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Lohaus, Raphaela; Michel, Jonathan; Mayer, Katharina; Lahmann, Anna Lena; Byrne, Robert A.; Wolk, Annabelle; ten Berg, Jurrien M.; Neumann, Franz-Josef; Han, Yaling; Adriaenssens, Tom; Tölg, Ralph; Seyfarth, Melchior; Maeng, Michael; Zrenner, Bernhard; Jacobshagen, Claudius; Wöhrle, Jochen; Kufner, Sebastian; Morath, Tanja; Ibrahim, Tareq; Bernlochner, Isabell; Fischer, Marcus; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Mehilli, Julinda; Kastrati, Adnan; Schulz-Schüpke, Stefanie (2016): Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis. In: Scientific Reports, Vol. 6, 33054
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Abstract

In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months;hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41-1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group;HR 1.00, 95% CI 0.14-7.09, P = >0.99. Major bleeding occurred in 3 patients (0.4%) receiving 6 months clopidogrel and 5 (0.6%) receiving 12 months;HR 0.60, 95% CI 0.15-2.49, P = 0.49. There was no significant difference in net clinical outcomes after DES implantation in ACS patients treated with 6 versus 12 months clopidogrel. Ischaemic and bleeding events were low beyond 6-months.