Catheter ablation vs. anti arrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study)
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2014
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Oxford University Press
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Mont L, Bisbal F, Hernández-Madrid A, Pérez-Castellano N, Viñolas X, Arenal A, Arribas F, Fernández-Lozano I, Bodegas A, Cobos A, Matía R, Pérez-Villacastín J, Guerra JM, Ávila P, López-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501-7. doi: 10.1093/eurheartj/eht457
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.
Description
La ablación es una terapia altamente efectiva en el tratamiento de la fibrilación auricular paroxística cuando se compara con la terapia farmacológica. Sin embargo, su elección en pacientes con fibrilación auricular persistente sigue siendo controvertida ya que la evidencia a favor de la ablación es débil, puesto que deriva de ensayos clínicos que comparan estas dos terapias pero que no son aleatorios.
Se diseñó este estudio, primer ensayo clínico aleatorizado y controlado para comparar la efectividad del control del ritmo frente a tratamiento antiarrítmico convencional.
El objetivo de este estudio fue pues, comparar la eficacia y la seguridad de la ablación frente a la terapia farmacológica antiarrítmica en el mantenimiento del ritmo sinusal en pacientes con fibrilación auricular persistente.
Este estudio demuestra que la ablación es superior al tratamiento farmacológico antiarrítmico para lograr el mantenimiento del ritmo sinusal en pacientes con fibrilación auricular persistente a los 12 meses de seguimiento