Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study)

Lluís Mont, Felipe Bisbal, Antonio Hernández-Madrid, Nicasio Pérez-Castellano, Xavier Viñolas, Angel Arenal, Fernando Arribas, Ignacio Fernández-Lozano, Andrés Bodegas, Albert Cobos, Roberto Matía, Julián Pérez-Villacastín, José M Guerra, Pablo Ávila, María López-Gil, Victor Castro, José Ignacio Arana, Josep Brugada, SARA investigators, Naiara Calvo, Antonio Berruezo, Elena Arbelo, José María Tolosana, Concepción Moro, José Luis Zamorano, Concepción Alonso-Martín, Enrique Rodríguez- Font, Javier Moreno, Roberto Fernández, Adolfo Fontenla, Marta de Riva, Jorge Toquero, Elena Perez-Pereira, Lluis Mont, Julián Villacastín, Ángel Arenal, Gregorio Marañón, Josep Brugada, Angel Moya, Ignasi Anguera, Ginés Sanz, Albert Cobos, Mariona Cardona, Lluís Mont, Felipe Bisbal, Antonio Hernández-Madrid, Nicasio Pérez-Castellano, Xavier Viñolas, Angel Arenal, Fernando Arribas, Ignacio Fernández-Lozano, Andrés Bodegas, Albert Cobos, Roberto Matía, Julián Pérez-Villacastín, José M Guerra, Pablo Ávila, María López-Gil, Victor Castro, José Ignacio Arana, Josep Brugada, SARA investigators, Naiara Calvo, Antonio Berruezo, Elena Arbelo, José María Tolosana, Concepción Moro, José Luis Zamorano, Concepción Alonso-Martín, Enrique Rodríguez- Font, Javier Moreno, Roberto Fernández, Adolfo Fontenla, Marta de Riva, Jorge Toquero, Elena Perez-Pereira, Lluis Mont, Julián Villacastín, Ángel Arenal, Gregorio Marañón, Josep Brugada, Angel Moya, Ignasi Anguera, Ginés Sanz, Albert Cobos, Mariona Cardona

Abstract

Background: Catheter ablation (CA) is a highly effective therapy for the treatment of paroxysmal atrial fibrillation (AF) when compared with antiarrhythmic drug therapy (ADT). No randomized studies have compared the two strategies in persistent AF. The present randomized trial aimed to compare the effectiveness of CA vs. ADT in treating persistent AF.

Methods and results: Patients with persistent AF were randomly assigned to CA or ADT (excluding patients with long-standing persistent AF). Primary endpoint at 12-month follow-up was defined as any episode of AF or atrial flutter lasting >24 h that occurred after a 3-month blanking period. Secondary endpoints were any atrial tachyarrhythmia lasting >30 s, hospitalization, and electrical cardioversion. In total, 146 patients were included (aged 55 ± 9 years, 77% male). The ADT group received class Ic (43.8%) or class III drugs (56.3%). In an intention-to-treat analysis, 69 of 98 patients (70.4%) in the CA group and 21 of 48 patients (43.7%) in the ADT group were free of the primary endpoint (P = 0.002), implying an absolute risk difference of 26.6% (95% CI 10.0-43.3) in favour of CA. The proportion of patients free of any recurrence (>30 s) was higher in the CA group than in the ADT group (60.2 vs. 29.2%; P < 0.001) and cardioversion was less frequent (34.7 vs. 50%, respectively; P = 0.018).

Conclusion: Catheter ablation is superior to medical therapy for the maintenance of sinus rhythm in patients with persistent AF at 12-month follow-up.

Clinical trial registration information: NCT00863213 (https://ichgcp.net/clinical-trials-registry/NCT00863213).

Keywords: Antiarrhythmic drug; Atrial fibrillation; Atrial flutter; Catheter ablation; Clinical trial.

Figures

Figure 1
Figure 1
Study design flowchart (CONSORT flow diagram). CA, catheter ablation; ADT, antiarrhythmic drug therapy.
Figure 2
Figure 2
Survival curves for the primary endpoint.

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