Rationale and design of a multicenter randomized trial to compare the graft patency between no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery

Background Vein graft failure is a crucial challenge in coronary artery bypass graft (CABG) surgery. Previous studies have suggested a patency benefit of the No-Touch vein harvesting technique, but only with small sample sizes. Materials and methods This study is a prospective, multicenter randomized clinical trial with a large sample size, aiming to investigate the efficacy of the No-Touch technique compared with the conventional approach. All patients requiring isolated CABG with left internal mammary artery plus at least one saphenous vein graft will be considered for entry into the study. Two thousand cases (1000 in each arm) will be enrolled over 1 to 2 years in 7 hospitals in China. Participants will be randomized in equal proportions between two surgical strategies: the No-Touch or conventional technique. The primary endpoint is graft vessel occlusion at 3 months after CABG surgery by CT coronary angiography. Secondary outcomes are major adverse cardiac or cerebrovascular events at 3 and 12 months post-operation and graft vessel occlusion at 1 year. Discussion This study will define the role of the No-Touch vein harvesting technique in CABG surgery and provide strong evidence to answer whether this technique could reduce vein graft occlusion.