title: Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results.
abstract: BACKGROUND
  Edifoligide, an E2F transcription factor decoy, does not prevent vein graft failure or adverse clinical outcomes at 1 year in patients undergoing coronary artery bypass grafting (CABG). We compared the 5-year clinical outcomes of patients in PREVENT IV treated with edifoligide and placebo to identify predictors of long-term clinical outcomes.
  
  
  METHODS
  A total of 3,014 patients undergoing CABG with at least 2 planned vein grafts were enrolled. Kaplan-Meier curves were generated to compare the long-term effects of edifoligide and placebo. A Cox proportional hazards model was constructed to identify factors associated with 5-year post-CABG outcomes. The main outcome measures were death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years.
  
  
  RESULTS
  Five-year follow-up was complete in 2,865 patients (95.1%). At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%, respectively), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%, respectively; hazard ratio 1.03 [95% CI 0.89-1.18], P = .721). Factors associated with death, MI, or revascularization at 5 years included peripheral and/or cerebrovascular disease, time on cardiopulmonary bypass, lung disease, diabetes mellitus, and congestive heart failure.
  
  
  CONCLUSIONS
  Up to a quarter of patients undergoing CABG will have a major cardiac event or repeat revascularization procedure within 5 years of surgery. Edifoligide does not affect outcomes after CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes after CABG.
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA. renatolopes@duke.edu
authors.forename: Renato D
authors.initials: RD
authors.lastname: Lopes
authors.forename: Judson B
authors.initials: JB
authors.lastname: Williams
authors.forename: Rajendra H
authors.initials: RH
authors.lastname: Mehta
authors.forename: Eric M
authors.initials: EM
authors.lastname: Reyes
authors.forename: Gail E
authors.initials: GE
authors.lastname: Hafley
authors.forename: Keith B
authors.initials: KB
authors.lastname: Allen
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Nicholas T
authors.initials: NT
authors.lastname: Kouchoukos
authors.forename: T Bruce
authors.initials: TB
authors.lastname: Ferguson
authors.forename: Todd J
authors.initials: TJ
authors.lastname: Lorenz
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D009841:Oligonucleotides / Q000627:therapeutic use*; D010359:Patient Readmission / Q000706:statistics & numerical data; D011183:Postoperative Complications; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009841:Oligonucleotides; C502518:edifoligide