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One month of DAPT followed by clopidogrel alone is superior to 12 months of DAPT after PCI (STOPDAPT-2)

Question clinique

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?

L’Essentiel

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

Référence

Watanabe H, Domei T, Morimoto T, et al, for the 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.

Plan de l'etude: Randomized controlled trial (single-blinded)

Financement: Industry

Cadre: Inpatient (any location) with outpatient follow-up

Sommaire

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


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Anonymous

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this is a test

août 12, 2019
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