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Updated: Mar 3, 2026
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Catheter Ablation and Oral Anticoagulation for Secondary Stroke Prevention in Atrial Fibrillation: The STABLED
Kazumi Kimura1,2, Yasuhiro Nishiyama1,3, Yu-Ki Iwasaki4
1Department of Neurology, Nippon Medical School, Tokyo, Japan.
Insights
Catheter ablation added to standard therapy did not significantly lower stroke or composite event risk in atrial fibrillation patients with recent stroke. The study was underpowered to detect meaningful differences.
Area of Science:
- Cardiology
- Neurology
- Medical Interventions
Background:
- Patients with atrial fibrillation (AF) and recent stroke face high recurrence risk.
- Catheter ablation is hypothesized to mitigate risks of recurrent stroke, heart failure, and mortality in AF patients.
Purpose of the Study:
- To assess the efficacy and safety of catheter ablation combined with standard therapy for reducing recurrent stroke or composite outcomes in AF patients with recent stroke.
- The STABLED trial aimed to provide crucial data on this intervention.
Main Methods:
- An open-label, randomized clinical trial (STABLED) involving 249 patients with nonvalvular AF and recent ischemic stroke.
- Participants received either standard therapy or standard therapy plus catheter ablation after 4 weeks of edoxaban.
- The primary endpoint was a composite of recurrent ischemic stroke, systemic embolism, all-cause death, and heart failure hospitalization.
Main Results:
- No significant reduction in the primary composite endpoint was observed with catheter ablation plus standard therapy (4.9% vs 5.6% per person-year).
- Mortality rates were 1.0 and 2.8 per 100 person-years for standard therapy and catheter ablation groups, respectively.
- Two ablation-related adverse events (cardiac tamponade, stroke) occurred (0.8% each).
Conclusions:
- Catheter ablation added to standard therapy did not significantly reduce the primary composite endpoint in AF patients with recent stroke.
- The study suggests it may be underpowered to detect clinically significant differences due to lower-than-anticipated event rates.
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.
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