Clinical cardiology
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Clinical cardiology · Jun 2014
Randomized Controlled Trial Multicenter StudyChoice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial.
The Randomized Endo-vein Graft Prospective (REGROUP) trial (ClinicalTrials.gov NCT01850082) is a randomized, intent-to-treat, 2-arm, parallel-design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre-established inclusion/exclusion criteria. ⋯ Telephone follow-ups will occur at 3-month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long-term outcomes, centralized follow-up of MACE for 2 additional years will be centrally performed using VA and non-VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration.