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- Title
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.
- Authors
Watanabe, Hirotoshi; Domei, Takenori; Morimoto, Takeshi; Natsuaki, Masahiro; Shiomi, Hiroki; Toyota, Toshiaki; Ohya, Masanobu; Suwa, Satoru; Takagi, Kensuke; Nanasato, Mamoru; Hata, Yoshiki; Yagi, Masahiro; Suematsu, Nobuhiro; Yokomatsu, Takafumi; Takamisawa, Itaru; Doi, Masayuki; Noda, Toshiyuki; Okayama, Hideki; Seino, Yoshitane; Tada, Tomohisa
- Abstract
<bold>Importance: </bold>Very short mandatory dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with a drug-eluting stent may be an attractive option.<bold>Objective: </bold>To test the hypothesis of noninferiority of 1 month of DAPT compared with standard 12 months of DAPT for a composite end point of cardiovascular and bleeding events.<bold>Design, Setting, and Participants: </bold>Multicenter, open-label, randomized clinical trial enrolling 3045 patients who underwent PCI at 90 hospitals in Japan from December 2015 through December 2017. Final 1-year clinical follow-up was completed in January 2019.<bold>Interventions: </bold>Patients were randomized either to 1 month of DAPT followed by clopidogrel monotherapy (n=1523) or to 12 months of DAPT with aspirin and clopidogrel (n=1522).<bold>Main Outcomes and Measures: </bold>The primary end point was a composite of cardiovascular death, myocardial infarction (MI), ischemic or hemorrhagic stroke, definite stent thrombosis, or major or minor bleeding at 12 months, with a relative noninferiority margin of 50%. The major secondary cardiovascular end point was a composite of cardiovascular death, MI, ischemic or hemorrhagic stroke, or definite stent thrombosis and the major secondary bleeding end point was major or minor bleeding.<bold>Results: </bold>Among 3045 patients randomized, 36 withdrew consent; of 3009 remaining, 2974 (99%) completed the trial. One-month DAPT was both noninferior and superior to 12-month DAPT for the primary end point, occurring in 2.36% with 1-month DAPT and 3.70% with 12-month DAPT (absolute difference, -1.34% [95% CI, -2.57% to -0.11%]; hazard ratio [HR], 0.64 [95% CI, 0.42-0.98]), meeting criteria for noninferiority (P < .001) and for superiority (P = .04). The major secondary cardiovascular end point occurred in 1.96% with 1-month DAPT and 2.51% with 12-month DAPT (absolute difference, -0.55% [95% CI, -1.62% to 0.52%]; HR, 0.79 [95% CI, 0.49-1.29]), meeting criteria for noninferiority (P = .005) but not for superiority (P = .34). The major secondary bleeding end point occurred in 0.41% with 1-month DAPT and 1.54% with 12-month DAPT (absolute difference, -1.13% [95% CI, -1.84% to -0.42%]; HR, 0.26 [95% CI, 0.11-0.64]; P = .004 for superiority).<bold>Conclusions and Relevance: </bold>Among patients undergoing PCI, 1 month of DAPT followed by clopidogrel monotherapy, compared with 12 months of DAPT with aspirin and clopidogrel, resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, meeting criteria for both noninferiority and superiority. These findings suggest that a shorter duration of DAPT may provide benefit, although given study limitations, additional research is needed in other populations.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02619760.
- Subjects
PERCUTANEOUS coronary intervention; CLOPIDOGREL; ASPIRIN; HEMORRHAGE; MYOCARDIAL infarction; ISCHEMIA; PLATELET aggregation inhibitors; RANDOMIZED controlled trials; RESEARCH; COMBINATION drug therapy; DRUG-eluting stents; RESEARCH methodology; MEDICAL care; NEUROTRANSMITTERS; EVALUATION research; MEDICAL cooperation; CARDIOVASCULAR system; DRUG administration; COMPARATIVE studies; DRUGS
- Publication
JAMA: Journal of the American Medical Association, 2019, Vol 321, Issue 24, p2414
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2019.8145