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替卡格雷单药治疗急性冠脉综合征患者可降低大出血和心血管事件的风险

本期文章:《美国医学会杂志》:Vol 323 No 23

韩国延世大学医学院Yangsoo Jang团队分析了替卡格雷单用或联合阿司匹林对急性冠脉综合征患者大出血和心血管事件的影响。相关论文于2020年6月16日发表在《美国医学会杂志》上。

短期双重抗血小板治疗(DAPT)后停用阿司匹林的策略可减少出血。但替卡格雷单药治疗策略尚未对急性冠脉综合征(ACS)患者进行评估。

为了确定在药物洗脱支架治疗的ACS患者中,与基于替卡格雷的12个月DAPT相比,DAPT 3个月后改用替卡格雷单药治疗是否能减少净不良临床事件,2015年8月至2018年10月,研究组在韩国38个中心进行了一项随机多中心试验,招募了3056例接受药物洗脱支架治疗的ACS患者。将其随机分组,其中1527例在3个月DAPT后接受替卡格雷单药治疗,1529例接受基于替卡格雷的12个月DAPT。主要结局为1年净不良临床事件,定义为大出血和不良心脏和脑血管事件(死亡、心肌梗塞、支架血栓形成、中风或靶血管血运重建)的综合结局。

3056名患者的中位年龄为61岁,女性占20%,ST抬高型心肌梗死占36%,共有2978名患者(97.4%)完成了试验。3个月DAPT+替卡格雷单药组中有59例(3.9%)发生主要结局,显著低于基于替卡格雷的12个月DAPT组(89例,占5.9%)。在10个预先指定的次要结局中,有8个没有显著差异。3个月DAPT+替卡格雷单药组中有1.7%的患者发生大出血,显著低于基于替卡格雷的12个月DAPT组(3.0%)。两组间重大不良心脑血管事件发生率分别为2.3%和3.4%,差异无统计学意义。

总之,对于使用药物洗脱支架治疗的ACS患者,与基于替卡格雷的12个月双重抗血小板治疗相比,双重抗血小板治疗3个月后进行替卡格雷单药治疗可显著改善临床结局,降低严重出血和1年内发生心血管事件的风险。

附:英文原文

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

Author: Byeong-Keuk Kim, Sung-Jin Hong, Yun-Hyeong Cho, Kyeong Ho Yun, Yong Hoon Kim, Yongsung Suh, Jae Young Cho, Ae-Young Her, Sungsoo Cho, Dong Woon Jeon, Sang-Yong Yoo, Deok-Kyu Cho, Bum-Kee Hong, Hyuckmoon Kwon, Chul-Min Ahn, Dong-Ho Shin, Chung-Mo Nam, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Myeong-Ki Hong, Yangsoo Jang

Issue&Volume: 2020/06/16

Abstract: Importance  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).

Objective  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.

Design, Setting, and Participants  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.

Interventions  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).

Main Outcomes and Measures  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.

Results  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).

Conclusions and Relevance  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.

DOI: 10.1001/jama.2020.7580

Source: https://jamanetwork.com/journals/jama/article-abstract/2767161

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