Researchers at the Cardiopulmonary Research Science & Technology Institute in Dallas, Texas, analyzed the one-year vein graft patency and major adverse cardiac and cerebral events (MACCE—death, myocardial infarction, or stroke) in on-pump and off-pump patients enrolled in PREVENT IV (the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV).
The PREVENT IV Trial was a multicenter (107 sites) randomized trial testing the use of edifoligide to prevent vein graft failure from neointimal hyperplasia in 3,014 patients undergoing primary, isolated coronary artery bypass grafting (CABG) with at least two vein grafts. One-year angiographic follow-up was completed on 1,920 patients (4,736 grafts) with MACCE follow-up on 99.4% of enrolled patients.
In the study, 79% of the 2,377 patients underwent on-pump CABG; 21% underwent off-pump CABG. In both groups, saphenous vein failure rate was 25%. The incidence of chronic lung disease was 17% for on-pump versus 11% for off-pump patients. Congestive heart failure was 10% for on-pump versus 7% for off-pump CABG patients. The ejection fraction for on-pump patients was 50%, versus 55% for off-pump patients. The quality of the target coronary artery was better with the off-pump patients. One-year mortality was 3.3% for on-pump patients versus 2.5% for off-pump patients. One-year clinical outcomes (MACCE) were better with off-pump (11.3%) than with on-pump (15.4%) patients, suggesting that benefits were not related to vein graft patency.
References: Magee MJ et al., “Coronary artery bypass graft failure after on-pump and off-pump coronary artery bypass: findings from PREVENT IV,” J Ann Thorac Surg 2008; 85(2): 494-9; discussion 499-500. (Transonic Reference # 10609AHR)
Alexander JH et al., “Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial,” JAMA 2005; 294(19): 2446-54. (Transonic Reference # 10608AHR)