"Dual Antiplatelet Therapy with Clopidogrel and Aspirin in Coronary Stenting". The New England Journal of Medicine.

Clinical Question

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?

Bottom Line

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.

Major Points

Guidelines

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.

Design

Multicenter, randomized, placebo-controlled trial.

Population

9,961 patients undergoing drug-eluting stenting with dual antiplatelet therapy for one year without any major complications or nonadherence to therapy.

Interventions

Patients were randomized to continue thienopyridine therapy (clopidogrel or prasugrel) or receive a placebo for additional 18 months; all continued aspirin.

Outcomes

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)

Criticisms

The study's population may be biased towards lower-risk individuals as those who had complications or nonadherence were excluded from the randomization process.

Funding

Consortium of eight device and drug manufacturers and others; grant (1RO1FD003870-01) from the Department of Health and Human Services.

Further Reading

The full text of this article can be found at NEJM.org.