Randomized comparison of HARVesting the Left Internal Thoracic Artery in a skeletonized versus pedicled technique: the HARVITA trial-study protocol.

ABSTRACT

Latest research has indicated a potential adverse effect on graft patency rates and clinical outcomes with skeletonizing the left internal thoracic artery. We aim to provide a prospective, randomized, multicentre trial to compare skeletonized versus pedicled harvesting technique of left internal thoracic artery concerning graft patency rates and patient survival. A total of 1350 patients will be randomized to either skeletonized or pedicled harvesting technique and undergo surgical revascularization. Follow-up will be performed at 30 days, 1 year, 2 years and 5 years after surgery. The primary outcome will be death or left internal thoracic artery graft occlusion in coronary computed tomography angiography or invasive angiography within 2 years (+/- 3 months) after surgery. The secondary outcome will be major adverse cardiac events (composite outcome of all-cause death, myocardial infarction and repeated revascularization) within 1 year, 2 years and 5 years after surgery. The primary end point will be compared in the modified intention-to-treat population between the two treatment groups using Kaplan-Meier graphs, together with log-rank testing. Hereby, we present the study protocol of the first adequately powered prospective, randomized, multicentre trial which compares skeletonized and pedicled harvesting technique of left internal thoracic artery regarding graft patency rates and patient survival.