564 Zofenopril and Ramipril Plus Asa in Post- Myocardial Infarction Patients With Left Ventricular Systolic Dysfunction

Background: In the randomized, double-blind, parallel-group, multicenter, international SMILE-4 Study zofenopril (Z) 60 mg plus ASA was more effective than ramipril (R) 10 mg plus acetyl salicylic acid (ASA) 100 mg in reducing 1-year occurrence of major cardiovascular events in patients with acute myocardial infarction complicated by left ventricular dysfunction. Objective: To compare efficacy of Z and R plus ASA in patients with arterial hypertension from the SMILE-4 Study. Methods: The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. Results: In the main study population (n = 716) the primary outcome was significantly reduced by Z vs. R (odds ratio, OR and 95% confidence interval, CI: 0.70, 0.51–0.96; p = 0.028). The majority of patients (437, 64.1%) had arterial hypertension and showed a rate of major cardiovascular events slightly, but not significantly, lower under Z than under R (32.1% vs. 39.5%; OR: 0.72, 0.49–1.07; p = 0.106). This was the case also for the group of patients without hypertension (24.1% Z vs. 32.3% R; OR: 0.67, 0.38–1.17; p = 0.156). However, in the group with an entry systolic blood pressure ≥140 mmHg the 1-year hazard of cardiovascular events was significantly (p = 0.003) lower under Z (28.9% vs. 43.9% R; OR: 0.52, 0.34–0.80). The reduction in the risk of cardiovascular events was similar in patients with and without hypertension. Conclusions: This retrospective analysis of the SMILE-4 Study confirmed the good efficacy of Z plus ASA in the prevention of long-term cardiovascular outcomes also in the subgroup of patients with arterial hypertension.