{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Xin Yuan"
    },
    {
      "affiliations": [
        "National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Jingkuo Li"
    },
    {
      "affiliations": [
        "National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Lubi Lei"
    },
    {
      "affiliations": [
        "National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Lihua Zhang"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Kai Chen"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Qing Chu"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Wei Feng"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Xianqiang Wang"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Xin Wang"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Fei Xu"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Sheng Liu"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Yan Yang"
    },
    {
      "affiliations": [
        "Yunnan Fuwai Cardiovascular Hospital, Kunming City, Yunnan Province, China"
      ],
      "name": "Xiaoqi Wang"
    },
    {
      "affiliations": [
        "General Hospital of Northern Theatre Command, Shenyang City, Liaoning Province, China"
      ],
      "name": "Huishan Wang"
    },
    {
      "affiliations": [
        "The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou City, Zhejiang Province, China"
      ],
      "name": "Aiqiang Dong"
    },
    {
      "affiliations": [
        "Fuwai Central China Cardiovascular Hospital, Zhengzhou City, Henan Province, China"
      ],
      "name": "Zhaoyun Cheng"
    },
    {
      "affiliations": [
        "Guangdong Provincial People’s Hospital, Guangzhou City, Guangdong Province, China"
      ],
      "name": "Huiming Guo"
    },
    {
      "affiliations": [
        "Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan City, Hubei Province, China"
      ],
      "name": "Tingwen Zhou"
    },
    {
      "affiliations": [
        "Nanjing First Hospital, Nanjing Medical University, Nanjing City, Jiangsu Province, China"
      ],
      "name": "Xin Chen"
    },
    {
      "affiliations": [
        "The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei City, Anhui Province, China"
      ],
      "name": "Jianjun Ge"
    },
    {
      "affiliations": [
        "Anhui Provincial Chest Hospital, Hefei City, Anhui Province, China"
      ],
      "name": "Liang Zhang"
    },
    {
      "affiliations": [
        "The Second Hospital of Hebei Medical University, Shijiazhuang City, Hebei Province, China"
      ],
      "name": "Su Liu"
    },
    {
      "affiliations": [
        "The First Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China"
      ],
      "name": "Zhenya Shen"
    },
    {
      "affiliations": [
        "The First Affiliated Hospital of Wenzhou Medical University, Wenzhou City, Zhejiang Province, China"
      ],
      "name": "Jue Wang"
    },
    {
      "affiliations": [
        "Medical Research and Biometrics Centre, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Yang Wang"
    },
    {
      "affiliations": [
        "National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China",
        "Medical Research and Biometrics Centre, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Wei Li"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China",
        "National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, National Centre for Cardiovascular Diseases, Beijing, China"
      ],
      "name": "Shengshou Hu"
    },
    {
      "affiliations": [],
      "name": "on behalf of the TOP-CABG Collaborative Group"
    }
  ],
  "title": "Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial",
  "uid": "25f75a52-4ce9-5aee-a71d-a7bf9e38e9ea"
}