Comparación de la eficacia y seguridad de flecainida y dronedarona como terapias antiarrítmicas para mantenimiento de ritmo sinusal en fibrilación auricular / Comparison of the efficacy and safety of dronedarone and flecainide as maintenance antiarrhythmic therapy for sinus rhythm in atrial fibrillation

Resumen Introducción y objetivos: Dronedarona y flecainida son antiarrítmicos de primera elección para reducir recurrencias de fibrilación auricular (FA), sin existir estudios que los comparen entre sí. Nuestro objetivo es comparar la eficacia en cuanto a prevención de recurrencias y seguridad de ambos fármacos. Métodos: Estudio retrospectivo en el que se incluyeron 123 pacientes de forma consecutiva en tratamiento con flecainida o dronedarona desde octubre de 2010 hasta febrero de 2013 por FA paroxística (76.4%) y FA persistente (23.6%). Se realizó cardioversión eléctrica en un 7.3% de los pacientes y farmacológica en un 16.3%. La mediana (rango intercuartílico) de seguimiento fue de 301 días (92-474), con una media de 2.8 revisiones por paciente. Se realizó análisis de tiempo hasta el primer evento mediante Kaplan-Meier y regresión de Cox ajustada por un índice de propensión. Resultados: De entre los 123 sujetos incluidos con FA, 71 fueron tratados con flecainida y 52 con dronedarona. Durante el seguimiento se registraron 36 recurrencias y 20 efectos adversos. Se documentaron un 36.6% de recurrencias en los pacientes tratados con flecainida en comparación con un 21% en los tratados con dronedarona (p = 0.073). En el análisis multivariante, dronedarona se mostró al menos tan eficaz como flecainida para prevenir recurrencias de FA (HR: 0.53, IC 95%: 0.20-1.44, p = 0.221) y demostró un perfil de seguridad comparable al de flecainida (HR: 0.68, IC 95%: 0.18-2.53, p = 0.566). Conclusiones: Según nuestra experiencia, dronedarona resulta al menos tan eficaz como flecainida para el mantenimiento de ritmo sinusal, con un buen perfil de tolerabilidad, a pesar de pautarse en pacientes con un perfil clínico más desfavorable.

Abstract Introduction and objectives: Dronedarone and flecainide are the first pharmacological choice to reduce recurrence of atrial fibrillation (AF); however, there are no studies comparing them. A study was performed to compare the efficacy in terms of recurrence of AF and safety of both drugs. Methods: A retrospective cohort study was conducted that included 123 consecutive patients treated with flecainide or dronedarone due to paroxysmal AF (76.4%) or persistent AF (23.6%), from October 2010 to February 2013. Electrical cardioversion was performed in 7.3% of patients and pharmacological cardioversion in 16.3%. The median (interquartile range) follow-up was 301 days (92-474) with a mean of 2.8 reviews per patient. Time to first event analysis was performed using Kaplan-Meier and Cox regression, adjusted for propensity score. Results: Of the 123 consecutive patients with AF included, 71 were on dronedarone and 52 on flecainide. During the follow-up, there were 36 AF recurrences and 20 safety events. There were recurrences in 36.6% of patients treated with flecainide, compared with 21% of those receiving dronedarone (P = .073). Dronedarone showed to be at least as effective as flecainide in preven- ting recurrence of atrial fibrillation (HR: 0.53, 95% CI: 0.20-1.44, P = .221), and demonstrated an acceptable safety profile when compared with flecainide (HR: 0.68, 95% CI: 0.18-2.53, P = .566). Conclusions: In our experience, dronedarone has been at least as effective and safe as flecainide, despite it was most frequently prescribed in patients with worse baseline risk profile.

[Comparison of the efficacy and safety of dronedarone and flecainide as maintenance antiarrhythmic therapy for sinus rhythm in atrial fibrillation]. / Comparación de la eficacia y seguridad de flecainida y dronedarona como terapias antiarrítmicas para mantenimiento de ritmo sinusal en fibrilación auricular.

INTRODUCTION AND OBJECTIVES: Dronedarone and flecainide are the first pharmacological choice to reduce recurrence of atrial fibrillation (AF); however, there are no studies comparing them. A study was performed to compare the efficacy in terms of recurrence of AF and safety of both drugs. METHODS: A retrospective cohort study was conducted that included 123 consecutive patients treated with flecainide or dronedarone due to paroxysmal AF (76.4%) or persistent AF (23.6%), from October 2010 to February 2013. Electrical cardioversion was performed in 7.3% of patients and pharmacological cardioversion in 16.3%. The median (interquartile range) follow-up was 301days (92-474) with a mean of 2.8 reviews per patient. Time to first event analysis was performed using Kaplan-Meier and Cox regression, adjusted for propensity score. RESULTS: Of the 123 consecutive patients with AF included, 71 were on dronedarone and 52 on flecainide. During the follow-up, there were 36 AF recurrences and 20 safety events. There were recurrences in 36.6% of patients treated with flecainide, compared with 21% of those receiving dronedarone (P=.073). Dronedarone showed to be at least as effective as flecainide in preventing recurrence of atrial fibrillation (HR: 0.53, 95% CI: 0.20-1.44, P=.221), and demonstrated an acceptable safety profile when compared with flecainide (HR: 0.68, 95% CI: 0.18-2.53, P=.566). CONCLUSIONS: In our experience, dronedarone has been at least as effective and safe as flecainide, despite it was most frequently prescribed in patients with worse baseline risk profile.