Evidence map›Paper›PMID 25261549›Full record

Trial reportCirculation2014

Saphenous vein graft failure after coronary artery bypass surgery: insights from PREVENT IV.

Connie N Hess, Renato D Lopes, C Michael Gibson, Rebecca Hager, Daniel M Wojdyla, Brian R Englum, Michael J Mack, Robert M Califf, Nicholas T Kouchoukos, Eric D Peterson and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 85 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

85 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Connie N HessFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Renato D LopesFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
C Michael GibsonFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Rebecca HagerFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Daniel M WojdylaFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Brian R EnglumFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Michael J MackFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Robert M CaliffFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Nicholas T KouchoukosFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
Eric D PetersonFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.).
John H AlexanderFrom the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.); Harvard Medical School, Harvard University, Boston, MA (C.M.G.); Baylor Health Care System, Baylor, TX (M.J.M.); Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.); and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.). john.h.alexander@duke.edu.

Funding

Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI MARK, DANIEL B · 2003 to 2023
$6.7M
Integrated Biostatistical Training for CVD ResearchT32HL079896 · NHLBI · NORTH CAROLINA STATE UNIVERSITY RALEIGH · PI Sean M O'Brien, Ana-Maria Staicu · 2006 to 2026
$4.1M
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 5T32HL069749-09NHLBI NIH HHS T32 HL069749NHLBI NIH HHS T32 HL079896NHLBI NIH HHS T32HL079896NHLBI NIH HHS U01 HL088953NHLBI NIH HHS U01-HL088953NHLBI NIH HHS UM1 HL088953
6 · The paper itself

Abstract

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 URL: http://www.clinicaltrials.gov. Unique identifier: NCT00042081.

Indexed as

AgedClopidogrelCoronary Artery BypassCoronary Artery DiseaseDouble-Blind MethodFemaleGraft Occlusion, VascularHumansMaleMiddle AgedPlatelet Aggregation InhibitorsPostoperative ComplicationsPredictive Value of TestsRisk AssessmentSaphenous VeinTiclopidineClopidogrelPlatelet Aggregation InhibitorsTiclopidinecoronary artery bypasscoronary diseasemyocardial revascularization

Identifiers

PMID25261549
PMCPMC4206593

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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.