Short- Versus Long-term Duration of Dual Antiplatelet Therapy After Coronary Stenting: A Randomized Multicentre Trial
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 versus24 month duration of dual antiplatelet therapy in a broad all comer patient population receiving a balanced proportion of Food and Drug Administration-approved drug-eluting or bare metal stents.
Methods and Results—We randomly assigned 2,013 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 clopidogrel therapy on top of aspirin. The primary endpoint was a composite of death from any cause, myocardial infarction or cerebrovascular accident. The cumulative risk of the primary outcome at 2 years was 10.1% with the 24-month dual antiplatelet therapy, as compared to 10.0% with the 6-month dual antiplatelet therapy (hazard ratio, 0.98; 95% CI, 0.74 to 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 consistent greater risk of haemorrhage in the 24-month clopidogrel group according to all prespecifed bleeding definitions including the recently proposed Bleeding Academic Research Consortium classification.
Conclusions—A 24-month 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 for any cause, myocardial infarction or cerebrovascular accident.
Clinical Trial Registration Information—clinicaltrials.gov; Identifier: NCT00611286
- Received October 2, 2011.
- Accepted February 27, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited