Early Treatment With Zofenopril And Ramipril In Combination With Acetyl Salicylic Acid In Patients With Left Ventricular Systolic Dysfunction After Acute Myocardial Infarction: Results Of A 5-Year Follow-Up Of Patients Of The Smile-4 Study

ABSTRACT: The SMILE-4 study showed that in patients with left ventricular dysfunction (LVD) following acute myocardial infarction (AMI), early treatment with zofenopril plus acetyl salicylic acid (ASA) is associated with an improved 1-year survival, free from death or hospitalization for cardiovascular (CV) causes, as compared to ramipril plus ASA. We now report on CV outcomes during a 5-year follow-up of the patients of the SMILE-4 study. 386 of the 518 patients completing the study (51.2%) could be tracked after the study end and 265 could be included in the analysis. During the 5.5 (±2.1) years of follow-up the primary end-point occurred in 27.8% of patients originally randomized and treated with zofenopril and in 43.8% of patients treated with ramipril [odds ratio, OR and 95% confidence interval, CI: 0.65 (0.43, 0.98), p=0.041]. Such a result was achieved through a significantly larger reduction in cardiovascular hospitalization under zofenopril [OR: 0.61 (0.37, 0.99), p=0.047], whereas reduction in mortality rate with zofenopril did not achieve statistical significance vs. ramipril [OR: 0.75 (0.36, 1.59), p=0.459]. These results were in line with those achieved during the initial 1-year follow-up. Benefits of early treatment of patients with LVD following AMI with zofenopril is sustained over many years as compared to ramipril.