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ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting

S. Schulz-Schupke, R. A. Byrne, J. M. ten Berg, F.-J. Neumann, Y. Han, T. Adriaenssens, R. Tolg, M. Seyfarth, M. Maeng, B. Zrenner, C. Jacobshagen, H. Mudra (+23 others)
2015 European Heart Journal  

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In patients receiving aspirin, the optimal duration of clopidogrel therapy after drug-eluting stent (DES) implantation remains unclear. Methods This multicentre, randomized, double-blind, placebo-controlled trial tested the hypothesis that in patients undergoing DES implantation, 6 months of clopidogrel is non-inferior to 12 months in terms of clinical outcomes. At 6 months after DES implantation, patients on clopidogrel were randomly assigned to either a 6-month period of placebo or an
more » ... al 6-month period of clopidogrel. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, and thrombolysis in myocardial infarction major bleeding at 9 months after randomization. Results Owing to slow recruitment and low event rates, the trial was stopped prematurely after enrolment of 4005 of 6000 planned patients. Of 4000 patients included in the final analysis, 1997 received 6 months of clopidogrel and 2003 received 12 months. The primary endpoint occurred in 29 patients (1.5%) assigned to 6 months of clopidogrel and 32 patients (1.6%) assigned to 12 months, observed difference 20.1%, upper limit of one-sided 95% confidence interval (CI) 0.5%, limit of non-inferiority 2%, P for noninferiority ,0.001. Stent thrombosis was observed in five patients (0.3%) assigned
doi:10.1093/eurheartj/ehu523 pmid:25616646 fatcat:3jh7wveefbgjfdh62vldbosowy
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S. Schulz-Schupke, R. A. Byrne, J. M. ten Berg, F.-J. Neumann, Y. Han, T. Adriaenssens, R. Tolg, M. Seyfarth, M. Maeng, B. Zrenner, C. Jacobshagen, H. Mudra, E. von Hodenberg, J. Wohrle, D. J. Angiolillo, B. von Merzljak, N. Rifatov, S. Kufner, T. Morath, A. Feuchtenberger, T. Ibrahim, P. W. A. Janssen, C. Valina, Y. Li, W. Desmet, M. Abdel-Wahab, K. Tiroch, C. Hengstenberg, I. Bernlochner, M. Fischer, H. Schunkert, K.-L. Laugwitz, A. Schomig, J. Mehilli, A. Kastrati. "ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting." European Heart Journal 36.20 (2015) 1252-1263