ACC.24 – In EMPACT-MI, empagliflozin did not reduce time to first hospitalization for HF (HHF) or all-cause mortality compared with placebo in patients at increased risk of HF following AMI. Empagliflozin reduced the HHF-component of the primary endpoint.

This summary is based on the presentation of Javed Butler, MD (Dallas, TX, US and Jackson, MS, US) at the ACC.24 Scientific Session - Empagliflozin after Acute Myocardial Infarction: Results of the The EMPACT-MI trial.

Introduction and methods

Patients after acute MI (AMI) are at higher risk to develop HF. SGTL2 inhibitors have been shown to reduce to risk of HF events in patients who are at high-risk for developing HF, such as patients with CKD or T2D, and in patients with prevalent HF. The goal of the EMPACT-MI trial was to evaluate the efficacy and safety of empagliflozin in patients after AMI.

EMPACT-MI was a multicentre, randomized, double-blind, phase 3, placebo-controlled superiority trial. A total of 6522 patients with AMI (STEMI or NSTEMI; ≤14 days after hospital admission) and without chronic HF, who were at high-risk of HF, and had at least one HF-risk factor, were randomized to empagliflozin 10 mg once daily or placebo on top of standard care. High-risk of HF was defined as signs or symptoms of congestion requiring treatment and/or a newly developed LVEF <45%.

The primary endpoint was time to first hospitalization for HF (HHF) or all-cause mortality.

Main results

• The primary endpoint occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group (HR: 0.90; 95%CI: 0.76-1.06; P=0.021). The majority of the primary outcome first events were all-cause mortality (52%). 
• Empagliflozin reduced time to first HHF compared with placebo (HR: 0.77; 95%CI: 0.60-0.98; P=0.03), but had no effect on time to all-cause mortality (HR: 0.96; 95%CI: 0.78-1.19; P=0.73).
• Empagliflozin reduced the total number of HHF compared with placebo (RR: 0.67; 95%CI: 0.51-0.89; P=0.006).
• The safety profile of empagliflozin in EMPACT-MI was consistent with the known safety profile of empagliflozin.

Conclusion

In EMPACT-MI, treatment with empagliflozin did not reduce the risk of time to first HHF or all-cause mortality in patients at increased risk of HF following AMI compared with placebo. In contrast, treatment with empagliflozin was associated with reduced risk of first HHF and total HHF in patients after AMI compared with placebo.

- Our reporting is based on the information provided at the ACC.24 Scientific Session -

The findings of this study were simultaneously published in N Engl J Med.

Watch a presentation by Javed Butler, MD