Objective: We compared the outcome of drug eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction with the outcome of a similar group of patients undergoing coronary artery by-pass grafting (CABG).
Background: Revascularization provides long-term benefits in patients with severe LV dysfunction. However the modality to achieve it is still unsettled in this high risk group of patients.
Methods: Two-hundred-twenty patients (20% women) with severe LV dysfunction (LV Ejection Fraction <or=35%) underwent revascularization with either coronary stent implantation or CABG between May 2002 and May 2005. One-hundred-twenty-eight patients received DES (Sirolimus in 72 and Paclitaxel in 54) and 92 patients underwent surgery. Patients with acute STEMI were excluded. The primary endpoint was all cause mortality. A composite endpoint of major cardiac adverse events (MACCE), including all cause mortality, stroke, myocardial infarction (STEMI), and TVR was the secondary endpoint.
Results: Mean follow-up was 15 +/- 9 months. No differences were noted in age (69 +/- 10 years vs. 68 +/- 10 years, P = NS), LVEF (28 +/- 6 vs. 27 +/- 8, P = NS) history of diabetes (48% vs. 45%, P = NS), congestive heart failure (47% vs. 37%, P = NS) or MI (60% vs. 50%, P = NS) between the DES and CABG groups. The NYHA class was also similar between the two groups (2.6 +/- 0.9 vs. 2.7 +/- 0.8). More patients in DES group had previous CABG (24% vs. 7%. P = 0.001). Patients undergoing CABG had a greater number of vessel disease (2.8 +/- 0.5 vs. 2.3 +/- 0.7, P = 0.001) and received a mean of 3.0 +/- 0.8 graft per patient. Most of the CABG patients had a left internal mammary artery (83%) graft and 24% had off-pump surgery. The DES group had 1.3 artery/patient treated and 1.3 stents were implanted per artery. During the follow-up there were a total of 20 deaths of which three were cancer related (two in DES group and one in the CABG group). Ten deaths (8%) occurred in the DES group and 10 (11%) in the CABG group (P = NS by log-rank test). The 30-day mortality was significantly greater in patients undergoing CABG than DES (five patients in the CABG vs. only one patient in DES group, P = 0.04). At 6 months there was only a trend toward better survival in DES group (97% vs. 93%, P = 0.2). At 2 years follow-up however both groups had the same survival probability from death (83% in both groups). The 2 years MACCE free survival rate was 76% in DES group and 79% in the CABG cohort (P = NS by log rank test). Eight (6%) DES patients needed additional PCI in nontarget vessel during follow-up. The magnitude of NYHA class improvement was greater for the CABG than DES patients (0.9 vs. 1.5, P = 0.01).
Conclusion: In selected high risk patients with severe LV dysfunction revascularization with DES implantation offers comparable long term mortality and MACCE rate to CABG patients.
(c) 2007 Wiley-Liss, Inc.