After approximately one year of treatment with dapagliflozin, patients with acute myocardial infarction (MI) experienced significant improvements in cardiometabolic outcomes but saw no significant benefits in the composite of cardiovascular death or hospitalization for heart failure (HF), based on findings from the DAPA-MI trial presented Nov. 11 at AHA 2023 and simultaneously published in NEJM Evidence.

Stefan James, MD, PhD, et al., randomized 4,017 patients enrolled in the SWEDEHEART Registry in Sweden and the MINAP Registry in the UK to either 10 mg of dapagliflozin (n=2,019) or placebo (n=1,998) once daily. All patients presented with acute MI and impaired left ventricular systolic function and did not have prior diabetes or chronic HF. The primary outcome was the hierarchical composite of death, hospitalization for HF, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and a body weight decrease of 5% or greater at the last visit using the win ratio analysis method.

Overall results showed significantly more wins (34%) for dapagliflozin compared with placebo (win ratio, 1.24; 95% confidence interval, 1.20 to 1.50; p<0.001), largely due to cardiometabolic outcomes. Researchers noted that “the lower incidence of new-onset diabetes and greater weight reduction were important contributors to the primary outcome.”

Without the cardiometabolic factors, the composite of time to cardiovascular death or hospitalization for HF was similar across both groups (2.5% for dapagliflozin vs. 2.6% for placebo). Researchers said the rates of other cardiovascular events were low, with no statistical significance. Additionally, no safety concerns were identified.

In commenting on the trial design, researchers said that allowing collection of patient data and outcomes from registries already incorporated into routine health care practice made for a “robust yet streamlined trial that yielded high-quality evidence with a high enrollment rate” despite the COVID pandemic.