Zofenopril and ramipril in patients with left ventricular systolic dysfunction after acute myocardial infarction: A propensity analysis of the Survival of Myocardial Infarction Long-term Evaluation (SMILE) 4 study

J Renin Angiotensin Aldosterone Syst. 2016 Oct 5;17(4):1470320316656480. doi: 10.1177/1470320316656480. Print 2016 Oct.


Introduction: This was a propensity score analysis of the prospective, randomized, double-blind Survival of Myocardial Infarction Long-term Evaluation (SMILE) 4 study in which one-year treatment with zofenopril 60 mg plus acetylsalicylic acid (ASA) 100 mg gave superior results compared to ramipril 10 mg plus ASA in terms of death or hospitalization for cardiovascular causes in patients with acute myocardial infarction (AMI) complicated by left ventricular dysfunction (LVD).

Materials and methods: A total of 716 patients of the intention-to-treat population were divided into homogeneous propensity quintiles (Q) using a logistic regression model (QI: best risk profile; QV: worst risk profile).

Results: Treatment was associated with a similar low rate of major cardiovascular events in any Q. However, the efficacy of zofenopril was better than that of ramipril in QII, QV, and particularly QIII (odds ratio (OR) and 95% confidence interval: 0.43 (0.21-0.87), p<0.05]. This result was primarily attributed to a decrease in the risk of cardiovascular hospitalization, particularly striking in the QIII (OR: 0.40, 0.19-0.85; p<0.05). Mortality rate did not significantly differ between the two treatments in any Q.

Conclusions: In the SMILE-4 study the propensity analysis confirmed the efficacy of zofenopril in the prevention of long-term cardiovascular outcomes irrespective of the cardiovascular risk profile of post-AMI patients.

Keywords: Acute myocardial infarction; acetylsalicylic acid; angiotensin-converting enzyme inhibitors; left ventricular dysfunction; propensity analysis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Captopril / analogs & derivatives*
  • Captopril / therapeutic use
  • Demography
  • Drug Therapy, Combination
  • Endpoint Determination
  • Female
  • Hospitalization
  • Humans
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Myocardial Infarction / complications
  • Myocardial Infarction / drug therapy*
  • Myocardial Infarction / mortality
  • Myocardial Infarction / physiopathology*
  • Propensity Score*
  • Ramipril / therapeutic use*
  • Survival Analysis
  • Time Factors
  • Ventricular Dysfunction, Left / complications
  • Ventricular Dysfunction, Left / drug therapy*
  • Ventricular Dysfunction, Left / physiopathology


  • zofenopril
  • Captopril
  • Ramipril