Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after heart valve surgery: a double-blind, randomized, placebo-controlled trial

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 < 0.05). No significant differences were observed in postoperative CRP levels (p = 0.12) or adverse event rates, including hypoglycemia and infection. Conclusion Short-term perioperative empagliflozin did not significantly reduce the incidence of POAF after heart valve surgery; however, the results suggest a possible reduction in POAF and improved postoperative glycemic control, without an apparent increase in adverse events in this selected, closely monitored population. These findings require confirmation in larger randomized trials.