ESC Heart Failure 2024 - Following acute MI, patients with high HF risk and T2D had a higher risk of first HF hospitalization or all-cause mortality than those with no T2D. Empagliflozin reduced HF hospitalizations but not mortality, regardless of T2D status.

This summary is based on the presentation of Javed Butler, MD (Dallas, TX, USA) at the ESC Heart Failure Congress 2024 - The effect of empagliflozin after acute myocardial infarction in patients with and without diabetes: a pre-specified analysis of the EMPACT-MI trial.

Introduction and methods

The EMPACT-MI (Trial to Evaluate the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction) trial recently showed that empagliflozin reduced the risk of first and total HF hospitalizations after an acute MI (AMI) compared with placebo but not the mortality risk. In a prespecified analysis of the EMPACT-MI trial, outcomes were assessed in AMI patients with or with no T2D, as well as empagliflozin’s effects on these outcomes.

The EMPACT-MI trial was a multicenter, double-blind, placebo-controlled, event-driven, superiority, phase 3 RCT in which 6522 patients were randomized within 14 days of AMI (STEMI or NSTEMI) to empagliflozin 10 mg once-daily or placebo, in addition to standard of care. Participants had to have a high risk of HF (defined as either congestion requiring treatment or newly developed LVEF <45%) and ≥1 HF risk factor (e.g., age ≥65 years, LVEF <35%, prior MI, T2D). Median follow-up time was 17.9 months. The primary endpoint was time to first HF hospitalization or all-cause mortality.

Main results

• In the placebo arm, the incidence of the primary endpoint was higher in patients with T2D (n=1085) compared with those with no T2D (n=999) (HR: 1.44; 95%CI: 1.06–1.95; P=0.0180), which became apparent at ~6 months.
• The risk of all-cause mortality was also increased in patients with T2D receiving placebo compared with placebo-treated patients with no T2D (HR: 1.70; 95%CI: 1.13–2.56; P=0.0116), from ~3 months and onwards.
• The risks of first HF hospitalization (HR: 1.22; 95%CI: 0.82–1.83; P=0.3298) and total HF hospitalizations (HR: 1.49; 95%CI: 0.92–2.41; P=0.1014) were not increased among placebo-treated patients with T2D.
• T2D status at baseline did not influence empagliflozin’s treatment effect on the primary endpoint, its individual components, or total HF hospitalizations (all P for interaction>0.05).
• Safety analysis indicated that baseline T2D status also did not interact with the frequencies of adverse events and serious adverse events in the empagliflozin and placebo groups.

Conclusion

In the EMPACT-MI trial, patients with high HF risk after AMI who also had T2D had an increased risk of the primary endpoint of first HF hospitalization or all-cause mortality and a higher mortality rate compared with those with no T2D. Empagliflozin reduced HF hospitalizations but not mortality, regardless of T2D status.

- Our reporting is based on the information provided at the ESC Heart Failure Congress 2024 -