Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after heart valve surgery: a double-blind, randomized, placebo-controlled trial
摘要
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.
MethodsIn 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.
ResultsPOAF 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.
ConclusionShort-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.
Graphical abstract