Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China.
BMJ. 2024 Jun 11;385:e075707. doi: 10.1136/bmj-2023-075707.
To assess the effect of different antiplatelet strategies on clinical outcomes after coronary artery bypass grafting.
Five year follow-up of randomised Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Grafting (DACAB) trial.
Six tertiary hospitals in China; enrolment between July 2014 and November 2015; completion of five year follow-up from August 2019 to June 2021.
500 patients aged 18-80 years (including 91 (18.2%) women) who had elective coronary artery bypass grafting surgery and completed the DACAB trial.
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.
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.
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% 29.9%; hazard ratio 0.65, 95% confidence interval 0.43 to 0.99; P=0.04) and versus ticagrelor monotherapy (22.6% 32.9%; 0.66, 0.44 to 1.00; P=0.05). Results were consistent in all sensitivity analyses.
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.
NCT03987373ClinicalTrials.gov NCT03987373.
评估冠状动脉旁路移植术后不同抗血小板策略对临床结局的影响。
冠状动脉旁路移植术后不同抗血小板治疗策略（DACAB）试验的 5 年随访。
中国六所三级医院；2014 年 7 月至 2015 年 11 月入组；2019 年 8 月至 2021 年 6 月完成 5 年随访。
500 名年龄在 18-80 岁（包括 91 名[18.2%]女性）的接受择期冠状动脉旁路移植术的患者，并完成了 DACAB 试验。
患者以 1:1:1 的比例随机分为三组：替格瑞洛 90mg 每日 2 次联合阿司匹林 100mg 每日 1 次（双联抗血小板治疗；n=168）、替格瑞洛单药治疗 90mg 每日 2 次（n=166）或阿司匹林单药治疗 100mg 每日 1 次（n=166），术后用药 1 年。第 1 年后，根据治疗医生的标准治疗方案开具抗血小板药物。
主要不良心血管事件（所有原因死亡、心肌梗死、卒中和冠状动脉血运重建的复合终点）是主要结局，采用意向治疗原则进行分析。采用时间事件分析比较治疗组之间的风险。进行了多次事后敏感性分析以检验结果的稳健性。
500 名患者中，有 477 名（95.4%）完成了 5 年主要不良心血管事件的随访；148 名患者发生了主要不良心血管事件，其中双联抗血小板治疗组 39 例，替格瑞洛单药组 54 例，阿司匹林单药组 55 例。与阿司匹林单药治疗相比，双联抗血小板治疗显著降低了 5 年时的主要不良心血管事件风险（22.6% 29.9%；风险比 0.65，95%置信区间 0.43 至 0.99；P=0.04），与替格瑞洛单药治疗相比也显著降低了风险（22.6% 32.9%；0.66，0.44 至 1.00；P=0.05）。所有敏感性分析结果均一致。
与阿司匹林单药或替格瑞洛单药治疗相比，术后替格瑞洛双联抗血小板治疗 1 年可降低冠状动脉旁路移植术后 5 年主要不良心血管事件的风险。
NCT03987373（ClinicalTrials.gov NCT03987373）。
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