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- Title
Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial.
- Authors
Kim, Byeong-Keuk; Hong, Sung-Jin; Cho, Yun-Hyeong; Yun, Kyeong Ho; Kim, Yong Hoon; Suh, Yongsung; Cho, Jae Young; Her, Ae-Young; Cho, Sungsoo; Jeon, Dong Woon; Yoo, Sang-Yong; Cho, Deok-Kyu; Hong, Bum-Kee; Kwon, Hyuckmoon; Ahn, Chul-Min; Shin, Dong-Ho; Nam, Chung-Mo; Kim, Jung-Sun; Ko, Young-Guk; Choi, Donghoon
- Abstract
<bold>Importance: </bold>Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS).<bold>Objective: </bold>To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents.<bold>Design, Setting, and Participants: </bold>A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019.<bold>Interventions: </bold>Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529).<bold>Main Outcomes and Measures: </bold>The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events.<bold>Results: </bold>Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, -1.98% [95% CI, -3.50% to -0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09).<bold>Conclusions and Relevance: </bold>Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02494895.
- Subjects
ASPIRIN; PLATELET aggregation inhibitors; HEMORRHAGE prevention; ACUTE coronary syndrome; DRUG-eluting stents; TREATMENT of acute coronary syndrome; CARDIOVASCULAR disease prevention; TICLOPIDINE; RESEARCH; COMBINATION drug therapy; RAPAMYCIN; RESEARCH methodology; CARDIOVASCULAR diseases; MEDICAL care; EVALUATION research; MEDICAL cooperation; CARDIOVASCULAR system; COMPARATIVE studies; RANDOMIZED controlled trials; HEMORRHAGE
- Publication
JAMA: Journal of the American Medical Association, 2020, Vol 323, Issue 23, p2407
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2020.7580