No-touch Harvesting in Off-pump Coronary Artery Bypass Grafting With Sequential Saphenous Vein Graft: A Single-center Prospective Randomized Controlled Trial

Abstract

Background: Coronary artery bypass grafting (CABG) materials comprise the combination of the left internal mammary artery and saphenous vein. The patency rate of vein grafts is considered not ideal; more studies support that the no-touch (NT) procedure can improve the patency rate of vein grafts. However, it is not clear that the NT technology is used in the sequential saphenous vein grafting during off-pump coronary artery bypass surgery. This study explored whether the NT technique is safety and efficacy compared to the conventional manner in the off-pump coronary artery bypass surgery using sequential vein graft.Methods: This was a prospective single-center randomized controlled clinical trial. A total of 200 patients undergoing off-pump coronary artery bypass grafting in the sequential saphenous graft were randomly assigned to two groups: The no-touch(NT) and the conventional (CON) groups. Perioperative and postoperative data were collected prospectively during the hospital stay. The occlusion of sequential grafts was measured by cardiac computed tomography angiography (CCTA) 3-months post CABG. Leg wound complications were followed up. The mean diameter of sequential grafts for the first 100 patients was measured using CCTA, 3-months after the operation.Results: The primary endpoint was that there was no difference in occlusion of sequential venous grafts between the two groups (NT: 9/180 (4.4%), CON: 5/194 (1.5%), p=0.22). Similarly, there were no differences in composite clinical events (NT: 2/91 (2.2%), CON: 1/96 (1.0%), p=0.96). There was no difference in the leg wound complications between the two groups (NT: 8/91 (8.8%), CON: 4/96 (4.2%), p=0.20). However, there was a significant difference in the average diameter of sequential grafts between the two groups (NT: (2.98±0.42), CON: (3.26±0.51), p=0.005).Conclusions: The early clinical results suggest that the NT technique is safety and efficacy compared to the conventional technique in sequential grafting in off-pump coronary artery bypass surgery. The sequential grafts early expansion in the NT technique is not as pronounced as the conventional technique, which may have a long-term protective effect on the grafts.Trial Registration: Registered 1 November 2018, ClinicalTrials.gov NCT03729531, http://www.clinicaltrials.gov