Abstract：
Previous studies suggested only the radial artery and the No-touch (NT) technique were effective in reducing graft occlusion after coronary artery bypass grafting (CABG) surgery. However, there is no randomized trial comparing these 2 graft conduits. The optimum second conduit for CABG remains undetermined.
This study is a prospective, single-center randomized clinical trial, aiming to compare the graft patency between the radial artery and the NT vein graft. All patients undergoing isolated CABG with left internal mammary artery (LIMA) plus at least 2 additional grafts will be considered eligible. About 774 cases (516 in the radial artery group and 258 in the NT vein group) will be enrolled in over 1 to 2 years. Participants will be randomized and allocated to two bypass strategies: the LIMA plus 1 radial artery and 1 conventional vein graft, or the LIMA plus 2 NT vein grafts. The primary outcome is graft occlusion at 1 year after CABG evaluated by CT angiography. The secondary outcomes include graft occlusion at 3 and 5 years and major adverse cardiac or cerebrovascular events at 1, 3, and 5 years follow-ups.
This study will define whether or not the NT vein has a lower graft occlusion rate than the radial artery in short and mid-term follow-ups, and provide new evidence for the second conduit choice in CABG surgery.
ClinicalTrials.gov NCT06014047. Registered on October 15th, 2023.
This study is a prospective, single-center randomized clinical trial, aiming to compare the graft patency between the radial artery and the NT vein graft. All patients undergoing isolated CABG with left internal mammary artery (LIMA) plus at least 2 additional grafts will be considered eligible. About 774 cases (516 in the radial artery group and 258 in the NT vein group) will be enrolled in over 1 to 2 years. Participants will be randomized and allocated to two bypass strategies: the LIMA plus 1 radial artery and 1 conventional vein graft, or the LIMA plus 2 NT vein grafts. The primary outcome is graft occlusion at 1 year after CABG evaluated by CT angiography. The secondary outcomes include graft occlusion at 3 and 5 years and major adverse cardiac or cerebrovascular events at 1, 3, and 5 years follow-ups.
This study will define whether or not the NT vein has a lower graft occlusion rate than the radial artery in short and mid-term follow-ups, and provide new evidence for the second conduit choice in CABG surgery.
ClinicalTrials.gov NCT06014047. Registered on October 15th, 2023.
摘要：
背景：先前的研究表明，只有桡动脉和无接触（NT）技术可有效减少冠状动脉旁路移植术（CABG）手术后的移植物闭塞。然而,没有随机试验比较这两种移植导管.CABG的最佳第二导管仍未确定。
方法：本研究是前瞻性的，单中心随机临床试验，旨在比较桡动脉和NT静脉移植物之间的移植物通畅性。所有接受具有左乳内动脉（LIMA）加至少两个额外移植物的孤立CABG的患者将被认为是合格的。将在1至2年内纳入774例（桡动脉组516例，NT静脉组258例）。参与者将被随机分配到两种旁路策略：LIMA加一个桡动脉和一个常规静脉移植物，或LIMA加两个NT静脉移植物。主要结果是通过CT血管造影评估CABG后1年的移植物闭塞。次要结果包括3年和5年的移植物闭塞以及1年、3年和5年随访时的主要不良心脏或脑血管事件。
结论：本研究将确定在短期和中期随访中，NT静脉的移植物闭塞率是否低于桡动脉，为CABG手术的第二导管选择提供新的证据。
背景：ClinicalTrials.govNCT06014047。10月15日注册,2023年。
方法：本研究是前瞻性的，单中心随机临床试验，旨在比较桡动脉和NT静脉移植物之间的移植物通畅性。所有接受具有左乳内动脉（LIMA）加至少两个额外移植物的孤立CABG的患者将被认为是合格的。将在1至2年内纳入774例（桡动脉组516例，NT静脉组258例）。参与者将被随机分配到两种旁路策略：LIMA加一个桡动脉和一个常规静脉移植物，或LIMA加两个NT静脉移植物。主要结果是通过CT血管造影评估CABG后1年的移植物闭塞。次要结果包括3年和5年的移植物闭塞以及1年、3年和5年随访时的主要不良心脏或脑血管事件。
结论：本研究将确定在短期和中期随访中，NT静脉的移植物闭塞率是否低于桡动脉，为CABG手术的第二导管选择提供新的证据。
背景：ClinicalTrials.govNCT06014047。10月15日注册,2023年。
