Study Title: ALONE-AF: Discontinuing Long-Term Oral Anticoagulation After Successful Atrial Fibrillation Ablation

Published in Congress: ESC Congress 2025

Link: https://esc365.escardio.org/presentation/312218

Prepared by: Dr. Abdalrahman Shawky A. Mostafa, Dr. Mustafa Yenerçağ

Introduction:
In patients undergoing catheter ablation for atrial fibrillation (AF), the optimal strategy for long-term anticoagulation—whether to continue or discontinue therapy—remains unclear. Randomized controlled trial data in this area are limited, and clinicians typically rely on individual risk assessments when making treatment decisions. Both the risk of stroke and systemic embolism, as well as the impact of anticoagulation therapy on bleeding complications, play a critical role in this decision-making process.

Objective:
The aim of this study was to compare the safety and efficacy of discontinuing versus continuing oral anticoagulation in patients with no recurrence of atrial arrhythmia for at least 12 months after ablation. The study seeks to provide more definitive evidence to guide clinical practice.

Methods:
This was a randomized controlled clinical trial conducted across 18 centers in South Korea. Eligible participants were 19–80 years old with a CHA²DS²-VASc score ≥1 and had no documented atrial arrhythmia recurrence for at least 1-year post-ablation. A total of 840 patients were enrolled and randomly assigned to either discontinue anticoagulation (n=417) or continue therapy with direct oral anticoagulants (DOACs, n=423). The primary endpoint was the first occurrence of stroke, systemic embolism, or major bleeding within 2 years.

Results:
The mean age of participants was 64 years, 25% were female, and the mean CHA²DS²-VASc score was 2.1. Over 2 years, the primary endpoint occurred in 0.3% (1 patient) of the discontinuation group versus 2.2% (8 patients) of the continuation group (p=0.02). Additionally, ischemic stroke occurred in 0.3% versus 0.8%, and major bleeding in 0% versus 1.4% of patients, respectively.

Conclusions:
Patients who discontinued anticoagulation experienced lower rates of the composite endpoint of stroke, systemic embolism, and major bleeding compared to those who continued therapy.

Comment:
In AF patients with no recurrence after ablation and a moderate risk of stroke, discontinuing anticoagulation appears safe and may reduce major bleeding, offering clinical benefit. However, these findings should be validated in different populations and with longer-term follow-up.