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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized
Daehoon Kim1, Jaemin Shim2, Eue-Keun Choi3
1Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Insights
Discontinuing oral anticoagulation after atrial fibrillation ablation in patients without arrhythmia recurrence may lower stroke and bleeding risks. This strategy showed a reduced composite outcome compared to continuing anticoagulation therapy.
Area of Science:
- Cardiology
- Clinical Trials
- Atrial Fibrillation Management
Background:
- Randomized clinical trial data on long-term anticoagulation strategies post-catheter ablation for atrial fibrillation (AF) are limited.
- Patients undergoing AF ablation often have stroke risk factors requiring careful management.
Purpose of the Study:
- To compare clinical outcomes of discontinuing versus continuing oral anticoagulant therapy (OAT) in patients post-AF ablation without arrhythmia recurrence.
- To assess the efficacy and safety of OAT cessation in this specific patient population.
Main Methods:
- An 840-patient randomized clinical trial conducted in South Korea.
- Patients with at least one stroke risk factor (CHA2DS2-VASc score) and no AF recurrence post-ablation were randomized 1:1 to discontinue or continue OAT (direct oral anticoagulants).
- Primary outcome: composite of stroke, systemic embolism, and major bleeding at 2 years.
Main Results:
- The primary composite outcome occurred in 0.3% of patients discontinuing OAT versus 2.2% of those continuing OAT (P=.02).
- Discontinuing OAT showed a trend towards lower ischemic stroke incidence (0.3% vs 0.8%) and significantly lower major bleeding rates (0% vs 1.4%).
- The study enrolled patients with a mean CHA2DS2-VASc score of 2.1 and predominantly paroxysmal AF (67.6%).
Conclusions:
- Discontinuing OAT in selected patients post-AF ablation without arrhythmia recurrence is associated with a lower risk of the composite outcome of stroke, systemic embolism, and major bleeding.
- This strategy may offer a safer alternative for long-term management in this population, warranting further investigation.
Importance:
Data from randomized clinical trials on a long-term anticoagulation strategy for patients after catheter-based ablation for atrial fibrillation (AF) are lacking.
Objective:
To evaluate whether discontinuing oral anticoagulant therapy provides superior clinical outcomes compared with continuing oral anticoagulant therapy in patients without documented atrial arrhythmia recurrence after catheter ablation for AF.
Design, Setting, And Participants:
A randomized clinical trial including 840 adult patients (aged 19-80 years) who were enrolled and randomized from July 28, 2020, to March 9, 2023, at 18 hospitals in South Korea. Enrolled patients had at least 1 non-sex-related stroke risk factor (determined using the CHA2DS2-VASc score [range, 0-9]) and no documented recurrence of atrial arrhythmia for at least 1 year after catheter ablation for AF. The CHA2DS2-VASc score is used as an assessment of stroke risk among patients with AF (calculated using point values for congestive heart failure, hypertension, ≥75 years of age, diabetes, stroke or transient ischemic attack, vascular disease, between 65 and 74 years of age, and sex category). The date of final follow-up was June 4, 2025.
Interventions:
The patients were randomly assigned in a 1:1 ratio to discontinue oral anticoagulant therapy (n = 417) or continue oral anticoagulant therapy (with direct oral anticoagulants; n = 423).
Main Outcomes And Measures:
The primary outcome was the first occurrence of a composite of stroke, systemic embolism, and major bleeding at 2 years. Individual components of the primary outcome (such as ischemic stroke and major bleeding) were assessed as secondary outcomes.
Results:
Of the 840 adults randomized, the mean age was 64 (SD, 8) years, 24.9% were women, the mean CHA2DS2-VASc score was 2.1 (SD, 1.0), and 67.6% had paroxysmal AF. At 2 years, the primary outcome occurred in 1 patient (0.3%) in the discontinue oral anticoagulant therapy group vs 8 patients (2.2%) in the continue oral anticoagulant therapy group (absolute difference, -1.9 percentage points [95% CI, -3.5 to -0.3]; P = .02). The 2-year cumulative incidence of ischemic stroke was 0.3% in the discontinue oral anticoagulant therapy group vs 0.8% in the continue oral anticoagulant therapy group (absolute difference, -0.5 percentage points [95% CI, -1.6 to 0.6]). Major bleeding occurred in 0 patients in the discontinue oral anticoagulant therapy group vs 5 patients (1.4%) in the continue oral anticoagulant therapy group (absolute difference, -1.4 percentage points [95% CI, -2.6 to -0.2]).
Conclusions And Relevance:
Among patients without documented atrial arrhythmia recurrence after catheter ablation for AF, discontinuing oral anticoagulant therapy resulted in a lower risk for the composite outcome of stroke, systemic embolism, and major bleeding vs continuing direct oral anticoagulant therapy.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04432220.
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