Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation.

Authors

• Oussama M Wazni
• K R Julian Chun
• Devi G Nair
• Ante Anic
• Mattias Duytschaever
• Jonathan Chrispin
• Anish Amin, OhioHealth
• Olujimi A Ajijola
• Douglas N Gibson
• Moussa Mansour
• Jonathan P Piccini
• Andrea Natale
• Auroa Badin
• Joaquin Osca
• Jonathan Dukes
• Karan Bhalla
• Ayman Hussein
• Todd Senn
• Stanislav Weiner
• Nitesh Sood
• Antonio Dello Russo
• Ashish Sadhu
• Jason Meyers
• Kevin Trulock
• Mark T K Tam
• David B DeLurgio
• Jean Champagne
• Saverio Iacopino
• Brian Kwan
• Elizabeth M Albrecht
• Sheryl McCammon
• Ann C Garlitski
• Brad S Sutton
• Kenneth M Stein
• Jason G Andrade

Document Type

Article

Publication Title

The New England journal of medicine

Abstract

BACKGROUND: Guidelines recommend a trial of antiarrhythmic drugs before catheter ablation for persistent atrial fibrillation. Whether pulsed field ablation (PFA) may be a preferred initial treatment is unclear.

METHODS: We conducted an international, randomized trial involving patients with previously untreated persistent atrial fibrillation. The patients were randomly assigned in a 2:1 ratio to receive PFA performed with a pentaspline catheter or to receive antiarrhythmic-drug therapy. An additional group of patients (PFA-assigned) underwent PFA for the analysis of the primary safety end point alone. All the patients received an insertable cardiac monitor. The primary effectiveness end point was the short-term and long-term success of treatment through 12 months. Short-term success was defined as procedural success in the PFA group and the absence of ablation during the blanking period (90 days after treatment initiation) in the antiarrhythmic-drug group. Long-term success was defined as freedom from recurrence of atrial arrhythmias, repeat ablation, or need for antiarrhythmic drugs from 90 days through 12 months (in the PFA group) and freedom from amiodarone use at any time. The primary safety end point was device- and procedure-related serious adverse events.

RESULTS: At 12 months, treatment success was observed in 128 of 207 patients (Kaplan-Meier estimate, 56%; 95% confidence interval [CI], 48 to 63) in the PFA group and in 40 of 103 patients (Kaplan-Meier estimate, 30%; 95% CI, 21 to 40) in the antiarrhythmic-drug group (hazard ratio for composite treatment failure [a lack of short- and long-term success], 0.46; 95% CI, 0.33 to 0.65; P< 0.001). A primary safety end-point event occurred in 13 of 257 patients (5.1%) in the combined PFA group (both randomized and PFA-assigned groups). At 12 months, serious adverse events had occurred in 45 patients (25%) in the PFA group and in 20 patients (21%) in the antiarrhythmic-drug group.

CONCLUSIONS: Among patients with persistent atrial fibrillation, the risk of recurrence of atrial arrhythmia was significantly lower among those who received PFA as first-line treatment than among those who received antiarrhythmic-drug therapy. (Funded by Boston Scientific; AVANT GUARD ClinicalTrials.gov number, NCT06096337.).

DOI

10.1056/NEJMoa2600929

Publication Date

4-25-2026

Recommended Citation

Wazni OM, Chun KRJ, Nair DG, Anic A, Duytschaever M, Chrispin J, Amin A, Ajijola OA, Gibson DN, Mansour M, Piccini JP, Natale A, Badin A, Osca J, Dukes J, Bhalla K, Hussein A, Senn T, Weiner S, Sood N, Dello Russo A, Sadhu A, Meyers J, Trulock K, Tam MTK, DeLurgio DB, Champagne J, Iacopino S, Kwan B, Albrecht EM, McCammon S, Garlitski AC, Sutton BS, Stein KM, Andrade JG; AVANT GUARD Study Investigators. Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation. N Engl J Med. 2026 Apr 25. doi: 10.1056/NEJMoa2600929. Epub ahead of print. PMID: 42041224.