Morphologic changes of the no-touch saphenous vein as Y-composite versus aortocoronary grafts (CONFIG Trial)

Abstract

Objective This randomized controlled trial was aimed to compare 1-year morphologic changes of the no-touch saphenous vein graft as Y-composite (Composite group) versus aortocoronary (Aorta group) configurations in coronary artery bypass grafting. Methods The primary endpoint was intima-media thickness of the saphenous vein graft as measured by intravascular ultrasound (IVUS) at the 1-year angiographic evaluation. Recruitment of 25 patients in each group was necessary based on a superiority design. Among the 50 patients, IVUS data were obtained in 22 and 24 patients from the Composite and Aorta groups, respectively. Results Mean age was 64.8 ± 9.2 years, and the proportion of females was 20.0%. The numbers of distal anastomoses per saphenous vein graft were 2.7 ± 1.1 and 2.6 ± 0.8 in the Composite and Aorta groups, respectively. The intima-media thickness of the saphenous vein graft 1 year after surgery were 0.25 ± 0.04 mm and 0.24 ± 0.06 mm in the Composite and Aorta groups, respectively (P for superiority = .99). Other IVUS parameters of saphenous vein grafts, including vessel diameter, luminal diameter, and the ratio of intima-media thickness to vessel diameter, also demonstrated no differences between the groups. No neointimal hyperplasia or plaque formation was detected using IVUS. All study patients underwent 1-year angiographic evaluation, and the patency rates were 94.7%(89 out of 94 anastomoses) and 100.0%(90 out of 90 anastomoses) in the Composite and Aorta groups, respectively. Conclusions The intima-media thickness of the saphenous vein graft 1 year after surgery demonstrated no significant difference between the Y-composite and aortocoronary configurations (NCT04782492). Trial Registration: ClinicalTrials.gov NCT04782492.