*Research Center of the Centre Hospitalier de l'Université de Montréal (CRCHUM) †Division of Cardiac Surgery ‡Department of Radiology §Division of Cardiology, Centre Hospitalier de l'Université de Montréal, Montreal, QC ∥Division of Cardiac Surgery, McMaster University #Population Health Research Institute (PHRI), Hamilton Health Sciences, Hamilton, ON ¶University of Calgary, Calgary, AB, Canada.
J Thorac Imaging. 2017 Nov;32(6):370-377. doi: 10.1097/RTI.0000000000000277.
A large multicenter randomized trial (RCT) is needed to assess off-pump coronary artery bypass graft (CABG) patency when performed by skilled surgeons. This prospective multicenter randomized pilot study compares graft patency after on-pump and off-pump techniques and addresses the feasibility of such an RCT.
Consecutive patients were prospectively recruited for ≥64-slice computed tomography angiography graft patency assessment 1 year after randomization to off-pump or on-pump CABG. Blinded assessment of graft patency was performed, and the results were categorized as normal, ≥50% stenosis, or occlusion. A multilevel model with random effects on the patient was used to account for correlation of results in patients with multiple grafts.
A total of 157 patients (3 centers, 84 off-pump and 73 on-pump patients, 512 grafts, assessability rate 98.4%) were included. Patency index (% nonoccluded grafts) was 89% for the off-pump technique and 95% for the on-pump technique (P=0.09). Patency was similar for arterial and vein grafts (both 92%; P=0.88), as well as between target territories (89% to 94%; P=0.53).
In this pilot study, 1-year graft patency results after off-pump and on-pump surgery were similar. This feasibility trial demonstrates that a large multicenter RCT to compare CABG patency after on-pump with that after off-pump techniques is feasible and can be reliably undertaken using computed tomography angiography.
需要一项大型多中心随机试验（RCT）来评估由熟练外科医生进行的非体外循环冠状动脉旁路移植术（CABG）的通畅性。这项前瞻性多中心随机试验研究比较了体外循环和非体外循环技术后的吻合口通畅性，并解决了进行此类 RCT 的可行性问题。
连续患者前瞻性招募≥64 层计算机断层血管造影术（CTA）吻合口通畅性评估，随机分为非体外循环或体外循环 CABG 后 1 年。对吻合口通畅性进行盲法评估，并将结果分为正常、≥50%狭窄或闭塞。使用具有患者随机效应的多级模型来解释具有多个吻合口的患者结果的相关性。
共纳入 157 例患者（3 个中心，84 例非体外循环和 73 例体外循环患者，512 个吻合口，可评估率 98.4%）。非体外循环技术的通畅指数（%无闭塞吻合口）为 89%，体外循环技术为 95%（P=0.09）。动脉和静脉吻合口的通畅性相似（均为 92%；P=0.88），以及靶区之间的通畅性相似（89%至 94%；P=0.53）。
在这项初步研究中，非体外循环和体外循环手术后 1 年的吻合口通畅性结果相似。这项可行性试验表明，一项比较体外循环与非体外循环技术后 CABG 通畅性的大型多中心 RCT 是可行的，并且可以使用 CTA 可靠地进行。
