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。
冠状动脉旁路移植术后随机不同抗血小板治疗策略的五年随访(DACAB)试验.
中国六家三级医院;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岁的患者(包括91名(18.2%)女性)接受了择期冠状动脉旁路移植术并完成了DACAB试验。
患者以1:1:1的比例随机分配给替格瑞洛90mg,每天两次,加上阿司匹林100mg,每天一次(双联抗血小板治疗;n=168),替格瑞洛单药90mg,每日两次(n=166),或阿司匹林单药100mg,每日一次(n=166),手术后一年。第一年之后,抗血小板治疗是根据治疗医师的标准进行的.
主要结局是主要不良心血管事件(全因死亡的复合,心肌梗塞,中风,和冠状动脉血运重建),使用意向治疗原则进行分析。使用时间至事件分析来比较治疗组之间的风险。多项事后敏感性分析检查了调查结果的稳健性。
对500例患者中的477例(95.4%)完成了5年主要不良心血管事件的随访;148例患者有主要不良心血管事件,包括双重抗血小板治疗组的39人,替格瑞洛单药治疗组54,阿司匹林单药治疗组55例。与阿司匹林单药治疗(22.6%v29.9%;风险比0.65,95%置信区间0.43~0.99;P=0.04)和替格瑞洛单药治疗(22.6%v32.9%;0.66,0.44~1.00;P=0.05)相比,5年主要不良心血管事件的风险显著降低。所有敏感性分析结果一致。
与阿司匹林单药或替格瑞洛单药相比,术后1年替格瑞洛双联抗血小板治疗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。
NCT03987373ClinicalTrials.govNCT03987373。
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% 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.
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.