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Zhiyuan Song - One of the best experts on this subject based on the ideXlab platform.
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Safety and efficacy of ultrathin strut Biodegradable Polymer sirolimus-eluting stent versus durable Polymer drug-eluting stents: a meta-analysis of randomized trials
BMC Cardiovascular Disorders, 2018Co-Authors: Xin Zhou, Chen-liang Zhang, Huakang Li, Zhihui Zhang, Zhiyuan SongAbstract:Background The Orsiro Biodegradable Polymer sirolimus-eluting stent (O-SES) is a new-generation Biodegradable Polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro Biodegradable Polymer sirolimus-eluting stent (O-SES) compared with durable Polymer drug-eluting stents (DP-DESs).
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Safety and efficacy of ultrathin strut Biodegradable Polymer sirolimus-eluting stent versus durable Polymer drug-eluting stents: a meta-analysis of randomized trials
BMC Cardiovascular Disorders, 2018Co-Authors: Xin Zhou, Chen-liang Zhang, Huakang Li, Zhihui Zhang, Zhiyuan SongAbstract:Background The Orsiro Biodegradable Polymer sirolimus-eluting stent (O-SES) is a new-generation Biodegradable Polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro Biodegradable Polymer sirolimus-eluting stent (O-SES) compared with durable Polymer drug-eluting stents (DP-DESs).
Stephane Cook - One of the best experts on this subject based on the ideXlab platform.
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ultrathin strut Biodegradable Polymer sirolimus eluting stents versus thin strut durable Polymer everolimus eluting stents for percutaneous coronary revascularisation 5 year outcomes of the bioscience randomised trial
The Lancet, 2018Co-Authors: Thomas Pilgrim, David Tüller, Stephane Cook, Olivier Muller, Marco Roffi, Raffaele Piccolo, Dik Heg, Igal Moarof, George C M Siontis, Daniel WeilenmannAbstract:Summary Background Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a Biodegradable Polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-Polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. Methods In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared Biodegradable-Polymer sirolimus-eluting stents with durable-Polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov , number NCT01443104 . Findings 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with Biodegradable-Polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-Polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88–1·31; p=0·487). All-cause mortality was significantly higher in patients treated with Biodegradable-Polymer sirolimus-eluting stents than in those treated with durable-Polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06–1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51–2·05; p=0·950). Interpretation 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, Biodegradable-Polymer, sirolimus-eluting stents or thin-strut, durable-Polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with Biodegradable-Polymer stents eluting sirolimus than in those treated with durable-Polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. Funding Clinical Trials Unit of the University of Bern and Biotronik.
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comparison of a novel Biodegradable Polymer sirolimus eluting stent with a durable Polymer everolimus eluting stent
Jacc-cardiovascular Interventions, 2018Co-Authors: Thierry Lefevre, Ton Slagboom, Michael Haude, Franzjosef Neumann, Karl Stangl, Carsten Skurk, Manel Sabate, Javier Goicolea, Paul Barragan, Stephane CookAbstract:AbstractObjectives: The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active Biodegradable Polymer that releases sirolimu...
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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, Daniel Weilenmann, Christoph Kaiser, Stephane Cook, Olivier Muller, Marco Roffi, Peiman Jamshidi, 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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randomized comparison of Biodegradable Polymer sirolimus eluting stents versus durable Polymer everolimus eluting stents for percutaneous coronary revascularization rationale and design of the bioscience trial
American Heart Journal, 2014Co-Authors: Thomas Pilgrim, David Tüller, André Vuilliomenet, Daniel Weilenmann, Christoph Kaiser, Stephane Cook, Olivier Muller, Marco Roffi, Peiman Jamshidi, Dik HegAbstract:Background Biodegradable Polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide–coating releasing sirolimus from a Biodegradable Polymer (O-SES, Orsiro; Biotronik, Bulach, Switzerland) with the durable Polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. Design The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with Biodegradable Polymer sirolimus-eluting stents (SES) or durable Polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non–ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the Biodegradable Polymer SES compared with the durable Polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. Conclusion The BIOSCIENCE trial will determine whether the Biodegradable Polymer SES is noninferior to the durable Polymer EES with respect to TLF.
Stephan Windecker - One of the best experts on this subject based on the ideXlab platform.
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Biodegradable Polymer drug eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention a pooled analysis of individual patient data from the isar test 3 isar test 4 and leaders randomized tr
European Heart Journal, 2012Co-Authors: Giulio G Stefanini, Stephan Windecker, Robert A Byrne, Patrick W Serruys, Antoinette De Waha, Bernhard Meier, Steffen Massberg, Peter Juni, Albert SchomigAbstract:Aims The efficacy of durable Polymer drug-eluting stents (DES) is delivered at the expense of delayed healing of the stented vessel. Biodegradable Polymer DES aim to avoid this shortcoming and may potentially improve long-term clinical outcomes, with benefit expected to accrue over time. We sought to compare long-term outcomes in patients treated with Biodegradable Polymer DES vs. durable Polymer sirolimus-eluting stents (SES). Methods and results We pooled individual patient data from three large-scale multicentre randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing Biodegradable Polymer DES with durable Polymer SES and assessed clinical outcomes during follow-up through 4 years. The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. Out of 4062 patients included in the present analysis, 2358 were randomly assigned to treatment with Biodegradable Polymer DES (sirolimus-eluting, n = 1501; biolimus-eluting, n = 857) and 1704 patients to durable Polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, the risk of target lesion revascularization was significantly lower among patients treated with Biodegradable Polymer DES vs. durable Polymer SES (hazard ratio 0.82, 95% CI 0.68–0.98, P = 0.029). In addition, the risk of stent thrombosis was significantly reduced with Biodegradable Polymer DES vs. durable Polymer SES (hazard ratio 0.56, 95% CI 0.35–0.90, P = 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio 0.22, 95% CI 0.08–0.61, P = 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with Biodegradable Polymer DES vs. durable Polymer SES (hazard ratio 0.59, 95% CI 0.73–0.95, P = 0.031). Conclusion Biodegradable Polymer DES improve safety and efficacy compared with durable Polymer SES during long-term follow-up to 4 years.
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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, Paweł Buszman, Axel Linke, Thomas Ischinger, Karsten Lenk, Stanislaw Trznadel, Patrick W.j.c. Serruys, Simon Wandel, Volker Klauss, 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.
Thomas Pilgrim - One of the best experts on this subject based on the ideXlab platform.
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ultrathin strut Biodegradable Polymer sirolimus eluting stents versus thin strut durable Polymer everolimus eluting stents for percutaneous coronary revascularisation 5 year outcomes of the bioscience randomised trial
The Lancet, 2018Co-Authors: Thomas Pilgrim, David Tüller, Stephane Cook, Olivier Muller, Marco Roffi, Raffaele Piccolo, Dik Heg, Igal Moarof, George C M Siontis, Daniel WeilenmannAbstract:Summary Background Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a Biodegradable Polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-Polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. Methods In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared Biodegradable-Polymer sirolimus-eluting stents with durable-Polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov , number NCT01443104 . Findings 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with Biodegradable-Polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-Polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88–1·31; p=0·487). All-cause mortality was significantly higher in patients treated with Biodegradable-Polymer sirolimus-eluting stents than in those treated with durable-Polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06–1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51–2·05; p=0·950). Interpretation 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, Biodegradable-Polymer, sirolimus-eluting stents or thin-strut, durable-Polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with Biodegradable-Polymer stents eluting sirolimus than in those treated with durable-Polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. Funding Clinical Trials Unit of the University of Bern and Biotronik.
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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, Daniel Weilenmann, Christoph Kaiser, Stephane Cook, Olivier Muller, Marco Roffi, Peiman Jamshidi, 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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randomized comparison of Biodegradable Polymer sirolimus eluting stents versus durable Polymer everolimus eluting stents for percutaneous coronary revascularization rationale and design of the bioscience trial
American Heart Journal, 2014Co-Authors: Thomas Pilgrim, David Tüller, André Vuilliomenet, Daniel Weilenmann, Christoph Kaiser, Stephane Cook, Olivier Muller, Marco Roffi, Peiman Jamshidi, Dik HegAbstract:Background Biodegradable Polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide–coating releasing sirolimus from a Biodegradable Polymer (O-SES, Orsiro; Biotronik, Bulach, Switzerland) with the durable Polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. Design The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with Biodegradable Polymer sirolimus-eluting stents (SES) or durable Polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non–ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the Biodegradable Polymer SES compared with the durable Polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. Conclusion The BIOSCIENCE trial will determine whether the Biodegradable Polymer SES is noninferior to the durable Polymer EES with respect to TLF.
Daniel Weilenmann - One of the best experts on this subject based on the ideXlab platform.
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Biodegradable Polymer sirolimus eluting stents versus durable Polymer everolimus eluting stents in patients with st segment elevation myocardial infarction biostemi a single blind prospective randomised superiority trial
The Lancet, 2019Co-Authors: Juan F Iglesias, Daniel Weilenmann, Christoph Kaiser, Olivier Muller, Marco Roffi, Dik Heg, Igal Moarof, David J Kurz, Maxime Tapponnier, Stefan StorteckyAbstract:Summary Background Newer-generation drug-eluting stents that combine ultrathin strut metallic platforms with Biodegradable Polymers might facilitate vascular healing and improve clinical outcomes in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI) compared with contemporary thin strut second-generation drug-eluting stents. We did a randomised clinical trial to investigate the safety and efficacy of ultrathin strut Biodegradable Polymer sirolimus-eluting stents versus thin strut durable Polymer everolimus-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Methods The BIOSTEMI trial was an investigator-initiated, multicentre, prospective, single-blind, randomised superiority trial at ten hospitals in Switzerland. Patients aged 18 years or older with acute STEMI who were referred for primary PCI were eligible to participate. Patients were randomly allocated (1:1) to either Biodegradable Polymer sirolimus-eluting stents or durable Polymer everolimus-eluting stents. Central randomisation was done based on a computer-generated allocation sequence with variable block sizes of 2, 4, and 6, which was stratified by centre, diabetes status, and presence or absence of multivessel coronary artery disease, and concealed using a secure web-based system. Patients and treating physicians were aware of group allocations, whereas outcome assessors were masked to the allocated stent. The experimental stent (Orsiro; Biotronik; Bulach, Switzerland) consisted of an ultrathin strut cobalt–chromium metallic stent platform releasing sirolimus from a Biodegradable Polymer. The control stent (Xience Xpedition/Alpine; Abbott Vascular, Abbott Park, IL, USA) consisted of a thin strut cobalt–chromium stent platform that releases everolimus from a durable Polymer. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial reinfarction (Q-wave and non-Q-wave), and clinically-indicated target lesion revascularisation, within 12 months of the index procedure. All analyses were done with the individual participant as the unit of analysis and according to the intention-to-treat principle. The trial was registered with ClinicalTrials.gov , number NCT02579031 . Findings Between April 26, 2016, and March 9, 2018, we randomly assigned 1300 patients (1623 lesions) with acute myocardial infarction to treatment with Biodegradable Polymer sirolimus-eluting stents (649 patients and 816 lesions) or durable Polymer everolimus-eluting stents (651 patients and 806 lesions). At 12 months, follow-up data were available for 614 (95%) patients treated with Biodegradable Polymer sirolimus-eluting stents and 626 (96%) patients treated with durable Polymer everolimus-eluting stents. The primary composite endpoint of target lesion failure occurred in 25 (4%) of 649 patients treated with Biodegradable Polymer sirolimus-eluting stents and 36 (6%) of 651 patients treated with durable Polymer everolimus-eluting stents (difference −1·6 percentage points; rate ratio 0·59, 95% Bayesian credibility interval 0·37–0·94; posterior probability of superiority 0·986). Cardiac death, target vessel myocardial reinfarction, clinically-indicated target lesion revascularisation, and definite stent thrombosis were similar between the two treatment groups in the 12 months of follow-up. Interpretation In patients with acute STEMI undergoing primary PCI, Biodegradable Polymer sirolimus-eluting stents were superior to durable Polymer everolimus-eluting stents with respect to target lesion failure at 1 year. This difference was driven by reduced ischaemia-driven target lesion revascularisation in patients treated with Biodegradable Polymer sirolimus-eluting stents compared with durable Polymer everolimus-eluting stents. Funding Biotronik.
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ultrathin strut Biodegradable Polymer sirolimus eluting stents versus thin strut durable Polymer everolimus eluting stents for percutaneous coronary revascularisation 5 year outcomes of the bioscience randomised trial
The Lancet, 2018Co-Authors: Thomas Pilgrim, David Tüller, Stephane Cook, Olivier Muller, Marco Roffi, Raffaele Piccolo, Dik Heg, Igal Moarof, George C M Siontis, Daniel WeilenmannAbstract:Summary Background Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a Biodegradable Polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-Polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. Methods In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared Biodegradable-Polymer sirolimus-eluting stents with durable-Polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov , number NCT01443104 . Findings 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with Biodegradable-Polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-Polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88–1·31; p=0·487). All-cause mortality was significantly higher in patients treated with Biodegradable-Polymer sirolimus-eluting stents than in those treated with durable-Polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06–1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51–2·05; p=0·950). Interpretation 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, Biodegradable-Polymer, sirolimus-eluting stents or thin-strut, durable-Polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with Biodegradable-Polymer stents eluting sirolimus than in those treated with durable-Polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. Funding Clinical Trials Unit of the University of Bern and Biotronik.
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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, Daniel Weilenmann, Christoph Kaiser, Stephane Cook, Olivier Muller, Marco Roffi, Peiman Jamshidi, 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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randomized comparison of Biodegradable Polymer sirolimus eluting stents versus durable Polymer everolimus eluting stents for percutaneous coronary revascularization rationale and design of the bioscience trial
American Heart Journal, 2014Co-Authors: Thomas Pilgrim, David Tüller, André Vuilliomenet, Daniel Weilenmann, Christoph Kaiser, Stephane Cook, Olivier Muller, Marco Roffi, Peiman Jamshidi, Dik HegAbstract:Background Biodegradable Polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide–coating releasing sirolimus from a Biodegradable Polymer (O-SES, Orsiro; Biotronik, Bulach, Switzerland) with the durable Polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population. Design The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with Biodegradable Polymer sirolimus-eluting stents (SES) or durable Polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non–ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the Biodegradable Polymer SES compared with the durable Polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years. Conclusion The BIOSCIENCE trial will determine whether the Biodegradable Polymer SES is noninferior to the durable Polymer EES with respect to TLF.