Sohn Suk Ho, Kang Yoonjin, Kim Ji Seong, Kang Jeehoon, Hwang Ho Young
Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
PLoS One. 2025 May 8;20(5):e0322176. doi: 10.1371/journal.pone.0322176. eCollection 2025.
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.
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.
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.
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.
本随机对照试验旨在比较冠状动脉旁路移植术中，Y型复合（复合组）与主动脉冠状动脉（主动脉组）构型的非接触式大隐静脉移植物1年的形态学变化。
主要终点是在1年血管造影评估时，通过血管内超声（IVUS）测量的大隐静脉移植物的内膜中层厚度。基于优效性设计，每组需要招募25名患者。在这50名患者中，分别从复合组和主动脉组的22名和24名患者中获得了IVUS数据。
平均年龄为64.8±9.2岁，女性比例为20.0%。复合组和主动脉组每条大隐静脉移植物的远端吻合口数量分别为2.7±1.1和2.6±0.8。术后1年，复合组和主动脉组大隐静脉移植物的内膜中层厚度分别为0.25±0.04mm和0.24±0.06mm（优效性P=0.99）。大隐静脉移植物的其他IVUS参数，包括血管直径、管腔直径以及内膜中层厚度与血管直径的比值，两组之间也无差异。使用IVUS未检测到新内膜增生或斑块形成。所有研究患者均接受了1年的血管造影评估，复合组和主动脉组的通畅率分别为94.7%（94个吻合口中的89个）和100.0%（90个吻合口中的90个）。
术后1年，Y型复合与主动脉冠状动脉构型的大隐静脉移植物内膜中层厚度无显著差异（NCT04782492）。试验注册：ClinicalTrials.gov NCT04782492。
