Document Detail

The PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) trial: study rationale, design, and baseline patient characteristics.
MedLine Citation:
PMID:  16209958     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Coronary artery bypass graft (CABG) surgery with autologous vein graft (VG) conduit is one of the most frequently performed operations in the United States. Unfortunately, many VGs become occluded during long-term follow-up largely because of neointimal hyperplasia. A novel approach to preventing neointimal hyperplasia is with the double-stranded oligonucleotide edifoligide (Corgentech Inc, South San Francisco, Calif). Edifoligide inhibits E2F, a transcription factor that activates cell-cycle genes responsible for neointimal hyperplasia. METHODS: PREVENT IV is a phase-III, multicenter, randomized double-blind placebo-controlled trial of ex vivo treatment of autologous VGs with edifoligide in patients undergoing initial CABG surgery. The primary end point is VG failure, defined as death or > or =75% stenosis in a treated VG at 12- to 18-month angiographic follow-up. Secondary end points include major adverse cardiac events through at least 5 years and adverse events through 30 days. RESULTS: Enrollment of 3014 patients from 107 sites was completed on October 22, 2003. The baseline and procedural characteristics of the PREVENT IV population are generally well matched to a contemporary population of patients undergoing initial CABG from the Society of Thoracic Surgeons National Database. Angiographic follow-up is ongoing and scheduled to be completed in March 2005. CONCLUSIONS: The PREVENT IV data will establish whether VG pretreatment with an E2F transcription factor decoy, edifoligide, can improve graft patency and reduce the long-term morbidity and mortality of patients undergoing CABG surgery.
John H Alexander; T Bruce Ferguson; Diane M Joseph; Michael J Mack; Randall K Wolf; C Michael Gibson; Daniel Gennevois; Todd J Lorenz; Robert A Harrington; Eric D Peterson; Kerry L Lee; Robert M Califf; Nicholas T Kouchoukos;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  150     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-10-07     Completed Date:  2005-11-28     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  643-9     Citation Subset:  AIM; IM    
Duke University Medical Center, Duke Clinical Research Institute, Durham, NC 27715, USA.
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MeSH Terms
Coronary Artery Bypass / adverse effects,  methods*
DNA / therapeutic use*
Equipment Design
Follow-Up Studies
Hyperplasia / prevention & control
Injections, Intravenous / instrumentation
Middle Aged
Multicenter Studies as Topic
Postoperative Complications / prevention & control
Randomized Controlled Trials as Topic / methods*
Research Design
Tunica Intima / pathology
Reg. No./Substance:
0/Oligonucleotides; 0/edifoligide; 9007-49-2/DNA

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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