Effect of Empagliflozin on Heart Failure Outcomes After Acute Myocardial Infarction: Insights From the EMPACT-MI Trial
Adrian F. Hernandez, Jacob A. Udell, W. Schuyler Jones, Stefan D. Anker, Mark C. Petrie, Josephine Harrington, Michaela Mattheus, Svenja Seide, Isabella Zwiener, Offer Amir, M. Cecilia Bahit, Johann Bauersachs, Antoni Bayés‐Genís, Yundai Chen, Vijay Chopra, Gemma A. Figtree, Junbo Ge, Shaun G. Goodman, Nina Gotcheva, Shinya Goto, Tomasz Gąsior, Waheed Jamal, James L. Januzzi, Myung Ho Jeong, Yu. M. Lopatin, Renato D. Lópes, Béla Merkely, Puja B. Parikh, Alexander Parkhomenko, Piotr Ponikowski, Xavier Rosselló, Morten Schou, Dragan Šimić, Philippe Gabríel Steg, Joanna Szachniewicz, Peter van der Meer, Dragoş Vinereanu, Shelley Zieroth, Martina Brueckmann, Mikhail Sumin, Deepak L. Bhatt, Javed Butler
Abstract
BACKGROUND: Empagliflozin reduces the risk of heart failure (HF) events in patients with type 2 diabetes at high cardiovascular risk, chronic kidney disease, or prevalent HF irrespective of ejection fraction. Whereas the EMPACT-MI trial (Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients With Acute Myocardial Infarction) showed that empagliflozin does not reduce the risk of the composite of hospitalization for HF and all-cause death, the effect of empagliflozin on first and recurrent HF events after myocardial infarction is unknown. METHODS: EMPACT-MI was a double-blind, randomized, placebo-controlled, event-driven trial that randomized 6522 patients hospitalized for acute myocardial infarction at risk for HF on the basis of newly developed left ventricular ejection fraction of <45% or signs or symptoms of congestion to receive empagliflozin 10 mg daily or placebo within 14 days of admission. In prespecified secondary analyses, treatment groups were analyzed for HF outcomes. RESULTS: Over a median follow-up of 17.9 months, the risk for first HF hospitalization and total HF hospitalizations was significantly lower in the empagliflozin compared with the placebo group (118 [3.6%] versus 153 [4.7%] patients with events; hazard ratio, 0.77 [95% CI, 0.60, 0.98]; P =0.031, for first HF hospitalization; 148 versus 207 events; rate ratio, 0.67 [95% CI, 0.51, 0.89]; P =0.006, for total HF hospitalizations). Subgroup analysis showed consistency of empagliflozin benefit across clinically relevant patient subgroups for first and total HF hospitalizations. The need for new use of diuretics, renin-angiotensin modulators, or mineralocorticoid receptor antagonists after discharge was less in patients randomized to empagliflozin versus placebo (all P <0.05). CONCLUSIONS: Empagliflozin reduced the risk of HF in patients with left ventricular dysfunction or congestion after acute myocardial infarction. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04509674.