"Dual Antiplatelet Therapy with Clopidogrel and Aspirin in Coronary Stenting". The New England Journal of Medicine.
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Does extending dual antiplatelet therapy beyond 1 year after placement of a drug-eluting stent reduce the risk of stent thrombosis and major adverse cardiovascular and cerebrovascular events?
Extended dual antiplatelet therapy beyond one year after drug-eluting stent placement reduces the risk of stent thrombosis and major adverse cardiovascular and cerebrovascular events at the cost of increased risk of moderate or severe bleeding.
Though dual antiplatelet therapy is recommended for up to 1 year post drug-eluting coronary stenting, the benefits and risks beyond this period were uncertain. The Dual Antiplatelet Therapy (DAPT) study found that continued thienopyridine therapy (clopidogrel or prasugrel) with aspirin for an additional 18 months significantly reduced stent thrombosis and major adverse events compared to aspirin alone, but it was associated with an increased risk of bleeding.
Current guidelines typically recommend dual antiplatelet therapy with a P2Y12-receptor inhibitor combined with aspirin for 6 to 12 months post drug-eluting stent implantation.
Multicenter, randomized, placebo-controlled trial.
9,961 patients undergoing drug-eluting stenting with dual antiplatelet therapy for one year without any major complications or nonadherence to therapy.
Patients were randomized to continue thienopyridine therapy (clopidogrel or prasugrel) or receive a placebo for additional 18 months; all continued aspirin.
Primary efficacy endpoints were stent thrombosis and major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, or stroke) from 12 to 30 months. The primary safety endpoint was moderate or severe bleeding. - Stent thrombosis: 0.4% in continued thienopyridine group vs. 1.4% in placebo (P<0.001) - Major adverse cardiovascular and cerebrovascular events: 4.3% in continued thienopyridine group vs. 5.9% in placebo (P<0.001) - Moderate or severe bleeding: 2.5% in continued thienopyridine group vs. 1.6% in placebo (P=0.001)
The study's population may be biased towards lower-risk individuals as those who had complications or nonadherence were excluded from the randomization process.
Consortium of eight device and drug manufacturers and others; grant (1RO1FD003870-01) from the Department of Health and Human Services.
The full text of this article can be found at NEJM.org.