- Question
- Can pulsed field ablation (PFA) be a preferred initial treatment over antiarrhythmic drugs in patients with previously untreated persistent atrial fibrillation?
- Design
- International, randomized, open-label (no masking) trial with 2:1 assignment to PFA or antiarrhythmic-drug therapy, with 484 patients enrolled per the registry. An additional PFA-assigned group was included for the primary safety analysis alone, and all patients received an insertable cardiac monitor.
- Population
- Patients with persistent atrial fibrillation who had not received prior treatment.
- Intervention
- PFA performed with a pentaspline catheter as initial therapy.
- Control
- Antiarrhythmic-drug therapy as first-line treatment.
- Primary outcome
- Treatment success through 12 months, combining short-term success (procedural success with PFA; no ablation during the 90-day blanking period in the drug group) and long-term success (freedom from atrial arrhythmia recurrence, repeat ablation or antiarrhythmic drug need from day 90 to 12 months with PFA, and freedom from amiodarone use). The primary safety end point was serious device- or procedure-related adverse events.
- Results
- At 12 months, treatment success occurred in 128 of 207 patients in the PFA group (Kaplan-Meier estimate 56%; 95% CI 48 to 63) versus 40 of 103 in the antiarrhythmic-drug group (30%; 95% CI 21 to 40), with a hazard ratio for composite treatment failure of 0.46 (95% CI 0.33 to 0.65; P<0.001).
- Safety
- A primary safety end-point event occurred in 13 of 257 patients (5.1%) in the combined PFA group. At 12 months, serious adverse events had occurred in 45 patients (25%) with PFA and in 20 (21%) with antiarrhythmic drugs.
- Conclusion
- In persistent atrial fibrillation, first-line PFA significantly lowered the risk of atrial arrhythmia recurrence compared with antiarrhythmic-drug therapy.
- Why it matters
- It adds evidence supporting pulsed field ablation as an initial strategy, without necessarily requiring a prior trial of antiarrhythmic drugs, in persistent atrial fibrillation.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026