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Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis #MMPMID27624287
Lohaus R; Michel J; Mayer K; Lahmann AL; Byrne RA; Wolk A; ten Berg JM; Neumann FJ; Han Y; Adriaenssens T; Tölg R; Seyfarth M; Maeng M; Zrenner B; Jacobshagen C; Wöhrle J; Kufner S; Morath T; Ibrahim T; Bernlochner I; Fischer M; Schunkert H; Laugwitz KL; Mehilli J; Kastrati A; Schulz-Schüpke S
Sci Rep 2016[]; 6 (ä): ä PMID27624287show ga
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.