A landmark randomized trial has provided the first evidence that patients with atrial fibrillation (AFib) may safely discontinue oral anticoagulant therapy one year after successful catheter ablation, challenging current clinical practice guidelines that recommend lifelong anticoagulation for patients with stroke risk factors.
The ALONE-AF trial, presented at ESC Congress 2025 and simultaneously published in JAMA, randomized 840 patients from 18 hospitals in South Korea to either discontinue oral anticoagulant (OAC) therapy or continue direct oral anticoagulant therapy. All participants had at least one non-sex-related stroke risk factor based on CHA2DS2-VASc scoring and no documented atrial arrhythmia recurrence for at least one year following catheter ablation.
Primary Outcomes Show Dramatic Risk Reduction
The primary composite outcome of stroke, systemic embolism, and major bleeding at two years occurred in only one patient (0.3%) in the discontinuation group compared with eight patients (2.2%) in the continuation group. The results were driven by a complete absence of major bleeding events in the discontinuation group, while five patients (1.4%) in the continuation group experienced major bleeding.
Ischemic stroke rates remained low in both groups, with a two-year cumulative incidence of 0.3% in the discontinuation group versus 0.8% in the continuation group. However, the study was limited by its design, which wasn't powered to detect potential differences in ischemic events that occurred at lower-than-expected rates.
"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 randomized trials to indicate that this is necessary," said Principal Investigator Boyoung Joung, MD. "In the first randomized trial to address this question, receiving no OAC treatment resulted in a lower risk of harmful events than OAC treatment."
Clinical Implications for Post-Ablation Management
The findings have significant implications for clinical practice, as noted in a related editorial by Edward P. Gerstenfeld, MD, MS, FACC, and Xiang Wen Lee, MBBS. They highlight that the study "provides much-needed data for patients undergoing AFib ablation, providing data supporting cessation of oral anticoagulants for patients with AFib at intermediate stroke risk and higher bleeding risk with preserved left atrial function one year after successful ablation."
Dr. Joung concluded that the findings "indicate that lifelong OAC might not be necessary in all patients who have had successful AFib ablation at least one year previously."
Supporting Evidence from OPTION Trial Subanalysis
Complementary data from a subanalysis of the OPTION clinical trial, presented by Oussama Wazni, MD, MBA, at ESC Congress 2025, provides additional context for post-ablation anticoagulation strategies. The analysis examined left atrial appendage closure (LAAC) as an alternative to oral anticoagulation across different stroke risk levels in 1,600 patients.
The subanalysis compared outcomes between patients with high stroke risk (CHA2DS2-VASc score ≥4) and lower stroke risk (CHA2DS2-VASc score ≤3). Results showed that LAAC provided equivalent efficacy to oral anticoagulation while significantly reducing bleeding risk across both stroke risk groups.
"In patients at both high and lower stroke risk, LAA closure was equally effective as oral anticoagulation while being associated with fewer bleeding events," said Dr. Wazni. "This means that LAA closure can be an especially good option for ablation patients at high risk of stroke if they discontinue oral anticoagulation due to bleeding."
Additional AFib Management Advances
Two other trials presented at ESC Congress 2025 addressed different aspects of AFib management. The CUVIA-PRR trial demonstrated that digital twin-guided ablation plus pulmonary vein isolation significantly improved arrhythmia-free survival compared with PVI alone, without compromising safety or prolonging procedure time.
"Our tailored, patient-specific ablation approach improved outcomes by precisely targeting the individual mechanisms underlying AFib, without compromising safety or extending procedure time," said Principal Investigator Daehoon Kim, MD.
The BEAT-PAROX-AF trial found that pulsed field ablation (PFA) showed similar efficacy to radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal AFib, with primary endpoint success rates of 77.2% for PFA and 77.6% for RFA at 12 months. However, PFA demonstrated significantly shorter procedure duration (56 vs. 95 minutes).
Future Clinical Considerations
Tyler Taigen, MD, Co-Director of Electrophysiology Laboratories at Cleveland Clinic, emphasized the clinical significance of these findings: "To reduce risk of stroke, best practice for most patients has been to continue anticoagulation even after a successful AF ablation procedure. This most recent analysis of OPTION is important because it demonstrates effective stroke prevention and less bleeding in patients who received the LAAC device, including those at highest risk."
The convergent evidence from both ALONE-AF and OPTION suggests that personalized approaches to post-ablation anticoagulation management may be warranted, moving away from the current one-size-fits-all approach of lifelong anticoagulation for all patients with stroke risk factors.
