Marco A Zenati1, Deepak L Bhatt1, Faisal G Bakaeen1, Eileen M Stock1, Kousick Biswas1, J Michael Gaziano1, Rosemary F Kelly1, Elaine E Tseng1, Jerene Bitondo1, Jacquelyn A Quin1, G Hossein Almassi1, Miguel Haime1, Brack Hattler1, Ellen DeMatt1, Alexandra Scrymgeour1, Grant D Huang1. 1. From the Divisions of Cardiac Surgery (M.A.Z., J.A.Q., M.H.) and Cardiology (D.L.B., J.M.G.), Veterans Affairs (VA) Boston Healthcare System and Harvard Medical School, the Department of Surgery, Brigham and Women's Hospital and Harvard Medical School (M.A.Z., J.A.Q., M.H.), Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B.), and Massachusetts General Hospital (J.B.) - all in Boston; the Departments of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland (F.G.B.); the VA Pittsburgh Healthcare System, Pittsburgh (F.G.B.); the Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD (E.M.S., K.B., E.D.); Minneapolis VA Medical Center and University of Minnesota, Minneapolis (R.F.K.); San Francisco VA Medical Center and University of California, San Francisco, San Francisco (E.E.T.); Zablocki VA Medical Center and Medical College of Wisconsin, Milwaukee (G.H.A.); VA Eastern Colorado Healthcare System, Denver (B.H.); the Cooperative Studies Program Pharmacy Coordinating Center, Department of Veterans Affairs, Albuquerque, NM (A.S.); and the Cooperative Studies Program Central Office, Office of Research and Development, Department of Veterans Affairs, Washington, DC (G.D.H.).
Abstract
BACKGROUND: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized. METHODS: We randomly assigned patients undergoing CABGat 16 Veterans Affairs cardiac surgery centers to eitheropen or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated. RESULTS: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15). CONCLUSIONS: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .).
RCT Entities:
BACKGROUND: The saphenous-vein graft is the most common conduit for coronary-artery bypass grafting (CABG). The influence of the vein-graft harvesting technique on long-term clinical outcomes has not been well characterized. METHODS: We randomly assigned patients undergoing CABG at 16 Veterans Affairs cardiac surgery centers to either open or endoscopic vein-graft harvesting. The primary outcome was a composite of major adverse cardiac events, including death from any cause, nonfatal myocardial infarction, and repeat revascularization. Leg-wound complications were also evaluated. RESULTS: A total of 1150 patients underwent randomization. Over a median follow-up of 2.78 years, the primary outcome occurred in 89 patients (15.5%) in the open-harvest group and 80 patients (13.9%) in the endoscopic-harvest group (hazard ratio, 1.12; 95% confidence interval [CI], 0.83 to 1.51; P=0.47). A total of 46 patients (8.0%) in the open-harvest group and 37 patients (6.4%) in the endoscopic-harvest group died (hazard ratio, 1.25; 95% CI, 0.81 to 1.92); myocardial infarctions occurred in 34 patients (5.9%) in the open-harvest group and 27 patients (4.7%) in the endoscopic-harvest group (hazard ratio, 1.27; 95% CI, 0.77 to 2.11), and revascularization occurred in 35 patients (6.1%) in the open-harvest group and 31 patients (5.4%) in the endoscopic-harvest group (hazard ratio, 1.14; 95% CI, 0.70 to 1.85). Leg-wound infections occurred in 18 patients (3.1%) in the open-harvest group and in 8 patients (1.4%) in the endoscopic-harvest group (relative risk, 2.26; 95% CI, 0.99 to 5.15). CONCLUSIONS: Among patients undergoing CABG, we did not find a significant difference between open vein-graft harvesting and endoscopic vein-graft harvesting in the risk of major adverse cardiac events. (Funded by the Cooperative Studies Program, Office of Research and Development, Department of Veterans Affairs; REGROUP ClinicalTrials.gov number, NCT01850082 .).
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