Discontinuing oral anticoagulation (OAC) therapy lowered the risk of a composite endpoint of stroke, systemic embolism, or major bleeding compared with continuing OAC in patients who had undergone successful atrial fibrillation (AF) ablation at least 12 months earlier, according to results from the late-breaking ALONE-AF (Anticoagulation One year after Ablation of Atrial Fibrillation in Patients with Atrial Fibrillation) trial presented in a Hot Line session at ESC Congress 2025 and simultaneously published in The Journal of the American Medical Association.
AF, the most common sustained arrhythmia, is characterised by an irregular heartbeat that raises the risk of stroke and thromboembolism. Catheter ablation can eliminate abnormal heart tissue that triggers AF, while OAC is routinely prescribed for at least two months after ablation to reduce stroke risk. Beyond this period, guidelines recommend continued OAC depending on an individual’s stroke risk profile.
Many patients who have had a successful ablation and have stroke risk factors remain on OAC for the rest of their lives, although there is no evidence from randomised trials to indicate that this is necessary. The ALONE-AF trial compared direct OAC therapy with no OAC therapy among patients 1 year after successful AF ablation who had at least one risk factor for stroke.
The trial was conducted at 18 sites in South Korea. Eligible patients had non-valvular AF, had undergone their first catheter-based ablation, remained free of atrial arrhythmia for ≥12 months post-ablation, and had at least one stroke risk factor by CHA₂DS₂-VASc score (≥1 for men; ≥2 for women). Participants were randomised 1:1 to either continue OAC or discontinue it. Standard doses of apixaban, rivaroxaban, or edoxaban were used in the OAC group unless dose-reduction criteria applied. The primary endpoint was net adverse clinical events, a composite of stroke, systemic embolism, or major bleeding, at 24 months. The study enrolled 840 patients (mean age 64 years; 25% women).
At 24 months, net adverse clinical events were significantly higher in the OAC group compared with the no-OAC group (2.2% vs. 0.3%). Rates of ischaemic stroke or systemic embolism did not differ significantly (0.8% vs. 0.3%). However, major bleeding occurred in 1.4% of patients receiving OAC and in none of those who discontinued.
In the first randomised trial to address this question, receiving no OAC treatment resulted in a lower risk of harmful events than OAC treatment. A limitation was that the trial was not designed to detect a potential difference in ischaemic events, which occurred at a lower-than-expected rate. These findings indicate that lifelong OAC might not be necessary in all patients who have had successful AF ablation at least one year previously.
Source: ESC
Image Credit: ESC
References:
Kim D et al. Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation - The ALONE-AF Randomized Clinical Trial. JAMA.
