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Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.

ABSTRACT: 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.To evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery.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.Preservation of vein grafts in saline, blood, or buffered saline solutions.One-year angiographic VGF and 5-year rates of death, myocardial infarction, and subsequent revascularization.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?

SUBMITTER: Harskamp RE

PROVIDER: S-EPMC4332522 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.

Harskamp Ralf E RE Alexander John H JH Schulte Phillip J PJ Brophy Colleen M CM Mack Michael J MJ Peterson Eric D ED Williams Judson B JB Gibson C Michael CM Califf Robert M RM Kouchoukos Nicholas T NT Harrington Robert A RA Ferguson T Bruce TB Lopes Renato D RD

JAMA surgery 20140801 8

<h4>Importance</h4>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.<h4>Objective</h4>To evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery.<h4>Design, setting, and participants</h4>Data from the Project of Ex-Vivo Vein Graft ...[more]

PMID: 25073921

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Project description:BackgroundCoronary artery bypass grafting success is limited by vein graft failure (VGF). Understanding the factors associated with VGF may improve patient outcomes.Methods and resultsWe examined 1828 participants in the Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) trial undergoing protocol-mandated follow-up angiography 12 to 18 months post-coronary artery bypass grafting or earlier clinically driven angiography. Outcomes included patient- and graft-level angiographic VGF (≥75% stenosis or occlusion). Variables were selected by using Fast False Selection Rate methodology. We examined relationships between variables and VGF in patient- and graft-level models by using logistic regression without and with generalized estimating equations. At 12 to 18 months post-coronary artery bypass grafting, 782 of 1828 (42.8%) patients had VGF, and 1096 of 4343 (25.2%) vein grafts had failed. Demographic and clinical characteristics were similar between patients with and without VGF, although VGF patients had longer surgical times, worse target artery quality, longer graft length, and they more frequently underwent endoscopic vein harvesting. After multivariable adjustment, longer surgical duration (odds ratio per 10-minute increase, 1.05; 95% confidence interval, 1.03-1.07), endoscopic vein harvesting (odds ratio, 1.41; 95% confidence interval, 1.16-1.71), poor target artery quality (odds ratio, 1.43; 95% confidence interval, 1.11-1.84), and postoperative use of clopidogrel or ticlopidine (odds ratio, 1.35; 95% confidence interval, 1.07-1.69) were associated with patient-level VGF. The predicted likelihood of VGF in the graft-level model ranged from 12.1% to 63.6%.ConclusionsVGF is common and associated with patient and surgical factors. These findings may help identify patients with risk factors for VGF and inform the development of interventions to reduce VGF.Clinical trial registration urlhttp://www.clinicaltrials.gov. Unique identifier: NCT00042081.

Project description:Importance:The effect of ticagrelor with or without aspirin on saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG) is unknown. Objective:To compare the effect of ticagrelor + aspirin or ticagrelor alone vs aspirin alone on saphenous vein graft patency 1 year after CABG. Design, Setting, and Participants:Randomized, multicenter, open-label, clinical trial among 6 tertiary hospitals in China. Eligible patients were aged 18 to 80 years with indications for elective CABG. Patients requiring urgent revascularization, concomitant cardiac surgery, dual antiplatelet or vitamin K antagonist therapy post-CABG, and who were at risk of serious bleeding were excluded. From July 2014 until November 2015, 1256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017. Interventions:Patients were randomized (1:1:1) to start ticagrelor (90 mg twice daily) + aspirin (100 mg once daily) (n = 168), ticagrelor (90 mg twice daily) (n = 166), or aspirin (100 mg once daily) (n = 166) within 24 hours post-CABG. Neither patients nor treating physicians were blinded to allocation. Main Outcomes and Measures:Primary outcome was saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) adjudicated independently by a committee blinded to allocation. Saphenous vein graft patency was assessed by multislice computed tomographic angiography or coronary angiography. Results:Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. Saphenous vein graft patency rates 1 year post-CABG were 88.7% (432 of 487 vein grafts) with ticagrelor + aspirin; 82.8% (404 of 488 vein grafts) with ticagrelor alone; and 76.5% (371 of 485 vein grafts) with aspirin alone. The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P < .001), whereas the difference between ticagrelor alone vs aspirin alone was not statistically significant (6.3% [95% CI, -1.1% to 13.7%]; P = .10). Five major bleeding episodes occurred during 1 year of follow-up (3 with ticagrelor + aspirin; 2 with ticagrelor alone). Conclusions and Relevance:Among patients undergoing elective CABG with saphenous vein grafting, ticagrelor + aspirin significantly increased graft patency after 1 year vs aspirin alone; there was no significant difference between ticagrelor alone and aspirin alone. Further research with more patients is needed to assess comparative bleeding risks. Trial Registration:clinicaltrials.gov Identifier: NCT02201771.

Project description:Objectives: Coronary artery bypass grafting (CABG) success is reduced by graft occlusion. Understanding factors associated with graft occlusion may improve patient outcomes. The aim of this study was to develop a predictive risk score for saphenous vein graft (SVG) occlusion after CABG. Methods: This retrospective cohort study enrolled 3,716 CABG patients from January 2012 to March 2013. The development cohort included 2,477 patients and the validation cohort included 1,239 patients. The baseline clinical data at index CABG was analyzed for their independent impact on graft occlusion in our study using Cox proportional hazards regression. The predictive risk scoring tool was weighted by beta coefficients from the final model. Concordance (c)-statistics and comparison of the predicted and observed probabilities of predicted risk were used for discrimination and calibration. Results: A total of 959 (25.8%) out of 3,716 patients developed at least one late SVG occlusion. Significant risk factors for occlusion were female sex [beta coefficients (β) = 0.52], diabetes (β = 0.21), smoking (currently) (β = 0.32), hyperuricemia (β = 0.22), dyslipidemia (β = 0.52), prior percutaneous coronary intervention (PCI) (β = 0.21), a rising number of SVG (β = 0.12) and lesion vessels (β = 0.45). On-pump surgery (β = -0.46) and the use of angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB) (β = -0.59) and calcium channel blockers (CCB) (β = -0.23) were protective factors. The risk scoring tool with 11 variables was developed from the derivation cohort, which delineated each patient into risk quartiles. The c-statistic for this model was 0.71 in the validation cohort. Conclusions: An easy-to-use risk scoring tool which included female sex, diabetes, smoking, hyperuricemia, dyslipidemia, prior PCI, a rising number of SVG and lesion vessels, on-pump surgery, the use of ACEI/ ARB and CCB was developed and validated. The scoring tool accurately estimated the risk of late SVG occlusion after CABG (c-statistic = 0.71).

Dataset Information

Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.

Publications

Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.

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