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.Materials and Methods:
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.Results:
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).Conclusions:
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.