Empagliflozin in STEMI Patients: A Randomized Controlled Trial on Left Ventricular Recovery and Cardiovascular Outcomes
Abstract
Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors provide cardiovascular benefits in diabetes, but their role in the acute post-myocardial infarction (MI) setting is uncertain. This study evaluated the association of empagliflozin with left ventricular ejection fraction (LVEF) recovery and major adverse cardiac events (MACE) in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).
Methods: In a single-center, double-blind, randomized, placebo-controlled trial, patients with STEMI were randomized to empagliflozin 10 mg or placebo daily for 40 days. The primary endpoint was change in left ventricular ejection fraction (LVEF) from baseline to day 40, with sample size calculated a priori based on data from the EMMY trial (minimum 27 per group; 53 per group enrolled). Major adverse cardiac events (MACE)-defined as cardiovascular death, myocardial infarction, or stroke-were assessed as a secondary exploratory endpoint.
Results: A total of 117 patients were randomized (59 empagliflozin, 58 placebo), of whom 106 completed follow-up and were analyzed (53 per group). Empagliflozin was associated with significantly greater LVEF recovery at day 40 (mean increase: 7.35% ± 6.11% versus 2.96% ± 5.49%; mean difference 4.39%, 95% CI 2.09-6.70%; P = 0.000272), which remained significant after adjustment for baseline LVEF, age, sex, and diabetes status (adjusted difference: 3.44%, 95% CI 1.22-5.66%; P = 0.003; Cohen's d =…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 117 participants or records.
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