Xin Yuan, Jingkuo Li, Lubi Lei, Lihua Zhang, Kai Chen, Qing Chu, W E I Feng, Xianqiang Wang, Xin Wang, Fei Xu, S L Liu, Yan Yang, Xiaoqi Wang, Huishan Wang, Aiqiang Dong, Zhaoyun Cheng, Huiming Guo, Tingwen Zhou, X Chen, Jianjun Ge, Liang Zhang, S L Liu, Zhenya Shen, Yi-Xiang Wang, Yuxing Wang, Wenhua Li, Hu S
OBJECTIVES: To evaluate the efficacy of dual antiplatelet therapy (DAPT) for three months versus 12 months in saphenous vein graft occlusion while reducing bleeding risk. DESIGN: Multicentre, non-inferiority, double blind, randomised controlled trial. SETTING: 13 cardiac surgery centres in China, with enrolment between February 2023 and July 2024. PARTICIPANTS: 2300 participants aged 18 to 80 years who underwent elective primary coronary artery bypass grafting with ≥1 saphenous vein graft. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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). Secondary outcomes were major adverse cardiovascular events (MACCE), saphenous vein graft failure, venous or arterial graft stenosis, and venous or arterial graft occlusion. 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-treat set. 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. 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). 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). The number needed to treat to prevent one bleeding event was 21 (95% CI 13 to 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%). The findings for other secondary outcomes were also similar between the two groups. 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05380063.