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One month of DAPT followed by clopidogrel alone is superior to 12 months of DAPT after PCI (STOPDAPT-2)
Clinical Question
Is 1 month of dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy noninferior or superior to 12 months of DAPT in adults receiving percutaneous coronary intervention?
Bottom line
This study found that 1 month of DAPT (aspirin plus clopidogrel or prasugrel) followed by clopidogrel monotherapy for up to 5 years is both noninferior and superior to 12 months of DAPT followed by aspirin for up to 5 years for reducing the risk of adverse cardiovascular outcomes and major bleeding complications in adults undergoing successful percutaneous coronary intervention (PCI) 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 lower adverse bleeding events after 3 months of DAPT followed by P2Y12 inhibitor monotherapy (eg, clopidogrel, prasugrel, or ticagrelor) compared with 12 months of DAPT. 1b
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Industry
Setting: Inpatient (any location) with outpatient follow-up
Synopsis
The optimal duration of DAPT after PCI with drug-eluting stents remains uncertain, especially since the mortality associated with a bleeding event is comparable with cardiovascular mortality following acute myocardial infarction. These investigators identified consenting adults (N = 3045) who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. Before hospital discharge, eligible patients randomly received (concealed allocation assignment) 1 month of DAPT with either (1) aspirin (81 mg/day - 200 mg/day) and clopidogrel (75 mg/day) or aspirin and prasugrel (3.75 mg/day) followed by clopidogrel monotherapy for up to 5 years, or (2) DAPT with aspirin and clopidogrel for up to 12 months, followed by aspirin monotherapy for up to 5 years. The primary endpoint 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 both intention-to-treat and per-protocol analyses, 1 month of DAPT was both significantly noninferior and superior to 12 months of DAPT for the primary endpoint (2.36% vs 3.70%; number needed to treat = 76.3; 95% CI 39.0 - 1128.6). In addition, major bleeding occurred in significantly fewer patients in the 1-month DAPT group compared with the 12-month DAPT group (0.41% vs 1.54%; number needed to treat to harm = 116.2; 65.4 - 334.0).
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
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