Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
J Thorac Cardiovasc Surg. 2010 Feb;139(2):294-301, 301.e1. doi: 10.1016/j.jtcvs.2009.09.048. Epub 2009 Dec 16.
This trial aimed to determine whether intraoperative graft assessment with criteria for graft revision would decrease the proportion of patients with 1 or more graft occlusions or stenoses or major adverse cardiac events 1 year after coronary artery bypass grafting.
A single-center, randomized, single-blinded, controlled clinical trial was designed. Patients were randomized to either of 2 groups: intraoperative graft patency assessment using indocyanine-green fluorescent angiography and transit-time flowmetry, with graft revision according to a priori criteria (imaging group), or standard intraoperative management (control group). Patients underwent follow-up angiography at 1 year.
Between September 2005 and August 2008, 156 patients undergoing isolated coronary bypass grafting were enrolled (imaging, n = 78; control, n = 78). Demographic and angiographic characteristics were similar between groups. Operative, crossclamp, and cardiopulmonary bypass times were all nonsignificantly longer in the imaging arm. The number of grafts per patients was similar (imaging, 3.0 +/- 0.7; control, 3.0 +/- 0.7). The frequency of major adverse cardiac events (death, myocardial infarction, repeat revascularization) was not different between groups at 1 year postoperatively (imaging, 7.7%; control, 7.7%). One-year angiography was performed in 107 patients (imaging, 55 patients/160 grafts; control, 52 patients/152 grafts). The proportion of patients with 1 graft occlusion or more was comparable in the imaging (30.9%) and control (28.9%) groups (relative risk [95% confidence interval], 1.1 [0.6-1.9]; P = .82), as were other graft patency end points. The incidence of saphenous vein graft occlusion was high in both groups.
Routine intraoperative graft assessment is safe but does not lead to a marked reduction in graft occlusion 1-year after bypass grafting. The incidence of saphenous vein graft failure remains high despite contemporary practice and routine intraoperative graft surveillance.
本试验旨在确定术中使用移植修正标准评估移植物是否会降低冠状动脉旁路移植术后 1 年发生 1 处或多处移植物闭塞或狭窄或主要不良心脏事件的患者比例。
设计了一项单中心、随机、单盲、对照临床试验。患者被随机分为两组：使用吲哚菁绿荧光血管造影和渡越时间血流测量术进行术中移植物通畅性评估，并根据预设标准进行移植物修正（成像组），或进行标准术中管理（对照组）。患者在 1 年后进行随访血管造影。
2005 年 9 月至 2008 年 8 月期间，共纳入 156 例接受单纯冠状动脉旁路移植术的患者（成像组，n = 78；对照组，n = 78）。两组患者的人口统计学和血管造影特征相似。成像组的手术、体外循环和心肺转流时间均无显著延长。每位患者的移植数量相似（成像组，3.0 ± 0.7；对照组，3.0 ± 0.7）。主要不良心脏事件（死亡、心肌梗死、再次血运重建）的发生率在术后 1 年时两组间无差异（成像组，7.7%；对照组，7.7%）。107 例患者（成像组，55 例/160 个移植物；对照组，52 例/152 个移植物）进行了 1 年的血管造影检查。成像组和对照组中，1 个或多个移植物闭塞的患者比例相似（成像组，30.9%；对照组，28.9%）（相对风险[95%置信区间]，1.1[0.6-1.9]；P =.82），其他移植物通畅终点也相似。两组的大隐静脉移植闭塞发生率均较高。
常规术中移植物评估是安全的，但不能显著降低旁路移植术后 1 年的移植物闭塞发生率。尽管采用了当代实践和常规术中移植物监测，但大隐静脉移植失败的发生率仍然很高。
