Revascularization in severe left ventricular dysfunction: outcome comparison of drug-eluting stent implantation versus coronary artery by-pass grafting.
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).


CONCLUSIONS
In selected high risk patients with severe LV dysfunction revascularization with DES implantation offers comparable long term mortality and MACCE rate to CABG patients.
Gioia
Giuseppe
G
Atlantic City Medical Center, Pomona, NJ 08240, USA. giuseppe.gioia@atlanticare.org
Matthai
William
W
Gillin
Karen
K
Dralle
James
J
Benassi
Alberto
A
Gioia
Maria Francesca
MF
White
Jacqueline
J
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation; D009202:Cardiomyopathies / Q000150:complications* / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications; D017239:Paclitaxel / Q000008:administration & dosage*; D011474:Prosthesis Design; D012107:Research Design; D012189:Retrospective Studies; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000209:etiology / Q000401:mortality / Q000628:therapy*
D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus