Short- Versus Long-Term Duration of Dual Antiplatelet Therapy After Coronary Stenting: A Randomized Multicentre Trial

Apr 05, 2012
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Authors:
Valgimigli M, Campo G, Monti M, et al., on behalf of the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) Investigators.
Citation:
Circulation 2012;Mar 21:[Epub ahead of print].
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What is the impact of up to 6- versus 24-month duration of dual antiplatelet therapy in a broad all-comer patient population receiving drug-eluting or bare-metal stents?

Methods:

The PRODIGY investigators 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 of clopidogrel therapy on top of aspirin. The primary endpoint was a composite of death from any cause, myocardial infarction, or cerebrovascular accident.

Results:

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% 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 consistent 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:

The authors concluded that 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.

Perspective:

This study found no significant benefit associated with clopidogrel continuation (use of clopidogrel plus aspirin) as compared with clopidogrel discontinuation (use of aspirin alone) after 6 months, in reducing the incidence of death from any cause, myocardial infarction, or cerebrovascular accident at 2 years. On the other hand, 2-year clopidogrel therapy resulted in a significant increase of actionable bleeding episodes, which included events requiring medical or surgical treatment, red blood cell transfusion, and life-threatening events. There seems to be little rationale for continuing dual antiplatelet therapy for more than a year after percutaneous coronary intervention, based on this and other available evidence.

Keywords: Stroke, Myocardial Infarction, Erythrocyte Transfusion, Coronary Restenosis, Hyperplasia, Percutaneous Coronary Intervention, Stents, Incidence, Endothelium, Coronary Angiography, Thrombosis, Cardiology, Hemorrhage


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