Three-month DAPT was non-inferior to 12-month DAPT for saphenous vein graft occlusion (10.8% vs 11.2%; P=0.008 for non-inferiority) and superior for reducing BARC 2, 3, or 5 bleeding.
RCT (n=2,300)
Double-blind
1:1
Yes
Does a 3-month dual antiplatelet therapy strategy reduce bleeding without increasing saphenous vein graft occlusion compared to a 12-month strategy in patients undergoing elective coronary artery bypass grafting?
Shortening dual antiplatelet therapy to 3 months after coronary artery bypass grafting significantly reduces bleeding risk without compromising saphenous vein graft patency compared to 12 months of therapy.
Effect estimate: Absolute difference -0.31% (95% CI -3.13% to 2.52%)
Absolute Event Rate: 10.8% vs 11.2%
p-value: p=0.008 for non-inferiority
Abstract 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 .
Yuan et al. (Tue,) conducted a rct in coronary artery bypass grafting (n=2,300). 3-month DAPT vs. 12-month DAPT was evaluated on saphenous vein graft occlusion at one year (Absolute difference -0.31%, 95% CI -3.13% to 2.52%, p=0.008 for non-inferiority). Three-month DAPT was non-inferior to 12-month DAPT for saphenous vein graft occlusion (10.8% vs 11.2%; P=0.008 for non-inferiority) and superior for reducing BARC 2, 3, or 5 bleeding.