Abfalterer Hannes, Ruttmann-Ulmer Elfriede, Grimm Michael, Feuchtner Gudrun, Maier Sarah, Ulmer Hanno, Sandner Sigrid, Zimpfer Daniel, Doenst Torsten, Czerny Martin, Thielmann Matthias, Böning Andreas, Gaudino Mario, Siepe Matthias, Bonaros Nikolaos
Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria.
Interdiscip Cardiovasc Thorac Surg. 2024 Mar 29;38(4). doi: 10.1093/icvts/ivae045.
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.
最新研究表明，对左胸廓内动脉进行骨骼化处理可能会对移植物通畅率和临床结果产生不良影响。我们旨在开展一项前瞻性、随机、多中心试验，比较左胸廓内动脉骨骼化与带蒂获取技术在移植物通畅率和患者生存率方面的差异。总共1350例患者将被随机分为骨骼化或带蒂获取技术组，并接受手术血运重建。术后30天、1年、2年和5年进行随访。主要结局将是术后2年（±3个月）内冠状动脉计算机断层扫描血管造影或有创血管造影中出现死亡或左胸廓内动脉移植物闭塞。次要结局将是术后1年、2年和5年内的主要不良心脏事件（全因死亡、心肌梗死和再次血运重建的综合结局）。两个治疗组之间的主要终点将在改良意向性治疗人群中使用Kaplan-Meier曲线以及对数秩检验进行比较。在此，我们展示了第一项有足够效力的前瞻性、随机、多中心试验的研究方案，该试验比较了左胸廓内动脉骨骼化和带蒂获取技术在移植物通畅率和患者生存率方面的差异。
