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 withbiodegradable 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 withbiodegradable 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 withbiodegradable 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.
RCT Entities:
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 polymersirolimus-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 polymerSES 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 polymerSES. 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 polymerSES (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 polymerSES (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 polymerSES (hazard ratio 0.59, 95% CI 0.73-0.95, P= 0.031). CONCLUSION: Biodegradable polymer DES improve safety and efficacy compared with durable polymerSES during long-term follow-up to 4 years.
Authors: Salvatore Cassese; Sebastian Kufner; Erion Xhepa; Robert A Byrne; Johanna Kreutzer; Tareq Ibrahim; Klaus Tiroch; Marco Valgimigli; Ralph Tölg; Massimiliano Fusaro; Heribert Schunkert; Karl-Ludwig Laugwitz; Julinda Mehilli; Adnan Kastrati Journal: Clin Res Cardiol Date: 2015-12-22 Impact factor: 5.460
Authors: Tomohisa Tada; Adnan Kastrati; Robert A Byrne; Tibor Schuster; Rezarta Cuni; Lamin A King; Salvatore Cassese; Michael Joner; Jürgen Pache; Steffen Massberg; Albert Schömig; Julinda Mehilli Journal: Int J Cardiovasc Imaging Date: 2014-01-23 Impact factor: 2.357
Authors: Celso Kiyochi Takimura; Carlos Augusto Homem M Campos; Pedro Henrique Magualhães Craveiro Melo; Julliana Carvalho Campos; Paulo Sampaio Gutierrez; Thiago Francisco Costa Borges; Luciano Curado; Spero Penha Morato; Francisco Rafael Martins Laurindo; Pedro Alves Lemos Neto Journal: Arq Bras Cardiol Date: 2014-04-17 Impact factor: 2.000