Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.
(Clinical Trial, Phase III;Journal Article;Multicenter Study)
IMPORTANCE: In 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. OBJECTIVE: To evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery. DESIGN, SETTING, AND PARTICIPANTS: Data 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. INTERVENTIONS: Preservation of vein grafts in saline, blood, or buffered saline solutions. MAIN OUTCOMES AND MEASURES: One-year angiographic VGF and 5-year rates of death, myocardial infarction, and subsequent revascularization. RESULTS: Most 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 RELEVANCE: Patients 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 REGISTRATION: clinicaltrials.gov Identifier: NCT00042081.
Harskamp, RE; Alexander, JH; Schulte, PJ; Brophy, CM; Mack, MJ; Peterson, ED; Williams, JB; Gibson, CM; Califf, RM; Kouchoukos, NT; Harrington, RA; Ferguson, TB; Lopes, RD
Volume / Issue
Start / End Page
Pubmed Central ID
Electronic International Standard Serial Number (EISSN)
Digital Object Identifier (DOI)