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

Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.


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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aspirin / therapeutic use
  • Cause of Death
  • Clopidogrel
  • Coronary Restenosis / mortality
  • Coronary Restenosis / prevention & control
  • Coronary Vessels / surgery*
  • Drug Therapy, Combination
  • Drug-Eluting Stents*
  • Everolimus
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / prevention & control
  • Paclitaxel / therapeutic use
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Risk
  • Sirolimus / analogs & derivatives
  • Sirolimus / therapeutic use
  • Stroke / mortality
  • Stroke / prevention & control
  • Thrombosis / mortality
  • Thrombosis / prevention & control
  • Ticlopidine / analogs & derivatives
  • Ticlopidine / therapeutic use
  • Treatment Outcome


  • Platelet Aggregation Inhibitors
  • Everolimus
  • Clopidogrel
  • zotarolimus
  • Ticlopidine
  • Paclitaxel
  • Aspirin
  • Sirolimus

Associated data