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Antiplatelet therapy after coronary artery bypass surgery: five year follow-up of randomised DACAB trial
The BMJ ( IF 93.6 ) Pub Date : 2024-06-11 , DOI: 10.1136/bmj-2023-075707
Yunpeng Zhu 1 , Wei Zhang 2 , Arnaldo Dimagli 3 , Lin Han 4 , Zhaoyun Cheng 5 , Ju Mei 6 , Xin Chen 7 , Xiaowei Wang 8 , Yanzai Zhou 1 , Qing Xue 4 , Junlong Hu 5 , Min Tang 6 , Rui Wang 7 , Yuanyuan Song 8 , Lei Kang 1 , Bjorn Redfors 9 , Mario Gaudino 3 , Qiang Zhao 10
Affiliation  

Objective To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting. Design Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial. Setting Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019 to June 2021. Participants 500 patients aged 18-80 years (including 91 (18.2%) women) who had elective coronary artery bypass grafting surgery and completed the DACAB trial. Interventions Patients were randomised 1:1:1 to ticagrelor 90 mg twice daily plus aspirin 100 mg once daily (dual antiplatelet therapy; n=168), ticagrelor monotherapy 90 mg twice daily (n=166), or aspirin monotherapy 100 mg once daily (n=166) for one year after surgery. After the first year, antiplatelet therapy was prescribed according to standard of care by treating physicians. Main outcome measures The primary outcome was major adverse cardiovascular events (a composite of all cause death, myocardial infarction, stroke, and coronary revascularisation), analysed using the intention-to-treat principle. Time-to-event analysis was used to compare the risk between treatment groups. Multiple post hoc sensitivity analyses examined the robustness of the findings. Results Follow-up at five years for major adverse cardiovascular events was completed for 477 (95.4%) of 500 patients; 148 patients had major adverse cardiovascular events, including 39 in the dual antiplatelet therapy group, 54 in the ticagrelor monotherapy group, and 55 in the aspirin monotherapy group. Risk of major adverse cardiovascular events at five years was significantly lower with dual antiplatelet therapy versus aspirin monotherapy (22.6% v 29.9%; hazard ratio 0.65, 95% confidence interval 0.43 to 0.99; P=0.04) and versus ticagrelor monotherapy (22.6% v 32.9%; 0.66, 0.44 to 1.00; P=0.05). Results were consistent in all sensitivity analyses. Conclusions Treatment with ticagrelor dual antiplatelet therapy for one year after surgery reduced the risk of major adverse cardiovascular events at five years after coronary artery bypass grafting compared with aspirin monotherapy or ticagrelor monotherapy. Trial registration NCT03987373ClinicalTrials.gov [NCT03987373][1]. All data that underlie the results reported in this article will be provided on reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03987373&atom=%2Fbmj%2F385%2Fbmj-2023-075707.atom

中文翻译:


冠状动脉搭桥手术后的抗血小板治疗:随机 DACAB 试验的五年随访



目的 评估不同抗血小板策略对冠状动脉旁路移植术后临床结局的影响。设计冠状动脉搭桥术 (DACAB) 试验后随机不同抗血小板治疗策略的五年随访。国内设有六家三级医院; 2014年7月至2015年11月期间入学;完成2019年8月至2021年6月的五年随访。研究对象为500名年龄在18-80岁之间的患者(其中91名(18.2%)女性)接受了选择性冠状动脉搭桥手术并完成了DACAB试验。干预措施 患者按 1:1:1 随机分配至替格瑞洛 90 mg 每日两次加阿司匹林 100 mg 每日一次(双重抗血小板治疗;n=168)、替格瑞洛单药治疗 90 mg 每日两次 (n=166) 或阿司匹林单药治疗 100 mg 每日一次(n=166) 术后一年。第一年后,治疗医生根据护理标准规定进行抗血小板治疗。主要结局指标 主要结局指标是主要不良心血管事件(全因死亡、心肌梗死、中风和冠状动脉血运重建的综合结果),采用意向治疗原则进行分析。使用事件发生时间分析来比较治疗组之间的风险。多项事后敏感性分析检验了研究结果的稳健性。结果 500 名患者中,477 名(95.4%)完成了主要不良心血管事件的五年随访; 148名患者出现重大心血管不良事件,其中双联抗血小板治疗组39名,替格瑞洛单药治疗组54名,阿司匹林单药治疗组55名。与阿司匹林单药治疗相比,双联抗血小板治疗五年内主要不良心血管事件的风险显着降低(22.6% 对 29.9%;风险比0.65,95%置信区间0.43至0.99; P=0.04)以及与替格瑞洛单药治疗相比(22.6% vs 32.9%;0.66、0.44 至 1.00;P=0.05)。所有敏感性分析的结果都是一致的。结论 与阿司匹林单药治疗或替格瑞洛单药治疗相比,术后一年替格瑞洛双重抗血小板治疗可降低冠状动脉旁路移植术后五年主要不良心血管事件的风险。试验注册 NCT03987373ClinicalTrials.gov [NCT03987373][1]。本文报告结果的所有数据将根据合理要求提供。 [1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03987373&atom=%2Fbmj%2F385%2Fbmj-2023-075707。原子
更新日期:2024-06-11
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