Heading into the American College of Cardiology 2024 (ACC.24) Annual Scientific Sessions, few planned data releases garnered as much attention and anticipation as the EMPACT-MI trial offered the prospect of further insight into the effects of SGLT2 inhibitors among a patient population with acute myocardial infarction.
An event-driven, double-blind, randomized, placebo-controlled trial, EMPACT-MI randomized 6522 patients in a 1:1 ratio to empagliflozin or placebo in addition to standard of care within 14 days of admission, with 3260 randomized to empagliflozin and 3262 randomized to placebo. The trial’s primary endpoint was a composite of first hospitalization for heart failure and all-cause mortality assessed in a time-to-first-event analysis.
Results of the trial presented by lead investigator Javed Butler, MD, president of the Baylor Scott and White Research Institute in Dallas, distinguished professor of medicine at the University of Mississippi, indicate use of 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). Additional analysis indicated 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).
In this episode of Don’t Miss a Beat, Butler joins hosts Muthiah Vaduganathan, MD, MPH, co-director of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, and Steve Greene, MD, advanced heart failure specialist at the Duke Clinical Research Institute, for a breakdown of the trial, including primary results, secondary findings, how data from DAPA-MI and EMPACT-MI complement each other, and what is next for the SGLT2 inhibitor class.
Disclosures:
Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others.
Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.
Relevant disclosures for Butler include AstraZeneca, Bayer Healthcare, Boehringer Ingelheim Pharmaceuticals, Eli Lilly and Company, and others.
References:
Butler J, Anker SD, Bhatt DL, et al. Empagliflozin After Acute Myocardial Infarction: Results Of The EMPACT-MI Trial. Presented at: American College of Cardiology (ACC.24) Annual Scientific Session. April 6 – 8, 2024. Atlanta, GA.
James S, Erlinge D, Storey RF, et al. Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure. NEJM Evid. 2024;3(2):EVIDoa2300286. doi:10.1056/EVIDoa2300286