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Randomized Controlled Trial Multicenter Study Comparative Study
Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.
- Ralf E Harskamp, John H Alexander, Phillip J Schulte, Colleen M Brophy, Michael J Mack, Eric D Peterson, Judson B Williams, C Michael Gibson, Robert M Califf, Nicholas T Kouchoukos, Robert A Harrington, T Bruce Ferguson, and Renato D Lopes.
- Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina2Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
- JAMA Surg. 2014 Aug 1;149(8):798-805.
ImportanceIn vitro and animal model data suggest that intraoperative preservation solutions may influence endothelial function and vein graft failure (VGF) after coronary artery bypass graft (CABG) surgery. Clinical studies to validate these findings are lacking.ObjectiveTo evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery.Design, Setting, And ParticipantsData from the Project of Ex-Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) study, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that enrolled 3014 patients at 107 US sites from August 1, 2002, through October 22, 2003, were used. Eligibility criteria for the trial included CABG surgery for coronary artery disease with at least 2 planned vein grafts.InterventionsPreservation of vein grafts in saline, blood, or buffered saline solutions.Main Outcomes And MeasuresOne-year angiographic VGF and 5-year rates of death, myocardial infarction, and subsequent revascularization.ResultsMost patients had grafts preserved in saline (1339 [44.4%]), followed by blood (971 [32.2%]) and buffered saline (507 [16.8%]). Baseline characteristics were similar among groups. One-year VGF rates were much lower in the buffered saline group than in the saline group (patient-level odds ratio [OR], 0.59 [95% CI, 0.45-0.78; P < .001]; graft-level OR, 0.63 [95% CI, 0.49-0.79; P < .001]) or the blood group (patient-level OR, 0.62 [95% CI, 0.46-0.83; P = .001]; graft-level OR, 0.63 [95% CI, 0.48-0.81; P < .001]). Use of buffered saline solution also tended to be associated with a lower 5-year risk for death, myocardial infarction, or subsequent revascularization compared with saline (hazard ratio, 0.81 [95% CI, 0.64-1.02; P = .08]) and blood (0.81 [0.63-1.03; P = .09]) solutions.Conclusions And RelevancePatients undergoing CABG whose vein grafts were preserved in a buffered saline solution had lower VGF rates and trends toward better long-term clinical outcomes compared with patients whose grafts were preserved in saline- or blood-based solutions.Trial Registrationclinicaltrials.gov Identifier: NCT00042081.
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