EMPACT-MI Kidney: SGLT2 Initiation Can Preserve Kidney Function in Post-MI Population

Deepak Bhatt, MD, MPH, MBA
Credit: Mount Sinai

An analysis of the EMPACT-MI study presented at the European Society of Cardiology (ESC) Congress 2024 underlines the safety of initiating SGLT2 inhibitor therapy in patients with a history of acute myocardial infarction.

The analysis demonstrates use of the SGLT2 inhibitor empagliflozin (Jardiance) provided meaningful reductions in heart failure events among patients in the trial, regardless of baseline kidney function.

“It is especially important to understand the safety profile of SGLT2 inhibitors since about 40% of patients with acute [myocardial infarction] have chronic kidney disease,” said study investigator Deepak Bhatt, MD, MPH, MBA, director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai. “Our research showed that empagliflozin exhibited kidney-protective effects by reducing the decline in the eGFR, which measures how well the kidneys are filtering waste, compared with placebo. Importantly, our data also showed that empagliflozin was safe to initiate soon after an acute [myocardial infarction], regardless of the patient’s baseline kidney function.”

Originally presented at the American College of Cardiology 2024 Annual Scientific Sessions, EMPACT-MI was an event-driven, double-blind, randomized, placebo-controlled trial that randomized 6522 patients in a 1:1 ratio to empagliflozin or placebo in addition to standard of care within 14 days of admission for acute myocardial infarction. The trial’s primary endpoint was a composite of the first hospitalization for heart failure and all-cause mortality assessed in a time-to-first-event analysis.

The study cohort had a mean age of 64 years, 75.1% were male, and 83.6% were White. The median follow-up of the study population was 17.9 months and the median time to randomization after acute myocardial infarction was 5 days.

Results of the trial indicated empagliflozin did not provide a significant benefit in reducing overall heart failure hospitalizations or death from any cause (Hazard Ratio [HR], 0.90; 95% Confidence Interval [CI], 0.76 to 1.06; P= .21), with additional analysis indicating the trend toward benefit observed in the trial was driven by a statistically significant reduction in heart failure hospitalization (HR, 0.77; 95% CI, 0.60 to 0.98).

At ESC Congress, Bhatt presented data related to the primary outcomes stratified according to baseline kidney function. Similar to the original study, results indicated there was no statistically significant difference in all-cause mortality, but a reduction in risk of hospitalization for heart failure waas observed regardless of baseline kidney function within the trial.

When assessing kidney-specific endpoints, results of the analysis suggested patients in the empagliflozin cohort had stable eGFR at 24 months relative to baseline. In contrast, patients in the placebo group experienced a decline in eGFR. Bhatt noted this benefit was consistent regardless of baseline kidney function.

“Our study will help to fill a key gap in the understanding of the clinical use of SGLT2 inhibitors in people who have suffered a heart attack,” Bhatt added. “By reassuring physicians of the safety and efficacy of empagliflozin early after a heart attack, EMPACT-MI has enormous implications for treating a very vulnerable population of patients with cardiovascular disease worldwide.”

References:

1. DL Bhatt. Cardiorenal effects and safety of initiation of empagliflozin after acute myocardial infarction. Presented at: European Society of Cardiology Congress 2024. August 30 - September 2, 2024. London, UK.
2. Campbell P. Empagliflozin misses primary endpoint in Post-MI patient population, empact-mi trial. HCP Live. April 8, 2024. Accessed September 2, 2024. https://www.hcplive.com/view/empagliflozin-misses-primary-endpoint-in-post-mi-patient-population-empact-mi-trial.