Catheter Ablation and Oral Anticoagulation for Secondary Stroke Prevention in Atrial Fibrillation: The STABLED Randomized Clinical Trial.

Importance: Among patients with atrial fibrillation, those with a recent stroke are at significantly higher risk of recurrence than those without. Catheter ablation is expected to reduce the risk of recurrent stroke, heart failure, and mortality in these patients. Objective: To evaluate the efficacy and safety of catheter ablation added to standard therapy for reducing the risk of recurrent stroke or composite outcomes in patients with atrial fibrillation and a recent history of stroke. Design, Setting, and Participants: The Stroke Secondary Prevention With Catheter Ablation and Edoxaban for Patients With Nonvalvular Atrial Fibrillation (STABLED) study was an open-label, parallel-group, randomized clinical trial. Patients were enrolled from January 2018 to March 2021 and observed until March 2024. This study was conducted at 45 sites in Japan. Patients aged 20 years or older and 85 years or younger and those with a definitive diagnosis of nonvalvular atrial fibrillation on electrocardiogram, a history of ischemic stroke, currently receiving or scheduled to receive edoxaban, and having a modified Rankin Scale score of 3 or less were enrolled. Study data were analyzed from September 2024 to July 2025. Interventions: Patients were randomized to receive standard therapy or standard therapy plus catheter ablation (after ≥4 weeks of edoxaban, within 1-6 months of index stroke onset). Main Outcomes and Measures: The primary end point was a composite of recurrent ischemic stroke, systemic embolism, all-cause death, and hospitalization for heart failure. Safety related to the catheter ablation procedure was assessed. Results: A total of 251 patients were enrolled and 249 (mean [SD] age, 71.7 [7.5] years; 187 male [75.1%]) were randomized (standard therapy, 124; standard therapy plus catheter ablation, 125). Median follow-up was greater than 3 years. The primary end point occurred at rates of 4.9% and 5.6% per person-year (hazard ratio, 1.11; 95% CI, 0.62-2.01) with standard therapy vs catheter ablation, respectively. The respective mortality rates were 1.0 and 2.8 per 100 person-years. Two ablation-related adverse events (cardiac tamponade, stroke) were reported (0.8% each). Conclusions and Relevance: In patients with atrial fibrillation and a recent stroke history, standard therapy plus catheter ablation did not significantly reduce the risk of the primary composite end point. The observed event rate was lower than anticipated, suggesting that the study was underpowered to detect clinically meaningful differences. Trial Registration: ClinicalTrials.gov Identifier: NCT03777631.