Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after heart valve surgery: a double-blind, randomized, placebo-controlled trial
Abstract
Background: Postoperative atrial fibrillation (POAF) commonly complicates heart valve surgery. Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, may offer antiarrhythmic benefits. This trial evaluated its efficacy in preventing POAF.
Methods: In a double-blind placebo-controlled trial, 110 patients undergoing elective heart valve surgery were randomized to oral empagliflozin 10 mg daily (n = 55) or placebo (n = 55) from 3 days pre-op to 3 days post-op. All patients received standard care. The primary analysis was performed in a modified intention-to-treat (mITT) population, defined as randomized patients with at least one assessable primary outcome measurement; 81 patients were included in the final mITT analysis. The primary outcome was POAF incidence within 72 h, assessed via continuous electrocardiography (ECG) monitoring. Secondary outcomes included other arrhythmias, C-reactive protein (CRP) levels, and glycemic control.
Results: POAF occurred in 8 patients (20.0%) in the empagliflozin group and 16 patients (39.0%) in the placebo group, corresponding to a 49% relative risk reduction, although this difference did not reach statistical significance (p = 0.088). Empagliflozin was associated with non-significant reductions in ventricular tachycardia (2.5% vs. 14.6%, p = 0.109) and premature ventricular contractions (45.0% vs. 65.9%, p = 0.075). Postoperative blood glucose levels were significantly lower in the empagliflozin group on days 1 and 2 (p p =…
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: 110 participants or records.
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