Abstract 9207: Zofenopril and Ramipril Plus ASA in Post-myocardial Infarction Patients With Left Ventricular Systolic Dysfunction: A Post-hoc Analysis in Preserved or Impaired Left Ventricular Fraction at Entry
Introduction: in the randomized, double-blind, parallel-group, multicenter, international SMILE-4 Study zofenopril 60 mg plus acetyl salicylic acid (ASA) was more effective than ramipril 10 mg plus ASA 100 mg in reducing 1-year occurrence of major cardiovascular (CV) events in patients with acute myocardial infarction (AMI) complicated by left ventricular dysfunction (LVD).
Objective: to compare zofenopril and ramipril efficacy in combination with ASA in a subgroup of patients of the SMILE-4 with preserved (>40%) or impaired (≤40%) left ventricular ejection fraction at the time of enrolment in the study.
Methods: the SMILE-4 was a phase IIIb, randomized, double-blind, parallel-group, multicenter, European study comparing the safety and efficacy of zofenopril 60 mg/day and ramipril 10 mg/day plus ASA 100 mg/day, in patients with LVD (clinical signs of heart failure or a left ventricular ejection fraction or LVEF <45%) following AMI. We analyzed the 1-year combined occurrence of death or hospitalization for CV causes. Information on LVEF at baseline was available in 710 out of the 716 patients of the intention-to-treat population.
Results: in the main study population the primary outcome was significantly reduced by zofenopril vs. ramipril (odds ratio, OR and 95% confidence interval, CI: 0.70, 0.51-0.96; p=0.028). Overall, 448 (63.1%) patients had preserved and 262 (36.9%) impaired LVEF at baseline. In the first group, the rate of major CV events was significantly lower under zofenopril than under ramipril (22.5% vs. 32.8%; OR: 0.60, 0.39-0.91; p=0.016). This was the case also for the group of patients with impaired LVEF, though between-group difference was not statistically significant (37.7% zofenopril vs. 44.4% ramipril; OR: 0.77, 0.47-1.26; p=0.297). The reduction in the risk of major CV events was significantly larger (p=0.019) in patients with preserved LVEF at baseline.
Conclusions: this retrospective analysis of the SMILE-4 Study confirmed the superiority of zofenopril plus ASA as compared to ramipril plus ASA in the prevention of long-term CV outcomes. The benefit was particularly evident in subjects with preserved left ventricular function at study entry.
- © 2012 by American Heart Association, Inc.