Choice of Vein‐Harvest Technique for Coronary Artery Bypass Grafting: Rationale and Design of the REGROUP Trial |
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| Authors: | Marco A. Zenati MD MSc J. Michael Gaziano MD MPH Joseph F. Collins ScD Kousick Biswas PhD Jennifer M. Gabany MSN CRNP CCRC Jacquelyn A. Quin MD MPH Jerene M. Bitondo PA‐C Faisal G. Bakaeen MD Rosemary F. Kelly MD A. Laurie Shroyer PhD Deepak L. Bhatt MD MPH |
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| Affiliation: | 1. Division of Cardiothoracic Surgery, Surgical Service, Veterans Affairs Boston Healthcare System;2. Department of Surgery, Harvard Medical School, Boston, Massachusetts;3. MAVERIC, Veterans Affairs Boston Healthcare System;4. Department of Medicine, Brigham and Women's Hospital, harvard Medical School, Boston, Massachusetts;5. Veterans Affairs Cooperative Studies Program Coordinating Center, Perry Point, Maryland;6. Division of Cardiac Surgery, Massachusetts General Hospital, Boston, Massachusetts;7. Division of Cardiac Surgery, Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas;8. Division of Cardiac Surgery, Minneapolis Veterans Affairs Medical Center and University of Minnesota, Minneapolis, Minnesota;9. Northport Veterans Affairs Medical Center, Northport, New York, and Department of Surgery, Stony Brook University School of Medicine, Stony Brook, New York;10. Division of Cardiology, Veterans Affairs Boston Healthcare System, and Heart & Vascular Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts |
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| Abstract: | 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. Enrolled subjects (planned N = 1150) will be randomized to 1 of the 2 arms (EVH or OVH) after an experienced vein harvester has been assigned. The primary outcomes measure is the rate of major adverse cardiac events (MACE), including death, myocardial infarction, or revascularization. Subject assessments will be performed at multiple times, including at baseline, intraoperatively, postoperatively, and at discharge (or 30 days after surgery, if still hospitalized). Assessment of leg‐wound complications will be completed at 6 weeks after surgery. 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. |
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