Discontinuing oral anticoagulant (OAC) therapy in patients with no documented atrial arrhythmia recurrence one year after catheter ablation for atrial fibrillation (AFib) resulted in a lower risk for the composite of stroke, systemic embolism and major bleeding compared with continuing direct oral anticoagulant therapy, based on results from the ALONE-AF trial presented at ESC Congress 2025 and simultaneously published in JAMA.

The trial randomized 840 patients from 18 hospitals in South Korea to discontinue OAC therapy (n=417) or continue OAC therapy (with direct oral anticoagulants; n=423). All participants had at least one 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 one year following catheter ablation for AFib.

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, including ischemic stroke and major bleeding, were assessed as secondary outcomes.

The primary outcome occurred in only one patient (0.3%) assigned to the discontinue group compared with eight patients (2.2%) continuing OAC therapy. In other findings, the two-year cumulative incidence of ischemic stroke was 0.3% in the discontinue group vs. 0.8% in the continuing group. No incidence of major bleeding was reported in the discontinue group compared with five patients (1.4%) in the continuing group. The study was limited in that it wasn't designed to detect a potential difference in ischemic events, which occurred at a lower-than-expected rate.

"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. Our findings indicate that lifelong OAC might not be necessary in all patients who have had successful AFib ablation at least one year previously."

In a related editorial, Edward P. Gerstenfeld, MD, MS, FACC, and Xiang Wen Lee, MBBS, 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."

Meanwhile two additional hot line trials presented at ESC Congress 2025 also addressed various aspects of AFib management.

In CUVIA-PRR, researchers in South Korea found digital twin-guided ablation plus pulmonary vein isolation (PVI) significantly improved arrhythmia-free survival compared with PVI alone, without compromising safety or prolonging the procedure time.

"Previous methods adopting a uniform approach to improve PVI success rates have not been effective and artificial intelligence-guided ablation was found to prolong procedure time," said Principal Investigator Daehoon Kim, MD. "Our tailored, patient-specific ablation approach improved outcomes by precisely targeting the individual mechanisms underlying AFib, without compromising safety or extending procedure time."

In the BEAT-PAROX-AF Trial, pulsed field ablation (PFA) did not have superior efficacy to radiofrequency ablation (RFA) in patients with drug-resistant paroxysmal (intermittent) AFib.

The primary endpoint of single-procedure success at 12 months was high and similar between the procedure types (77.2% PFA and 77.6% RFA). The safety profile was also similar across both groups. However, researchers noted the mean total procedure duration was significantly shorter for PFA than RFA (56 vs. 95 minutes), with an adjusted difference of −39 minutes.

"Pulmonary vein isolation using thermal RFA is a widely accepted and established treatment for antiarrhythmic drug-resistant AFib," said Principal Investigator Pierre Jaïs, MD. "However, pulmonary vein isolation has evolved with the introduction of PFA, which is a faster, more straightforward nonthermal procedure that potentially offers more selective tissue targeting than thermal energy sources. Other trials have compared PFA with thermal energy sources with inconclusive results."