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 and to identify predictors of long-term clinical outcomes.
Methods
A total of 3014 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 measure was death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years.
Results
Five-year follow-up was complete in 2865 (95.1%) patients. At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The 5-year composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%; hazard ratio 1.03 [95% confidence interval 0.89–1.18]; P=0.721). Factors associated with death, MI, or revascularization at 5 years included diabetes, sex, worst graft quality, peri-index CABG MI, and ejection fraction.
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 following CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes following CABG.