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Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial

Marco Valgimigli, Gianluca Campo, Monia Monti, Pascal Vranckx, Gianfranco Percoco, Carlo Tumscitz, Fausto Castriota, Federico Colombo, Matteo Tebaldi, Giuseppe Fucà, Moh'd Kubbajeh, Elisa Cangiano, Monica Minarelli, Antonella Scalone, Caterina Cavazza, Alice Frangione, Marco Borghesi, Jlenia Marchesini, Giovanni Parrinello, Roberto Ferrari
Circulation 2012 April 24, 125 (16): 2015-26

BACKGROUND: The optimal duration of dual-antiplatelet therapy and the risk-benefit ratio for long-term dual-antiplatelet therapy after coronary stenting remain poorly defined. We evaluated the impact of up to 6 versus 24 months of dual-antiplatelet therapy in a broad all-comers patient population receiving a balanced proportion of Food and Drug Administration-approved drug-eluting or bare-metal stents.

METHODS AND RESULTS: We randomly assigned 2013 patients to receive bare-metal, zotarolimus-eluting, paclitaxel-eluting, or everolimus-eluting stent implantation. At 30 days, patients in each stent group were randomly allocated to receive up to 6 or 24 months of clopidogrel therapy in addition to aspirin. The primary end point was a composite of death of any cause, myocardial infarction, or cerebrovascular accident. The cumulative risk of the primary outcome at 2 years was 10.1% with 24-month dual-antiplatelet therapy compared with 10.0% with 6-month dual-antiplatelet therapy (hazard ratio, 0.98; 95% confidence interval, 0.74-1.29; P=0.91). The individual risks of death, myocardial infarction, cerebrovascular accident, or stent thrombosis did not differ between the study groups; however, there was a consistently greater risk of hemorrhage in the 24-month clopidogrel group according to all prespecified bleeding definitions, including the recently proposed Bleeding Academic Research Consortium classification.

CONCLUSIONS: A regimen of 24 months of clopidogrel therapy in patients who had received a balanced mixture of drug-eluting or bare-metal stents was not significantly more effective than a 6-month clopidogrel regimen in reducing the composite of death due to any cause, myocardial infarction, or cerebrovascular accident.

CLINICAL TRIAL REGISTRATION: URL: Unique identifier: NCT00611286.

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