Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial.

Methods

Multicentre, non-inferiority, double blind, randomised controlled trial.

多中心、非劣效性、双盲、随机对照试验。

13 cardiac surgery centres in China, with enrolment between February 2023 and July 2024.

13个中国心脏外科中心，招募时间为2023年2月至2024年7月。

2300 participants aged 18 to 80 years who underwent elective primary coronary artery bypass grafting with ≥1 saphenous vein graft.

2300名年龄在18至80岁之间，接受了择期初次冠状动脉旁路移植术且至少使用了一根大隐静脉移植血管的参与者。

Participants were randomly assigned (1:1) to receive DAPT (ticagrelor 90 mg twice daily plus aspirin 100 mg once daily) for 12 months or the same dual antiplatelet regimen for the first three months, followed by placebo plus aspirin for nine months.

参与者被随机分配（1:1），接受DAPT（替格瑞洛90毫克每日两次加阿司匹林100毫克每日一次）治疗12个月，或者接受相同的双重抗血小板方案治疗前三个月，随后接受安慰剂加阿司匹林治疗九个月。

The primary outcomes were saphenous vein graft occlusion at one year (non-inferiority) and Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (superiority).

主要结果是1年时的大隐静脉移植闭塞（非劣效性）和Bleeding Academic Research Consortium（BARC）2型、3型或5型出血（优越性）。

Secondary outcomes were major adverse cardiovascular events (MACCE), saphenous vein graft failure, venous or arterial graft stenosis, and venous or arterial graft occlusion.

次要结果包括主要不良心血管事件（MACCE）、大隐静脉移植失败、静脉或动脉移植狭窄以及静脉或动脉移植闭塞。

Results

2290 patients (mean age 61.5 (standard deviation (SD) 8.4) years, 20.6% (n=472) women) were included in the modified intention-to-treatset.

共有2290名患者（平均年龄61.5岁（标准差（SD）8.4岁），女性占20.6%（n=472））被纳入改良意向治疗集。

The mean number of saphenous vein graft segments was 2.5 (SD 0.8). 2070 patients (90.4%) with a total of 5125 saphenous vein graft segments were assessed at one year.

大隐静脉移植段的平均数量为2.5（标准差0.8）。在一年时，共有2070名患者（占90.4%）的5125个大隐静脉移植段接受了评估。

Saphenous vein graft occlusion occurred in 280 of 2596 (10.8%) in the three month DAPT group and 283 of 2529 (11.2%) in the 12 month DAPT group (absolute difference -0.31%, 95% confidence interval(CI) -3.13% to 2.52%; P=0.008 for non-inferiority).

在三个月DAPT组中，2596名患者中有280名（占10.8%）发生了大隐静脉移植闭塞，在十二个月DAPT组中，2529名患者中有283名（占11.2%）发生了大隐静脉移植闭塞（绝对差异-0.31%，95%置信区间（CI）-3.13%至2.52%；P=0.008，用于非劣效性检验）。

During a median follow-up of 368 (interquartile range 358-382) days, BARC type 2, 3, or 5 bleeding occurred in 95 patients (8.3%) in the three month DAPT group and 149 patients (13.2%) in the 12 month DAPT group (absolute difference -4.67%, 95% CI -7.18% to -2.16%; P<0.001).

在中位随访时间为368（四分位数间距358-382）天期间，三月双联抗血小板治疗组中有95名患者（8.3%）发生了BARC 2型、3型或5型出血，而十二月双联抗血小板治疗组中有149名患者（13.2%）发生出血（绝对差异-4.67%，95%置信区间-7.18%至-2.16%；P<0.001）。

The number needed to treat to prevent one bleeding event was 21 (95% CI 13 to 46).

预防一次出血事件所需的治疗人数为21（95%置信区间13至46）。

MACCE occurred in 26 (2.3%) patients in the three month DAPT group and 27 (2.7%) in the 12 month DAPT group (absolute difference -0.11%, 95% CI -1.48% to 1.26%).

在三月双联抗血小板治疗（DAPT）组中有26名（2.3%）患者发生MACCE，在十二月DAPT组中有27名（2.7%）患者发生MACCE（绝对差异-0.11%，95%置信区间-1.48%至1.26%）。

The findings for other secondary outcomes were also similar between the two groups.

两个组别在其他次要结果上的发现也相似。

Conclusions

A three month DAPT strategy was non-inferior to the 12 month DAPT strategy in saphenous vein graft occlusion and was superior in reducing bleeding risk.

在隐静脉移植血管闭塞方面，三个月的双联抗血小板治疗策略不劣于12个月的策略，并且在减少出血风险方面更为优越。

trial_registration

ClinicalTrials.gov NCT05380063.

ClinicalTrials.gov NCT05380063。