Evidence map›Paper›PMID 25073921›Full record

Trial reportJAMA surgery2014

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 and 3 more

Erratum issued Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA surgery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00042081 (A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00042081 phase3completednot on this map

A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures

TypeinterventionalSponsorAnesiva, Inc.Ran2002 to 2005Enrolled3,000ConditionsCoronary Artery DiseaseArmsCGT003 (E2F Duplex Decoy)
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

Ralf E HarskampDepartment of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina2Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
John H AlexanderDepartment of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Phillip J SchulteDepartment of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Colleen M BrophyDivision of Vascular Surgery, Vanderbilt University, Nashville, Tennessee.
Michael J MackCardiopulmonary Research Science and Technology Institute, Dallas, Texas.
Eric D PetersonDepartment of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Judson B WilliamsDepartment of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.
C Michael GibsonPERFUSE Angiographic Laboratory, Boston, Massachusetts.
Robert M CaliffDepartment of Medicine, Duke Translational Medicine Institute, Duke University, Durham, North Carolina.
Nicholas T KouchoukosHeart Center, Missouri Baptist Medical Center, St Louis, Missouri.
Robert A HarringtonDepartment of Medicine, Stanford University, Stanford, California.
T Bruce FergusonDepartment of Cardiovascular Sciences, East Carolina University, Greenville, North Carolina.
Renato D LopesDepartment of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Clinical Research Institute · USDuke University · USAcademic Medical Center · NLCardiopulmonary Research Science and Technology Institute · USEast Carolina University · USMissouri Baptist Medical Center · USStanford University · USVanderbilt University · US

Funding

PREVENTION OF VEIN GRAFT SPASMR01HL070715 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BROPHY, COLLEEN M · 2003 to 2021
$7.2M
Cardiothoracic Surgical Network Clinical CenterU01HL088953 · NHLBI · DUKE UNIVERSITY · PI SMITH, PETER K · 2007 to 2013
$2.6M
Core Clinical Centers for the CTSNUM1HL088953 · NHLBI · DUKE UNIVERSITY · PI SMITH, PETER K · 2013 to 2017
$2.5M
NHLBI NIH HHS R01 HL070715NHLBI NIH HHS U01 HL088953NHLBI NIH HHS UM1 HL088953
6 · The paper itself

Abstract

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 MEASURES: One-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 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 registrationclinicaltrials.gov Identifier: NCT00042081.

Indexed as

Coronary Artery BypassOligonucleotidesOrgan Preservation SolutionsVeinsAgedBuffersDouble-Blind MethodFemaleFollow-Up StudiesGraft Occlusion, VascularHumansMaleMiddle AgedSodium ChlorideTreatment OutcomeVascular PatencyBuffersedifoligideOligonucleotidesOrgan Preservation SolutionsSodium Chloride

Identifiers

PMID25073921
PMCPMC4332522
OpenAlexW2000267893

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.