DARE-AF: dapagliflozine vermindert vroeg AF-recidief na ablatie

BACKGROUND: Observational studies have suggested that SGLT2 (sodium-glucose cotransporter 2) inhibitors are associated with a lower risk of atrial fibrillation (AF) recurrence after catheter ablation in patients with AF with concomitant diabetes, heart failure, or chronic kidney disease. However, no randomized trial to date has tested whether SGLT2 inhibitors reduce AF recurrence after ablation in patients without established indications. We therefore investigated the effect of dapagliflozin on prevention of early recurrence of AF after catheter ablation in patients without current indications for SGLT2 inhibitors. METHODS: The DARE-AF trial (Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation) was a prospective, open-label, parallel-assignment randomized controlled trial that enrolled 200 patients with persistent AF between July 2024 and March 2025, scheduled to undergo a first catheter ablation procedure and without established indications for dapagliflozin (diabetes, heart failure, or chronic kidney disease). Patients were randomly assigned at a 1:1 ratio to dapagliflozin (10 mg once daily for 3 months after the ablation) or control. The primary end point was AF burden at 3 months after ablation, assessed by 7-day single-lead ECG patches. Secondary outcomes included time to events, quality of life, and improvement of atrial remodeling. RESULTS: A total of 200 patients (mean age 58.5 years, 19.5% women, 29.0% with persistent AF ≥1 year) were randomized, and 198 patients (98 in the dapagliflozin group, 100 in the control group) were included in the primary analysis. Three months after ablation, the difference in AF burden was insignificant between the dapagliflozin group and the control group (7.5±23.6% versus 8.1±25.5%; P=0.48). Atrial arrhythmia recurrence occurred in 29 patients (29.6%) in the dapagliflozin group and 28 patients (28.0%) in the control group (hazard ratio, 1.11 [95% CI, 0.66-1.86]; P=0.70). No significant between-group differences were observed in changes in quality of life or left atrial diameter. CONCLUSIONS: Three-month treatment with dapagliflozin did not reduce the early recurrence of arrhythmia after catheter ablation in patients with persistent AF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06433479.