Baseline characteristics of patients enrolled in the EMPACT-MI trial

Abstract

Abstract Background Empagliflozin has been shown to reduce the risk of adverse cardiovascular (CV) outcomes in patients with type 2 diabetes (T2DM) and in those with heart failure (HF). The impact of empagliflozin in post-acute myocardial infarction (AMI) patients is unknown. Methods and Results The Study to Test the Effect of Empagliflozin on Hospitalization For Heart Failure And Mortality In Patients With Acute Myocardial Infarction (EMPACT-MI) trial screened 6610 participants with AMI and 6522 were randomized to empagliflozin or placebo in addition to standard of care. Patients were eligible for enrollment if they had no history of HF, had been hospitalized with a AMI and had either acute signs or symptoms of congestion that required treatment, and/or a newly depressed LVEF<45%. Patients were also required to have at least one additional risk factor (enrichment criterion). The median (interquartile range) age of trial population was 64 (56-71) years and 75.1% were male. Major comorbidities included hypertension (69.1%), atrial fibrillation (10.9%), prior myocardial infarction (13.0%), and type 2 diabetes (31.7%). The majority (74.3%) of patients presented with an ST elevation myocardial infarction. Overall, 56.9% of patients randomized had acute signs or symptoms of congestion that required treatment, and 78.3% had newly developed left ventricular systolic dysfunction with ejection fraction <45%. Key characteristics of EMPACT-MI patient population are presented on the figure 1. Conclusion EMPACT-MI has randomized 6522 patients with acute MI. EMPACT-MI will establish the benefit and risks of empagliflozin in these patients.