Authors
Valgimigli M, Campo G, Monti M, et al.
Title
Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial.
References
Circulation 2012;125:2015-26
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.
Purpose
To evaluate 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.
Design
  • 4-by-2 randomized, multicenter, open-label clinical trial designed to evaluate the efficacy and safety of prolonging the duration of clopidogrel therapy for up to 24 months in all-comer patients receiving a balanced mixture of stents with varying anti-intimal hyperplasia potency and belonging to both first- and second-generation DES.
  • 2013 patients were randomly assigned 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.
  • Patients were included with chronic stable coronary artery disease or acute coronary syndromes, including non–ST-elevation and ST-elevation myocardial infarction. They were eligible if they had at least 1 lesion with a diameter stenosis of ≥50% that was suitable for coronary stent implantation in a vessel with a reference vessel diameter of ≥2.25 mm.
  • The primary end point was a composite of death of any cause, myocardial infarction, or cerebrovascular accident
Exclusion Criteria
  • Known allergy to acetylsalicylic acid or clopidogrel
  • Planned surgery within 24 months of percutaneous coronary intervention unless the dual-antiplatelet therapy (DAPT) could be maintained throughout the peri-surgical period
  • History of bleeding diathesis;
  • Major surgery within 15 days
  • Active bleeding or previous stroke in the past 6 months;
  • Concomitant or foreseeable need for oral anticoagulation therapy
  • Pregnancy
  • Life expectancy <24 months
  • Participation in another trial
  • Inability to provide informed consent
Follow-Up
30 days, then every 6 months up to 2 years
Treatment Regimen
Clopidogrel after implantation of DES for up to 6 months versus 24 months
Results
Primary Endpoints:
  • Primary outcome at 2 years was not different in both groups: event rate 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).

Secondary Endpoints:

  • The individual risks of death, myocardial infarction, cerebrovascular accident, or stent thrombosis did not differ between the study groups.
  • 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.
Summary
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.
Implications
The study was performed in a mixed population but added to the growing body of evidence that prolonged DAPT may not be beneficial for patients after implantation of a drug eluting stent (DES).
Related Figures
None.