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Stéphane Cook - One of the best experts on this subject based on the ideXlab platform.
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comparison of a novel biodegradable polymer sirolimus Eluting Stent with a durable polymer everolimus Eluting Stent results of the randomized bioflow ii trial
Circulation-cardiovascular Interventions, 2015Co-Authors: Stephan Windecker, Ton Slagboom, Michael Haude, Franzjosef Neumann, Karl Stangl, Bernhard Witzenbichler, Manel Sabate, Javier Goicolea, Paul Barragan, Stéphane CookAbstract:Background—Biodegradable polymers for release of antiproliferative drugs from drug-Eluting Stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-Eluting Stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-Eluting Stent (X-EES) in terms of the primary end point in-Stent late lumen loss at 9 months. Methods and Results—A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-Stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, −0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40–1.68; log-r...
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ultrathin strut biodegradable polymer sirolimus Eluting Stent versus durable polymer everolimus Eluting Stent for percutaneous coronary revascularisation bioscience a randomised single blind non inferiority trial
The Lancet, 2014Co-Authors: Thomas Pilgrim, David Tüller, André Vuilliomenet, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Peiman Jamshidi, Olivier Muller, Marco Roffi, Therese FahrniAbstract:Summary Background Refinements in Stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-Eluting Stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium Stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-Eluting Stent. Methods We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-Eluting Stents or durable polymer everolimus-Eluting Stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-Eluting Stent compared with the durable polymer everolimus-Eluting Stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Findings Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-Eluting Stents (1063 patients, 1594 lesions) or everolimus-Eluting Stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-Eluting Stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-Eluting Stents (70 cases; 6·6%) at 12 months (absolute risk difference −0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority vs 4 [0·4%], rate ratio [RR] 2·26, 95% CI 0·70–7·33, p=0·16). In pre-specified stratified analyses of the primary endpoint, biodegradable polymer sirolimus-Eluting Stents were associated with improved outcome compared with durable polymer everolimus-Eluting Stents in the subgroup of patients with ST-segment elevation myocardial infarction (7 [3·3%] vs 17 [8·7%], RR 0·38, 95% CI 0·16–0·91, p=0·024, p for interaction=0·014). Interpretation In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy, biodegradable polymer sirolimus-Eluting Stents were non-inferior to durable polymer everolimus-Eluting Stents for the combined safety and efficacy outcome target lesion failure at 12 months. The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study. Funding Clinical Trials Unit, University of Bern, and Biotronik, Bulach, Switzerland.
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Ultrathin strut biodegradable polymer sirolimus-Eluting Stent versus durable polymer everolimus-Eluting Stent for percutaneous coronary revascularisation (BIOSCIENCE): A randomised, single-blind, non-inferiority trial
The Lancet, 2014Co-Authors: Thomas Pilgrim, Dik Heg, David Tüller, André Vuilliomenet, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Olivier Muller, Marco Roffi, Peiman JamshidiAbstract:Background Refinements in Stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-Eluting Stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium Stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-Eluting Stent. Methods We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-Eluting Stents or durable polymer everolimus-Eluting Stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-Eluting Stent compared with the durable polymer everolimus-Eluting Stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Findings Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-Eluting Stents (1063 patients, 1594 lesions) or everolimus-Eluting Stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-Eluting Stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-Eluting Stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority
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correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug Eluting Stent thrombosis
Circulation, 2009Co-Authors: Stéphane Cook, Mario Togni, Gaku Nakazawa, Peter Wenaweser, Elena Ladich, Parham Eshtehardi, Michel Neidhart, Rolf Vogel, Michael Billinger, Christian SeilerAbstract:BACKGROUND: Intravascular ultrasound of drug-Eluting Stent (DES) thrombosis (ST) reveals a high incidence of incomplete Stent apposition (ISA) and vessel remodeling. Autopsy specimens of DES ST show delayed healing and hypersensitivity reactions. The present study sought to correlate histopathology of thrombus aspirates with intravascular ultrasound findings in patients with very late DES ST. METHODS AND RESULTS: The study population consisted of 54 patients (28 patients with very late DES ST and 26 controls). Of 28 patients with very late DES ST, 10 patients (1020+/-283 days after implantation) with 11 ST segments (5 sirolimus-Eluting Stents, 5 paclitaxel-Eluting Stents, 1 zotarolimus-Eluting Stent) underwent both thrombus aspiration and intravascular ultrasound investigation. ISA was present in 73% of cases with an ISA cross-sectional area of 6.2+/-2.4 mm(2) and evidence of vessel remodeling (index, 1.6+/-0.3). Histopathological analysis showed pieces of fresh thrombus with inflammatory cell infiltrates (DES, 263+/-149 white blood cells per high-power field) and eosinophils (DES, 20+/-24 eosinophils per high-power field; sirolimus-Eluting Stents, 34+/-28; paclitaxel-Eluting Stents, 6+/-6; P for sirolimus-Eluting Stents versus paclitaxel-Eluting Stents=0.09). The mean number of eosinophils per high-power field was higher in specimens from very late DES ST (20+/-24) than in those from spontaneous acute myocardial infarction (7+/-10), early bare-metal Stent ST (1+/-1), early DES ST (1+/-2), and late bare-metal Stent ST (2+/-3; P from ANOVA=0.038). Eosinophil count correlated with ISA cross-sectional area, with an average increase of 5.4 eosinophils per high-power field per 1-mm(2) increase in ISA cross-sectional area. CONCLUSIONS: Very late DES thrombosis is associated with histopathological signs of inflammation and intravascular ultrasound evidence of vessel remodeling. Compared with other causes of myocardial infarction, eosinophilic infiltrates are more common in thrombi harvested from very late DES thrombosis, particularly in sirolimus-Eluting Stents, and correlate with the extent of Stent malapposition.
Seungjung Park - One of the best experts on this subject based on the ideXlab platform.
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optical coherence tomographic analysis of in Stent neoatherosclerosis after drug Eluting Stent implantation
Circulation, 2011Co-Authors: Soojin Kang, Dukwoo Park, Seongwook Park, Takashi Akasaka, Gary S Mintz, Seungjung ParkAbstract:Background—We report findings from optical coherence tomography (OCT) of in-Stent neoatherosclerosis as a cause of drug-Eluting Stent (DES) failure. Methods and Results—Optical coherence tomography and grayscale and virtual histology intravascular ultrasound were performed in 50 patients (30 stable, 20 unstable angina) with 50 DES in-Stent restenosis lesions and intimal hyperplasia >50% of Stent area. Median follow-up time was 32.2 months. Overall, 26 lesions (52%) had at least 1 OCT-defined in-Stent thin-cap fibroatheroma (TCFA)–containing neointima and 29 (58%) had at least 1 in-Stent neointimal rupture. Patients presenting with unstable angina showed a thinner fibrous cap (55 μm [interquartile range 42 to 105 μm] versus 100 μm [interquartile range 60 to 205 μm], P=0.006) and higher incidence of OCT-defined TCFA-containing neointima (75% versus 37%, P=0.008), intimal rupture (75% versus 47%, P=0.044), thrombi (80% versus 43%, P=0.010), and red thrombi (30% versus 3%, P=0.012) than stable patients. Fibro...
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impact of angiographic complete revascularization after drug Eluting Stent implantation or coronary artery bypass graft surgery for multivessel coronary artery disease
Circulation, 2011Co-Authors: Dukwoo Park, Hae Geun Song, Junhyok Oh, Soojin Kang, Seongwook Park, Jong Seon Park, Seungjung ParkAbstract:Background—This study sought to evaluate the clinical impact of angiographic complete revascularization (CR) after drug-Eluting Stent implantation or coronary artery bypass graft surgery for multivessel coronary disease. Methods and Results—A total of 1914 consecutive patients with multivessel coronary disease undergoing drug-Eluting Stent implantation (1400 patients) or coronary artery bypass graft surgery (514 patients) were enrolled. Angiographic CR was defined as revascularization in all diseased segments according to the Synergy Between PCI With Taxus and Cardiac Surgery classification. The outcomes of patients undergoing CR were compared with those undergoing incomplete revascularization (IR) after adjustments with the inverse-probability-of-treatment weighting method. Angiographic CR was performed in 917 patients (47.9%) including 573 percutaneous coronary intervention (40.9%) and 344 coronary artery bypass graft (66.9%) patients. CR patients were younger and had more extensive coronary disease tha...
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late and very late Stent thrombosis following drug Eluting Stent implantation in unprotected left main coronary artery a multicentre registry
European Heart Journal, 2008Co-Authors: Alaide Chieffo, Seungjung Park, Marco Valgimigli, Emanuele Meliga, Imad Sheiban, Azeem Latib, Dario Sillano, Valeria Magni, Giuseppe Biondizoccai, Matteo MontorfanoAbstract:Aims To evaluate the occurrence of late and very late Stent thrombosis (ST) following elective drug-Eluting Stent (DES) implantation in unprotected left main coronary artery (LMCA) stenosis in a large multicentre registry. Methods and results All 731 consecutive patients who had sirolimus- or paclitaxel-Eluting Stent electively implanted in de novo lesions on unprotected LMCA in five centres were included. ST was defined according to Academic Research Consortium definitions. Four (0.5%) patients had a definite ST: three early (two acute and one subacute) and one late ST, no cases of very late definite ST were recorded. All patients survived from the event. Three patients had a probable ST. Therefore, 7/731 (0.95%) patients had a definite or a probable ST and all were on dual antiplatelet therapy at the time of the event. Possible (eight late and 12 very late) ST occurred in 20 (2.7%) patients. At 29.5 ± 13.7 months follow-up, a total of 45 (6.2%) patients had died; 31 (4.2%) of cardiac death. Ninety five (12.9%) patients had a target-vessel and 76 (10.4%) a target-lesion revascularization. Angiographic follow-up was performed in 548 patients (75%): restenosis occurred in 77 (14.1%) patients. Conclusion Elective treatment of LMCA stenosis with DES appears safe with a 0.9% incidence of definite and probable ST at 29.5 ± 13.7 months.
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late Stent malapposition after drug Eluting Stent implantation an intravascular ultrasound analysis with long term follow up
Circulation, 2006Co-Authors: Myeongki Hong, Dukwoo Park, Seongwook Park, Gary S Mintz, Kyoungmin Park, Jongmin Song, Dukhyun Kang, Sangsig Cheong, Jaekwan Song, Seungjung ParkAbstract:Background— Late Stent malapposition (LSM) after drug-Eluting Stent (DES) implantation has not been evaluated sufficiently in real-world practice. Methods and Results— We evaluated the incidence, mechanisms, predictors, and long-term prognosis of LSM after DES implantation in 557 patients (705 native lesions; sirolimus-Eluting Stent in 538 lesions and paclitaxel-Eluting Stent in 167 lesions) in whom intravascular ultrasound was performed at index and 6-month follow-up. LSM occurred in 82 patients with 85 lesions (12.1% overall, 95% CI 9.7% to 14.5%, 71 lesions (13.2%) in sirolimus-Eluting Stents and 14 lesions [8.4%] in paclitaxel-Eluting Stents, P=0.12]; the incidence was 25.0% (4/16) after directional coronary atherectomy before Stenting, 27.5% (14/51) in chronic total occlusion lesions, and 31.8% (7/22) after primary Stenting in acute myocardial infarction (P=0.13, P<0.001, and P=0.001, respectively, versus elective Stenting with conventional balloon predilation, 9.7% [60/616]). There was an increase o...
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sirolimus Eluting Stent implantation for unprotected left main coronary artery stenosis comparison with bare metal Stent implantation
Journal of the American College of Cardiology, 2005Co-Authors: Seungjung Park, Gary S Mintz, Myeongki Hong, Seongwook ParkAbstract:Objectives This study was designed to compare the clinical and angiographic outcomes of sirolimus-Eluting Stent (SES) and bare metal Stent (BMS) implantation for unprotected left main coronary artery (LMCA) stenosis. Background The safety and effectiveness of SES implantation for unprotected LMCA stenosis have not been ascertained. Methods Elective SES implantation for de novo unprotected LMCA stenosis was performed in 102 consecutive patients with preserved left ventricular function from March 2003 to March 2004. Data from this group were compared to those from 121 patients treated with BMS during the preceding two years. Results Compared to the BMS group, the SES group received more direct Stenting, had fewer debulking atherectomies, had a greater number of Stents, had more segments Stented, and underwent more bifurcation Stenting. The procedural success rate was 100% for both groups. There were no incidents of death, Stent thrombosis, Q-wave myocardial infarction (MI), or emergent bypass surgery during hospitalization in either group. Despite less acute gain (2.06 ± 0.56 mm vs. 2.73 ± 0.73 mm, p Conclusions Sirolimus-Eluting Stent implantation for unprotected LMCA stenosis appears safe with regard to acute and midterm complications and is more effective in preventing restenosis compared to BMS implantation.
Stephan Windecker - One of the best experts on this subject based on the ideXlab platform.
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comparison of a novel biodegradable polymer sirolimus Eluting Stent with a durable polymer everolimus Eluting Stent results of the randomized bioflow ii trial
Circulation-cardiovascular Interventions, 2015Co-Authors: Stephan Windecker, Ton Slagboom, Michael Haude, Franzjosef Neumann, Karl Stangl, Bernhard Witzenbichler, Manel Sabate, Javier Goicolea, Paul Barragan, Stéphane CookAbstract:Background—Biodegradable polymers for release of antiproliferative drugs from drug-Eluting Stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-Eluting Stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-Eluting Stent (X-EES) in terms of the primary end point in-Stent late lumen loss at 9 months. Methods and Results—A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-Stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, −0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40–1.68; log-r...
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4 year clinical outcomes and predictors of repeat revascularization in patients treated with new generation drug Eluting Stents a report from the resolute all comers trial a randomized comparison of a zotarolimus Eluting Stent with an everolimus elut
Journal of the American College of Cardiology, 2014Co-Authors: Masanori Taniwaki, Patrick W.j.c. Serruys, Stephan Windecker, Giulio G Stefanini, Sigmund Silber, Gert Richardt, Pascal Vranckx, Pawel Buszman, Henning Kelbaek, Resolute Allcomers InvestigatorsAbstract:Objectives The aim of the study was to investigate 4-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-Eluting Stent (R-ZES) (Medtronic, Minneapolis, Minnesota) and XIENCE V everolimus-Eluting Stent (EES) (Abbott Vascular, Abbott Park, Illinois) in the RESOLUTE (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) All-Comers trial. Background Data on long-term outcomes of new-generation drug-Eluting Stents are limited, and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown. Methods Patients were randomly assigned to treatment with the R-ZES (n = 1,140) or the EES (n = 1,152). We assessed pre-specified safety and efficacy outcomes at 4 years including target lesion failure and Stent thrombosis. Predictors of revascularization at 4 years were identified by Cox regression analysis. Results At 4 years, the rates of target lesion failure (15.2% vs. 14.6%, p = 0.68), cardiac death (5.4% vs. 4.7%, p = 0.44), and target vessel myocardial infarction (5.3% vs. 5.4%, p = 1.00), clinically-indicated target lesion revascularization (TLR) (7.0% vs. 6.5%, p = 0.62), and definite/probable Stent thrombosis (2.3% vs. 1.6%, p = 0.23) were similar with the R-ZES and EES. Independent predictors of TLR were age, insulin-treated diabetes, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) score, treatment of saphenous vein grafts, ostial lesions, and in-Stent restenosis. Independent predictors of any revascularization were age, diabetes, previous percutaneous coronary intervention, absence of ST-segment elevation myocardial infarction, smaller reference vessel diameter, SYNTAX score, and treatment of left anterior descending, right coronary artery, saphenous vein grafts, ostial lesions, or in-Stent restenosis. Conclusions R-ZES and EES demonstrated similar safety and efficacy throughout 4 years. TLR represented less than one-half of all repeat revascularization procedures. Patient- and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap. (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention [RESOLUTE-AC]; NCT00617084 )
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an optical coherence tomography study of a biodegradable vs durable polymer coated limus Eluting Stent a leaders trial sub study
European Heart Journal, 2010Co-Authors: Peter Barlis, Patrick W.j.c. Serruys, Stephan Windecker, Simon Wandel, Evelyn Regar, Konstantinos Dimopoulos, Willem J Van Der Giessen, Robert Jan Van Geuns, Giuseppe Ferrante, Pedro EerdmansAbstract:Aims Incomplete endothelialization has been found to be associated with late Stent thrombosis, a rare but devastating phenomenon, more frequent after drug-Eluting Stent implantation. Optical coherence tomography (OCT) has 10 times greater resolution than intravascular ultrasound and thus appears to be a valuable modality for the assessment of Stent strut coverage. The LEADERS trial was a multi-centre, randomized comparison of a biolimus-Eluting Stent (BES) with biodegradable polymer with a sirolimus-Eluting Stent (SES) using a durable polymer. This study sought to evaluate tissue coverage and apposition of Stents using OCT in a group of patients from the randomized LEADERS trial. Methods and results Fifty-six consecutive patients underwent OCT during angiographic follow-up at 9 months. OCT images were acquired using a non-occlusive technique at a pullback speed of 3 mm/s. Data were analysed using a Bayesian hierarchical random-effects model, which accounted for the correlation of lesion characteristics within patients and implicitly assigned analytical weights to each lesion depending on the number of struts observed per lesion. Primary outcome was the difference in percentage of uncovered struts between BESs and SESs. Twenty patients were included in the analysis in the BES group (29 lesions with 4592 struts) and 26 patients in the SES group (35 lesions with 6476 struts). A total of 83 struts were uncovered in the BES group and 407 out of 6476 struts were uncovered in the SES group [weighted difference −1.4%, 95% confidence interval (CI) −3.7 to 0.0, P = 0.04]. Results were similar after adjustment for pre-procedure lesion length, reference vessel diameter, number of implanted study Stents, and presence of Stent overlap. There were three lesions in the BES group and 15 lesions in the SES group that had ≥5% of all struts uncovered (difference −33.1%, 95% CI −61.7 to −10.3, P < 0.01). Conclusion Strut coverage at an average follow-up of 9 months appears to be more complete in patients allocated to BESs when compared with SESs. The impact of this difference on clinical outcome and, in particular, on the risk of late Stent thrombosis is yet to be determined.
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biolimus Eluting Stent with biodegradable polymer versus sirolimus Eluting Stent with durable polymer for coronary revascularisation leaders a randomised non inferiority trial
The Lancet, 2008Co-Authors: Stephan Windecker, Patrick W.j.c. Serruys, Axel Linke, Thomas Ischinger, Volker Klauss, Karsten Lenk, Pawel Buszman, Simon Wandel, Stanislaw Trznadel, Franz R. EberliAbstract:BACKGROUND: A novel Stent platform Eluting biolimus, a sirolimus analogue, from a biodegradable polymer showed promising results in preliminary studies. We compared the safety and efficacy of a biolimus-Eluting Stent (with biodegradable polymer) with a sirolimus-Eluting Stent (with durable polymer). METHODS: We undertook a multicentre, assessor-blind, non-inferiority study in ten European centres. 1707 patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes were centrally randomised by a computer-generated allocation sequence to treatment with either biolimus-Eluting (n=857) or sirolimus-Eluting (n=850) Stents. The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months. Analysis was by intention to treat. 427 patients were randomly allocated to angiographic follow-up, with in-Stent percentage diameter stenosis as principal outcome measure at 9 months. The trial is registered with ClinicalTrials.gov, number NCT00389220. FINDINGS: We analysed all randomised patients. Biolimus-Eluting Stents were non-inferior to sirolimus-Eluting Stents for the primary endpoint at 9 months (79 [9%] patients vs 89 [11%], rate ratio 0.88 [95% CI 0.64-1.19], p for non-inferiority=0.003, p for superiority=0.39). Frequency of cardiac death (14 [1.6%] vs 21 [2.5%], p for superiority=0.22), myocardial infarction (49 [5.7%] vs 39 [4.6%], p=0.30), and clinically-indicated target vessel revascularisation (38 [4.4%] vs 47 [5.5%], p=0.29) were similar for both Stent types. 168 (79%) patients in the biolimus-Eluting group and 167 (78%) in the sirolimus-Eluting group had data for angiographic follow-up available. Biolimus-Eluting Stents were non-inferior to sirolimus-Eluting Stents in in-Stent percentage diameter stenosis (20.9%vs 23.3%, difference -2.2% [95% CI -6.0 to 1.6], p for non-inferiority=0.001, p for superiority=0.26). INTERPRETATION: Our results suggest that a Stent Eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a Stent Eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. FUNDING: Biosensors Europe SA, Switzerland.
Jeffrey J Popma - One of the best experts on this subject based on the ideXlab platform.
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a randomized comparison of the endeavor zotarolimus Eluting Stent versus the taxus paclitaxel Eluting Stent in de novo native coronary lesions 12 month outcomes from the endeavor iv trial
Journal of the American College of Cardiology, 2010Co-Authors: Martin B Leon, Donald E Cutlip, Jeffrey J Popma, Laura Mauri, Eugenia Nikolsky, Charles Oshaughnessy, Paul A Overlie, Brent T Mclaurin, Stuart L Solomon, John S DouglasAbstract:Objectives The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-Eluting Stent (ZES) compared with the paclitaxel-Eluting Stent (PES). Background First-generation drug-Eluting Stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-Eluting Stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut Stent has shown promising experimental and early clinical results. Methods This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Results Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (pnoninferiority≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or Stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). Conclusions These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269 )
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a randomized comparison of the endeavor zotarolimus Eluting Stent versus the taxus paclitaxel Eluting Stent in de novo native coronary lesions 12 month outcomes from the endeavor iv trial
Journal of the American College of Cardiology, 2010Co-Authors: Martin B Leon, Donald E Cutlip, Jeffrey J Popma, Laura Mauri, Eugenia Nikolsky, Charles Oshaughnessy, Paul A Overlie, Brent T Mclaurin, Stuart L Solomon, John S DouglasAbstract:OBJECTIVES: The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-Eluting Stent (ZES) compared with the paclitaxel-Eluting Stent (PES). BACKGROUND: First-generation drug-Eluting Stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-Eluting Stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut Stent has shown promising experimental and early clinical results. METHODS: This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. RESULTS: Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (p(noninferiority) < or = 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or Stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). CONCLUSIONS: These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).
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impact of coronary culprit lesion calcium in patients undergoing paclitaxel Eluting Stent implantation a taxus iv sub study
American Journal of Cardiology, 2005Co-Authors: Issam Moussa, Stephen G. Ellis, Michael R Jones, Dean J Kereiakes, Daniel Mcmartin, Barry D Rutherford, Roxana Mehran, Michael Collins, Martin B Leon, Jeffrey J PopmaAbstract:Randomized clinical trials have shown that paclitaxel-Eluting Stents significantly reduce restenosis after percutaneous coronary intervention. The impact of lesion calcification on the efficacy of paclitaxel-Eluting Stents is unknown. In the TAXUS-IV trial, 1,314 patients who underwent percutaneous coronary intervention were randomly assigned to a bare-metal or paclitaxel-Eluting Stent. By core laboratory analysis, 247 lesions (19%) were moderately or severely calcified. At the 9-month angiographic follow-up examination, the paclitaxel-Eluting Stent had significantly reduced the amount of late loss compared with the control Stent (0.26 ± 0.56 vs 0.51 ± 0.48 mm, p = 0.015) within the analysis segment in the calcific lesions. The analysis segment restenosis rate was similar in patients with calcified and noncalcified lesions after paclitaxel-Eluting Stent implantation (7.5% vs 8.0%, respectively; p = 1.0). The rate of ischemia-driven target lesion revascularization (TLR) at 1 year was reduced by 56% in patients with calcified lesions (11.9% vs 5.1%, p = 0.09) and by 75% in noncalcified lesions (15.7% vs 4.3%, p <0.0001). By interaction testing, the efficacy of the paclitaxel-Eluting Stent in reducing TLR at 1 year was similar in the calcified and noncalcified lesions (p = 0.30). Moreover, by multivariate analysis, implantation of the paclitaxel-Eluting Stent was a powerful independent predictor of freedom from TLR, with similar hazard ratios for efficacy in calcified and noncalcified lesions (0.30 and 0.26, respectively). In conclusion, implantation of paclitaxel-Eluting Stents in patients with de novo coronary lesions significantly reduced restenosis in patients with and without calcified lesions.
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comparison of a polymer based paclitaxel Eluting Stent with a bare metal Stent in patients with complex coronary artery disease a randomized controlled trial
JAMA, 2005Co-Authors: Gregg W Stone, Stephen G. Ellis, Charles Oshaughnessy, Joel Greenberg, Louis Cannon, Tift J Mann, Douglas Spriggs, Samuel Demaio, Patrick Hall, Jeffrey J PopmaAbstract:ContextCompared with bare metal Stents, drug-Eluting Stents reduce restenosis in noncomplex lesions. The utility of drug-Eluting Stents has not been evaluated in more difficult stenoses.ObjectiveTo investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-Eluting Stent in a patient population with more complex lesions than previously studied.Design, Setting, and PatientsProspective, placebo-controlled, double-blind, multicenter randomized trial conducted from February 2003 to March 2004 at 66 academic and community-based institutions with 1156 patients who underwent Stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4%) with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple Stents) and 9-month clinical and angiographic follow-up.InterventionsPatients were randomly assigned to receive 1 or more bare metal Stents (n = 579) or identical-appearing paclitaxel-Eluting Stents (n = 577).Main Outcome MeasureIschemia-driven target vessel revascularization at 9 months.ResultsBaseline characteristics were well matched. Diabetes was present in 31% of patients. The mean (SD) reference vessel diameter was 2.69 (0.57) mm, the reference lesion length was 17.2 (9.2) mm, and 78% of lesions were type B2/C. A mean (SD) of 1.38 (0.58) Stents (total mean [SD] length, 28.4 [13.1] mm) were implanted per lesion; 33% of lesions required multiple Stents. Stents that were 2.25 mm and 4.0 mm in diameter were used in 18% and 17% of lesions, respectively. Compared with bare metal Stents, paclitaxel-Eluting Stents reduced the 9-month rate of target lesion revascularization from 15.7% to 8.6% (P<.001) and target vessel revascularization from 17.3% to 12.1% (P = .02). Similar rates were observed for cardiac death or myocardial infarction (5.5% for bare metal Stent group vs 5.7% for paclitaxel-Eluting Stent group) and Stent thrombosis (0.7% in both groups). Angiographic restenosis was reduced from 33.9% to 18.9% in the entire study cohort (P<.001), including among patients receiving 2.25-mm Stents (49.4% vs 31.2%; P = .01), 4.0-mm Stents (14.4% vs 3.5%; P = .02), and multiple Stents (57.8% vs 27.2%; P<.001).ConclusionCompared with a bare metal Stent, implantation of the paclitaxel-Eluting Stent in a patient population with complex lesions effectively reduces clinical and angiographic restenosis.
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the canadian study of the sirolimus Eluting Stent in the treatment of patients with long de novo lesions in small native coronary arteries c sirius
Journal of the American College of Cardiology, 2004Co-Authors: Erick Schampaert, Eric A Cohen, Michael Schluter, Francois Reeves, Mouhieddin Traboulsi, Lawrence M Title, Richard E Kuntz, Jeffrey J PopmaAbstract:Abstract Objectives We assessed the safety and effectiveness of the sirolimus-Eluting Stent (SES) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal Stent (BMS). Background The SES was previously demonstrated to reduce restenosis significantly. However, patients with long lesions in small vessels have not been well studied and may define a group at very high risk. Methods The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries (C-SIRIUS) was a multicenter, randomized, double-blind trial comparing SES versus identical BMS. The primary end point was in-Stent minimal lumen diameter (MLD) at eight months. Secondary end points included angiographic restenosis at 8 months, target lesion revascularization (TLR), and major adverse cardiac events (MACE) at 270 days. Results A total of 100 patients were enrolled at eight Canadian sites. The in-Stent MLD at eight months was 2.46 ± 0.37 mm in the SES compared with 1.49 ± 0.75 mm in the BMS (a 65% increase, p Conclusions Patients with long lesions in small vessels are at very high risk of restenosis. In these patients, the SES dramatically reduces the risk of restenosis at eight months, translating into an excellent clinical outcome at nine months.
Marco Roffi - One of the best experts on this subject based on the ideXlab platform.
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zotarolimus Eluting versus bare metal Stents in uncertain drug Eluting Stent candidates
Journal of the American College of Cardiology, 2015Co-Authors: Marco Valgimigli, Gianluca Campo, Eugene P Mcfadden, Athanasios Patialiakas, Attila Thury, Salvatore Colangelo, Matteo Tebaldi, Imre Ungi, Stefano Tondi, Marco RoffiAbstract:Abstract Background The use of drug-Eluting Stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk. Objectives This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-Eluting Stent (ZES) with a unique drug fast-release profile versus bare-metal Stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT). Methods We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than Stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR). Results Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p Conclusions Compared with BMS, DES implantation using a Stent with a biocompatible polymer and fast drug-Eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319)
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ultrathin strut biodegradable polymer sirolimus Eluting Stent versus durable polymer everolimus Eluting Stent for percutaneous coronary revascularisation bioscience a randomised single blind non inferiority trial
The Lancet, 2014Co-Authors: Thomas Pilgrim, David Tüller, André Vuilliomenet, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Peiman Jamshidi, Olivier Muller, Marco Roffi, Therese FahrniAbstract:Summary Background Refinements in Stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-Eluting Stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium Stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-Eluting Stent. Methods We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-Eluting Stents or durable polymer everolimus-Eluting Stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-Eluting Stent compared with the durable polymer everolimus-Eluting Stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Findings Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-Eluting Stents (1063 patients, 1594 lesions) or everolimus-Eluting Stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-Eluting Stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-Eluting Stents (70 cases; 6·6%) at 12 months (absolute risk difference −0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority vs 4 [0·4%], rate ratio [RR] 2·26, 95% CI 0·70–7·33, p=0·16). In pre-specified stratified analyses of the primary endpoint, biodegradable polymer sirolimus-Eluting Stents were associated with improved outcome compared with durable polymer everolimus-Eluting Stents in the subgroup of patients with ST-segment elevation myocardial infarction (7 [3·3%] vs 17 [8·7%], RR 0·38, 95% CI 0·16–0·91, p=0·024, p for interaction=0·014). Interpretation In a patient population with minimum exclusion criteria and high adherence to dual antiplatelet therapy, biodegradable polymer sirolimus-Eluting Stents were non-inferior to durable polymer everolimus-Eluting Stents for the combined safety and efficacy outcome target lesion failure at 12 months. The noted benefit in the subgroup of patients with ST-segment elevation myocardial infarction needs further study. Funding Clinical Trials Unit, University of Bern, and Biotronik, Bulach, Switzerland.
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Ultrathin strut biodegradable polymer sirolimus-Eluting Stent versus durable polymer everolimus-Eluting Stent for percutaneous coronary revascularisation (BIOSCIENCE): A randomised, single-blind, non-inferiority trial
The Lancet, 2014Co-Authors: Thomas Pilgrim, Dik Heg, David Tüller, André Vuilliomenet, Stéphane Cook, Daniel Weilenmann, Christoph Kaiser, Olivier Muller, Marco Roffi, Peiman JamshidiAbstract:Background Refinements in Stent design affecting strut thickness, surface polymer, and drug release have improved clinical outcomes of drug-Eluting Stents. We aimed to compare the safety and efficacy of a novel, ultrathin strut cobalt-chromium Stent releasing sirolimus from a biodegradable polymer with a thin strut durable polymer everolimus-Eluting Stent. Methods We did a randomised, single-blind, non-inferiority trial with minimum exclusion criteria at nine hospitals in Switzerland. We randomly assigned (1:1) patients aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention to treatment with biodegradable polymer sirolimus-Eluting Stents or durable polymer everolimus-Eluting Stents. Randomisation was via a central web-based system and stratified by centre and presence of ST segment elevation myocardial infarction. Patients and outcome assessors were masked to treatment allocation, but treating physicians were not. The primary endpoint, target lesion failure, was a composite of cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation at 12 months. A margin of 3·5% was defined for non-inferiority of the biodegradable polymer sirolimus-Eluting Stent compared with the durable polymer everolimus-Eluting Stent. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01443104. Findings Between Feb 24, 2012, and May 22, 2013, we randomly assigned 2119 patients with 3139 lesions to treatment with sirolimus-Eluting Stents (1063 patients, 1594 lesions) or everolimus-Eluting Stents (1056 patients, 1545 lesions). 407 (19%) patients presented with ST-segment elevation myocardial infarction. Target lesion failure with biodegradable polymer sirolimus-Eluting Stents (69 cases; 6·5%) was non-inferior to durable polymer everolimus-Eluting Stents (70 cases; 6·6%) at 12 months (absolute risk difference -0·14%, upper limit of one-sided 95% CI 1·97%, p for non-inferiority