Three-month dual antiplatelet treatment versus twelve-month dual antiplatelet treatment after coronary artery bypass grafting: A multicentre, double-blinded, randomised controlled trial

Objective: To evaluate whether 3-month dual antiplatelet therapy (DAPT) preserves the efficacy of the 12-month treatment in saphenous vein graft occlusion while reducing the associated bleeding risk. Design: Multicentre, non-inferiority, double-blind, randomised controlled trial. Setting: Thirteen cardiac surgery centres in China; 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 3 months, followed by ticagrelor placebo plus aspirin for the next 9 months. Main Outcomes and Measures: The primary outcomes were one-year saphenous vein graft occlusion (non-inferiority) and Bleeding Academic Research Consortium [BARC] type 2, 3, or 5 bleeding (superiority). The secondary outcome included major adverse cardiovascular events (MACCE), saphenous vein graft failure, venous or arterial graft stenosis, and venous or arterial graft occlusion. Results: 2290 patients (mean [SD] age 61.46 ± 8.37 years, 20.61% women) were included in the modified intention-to-treat set. The mean number of saphenous vein graft segments was 2.48 ± 0.76. A total of 2070 patients (90.39%) with a total of 5125 saphenous vein graft segments were assessed at one year. Saphenous vein graft occlusion occurred in 280 of 2596 (10.79%) in the 3-month DAPT group and 283 of 2529 (11.19%) in the 12-month DAPT group (absolute difference -0.31%, 95% CI -3.13 to 2.52; P for non-inferiority = 0.008). During a median follow-up of 368 [IQR 358-382] days, BARC type 2, 3, or 5 bleeding occurred in 95 patients (8.26%) treated with 3-month DAPT and 149 patients (13.19%) treated with 12-month DAPT (absolute difference -4.67%, 95%CI -7.18 to -2.16; P < 0.001). Numbers needed-to-treat were 21 (95% CI 13 to 46) to prevent one bleeding event. MACCE occurred in 26 (2.27%) patients in the 3-month DAPT group and 27 (2.67%) patients in the 12-month DAPT group (absolute difference -0.11%, 95% CI -1.48 to 1.26). Other secondary outcomes were also similar between groups. Conclusions and Relevance: The 3-month DAPT strategy was non-inferior to 12-month DAPT in saphenous vein graft occlusion and superior in reducing bleeding risk. Trial Registration: ClinicalTrials.gov Identifier: NCT05380063.