Is one month of dual antiplatelet therapy followed by clopidogrel (Plavix) monotherapy noninferior or superior to 12 months of dual antiplatelet therapy in adults undergoing percutaneous coronary intervention?
This study found that one month of dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel [Effient]) followed by clopidogrel monotherapy for up to five years is both noninferior and superior to 12 months of dual antiplatelet therapy followed by aspirin for up to five years for reducing the risk of adverse cardiovascular outcomes and major bleeding complications in adults undergoing successful percutaneous coronary intervention with a drug-eluting stent. Another study of similar patients in the same journal also reported noninferior rates of major adverse cardiovascular events and significantly fewer adverse bleeding events after three months of dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy (e.g., clopidogrel, prasugrel, ticagrelor [Brilinta]) compared with 12 months of dual antiplatelet therapy. (Level of Evidence = 1b)
The optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stents remains uncertain, especially because the mortality associated with a bleeding event is comparable with cardiovascular mortality following acute myocardial infarction. The investigators identified consenting adults (N = 3,045) who underwent successful percutaneous coronary intervention with a cobalt-chromium everolimus–eluting stent. Before hospital discharge, eligible patients randomly received (concealed allocation assignment) one month of dual antiplatelet therapy with either aspirin (81 to 200 mg per day) and clopidogrel (75 mg per day) or aspirin and prasugrel (3.75 mg per day) followed by clopidogrel monotherapy for up to five years, or dual antiplatelet therapy with aspirin and clopidogrel for up to 12 months, followed by aspirin monotherapy for up to five years. The primary end point was a composite of cardiovascular death, myocardial infarction, stent thrombosis, stroke, or bleeding. Individuals masked to treatment group assignment adjudicated all clinical events. Complete follow-up occurred for 98.8% of participants at 12 months.
Using intention-to-treat and per-protocol analyses, one month of dual antiplatelet therapy was both significantly noninferior and superior to 12 months of dual antiplatelet therapy for the primary end point (2.36% vs. 3.70%; number needed to treat = 76.3; 95% CI, 39.0 to 1,128.6). Major bleeding occurred in significantly fewer patients in the one-month dual antiplatelet therapy group compared with the 12-month dual antiplatelet therapy group (0.41% vs. 1.54%; number needed to harm = 116.2; 65.4 to 334.0).
Study design: Randomized controlled trial (single-blinded)
Funding source: Industry
Setting: Inpatient (any location) with outpatient follow-up
Reference: Watanabe H, Domei T, Morimoto T, et al.; STOPDAPT-2 Investigators. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: The STOPDAPT-2 randomized clinical trial. JAMA. 2019;321(24):2414–2427.