Major Leg Wound Complications between the Proximal and Distal Segments of Saphenous Veins Harvested by No-Touch Technique in Coronary Artery Bypass Graft Surgery: study protocol for a single-center randomized within-subject controlled clinical trial

Background : The No-Touch saphenous vein harvesting technique has been proved to reduce vein graft occlusion after coronary artery bypass graft surgery. However, the optimum segment of the saphenous vein for this technique is still undetermined. Previous studies implicated lower occlusion of proximal segments of saphenous veins compared to distal segments, but with concern of higher leg wound complications. No randomized trials have been carried out accordingly. This pilot study is a single-center randomized within-subject-controlled tria l, comparing the leg wound complications of proximal segments of saphenous veins harvested by No-Touch versus distal segments. Methods : The study is planning intending to enroll 100 coronary artery bypass graft surgery patients from our institution, with each patient requiring two vein grafts with or without cardiopulmonary bypass. Both proximal and distal segments of saphenous veins will be harvested by No-Touch technique from ipsilateral legs. The proximal vein segments will be randomized to the left or right coronary territory for bypassing. The primary endpoint is major leg wound complications at 6 days postoperatively. Secondary endpoints include major leg wound complications during 3-month follow-up and graft vessel occlusion at 3 months and 1 year. Clinical events include major adverse cardiac or cerebrovascular events and recurrence of angina Discussion : This is the first study assessing the safety and effectiveness between different segments of No-Touch saphenous veins for coronary artery bypass graft surgery, and will help to establish preliminary evidence for decision making of precise vein graft conduit choice. Trial registration : ClinicalTrials.gov: NCT04284956