability over time, a metal ball was placed in the most apical part of the vestibule and standardized cephalometric radiographs were taken before and 6 months after the procedure. Linear measurements of vestibular depths over the observation time were realized using specific software for radiographic analysis. The proposed technique augmented the band of attached masticatory mucosa, deepened the vestibule and prevented the muscle reinsertion. The difference between the 2 measurements of vestibular depths was 9.39 mm (initial 20.88 mm, final 11.49 mm) after a 6-month postoperative period. The technique, in combination with palatal mucosal graft and use of a postoperative stent, decreased the pull of mentalis muscle and provided a peri-implantally stable soft tissue around implants.

  15. Preventive effects of 125I seeds on benign restenosis following esophageal stent implantation in a dog model

    PubMed Central

    GAN, ZHEN; JING, JIAN; ZHU, GUANGYU; QIN, YONGLIN; TENG, GAOJUN; GUO, JINHE

    2015-01-01

    The present study aimed to evaluate the effects of iodine-125 (125I) seeds on the proliferation of primary esophageal fibroblasts in dogs, and to assess the safety and preventive efficacy of 125I seed-pre-loaded esophageal stents in benign restenosis following implantation. Primary fibroblasts were cultured with various 125I seed activities, which were then evaluated using cell proliferation and apoptosis assays as well as cell cycle analysis using Annexin V/propidium iodide (PI) double staining and PI staining. Prior to sacrification, animals were submitted to esophageal radiography under digital subtraction angiography. Esophageal tissues were collected and examined for macroscopic, microscopic and pathological alterations. The results demonstrated a significant and dose-dependent inhibition of fibroblast proliferation and increased apoptosis following exposure to 125I seeds. G0/G1 fibroblast populations increased in a dose-dependent manner following treatment with 125I seeds, in contrast to cells in S phase. Four weeks following implantation, α-smooth muscle actin and proliferating cell nuclear antigen expression levels in the experimental group were significantly lower compared with those in the control group; in addition, eight weeks following implantation, esophageal inner diameters were increased in the experimental group. 125I seeds inhibited proliferation of dog esophageal fibroblasts via cell cycle arrest and apoptosis. In conclusion, 125I seed-pre-loaded esophageal stents inhibited benign hyperplasia in the upper edge of the stent to a certain extent, which relieved benign restenosis following implantation with a good safety profile. PMID:25543838

  16. Thoracic Stent Graft Implantation for Aortic Coarctation with Patent Ductus Arteriosus via Retroperitoneal Iliac Approach in the Presence of Small Sized Femoral Artery

    PubMed Central

    Korkmaz, Ozge; Beton, Osman; Goksel, Sabahattin; Kaya, Hakkı; Berkan, Ocal

    2016-01-01

    Endovascular stent graft implantation is a favorable method for complex aortic coarctation accompanied by patent ductus arteriosus. Herein, an 18-year-old woman with complex aortic coarctation and patent ductus arteriosus was successfully treated by endovascular thoracic stent graft via retroperitoneal approach. The reason for retroperitoneal iliac approach was small sized common femoral arteries which were not suitable for stent graft passage. This case is the first aortic coarctation plus patent ductus arteriosus case described in the literature which is treated by endovascular thoracic stent graft via retroperitoneal approach. PMID:27242935

  17. Chronic vascular response after self-expanding nitinol stent implantation in superficial femoral arteries: a serial intravascular ultrasound analysis.

    PubMed

    Nishimura, Machiko; Fujii, Kenichi; Fukunaga, Masashi; Kawasaki, Daizo; Miki, Kojiro; Saita, Ten; Horimatsu, Tetsuo; Tamaru, Hiroto; Imanaka, Takahiro; Naito, Yoshiro; Masuyama, Tohru

    2016-10-01

    The mechanical properties of the self-expanding nitinol stents (SENS) and chronic biological stimulation on the wall from the SENS have not been fully investigated. This study evaluated the mechanical vascular response to SENS implantation in superficial femoral artery (SFA) lesions using serial volumetric intravascular ultrasound (IVUS). Twenty-five symptomatic patients due to de novo SFA lesions scheduled for SENS placement were prospectively enrolled. Serial IVUS studies were performed immediately after crossing with a guidewire, immediately after the procedure, and at a 8-month follow-up. Serial IVUS volumetric analysis was conducted after stent deployment and at follow-up. Mean stent, lumen and neointimal areas were calculated as the volume divided by the stent length, and the calcium arc was measured. At follow-up, SENS had increased 40.6 % in overall volume. The chronic stent expansion tended to be larger, and the mean neointimal area at the 8-month follow-up was significantly larger in less calcified lesions compared to heavily calcified lesions. As a result, the mean late lumen area loss was significantly larger in lesions with calcium arcs of 0° and in the first and second quadrants than in those with calcium arcs in the third and fourth quadrants (2.8 ± 7.2, 1.3 ± 5.6, 0.6 ± 5.9, 1.2 ± 5.4, -0.8 ± 5.2 mm(2), respectively; p < 0.001). SENSs continued to enlarge with intimal proliferation over 8 months in all lesions. Although arterial calcium affected the degree of chronic stent expansion during the follow-up period, neointimal proliferation was smaller in heavily calcified lesion compared to less calcified lesion following SENS implantation.

  18. Usual Dose of Simvastatin Does Not Inhibit Plaque Progression and Lumen Loss at the Peri-Stent Reference Segments after Bare-Metal Stent Implantation: A Serial Intravascular Ultrasound Analysis

    PubMed Central

    Hong, Young Joon; Choi, Yun Ha; Ma, Eun Hye; Ko, Jum Suk; Lee, Min Goo; Park, Keun Ho; Sim, Doo Sun; Yoon, Nam Sik; Youn, Hyun Ju; Kim, Kye Hun; Park, Hyung Wook; Kim, Ju Han; Ahn, Youngkeun; Cho, Jeong Gwan; Park, Jong Chun; Kang, Jung Chaee

    2010-01-01

    Background/Aims The aim of this study was to assess the effects of a usual dose of simvastatin (20 mg/day) on plaque regression and vascular remodeling at the peri-stent reference segments after bare-metal stent implantation. Methods We retrospectively investigated serial intravascular ultrasound (IVUS) findings in 380 peri-stent reference segments (184 proximal and 196 distal to the stent) in 196 patients (simvastatin group, n = 132 vs. non-statin group, n = 64). Quantitative volumetric IVUS analysis was performed in 5-mm vessel segments proximal and distal to the stent. Results IVUS follow-up was performed at a mean of 9.4 months after stenting (range, 5 to 19 months). No significant differences were observed in the changes in mean plaque plus media (P&M) area, mean lumen area, and mean external elastic membrane (EEM) area from post-stenting to follow-up at both proximal and distal edges between the simvastatin and non-statin group. Although lumen loss within the first 3 mm from each stent edge was primarily due to an increase in P&M area rather than a change in EEM area, and lumen loss beyond 3 mm from each stent edge was due to a combination of increased P&M area and decreased EEM area, no significant differences in changes were observed in P&M, EEM, and lumen area at every 1-mm subsegment between the simvastatin and non-statin group. Conclusions A usual dose of simvastatin does not inhibit plaque progression and lumen loss and does not affect vascular remodeling in peri-stent reference segments in patients undergoing bare-metal stent implantation. PMID:21179272

  19. One-Year Outcomes After Everolimus-Eluting Stents Implantation in Ostial Lesions of Left Anterior Descending Coronary Arteries

    PubMed Central

    Golmohamadi, Zahra; Sokhanvar, Sepideh; Aslanabadi, Naser; Ghaffari, Samad; Sohrabi, Bahram

    2013-01-01

    Background In recent years, stents are increasingly used in variety of coronary lesions. Ostial lesion of left anterior descending coronary artery (LAD) however remains a challenge area because of the invariable involvement of distal left main coronary artery (LMCA). This study was designed to evaluate the clinical and angiographic outcomes of everolimus-eluting stent (EES) implantation for ostial LAD. Methods EESs were implanted in 45 consecutive patients with ostial LAD stenoses. For complete lesion coverage, stent positing was extended into the distal LMCA in 6 patients (13.3%) with intermediated LMCA narrowing. We assess MACE during one-year follow-up. Results In-hospital success rate was 100%; neither cardiac death nor stent thrombosis in our patients, but two patients had myocardial infarction in non-related coronary artery during follow-up. Two patients had angiographic restenosis and underwent TLR. The cumulative MACE-free survival rate was 95.6% at one year. Conclusion EES was in ostial LAD lesions with complete lesion coverage achieving high procedural success rate and acceptable clinical outcomes during one-year follow-up period.

  20. Release of Intracoronary Microparticles during Stent Implantation into Stable Atherosclerotic Lesions under Protection with an Aspiration Device

    PubMed Central

    Kahlert, Philipp; Heiss, Christian; Westenfeld, Ralf; Kelm, Malte; Erbel, Raimund; Heusch, Gerd; Kleinbongard, Petra

    2015-01-01

    Objective Stent implantation into atherosclerotic coronary vessels impacts on downstream microvascular function and induces the release of particulate debris and soluble substances, which differs qualitatively and quantitatively between native right coronary arteries (RCAs) and saphenous vein grafts on right coronary arteries (SVG-RCAs). We have now quantified the release of microparticles (MPs) during stent implantation into stable atherosclerotic lesions and compared the release between RCAs and SVG-RCAs. Methods In symptomatic, male patients with stable angina and a stenosis in their RCA or SVG-RCA, respectively (n = 14/14), plaque volume and composition were analyzed using intravascular ultrasound before stent implantation. Coronary aspirate was retrieved during stent implantation with a distal occlusion/aspiration device and divided into particulate debris and plasma. Particulate debris was weighed. Platelet-derived MPs (PMPs) were distinguished by flow cytometry as CD41+, endothelium-derived MPs (EMPs) as CD144+, CD62E+ and CD31+/CD41-, leukocyte-derived MPs as CD45+, and erythrocyte-derived MPs as CD235+. Results In patients with comparable plaque volume and composition in RCAs and SVG-RCAs, intracoronary PMPs and EMPs were increased after stent implantation into their RCAs and SVG-RCAs (CD41+: 2729.6±645.6 vs. 4208.7±679.4 and 2355.9±503.9 vs. 3285.8±733.2 nr/µL; CD144+: 451.5±87.9 vs. 861.7±147.0 and 444.6±74.8 vs. 726.5±136.4 nr/µL; CD62E+: 1404.1±247.7 vs. 1844.3±378.6 and 1084.6±211.0 vs. 1783.8±384.3 nr/µL, P<0.05), but not different between RCAs and SVG-RCAs. Conclusion Stenting in stable atherosclerotic lesions is associated with a substantial release not only of PMPs, but also of EMPs in RCAs and SVG-RCAs. Their release does not differ between RCAs and SVG-RCAs. Trial Registration ClinicalTrials.gov NCT01430884 PMID:25915510

  1. Incidence and Clinical Impact of Stent Fracture After PROMUS Element Platinum Chromium Everolimus-Eluting Stent Implantation.

    PubMed

    Kuramitsu, Shoichi; Hiromasa, Takashi; Enomoto, Soichiro; Shinozaki, Tomohiro; Iwabuchi, Masashi; Mazaki, Toru; Domei, Takenori; Yamaji, Kyohei; Soga, Yoshimitsu; Hyodo, Makoto; Shirai, Shinichi; Ando, Kenji

    2015-08-17

    This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES). SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era. From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure. SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%). SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. Treatment of true bifurcation stenosis by elective stent implantation in parent vessel and non-stent dilatation of side branch: immediate and follow-up results.

    PubMed

    Gambhir, D S; Singh, S; Sinha, S C; Nair, G M; Arora, R

    2000-01-01

    Data of 67 consecutive patients who underwent stent implantation in the parent vessel and non-stent dilatation of the side branch of a true bifurcation stenosis was retrospectively analysed. The mean age was 53.2 +/- 9.7 years, with majority (89.6%) being males. Forty-seven (70.1%) lesions involved the bifurcation of left anterior descending artery and its major diagonal branch. The parent vessel was treated using balloon angioplasty in 50 (74.6%), rotational atherectomy in 15 (22.4%) and directional coronary atherectomy in 2 (3.0%) patients. All the patients subsequently received an intracoronary stent in the parent vessel. Depending upon the treatment strategy for the side branch, the patients were divided into two groups: (1) Percutaneous transluminal coronary angioplasty group, which included 37 patients in whom the side branch was dilated by plain balloon angioplasty, and (2) Debulking group, in which 30 patients underwent debulking of the side branch using rotablation or directional coronary atherectomy. Overall, the procedure was successful in 64 (95.6%) patients. One (1.5%) patient developed non-Q wave myocardial infarction during the hospital stay. There were no Q-wave myocardial infarction, need for emergency coronary artery bypass surgery or death. Clinical follow-up of at least six months was available in all patients with a mean duration of 9.5 +/- 3.2 months. Recurrence of symptoms developed in 19 (28.4%) patients. Fourteen (20.9%) patients required target vessel revascularisation, of which 11 (29.7%) belonged to the percutaneous transluminal coronary angioplasty group and 3 (10.0%) to the debulking group, the difference being statistically significant (p = 0.045). The freedom from target vessel revascularisation was 93.1 and 89.4 percent at 6 and 12 months in the debulking group, compared to 78.4 and 68.9 percent at the same time in the percutaneous transluminal coronary angioplasty group. This study thus demonstrates that percutaneous intervention

  3. Initial experience with paclitaxel-coated stents.

    PubMed

    Grube, Eberhard; Büllesfeld, Lutz

    2002-12-01

    Local delivery of immunosuppressive or antiproliferative agents using a drug-eluting stent is a new technology that is supposed to inhibit in-stent restenosis, thus providing a biological and mechanical solution. This technique is a very promising. To date, several agents have been used, including paclitaxel, QP-2, rapamycin, actinomycin D, dexamethason, tacrolimus, and everolimus. Several studies, published recently or still ongoing, have evaluated these drugs as to their release kinetics, effective dosage, safety in clinical practice, and benefit. These studies include: SCORE (paclitaxel derivative), TAXUS I-VI, ELUTES, ASPECT, DELIVER (paclitaxel), RAVEL, SIRIUS (sirolimus), ACTION (actinomycin), EVIDENT, PRESENT (tacrolimus), EMPEROR (dexamethason), and FUTURE (everolimus). Paclitaxel was one of the first stent-based antiproliferative agents under clinical investigation that provided profound inhibition of neointimal thickening depending on delivery duration and drug dosage. The randomized, multicenter SCORE trail (Quanam stent, paclitaxel-coated) enrolled 266 patients at 17 sites. At 6-month's follow-up, a drop of 83% in stent restenosis using the drug-eluting stent could be achieved (6.4% drug-eluting stent vs 36.9% control group), which was attributable to a remarkable decrease in intimal proliferation. Unfortunately, due to frequent stent thrombosis and side-branch occlusions, the reported 30-day MACE rate was 10.2%. The randomized TAXUS-I safety trial (BSC, NIRx, paclitaxel-coated) also demonstrated beneficial reduction of restenotic lesions at 6-month's follow-up (0% vs 10%) but was associated with the absence of thrombotic events presumably due to less drug dosage. The ongoing TAXUS II-VI trials are addressing additional insight regarding the efficacy of the TAXUS paclitaxel-eluting stent. ASPECT and ELUTES evaluated paclitaxel-coated stents (i.e., Cook and Supra G), including subgroups with different drug dosages. With respect to stent restenosis and

  4. In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

    PubMed

    Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

    2015-01-01

    An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

  5. The Characteristics of In-Stent Restenosis After Drug-Eluting Stent Implantation in Femoropopliteal Lesions and 1-Year Prognosis After Repeat Endovascular Therapy for These Lesions.

    PubMed

    Iida, Osamu; Takahara, Mitsuyoshi; Soga, Yoshimitsu; Hirano, Keisuke; Yamauchi, Yasutaka; Zen, Kan; Kawasaki, Daizo; Nanto, Shinsuke; Yokoi, Hiroyoshi; Uematsu, Masaaki

    2016-04-25

    This study sought to investigate the characteristics of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation for femoropopliteal (FP) lesions, and to examine 1-year prognosis after repeat endovascular therapy (re-EVT) for these DES-ISR. The morphology of DES-ISR and its association with clinical outcomes after re-EVT have not been well examined. This was a subanalysis of the ZEPHYR (Zilver PTX for the femoral artery and proximal popliteal artery) study. The current study included 210 cases with loss of patency confirmed 1 year after DES implantation. Morphology of DES-ISR was classified into the following subgroups: class I, focal lesions (≤50 mm in length), class II, diffuse lesions (>50 mm in length), and class III, totally occluded ISR. One-year prognosis after re-EVT for DES-ISR was assessed by restenosis and major adverse limb events (MALE). Classes I, II, and III accounted for 50%, 25%, and 25% of DES-ISR, respectively. Factors associated with the morphology of DES-ISR were the presence of chronic total occlusion and the size of the external elastic membrane area before DES implantation (p = 0.009 and 0.017). Compared with the class I restenotic lesion, the class II and III lesions had a significantly higher risk of restenosis (74% and 78% vs. 53%: p = 0.048 and 0.019, respectively) and MALE (56% and 56% versus 32%: p = 0.025 and 0.022, respectively) 1 year after re-EVT. We evaluated the characteristics of ISR after DES implantation for FP lesions and 1-year prognosis of re-EVT for DES-ISR. The morphology of DES-ISR had a significant association with 1-year prognosis after re-EVT. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Association of chronic kidney disease with periprocedural myocardial injury after elective stent implantation

    PubMed Central

    Jerkic, Helena; Letilovic, Tomislav; Stipinovic, Mario; Pocanic, Darko; Catic, Jasmina; Knotek, Mladen

    2016-01-01

    Abstract Coronary artery disease (CAD) is the leading cause of mortality in patients with chronic kidney disease (CKD). Patients with CKD who undergo percutaneous coronary intervention (PCI) may have more ischemic events than patients without CKD. The aim of our study was to determine the incidence of periprocedural myocardial injury (PMI) after elective stent implantation in patients with CKD using the Third Joint ESC/ACCF/AHA/WHF PMI definition. In a single center prospective cohort study, we enrolled 344 consecutive patients who underwent elective PCI in a period of 39 months. Serum troponin I (cTnI) concentrations were measured at baseline and at 8 and 16 hours after PCI. Periprocedural increase of cTnI, according to the most recent PMI definition, was used to define both the presence and intensity of PMI. Patients were further stratified according to the estimated glomerular filtration rate (eGFR) using 4 variable Modification of Diet in Renal Disease (MDRD) equation: control group with eGFR >90 mL/min/1.73 m2 and the CKD group with eGFR < 90 mL/min/1.73 m2, with further subdivision according to the CKD stage. We found no significant difference in the incidence as well as intensity of the PMI in the control (>90 mL/min/1.73 m2) and the CKD group (<90 mL/min/1.73 m2) both 8 and 16 hours after PCI. When the CKD patients were further subdivided according to their CKD stage, there was again no difference in the intensity or incidence of PMI compared to the control group. Further analyses of our data showed angina pectoris CCS IV, bare metal stent (BMS) implantation, and treatment with angiotensin-converting enzyme inhibitors (ACEI) as independent predictors of PMI. Furthermore, the presence of hypertension was inversely related to the occurrence of PMI. Applying the new guidelines for PMI and using the eGFR equation most suitable for our patients, we found no association between PMI and CKD. Further analyses showed other factors that could

  7. Intravascular Ultrasound Predictors of Major Adverse Cardiovascular Events After Implantation of Everolimus-eluting Stents for Long Coronary Lesions.

    PubMed

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

    2017-02-01

    There are limited data on the usefulness of intravascular ultrasound (IVUS) for long coronary lesions treated with second-generation drug-eluting stents. We evaluated IVUS predictors of major adverse cardiovascular events (MACE) 12 months after implantation of everolimus-eluting stents for long coronary lesions. A total of 804 patients who underwent both postintervention IVUS examination and long everolimus-eluting stent (≥ 28mm in length) implantation were included from 2 randomized trials. MACE was defined as a composite of cardiac death, myocardial infarction, and target-lesion revascularization. MACE occurred in 24 patients (3.0%) over 12 months. On multivariable Cox regression analysis, independent IVUS predictors of MACE included the postintervention minimum lumen area (MLA) at the target lesion (HR = 0.623; 95%CI, 0.433-0.895; P=.010) and the ratio of MLA/distal reference segment lumen area (HR = 0.744; 95%CI, 0.572-0.969; P=.028). The MLA and MLA-to-distal reference segment lumen area ratio that best predicted patients with MACE from those without these events were 5.0 mm(2) and 1.0, respectively. Patients with MLA<5.0 mm(2) or a distal reference segment lumen area had a higher risk of MACE (HR = 6.231; 95%CI, 1.859-20.891; P=.003) than those without MACE. Patients with a postintervention IVUS-measured MLA of<5.0 mm(2) or a distal reference segment lumen area were at risk for MACE after long everolimus-eluting stent implantation. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  8. Prompt and safe femoral hemostasis with a collagen device after intracoronary implantation of Palmaz-Schatz stents.

    PubMed

    Bartorelli, A L; Sganzerla, P; Fabbiocchi, F; Montorsi, P; De Cesare, N; Child, M; Tavasci, E; Passaretti, B; Loaldi, A

    1995-07-01

    We report the safety and efficacy of sealing the femoral puncture site with percutaneously applied collagen after Palmaz-Schatz stent implantation in 100 consecutive patients. Patients were anticoagulated with continuous heparin infusion, overlapping oral anticoagulants, and antiplatelet therapy by dextran, aspirin, and dipyridamole. At the time of sheath removal and collagen application, the mean activated partial thromboplastin time and prothrombin time values expressed as international normalized ratio were 3.2 +/- 2.1 and 1.6 +/- 0.7, respectively. The hemostasis time ranged from 1 to 8 minutes (mean 2.18 +/- 2.08 minutes). Only two (2%) patients had major puncture-site bleeding (not seal related in one case) that required surgery and blood transfusions. Small (< 6 cm) and medium (6 to 10 cm) hematomas observed in 12 (12%) and 2 (2%) patients, respectively, resolved spontaneously without sequelae. Local infection developed in 2 (2%) patients, who were successfully treated with antibiotics without clinical consequences. Subacute stent thrombosis was observed in only 1 (1%) patient. Repeat catheterization through the same femoral artery was performed at 6-month follow-up in 55 patients without difficulty or vascular complications. These findings suggest that percutaneous collagen application after coronary stenting is a secure method of achieving prompt and effective femoral hemostasis with a low incidence of major vascular bleeding complications despite intense anticoagulation. Stable hemostasis may allow continued full-dose anticoagulation, reducing the risk of stent subacute thrombosis.

  9. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease.

    PubMed

    Geraghty, Patrick J; Mewissen, Mark W; Jaff, Michael R; Ansel, Gary M

    2013-08-01

    The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. The long-term outcomes of

  10. CYP2C19 loss-of-function alleles are not associated with clinical outcome of clopidogrel therapy in patients treated with newer-generation drug-eluting stents

    PubMed Central

    Choi, Ik Jun; Koh, Yoon-Seok; Park, Mahn-Won; Her, Sung Ho; Choi, Yun-Seok; Park, Chul-Soo; Park, Hun-Jun; Kim, Pum-Joon; Chung, Wook-Sung; Kim, Ho-Sook; Shin, Jae-Gook; Seung, Ki-Bae; Chang, Kiyuk

    2016-01-01

    Abstract CYP2C19 loss-of-function (LOF) alleles adversely affect clinical outcome of clopidogrel therapy. Recent introduction of a newer-generation drug-eluting stent (DES) has significantly reduced the occurrence of stent thrombosis. The aim of this study was to evaluate the impact of CYP2C19 LOF alleles on clinical outcome in patients treated with the newer-generation DES. The effects of CYP2C19 genotypes were evaluated on clinical outcome of clopidogrel therapy in 2062 patients treated with percutaneous coronary intervention using either first-generation DES (sirolimus- and paclitaxel-eluting stent, n = 1349) or newer-generation DES (everolimus- and zotarolimus-eluting stent, n = 713). The primary clinical outcome was major cardiac and cerebrovascular event (MACCE) including cardiac death, nonfatal myocardial infarction, stroke, and stent thrombosis during 1 year of follow-up. CYP2C19 LOF alleles were significantly associated with a higher risk of MACCE in patients treated with first-generation DES (hazard ratio [HR] 2.599, 95% confidence interval [CI] 1.047–6.453; P = 0.034). In contrast, CYP2C19 LOF alleles were not associated with primary outcome in newer-generation DES (HR 0.716, 95% CI 0.316–1.622; P = 0.522). In the further multivariate analysis, CYP2C19 LOF alleles were not associated with MACCE in patients receiving newer-generation DES (adjusted HR 0.540, 95% CI 0.226–1.291; P = 0.166), whereas they were demonstrated to be an independent risk factor for MACCE in those implanted with first-generation DES (adjusted HR 3.501, 95% CI 1.194–10.262; P = 0.022). In contradiction to their clinical impact in first-generation DES era, CYP2C19 LOF alleles may not affect clinical outcome of clopidogrel therapy in patients treated with newer-generation DES. PMID:27368038

  11. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent

    PubMed Central

    Spinetta, Roberta; Cannizzo, Paola Maria Loredana; Consolandi, Giulia; Lavia, Carlo; Germinetti, Francesco; Rolle, Teresa

    2017-01-01

    Objective To evaluate the efficacy and safety of the Xen Gel Stent and provide a macro- and microscopic analyses of bleb morphology. Methods A prospective 12-month study on patients with primary open-angle glaucoma. Patients underwent implantation of the XEN Gel Stent (Allergan INC, Dublin, Ireland) either alone or combined with a cataract surgery. Biomicroscopy, in vivo confocal microscopy (IVCM), and anterior segment-optical coherence tomography (AS-OCT) were used to assess bleb morphology. Safety parameters were adverse events, best corrected visual acuity, visual field, and corneal endothelial cell loss. A postoperative IOP ≤ 18 mmHg without or on medications was respectively defined as complete and qualified success while an IOP ≥ 18 mmHg was defined as failure. Results Twelve eyes of 11 patients were evaluated. At one year, 5 out of 10 patients available achieved a complete success while five were qualified success. AS-OCT showed that bleb wall reflectivity was significantly higher in the failure group; IVCM revealed that stromal density was significantly lower in the success group. No safety issues were recorded. Conclusion Implantation of the XEN Gel Stent appears to be a safe and effective procedure. AS-OCT and IVCM may be helpful in bleb assessment. PMID:28751986

  12. Cuspal dehiscence at a post and along the stent cloth in a bovine pericardium heart valve implanted for seven years.

    PubMed

    Guidoin, Robert; Bes, Taniela Marli; Cianciulli, Tomas Francisco; Klein, Julianne; Li, Bin; Gauvin, Robert; Guzman, Randolph; Rochette-Drouin, Olivier; Germain, Lucie; Zhang, Ze

    2012-01-01

    A failing mitral valve prosthesis made from bovine pericardium was explanted from a 50-year-old patient. Preoperative transthoracic-echocardiography had confirmed severe mitral regurgitation due to structural failure of this HP Bio bovine pericardium heart valve prosthesis. The explanted device was examined macroscopically, by scanning electron microscopy (SEM), by light microscopy, and by transmission electron microscopy (TEM). Samples of unassembled patches of bovine pericardium were used as a pre-implantation control to better understand the changes that occurred in the structure of the pericardium following the 7 years of implantation. Examination confirmed complete dehiscence of a cusp along a valve post and the stent: This detached cusp was observed floating in the bloodstream at echocardiography. The fibrous pannus overgrowth was well developed along the stent and extended to the bottom of the cusps both on the inflow and the outflow sides. The fibrous panni were found to be poorly adhesive to the pericardium cusps and had become stiff, thus impairing the opening and closure of the valve. The structure of the pericardium cusps was severely deteriorated compared to the control bovine pericardium tissue samples. The collagen bundles were frequently broken and more stretched in the explanted device, lacking the wavy histological pattern of normal collagen fibers. However, the tissues were devoid of any calcification. In conclusion, the failure mode of this valve was the dehiscence of a cusp from a valve post and along the stent cloth in the absence calcification.

  13. Improved anticoagulation management after Palmaz Schatz coronary stent implantation by sealing the arterial puncture site with a vascular hemostasis device.

    PubMed

    Kiemeneij, F; Laarman, G J

    1993-12-01

    Sealing the arterial puncture site with a vascular hemostasis device has the potential to maintain optimal anticoagulation after stent implantation. The level of heparinization during the first 3 days after successful stent implantation was retrospectively compared between 2 groups of medically treated patients with (group A; n = 18) and without (group B; n = 17) a Vasoseal after sheath removal. The number of APTTs sampled in group A and B was 233 and 168, respectively. Respective mean values of APTT (seconds) in group A and B were 180 +/- 79 and 172 +/- 91 at day 1 (p = NS), 132 +/- 43 and 125 +/- 61 at day 2 (p = NS) and 123 +/- 36 and 116 +/- 48 at day 3 (p = NS). More APTTs were suboptimal (< 80 secs) in group B (34/168; 20%) compared to group A (17/233; 7%) [p < 0.001]. More patients in group B compared to group A had 1 or more (14/17; 82% vs. 8/18; 44%; p = 0.04), 2 or more (10/17; 59% versus 3/18; 17%; p = 0.02) and 3 or more (8/17; 47% vs. 2/18; 11%; p = 0.03) suboptimal APTTs. Bleeding complications were seen in 4 patients without and in 3 patients with a Vasoseal. Thus application of a vascular hemostasis device results in a less variable anticoagulation after coronary stenting, but it does not abolish entry site-related bleeding complications.

  14. Relationship between the Level of Circulating CD45(+) Platelets and Development of Restenosis after Implantation of Drug-Eluting Stents to Patients with Coronary Heart Disease.

    PubMed

    Gabbasov, Z A; Kozlov, S G; Byazrova, S V; Mel'nikov, I S; Saburova, O S

    2017-02-01

    The study was carried out in 126 patients with stable angina pectoris, who underwent elective coronary artery stenting with drug-eluting stents and follow-up angiography within 6-12 months thereafter. Five significant risk factors of restenosis were identified by binary comparisons of different variables. The logistic regression equation that included the level of CD45-positive platelets, diabetes, small vessel stenting, number of simultaneously implanted stents in one patient, and lesion length demonstrates the highest level of prediction of in-stent restenosis (OR=22.8; p<0.001). ROC-analysis demonstrated high prognostic value of the logit model (area under ROC curve 0.87, p<0.001). The data suggest that a close relationship exists between the development of restenosis and the level of circulating CD45(+) platelets.

  15. Intra-cardiac echocardiography-guided stent implantation into stenosed superior vena cava in a patient with a history of contrast anaphylaxis.

    PubMed

    Yoshimoto, Hironaga; Suda, Kenji; Kishimoto, Shintaro; Kudo, Yoshiyuki

    2016-04-01

    A 37-year-old patient, who suffered from a repeated superior vena cava (SVC) syndrome, was scheduled for stent implantation into SVC, but suffered from contrast anaphylaxis. To monitor the procedure, we used intra-cardiac echocardiography and successfully implanted a stent. Placing an intra-cardiac echocardiographic catheter in the main pulmonary artery and facing towards the right, we could readily visualize stenosis in the SVC and inflation of the stent. Also looking up from right atrium, we noted proximal obstruction of the stent and confirmed the relief of obstruction after additional balloon dilation. This report leads to new application of intra-cardiac echocardiography for intervention of structural and vascular diseases other than inter-atrial septum.

  16. Bioabsorbable stent implantation vs. common femoral artery endarterectomy: early results of a randomized trial.

    PubMed

    Linni, Klaus; Ugurluoglu, Ara; Hitzl, Wolfgang; Aspalter, Manuela; Hölzenbein, Thomas

    2014-08-01

    To compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery (CFA) atherosclerotic lesions by bioabsorbable stent implantation (BASI group) or by common femoral artery endarterectomy (CFE group). A randomized, controlled, single-center, open-label trial was initiated to compare outcomes of BASI or CFE in patients with chronic atherosclerotic occlusive lesions in the CFA. From May 2011 to April 2013, 116 consecutive patients were recruited; after excluding 36 patients, 80 patients (52 men; mean age 72.2±9.6 years) were enrolled 1:1 and are the subject of this intention-to-treat interim analysis (40 patients in each group). The primary endpoint was surgical site infections; secondary outcome measures were technical success, hemodynamic improvement, clinical improvement, patency, limb salvage, and survival. There was no statistically significant difference between both groups regarding demographic data, cardiovascular risk factors, or CFA occlusions. The CFE patients presented with 7 surgical site infections (all minor) vs. none in the BASI group (p=0.002) and a longer mean postoperative hospital stay of 7 vs. 2 days for BASI patients (p<0.001). Technical success rates were 97.5% and 100% for the BASI and CFE groups, respectively. Postoperative ankle-brachial index means were comparable (p=0.38). The 30-day primary patency rates were 92.5% and 100% for the BASI and CFE groups, respectively (p=0.038). There were 6 reconstruction failures in CFE patients vs. none in the BASI group (p=0.02); 5 failures involved initial CFA occlusions. At 1 year, the primary and secondary patency rates were 80% vs. 100% (p=0.007) and 84% vs. 100% (p=0.01) for BASI and CFE patients, respectively. Limb salvage was equivalent, and survival rates were 88% and 90% for BASI vs. CFE patients (p=0.51) at 1 year. This interim analysis suggests that BASI is not an option for CFA occlusion and is only a limited option for CFA stenosis. Clinical and

  17. Five-year outcomes of self-expanding nitinol stent implantation for chronic total occlusion of the superficial femoral and proximal popliteal artery.

    PubMed

    Sakamoto, Yasunari; Hirano, Keisuke; Iida, Osamu; Soga, Yoshimitsu; Suzuki, Kenji; Muramatsu, Toshiya; Tsukahara, Reiko

    2013-09-01

    To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions. Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified. From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis. Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis. Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable. Copyright © 2013 Wiley Periodicals, Inc.

  18. Aortic valvular calcification predicts restenosis after implantation of drug-eluting stents in patients on chronic haemodialysis.

    PubMed

    Ishii, Hideki; Kumada, Yoshitake; Toriyama, Takanobu; Aoyama, Toru; Takahashi, Hiroshi; Amano, Tetsuya; Yasuda, Yoshinari; Yuzawa, Yukio; Maruyama, Syoichi; Matsuo, Seiichi; Matsubara, Tatsuaki; Murohara, Toyoaki

    2009-05-01

    Even in the drug-eluting stent (DES) era, the restenosis rate of the follow-up period after percutaneous coronary intervention (PCI) is higher in haemodialysis (HD) patients than in non-HD patients. Therefore, higher restenosis remains a clinical limitation in HD patients, and a simple clinical method to predict patients likely to have restenosis after stent implantation is attractive. The present study investigated the potential relationship between aortic valvular calcification (AVC) and angiographical restenosis at follow-up after DES implantation in patients on maintenance HD. In the study, 97 patients were enrolled. We prospectively performed echocardiography before elective PCI with DES implantation. Angiographic follow-up was scheduled between 6 and 8 months after PCI. Restenosis at follow-up was defined as a diameter stenosis of > or =50% by measuring quantitative coronary angiography. Of the enrolled patients, 59 patients (60.8%) had AVC. Complete angiographical follow-up was obtained in 86 patients (88.7%). The angiographical restenosis rate during the follow-up period was 24.7% in patients with AVC and 8.9% in patients without AVC [hazard ratio (HR) 3.36; 95% confidence interval (CI) 1.18-9.56, P = 0.023]. Even after multivariate adjustment including covariates related to atherogenecity, AVC remained an independent predictor of restenosis after implanting DES (HR 3.83; 95% CI 1.14-12.9, P = 0.029). Late lumen loss suggesting neointimal growth after DES implantation was 0.28 +/- 0.70 mm in the non-AVC group and 0.64 +/- 0.90 mm in the AVC group (P = 0.013). AVC provides predictive information regarding DES implantation in patients on maintenance HD.

  19. Computational blood flow and vessel wall modeling in a CT-based thoracic aorta after stent-graft implantation

    NASA Astrophysics Data System (ADS)

    Hazer, Dilana; Stoll, Markus; Schmidt, Eduard; Richter, Goetz-M.; Dillmann, Rüdiger

    2010-03-01

    Abnormal blood flow conditions and structural fatigue within stented vessels may lead to undesired failure causing death to the patient. Image-based computational modeling provides a physical and realistic insight into the patientspecific biomechanics and enables accurate predictive simulations of development, growth and failure of cardiovascular diseases as well as associated risks. Controlling the efficiency of an endovascular treatment is necessary for the evaluation of potential complications and predictions on the assessment of the pathological state. In this paper we investigate the effects of stent-graft implantation on the biomechanics in a patient-specific thoracic aortic model. The patient geometry and the implanted stent-graft are obtained from morphological data based on a CT scan performed during a controlling routine. Computational fluid dynamics (CFD) and computational structure mechanics (CSM) simulations are conducted based on the finite volume method (FVM) and on the finite element method (FEM) to compute the hemodynamics and the elastomechanics within the aortic model, respectively. Physiological data based on transient pressure and velocity profiles are used to set the necessary boundary conditions. Further, the effects of various boundary conditions and definition of contact interactions on the numerical stability of the blood flow and the vessel wall simulation results are also investigated. The quantification of the hemodynamics and the elastomechanics post endovascular intervention provides a realistic controlling of the state of the stented vessel and of the efficiency of the therapy. Consequently, computational modeling would help in evaluating individual therapies and optimal treatment strategies in the field of minimally invasive endovascular surgery.

  20. Midterm to long-term safety and efficacy of self-expandable nitinol stent implantation for coarctation of aorta in adults.

    PubMed

    Haji Zeinali, Ali Mohammad; Sadeghian, Mohammad; Qureshi, Shakeel A; Ghazi, Payam

    2017-09-01

    Endovascular treatment of coarctation of aorta (CoA) by self-expandable Nitinol stents is one of the recognized treatment methods and may be an alternative to surgery or balloon-expandable stent implantation for CoA but there is little information about midterm to long term results of self-expandable stents. Sixty-two patients with CoA (40 men), with a mean age of 30.7 ± 11 years, (range 17-63 years) underwent stent implantation with Optimed self-expandable Nitinol stents between 2005 and 2014. Successful outcome was defined as peak systolic pressure gradient ≤20 mmHg after stent implantation. The patients were followed-up clinically and by echocardiography and in patients, in whom there was suspicion of recoarctation, CT angiography or recatheterization was performed. 65 stents were successfully implanted in all 62 patients. Peak systolic pressure gradient decreased from mean 62.4 ± 18 mmHg (range 35-100 mmHg) to mean 2.8 ± 5 mmHg (range 0-15 mmHg; P < 0.001). Stent displacement occurred in 3 patients during the procedure. These were managed successfully by an overlapping second stent. None of the patients had major complications such as aortic dissection, rupture, or vascular access problems. In follow up, only three patients had recoarctation, and two of these were managed successfully by balloon redilation or further stenting 16 and 18 months after the first procedure and one patient refused reintervention. There were two deaths, unrelated to the procedure, 12 and 78 months after the initial intervention. Follow-up of a mean of 45.5 ± 17 months (range 12-105 months) demonstrated no evidence of aneurysm formation or stent fracture. Self-expandable nitinol stents for the treatment of native and recurrent CoA is safe and has good efficacy with acceptable midterm to long-term outcome. © 2017 Wiley Periodicals, Inc.

  1. Changes in cerebrospinal fluid and blood lactate concentrations after stent-graft implantation at critical aortic segment: a preliminary study.

    PubMed

    Bashar, Abul Hasan Muhammad; Suzuki, Kazuya; Kazui, Teruhisa; Okada, Mitsuo Yamaguchi; Suzuki, Takayasu; Washiyama, Naoki; Terada, Hitoshi; Yamashita, Katsushi

    2008-04-01

    Obstruction of blood flow through the arteria radicularis magna (ARM) has been linked with ischemic spinal cord injury after conventional thoracic aortic repair. Whether or not endoluminal stent-grafts, deliberately positioned against this artery can cause similar damage to the spinal cord has not been comprehensively investigated. The purpose of this study was to assess the blood and cerebrospinal fluid (CSF) concentrations of lactate - a well-known biochemical marker of ischemic neurological injury, before and after stent-graft implantation against the ARM. Endoluminal stent-grafting was performed in ten mongrel dogs. In five animals (experimental group), stent-grafts covered the fourth and fifth lumbar segmental arteries - which have been described as the canine equivalents to the ARM in humans. In the remaining five animals (control group), devices of similar length were placed in the lower thoracic aorta. CSF was obtained by cisternal puncture technique at the following time points; before stent-grafting, and 15, 30 and 60 min after stent-grafting. Parallel arterial blood samples were also obtained using a heparinized syringe. All samples were centrifuged and the supernatant analysed for lactate. The mean preprocedural lactate concentration in the CSF was 1.7+/-0.3 mmol/l. Mean postprocedural levels in the experimental group at 15, 30 and 60 min were 3.1+/-1.9, 3.9+/-1.1 and 11.9+/-2.5 mmol/l, respectively (control values; 2.1+/-1.9, 2.7+/-1.1 and 1.9+/-1.5 mmol/l, respectively). Mean preprocedural blood lactate level was 1.8+/-0.6 mmol/l, while the mean postprocedural concentrations in the experimental group at 15, 30 and 60 min were 2.9+/-1.2, 3.4+/-1.7 and 3.9+/-2.0 mmol/l, respectively. Two out of the five animals in the experimental group suffered mild to moderate hind limb weakness. Selective placement of stent-grafts against the ARM in dogs resulted in a conspicuous increase in CSF and blood lactate concentrations 60 min after the procedure with or

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

    PubMed

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

    2016-07-01

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

  3. AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.

    PubMed

    Bosiers, Marc; Peeters, Patrick; D'Archambeau, Olivier; Hendriks, Jeroen; Pilger, Ernst; Düber, Christoph; Zeller, Thomas; Gussmann, Andreas; Lohle, Paul N M; Minar, Erich; Scheinert, Dierk; Hausegger, Klaus; Schulte, Karl-Ludwig; Verbist, Jürgen; Deloose, Koen; Lammer, J

    2009-05-01

    Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

  4. Association between discordance of LDL-C and non-HDL-C and clinical outcomes in patients with stent implantation: from the FU-Registry.

    PubMed

    Shiiba, Michiyo; Zhang, Bo; Miura, Shin-Ichiro; Ike, Amane; Nose, Daisuke; Kuwano, Takashi; Imaizumi, Satoshi; Sugihara, Makoto; Iwata, Atushi; Nishikawa, Hiroaki; Kawamura, Akira; Shirai, Kazuyuki; Yasunaga, Shin'ichiro; Saku, Keijiro

    2017-08-16

    It is not yet clear whether the discordance of low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) predicts the follow-up clinical outcome (major adverse cardiovascular events: MACEs) in patients with coronary stent implantation. Among 2015 patients with coronary stent implantation (Fukuoka University [FU]-Registry), excluding those with acute coronary syndrome or hemodialysis, we selected 801 patients who had undergone successful stent implantation with a follow-up until 18 months, and classified them into 3 groups according to baseline LDL-C and non-HDL-C levels [percentile(P)non-HDL-C more than (P)LDL-C, (P)non-HDL-C equal to (P)LDL-C, and (P)non-HDL-C less than (P) LDL-C]. We found that the discordance of (P)LDL-C and (P)non-HDL-C was not a significant predictor of MACEs. Higher LDL-C level was consistently and independently associated with higher incidences of MACEs after controlling for conventional risk factors and the type of stent used by multivariate Cox regression analyses. In conclusion, LDL-C levels are more important than non-HDL-C levels and the discordance of LDL-C and non-HDL-C levels as predictors of MACEs in patients with stable angina after stent implantation.

  5. Dr. Sun's Procedure for Type A Aortic Dissection: Total Arch Replacement Using Tetrafurcate Graft With Stented Elephant Trunk Implantation

    PubMed Central

    Ma, Wei-Guo; Zheng, Jun; Liu, Yong-Min; Zhu, Jun-Ming; Sun, Li-Zhong

    2013-01-01

    Sun's procedure is a modified elephant trunk technique that integrates the advantages of open surgical and endovascular repairs as a treatment of type A aortic dissection. It is named after Dr. Li-Zhong Sun and refers to total arch replacement using a four-branched graft with implantation of a special stented endovascular graft. Since its introduction, it has produced excellent early and late clinical outcomes. We present a video of this procedure and make an overview regarding the technical aspects, surgical indications, and clinical outcomes of Sun's procedure. PMID:26798674

  6. QUANTIFICATION OF LOCAL HEMODYNAMIC ALTERATIONS CAUSED BY VIRTUAL IMPLANTATION OF THREE COMMERCIALLY-AVAILABLE STENTS FOR THE TREATMENT OF AORTIC COARCTATION

    PubMed Central

    Kwon, Sung; Feinstein, Jeffrey A.; Dholakia, Ronak J.; LaDisa, John F.

    2014-01-01

    Patients with coarctation of the aorta (CoA) are prone to morbidity including atherosclerotic plaque that has been shown to correlate with altered wall shear stress (WSS) in the descending thoracic aorta (dAo). We created the first patient-specific computational fluid dynamics (CFD) model of a CoA patient treated by Palmaz stenting to date, and compared resulting WSS distributions to those from virtual implantation of GenesisXD and modified NumedCP stents also commonly used for CoA. CFD models were created from magnetic resonance imaging, fluoroscopy and blood pressure (BP) data. Simulations incorporated vessel deformation, downstream vascular resistance and compliance to match measured data and generate blood flow velocity and time-averaged WSS (TAWSS) results. TAWSS was quantified longitudinally and circumferentially in the stented region and dAo. While modest differences were seen in the distal portion of the stented region, marked differences were observed downstream along the posterior dAo and depended on stent type. The GenesisXD model had the least area of TAWSS values exceeding the threshold for platelet aggregation in vitro, followed by the Palmaz and NumedCP stents. Alterations in local blood flow patterns and WSS imparted on the dAo appear to depend on the type of stent implanted for CoA. Following confirmation in larger studies, these findings may aid pediatric interventional cardiologists in selecting the most appropriate stent for each patient, and ultimately reduce long-term morbidity following treatment for CoA by stenting. PMID:24259013

  7. 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.

  8. Postoperative analysis of the mechanical interaction between stent and host tissue in patients after transcatheter aortic valve implantation.

    PubMed

    Hopf, Raoul; Sündermann, Simon H; Born, Silvia; Ruiz, Carlos E; Van Mieghem, Nicolas M; de Jaegere, Peter P; Maisano, Francesco; Falk, Volkmar; Mazza, Edoardo

    2017-02-28

    The analysis is based on a finite element procedure to extract the contact forces between an implanted Nitinol stent and the surrounding host tissue using postoperative CT images. The methodology was applied for patients (N=46) which have undergone a TAVI procedure with the Medtronic CoreValve Revalving System (MCRS) to obtain corresponding deformation and force maps. The postoperative CT data were recorded for each patient in both systolic and diastolic phase of the heart cycle. Scalar parameters were defined, which map deformed geometry and contact force field to mechanically relevant quantities: radial dilatation, radial shape distortion, non-convex points, mean force, a force deviation measure and a pressure equivalent. The latter demonstrates that in the area of the aortic root, the added circumferential loading is of the same order as the baseline average blood pressure, thus leading to a doubling of the local mechanical load. Generally the force distribution along the stent is non-homogeneous. A comparison of systolic and diastolic data revealed slightly higher contact forces during the diastole, indicating that the stent has to carry more load in this phase. The geometrical and mechanical parameters were compared for two types of clinical complication: para-valvular leakage (PVL) and permanent pacemaker requirement (PPM). It was found that an increase in mean force can be associated with both complications; significantly for PVL and as a trend for PPM.

  9. Nitinol stent implantation for femoropopliteal disease in patients on hemodialysis: results of the 3-year retrospective multicenter APOLLON study.

    PubMed

    Fujihara, Masahiko; Higashimori, Akihiro; Kato, Yoshihiro; Taniguchi, Hiromasa; Iwasaki, Yusuke; Amano, Tomonori; Sumiyoshi, Akinori; Nishiya, Daisuke; Yokoi, Yoshiaki

    2016-09-01

    The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N = 161) and non-hemodialysis group (N = 323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5 ± 13.5 months. The primary patency rate at 3 years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3 years was 55.0 % in the hemodialysis group and 66.1 % in the non-hemodialysis group (p = 0.032). The hemodialysis group showed a significantly lower AFS rate at 3 years than the non-hemodialysis group (86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

  10. Duration of dual antiplatelet therapy after drug-eluting stent implantation: Meta-analysis of large randomised controlled trials

    PubMed Central

    Tsoi, Man-Fung; Cheung, Ching-Lung; Cheung, Tommy Tsang; Wong, Ian Chi-Kei; Kumana, Cyrus Rustam; Tse, Hung-Fat; Cheung, Bernard Man-Yung

    2015-01-01

    Patients receive dual antiplatelet therapy (DAPT) for 6–12 months after drug-eluting stents (DES) implantation. The efficacy and safety of prolonged DAPT has been questioned. Therefore, we performed a meta-analysis on randomised trials comparing different DAPT durations. Literature was searched on trials comparing different DAPT durations. For inclusion, reports must report frequency of cardiovascular and bleeding events. Ten trials were included. Compared to 12 months, DAPT beyond 12 months was associated with fewer myocardial infarctions (OR 0.58 95%CI: 0.40–0.84) and stent thrombosis (OR 0.35 95%CI: 0.20–0.62), but more major bleeds (OR 1.60 95%CI: 1.22–2.11) and all-cause (OR 1.30 95%CI: 1.02–1.66) mortality. There was no significant alteration in risk of stroke (OR 0.93 95%CI: 0.66–1.31) or cardiac (OR 1.12 95%CI: 0.73–1.71) mortality. Compared to less than 12 months DAPT, 12 months DAPT did not reduce risk of myocardial infarction, stent thrombosis, strokes, cardiac or all-cause mortality, but increased the risk of major bleeds (OR 1.60 95%CI: 1.22–2.11). DAPT beyond 12 months reduce risk of myocardial infarction and stent thrombosis, but there is substantial increase in major bleeding risk and all-cause mortality which need to be addressed. DAPT beyond 12 months does not appear to alter the risk of stroke. PMID:26278959

  11. Background, incidence, and predictors of antiplatelet therapy discontinuation during the first year after drug-eluting stent implantation.

    PubMed

    Ferreira-González, Ignacio; Marsal, Josep R; Ribera, Aida; Permanyer-Miralda, Gaietà; García-Del Blanco, Bruno; Martí, Gerard; Cascant, Purificación; Martín-Yuste, Victoria; Brugaletta, Salvatore; Sabaté, Manuel; Alfonso, Fernando; Capote, Mari L; De La Torre, Jose M; Ruíz-Lera, Marta; Sanmiguel, Dario; Cárdenas, Mérida; Pujol, Beth; Baz, Jose A; Iñiguez, Andrés; Trillo, Ramiro; González-Béjar, Omar; Casanova, Juan; Sánchez-Gila, Joaquín; García-Dorado, David

    2010-09-07

    Predictors of antiplatelet therapy discontinuation (ATD) during the first year after drug-eluting stent implantation are poorly known. This was a prospective study with 3-, 6-, 9-, and 12-month follow-up of patients receiving at least 1 drug-eluting stent between January and April 2008 in 29 hospitals. Individual- and hospital-level predictors of ATD were assessed by hierarchical-multinomial regression analysis. ATD could be assessed in 1622 candidates for follow-up (82.5%). A total of 234 patients (14.4%) interrupted at least 1 antiplatelet therapy drug, predominantly clopidogrel (n=182, 11.8%). Bleeding events or invasive procedures led to ATD in 109 patients. This was predicted by renal impairment (odds ratio [OR] 2.81, 95% confidence interval [CI] 1.48 to 5.34), prior major hemorrhage (OR 3.77, 95% CI 1.41 to 10.03), and peripheral arterial disease (OR 1.78, 95% CI 1.01 to 3.15). Medical decisions led to ATD in 70 patients; this was predicted by long-term use of anticoagulant therapy (OR 3.88, 95% CI 1.26 to 11.98), undergoing the procedure in a private hospital (OR 13.3, 95% CI 1.69 to 105), and not receiving instructions about medication (OR 2.8, 95% CI 1.23 to 6.36). Thirty-nine patients interrupted ATD on their own initiative, mainly immigrants (OR 3.78, 95% CI 1.2 to 11.98) and consumers of psychotropic drugs (OR 2.58, 95% CI 1.3 to 5.12). ATD during the first year after drug-eluting stent implantation is based mainly on patient decision or a medical decision not associated with major bleeding events or major surgical procedures. Individual- and hospital-level variables are important to predict ATD.

  12. Non-invasive and invasive predictors of paravalvular regurgitation post CoreValve® stent prosthesis implantation in aortic valves.

    PubMed

    Anger, Thomas; Bauer, Verena; Plachtzik, Claudia; Geisler, Tobias; Gawaz, Meinrad; Oberhoff, Martin; Höher, Martin

    2014-06-01

    The long-term success of CoreValve® stent prosthesis (Medtronic) implantation for severe aortic valve stenosis is limited by postprocedural paravalvular regurgitation (PVR). We have retrospectively investigated preinterventional cardiac 256-slice computed tomography (CT) scans and aortography to define predictors for mild, moderate, or severe PVR, in a blinded fashion. We investigated 100 consecutive patients with a mean aortic valve area (AVA) of 0.69 cm(2) and a mean age of 79.4 years. PVR was defined by echocardiography as mild (63), moderate (18), or severe (19). We found no differences according to AVA, left ventricular function, deployed stent size, calcification rate of the aortic valve, and stent position. Anatomically, the annular size and the angle between the left ventricular outflow tract (LVOT) and the ascending aorta demonstrated significant (P < 0.05) differences in the severity of the PVR: an LVOT: ascending aorta angle >12.6°, annulus area >8.9 cm(2) , and annulus diameter difference >3.9 mm. The multivariate analysis demonstrated that deviation angle, difference of aortic annulus (longitudinal-orthogonal), and CoreValve size were independent predictors of PVR. Our data demonstrate the feasibility of cardiac CT to evaluate predictors of PVR post-CoreValve placement. We support the aortic annulus (the area as well as the diameter differences) and the deviation of the linear slope from LVOT to ascending aorta as predictors of severe paravalvular regurgitations poststent implantation. © 2014, Wiley Periodicals, Inc.

  13. Fatty acid profile in erythrocyte membranes and plasma phospholipids affects significantly the extent of inflammatory response to coronary stent implantation.

    PubMed

    Čermák, T; MuŽáková, V; Matějka, J; Skalický, J; Laštovička, P; Líbalová, M; Kanďár, R; Novotný, V; Čegan, A

    2016-12-13

    In coronary heart disease, the treatment of significant stenosis by percutaneous coronary intervention (PCI) with stent implantation elicits local and systemic inflammatory responses. This study was aimed at evaluation of the dynamics of inflammatory response and elucidation of the relationship between the fatty acid profile of red blood cell (RBC) membranes or plasma phospholipids and inflammation after PCI. High-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), serum amyloid A (SAA), malondialdehyde (MDA) and the fatty acid profiles were determined in patients with advanced coronary artery disease undergoing PCI before, 24 h and 48 h after drug-eluting stent implantation (n=36). Patients after PCI exhibited a significant increase in studied markers (hsCRP, IL-6, SAA, MDA). Many significant associations were found between the increase of IL-6, resp. SAA and the amounts of n-6 polyunsaturated fatty acids (namely linoleic, dihomo-gamma-linolenic, docosatetraenoic and docosapentaenoic acid), resp. saturated fatty acids (pentadecanoic, stearic, nonadecanoic) in erythrocyte membranes. The magnitude of the inflammatory response to PCI is related to erythrocyte membrane fatty acid profile, which seems to be a better potential predictor of elevation of inflammatory markers after PCI than plasma phospholipids.

  14. Short-Term and Long-Term Outcomes After Polytetrafluoroethylene-Covered Stent Implantation for the Treatment of Coronary Perforation.

    PubMed

    Kawamoto, Hiroyoshi; Tanaka, Kentaro; Ruparelia, Neil; Takagi, Kensuke; Yabushita, Hiroto; Watanabe, Yusuke; Mitomo, Satoru; Matsumoto, Takahiro; Naganuma, Toru; Fujino, Yusuke; Ishiguro, Hisaaki; Tahara, Satoko; Kurita, Naoyuki; Nakamura, Shotaro; Hozawa, Koji; Nakamura, Sunao

    2015-12-15

    This study sought to evaluate the short-term and 3-year outcomes of polytetrafluoroethylene-covered stent (PCS) for patients with coronary perforation. Implantation of a PCS has improved the immediate clinical outcomes of patients with coronary perforation. However, there are few reports regarding long-term outcomes. We evaluated a total of 57 patients who were treated with PCS for coronary perforation from April 2004 to March 2015 at a single high-volume center in Japan. Landmark analysis was performed at 30 days to determine short-term and long-term outcomes. Major adverse cardiac events (MACE) were defined as death, myocardial infarction, target vessel revascularization, and requirement for surgical repair. Of 285 patients who experienced coronary perforation, 57 patients (20%) were treated with PCS. The MACE rates were 28% at 30 days, 22% at 1 year, and 38% at 3 years. 30-day MACE was mainly driven by high rates of myocardial infarction (18%) and surgical repair (16%). The rates of target lesion revascularization were 8% and 12% at 1 and 3 years, respectively. Definite stent thrombosis was reported in 2 patients during the follow-up period. In conclusion, despite the relatively high incidence of MACE during early stage of follow-up, implantation of a PCS provides acceptable late clinical outcomes.

  15. Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.

    PubMed

    Hong, Sung-Jin; Kim, Byeong-Keuk; Shin, Dong-Ho; Nam, Chung-Mo; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon; Kang, Tae-Soo; Kang, Woong-Chol; Her, Ae-Young; Kim, Yong Hoon; Kim, Yonghoon; Hur, Seung-Ho; Hong, Bum-Kee; Kwon, Hyuckmoon; Jang, Yangsoo; Hong, Myeong-Ki

    2015-11-24

    Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents. To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions. The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent ≥28 mm in length) between October 2010 and July 2014 at 20 centers in Korea. Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat. One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% [95% CI, -5.14% to -0.79%]) (hazard ratio [HR], 0.48 [95% CI, 0.28 to 0.83], P = .007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 [95% CI, 0

  16. Histological changes in canine aorta 1 year after stent-graft implantation: implications for the long-term stability of device anchoring zones.

    PubMed

    Bashar, Abul Hasan Muhammad; Kazui, Teruhisa; Terada, Hitoshi; Suzuki, Kazuya; Washiyama, Naoki; Yamashita, Katsushi; Baba, Satoshi

    2002-06-01

    To examine aortic histology 1 year after stent-graft implantation in a canine model as a means of assessing the durability of endograft fixation. Fourteen mongrel dogs each received 1 stent-graft and 1 bare stent placed endoluminally in the abdominal aorta. Eight animals were followed for 1 year, 3 for 4 to 8 weeks, and the remaining 3 for 24 to 48 hours. Aortic specimens were stained with hematoxylin-eosin, elastica-van Gieson, and Masson's trichrome and examined with light and electron microscopy and immunohistochemistry to identify smooth muscle cells (SMC), endothelialization, aortic wall ultrastructure, and changes at the device anchoring sites. No dilatation or dissection was noted at any of the device anchoring sites. The aortic media at 1 year was remarkably decreased in thickness: 891 +/- 196 microm in the control tissue versus 388 +/- 70 microm for the proximal stent-grafted aorta and 457 +/- 148 microm for the bare-stented aortic segment. Other important histological features were reduced elastic lamellae in the stent-grafted aorta versus control (p<0.0001), increased SMC density in the stent-grafted aortic region (p<0.0001 versus control), and absence of inflammatory infiltrate. Complete neointimal covering and endothelialization of the luminal endograft surface were found. SMCs generally showed no ultrastructural features of necrosis. Aortic stent-grafts induce distinctive histological changes in the aortic wall at 1 year, even when implanted in a healthy aorta. Although there is considerable medial elastin loss, an increased medial SMC density, an exuberant neointima, and a general absence of perigraft inflammation suggest an ongoing process of structural restoration at the device anchoring sites.

  17. Renal Denervation Suppresses Coronary Hyperconstricting Responses After Drug-Eluting Stent Implantation in Pigs In Vivo Through the Kidney-Brain-Heart Axis.

    PubMed

    Uzuka, Hironori; Matsumoto, Yasuharu; Nishimiya, Kensuke; Ohyama, Kazuma; Suzuki, Hideaki; Amamizu, Hirokazu; Morosawa, Susumu; Hirano, Michinori; Shindo, Tomohiko; Kikuchi, Yoku; Hao, Kiyotaka; Shiroto, Takashi; Ito, Kenta; Takahashi, Jun; Fukuda, Koji; Miyata, Satoshi; Funaki, Yoshihito; Ishibashi-Ueda, Hatsue; Yasuda, Satoshi; Shimokawa, Hiroaki

    2017-10-01

    Drug-eluting stent-induced coronary hyperconstricting responses remain an important issue. The adventitia harbors a variety of components that potently modulate vascular tone, including sympathetic nerve fibers (SNF) and vasa vasorum. Catheter-based renal denervation (RDN) inhibits sympathetic nerve activity. We, thus, examined whether RDN suppresses drug-eluting stent-induced coronary hyperconstricting responses, and if so, what mechanisms are involved. Protocol 1: pigs implanted with everolimus-eluting stents into the left coronary arteries underwent coronary angiography at 1 month after implantation for assessment of coronary vasomotion and adventitial SNF formation. Drug-eluting stent-induced coronary hyperconstricting responses were significantly enhanced associated with enhanced coronary adventitial SNF and vasa vasorum formation. Protocol 2: pigs implanted with everolimus-eluting stents were randomly assigned to the RDN or sham group. The RDN group underwent renal ablation. At 1 month, RDN significantly caused marked damage of the SNF at the renal arteries without any stenosis, thrombus, or dissections. Notably, RDN significantly upregulated the expression of α2-adrenergic receptor-binding sites in the nucleus tractus solitarius, attenuated muscle sympathetic nerve activity, and decreased systolic blood pressure and plasma renin activity. In addition, RDN attenuated coronary hyperconstricting responses to intracoronary serotonin at the proximal and distal stent edges associated with decreases in SNF and vasa vasorum formation, inflammatory cell infiltration, and Rho-kinase expression/activation. Furthermore, there were significant positive correlations between SNF and vasa vasorum and between SNF and coronary vasoconstricting responses. These results provide the first evidence that RDN ameliorates drug-eluting stent-induced coronary hyperconstricting responses in pigs in vivo through the kidney-brain-heart axis. © 2017 American Heart Association, Inc.

  18. Endoscopic esophageal self-expanding stent implantation WallFlex™ (Boston Scientific) in the management of a gastrocutaneous fistula, as a complication of sleeve bariatric gastrectomy.

    PubMed

    Janczak, Dariusz; Pawłowski, Wiktor; Ziomek, Agnieszka; Dorobisz, Tadeusz; Janczak, Dawid; Janus, Werner; Chabowski, Mariusz

    2015-06-01

    The study presented a case of a gastrocutaneous fistula, as a result of bariatric sleeve gastrectomy. The discussion considered the main pathogenesis, etiology, diagnostics and endoscopic treatment using the implantation of covered esophageal stents. Special attention was placed upon the multifactorial origin of this life-threatening clinical condition, typical for bariatric surgery.

  19. Treatment of a Celiac Trunk Aneurysm Close to the Hepato-splenic Bifurcation by Using Hepatic Stent-graft Implantation and Splenic Artery Embolization

    SciTech Connect

    Basile, Antonio Lupattelli, Tommaso; Magnano, Marco; Giulietti, Giorgio; Privitera, Giambattista; Battaglia, Giuseppe; Monaca, Vincenzo; Ettorre, Giancarlo

    2007-02-15

    We present a case of a 73-year-old man in whom a celiac trunk aneurysm close to the hepato-splenic bifurcation was discovered and treated by using celiac-hepatic stent-grafts implantation and splenic artery embolization.

  20. First-generation paclitaxel- vs. second-generation zotarolimus-eluting stents in small coronary arteries: the BASKET-SMALL Pilot Study

    PubMed Central

    Pfisterer, Matthias; Pfister, Otmar; Rickenbacher, Peter; Handke, Michael; Gilgen, Nicole; Coslovsky, Michael; Kaiser, Christoph

    2016-01-01

    Introduction Event rates after percutaneous coronary interventions (PCI) are higher in small than large coronary vessels but may vary between different drug-eluting stent (DES) types. Aim To assess the efficacy of two different DES in small vessel disease. Material and methods Patients with small vessel PCI were randomised 1 : 1 to a first-generation paclitaxel- vs. a second-generation zotarolimus-eluting stent. The primary endpoint was a composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularisation after 2 years. Results Overall, 191 patients were enrolled: 100 with a paclitaxel- and 91 with a zotarolimus-eluting stent. Baseline characteristics were similar in both groups. After 2 years, rates of the primary endpoint were numerically higher for zotarolimus- than paclitaxel-eluting stents (9.9% vs. 5.0%, hazard ratio 2.09, 95% confidence interval (CI) 0.7–6.2, p = 0.19), which was mainly driven by higher rates of target vessel revascularisation (6.6% vs. 2.0%, hazard ratio 3.39, 95% CI: 0.68–16.78, p = 0.14). Based on this, a total of 1,019 patients would be necessary to demonstrate at least non-inferiority between the DES used. Conclusions In this pilot study, paclitaxel-eluting stents had a favourable efficacy profile in small vessel disease, although the numbers were too small to draw final conclusions. Based on the prohibitively high sample size for a randomized controlled trial between DES, other treatment options should be considered. PMID:27980544

  1. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents.

    PubMed

    Nagoshi, Ryoji; Shinke, Toshiro; Otake, Hiromasa; Shite, Junya; Matsumoto, Daisuke; Kawamori, Hiroyuki; Nakagawa, Masayuki; Kozuki, Amane; Hariki, Hirotoshi; Inoue, Takumi; Ohsue, Tsuyoshi; Taniguchi, Yu; Iwasaki, Masamichi; Nishio, Ryo; Hiranuma, Noritoshi; Konishi, Akihide; Kinutani, Hiroto; Miyoshi, Naoki; Takaya, Tomofumi; Yamada, Shinichiro; Yasaka, Yoshinori; Hayashi, Takatoshi; Yokoyama, Mitsuhiro; Kato, Hiroki; Kadotani, Makoto; Ohnishi, Yoshio; Hirata, Ken-ichi

    2013-01-01

    We hypothesized that the tissue components of in-stent restenosis (ISR) might differ between drug-eluting stents (DES) and bare-metal stents (BMS) and that these differences could be distinguished by qualitative and quantitative optical coherence tomography (OCT) analyses. One-hundred and twenty-two initial ISR lesions (sirolimus-eluting stents: n=28; paclitaxel-eluting stents: n=51; BMS: n=43) were evaluated with OCT. Based on their OCT appearance, the lesions were classified as homogeneous, layered or heterogeneous. The optical properties of backscatter, attenuation and signal intensity of the neointimal tissue (NIT) were quantified. To evaluate the vascular response after balloon angioplasty (BA), the rate of reduction of the NIT area (NITA) was calculated (NITA before - after BA/NITA before BA at the minimum lumen cross-sectional area). Among the morphologic OCT patterns, the layered type was predominant with DES, whereas lesions were homogeneous with BMS (P<0.001). Backscatter and signal intensity were significantly higher with BMS (P<0.05 and P<0.001 respectively). The NITA reduction rate was significantly greater in the layered and heterogeneous groups than in the homogeneous group (P<0.01). The morphologic OCT patterns of the NIT in ISR differed significantly between DES and BMS, probably reflecting pathologic differences. Layered and heterogeneous tissues might respond better than homogeneous tissue to simple balloon dilatation, suggesting a possible direction for OCT-based ISR treatment strategies. 

  2. Flapless surgery and immediately loaded implants: a retrospective comparison between implantation with and without computer-assisted planned surgical stent.

    PubMed

    Danza, Matteo; Carinci, Francesco

    2010-01-01

    Computer planned flapless surgery and immediate loading are the most recent topics in implantology. One new computer-planned implant system uses a three-dimensional parallelometer able to transfer the implant position from the virtual project to the master model. The aim of this study was to verify if the new medical device gives an advantage in term of implant failures and/or crestal bone remodeling. A retrospective study was planned to analyze a series of 193 immediately loaded fixtures inserted by means of flapless surgery. From those sixty six implants were inserted with computer planning whereas 127 were inserted "free-hand". Several variables related to patient, anatomy, implant, surgery and prosthesis were investigated. To detect the clinical outcome implant' failure and peri-implant bone resorption were considered. Kaplan-Meier algorithm and Cox regression were then performed to detect those variables statistically associated with the clinical outcome. Implant length and diameter ranged from 10 to 16 mm and from 3.75 to 6.0 mm, respectively. Implants were inserted to replace 46 incisors, 30 cuspids, 75 premolars and 42 molars. The mean follow-up period was 15 months. Seven implants were lost (survival rate 96.4%) but no studied variable has a statistical impact on failures. On the contrary, implants inserted in sites with completed bone healing, wide diameter fixtures and implants inserted in totally edentulous jaw had a significantly lower crestal bone resorption. The other variables (age, gender, upper/lower jaws, tooth site, implant' type and length, number of prosthetic units antagonist condition) did not have impact on crestal remodeling. Computer-planned and cast model transferred implantology is a reliable technology that provides a slightly higher clinical outcome than "free hand" technique at least in healed sites, wider implants and totally edentulous jaws.

  3. Drug-eluting stents in superficial femoral artery treatment: could they be the standard of care?

    PubMed

    Bosiers, Marc; Deloose, Koen; Callaert, Joren; Peeters, Patrick; Bosiers, Michel

    2016-12-01

    Endovascular techniques have improved markedly over the past several decades. Plain old balloon angioplasty can only reach patencies around 40% after 1 year. Scaffolding stents have resulted in improved short-term results but encountered limitations for longer-term durability. With the introduction of drug-eluting technologies the process of intimal hyperplasia might be slowed, resulting in improved long-term patency results. At first, limus-eluting technologies were not able to transfer the enthusiasm from the coronaries to the infrainguinal vascular bed. However, the newer generation paclitaxel-eluting technologies perform significantly better in femoropopliteal arteries than their non-eluting or non-coated counterparts. The results of a prospective randomized trial comparing DES versus DCB is eagerly awaited. For the moment there seems, based on the meta-analysis, no difference between the two treatment modalities. Although, we need to keep in mind that DCB perform worse in long calcified lesions.

  4. Prolonged high-pressure balloon angioplasty of femoropopliteal lesions: Impact on stent implantation rate and mid-term outcome

    PubMed Central

    Rigatelli, Gianluca; Palena, Mariano; Cardaioli, Paolo; dell'Avvocata, Fabio; Giordan, Massimo; Vassilev, Dobrin; Manzi, Marco

    2014-01-01

    Objectives To assess the impact on stent implantation rate and mid-term outcomes of prolonged high pressure angioplasty of femoropopliteal lesions. Methods We retrospectively enrolled 620 consecutive patients from January 2011 to December 2011 (75.6 ± 12.3 years, 355 males, 76.5% in Rutherford class 5–6), referred for critical limb ischemia and submitted to prolonged high-pressure angioplasty of femoropopliteal lesions. The definition of prolonged high-pressure angioplasty includes dilation to at least 18 atm for at least 120 s. Procedural data, and clinical and instrumental follow-up were analyzed to assess stent implantation rate and mid-term outcomes. Results The preferred approach was ipsilateral femoral antegrade in 433/620 patients (69.7%) and contralateral cross-over in 164/620 (26.4%) and popliteal retrograde + femoral antegrade in 23/620 (3.7%). Techniques included subintimal angioplasty in 427/620 patients (68.8%) and endoluminal angioplasty in 193/620 patients (31.2%). The prolonged high pressure balloon angioplasty procedure was successful in 86.2% (minor intra-procedural complications rate 15.7 %), stent implantation was performed in 74 patients (11.9%), with a significant improvement of ankle-brachial index (0.29 ± 0.6 vs. 0.88 ± 0.3, P < 00.1) and Rutherford class (5.3 ± 0.8 vs. 0.7 ± 1.9, P < 0.01), a primary patency rate of 86.7%, restenosis of 18.6 % on Doppler ultrasound and a target lesion revascularization of 14.8% at a mean follow-up of 18.1 ± 6.4 months (range 1–24 months). Secondary patency rate was 87.7%. Conclusions Prolonged high pressure angioplasty of femoropopliteal lesions appears to be safe and effective allowing for an acceptable patency and restenosis rates on mid-term. PMID:25009562

  5. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    PubMed

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  6. 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.

  7. Airport and superficial femoral artery obstruction due to a wandering coronary stent: the possibility of airport detection of modern implant metals.

    PubMed

    Teijink, J A W; van Herwaarden, J A; van den Berg, J C; Overtoom, T C; Moll, F L

    2004-06-01

    In the treatment of coronary artery disease, peripheral loss of a coronary stent is an unusual complication. We present the case of a patient who suggested that his right leg claudication was caused by a slipped coronary stent 2 years previously. The patient was convinced about this unusual finding based on an airport security check. Examination proved him to be right. However, the ability to detect an object using eddy currents is dependent on the object's permeability and its conductivity. Ferrous (iron) content is not the critical factor. Modern implant materials and processing techniques result in implants that are difficult to magnetize i.e. their permeability is very low. In addition their conductivity is very low. This enables modern implants to escape detection at airports. For this reason the event at the airport, as described by our patient, is considered coincidental.

  8. Patient-level meta-analysis of 999 claudicants undergoing primary femoropopliteal nitinol stent implantation.

    PubMed

    Rocha-Singh, Krishna J; Beckman, Joshua A; Ansel, Gary; Lyden, Sean P; Schneider, Peter; Mehta, Manish; Dake, Michael; Mullin, Christopher M; Jaff, Michael R

    2017-06-01

    The factors that impact the clinical effectiveness of bare nitinol stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed. Peripheral Artery Disease BACKGROUND: The performance of bare metal nitinol stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined. Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates. About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates

  9. Portal Vein Stenting Combined with Iodine-125 Seeds Endovascular Implantation Followed by Transcatheter Arterial Chemoembolization for Treatment of Hepatocellular Carcinoma Patients with Portal Vein Tumor Thrombus

    PubMed Central

    Zhou, Tanyang; Zhu, Tongyin; Zhang, Yuelin; Nie, Chunhui; Ai, Jing; Zhou, Guanhui; Zhang, Aibin; Dong, Meng-Jie; Wang, Wei-Lin

    2016-01-01

    Aim was to assess the therapeutic value of portal vein stenting (PVS) combined with iodine-125 seed (125I seed) strand endovascular implantation followed by transcatheter arterial chemoembolization (TACE) for treating patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT). This was a retrospective study of 34 patients aged 29–81 years, diagnosed HCC with PVTT, and treated with PVS combined with 125I seed strand endovascular implantation followed by TACE between January 2012 and August 2014. Survival, stent patency, technical success rate, complications related to the procedure, and adverse events were recorded. The technical success rate was 100%. No serious procedure-related adverse event was recorded. The median survival was 147 days. The cumulative survival rates and stent patency rates at 90, 180, and 360 days were 94.1%, 61.8%, and 32.4% and 97.1% (33/34), 76.9% (24/34), and 29.4% (10/34), respectively. PVS combined with 125I seed strand endovascular implantation followed by TACE is feasible for patients with HCC and PVTT. It resulted in appropriate survival and stent patency, with no procedure-related adverse effects. PMID:27999793

  10. Prevalence and Predictors of Early Discontinuation of Dual-Antiplatelet Therapy After Drug-Eluting Stent Implantation in Korean Population.

    PubMed

    Cho, Mi Hee; Shin, Dong Wook; Yun, Jae Moon; Shin, Joong Hyun; Lee, Seung Pyo; Lee, Hyejin; Lim, Yoo Kyoung; Kim, Eun Ha; Kim, Hyun Kyoung

    2016-11-15

    The administration of antiplatelet drugs for months after a drug-eluting stent implantation is critical in decreasing the risk of complications, and premature discontinuation of antiplatelet therapy before the recommended period is the most important predictor for late complications. Therefore, we investigated the prevalence and associated factors of premature discontinuation of antiplatelet therapy in patients in Korea. This retrospective cohort study was conducted using the Korean National Health Insurance Service-National Sample Cohort data. Patients who were treated with dual-antiplatelet therapy (DAPT) were identified with medication prescription data. The Kaplan-Meier failure time plot was used to illustrate the cumulative probability of treatment discontinuation. Cox regression analysis was conducted to compare predictors of early discontinuation of DAPT. The characteristics of the early discontinuation group were not significantly different from the guideline concordance group, except for a higher prevalence of disability and a lower rate of chronic kidney disease. In a Cox regression model, the presence of hypertension was identified as a negative predictor of early discontinuation, and disability was not a statistically significant predictor. The prevalence of early discontinuation was 31.0% and seems to be significantly higher than those reported from prospective studies, which may more accurately reflect the real-world situation. In conclusion, physicians should make more effort to educate patients on the risk associated with premature discontinuation of antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent, and further studies investigating the reasons for nonadherence of DAPT are needed to improve DAPT compliance.

  11. New stents for SFA.

    PubMed

    MINAR, E; SCHILLINGER, M

    2009-10-01

    Endovascular stent implantation was introduced to femoropopliteal procedures almost two decades ago. Initial results with balloon-expandable stainless steel stents and self expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were rather high, in the range of 60% to 80% at 1 year. After years of stagnation, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices. The second generation of Nitinol stents have an enhanced flexibility particularly also in axial direction due to a reduction of cell interconnections and a more spiral orientation of the interconnections. However, until now there is no proof of any impact of the stent design on restenosis rate. Otherwise, stenting has been shown to be beneficial compared to balloon angioplasty especially in longer femoropopliteal lesions. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The main unresolved problem with femoropopliteal stenting is the treatment of instent restenosis. Future concepts to further improve long-term patency after femoropopliteal stenting are therefore under investigation, including drug-eluting stents (DES), biodegradable stents, and coated stent-grafts. Stent grafts appear to be a viable option for the treatment of complex superficial femoral artery lesions, with comparable outcomes to prosthetic above-knee femoropopliteal bypass surgery. Concerning DES, we have to wait for the results of the ongoing studies.

  12. Blood level of CD45+ platelets and development of restenosis after drug-eluting stent implantation in patients with stable coronary artery disease.

    PubMed

    Gabbasov, Zufar; Kozlov, Sergey; Byazrova, Svetlana; Saburova, Olga; Melnikov, Ivan; Caprnda, Martin; Curilla, Eduard; Gaspar, Ludovit; Kruzliak, Peter; Smirnov, Vladimir

    2016-12-01

    The aim of this study was to assess CD45-positive platelets (CD45+ platelets) involvement in restenosis development after drug-eluting stent (DES) implantation in patients with stable coronary artery disease (CAD). The study comprised 126 male and female patients with stable angina pectoris, who underwent elective coronary stenting with DES and follow-up angiography within 6-12 months. The patients were assigned to the group with restenosis (n = 53) or group without restenosis (n = 73) according to the follow-up angiograms. In both groups we compared the level in blood of CD45+ platelets, the clinical, laboratory and angiographic variables, which may affect the development of restenosis. We have also constructed a logit regression model for prognosis of restenosis occurrence after DES implantation. The blood count of CD45+ platelets was higher in patients with restenosis than in patients without: 0.82 % (0.58; 1.12) vs. 0.34 % (0.20; 0.68), p < 0.001, data are expressed as median (lower quartile; upper quartile). By binary comparisons of more than 35 different clinical, laboratory and angiographic variables we identified 8 significant risk factors for the development of stent restenosis after DES. In order to define the risk of the development of restenosis, we have built a logit regression model. The resulting logit regression equation included the level of CD45+ platelets, the neutrophil to lymphocyte ratio (NLR), small diameter arteries stenting and the number of simultaneously implanted stents in one patient. Receiver operating characteristic (ROC) curve analysis has demonstrated the high prognostic value of the resulting logit regression equation with an area under the curve (AUC) of 0.91 % (p < 0.001). The acquired data indicate the presence of a close relationship between circulating CD45+ platelets and restenosis development after DES implantation in patients with stable CAD.

  13. Myocardial blush grade: a predictor for major adverse cardiac events after primary PTCA with stent implantation for acute myocardial infarction.

    PubMed

    Kaya, Mehmet G; Arslan, Fatih; Abaci, Adnan; van der Heijden, Geert; Timurkaynak, Timur; Cengel, Atiye

    2007-10-01

    Optimal myocardial reperfusion is of great importance for survival of patients with AMI undergoing PTCA. According to the Thrombolysis In Myocardial Infarction (TIMI) 3 score, restoration of epicardial flow is achieved in the majority of patients. However, the myocardial blush grade (MBG) may offer additional information for survival. Therefore, we sought to determine whether myocardial blush grades were associated with MACE during follow-up in a high-risk AMI population undergoing primary PTCA with stent implantation. Hundred-and-thirty patients with AMI underwent PTCA with stent implantation from 1999 to 2004. The clinical, angiographic and follow-up data were extracted from the hospital records. Apart from the availability and technical adequacy of the angiograms for angiographic analysis, there were no exclusion criteria. Post-procedural TIMI 3 flow was achieved in 103 (79%) patients, while MBG-3 was observed in only 44 (34%) patients. Less post-intervention AMI, cardiac deaths or any MACE occurred in patients with MBG 3 (4/44) compared with MBG 1 or 2 (36/86) (P < 0.01). MBG 3 was a strong predictor of absence of MACE during 5-year follow-up (P < 0.01), whereas no association was found between TIMI 3 and event-free survival (P > 0.5) in our population. Our data show that (1) MBG 3 is an important marker for survival and (2) the predictive value of MBG is superior to the TIMI flow grades. Given the predictive validity of MBG shown for MACE-free survival and low rate of MBG 3 despite achievement of TIMI 3 flow, a prospective study with adjunctive therapies to enhance myocardial perfusion is warranted.

  14. Five-Year Clinical Outcomes After Drug-Eluting Stent Implantation Following Rotational Atherectomy for Heavily Calcified Lesions.

    PubMed

    Jinnouchi, Hiroyuki; Kuramitsu, Shoichi; Shinozaki, Tomohiro; Hiromasa, Takashi; Kobayashi, Yohei; Takeji, Yasuaki; Miura, Mizuki; Masuda, Hisaki; Matsumura, Yukiko; Yamaji, Yuhei; Sakakura, Kenichi; Domei, Takenori; Soga, Yoshimitsu; Hyodo, Makoto; Shirai, Shinichi; Ando, Kenji

    2017-09-09

    Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA.Methods and Results:Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04). Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

  15. Sun's procedure for complex aortic arch repair: total arch replacement using a tetrafurcate graft with stented elephant trunk implantation.

    PubMed

    Ma, Wei-Guo; Zhu, Jun-Ming; Zheng, Jun; Liu, Yong-Min; Ziganshin, Bulat A; Elefteriades, John A; Sun, Li-Zhong

    2013-09-01

    The Sun's procedure is a surgical technique proposed by Dr. Li-Zhong Sun in 2002 that integrates total aortic arch replacement using a tetrafurcated graft with implantation of a specially designed frozen elephant trunk (Cronus(®)) in the descending aorta. It is used as a treatment option for extensive aortic dissections or aneurysms involving the ascending aorta, aortic arch and the descending aorta. The technical essentials of Sun's procedure include implantation of the special open stented graft into the descending aorta, total arch replacement with a 4-branched vascular graft, right axillary artery cannulation, selective antegrade cerebral perfusion for brain protection, moderate hypothermic circulatory arrest at 25 °C, a special anastomotic sequence for aortic reconstruction (i.e., proximal descending aorta → left carotid artery → ascending aorta → left subclavian artery → innominate artery), and early rewarming and reperfusion after distal anastomosis to minimize cerebral and cardiac ischemia. The core advantage of Sun's procedure lies in the use of a unique stented graft, which has superior technical simplicity, flexibility, inherent mechanical durability and an extra centimeter of attached regular vascular graft at both ends. Since its introduction in 2003, the Sun's procedure has produced satisfactory early and long-term results in over 8,000 patients in China and more than 200 patients in South American countries. In a series of 1,092 patients, the authors have achieved an in-hospital mortality rate of 6.27% (7.98% in emergent or urgent vs. 3.98% in elective cases). Given the accumulating clinical experience and the consequent, continual evolution of surgical indications, the Sun's procedure is becoming increasingly applied/used worldwide as an innovative and imaginative enhancement of surgical options for the dissected (or aneurysmal) ascending aorta, aortic arch and proximal descending aorta, and may become the next standard treatment for type

  16. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma

    PubMed Central

    Donnenfeld, Eric D; Solomon, Kerry D; Voskanyan, Lilit; Chang, David F; Samuelson, Thomas W; Ahmed, Iqbal Ike K; Katz, L Jay

    2015-01-01

    Purpose To evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication. Patients and methods In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. Results Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001). Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation. Conclusion In a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months. PMID:26604675

  17. Experience with multiple stent implantations in primary antiphospholipid syndrome in childhood: a case report.

    PubMed

    Bakkaloglu, S A; Keefer, M S; Schroeder, S; Stanley, P; Harrell, D S; Reiff, A

    2009-01-01

    The antiphospholipid syndrome (APS) is an autoimmune condition characterized by the persisting presence of antiphospholipid antibodies in association with thrombosis and/or pregnancy morbidity. Primary APS is quite rare in childhood and exact prevalence is not known. However, substantial proportion of thrombotic events in children is being attributed to APS. We herein present a 9-year-old boy presented with impending pericardial tamponade and large pleural effusions likely secondary to transudation of fluid from his gradually developed collateral circulation which was resulted from almost completely occluded vena caval system due to primary APS. He was treated with multiple angioplasty-stenting which offered symptomatic relief and better quality of life. To our knowledge, this is the first reported paediatric case of primary APS presented with extensive occlusive lesions in both caval systems and treated with repeated endovascular stent placements.

  18. Double antiplatelet therapy after drug-eluting stent implantation: risk associated with discontinuation within the first year.

    PubMed

    Ferreira-González, Ignacio; Marsal, Josep R; Ribera, Aida; Permanyer-Miralda, Gaietà; García-Del Blanco, Bruno; Martí, Gerard; Cascant, Purificación; Masotti-Centol, Mónica; Carrillo, Xavier; Mauri, Josepa; Batalla, Nuria; Larrousse, Eduard; Martín, Eva; Serra, Antonio; Rumoroso, José Ramón; Ruiz-Salmerón, Rafael; de la Torre, Jose M; Cequier, Angel; Gómez-Hospital, Jose A; Alfonso, Fernando; Martín-Yuste, Victoria; Sabatè, Manel; García-Dorado, David

    2012-10-09

    The goal of this study was to assess the risk associated with double antiplatelet therapy (DAT) discontinuation, and specifically, temporary discontinuation, during the first year after drug-eluting stent (DES) implantation. Doubts remain about the risk of temporary DAT discontinuation within 1 year after DES implantation. A total of 1,622 consecutive patients undergoing DES implantation at 29 hospitals were followed up at 3, 6, 9, and 12 months to record the 1-year antiplatelet therapy discontinuation (ATD) rate, the number of days without DAT, and the rate of 1-year major cardiac events. Cox regression was used to analyze the association between ATD considered as a time-dependent covariate and 1-year cardiac events. One hundred seventy-two (10.6%) patients interrupted at least 1 antiplatelet drug during the first year after DES implantation, although only 1 during the first month. Most (n=111, 64.5%) interrupted DAT temporarily (median: 7 days; range: 5 to 8.5): 79 clopidogrel (31 temporarily), 38 aspirin (27 temporarily), and 55 both drugs (53 temporarily). Discontinuation was followed by acute coronary syndrome in 7 (4.1%; 95% confidence interval [CI]: 1.7 to 8.2), a similar rate of major cardiac events to that in patients without ATD (n=80; 5.5%; 95% CI: 4.4 to 6.8; p=0.23). ATD was not independently associated with 1-year major cardiac events (hazard ratio: 1.32 [95% CI: 0.56 to 3.12]). ATD within the first year and beyond the first month after DES is not exceptional, is usually temporary, and does not appear to have a large impact on risk. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. Impact of the distance from the stent edge to the residual plaque on edge restenosis following everolimus-eluting stent implantation.

    PubMed

    Takahashi, Masao; Miyazaki, Susumu; Myojo, Masahiro; Sawaki, Daigo; Iwata, Hiroshi; Kiyosue, Arihiro; Higashikuni, Yasutomi; Tanaka, Tomofumi; Fujita, Daishi; Ando, Jiro; Fujita, Hideo; Hirata, Yasunobu; Komuro, Issei

    2015-01-01

    This study aimed to assess the relation between stent edge restenosis (SER) and the distance from the stent edge to the residual plaque using quantitative intravascular ultrasound. Although percutaneous coronary intervention with drug-eluting stents has improved SER rates, determining an appropriate stent edge landing zone can be challenging in cases of diffuse plaque lesions. It is known that edge vascular response can occur within 2 mm from the edge of a bare metal stent, but the distance to the adjacent plaque has not been evaluated for drug-eluting stents. A total of 97 proximal residual plaque lesions (plaque burden [PB] >40%) treated with everolimus-eluting stents were retrospectively evaluated to determine the distance from the stent edge to the residual plaque. The SER group had significantly higher PB (59.1 ± 6.1% vs. 51.9 ± 9.1% for non-SER; P = 0.04). Higher PB was associated with SER, with the cutoff value of 54.74% determined using receiver operating characteristic (ROC) curve analysis. At this cutoff value of PB, the distance from the stent edge to the lesion was significantly associated with SER (odds ratio = 2.05, P = 0.035). The corresponding area under the ROC curve was 0.725, and the cutoff distance value for predicting SER was 1.0 mm. An interval less than 1 mm from the proximal stent edge to the nearest point with the determined PB cutoff value of 54.74% was significantly associated with SER in patients with residual plaque lesions.

  20. 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

  1. 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.

  2. Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2.

    PubMed

    de la Torre Hernández, José M; Oteo Domínguez, Juan F; Hernández, Felipe; García Camarero, Tamara; Abdul-Jawad Altisent, Omar; Rivero Crespo, Fernando; Cascón, José D; Zavala, Germán; Gimeno, Federico; Arrebola Moreno, Antonio L; Andraka, Leire; Gómez Menchero, Antonio; Bosa, Francisco; Carrillo, Xavier; Sánchez Recalde, Ángel; Alfonso, Fernando; Pérez de Prado, Armando; López Palop, Ramón; Sanchis, Juan; Diarte de Miguel, José A; Jiménez Navarro, Manuel; Muñoz, Luz; Ramírez Moreno, Antonio; Tizón Marcos, Helena

    2015-10-01

    The recommendation for dual antiplatelet therapy following drug-eluting stent implantation ranges from 6 months to 12 months or beyond. Recent trials have suggested the safety of a 6-month dual antiplatelet therapy regimen, yet certain caveats to these studies limit the applicability of this shorter duration dual antiplatelet therapy strategy in real world settings. A registry was constructed with consecutive recruitment of patients undergoing new-generation drug-eluting stent implantation and prescribed 6 months of dual antiplatelet therapy. Propensity score matching was undertaken with a historical cohort of patients treated with second-generation drug-eluting stents who received 12 months of dual antiplatelet therapy from the ESTROFA-2 registry. The sample size was calculated using a noninferiority basis and the primary endpoint was the combination of cardiac death, myocardial infarction, revascularization, or major bleeding at 12 months. The analysis included 1286 patients in each group, with no significant differences in baseline characteristics. The primary endpoint occurred in 5.0% and 6.6% in the 6-month and 12-month groups, respectively (P = .001 for noninferiority). The incidence of definite or probable stent thrombosis was 0.5% and 0.7% in the 6-month and 12-month groups, respectively (P = .4). Major bleeding events were lower in the 6-month group than in the 12-month group (0.8% vs 1.4%; P = .2) CONCLUSIONS: In selected patients in this large multicenter study, the safety and efficacy of a 6-month dual antiplatelet therapy regimen after implantation of new-generation drug-eluting stents appeared to be noninferior to those of a 12-month dual antiplatelet therapy regimen. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  3. Association Between Helicobacter Pylori Infection and Long-term Outcome in Patients with Drug-eluting Stent Implantation

    NASA Astrophysics Data System (ADS)

    Wang, Rui; Chen, Lei-Lei; Wang, De-Zhao; Chen, Bu-Xing

    2017-07-01

    To investigate the relationship between Helicobacter pylori (Hp) infection and the long-term outcome in acute coronary syndrome (ACS) patients with drug-eluting stent (DES) implantation and so as to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB). 539 ACS patients with DES implantation from January 1, 2010 to December 31, 2012 were analyzed. All the patients were divided into two groups according to the result of 13C urea breath test. 253 patients with Hp infection were put into group A (Hp+), and 286 cases without Hp infection were put into group B (Hp-). Demographic data was collected and all patients went through biochemical indicators and other routine blood examinations. We explored the correlations of Hp infection with MACE and UGIB after 3 to 5 years of follow-up using survival analysis. Survival analysis showed that Hp infection was a predictor of MACE and UGI. Sub-group analysis showed that patients with Hp eradication therapy had no relationship with MACE but had a lower rate of UGIB than those without Hp eradication therapy.

  4. 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.

  5. In Situ Fracture of Stents Implanted for Relief of Pulmonary Arterial Stenosis in Patients with Congenitally Malformed Hearts

    PubMed Central

    McElhinney, Doff B.; Bergersen, Lisa; Marshall, Audrey C.

    2014-01-01

    Background One of the most common uses of stents in patients with congenitally malformed hearts is treatment of pulmonary arterial stenosis. Although there are reports of fractured pulmonary arterial stents, little is known about the risk factors for, and implications of, such fractures. Methods We reviewed angiograms to identify fractures in stents previously inserted to relieve stenoses in pulmonary arteries from 1990 through 2001 in patients who also underwent follow-up catheterization at least 3 years after placement of the stent. We undertook matched cohort analysis, matching a ratio of 2 fractured to 1 unfractured stent. Results Overall, 166 stents meeting the criterions of our study had been placed in 120 patients. We identified fractures in 35 stents (21%) in 29 patients. All fractured stents were in the central pulmonary arteries, 24 (69%) in the central part of the right pulmonary artery, and all were complete axial fractures, or complex fractures along at least 2 planes. Stent-related factors associated with increased risk of fracture identified by multivariable logistic regression included placement in close apposition to the ascending aorta (p = 0.001), and a larger expanded diameter (p = 0.002). There was obstruction across 28 of 35 fractured stents, which was severe in 11. We re-stented 21 of the fractured stents, and recurrent fracture was later diagnosed in 3 of these. A fragment of the fractured stent embolized distally in 2 patients, without clinically important effects. Conclusions In situ fracture of pulmonary arterial stents is relatively common, and in most cases is related to compression by the aorta. There is usually recurrent obstruction across the fractured stent, but fractured stents rarely embolize, and are not associated with other significant complications. PMID:18559137

  6. Three-year-old child with middle aortic syndrome treated by endovascular stent implantation.

    PubMed

    Moszura, Tomasz; Goreczny, Sebastian; Dryzek, Pawel; Niwald, Marek

    2013-04-01

    Middle aortic syndrome (MAS) is an extremely rare anomaly and represents both a diagnostic and therapeutic challenge, particularly in young children. A case of a 3.5 year-old child with MAS and arterial hypertension is reported, where owing to the patient's young age and the length of the hypoplastic aortic segment, surgical correction with end-to-end anastomosis was not feasible. Instead of palliative bypass grafting between the thoracic and abdominal aorta, successful percutaneous balloon angioplasty and stenting of the lesion was performed with the assistance of three-dimensional rotational angiography.

  7. Implantation of a stent graft in the right pulmonary artery enables radical resection of a central endothelial sarcoma of the left pulmonary artery.

    PubMed

    Kissling, Pascal; Brosi, Philippe; Kull, Christof; Toia, Damien; Maurer, Christoph Andreas

    2013-09-01

    In a patient with a huge endothelial sarcoma of the left pulmonary artery, we report successful implantation of a stent graft in the right pulmonary artery, including the pulmonary arterial trunk. This preoperative measure enabled a safe and radical left-sided pneumonectomy, including the tumor and the central parts of the left pulmonary artery. No major blood loss occurred, and neither use of a heart-lung machine nor cardiopulmonary bypass was necessary.

  8. Report of successful use of argatroban as an alternative anticoagulant during coronary stent implantation in a patient with heparin-induced thrombocytopenia and thrombosis syndrome.

    PubMed

    Lewis, B E; Iaffaldano, R; McKiernan, T L; Rao, L; Donkin, J; Wallenga, J M

    1996-06-01

    Heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) is a severe complication of heparin caused by an antibody response to the heparin-platelet factor 4 complex which results in severe thrombosis. Heparin rechallenge in HITTS patients carries a high risk of inducing thrombosis. Antithrombin agents represent treatment alternatives in HITTS patients who require anticoagulation. We report successful coronary stent implantation in a HITTS patient using the antithrombin agent argatroban.

  9. 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

  10. Process for making electroformed stents

    DOEpatents

    Hines, Richard A.

    2000-02-01

    This invention is directed to an expandable stent useful for implantation into an artery or the like. The stents are made using electroforming techniques in which an electrically-conductive mandrel is coated with a suitable resist material, after which the resist is exposed to an appropriate light pattern and frequency so as to form a stent pattern in the resist. The mandrel is then electroplated with a suitable stent material. The mandrel is etched away once a sufficient layer of stent material is deposited, leaving a completed stent.

  11. 6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial.

    PubMed

    Hong, Sung-Jin; Shin, Dong-Ho; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Her, Ae-Young; Kim, Yong Hoon; Jang, Yangsoo; Hong, Myeong-Ki

    2016-07-25

    The aim of this study was to investigate whether a 6-month dual-antiplatelet therapy (DAPT) duration was comparable with a 12-month duration in patients who underwent everolimus-eluting stent implantation. Well-designed studies that determine optimal DAPT strategies after everolimus-eluting stent implantation are limited. A total of 1,400 patients (implanted mean total stent length >45 mm) were randomly assigned to receive 6-month (n = 699) or 12-month (n = 701) DAPT between October 2010 and July 2014 at 20 centers in Korea. The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding at 1 year, analyzed using an intention-to-treat approach. The primary endpoint occurred in 15 patients (2.2%) in the 6-month DAPT group and 14 patients (2.1%) in the 12-month DAPT group (hazard ratio [HR]: 1.07; p = 0.854). Definite or probable stent thrombosis occurred in 2 patients (0.3%) in the 6-month DAPT group and in 2 patients (0.3%) in the 12-month DAPT group (HR: 1.00; p = 0.999). There were no significant between-group differences in the primary endpoint in 686 patients with acute coronary syndrome (2.4% in both groups; HR: 1.00; p = 0.994) and in 506 patients with diabetes mellitus (2.2% [6-month] vs. 3.3% [12-month]; HR: 0.64; p = 0.428). Compared with 12-month DAPT, 6-month DAPT did not increase the composite events of cardiac death, myocardial infarction, stroke, or TIMI major bleeding at 1 year in patients who underwent everolimus-eluting stent implantation. (Impact of Intravascular Ultrasound Guidance on Outcomes of XIENCE PRIME Stents in Long Lesions [IVUS-XPL Study]; NCT01308281). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  12. Long-term (8 year) outcomes and predictors of major adverse cardiac events after full metal jacket drug-eluting stent implantation.

    PubMed

    Lee, Cheol Whan; Ahn, Jung-Min; Lee, Jong-Young; Kim, Won-Jang; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

    2014-09-01

    We examined long-term outcomes and predictors of major adverse cardiac events after the full metal jacket (FMJ) stent implantation. The FMJ procedure has been used to treat diffuse coronary artery disease (CAD), but long-term outcomes remain unknown. The study population consisted of 347 consecutive patients (352 lesions) who had been treated for de novo diffuse CAD with FMJ stents (stent length ≥ 60 mm). The mean age was 61.0 ± 10.1 years, and the stent length was 71.9 ± 13.7 mm. The procedural success rate was 97.7%. Major in-hospital complications (one death and two acute stent thromboses) occurred in three patients (0.7%). The median follow-up was 101 months (interquartile range, 95-108 months). During follow-up, there were 60 deaths (33 cardiac), 20 myocardial infarctions, and 94 revascularizations. Definite stent thrombosis occurred in 12 patients. The event-free survival rate for cardiac death, cardiac death/myocardial infarction, or cardiac death/myocardial infarction/target lesion revascularization was 90.5 ± 1.6, 85.8 ± 1.9, and 71.6 ± 2.5% at 8 years, respectively. Left ventricular dysfunction (ejection fraction < 45%) was an independent predictor of cardiac death (OR: 4.88; 95% CI: 1.81-13.13; P = 0.002). Left ventricular dysfunction and a stent length > 80 mm were significantly related to cardiac death/myocardial infarction. Likewise, a stent length > 80 mm was an independent predictor of cardiac death/myocardial infarction/target lesion revascularization (OR: 2.45; 95% CI: 1.16-5.19; P = 0.019). Long-term outcomes appear favorable after FMJ procedures, and left ventricular dysfunction and a stent length > 80 mm are major predictors of major adverse cardiac events. These findings might be useful in identifying the most suitable treatments for patients with very diffuse CAD. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

  13. Aspiration Thrombectomy and Drug-Eluting Stent Implantation Decrease the Occurrence of Angina Pectoris One Year After Acute Myocardial Infarction

    PubMed Central

    Lee, Wei-Chieh; Fang, Chih-Yuan; Chen, Huang-Chung; Hsueh, Shu-Kai; Chen, Chien-Jen; Yang, Cheng-Hsu; Yip, Hon-Kan; Hang, Chi-Ling; Wu, Chiung-Jen; Fang, Hsiu-Yu

    2016-01-01

    Abstract Angina pectoris is a treatable symptom that is associated with mortality and decreased quality of life. Angina eradication is a primary care goal of care after an acute myocardial infarction (AMI). Our aim was to evaluate factors influencing angina pectoris 1 year after an AMI. From January 2005 to December 2013, 1547 patient received primary percutaneous intervention in our hospital for an acute ST-segment elevation myocardial infarction (MI). Of these patients, 1336 patients did not experience post-MI angina during a 1-year follow-up, and 211 patients did. Univariate and multivariate logistic regression analyses were performed to identify the factors influencing angina pectoris 1 year after an AMI. Propensity score matched analyses were performed for subgroups analyses. The average age of the patients was 61.08 ± 12.77 years, with a range of 25 to 97 years, and 82.9% of the patients were male. During 1-year follow-up, 13.6% of the patients experienced post-MI angina. There was a longer chest pain-to-reperfusion time in the post-MI angina group (P = 0.01), as well as a higher fasting sugar level, glycohemoglobin (HbA1C), serum creatinine, troponin-I and creatine kinase MB (CK-MB). The post-MI angina group also had a higher prevalence of multiple-vessel disease. Manual thrombectomy, and distal protective device and intracoronary glycoprotein IIb/IIIa inhibitor injection were used frequently in the no post-MI angina group. Antiplatelet agents and post-MI medication usage were similar between the 2 groups. Multivariate logistic regression analyses demonstrated that prior MI was a positive independent predictor of occurrence of post-MI angina. Manual thrombectomy use and drug-eluting stent implantation were negative independent predictors of post-MI angina. Higher troponin-I and longer chest pain-to-reperfusion time exhibited a trend toward predicting post-MI angina. Prior MIs were strong, independent predictors of post-MI angina. Manual thrombectomy

  14. Aspiration Thrombectomy and Drug-Eluting Stent Implantation Decrease the Occurrence of Angina Pectoris One Year After Acute Myocardial Infarction.

    PubMed

    Lee, Wei-Chieh; Fang, Chih-Yuan; Chen, Huang-Chung; Hsueh, Shu-Kai; Chen, Chien-Jen; Yang, Cheng-Hsu; Yip, Hon-Kan; Hang, Chi-Ling; Wu, Chiung-Jen; Fang, Hsiu-Yu

    2016-04-01

    Angina pectoris is a treatable symptom that is associated with mortality and decreased quality of life. Angina eradication is a primary care goal of care after an acute myocardial infarction (AMI). Our aim was to evaluate factors influencing angina pectoris 1 year after an AMI.From January 2005 to December 2013, 1547 patient received primary percutaneous intervention in our hospital for an acute ST-segment elevation myocardial infarction (MI). Of these patients, 1336 patients did not experience post-MI angina during a 1-year follow-up, and 211 patients did. Univariate and multivariate logistic regression analyses were performed to identify the factors influencing angina pectoris 1 year after an AMI. Propensity score matched analyses were performed for subgroups analyses.The average age of the patients was 61.08 ± 12.77 years, with a range of 25 to 97 years, and 82.9% of the patients were male. During 1-year follow-up, 13.6% of the patients experienced post-MI angina. There was a longer chest pain-to-reperfusion time in the post-MI angina group (P = 0.01), as well as a higher fasting sugar level, glycohemoglobin (HbA1C), serum creatinine, troponin-I and creatine kinase MB (CK-MB). The post-MI angina group also had a higher prevalence of multiple-vessel disease. Manual thrombectomy, and distal protective device and intracoronary glycoprotein IIb/IIIa inhibitor injection were used frequently in the no post-MI angina group. Antiplatelet agents and post-MI medication usage were similar between the 2 groups. Multivariate logistic regression analyses demonstrated that prior MI was a positive independent predictor of occurrence of post-MI angina. Manual thrombectomy use and drug-eluting stent implantation were negative independent predictors of post-MI angina. Higher troponin-I and longer chest pain-to-reperfusion time exhibited a trend toward predicting post-MI angina.Prior MIs were strong, independent predictors of post-MI angina. Manual thrombectomy and drug

  15. Association of chronic kidney disease with periprocedural myocardial injury after elective stent implantation: A single center prospective cohort study.

    PubMed

    Jerkic, Helena; Letilovic, Tomislav; Stipinovic, Mario; Pocanic, Darko; Catic, Jasmina; Knotek, Mladen

    2016-11-01

    Coronary artery disease (CAD) is the leading cause of mortality in patients with chronic kidney disease (CKD). Patients with CKD who undergo percutaneous coronary intervention (PCI) may have more ischemic events than patients without CKD. The aim of our study was to determine the incidence of periprocedural myocardial injury (PMI) after elective stent implantation in patients with CKD using the Third Joint ESC/ACCF/AHA/WHF PMI definition.In a single center prospective cohort study, we enrolled 344 consecutive patients who underwent elective PCI in a period of 39 months. Serum troponin I (cTnI) concentrations were measured at baseline and at 8 and 16 hours after PCI. Periprocedural increase of cTnI, according to the most recent PMI definition, was used to define both the presence and intensity of PMI. Patients were further stratified according to the estimated glomerular filtration rate (eGFR) using 4 variable Modification of Diet in Renal Disease (MDRD) equation: control group with eGFR >90 mL/min/1.73 m and the CKD group with eGFR < 90 mL/min/1.73 m, with further subdivision according to the CKD stage.We found no significant difference in the incidence as well as intensity of the PMI in the control (>90 mL/min/1.73 m) and the CKD group (<90 mL/min/1.73 m) both 8 and 16 hours after PCI. When the CKD patients were further subdivided according to their CKD stage, there was again no difference in the intensity or incidence of PMI compared to the control group. Further analyses of our data showed angina pectoris CCS IV, bare metal stent (BMS) implantation, and treatment with angiotensin-converting enzyme inhibitors (ACEI) as independent predictors of PMI. Furthermore, the presence of hypertension was inversely related to the occurrence of PMI.Applying the new guidelines for PMI and using the eGFR equation most suitable for our patients, we found no association between PMI and CKD. Further analyses showed other factors that could potentially influence

  16. ACTH- and Cortisol-Associated Neutrophil Modulation in Coronary Artery Disease Patients Undergoing Stent Implantation

    PubMed Central

    Keresztes, Margit; Horváth, Tamás; Ocsovszki, Imre; Földesi, Imre; Serfőző, Gyöngyi; Boda, Krisztina; Ungi, Imre

    2013-01-01

    Background Psychosocial stress and activation of neutrophil granulocytes are increasingly recognized as major risk factors of coronary artery disease (CAD), but the possible relationship of these two factors in CAD patients is largely unexplored. Activation of neutrophils was reported to be associated with stenting; however, the issue of neutrophil state in connection with percutaneous coronary intervention (PCI) is incompletely understood from the aspect of stress and its hypothalamic-pituitary-adrenal axis (HPA) background. Thus, we aimed to study cortisol- and ACTH-associated changes in granulocyte activation in patients undergoing PCI. Methodology/Principal Findings Blood samples of 21 stable angina pectoris (SAP) and 20 acute coronary syndrome (ACS) patients were collected directly before (pre-PCI), after (post-PCI) and on the following day of PCI (1d-PCI). Granulocyte surface L-selectin, CD15 and (neutrophil-specific) lactoferrin were analysed by flow cytometry. Plasma cortisol, ACTH, and lactoferrin, IL-6 were also assayed. In both groups, pre- and post-PCI ratios of lactoferrin-bearing neutrophils were relatively high, these percentages decreased substantially next day; similarly, 1d-PCI plasma lactoferrin was about half of the post-PCI value (all p≤0.0001). Post-PCI ACTH was reduced markedly next day, especially in ACS group (SAP: p<0.01, ACS: p≤0.0001). In ACS, elevated pre-PCI cortisol decreased considerably a day after stenting (p<0.01); in pre-PCI samples, cortisol correlated with plasma lactoferrin (r∼0.5, p<0.05). In 1d-PCI samples of both groups, ACTH showed negative associations with the ratio of lactoferrin-bearing neutrophils (SAP: r = −0.601, p<0.005; ACS: r = −0.541, p<0.05) and with plasma lactoferrin (SAP: r = −0.435, p<0.05; ACS: r = −0.609, p<0.005). Conclusions/Significance Pre- and post-PCI states were associated with increased percentage of activated/degranulated neutrophils indicated by elevated lactoferrin

  17. Short versus prolonged dual antiplatelet therapy duration after bare-metal stent implantation: 2-month landmark analysis from the CREDO-Kyoto registry cohort-2.

    PubMed

    Natsuaki, Masahiro; Morimoto, Takeshi; Furukawa, Yutaka; Nakagawa, Yoshihisa; Kadota, Kazushige; Ando, Kenji; Shiomi, Hiroki; Toyota, Toshiaki; Watanabe, Hirotoshi; Ono, Koh; Shizuta, Satoshi; Tamura, Takashi; Inoko, Moriaki; Inada, Tsukasa; Shirotani, Manabu; Matsuda, Mitsuo; Aoyama, Takeshi; Onodera, Tomoya; Suwa, Satoru; Takeda, Teruki; Inoue, Katsumi; Kimura, Takeshi

    2016-09-19

    One-month duration of dual antiplatelet therapy (DAPT) has widely been adopted after bare-metal stent (BMS) implantation in the real clinical practice. However, it has not been adequately addressed yet whether DAPT for only 1-month could provide sufficient protection from ischemic events beyond 1-month after BMS implantation. We assessed the effects of short DAPT relative to prolonged DAPT on clinical outcomes with the landmark analysis at 2 month after BMS implantation. Among 13,058 consecutive patients enrolled in the CREDO-Kyoto registry cohort-2, this study population consisted of 4905 patients treated with BMS only in whom the information on the status of antiplatelet therapy was available at 2 month after stent implantation [single-antiplatelet therapy (SAPT) group: N = 2575 (acute myocardial infarction (AMI): N = 1257, and non-AMI: N = 1318), and DAPT group: N = 2330 (AMI: N = 1304, and non-AMI: N = 1026)]. Cumulative 3-year incidence of the primary outcome measure (a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, and GUSTO moderate/severe bleeding) was not significantly different between the SAPT and DAPT groups (9.8 versus 10.6 %, P = 0.34). After adjusting confounders, the risk of SAPT relative to DAPT for the primary outcome measure remained insignificant in the entire cohort (HR 0.97, 95 % CI 0.79-1.19, P = 0.77), and in both AMI and non-AMI strata without any significant interaction between clinical presentation (AMI versus non-AMI) and the effect of SAPT relative to DAPT (P interaction = 0.56). In conclusion, short DAPT <2 month after BMS implantation was as safe as prolonged DAPT ≥2-month in both AMI and non-AMI patients.

  18. 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.

  19. 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.

  20. Stent Implantation for Malignant Pulmonary Artery Stenosis in a Metastasizing Non-Small Cell Bronchial Carcinoma

    SciTech Connect

    Gutzeit, A.; Koch, S.; Meier, U. R.; Zollikofer, Ch.

    2008-07-15

    A 58-year-old patient with recently diagnosed non-small cell bronchial carcinoma was referred to us with increasing shortness of breath and orthopnea by her family practitioner. To exclude the possibility of a pulmonary embolism, contrast medium-enhanced angio-CT of the thorax was performed. This showed a large mediastinal tumor, which, on the one hand, infiltrated and occluded the left upper lobe bronchus and, on the other, constricted the left pulmonary artery over a considerable part of its length. In view of the palliative situation and massively increasing dyspnea, balloon dilatation of the obstructed left pulmonary artery followed by stent placement was performed. This resulted in an immediate improvement of the symptoms. The originally strongly oxygen-dependent and heavily dyspneic patient could be relieved of the external supply of oxygen and was able to sleep normally without additional medication within 24 h. The patient was able ambulate freely within 2 days, with a markedly improved quality of life.

  1. [Balloon dilatation and stent implantation in malignant and benign stenoses of the central venous system].

    PubMed

    Weber, J

    2001-06-01

    Compared with the excellent good results on the arterial side, venous angioplasty combined with stent-application was described relatively late in the literature, dealing in the majority of cases with palliative tumour stenoses of the superior and inferior vena cava. Recanalization of benign stenoses, especially of the pelvic venous spur (May/Thurner; syn. Pelvic compression syndrome, Cockett) was realized so far only in a limited number of cases. We have performed this interventional therapy since 1991 in 21 patients (female: 16, male: 5), with good long-term results in 18 cases. According to the special patho-anatomy of the "spur", developing intimal proliferation and progressive stenosis at the left-sided ilio-caval junction in about 20% of the average adult population, a restrictive indication is, however, mandatory. According to strong clinical symptoms (severe varicosis and leg oedema at the left-sided lower extremity), phlebographic and functional parameters (won by central venous blood pressure measurements) are indicating selected cases for this curative treatment.

  2. Successful treatment of bleeding large duodenal gastrointestinal stromal tumour in a patient under dual antiplatelet therapy after recent drug-eluting coronary stent implantation

    PubMed Central

    Fukuyama, Keita; Fujikawa, Takahisa; Kuramitsu, Shoichi; Tanaka, Akira

    2014-01-01

    We report a case of a 69-year-old man who started dual antiplatelet therapy (APT) with aspirin and clopidogrel after recent implantation of drug-eluting coronary stent and developed massive bleeding due to large duodenal gastrointestinal stromal tumour (GIST). Following endoscopic haemostasis and discontinuation of dual APT, neoadjuvant chemotherapy with imatinib was started under continuation of ‘single’ APT with aspirin. A good chemotherapeutic response was achieved without recurrence of bleeding, and subsequent less invasive surgical resection of the tumour was performed, while preoperative single APT was continued for prevention of stent thrombosis. The patient recovered well without any thromboembolic or bleeding events. Neoadjuvant imatinib therapy and subsequent less invasive surgery under continuation of APT is one of the preferred approaches for patients with duodenal GIST with severe thromboembolic comorbidities, as in the current case. PMID:24777088

  3. Intractable intraoperative bleeding requiring platelet transfusion during emergent cholecystectomy in a patient with dual antiplatelet therapy after drug-eluting coronary stent implantation (with video)

    PubMed Central

    Fujikawa, Takahisa; Noda, Tomohiro; Tada, Seiichiro; Tanaka, Akira

    2013-01-01

    We report a case of a 76-year-old man, receiving dual antiplatelet therapy (DAPT) with aspirin and ticlopidine for the past 6 years after implantation of drug-eluting coronary stent, developed a severe hypochondriac pain. After diagnosing severe acute cholecystitis by an enhanced CT, emergent laparotomy under continuation of DAPT was attempted. During the operation, intractable bleeding from the adhesiolysed liver surface was encountered, which required platelet transfusion. Subtotal cholecystectomy with abdominal drainage was performed, and the patient recovered without any postoperative bleeding or thromboembolic complications. Like the present case, the final decision should be made to perform platelet transfusion when life-threatening DAPT-induced intraoperative bleeding occurs during an emergent surgery, despite the elevated risk of stent thrombosis. PMID:23536626

  4. 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

  5. Hemodynamics in Transplant Renal Artery Stenosis and its Alteration after Stent Implantation Based on a Patient-specific Computational Fluid Dynamics Model

    PubMed Central

    Wang, Hong-Yang; Liu, Long-Shan; Cao, Hai-Ming; Li, Jun; Deng, Rong-Hai; Fu, Qian; Zhang, Huan-Xi; Fei, Ji-Guang; Wang, Chang-Xi

    2017-01-01

    Background: Accumulating studies on computational fluid dynamics (CFD) support the involvement of hemodynamic factors in artery stenosis. Based on a patient-specific CFD model, the present study aimed to investigate the hemodynamic characteristics of transplant renal artery stenosis (TRAS) and its alteration after stent treatment. Methods: Computed tomography angiography (CTA) data of kidney transplant recipients in a single transplant center from April 2013 to November 2014 were reviewed. The three-dimensional geometry of transplant renal artery (TRA) was reconstructed from the qualified CTA images and categorized into three groups: the normal, stenotic, and stented groups. Hemodynamic parameters including pressure distribution, velocity, wall shear stress (WSS), and mass flow rate (MFR) were extracted. The data of hemodynamic parameters were expressed as median (interquartile range), and Mann–Whitney U-test was used for analysis. Results: Totally, 6 normal, 12 stenotic, and 6 stented TRAs were included in the analysis. TRAS presented nonuniform pressure distribution, adverse pressure gradient across stenosis throat, flow vortex, and a separation zone at downstream stenosis. Stenotic arteries had higher maximal velocity and maximal WSS (2.94 [2.14, 3.30] vs. 1.06 [0.89, 1.15] m/s, 256.5 [149.8, 349.4] vs. 41.7 [37.8, 45.3] Pa at end diastole, P = 0.001; 3.25 [2.67, 3.56] vs. 1.65 [1.18, 1.72] m/s, 281.3 [184.3, 364.7] vs. 65.8 [61.2, 71.9] Pa at peak systole, P = 0.001) and lower minimal WSS and MFRs (0.07 [0.03, 0.13] vs. 0.52 [0.45, 0.67] Pa, 1.5 [1.0, 3.0] vs. 11.0 [8.0, 11.3] g/s at end diastole, P = 0.001; 0.08 [0.03, 0.19] vs. 0.70 [0.60, 0.81] Pa, 2.0 [1.3, 3.3] vs. 16.5 [13.0, 20.3] g/s at peak systole, P = 0.001) as compared to normal arteries. Stent implantation ameliorated all the alterations of the above hemodynamic factors except low WSS. Conclusions: Hemodynamic factors were significantly changed in severe TRAS. Stent implantation can restore or

  6. Hemodynamics in Transplant Renal Artery Stenosis and its Alteration after Stent Implantation Based on a Patient-specific Computational Fluid Dynamics Model.

    PubMed

    Wang, Hong-Yang; Liu, Long-Shan; Cao, Hai-Ming; Li, Jun; Deng, Rong-Hai; Fu, Qian; Zhang, Huan-Xi; Fei, Ji-Guang; Wang, Chang-Xi

    Accumulating studies on computational fluid dynamics (CFD) support the involvement of hemodynamic factors in artery stenosis. Based on a patient-specific CFD model, the present study aimed to investigate the hemodynamic characteristics of transplant renal artery stenosis (TRAS) and its alteration after stent treatment. Computed tomography angiography (CTA) data of kidney transplant recipients in a single transplant center from April 2013 to November 2014 were reviewed. The three-dimensional geometry of transplant renal artery (TRA) was reconstructed from the qualified CTA images and categorized into three groups: the normal, stenotic, and stented groups. Hemodynamic parameters including pressure distribution, velocity, wall shear stress (WSS), and mass flow rate (MFR) were extracted. The data of hemodynamic parameters were expressed as median (interquartile range), and Mann-Whitney U-test was used for analysis. Totally, 6 normal, 12 stenotic, and 6 stented TRAs were included in the analysis. TRAS presented nonuniform pressure distribution, adverse pressure gradient across stenosis throat, flow vortex, and a separation zone at downstream stenosis. Stenotic arteries had higher maximal velocity and maximal WSS (2.94 [2.14, 3.30] vs. 1.06 [0.89, 1.15] m/s, 256.5 [149.8, 349.4] vs. 41.7 [37.8, 45.3] Pa at end diastole, P= 0.001; 3.25 [2.67, 3.56] vs. 1.65 [1.18, 1.72] m/s, 281.3 [184.3, 364.7] vs. 65.8 [61.2, 71.9] Pa at peak systole, P= 0.001) and lower minimal WSS and MFRs (0.07 [0.03, 0.13] vs. 0.52 [0.45, 0.67] Pa, 1.5 [1.0, 3.0] vs. 11.0 [8.0, 11.3] g/s at end diastole, P= 0.001; 0.08 [0.03, 0.19] vs. 0.70 [0.60, 0.81] Pa, 2.0 [1.3, 3.3] vs. 16.5 [13.0, 20.3] g/s at peak systole, P= 0.001) as compared to normal arteries. Stent implantation ameliorated all the alterations of the above hemodynamic factors except low WSS. Hemodynamic factors were significantly changed in severe TRAS. Stent implantation can restore or ameliorate deleterious change of hemodynamic

  7. Stent evolution for peripheral arterial disease.

    PubMed

    Lejay, A; Thaveau, F; Girsowicz, E; Georg, Y; Heim, F; Durand, B; Chakfé, N

    2012-02-01

    Endovascular treatment and stent implantation for peripheral arterial disease have been proposed for over 20 years. However, the first experiments with stainless stents were relatively disappointing. The first improvement consisted in the introduction of nitinol self-expanding stents. This technology allowed an initial improvement of clinical performances, but the first generation of nitinol stents demonstrated a relatively high rate of fractures. Better knowledge of arterial biomechanics and advances in technology allowed to propose a second generation of nitinol stents with improved flexibility, which decreased the rates of fracture. In-stent restenosis related to neointimal hyperplasia has also led to the development of new concepts to improve patency rates after stenting: drug-eluting stents (coated-stents), biodegradable stents, and covered stents. These technologies will help to treat more complex lesions in the future, but we are still waiting for results of ongoing studies.

  8. Airway stents in children.

    PubMed

    Nicolai, T

    2008-04-01

    Airway obstruction in children is a rare, but difficult clinical problem, with no clear agreement on optimal therapeutic approach. Stenting of the airway has been used successfully in adults, and is an attractive alternative in children. Fundamental differences of pediatric compared to adult use include the benign nature of most stenoses, the narrow and soft airways of children, the required long-term tolerance and adaptation to growth. These differences may significantly alter the therapeutic balance, calling into question the precise role stents play in the treatment of airway obstruction in children. Stent placement can be technically demanding but is not exceedingly difficult. Experience is necessary to select the proper size and type of stent. Metal stents usually achieve airway patency and clinical improvement in the majority of cases, while this is less frequently the case with silicone stents. Some complications such as granulation and secretion retention seem to occur in most children after stent implantation. Unfortunately, severe complications including death have been reported in a significant proportion of children. Stent related mortality can be estimated at 12.9% from published data, but these include complication centered reports. The initial euphoria for airway stents in children has largely abated and most authors agree that they should only be employed in circumstances with no good alternatives. It is crucial that all surgical and medical alternatives are considered and the decision to place a stent is not made because other options are overlooked or not available locally. Stent use in a palliative setting has also been reported and is probably reasonable. Stents will only allow limited adaptation for the growth of pediatric airways by balloon dilatation. All metal stents should be considered as potentially permanent, and removal sometimes may only be possible through a surgical and sometimes risky approach.

  9. Endovascular implantation of covered stents in the extracranial carotid and vertebral arteries: Case series and review of the literature

    PubMed Central

    Alaraj, Ali; Wallace, Adam; Amin-Hanjani, Sepideh; Charbel, Fady T; Aletich, Victor

    2011-01-01

    Background: Covered stents are used endovascularly to seal arterial wall defects while preserving vessel patency. This report describes our experience with the use of covered stents to treat cervical pathology, and a review of the literature in regards to this topic is presented. Case Description: Two patients presenting with the carotid blowout syndrome and one patient with a vertebrojugular fistula were treated with covered stents. This allowed for preservation of the vessel and was a treatment alternative to cerebral bypass. Conclusion: Covered stents provide a viable means of preserving the cervical vessels in selected patients; however, long-term follow-up is necessary to determine stent patency and permanency of hemostasis. PMID:21697983

  10. Automatic three-dimensional registration of intra-vascular optical coherence tomography images for the clinical evaluation of stent implantation over time

    NASA Astrophysics Data System (ADS)

    Ughi, Giovanni J.; Adriaenssens, Tom; Larsson, Matilda; Dubois, Christophe; Sinnaeve, Peter; Coosemans, Mark; Desmet, Walter; D'hooghe, Jan

    2012-01-01

    In the last decade a large number of new intracoronary devices (i.e. drug-eluting stents, DES) have been developed to reduce the risks related to bare metal stent (BMS) implantation. The use of this new generation of DES has been shown to substantially reduce, compared with BMS, the occurrence of restenosis and recurrent ischemia that would necessitate a second revascularization procedure. Nevertheless, safety issues on the use of DES persist and full understanding of mechanisms of adverse clinical events is still a matter of concern and debate. Intravascular Optical Coherence Tomography (IV-OCT) is an imaging technique able to visualize the microstructure of blood vessels with an axial resolution <20 μm. Due to its very high spatial resolution, it enables detailed in-vivo assessment of implanted devices and vessel wall. Currently, the aim of several major clinical trials is to observe and quantify the vessel response to DES implantation over time. However, image analysis is currently performed manually and corresponding images, belonging to different IV-OCT acquisitions, can only be matched through a very labor intensive and subjective procedure. The aim of this study is to develop and validate a new methodology for the automatic registration of IV-OCT datasets on an image level. Hereto, we propose a landmark based rigid registration method exploiting the metallic stent framework as a feature. Such a tool would provide a better understanding of the behavior of different intracoronary devices in-vivo, giving unique insights about vessel pathophysiology and performance of new generation of intracoronary devices and different drugs.

  11. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial.

    PubMed

    Fea, Antonio M

    2010-03-01

    To compare phacoemulsification alone and phacoemulsification with micro-bypass stent implantation in eyes with primary open-angle glaucoma. Instituto di Fisiopatologia Clinica, Clinica Oculistica, Universita' di Torino, Torino, Italy. In this prospective double-masked randomized clinical trial, patients had phacoemulsification alone (control group) or phacoemulsification with iStent implantation (combined group). Primary outcomes were intraocular pressure (IOP) and reduction in medication use over 15 months and IOP after a 1-month washout of ocular hypotensive agents (ie, 16 months postoperatively). The baseline IOP was similar between groups (combined group: 17.9 mm Hg +/- 2.6 [SD]; control group: 17.3 +/- 3.0 mm Hg) (P = .512). Three patients in the control group were lost to follow-up. The mean IOP was 14.8 +/- 1.2 mm Hg in the combined group and 15.7 +/- 1.1 mm Hg in the control group at 15 months and 16.6 +/- 3.1 mm Hg and 19.2 +/- 3.5 mm Hg, respectively, after washout; the IOP was statistically significantly lower in the combined group than in the control group at both time points (P = .031 and P = .042, respectively). At 15 months, the mean number of medications was lower in the combined group than in the control group (0.4 +/- 0.7 and 1.3 +/- 1.0, respectively; P = .007), as was the proportion of patients on ocular hypotensive medication (33% and 76%, respectively). Phacoemulsification with stent implantation was more effective in controlling IOP than phacoemulsification alone; the safety profiles were similar. Copyright 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  12. 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.

  13. Usage patterns and 1-year outcomes with the TAXUS Liberté stent: results of the TAXUS OLYMPIA registry.

    PubMed

    Ahmed, Waqar H; Mendiz, Oscar A; Thomas, Martyn R

    2011-06-01

    The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice. The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year. Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting. Copyright © 2010 Wiley-Liss, Inc.

  14. Two problems and a single solution: Covered stent implantation to close an anterograde pulmonary flow and treat hypoplastic left pulmonary artery after Fontan operation.

    PubMed

    Butera, Gianfranco; Taha, Fatma

    2016-05-01

    Several issues may impact on the function of a Fontan circulation including accessory source of pulmonary blood flow and pulmonary artery anatomy. Here we report on a 5.5-year-old boy who showed failing Fontan circulation due to left pulmonary artery stenosis/hypoplasia and significant forward pulmonary blood flow through the native pulmonary artery. Successful implantation of a 34-mm CP covered stent in the left pulmonary artery in a Fontan patient was useful for simultaneous successful treatment of residual antegrade flow from the systemic ventricle to the pulmonary artery and enlargement of hypoplastic left pulmonary artery. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  15. Multiple coronary thrombosis and stent implantation to the subtotally occluded right renal artery in a patient with essential thrombocytosis: a case report with review.

    PubMed

    Ozben, Beste; Ekmekci, Ahmet; Bugra, Zehra; Umman, Sabahattin; Meric, Mehmet

    2006-08-01

    Essential thrombocytosis is a myeloproliferative disorder of unknown etiology manifested clinically by the overproduction of platelets in the absence of a definable cause. Platelet dysfunction in essential thrombocytosis results in both hemorrhage and thrombosis. It is one of the rare causes of ischemic cardiovascular events. Fewer than 20 cases of essential thrombocytosis with involvement of coronary arteries leading to acute coronary syndromes or myocardial infarction have been reported. We report a case of multiple coronary thrombosis involving the left anterior descending artery and circumflex artery and stent implantation to the subtotally stenotic right renal artery in a women with unstable angina pectoris, essential thrombocytosis and previous history of renal artery trombosis.

  16. 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

  17. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery.

    PubMed

    Katsanos, Konstantinos; Spiliopoulos, Stavros; Karunanithy, Narayan; Krokidis, Miltiadis; Sabharwal, Tarun; Taylor, Peter

    2014-04-01

    .16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years). Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery. Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  18. Implantability, Complications, and Follow-Up After Transjugular Intrahepatic Portosystemic Stent-Shunt Creation With the 6F Self-Expanding Sinus-SuperFlex-Visual Stent

    PubMed Central

    Spira, Daniel; Wiskirchen, Jakub; Lauer, Ulrich; Ketelsen, Dominik; Nikolaou, Konstantin; Wiesinger, Benjamin

    2016-01-01

    Background The transjugular intrahepatic portosystemic stent-shunt (TIPSS) builds a shortcut between the portal vein and a liver vein, and represents a sophisticated alternative to open surgery in the management of portal hypertension or its complications. Objectives To describe clinical experiences with a low-profile nitinol stent system in TIPSS creation, and to assess primary and long-term success. Patients and Methods Twenty-six patients (5 females, 21 males; mean age 54.6 years) were treated using a low-profile 6F self-expanding sinus-SuperFlex-Visual stent system. The indication for TIPSS creation was refractory bleeding in 9 of the 26 patients, refractory ascites in 18 patients, and acute thrombosis of the portal vein confluence in one patient. Portosystemic pressure gradients before and after TIPSS, periprocedural and long-term complications, and the time to orthotopic liver transplantation (OLT) or death were recorded. Results The portosystemic pressure gradient was significantly reduced, from 20.9 ± 6.3 mmHg before to 8.2 ± 2.3 mmHg after TIPSS creation (P < 0.001). Procedure-related complications included acute tract occlusion (n = 2), liver hematoma (n = 1), hepatic encephalopathy (n = 1), and cardiac failure (n = 1). Three of the 26 patients had late-onset TIPSS occlusion (at 12, 12, and 39 months after TIPSS creation). Three patients died within one week after the procedure due to their poor general condition (multiorgan failure, acute respiratory distress syndrome, necrotizing pancreatitis, and aspiration pneumonia). Another four patients succumbed to their underlying advanced liver disease within one year after TIPSS insertion. Seven patients underwent OLT at a mean time of 9.4 months after TIPSS creation. Conclusion The sinus-SuperFlex-Visual stent system can be safely deployed as a TIPSS device. The pressure gradient reduction was clinically sufficient to treat the patients’ symptoms, and periprocedural complications were due to the TIPSS

  19. Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter).

    PubMed

    Rittger, Harald; Waliszewski, Matthias; Brachmann, Johannes; Hohenforst-Schmidt, Wolfgang; Ohlow, Marc; Brugger, Andreas; Thiele, Holger; Birkemeyer, Ralf; Kurowski, Volkhard; Schlundt, Christian; Zimmermann, Stefan; Lonke, Sandra; von Cranach, Moritz; Markovic, Sinisa; Daniel, Werner G; Achenbach, Stephan; Wöhrle, Jochen

    2015-11-01

    The intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years. In the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years. A total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths ≤22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study. With a 2:1 randomization, 72 patients were randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients. At 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p = 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p = 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p = 0.001). PCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD

  20. 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.

  1. Course of thrombin activation markers in patients implanted with Palmaz-Schatz stents: first experiences with a post-interventional anticoagulation regimen.

    PubMed

    Haushofer, A; Halbmayer, W M; Dittel, M; Prachar, H; Mlczoch, J; Fischer, M

    1994-10-01

    Following implantation of coronary Palmaz-Schatz stents, 29 patients were anticoagulated with a combination of heparin, phenprocoumon and aspirin following a standard protocol. After removing the arterial and venous lines, post-interventional intravenous (i.v.) heparin treatment started with 1500 IU/h for patients > 80 kg and 1250 IU/h for patients < 80 kg. Heparin was monitored by the activated partial thromboplastin time (aPTT) and adjusted by increasing or reducing i.v. heparin by 250 IU/h to maintain the aPTT within the therapeutic range. Phenprocoumon therapy began the day after stent implantation (day 2) and lasted for 3 months. aPTT, Heptest, prothrombin fragment F1 and 2 (F1.2) and thrombin-antithrombin III complexes (TAT) were monitored at standard intervals for 10 days (mean monitoring time: 9.7 +/- 2.3 days). Anticoagulation was efficient with aPTT levels remaining within the therapeutic range on day 9 and the simultaneous, moderate-onset oral anticoagulation within the therapeutic range of the International Normalized Ratio (INR; 2.15-4.80) on day 8 on average, the mean INR being 2.43 +/- 0.76. On day 4, F1.2 levels were significantly higher than on the day of stenting (1.16 +/- 0.30 nmol/l vs 1.04 +/- 0.53 nmol/l; P < 0.005). F1.2 levels fell after day 5, the difference becoming significant from day 8 on (P < 0.05). F1.2 was negatively correlated with the Heptest (P < 0.05) and fell significantly as a function of the INR during phenprocoumon administration (P < 0.001). After phenprocoumon therapy was discontinued over 3 weeks, 25 patients were followed up by angiography. Despite adequate anticoagulation, mean F1.2 levels in patients showing restenosis at follow-up angiography were significantly higher (P < 0.005) than in those without restenosis. In one patient who developed subacute stent thrombosis, clotting factors were determined 20 min before stent occlusion. The levels of F1.2 and TAT were less than all other patients on this day (F1.2: 0.98 nmol

  2. Clinical Impact of Intravascular Ultrasound-Guided Chronic Total Occlusion Intervention With Zotarolimus-Eluting Versus Biolimus-Eluting Stent Implantation: Randomized Study.

    PubMed

    Kim, Byeong-Keuk; Shin, Dong-Ho; Hong, Myeong-Ki; Park, Hun Sik; Rha, Seung-Woon; Mintz, Gary S; Kim, Jung-Sun; Kim, Je Sang; Lee, Seung-Jin; Kim, Hee-Yeol; Hong, Bum-Kee; Kang, Woong-Chol; Choi, Jin-Ho; Jang, Yangsoo

    2015-07-01

    There have been no randomized studies comparing intravascular ultrasound (IVUS)-guided versus conventional angiography-guided chronic total occlusion (CTO) intervention using new-generation drug-eluting stent Therefore, we conducted a prospective, randomized, multicenter trial designed to test the hypothesis that IVUS-guided CTO intervention is superior to angiography-guided intervention. After successful guidewire crossing, 402 patients with CTOs were randomized to the IVUS-guided group (n=201) or the angiography-guided group (n=201) and secondarily randomized to Resolute zotarolimus-eluting stents or Nobori biolimus-eluting stents. The primary and secondary end points were cardiac death and a major adverse cardiac event defined as the composite of cardiac death, myocardial infarction, or target-vessel revascularization, respectively. After 12-month follow-up, the rate of cardiac death was not significantly different between the IVUS-guided group (0%) and the angiography-guided group (1.0%; P by log-rank test=0.16). However, major adverse cardiac event rates were significantly lower in the IVUS-guided group than that in the angiography-guided group (2.6% versus 7.1%; P=0.035; hazard ratio, 0.35; 95% confidence interval, 0.13-0.97). Occurrence of the composite of cardiac death or myocardial infarction was significantly lower in the IVUS-guided group (0%) than in the angiography-guided group (2.0%; P=0.045). The rates of target-vessel revascularization were not significantly different between the 2 groups. In the comparison between Resolute zotarolimus-eluting stent and Nobori biolimus-eluting stent, major adverse cardiac event rates were not significantly different (4.0% versus 5.7%; P=0.45). Although IVUS-guided CTO intervention did not significantly reduce cardiac mortality, this randomized study demonstrated that IVUS-guided CTO intervention might improve 12-month major adverse cardiac event rate after new-generation drug-eluting stent implantation when compared

  3. Long-Term Primary Patency Rate After Nitinol Self-Expandable Stents Implantation in Long, Totally Occluded Femoropopliteal (TASC II C & D) Lesions.

    PubMed

    Elmahdy, Mahmoud Farouk; Buonamici, Piergiovanni; Trapani, Maurizio; Valenti, Renato; Migliorini, Angela; Parodi, Guido; Antoniucci, David

    2017-06-01

    Endovascular therapy for long femoropopliteal lesions using percutaneous transluminal balloon angioplasty or first-generation of peripheral stents has been associated with unacceptable one-year restenosis rates. However, with recent advances in equipment and techniques, a better primary patency rate is expected. This study was conducted to detect the long-term primary patency rate of nitinol self-expandable stents implanted in long, totally occluded femoropopliteal lesions TransAtlantic Inter-Society Census (TASC II type C & D), and determine the predictors of reocclusion or restenosis in the stented segments. The demographics, clinical, anatomical, and procedural data of 213 patients with 240 de novo totally occluded femoropopliteal (TASC II type C & D) lesions treated with nitinol self-expandable stents were retrospectively analysed. Of these limbs, 159 (66.2%) presented with intermittent claudication, while 81 (33.8%) presented with critical limb ischaemia. The mean-time of follow-up was 36±22.6 months, (range: 6.3-106.2 months). Outcomes evaluated were, primary patency rate and predictors of reocclusion or restenosis in the stented segments. The mean age of the patients was 70.9±9.3 years, with male gender 66.2%. Mean pre-procedural ABI was 0.45±0.53. One-hundred-and-seventy-five (73%) lesions were TASC II type C, while 65 (27%) were type D lesions. The mean length of the lesions was 17.9±11.3mm. Procedure related complications occurred in 10 (4.1%) limbs. There was no periprocedural mortality. Reocclusion and restenosis were detected during follow-up in 45 and 30 limbs respectively, and all were re-treated by endovascular approach. None of the patients required major amputation. Primary patency rates were 81.4±1.1%, 77.7±1.9% and 74.4±2.8% at 12, 24, and 36 months respectively. Male gender, severe calcification, and TASC II D lesion were independent predictors for reocclusion, while predictors of restenosis were DM, smoking and TASC II D lesions

  4. 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.

  5. Prevalence, factors, and clinical impact of self-expanding stent fractures following iliac artery stenting.

    PubMed

    Higashiura, Wataru; Kubota, Yasushi; Sakaguchi, Shoji; Kurumatani, Norio; Nakamae, Mitsuhiro; Nishimine, Kiyoshi; Kichikawa, Kimihiko

    2009-03-01

    To evaluate the prevalence, factors, and clinical impact of self-expanding stent fracture following iliac artery stenting. A review of the endovascular registry database for our department showed 353 patients with occlusive diseases of the iliac artery who underwent stenting between 1997 and 2007. While clinical data and images were retrospectively reviewed for all patients, 165 patients who underwent self-expanding stenting and plain radiograph with >or=6-months follow-up were analyzed. Mean follow-up was 43 months for 305 stents (elgiloy, n = 83; nitinol, n = 222) implanted in 216 iliac arteries. The mean duration until the last imaging study was 38 months. Items concerning prevalence of stent fracture, factors associated with fracture, and outcomes for patients with stent fracture were analyzed. Stent fracture was detected in 11 of 216 iliac arteries (5.1%). In stent-based analysis, 11 of 305 stents (3.6%) showed stent fracture, classified as type I in 2 stents, type II in 3 stents, type III in 4 stents, type IV in 1 stent, and type V in 1 stent. Stent fracture was detected in 11 of 222 nitinol stents (5.0%), but no Elgiloy stents. Cox proportional hazards regression model indicated stenting for chronic occlusion as a risk factor associated with nitinol stent fracture (hazard ratio [HR] = 6.09, P = 0.008, 95% confidence interval [CI] 1.59-23.3). Cumulative primary patency rates in iliac arteries with and without fractured stents were 90% and 91% at 8 years (P = .80), respectively. Fracture of self-expanding stents is rare in iliac arteries, but stenting for chronic occlusion represents a risk factor for fracture. Fractures of stents placed in iliac arteries rarely affect patency.

  6. 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.

  7. Meta-analysis of randomized controlled trials on efficacy and safety of extended thienopyridine therapy after drug-eluting stent implantation

    PubMed Central

    Tang, Wenyi; Yeh, James; Chen, Jian; Liu, Mao; Ke, Jianting; Tan, Guangyi; Lin, Xiufang

    2016-01-01

    Background The potential benefits and risks of extended thienopyridine therapy beyond 12 months after drug-eluting stent (DES) implantation remain unclear. Methods Randomized controlled trials (RCTs) were searched in PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure databases. The adverse clinical endpoints were compared between 12 months group (aspirin alone) and >12 months group (additional thienopyridine plus aspirin after 12-month dual antiplatelet therapy). Odds ratios (ORs) with 95% confidence intervals (95% CIs) were used as summary statistics. A random-effect model was used in the meta-analysis process. Results Finally, three RCTs incorporating 16,265 participants were included in this meta-analysis. The results indicated that the incidences of myocardial infarction (1.55% vs. 2.90%; OR =0.58; 95% CI, 0.40–0.84; P=0.004) and stent thrombosis (0.32% vs. 0.98%; OR =0.35; 95% CI, 0.20–0.62; P<0.001) in the >12 months group were significantly lower than the 12 months group. However, compared to the 12 months group, the extended thienopyridine therapy markedly increased the risk of bleeding events (2.09% vs. 1.28%; OR =1.64; 95% CI, 1.23–2.17; P<0.001). The risks of stroke (0.78% vs. 0.84%; P=0.67) and cardiac death (0.94% vs. 0.89%; P=0.61) were similar between the two groups. Conclusions The synthesis of available evidence indicates that a regimen of extended thienopyridine therapy beyond 12 months may significantly reduce the risks of myocardial infarction and stent thrombosis but increase the risk of bleeding events in the patients who have received DESs implantation. PMID:27747163

  8. Broken Esophageal Stent Successfully Treated by Interventional Radiology Technique

    SciTech Connect

    Zelenak, Kamil; Mistuna, Dusan; Lucan, Jaroslav; Polacek, Hubert

    2010-06-15

    Esophageal stent fractures occur quite rarely. A 61-year-old male patient was previously treated for rupture of benign stenosis, occurring after dilatation, by implanting an esophageal stent. However, a year after implantation, the patient suffered from dysphagia caused by the broken esophageal stent. He was treated with the interventional radiology technique, whereby a second implantation of the esophageal stent was carried out quite successfully.

  9. Clinical Outcomes of SMART Versus Luminexx Nitinol Stent Implantation for Aortoiliac Artery Disease: A Propensity Score-Matched Multicenter Study.

    PubMed

    Shintani, Yoshiaki; Soga, Yoshimitsu; Takahara, Mitsuyoshi; Iida, Osamu; Kawasaki, Daizo; Yamauchi, Yasutaka; Suzuki, Kenji; Hirano, Keisuke; Kawasaki, Tomohiro

    2015-10-01

    Endovascular therapy for aortoiliac (AI) lesions using stents is widely accepted. However, the long-term outcome of 2 different types of nitinol stents for AI lesions is unknown. The aim of this study was to examine the long-term outcome of the SMART and Luminexx nitinol stents for the treatment of de novo AI lesions. This study was a multicenter retrospective analysis of a prospectively maintained database. The study enrolled consecutive patients undergoing primary stenting for de novo AI artery stenosis between January 2005 and December 2009. A total of 1503 lesions in 1229 patients treated with SMART or Luminexx primary stenting were enrolled. The primary end point was primary patency, secondary end points were the primary assisted patency, secondary patency, and major adverse limb events (MALEs), which included major amputation and major reintervention. To minimize the differences between the groups, a propensity score matching analysis was performed, and 284 lesions per group were analyzed to identify outcomes. After the propensity score matching analysis, the lesion length was 60 ± 37 and 57 ± 31 mm (P = .275), and the reference vessel diameter was 8.2 ± 1.5 and 8.3 ± 1.5 mm (P = .482) in the SMART and Luminexx groups, respectively. The primary patency at 3 years was not significantly different between the groups (83.5% vs 82.2%, P = .842, respectively). The assisted primary patency and secondary patency rates were also not significantly different (91.7% vs 93.2%, P = .340, 99.2% vs 98.8%, P = .922). In addition, the MALE rate was not significantly different between the groups (98.3% vs 97.3%, P = .821). The current data suggest that the use of nitinol stents for the AI artery provided good long-term patency and freedom from MALE for 3 years of follow-up, regardless of whether SMART or Luminexx stents were used. © The Author(s) 2014.

  10. Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents.

    PubMed

    Cohen, José E; Gomori, John Moshe; Moscovici, Samuel; Leker, Ronen R; Itshayek, Eyal

    2014-07-01

    We assessed the frequency and severity of changes in stent configuration and location after the treatment of intracranial aneurysms, and patterns of in-stent stenosis. We retrospectively reviewed data for consecutive aneurysm patients managed with endovascular implantation of flow-diverter stents (Silk Flow Diverter [Balt Extrusion, Montmorency, France] and Pipeline Embolization Device [ev3/Coviden, Minneapolis, MN, USA]) from October 2011 to July 2012. Routine 2, 6, 9-12, and 16-20 month follow-up angiograms were compared, with a focus on changes in stent configuration and location from immediately after deployment to angiographic follow-up, and the incidence and development of in-stent stenosis. Thirty-four patients with 42 aneurysms met inclusion criteria. The Silk device was implanted in 16 patients (47%, single device in 15), the Pipeline device in 18 (53%, single device in 16). On first follow-up angiography, in-stent stenosis was observed in 38% of Silk devices and 39% of Pipeline devices. In-stent stenosis was asymptomatic in 12 of 13 patients. One woman presented with transient ischemic attacks and required stent angioplasty due to end tapering and mild, diffuse in-stent stenosis. Configuration and location changes, including stent creeping and end tapering were seen in 2/16 patients (13%) with Silk devices, and 0/18 patients with Pipeline devices. We describe stent creeping and end tapering as unusual findings with the potential for delayed clinical complications. In-stent stenosis, with a unique behavior, is a frequent angiographic finding observed after flow-diverter stent implant. The stenosis is usually asymptomatic; however, close clinical and angiographic monitoring is mandatory for individualized management. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Dual Antiplatelet Therapy Can Be Discontinued at Three Months after Implantation of Zotarolimus-Eluting Stent in Patients with Coronary Artery Disease

    PubMed Central

    Wada, Tadashi; Nakahama, Makoto; Toda, Hironobu; Watanabe, Atsuyuki; Hashimoto, Katsushi; Terasaka, Ritsuko; Nakamura, Kazufumi; Yamada, Nobuyuki; Ito, Hiroshi

    2013-01-01

    Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention increases the risk of bleeding. We studied the safety and clinical outcomes of switching from DAPT to aspirin monotherapy at 3 months after ZES implantation. We retrospectively evaluated 168 consecutive patients with coronary artery disease who had been implanted with a ZES from June 2009 through March 2010. After excluding 40 patients according to exclusion criteria such as myocardial infarction, 128 patients were divided into a 3-month DAPT group (67 patients, 88 lesions) and a 12-month conventional DAPT group (61 patients, 81 lesions). Coronary angiographic followup and clinical followup were conducted at more than 8 months and at 12 months after ZES implantation, respectively. Minor and major bleeding events, stent thrombosis (ST), and major adverse cardiac events (MACE) (death, myocardial infarction, cerebrovascular accident, target lesion revascularization, and target vessel revascularization) were evaluated. There were no statistically significant differences in the incidences of ST and MACE between the two groups. The incidence of bleeding events was significantly lower in the 3-month group than in the 12-month group (1.5% versus 11.5%, P < 0.05). DAPT can be safely discontinued at 3 months after ZES implantation, which reduces bleeding risk. PMID:23762606

  12. Clinical outcomes of various continued antiplatelet therapies in patients who were administered DAPT following the implantation of drug-eluting stents and developed gastrointestinal hemorrhage

    PubMed Central

    Guo, Yujie; Wei, Jinru

    2016-01-01

    Although an increasing number of patients accept dual antiplatelet therapy (DAPT) following implantation of drug-eluting stents (DES) for coronary heart disease (CHD), the proportion of patients with DAPT who subsequently develop gastrointestinal hemorrhage continues to increase. To ensure the clinical outcomes from DES, it is important to formulate a novel continued antiplatelet therapy for patients who were administered DAPT and subsequently develop gastrointestinal hemorrhage following DES implantation. The present study aimed to evaluate the effects of continued aspirin, clopidogrel or DAPT use on the incidence of clinical adverse events and gastrointestinal rebleeding in patients who received DAPT and subsequently developed gastrointestinal hemorrhage following implantation of DES for CHD. Between 2004 and 2010, 108 consecutive patients receiving DAPT developed gastrointestinal hemorrhage following DES implantation for CHD at Liuzhou General Hospital (Liuzhou, Guangxi). These patients were divided into three groups according to the novel antiplatelet therapy. The occurrence of major adverse cardiac events (MACE), including cardiac death, non-fatal myocardial infarction, heart failure or target vessel revascularization, net adverse clinical events (NACE), including major bleeding, stroke or MACE, and gastrointestinal rebleeding during clinical follow-up following the initial procedure were compared among these three groups. The results of this analysis demonstrated that the occurrence rate of MACE, NECE and gastrointestinal rebleeding was not significantly different among these groups (P>0.05). Furthermore, survival analysis was performed and although the survival curves of MACE and NECE were not significantly different among these groups, gastrointestinal rebleeding was demonstrated to be significantly different among the three groups (P<0.05), and continued aspirin or clopidogrel use was superior to continued DAPT. In conclusion, the results of the present

  13. Short- versus standard-term dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stent implantation: A meta-analysis.

    PubMed

    Basaraba, Jade E; Barry, Arden R

    2017-01-01

    Twelve months of dual antiplatelet therapy (DAPT) is recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. However, certain clinical scenarios may require premature discontinuation of therapy (e.g. urgent surgical procedure, major bleeding). The objective of this systematic review and meta-analysis was to investigate clinically relevant outcomes associated with a shorter duration of DAPT after PCI with DES implantation. A systematic search of Medline and Embase (inception to December 2015) was conducted. Included were randomized controlled trials that compared 6 months (or less) of DAPT (defined as acetylsalicylic acid 75-200mg daily and a P2Y12 inhibitor) to the standard of 12 months. Outcomes of interest included death (all-cause and cardiac), myocardial infarction (MI), definite/probable stent thrombosis, and bleeding (major and overall). An odds ratio (OR) and 95% confidence interval (CI) were calculated for each outcome using a random effects model. Six trials (five open-label, one double-blind) were included (N=13,900). Four studies investigated 6 months of DAPT, and two studies investigated 3 months. Median follow-up was 12 months. There was no statistically significantly difference between groups regarding all-cause death (OR 0.88, 95% CI 0.64-1.20), cardiac death (OR 1.00, 95% CI 0.64-1.55), MI (OR 1.16, 95% CI 0.87-1.56), and stent thrombosis (OR 1.22, 95% CI 0.70-2.15). Both major and any bleeding were significantly decreased with shorter-term DAPT (OR 0.58, 95% CI 0.34-0.98, and OR 0.62, 95% CI 0.47-0.81, respectively). Shorter duration (3-6 months) of DAPT, as compared to 12 months, was not associated with a higher risk of death, MI, or stent thrombosis, but a lower rate of major and overall bleeding. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  14. 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.

  15. A randomized, double-blind, multicenter comparison study of triple antiplatelet therapy with dual antiplatelet therapy to reduce restenosis after drug-eluting stent implantation in long coronary lesions: results from the DECLARE-LONG II (Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients with Long Coronary Lesions) trial.

    PubMed

    Lee, Seung-Whan; Park, Seong-Wook; Kim, Young-Hak; Yun, Sung-Cheol; Park, Duk-Woo; Lee, Cheol Whan; Kang, Soo-Jin; Park, Seung-Jung; Lee, Jae-Hwan; Choi, Si Wan; Seong, In-Whan; Lee, Nae-Hee; Cho, Yoon Haeng; Shin, Won-Yong; Lee, Seung-Jin; Lee, Se-Whan; Hyon, Min-Su; Bang, Duk-Won; Choi, Young-Jin; Kim, Hyun-Sook; Lee, Bong-Ki; Lee, Keun; Park, Hoon-Ki; Park, Chang-Bum; Lee, Sang-Gon; Kim, Min-Kyu; Park, Kyoung-Ha; Park, Woo-Jung

    2011-03-15

    The purpose of this study was to determine whether cilostazol reduces intimal hyperplasia in patients undergoing long zotarolimus-eluting stent implantation (stent length: ≥ 30 mm) for native long coronary lesions (length: ≥ 25 mm). Restenosis after drug-eluting stent implantation remains a significant clinical problem in long coronary lesions. Patients (n = 499) were assigned randomly to triple (aspirin, clopidogrel, and cilostazol, triple group: n = 250) or dual antiplatelet therapy (aspirin and clopidogrel and placebo, dual group: n = 249) for 8 months after long zotarolimus-eluting stent implantation. The primary end point was in-stent late loss at the 8-month angiography according to the intention-to-treat principle. The 2 groups had similar baseline characteristics. The in-stent (0.56 ± 0.55 mm vs. 0.68 ± 0.59 mm, p = 0.045) and in-segment (0.32 ± 0.54 mm vs. 0.47 ± 0.54 mm, p = 0.006) late loss were significantly lower in the triple versus dual group, as were 8-month in-stent restenosis (10.8% vs. 19.1%, p = 0.016), in-segment restenosis (12.2% vs. 20.0%, p = 0.028), and 12-month ischemic-driven target lesion revascularization (5.2% vs. 10.0%, p = 0.042) rates. At 12 months, major adverse cardiac events including death, myocardial infarction, and ischemic-driven target lesion revascularization tended to be lower in the triple group than the dual group (7.2% vs. 12.0%, p = 0.07). Percent intimal hyperplasia volume by volumetric intravascular ultrasound analysis was reduced from 27.1 ± 13.2% for the dual group to 22.1 ± 9.9% for the triple group (p = 0.017). Patients receiving triple antiplatelet therapy after long zotarolimus-eluting stent implantation had decreased extent of late luminal loss, percent intimal hyperplasia volume, and angiographic restenosis, resulting in a reduced risk of 12-month target lesion revascularization compared with patients receiving dual antiplatelet therapy. (Triple Versus Dual Antiplatelet Therapy after ABT578-Eluting

  16. 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.

  17. Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

    PubMed Central

    Rzeszutko, Łukasz; Tokarek, Tomasz; Siudak, Zbigniew; Dziewierz, Artur; Żmudka, Krzysztof

    2016-01-01

    Introduction There are limited data on the comparison of bioresorbable vascular scaffold (BVS) and drug-eluting stent (DES)/bare-metal stent (BMS) implantation in an unselected population of patients with coronary artery disease. Aim To compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry. Material and methods A total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA), DES or BMS (all available types) implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA) or acute coronary syndrome were collected. Results Bioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; p = 0.001) and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; p = 0.001 for both). The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; p = 0.02), but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; p = 0.01), and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394–18.906; p = 0.001). Conclusions Patients treated with BVS implantation presented an acceptable safety and efficacy profile in comparison with

  18. [Changes in antithrombin III, prothrombin fragment 1 + 2 and thrombin-antithrombin III complex following implantation of a coronary Palmaz-Schatz stent].

    PubMed

    Dittel, M; Haushofer, A; Spiel, R; Halbmayer, W M; Prachar, H; Fischer, M; Mlczoch, J

    1995-01-01

    To detect changes in the clotting parameters antithrombin III (AT III), prothrombin-fragment 1 + 2 (F 1 + 2) and thrombin-antithrombin-III-complex (TAT) after implantation of Palmaz Schatz stents, coagulation was monitored at standardized time points in 35 patients for 10 days. All patients were anticoagulated using a combination of heparin, phenprocoumon, and acetyl salicylic acid. Heparin therapy was guided by APTT levels (normal range 25-35 s), which were still within the therapeutic range (median 49.6 s (25%/75% percentiles 41.6/54.4) on day 10. Simultaneous oral anticoagulation was found to be effective on day 8 on average (INR median 2.24 (1.93/2.50)). The AT III activity dropped significantly (p < 0.0001) after a heparin loading dose of 15,000 IU during stenting. As the heparin dose was reduced on the following days, AT III levels increased significantly (p < 0.0001) during the observation time. There was a highly significant (p < 0.001) negative correlation between AT III and heparin levels. On days 4 and 5 F 1 + 2 values were significantly (p < 0.001 and p < 0.05) higher than on the day of stenting (median 1.07 (0.90/1.31) 1.13 nmol/l and 1.06 (0.85/1.23) nmol/l vs. 0.97 (0.69/1.15) nmol/l) and dropped during anticoagulation. F 1 + 2 levels showed a significant negative correlation (p < 0.0005) with APTT values. TAT values showed no significant changes during the observation period.(ABSTRACT TRUNCATED AT 250 WORDS)

  19. Impact of Stent Design on In-Stent Stenosis in a Rabbit Iliac Artery Model

    SciTech Connect

    Sommer, C. M. Grenacher, L.; Stampfl, U.; Arnegger, F. U.; Rehnitz, C.; Thierjung, H.; Stampfl, S.; Berger, I.; Richter, G. M.; Kauczor, H. U.; Radeleff, B. A.

    2010-06-15

    The purpose of this study was to evaluate the impact of stent design on in-stent stenosis in rabbit iliac arteries. Four different types of stent were implanted in rabbit iliac arteries, being different in stent design (crown or wave) and strut thickness (50 or 100 {mu}m). Ten stents of each type were implanted. Each animal received one crown and one wave stent with the same strut thickness. Follow-up was either 12 weeks (n = 10 rabbits) or 24 weeks (n = 10 rabbits). Primary study end points were angiographic and microscopic in-stent stenosis. Secondary study end points were vessel injury, vascular inflammation, and stent endothelialization. Average stent diameter, relative stent overdilation, average and minimal luminal diameter, and relative average and maximum luminal loss were not significantly different. However, a trend to higher relative stent overdilation was recognized in crown stents compared to wave stents. A trend toward higher average and minimal luminal diameter and lower relative average and maximum luminal loss was recognized in crown stents compared to wave stents with a strut thickness of 100 {mu}m. Neointimal height, relative luminal area stenosis, injury score, inflammation score, and endothelialization score were not significantly different. However, a trend toward higher neointimal height was recognized in crown stents compared to wave stents with a strut thickness of 50 {mu}m and a follow-up of 24 weeks. In conclusion, in this study, crown stents seem to trigger neointima. However, the optimized radial force might equalize the theoretically higher tendency for restenosis in crown stents. In this context, also more favorable positive remodeling in crown stents could be important.

  20. [Endovascular implantation of iodine-125 seeds strand and portal vein stenting followed by transcatheter arterial chemoembolization combined therapy with sorafenib for hepatocellular carcinoma with main portal vein tumor thrombus].

    PubMed

    Li, W W; Dai, Z Y; Wan, H G; Yao, L Z; Zhu, J; Li, C L; Wang, X J; Pan, J; Chen, L Z

    2016-06-21

    To compare the therapeutic effect of portal vein stenting and endovascular implantation of iodine-125 seeds strand followed by transcatheter arterial chemoembolization combined with or without sorafenib in patients for hepatocellular carcinoma (HCC) with main portal vein tumor thrombus (MPVTT). A total of 53 patients with HCC complicated by MPVTT who received portal vein stenting and endovascular implantation of iodine-125 seeds strand followed by transcatheter arterial chemoembolization combined without (group A, n=38) or with (group B, n=15) sorafenib in Affiliated Yancheng Hospital of Southeast University Medical College during January 2010 and August 2015 were analyzed retropectively.Overal survival, progress free survival and procedure-related adverse event were compared between the two groups. The technical success rate was 100% for placement of (125)I seeds strand and stent in the obstructed main portal vein.No serious procedure-related adverse events occurred. Median survival time of group A and B were 12.1 and 14.8 months, respectively (P=0.037). Additionally, Median progress free survival time of group A and B were 2.8 and 4.0 months, respectively (P=0.002). Endovascular implantation of iodine-125 seeds strand and portal vein stenting followed by transcatheter arterial chemoembolization combined with sorafenib could improve the survival time, the progress free survival time of patients with HCC complicated by MPVTT.

  1. Clinical predictors of mortality following rotational atherectomy and stent implantation in high‐risk patients: A single center experience

    PubMed Central

    Édes, István F.; Ruzsa, Zoltán; Szabó, György; Nardai, Sándor; Becker, Dávid; Benke, Kálmán; Szilveszter, Bálint

    2015-01-01

    Objectives Our aim was to assess the procedural success and determine the clinical predictors of postprocedure mortality, following rotational atherectomy (RA) and stenting in high‐risk patients. Background RA is mainly used to facilitate stenting in complex lesions. Outcomes involving RA and stenting have been investigated, yet high‐risk patients have not been adequately described. Methods Data of 218 consecutive patients who underwent RA were evaluated in a prospective register. Primary endpoints were the angiographic success and long‐term mortality. Secondary endpoints were procedural success, consumption of the angioplasty equipment, and periprocedural major adverse cardiac events. The impact of the relevant angiographic and clinical characteristics on long‐term mortality was analyzed using uni‐ and multivariate Cox regression analysis. Results Mean age of the patients was 70 ± 8.2 years, diabetes was present in 44%, and chronic renal failure in 29%. Prior myocardial infarction and three‐vessel disease amounted to 42.2% and 32.6%, respectively. Altogether, 52.8% of patients underwent RA after a failed, non‐RA intervention attempt, and 30.7% of cases presented as acute coronary syndromes. Angiographic success was 100%, and all patients received stents after RA. Periprocedural major adverse cardiac events occurred in five (2.3%) patients. Postprocedural death was investigated, with a mean follow‐up of 36 months. Mortality amounted to 37.2%. Multivariate analysis revealed that left ventricular ejection fraction < 50%, glomerular filtration rate < 60 ml/min, cardiogenic shock, and diabetes were the only independent mortality predictors. Conclusions We have found that RA and stenting is feasible and viable in an elderly high‐risk population, with exceptional procedural success and acceptable long‐term results. © 2015 Wiley Periodicals, Inc. PMID:26032270

  2. Results of AFX Unibody Stent-Graft Implantation in Patients With TASC D Aortoiliac Lesions and Coexistent Abdominal Aortic Aneurysms.

    PubMed

    Sirignano, Pasqualino; Mansour, Wassim; Capoccia, Laura; Pranteda, Chiara; Montelione, Nunzio; Speziale, Francesco

    2017-09-01

    To describe results of AFX unibody stent-graft treatment for TransAtlantic Inter-Society Consensus (TASC) D aortoiliac occlusive disease (AIOD) with coexistent abdominal aortic aneurysm (AAA). A retrospective analysis was conducted of 21 consecutive patients (mean age 73.6±6.4 years; 17 men) with TASC D AIOD plus AAA (diameter >3.5 cm) treated electively using the AFX stent-graft. Common iliac artery (CIA) and external iliac artery (EIA) stenosis or occlusion was reported. Outcome measures were technical and clinical success, improvement in ankle-brachial index (ABI), and improvement in Rutherford category. Immediate and midterm patency, AAA exclusion, major adverse events (MAE), and mortality were also evaluated. After AFX deployment (100% technical success), 18 EIAs required adjunctive stenting (none required in the CIA). One patient required a reintervention for closure device failure. At 30-day follow-up, no death or MAE was recorded. Improvement in ABI was registered in all patients (mean 0.91±0.11), with 100% primary patency. At a mean follow-up of 25.2±11.1 months, primary patency was maintained in all cases. No death or amputation occurred; 2 patients had a myocardial infarction. Improvement in ABI was maintained (0.88±0.13) as well as Rutherford category. This study examined the use of the AFX unibody stent-graft for the treatment of TASC D AIOD with concomitant AAA. The AFX stent-graft appears to be a safe and effective solution for these complex lesions, with low morbidity and mortality.

  3. Angiographic and clinical comparisons of intravascular ultrasound- versus angiography-guided drug-eluting stent implantation for patients with chronic total occlusion lesions: two-year results from a randomised AIR-CTO study.

    PubMed

    Tian, Nai-Liang; Gami, Sandeep-Kumar; Ye, Fei; Zhang, Jun-Jie; Liu, Zhi-Zhong; Lin, Song; Ge, Zhen; Shan, Shou-Jie; You, Wei; Chen, Liang; Zhang, Yao-Jun; Mintz, Gary; Chen, Shao-Liang

    2015-04-01

    This study sought to compare angiographic endpoints at one-year follow-up after a drug-eluting stent implantation guided by either intravascular ultrasound (IVUS) or angiography in patients with chronic total occlusion (CTO) lesions. Patients with at least one CTO lesion recanalised successfully were randomly assigned to the IVUS-guided or the angiography-guided group. The use of IVUS for penetration of the true lumen and optimisation of stent expansion was only done in the IVUS-guided group. The primary endpoint was in-stent late lumen loss (LLL) at one-year follow-up. A total of 230 patients with CTO lesions after successful recanalisation were enrolled and followed with office visits or telephone contact up to 24 months. In-stent LLL in the IVUS-guided group was significantly lower compared to the angiography-guided group at one-year follow-up (0.28±0.48 mm vs. 0.46±0.68 mm, p=0.025), with a significant difference in restenosis of the "in-true-lumen" stent between the two groups (3.9% vs.13.7%, p=0.021). The minimal lumen diameter and minimal stent cross-section area significantly and negatively correlated with LLL (all p<0.001). The rates of adverse clinical events were comparable between the IVUS- and angiography-guided groups at two-year follow-up (21.7% vs. 25.2%, p=0.641). The IVUS-guided stenting of the CTO lesion was associated with less LLL and a lower incidence of "in-true-lumen" stent restenosis. Additional study is required to identify the clinical benefit of the IVUS-guided procedure for CTO lesions. [ChiCTR-TRC-10000996].

  4. Randomised, double-blind trial on the value of tapered discontinuation of clopidogrel maintenance therapy after drug-eluting stent implantation. Intracoronary Stenting and Antithrombotic Regimen: CAUTION in Discontinuing Clopidogrel Therapy--ISAR-CAUTION.

    PubMed

    Fiedler, K Anette; Mehilli, Julinda; Kufner, Sebastian; Schlichting, Anna; Ibrahim, Tareq; Sibbing, Dirk; Ott, Ilka; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan; Schulz, Stefanie

    2014-06-01

    There is little evidence on the optimal mode of clopidogrel discontinuation. Epidemiological studies observed clustering of thrombotic events after cessation of chronic clopidogrel therapy. The underlying mechanism has been ascribed to transient platelet hyper-reactivity. Gradual tapering of clopidogrel may have the potential to attenuate this phenomenon. The objective of the present study was to assess whether in patients with drug-eluting stents (DES) gradual discontinuation of clopidogrel maintenance therapy is superior to conventional, abrupt discontinuation. Patients with planned discontinuation of chronic clopidogrel therapy after DES implantation were randomised in a double-blinded fashion to either gradual discontinuation (according to a tapering schema over four weeks) or abrupt discontinuation (after continued clopidogrel therapy for additional four weeks). The primary endpoint was the composite of cardiac death, myocardial infarction, stroke, stent thrombosis, major bleeding or rehospitalisation due to an acute coronary syndrome at 90 days. Enrollment of 3,000 patients was planned. The study was stopped prematurely due to slow recruitment after enrollment of 782 patients. At 90 days, nine of 392 patients (2.3%) with tapered cessation reached the primary endpoint compared to five of 390 patients (1.3%) with abrupt cessation (p=0.284). The composite of death or myocardial infarction occurred in three patients with tapered and three patients with abrupt discontinuation (p=0.764). In conclusion, tapered discontinuation of chronic clopidogrel therapy is not superior to abrupt discontinuation regarding the primary endpoint in this study. However, the results must be interpreted in view of the premature termination of the trial and low event rates.

  5. 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.

  6. Wave reflection at a stent.

    PubMed

    Crespo, Antonio; García, Javier; Manuel, Fernando

    2013-01-01

    A simple analytical expression has been derived to calculate the characteristics of a wave that reflects at a stent implanted in a uniform vessel. The stent is characterized by its length and the wave velocity in the stented region. The reflected wave is proportional to the time derivative of the incident wave. The reflection coefficient is a small quantity of the order of the length of the stent divided by the wavelength of the unstented vessel. The results obtained coincide with those obtained numerically by Charonko et al. The main simplifications used are small amplitude of the waves so that equations can be linearized and that the length of the stent is small enough so that the values of the wave functions are nearly uniform along the stent. Both assumptions hold in typical situations.

  7. High-intensity Statin Treatments in Clinically Stable Patients on Aspirin Monotherapy 12 Months After Drug-eluting Stent Implantation: A Randomized Study.

    PubMed

    Im, Eui; Cho, Yun-Hyeong; Suh, Yongsung; Cho, Deok-Kyu; Her, Ae-Young; Kim, Yong Hoon; Lee, Kyounghoon; Kang, Woong Chol; Yun, Kyeong Ho; Yoo, Sang-Yong; Cheong, Sang-Sig; Shin, Dong-Ho; Ahn, Chul-Min; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki

    2017-07-14

    Current guidelines on the treatment of blood cholesterol recommend continuous maintenance of high-intensity statin treatment in drug-eluting stent (DES)-treated patients. However, high-intensity statin treatment is frequently underused in clinical practice after stabilization of DES-treated patients. Currently, the impact of continuous high-intensity statin treatment on the incidence of late adverse events in these patients is unknown. We investigated whether high-intensity statin treatment reduces late adverse events in clinically stable patients on aspirin monotherapy 12 months after DES implantation. Clinically stable patients who underwent DES implantation 12 months previously and received aspirin monotherapy were randomly assigned to receive either high-intensity (40mg atorvastatin, n = 1000) or low-intensity (20mg pravastatin, n = 1000) statin treatment. The primary endpoint was adverse clinical events at 12-month follow-up (a composite of all death, myocardial infarction, revascularization, stent thrombosis, stroke, renal deterioration, intervention for peripheral artery disease, and admission for cardiac events). The primary endpoint at 12-month follow-up occurred in 25 patients (2.5%) receiving high-intensity statin treatment and in 40 patients (4.1%) receiving low-intensity statin treatment (HR, 0.58; 95%CI, 0.36-0.92; P = .018). This difference was mainly driven by a lower rate of cardiac death (0 vs 0.4%, P = .025) and nontarget vessel myocardial infarction (0.1 vs 0.7%, P = .033) in the high-intensity statin treatment group. Among clinically stable DES-treated patients on aspirin monotherapy, high-intensity statin treatment significantly reduced late adverse events compared with low-intensity statin treatment. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01557075. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  8. Sun’s procedure for complex aortic arch repair: total arch replacement using a tetrafurcate graft with stented elephant trunk implantation

    PubMed Central

    Ma, Wei-Guo; Zhu, Jun-Ming; Zheng, Jun; Liu, Yong-Min; Ziganshin, Bulat A.; Elefteriades, John A.

    2013-01-01

    The Sun’s procedure is a surgical technique proposed by Dr. Li-Zhong Sun in 2002 that integrates total aortic arch replacement using a tetrafurcated graft with implantation of a specially designed frozen elephant trunk (Cronus®) in the descending aorta. It is used as a treatment option for extensive aortic dissections or aneurysms involving the ascending aorta, aortic arch and the descending aorta. The technical essentials of Sun’s procedure include implantation of the special open stented graft into the descending aorta, total arch replacement with a 4-branched vascular graft, right axillary artery cannulation, selective antegrade cerebral perfusion for brain protection, moderate hypothermic circulatory arrest at 25 °C, a special anastomotic sequence for aortic reconstruction (i.e., proximal descending aorta → left carotid artery → ascending aorta → left subclavian artery → innominate artery), and early rewarming and reperfusion after distal anastomosis to minimize cerebral and cardiac ischemia. The core advantage of Sun’s procedure lies in the use of a unique stented graft, which has superior technical simplicity, flexibility, inherent mechanical durability and an extra centimeter of attached regular vascular graft at both ends. Since its introduction in 2003, the Sun’s procedure has produced satisfactory early and long-term results in over 8,000 patients in China and more than 200 patients in South American countries. In a series of 1,092 patients, the authors have achieved an in-hospital mortality rate of 6.27% (7.98% in emergent or urgent vs. 3.98% in elective cases). Given the accumulating clinical experience and the consequent, continual evolution of surgical indications, the Sun’s procedure is becoming increasingly applied/used worldwide as an innovative and imaginative enhancement of surgical options for the dissected (or aneurysmal) ascending aorta, aortic arch and proximal descending aorta, and may become the next standard treatment

  9. Impact of admission creatinine level on clinical outcomes of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention with drug-eluting stent implantation.

    PubMed

    Zhang, Qi; Zhang, Rui-yan; Shen, Jie; Zhang, Jian-sheng; Hu, Jian; Yang, Zheng-kun; Zhang, Xian; Zheng, Ai-fang; Shen, Wei-feng

    2008-12-05

    Prognosis of patients with acute ST-elevation myocardial infarction (STEMI) and renal dysfunction (RD) who received primary percutaneous coronary intervention (PCI) has not been fully investigated in the drug-eluting stent (DES) era. This study aimed to evaluate the impact of admission serum creatinine level on short-term outcomes in patients with acute STEMI undergoing DES-based primary PCI. Primary PCI with DES implantation was attempted in 619 consecutive STEMI patients within 12 hours of symptom onset. Among them, 86 patients had a serum creatinine level > or = 115 micromol/L on admission (RD group), and the remaining 533 patients had normal renal function (non-RD group). The primary endpoint was 30-day major adverse cardiac events (MACE, including death, non-fatal reinfarction, and target vessel revascularization), and the secondary endpoint was subacute stent thrombosis. Patients in the RD group were older than those in the non-RD group. There are more female patients in the RD group and they had a history of hypertension, myocardial infarction and revascularization. The occurrence rates of Killip class > or = 2 (29.1% vs 18.6%, P = 0.02) and multi-vessel (62.8% vs 44.5%, P = 0.001) and triple vessel disease (32.6% vs 18.2%, P = 0.002), in-hospital mortality (9.3% vs 3.8%, P = 0.03), and MACE rate during hospitalization (17.4% vs 7.7%, P = 0.006) were higher in the RD group than those in the non-RD group. At a 30-day clinical follow-up, the MACE-free survival rate was significantly reduced in the RD group (76.7% vs 89.9%, P = 0.0003). Angiographic stent thrombosis occurred in 3 (3.5%) and 7 (1.3%) of patients in the RD group and non-RD group, respectively (P = 0.15). Multivariate analysis revealed that the serum creatinine level > or = 115 micromol/L on admission was an independent predictor for MACE rate at a 30-day follow-up (Hazard ratio (HR) 3.31, 95% CI 1.19 - 9.18, P < 0.001). Despite similar prevalence of stent thrombosis at a 30-day clinical follow

  10. Management of patients with recently implanted coronary stents on dual antiplatelet therapy who need to undergo major surgery.

    PubMed

    Savonitto, S; Caracciolo, M; Cattaneo, M; DE Servi, S

    2011-11-01

    About 5% of patients undergoing coronary stenting need to undergo surgery within the next year. The risk of perioperative cardiac ischemic events, particularly stent thrombosis (ST), is high in these patients, because surgery has a prothrombotic effect and antiplatelet therapy is often withdrawn in order to avoid bleeding. The clinical and angiographic predictors of ST are well known, and the proximity to an acute coronary syndrome adds to the risk. The current guidelines recommend delaying non-urgent surgery for at least 6 weeks after the placement of a bare metal stent and for 6-12 months after the placement of a drug-eluting stent, when the risk of ST is reduced. However, in the absence of formal evidence, these recommendations provide little support with regard to managing urgent operations. When surgery cannot be postponed, stratifying the risk of surgical bleeding and cardiac ischemic events is crucial in order to manage perioperative antiplatelet therapy in individual cases. Dual antiplatelet therapy should not be withdrawn for minor surgery or most gastrointestinal endoscopic procedures. Aspirin can be safely continued perioperatively in the case of most major surgery, and provides coronary protection. In the case of interventions at high risk for both bleeding and ischemic events, when clopidogrel withdrawal is required in order to reduce perioperative bleeding, perioperative treatment with the short-acting intravenous glycoprotein IIb-IIIa inhibitor tirofiban is safe in terms of bleeding, and provides strong antithrombotic protection. Such surgical interventions should be performed at hospitals capable of performing an immediate percutaneous coronary intervention at any time in the case of acute myocardial ischemia.

  11. New scoring model (DARSYM score) to predict post-discharge bleeding after successful second-generation drug-eluting stent implantation.

    PubMed

    Honda, Yohsuke; Yamawaki, Masahiro; Hirano, Keisuke; Araki, Motoharu; Kobayashi, Norihiro; Sakamoto, Yasunari; Mori, Shinsuke; Tsutumi, Masakazu; Takama, Takuro; Tokuda, Takahiro; Makino, Kenji; Shirai, Shigemitsu; Ito, Yoshiaki

    2017-05-30

    We aimed to create a scoring model to predict post-discharge bleeding (PDB) after drug-eluting stent (DES) implantation in Japanese subjects. We enrolled 1912 consecutive patients undergoing DES implantation (age 70 ± 10 years; 72% male). PDB was defined as a composite of type 5, 3, and 2 bleeding using the Bleeding Academic Research Consortium criteria. A Cox proportional hazard model assessed predictors, and we then derived a clinical model stratifying risk of PDB after DES implantation. Ninety-eight patients (6.7%) experienced PDB; gastrointestinal bleeding (GIB) was most common (n = 66, 67%), followed by intracranial bleeding (n = 24, 25%). PDB was independently associated with age >80 years [risk ratio (RR): 1.89, p < 0.001], hypertension (RR: 1.68, p = 0.03), severe renal dysfunction (RR: 1.56, p = 0.04), anemia on admission (RR: 1.75, p = 0.02), prior history of GIB (RR: 3.49, p < 0.001), NSAIDs use (RR: 2.33, p = 0.03), and introduction of triple antithrombotic therapy (RR: 2.94, p < 0.001). A clinical prediction rule for risk of bleeding events including seven baseline factors was derived. A better predictive ability for PDB was found using this new scoring system than the HAS-BLED score [c statistics, 0.85 (95% CI 0.83-0.87) and c statistics, 0.71 (95% CI 0.69-0.73), respectively; p < 0.001]. This new scoring system including patient characteristics and laboratory variables can identify patients at high risk of PDB after DES implantation.

  12. Two-year outcome after Xpert stent implantation for treating below the knee lesions in critical limb ischemia.

    PubMed

    Bosiers, Marc; Lioupis, Christos; Deloose, Koen; Verbist, Jürgen; Peeters, Patrick

    2009-01-01

    We investigated the efficacy of Xpert (Abbott Vascular, Abbott Park, IL) nitinol stents for the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia (CLI). Between May 2005 and November 2007, 94 CLI patients (70 male, mean age 73.5 years) received 134 Xpert stents in 102 limbs. Seventy-nine patients (71.2%) were scored as Rutherford Category 4, 31 patients (27.9%) as Category 5 and 1 patient (0.9%) as Category 6. Primary endpoint of this study was defined as 2-year duplex derived primary patency. Secondary endpoints were 2-year limb salvage rate and the absence of reintervention after the index procedure. Kaplan Meier analysis reported 2-year primary patency and limb salvage rates of 54.4% and 90.8%, respectively. Stratification by lesion location did not reveal any significant differences in 2-year primary patency rates in proximal and distal below the knee lesions. Our results suggest that treatment with nitinol Xpert stents can be considered effective for treating CLI patients, with satisfying patency outcome.

  13. iStent® Trabecular Microbypass Stent: An Update

    PubMed Central

    Resende, Arthur Fernandes; Patel, Neal Sanjay; Waisbourd, Michael; Katz, L. Jay

    2016-01-01

    Due to the high rates of complications and failure experienced with current glaucoma procedures, there is a continuous search for a safer and more effective glaucoma surgery. A new class of procedures termed minimally invasive glaucoma surgeries (MIGS) aim to fill this void by offering an alternative method of IOP reduction associated with markedly reduced complication rates and shorter recovery times. The iStent, a trabecular microbypass stent, is a MIGS device that has quickly gained popularity. The device allows aqueous humor to directly drain from the anterior chamber into Schlemm's canal by bypassing an obstructed trabecular meshwork. This review examines publications about the iStent, focusing on the device's efficacy, safety, and cost when a single iStent or multiple iStents are implanted in combination with cataract surgery or as a solo procedure. Current data suggest that the iStent is a safe and effective tool in the management of mild-to-moderate glaucoma, notable for its limited complications and absence of serious adverse events following implantation. As valuable experience is gained performing ab interno MIGS, increasing familiarity with angle anatomy and iStent placement, and as newer stent designs are developed, there is promise of continual improvement in the surgical management of glaucoma. PMID:27413541

  14. Refining stent technologies for femoral interventions.

    PubMed

    Bosiers, M; Deloose, K; Callaert, J; Maene, L; Keirse, K; Verbist, J; Peeters, P

    2012-08-01

    Stents were created as a mechanical scaffold to prevent vessel recoil and luminal renarrowing after percutaneous transluminal angioplasty (PTA). In femoropopliteal arteries, indication for stent implantation remains a topic much debated on, especially in long lesion configurations. Ever since the first stents were introduced on the market, in-stent restenosis (ISR) has been an important issue. The evolution in stent design has known a major progression in the last decades from the first generation of stents, plagued with high fracture rates and low primary patency rates, to the design of newer stents to tackle these outcomes. More flexible and longer stents decreased the high fracture rates and drug-eluting stents offered a solution to the restenosis rates by local drug application. The difficult recrossibility of the lesion because of the presence of a permanent vascular scaffold is an obstacle that the drug-coated balloon (DCB) overcomes. Future perspectives in the treatment of femoropopliteal lesions are found in the bioresorbable stent implantation. The bioresorbable stent combines the advantages of a drug-eluting scaffolding stent without the remainder of a foreign object in the long-term. Further investigations in this area will eventually evolve in the creation of a superior endovascular treatment modality with high long-term patency rates and minimal detriments.

  15. [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

  16. Rationale and design of the TAXUS Libertē Post-Approval Study: examination of patients receiving the TAXUS Liberté stent with concomitant prasugrel therapy in routine interventional cardiology practice.

    PubMed

    Garratt, Kirk N; Lee, David P; Rose, Eileen M; Windle, Kellie J; Liao, Hsini; Nwachuku, Chuke E; Winters, Kenneth J; Bowman, Thomas S; Dawkins, Keith D

    2012-02-01

    Observational studies of new coronary stents are necessary to assess performance in a variety of complex patient and lesion types. Furthermore, the optimal dose and duration of thienopyridine treatment is unclear, particularly in patients with complex clinical conditions. The TAXUS Libertē Post-Approval Study is designed to provide 5-year data on the TAXUS Liberté paclitaxel-eluting stent with concomitant prasugrel therapy in routine clinical practice and to contribute data to the DAPT study. The TAXUS Libertē Post-Approval Study is a prospective, multicenter, observational study. Enrollment of approximately 4,200 patients receiving ≥1 TAXUS Liberté stents is planned. All patients without a contraindication will be prescribed prasugrel plus aspirin for 1 year. The 12-month primary end point of cardiac death or myocardial infarction in on-label stent patients will be compared with historical TAXUS Express stent data from the TAXUS ATLAS and TAXUS ARRIVE studies. Secondary clinical end points include stent thrombosis, all-cause death, stroke, revascularization, and bleeding in all patients. In addition, this study will be the first to evaluate prasugrel use in a routine practice setting (including 5 and 10 mg daily doses) and will contribute data to the DAPT Study, comparing 12 versus 30 months of dual antiplatelet therapy after drug-eluting stent placement. The TAXUS Libertē Post-Approval Study will be the first to provide long-term real-world data on use of the TAXUS Liberté Stent with prasugrel treatment. The study is currently enrolling, and primary end point data are expected in mid 2013. Copyright © 2012 Mosby, Inc. All rights reserved.

  17. Reducing In-Stent Restenosis

    PubMed Central

    McDonald, Robert A.; Halliday, Crawford A.; Miller, Ashley M.; Diver, Louise A.; Dakin, Rachel S.; Montgomery, Jennifer; McBride, Martin W.; Kennedy, Simon; McClure, John D.; Robertson, Keith E.; Douglas, Gillian; Channon, Keith M.; Oldroyd, Keith G.; Baker, Andrew H.

    2015-01-01

    Background Drug-eluting stents reduce the incidence of in-stent restenosis, but they result in delayed arterial healing and are associated with a chronic inflammatory response and hypersensitivity reactions. Identifying novel interventions to enhance wound healing and reduce the inflammatory response may improve long-term clinical outcomes. Micro–ribonucleic acids (miRNAs) are noncoding small ribonucleic acids that play a prominent role in the initiation and resolution of inflammation after vascular injury. Objectives This study sought to identify miRNA regulation and function after implantation of bare-metal and drug-eluting stents. Methods Pig, mouse, and in vitro models were used to investigate the role of miRNA in in-stent restenosis. Results We documented a subset of inflammatory miRNAs activated after stenting in pigs, including the miR-21 stem loop miRNAs. Genetic ablation of the miR-21 stem loop attenuated neointimal formation in mice post-stenting. This occurred via enhanced levels of anti-inflammatory M2 macrophages coupled with an impaired sensitivity of smooth muscle cells to respond to vascular activation. Conclusions MiR-21 plays a prominent role in promoting vascular inflammation and remodeling after stent injury. MiRNA-mediated modulation of the inflammatory response post-stenting may have therapeutic potential to accelerate wound healing and enhance the clinical efficacy of stenting. PMID:26022821

  18. Shorter- versus Longer-duration Dual Antiplatelet Therapy in Patients with Diabetes Mellitus Undergoing Drug-eluting Stents Implantation: A Meta-analysis of Randomized Controlled Trials

    PubMed Central

    Huang, He; Li, Ya; Chen, Yu; Fu, Guo-Sheng

    2016-01-01

    Background: Patients with diabetes mellitus (DM) have a higher risk of thromboembolic events; however, the optimal duration of dual antiplatelet therapy (DAPT) remains unclear. The goal of this study was to assess the efficacy and safety of various DAPT durations in patients with DM undergoing drug-eluting stent implantation. Methods: We conducted a literature search for randomized controlled trials (RCTs). We searched databases including EMBASE, PubMed, Cochrane Library, and Scopus up to June 2016. Investigators extracted data independently, including outcomes, characteristics, and study quality. A random-effect model was used to pool odds ratios (ORs) with 95% confidence intervals (CIs) of the clinical outcomes. Results: Six RCTs totaling 6040 patients with DM were included in the study. Shorter-duration DAPT resulted in an increased rate of stent thrombosis (ST) (OR, 1.83, 95% CI: 1.03–3.26, P = 0.04), but did not increase the risk of myocardial infarction (OR, 1.33, 95% CI: 0.71–2.47, P = 0.37), stroke (OR, 0.96, 95% CI: 0.52–1.77, P = 0.90), target vessel revascularization (OR, 1.19, 95% CI: 0.46–3.07, P = 0.71), all-cause death (OR: 0.72, 95% CI: 0.48–1.09, P = 0.12), or cardiac death (OR, 0.82, 95% CI: 0.49–1.36, P = 0.44) significantly. Shorter-duration DAPT was associated with a decreased risk of major bleeding (OR, 0.60, 95% CI: 0.38–0.94, P = 0.02). Conclusion: In patients with DM, longer-duration DAPT had a lower risk of ST, but was associated with an increased bleeding risk. PMID:27901002

  19. Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry.

    PubMed

    Sabaté, Manel; Brugaletta, Salvatore; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio; Džavík, Vladimír; Ellis, Stephen; Holmes, David; Gao, Runlin; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Spaulding, Christian; Stoll, Hans-Peter; Worthley, Stephen; Urban, Philip

    2013-10-03

    Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown. A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months. The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P<0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. the NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P<0.04 and P<0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p=0.4). Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  20. Does intravascular ultrasound provide clinical benefits for percutaneous coronary intervention with bare-metal stent implantation? A meta-analysis of randomized controlled trials

    PubMed Central

    2012-01-01

    Background The role of intravascular ultrasound (IVUS) in percutaneous coronary interventions (PCI) is still controversial despite several previously published meta-analyses. A meta-analysis to evaluate the controversial role of IVUS-guided PCI with bare-metal stenting was performed and a previous published meta-analysis was re-evaluated in order to clarify the discrepancy between results of these studies. Methods A systematic review was performed by an electronic search of the PubMed, Embase and Web of Knowledge databases and by a manual search of reference lists for randomized controlled trials published until April 2011, with clinical outcomes and, at least, six months of clinical follow-up. A meta-analysis based on the intention to treat was performed with the selected studies. Results Five studies and 1,754 patients were included. There were no differences in death (OR = 1.86; 95% CI = 0.88-3.95; p = 0.10), non-fatal myocardial infarction (OR = 0.65; 95% CI = 0.27-1.58; p = 0.35) and major adverse cardiac events (OR = 0.74; 95% CI = 0.49-1.13; p = 0.16). An analysis of the previous published meta-analysis strongly suggested the presence of publication bias. Conclusions There is no evidence to recommend routine IVUS-guided PCI with bare-metal stent implantation. This may be explained by the paucity and heterogeneity of the studies published so far. PMID:22999055

  1. Intimal hyperplasia following implantation of helical-centreline and straight-centreline stents in common carotid arteries in healthy pigs: influence of intraluminal flow†

    PubMed Central

    Caro, Colin Gerald; Seneviratne, Anusha; Heraty, Kevin B.; Monaco, Claudia; Burke, Martin G.; Krams, Rob; Chang, Carlos C.; Coppola, Gianfilippo; Gilson, Paul

    2013-01-01

    Intimal hyperplasia (IH) is a leading cause of obstruction of vascular interventions, including arterial stents, bypass grafts and arteriovenous grafts and fistulae. Proposals to account for arterial stent-associated IH include wall damage, low wall shear stress (WSS), disturbed flow and, although not widely recognized, wall hypoxia. The common non-planarity of arterial geometry and flow, led us to develop a bare-metal, nitinol, self-expanding stent with three-dimensional helical-centreline geometry. This was deployed in one common carotid artery of healthy pigs, with a straight-centreline, but otherwise identical (conventional) stent deployed contralaterally. Both stent types deformed the arteries, but the helical-centreline device additionally deformed them helically and caused swirling of intraluminal flow. At sacrifice, one month post stent deployment, histology revealed significantly less IH in the helical-centreline than straight-centreline stented vessels. Medial cross-sectional area was not significantly different in helical-centreline than straight-centreline stented vessels. By contrast, luminal cross-sectional area was significantly larger in helical-centreline than straight-centreline stented vessels. Mechanisms considered to account for those results include enhanced intraluminal WSS and enhanced intraluminal blood–vessel wall mass transport, including of oxygen, in the helical-centreline stented vessels. Consistent with the latter proposal, adventitial microvessel density was lower in the helical-centreline stented than straight-centreline stented vessels. PMID:24132200

  2. Comparing the clinical outcomes in patients with atrial fibrillation receiving dual antiplatelet therapy and patients receiving an addition of an anticoagulant after coronary stent implantation

    PubMed Central

    Chaudhary, Nabin; Bundhun, Pravesh Kumar; Yan, He

    2016-01-01

    Abstract Background: Data regarding the clinical outcomes in patients with atrial fibrillation (AF) receiving dual antiplatelet therapy (DAPT) and an anticoagulant in addition to DAPT (DAPT + vitamin K antagonist [VKA]) after coronary stent implantation are still controversial. Therefore, in order to solve this issue, we aim to compare the adverse clinical outcomes in AF patients receiving DAPT and DAPT + VKA after percutaneous coronary intervention and stenting (PCI-S). Methods: Observational studies comparing the adverse clinical outcomes such as major bleeding, major adverse cardiovascular events, stroke, myocardial infarction, all-cause mortality, and stent thrombosis (ST) in AF patients receiving DAPT + VKA therapy, and DAPT after PCI-S have been searched from Medline, EMBASE, and PubMed databases. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to express the pooled effect on discontinuous variables, and the pooled analyses were performed with RevMan 5.3. Results: Eighteen studies consisting of a total of 20,456 patients with AF (7203 patients received DAPT + VKA and 13,253 patients received DAPT after PCI-S) were included in this meta-analysis. At a mean follow-up period of 15 months, the risk of major bleeding was significantly higher in DAPT + VKA group, with OR 0.62 (95% CI 0.50–0.77, P < 0.0001). There was no significant differences in myocardial infarction and major adverse cardiovascular event between DAPT + VKA and DAPT, with OR 1.27 (95% CI 0.92–1.77, P = 0.15) and OR 1.17 (95% CI 0.99–1.39, P = 0.07), respectively. However, the ST, stroke, and all-cause mortality were significantly lower in the DAPT + VKA group, with OR 1.98 (95% CI 1.03–3.81, P = 0.04), 1.59 (95% CI 1.08–2.34, P = 0.02), and 1.41 (95% CI 1.03–1.94, P = 0.03), respectively. Conclusion: At a mean follow-up period of 15 months, DAPT + VKA was associated with significantly lower risk of stroke, ST, and

  3. [A case of severe motor and intellectual disability with tracheal stenosis due to granulation caused by metal stents treated successfully by silicone stents].

    PubMed

    Kotani, Haruko; Hino, Hiroyuki; Shiraishi, Taisuke; Ogura, Hideo

    2002-11-01

    A silicone stent (Dumon stent) was used in a severe motor and intellectual disability with severe tracheal stenosis due to granulation caused by an implanted the expanded metal stent (Ultraflex Nitinol Stent). To treat tracheobronchial malacia, diagnosed in infancy, expanded metalic stent was implanted at the ages of 30 and 32 years. However, a few months after the second implantation, progressive dyspnea appeared, and he had to use a respirator under intravenous anesthesia. Bronchoscopy showed re-stenosis of the trachea due to a granulation tissue within the stent. A Dumon stent was applied to control the re-stenosis. He was successfully weaned from a respirator. Since granulation tissue had recurred at the end of the Dumon stent after 3 months, a long term care of the airway and regular observation is necessary after implantation of stents.

  4. Developments in metallic biodegradable stents.

    PubMed

    Hermawan, H; Dubé, D; Mantovani, D

    2010-05-01

    Interest in metallic degradable biomaterials research has been growing in the last decade. Both scientific journals and patent databases record a high increase in publications in this area. Biomedical implants with temporary function, such as coronary stents, are the targeted applications for this novel class of biomaterials. It is expected that stents made of degradable biomaterials, named biodegradable stents, will provide a temporary opening into a narrowed arterial vessel until the vessel remodels and will progressively disappear thereafter. Biodegradable stents made of metal have recently been progressed into preclinical tests in humans after their first introduction in early 2000s. By referring to patents and journal publications, this paper reviews the developments in biodegradable stents, with emphasis on those made of metals, starting from the first design ideas to validation testing.

  5. Paclitaxel-coated balloon for the treatment of drug-eluting stent restenosis: subanalysis results from the Valentines I trial.

    PubMed

    Loh, Joshua P; Stella, Pieter R; Sangiorgi, Giuseppe; Silber, Sigmund; Stahnke, Stefanie; von Strandmann, Rembert Pogge; Torguson, Rebecca; Waksman, Ron

    2014-01-01

    To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis. In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® PCB. Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR® PCB were compared. Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08±0.31 overall), mean PCB diameter (2.99±0.42mm overall), mean PCB length (24.4±11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231±43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015). In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure. © 2014.

  6. The Influence of Statin Therapy on Restenosis in Patients Who Underwent Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease: Two-Year Follow-up at a Single Center.

    PubMed

    Kim, Wonho; Gandhi, Ripal T; Peña, Constantino S; Herrera, Raul E; Schernthaner, Melanie B; Acuña, Juan M; Becerra, Victor N; Katzen, Barry T

    2016-10-01

    To determine whether statin therapy is associated with reduced restenosis following nitinol stent implantation for de novo femoropopliteal artery disease. A total of 135 limbs in 135 patients (mean age, 72 y) implanted with nitinol stents in femoropopliteal occlusions were analyzed (statin arm, n = 91; nonstatin arm, n = 44). The patients were treated with one type of nitinol stent. At baseline, lesions and procedural characteristics were comparable between groups, except that the statin group had more hypertension, coronary artery disease, and hyperlipidemia. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for nonstatin group vs 28.6% for statin group; P = .05) and 2 years (56.8% for nonstatin group vs 38.5% for statin group; P = .04). Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). Two-year target lesion revascularization rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). On univariate analysis, statin therapy was associated with decreased relative risk of binary restenosis at 1 year (odds ratio [OR], 0.480; 95% confidence interval [CI], 0.227-1.014; P = .050). On multivariate analysis, statin therapy did not significantly affect the odds of binary restenosis (OR, 0.415; 95% CI, 0.071-2.437; P = .330). The incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group following nitinol stent implantation for de novo femoropopliteal artery disease. Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.

  7. 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

  8. Nitinol Esophageal Stents: New Designs and Clinical Indications

    SciTech Connect

    Strecker, Ernst-Peter; Boos, Irene; Vetter, Sylvia; Strohm, Michael; Domschke, Sigurd

    1996-11-15

    Purpose: To evaluate the clinical use of covered and noncovered, knitted nitinol stents in patients presenting new stent indications. Methods: Self-expandable, knitted nitinol stents were implanted in four patients for treatment of dysphagia. In two patients who had malignant strictures and had esophago-respiratory fistulae and in one patient with an esophagocutaneous fistula, polytetrafluoroethylene (PTFE)-covered stents were implanted. One patient received a noncovered stent, but a retrograde approach through a percutaneous endoscopic gastrostomy (PEG) fistula had to be chosen for recanalization of an esophageal occlusion. Two patients received stents for treatment of benign strictures. Results: Recanalization of the stricture and stent implantation were performed under fluoroscopic control without any procedure-related morbidity or mortality. Dysphagia improved in all patients and the esophageal fistulae could be sealed off by covered stents. During a maximum follow-up of 18 months, there was no stent migration or esophageal perforation. Complications observed were stent stenosis due to food impaction (1/4) and benign stent stenosis (2/2). Most complications could be treated by the interventional radiologist. Conclusion: Self-expandable, covered Nitinol stents provide an option for the treatment of dysphagia combined with esophageal fistulae. In combination with interventional radiology techniques, even complex strictures are accessible. For benign strictures, the value of stent treatment has not yet been proven.

  9. Novel biodegradable polydioxanone stents in a rabbit airway model.

    PubMed

    Novotny, Ladislav; Crha, Michal; Rauser, Petr; Hep, Ales; Misik, Jan; Necas, Alois; Vondrys, David

    2012-02-01

    This study was undertaken to evaluate safety and biocompatibility of a novel biodegradable polydioxanone stent in a rabbit tracheal model. Metallic and silicone stents represent standard therapeutic approaches for hollow organ stenosis, although complications have been reported repeatedly. Biodegradable stents could reduce the risks associated with this procedure while still achieving the purpose of maintaining lumen patency. A commercially available polydioxanone suture strand with a long safety record was used to manufacture the self-expanding stents. The polydioxanone stents were then implanted bronchoscopically and under fluoroscopic guidance into the tracheas of white rabbits (N = 25). Periodic clinical examination was performed. Histopathologic examination concluded the study for the 5 experimental groups at 3, 4, 5, 10, and 15 weeks after implantation. There were no unexpected deaths and no stent displacements during the study. The animals remained in good condition, without stent debris expectoration. Macroscopic examination revealed that the tracheal lumen stayed open. Histologic examination showed that tracheal damage score was highest 5 weeks after stenting, including in-stent necrosis of the epithelium. Stent degradation was complete with no remnants after 10 weeks, leaving the trachea completely healed at 15 weeks after implantation. This animal airway model has demonstrated acceptable safety and biocompatibility of this novel biodegradable polydioxanone stent. We suggest that polydioxanone stenting be used for further clinical studies for cases in which complete stent degradation after temporary airway treatment is desirable. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  10. Biological behaviour of human umbilical artery smooth muscle cell grown on nickel-free and nickel-containing stainless steel for stent implantation

    NASA Astrophysics Data System (ADS)

    Li, Liming; An, Liwen; Zhou, Xiaohang; Pan, Shuang; Meng, Xin; Ren, Yibin; Yang, Ke; Guan, Yifu

    2016-01-01

    To evaluate the clinical potential of high nitrogen nickel-free austenitic stainless steel (HNNF SS), we have compared the cellular and molecular responses of human umbilical artery smooth muscle cells (HUASMCs) to HNNF SS and 316L SS (nickel-containing austenitic 316L stainless steel). CCK-8 analysis and flow cytometric analysis were used to assess the cellular responses (proliferation, apoptosis, and cell cycle), and quantitative real-time PCR (qRT-PCR) was used to analyze the gene expression profiles of HUASMCs exposed to HNNF SS and 316L SS, respectively. CCK-8 analysis demonstrated that HUASMCs cultured on HNNF SS proliferated more slowly than those on 316L SS. Flow cytometric analysis revealed that HNNF SS could activate more cellular apoptosis. The qRT-PCR results showed that the genes regulating cell apoptosis and autophagy were up-regulated on HNNF SS. Thus, HNNF SS could reduce the HUASMC proliferation in comparison to 316L SS. The findings furnish valuable information for developing new biomedical materials for stent implantation.

  11. Genetic and non-genetic factors responsible for antiplatelet effects of clopidogrel in Japanese patients undergoing coronary stent implantation: an algorithm to predict on-clopidogrel platelet reactivity.

    PubMed

    Miura, Go; Ariyoshi, Noritaka; Sato, Yasunori; Yamaguchi, Hiroki; Iwata, Yo; Fujimoto, Yoshihide; Kobayashi, Yoshio; Ishii, Itsuko

    2014-10-01

    Antiplatelet effects of clopidogrel appear to be affected by various factors including genetic polymorphism. So far, there has been little information about the response of clopidogrel in Asians, whose prevalence of a CYP2C19 loss-of-function (LOF) allele is high. We investigated background and clinical factors affecting on-clopidogrel platelet reactivity in Japanese patients undergoing coronary stent implantation (n=114). In univariate analysis, antiplatelet effects of clopidogrel in a steady state were associated with not only CYP2C19 genotypes but also several factors including dyslipidemia. In addition, we developed an algorithm that can estimate P2Y12 Reaction Units (PRU) in a steady state by multiple regression analysis and evaluated the adequacy of the algorithm by the Akaike Information Criterion. We revealed several factors influencing on-clopidogrel platelet reactivity in Japanese patients. We also succeeded in developing an algorithm that estimates PRU in a steady state, although it is uncertain whether the algorithm can be applied to other populations. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Biological behaviour of human umbilical artery smooth muscle cell grown on nickel-free and nickel-containing stainless steel for stent implantation

    PubMed Central

    Li, Liming; An, Liwen; Zhou, Xiaohang; Pan, Shuang; Meng, Xin; Ren, Yibin; Yang, Ke; Guan, Yifu

    2016-01-01

    To evaluate the clinical potential of high nitrogen nickel-free austenitic stainless steel (HNNF SS), we have compared the cellular and molecular responses of human umbilical artery smooth muscle cells (HUASMCs) to HNNF SS and 316L SS (nickel-containing austenitic 316L stainless steel). CCK-8 analysis and flow cytometric analysis were used to assess the cellular responses (proliferation, apoptosis, and cell cycle), and quantitative real-time PCR (qRT-PCR) was used to analyze the gene expression profiles of HUASMCs exposed to HNNF SS and 316L SS, respectively. CCK-8 analysis demonstrated that HUASMCs cultured on HNNF SS proliferated more slowly than those on 316L SS. Flow cytometric analysis revealed that HNNF SS could activate more cellular apoptosis. The qRT-PCR results showed that the genes regulating cell apoptosis and autophagy were up-regulated on HNNF SS. Thus, HNNF SS could reduce the HUASMC proliferation in comparison to 316L SS. The findings furnish valuable information for developing new biomedical materials for stent implantation. PMID:26727026

  13. Mesenchymal stem cell seeding promotes reendothelialization of the endovascular stent.

    PubMed

    Wu, Xue; Wang, Guixue; Tang, Chaojun; Zhang, Dechuan; Li, Zhenggong; Du, Dingyuan; Zhang, Zhengcai

    2011-09-01

    This study is designed to make a novel cell seeding stent and to evaluate reendothelialization and anti-restenosis after the stent implantation. In comparison with cell seeding stents utilized in previous studies, Mesenchymal stem cells (MSCs) have advantages on promoting of issue repair. Thus it was employed to improve the reendothelialization effects of endovascular stent in present work. MSCs were isolated by density gradient centrifugation and determined as CD29(+) CD44(+) CD34(-) cells by immunofluorescence and immunocytochemistry; gluten and polylysine coated stents were prepared by ultrasonic atomization spray, and MSCs seeded stents were made through rotation culture according to the optimized conditions that were determined in previous studies. The results from animal experiments, in which male New Zealand white rabbits were used, show that the reendothelialization of MSCs coated stents can be completed within one month; in comparison with 316L stainless steel stents (316L SS stents) and gluten and polylysine coated stents, the intimal hyperplasia and in-stent restenosis are significantly inhibited by MSCs coated stents. Endovascular stent seeded with MSCs promotes reendothelialization and inhibits the intimal hyperplasia and in-stent restenosis compared with the 316L SS stents and the gluten and polylysine coated stents.

  14. The clinical outcomes of triple antiplatelet therapy versus dual antiplatelet therapy for high-risk patients after coronary stent implantation: a meta-analysis of 11 clinical trials and 9,553 patients.

    PubMed

    Fan, Zhong-Guo; Ding, Guo-Bin; Li, Xiao-Bo; Gao, Xiao-Fei; Gao, Ya-Li; Tian, Nai-Liang

    2016-01-01

    The optimal antiplatelet regimen after in-coronary intervention among patients presenting with complex coronary artery lesions or acute coronary syndrome (ACS) has remained unclear. This study sought to evaluate the clinical outcomes of triple antiplatelet treatment (TAPT) (cilostazol added to aspirin plus clopidogrel) in these patients. The PubMed, EMBASE, MEDLINE, and other Internet sources were searched for relevant articles. The primary end point was major adverse cardiac events (MACE), including all-cause mortality, myocardial infarction, and target vessel revascularization. The incidence of definite/probable stent thrombosis and bleeding were analyzed as the safety end points. Eleven clinical trials involving 9,553 patients were analyzed. The risk of MACE was significantly decreased following TAPT after stent implantation in the ACS subgroup (odds ratio [OR]: 0.72; 95% confidence interval [CI]: 0.61-0.85; P<0.001), which might mainly result from the lower risk of all-cause mortality in this subset (OR: 0.62; 95% CI: 0.48-0.80; P<0.001). The risk of bleeding was not increased with respect to TAPT. TAPT after stent implantation was associated with feasible benefits on reducing the risk of MACE, especially on reducing the incidence of all-cause mortality among patients suffering from ACS, without higher incidence of bleeding. Larger and more powerful randomized trials are still warranted to prove the superiority of TAPT for such patients.

  15. Outcomes of ≤6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation

    PubMed Central

    Villablanca, Pedro A.; Massera, Daniele; Mathew, Verghese; Bangalore, Sripal; Christia, Panagiota; Perez, Irving; Wan, Ningxin; Schulz-Schüpke, Stefanie; Briceno, David F.; Bortnick, Anna E.; Garcia, Mario J.; Lucariello, Richard; Menegus, Mark; Pyo, Robert; Wiley, Jose; Ramakrishna, Harish

    2016-01-01

    Abstract Background: The benefit of ≤6-month compared with 12-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) placement remains controversial. We performed a meta-analysis and meta-regression of ≤6-month versus 12-month DAPT in patients undergoing PCI with DES placement. Methods: We conducted electronic database searches of randomized controlled trials (RCTs) comparing DAPT durations after DES placement. For studies with longer follow-up, outcomes at 12 months were identified. Odds ratios and 95% confidence intervals were computed with the Mantel–Haenszel method. Fixed-effect models were used; if heterogeneity (I2) > 40 was identified, effects were obtained with random models. Results: Nine RCTs were included with total n = 19,224 patients. No significant differences were observed between ≤6-month compared with 12-month DAPT in all-cause mortality (OR 0.87; 95% confidence interval (CI): 0.69–1.11), cardiovascular (CV) mortality (OR 0.89; 95% CI: 0.66–1.21), non-CV mortality (OR 0.85; 95% 0.58–1.24), myocardial infarction (OR 1.10; 95% CI: 0.89–1.37), stroke (OR 0.97; 95% CI: 0.67–1.42), stent thrombosis (ST) (OR 1.37; 95% CI: 0.89–2.10), and target vessel revascularization (OR 0.95; 95% CI: 0.77–1.18). No significant difference in major bleeding (OR 0.72; 95% CI: 0.49–1.05) was observed, though the all-bleeding event rate was significantly lower in the ≤6-month DAPT group (OR 0.76; 95% CI: 0.59–0.96). In the meta-regression analysis, a significant association between bleeding events and non-CV mortality with 12-month DAPT was found, as well as between ST and mortality in addition to MI with ≤6-month DAPT. Conclusion: DAPT for ≤6 months is associated with similar mortality and ischemic outcomes but less bleeding events compared with 12-month DAPT after PCI with DES. PMID:28033306

  16. 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.

  17. Late Stent Expansion and Neointimal Proliferation of Oversized Nitinol Stents in Peripheral Arteries

    SciTech Connect

    Zhao, Hugh Q. Nikanorov, Alexander; Virmani, Renu; Jones, Russell; Pacheco, Erica; Schwartz, Lewis B.

    2009-07-15

    For peripheral endovascular intervention, self-expanding (SE) stents are commonly oversized in relation to target arteries to assure optimal wall apposition and prevent migration. However, the consequences of oversizing have not been well studied. The purpose of this study was to examine the effects of SE stent oversizing (OS) with respect to the kinetics of late stent expansion and the long-term histological effects of OS. Pairs of overlapped 8 x 28-mm Nitinol SE stents were implanted into the iliofemoral arteries of 14 Yucatan swine. Due to variations in target artery size, the stent-to-artery ratio ranged from 1.2:1 to 1.9:1. Lumen and stent diameters were assessed by quantitative angiography at the time of implantation. Following angiographic assessment at 6 months, stented arteries were perfusion-fixed, sectioned, and stained for histological analysis. Immediately following implantation, the stents were found to be expanded to a range of 4.7-7.1 mm, largely conforming to the diameter of the recipient target artery. The stents continued to expand over time, however, and all stents had enlarged to nearly their 8-mm nominal diameter by 6 months. The histological effects of OS were profound, with marked increases in injury and luminal area stenosis, including a statistically significant linear correlation between stent-to-artery ratio and area stenosis. In this experimental model of peripheral endovascular intervention, oversized Nitinol SE stents are constrained by their target artery diameter upon implantation but expand to their nominal diameter within 6 months. Severe OS (stent-to-artery ratio >1.4:1) results in a profound long-term histological response including exuberant neointimal proliferation and luminal stenosis.

  18. The outcomes of intravascular ultrasound-guided drug-eluting stent implantation among patients with complex coronary lesions: a comprehensive meta-analysis of 15 clinical trials and 8,084 patients

    PubMed Central

    Fan, Zhong-Guo; Gao, Xiao-Fei; Li, Xiao-Bo; Shao, Ming-Xue; Gao, Ya-Li; Chen, Shao-Liang; Tian, Nai-Liang

    2017-01-01

    Objective: The effects of intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation in patients with complex coronary artery lesions remains to be controversial. This study sought to evaluate the outcomes of IVUS guidance in these patients. Methods: The EMBASE, Medline, and other internet sources were searched for relevant articles. The primary endpoint was major adverse cardiac events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularization (TVR). The incidence of definite/probable stent thrombosis (ST) was analyzed as the safety endpoint. Results: Fifteen clinical trials involving 8.084 patients were analyzed. MACE risk was significantly decreased following IVUS-guided DES implantation compared with coronary angiography (CAG) guidance (odds ratio [OR] 0.63, 95% confidence intervals [CI]: 0.53–0.73, p<0.001), which might mainly result from the lower all-cause mortality risk (OR 0.52, 95% CI: 0.40–0.67, p<0.001), MI (OR 0.70, 95% CI: 0.56–0.86, p=0.001), and TVR (OR 0.53, 95% CI: 0.40–0.70, p<0.001). The subgroup analyses indicated better outcomes of IVUS guidance in DES implantation for these patients with left main disease or bifurcation lesions. Conclusion: IVUS guidance in DES implantation is associated with a significant reduction in MACE risk in patients with complex lesions, particularly those with left main disease or bifurcation lesions. More large and powerful randomized trials are still warranted to guide stenting decision making. (Anatol J Cardiol 2017; 17: 258-68) PMID:28344214

  19. Comparison of outcomes after everolimus-eluting stent implantation in diabetic versus non-diabetic patients in the Tokyo-MD PCI study.

    PubMed

    Konishi, Yuji; Ashikaga, Takashi; Sasaoka, Taro; Kurihara, Ken; Yoshikawa, Syunji; Isobe, Mitsuaki

    2016-03-01

    Diabetes mellitus (DM), especially in those requiring insulin for treatment, is known to be a risk factor for adverse events after percutaneous coronary intervention using first-generation drug-eluting stents. However, the role of DM in patients treated with everolimus-eluting stents (EES) is less known. The purpose of the present analysis was to evaluate the outcomes of treatment with EES for DM patients both requiring and not requiring insulin, and to compare them with non-DM patients. Of patients treated with EES in the Tokyo-MD PCI study, an all-comer, multicenter, observational cohort study, we identified 199 insulin-requiring diabetics (IRDM), 575 non-insulin requiring diabetics (NIRDM), and 1092 non-diabetics (non-DM). The main outcomes were major adverse cardiovascular events (MACE) defined as a composite of all-cause death, myocardial infarction, and stroke, and target lesion revascularization (TLR). The cumulative incidence of MACE and TLR was significantly greater in patients with IRDM than non-DM [MACE: hazard ratio 1.97, 95% confidence interval (CI) 1.31-2.90, p<0.01; TLR: hazard ratio 3.43, 2.07-5.55, p<0.0001] according to univariate Cox proportional hazards model. After adjusting for confounders using the multivariate Cox proportional hazard model, the risk of IRDM versus non-DM for TLR remained significant (hazard ratio 1.92, 1.10-3.29, p=0.02). The incidence of TLR in NIRDM was slightly greater than that in non-DM according to univariate analysis (hazard ratio 1.65, 1.07-2.54, p=0.02). However, the risk was not statistically different in the multivariate analysis (hazard ratio 1.52, 0.97-2.35, p=0.06). In this all-comer, observational study, the risk of TLR was greater in IRDM compared with non-DM after EES implantation, while the increased risk for TLR from NIRDM did not reach statistical significance. Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  20. Next generation biodegradable ureteral stent in a yucatan pig model.

    PubMed

    Chew, Ben H; Lange, Dirk; Paterson, Ryan F; Hendlin, Kari; Monga, Manoj; Clinkscales, Kenneth W; Shalaby, Shalaby W; Hadaschik, Boris A

    2010-02-01

    Ureteral stents are commonly used to facilitate kidney drainage but they may produce significant stent symptoms and morbidity, and require a secondary procedure for removal. Previous biodegradable stents showed bio-incompatibility or inconsistent degradation, requiring extra procedures to remove undegraded stent fragments. We previously reported a first generation biodegradable stent composed of suture-like material that required placement through the lumen of a sheath and degraded by 10 weeks. We now report second and third generation biodegradable stents that degrade more rapidly and can be placed directly over a polytetrafluoroethylene guidewire. Two groups of 16 Yucatan pigs each were unilaterally stented endoscopically with a control nondegradable (biostable) stent or a second generation degradable Uriprene stent. Blood studies, renal ultrasound and excretory urography were done throughout the study to determine renal function, hydronephrosis and stent degradation. Genitourinary organs were harvested at necropsy for pathological analysis. A third generation stent designed to improve degradation time was bilaterally implanted endoscopically into 4 Yorkshire Farm pigs (total of 8 stents), followed by excretory urography weekly to assess degradation and kidney function. Biomaterial parameters were tested. Second generation stents began degrading at 2 weeks and were completely degraded by 10 weeks. All third generation stents were degraded by 4 weeks. Hydronephrosis was considerably less in the Uriprene group than in control biostable stented kidneys. Biostable stented ureters showed an average higher degree of inflammation, uropathy and nephropathy. Physical characteristics indicate that Uriprene stents are significantly more resistant to stent compression and have markedly higher tensile strength and coil strength comparable to that of other commercially available plastic stents. Our study confirms that Uriprene stents are biocompatible and provide good renal