Open AccessEfficacy and safety of dronedarone in patients with a prior ablation for atrial fibrillation/flutter: Insights from the ATHENA study
Author(s) -
Vamos Mate,
Calkins Hugh,
Kowey Peter R.,
TorpPedersen Christian T.,
Corp dit Genti Valérie,
Wieloch Mattias,
Koren Andrew,
Hohnloser Stefan H.
Publication year - 2020
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23309
Subject(s) - dronedarone , medicine , atrial fibrillation , atrial flutter , cardiology , placebo , catheter ablation , hazard ratio , ablation , sinus rhythm , confidence interval , amiodarone , anesthesia , alternative medicine , pathology
Abstract Background The role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established. Hypothesis We hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone. Methods We assessed the efficacy and safety of dronedarone in the treatment of paroxysmal/persistent atrial fibrillation/atrial flutter (AF/AFL) post‐ablation, based on a post hoc analysis of the ATHENA study. A total of 196 patients (dronedarone 90, placebo 106) had an ablation for AF/AFL before study entry. In these patients, the effect of treatment on the first hospitalization because of cardiovascular (CV) events/all‐cause death was assessed, as was AF/AFL recurrence in individuals with sinus rhythm at baseline. The safety of dronedarone vs placebo was also determined. Results In patients with prior ablation, dronedarone reduced the risk of AF/AFL recurrence (hazard ratio [HR]: 0.65 [95% confidence interval [CI]: 0.42, 1.00]; P < .05) as well as the median time to first AF/AFL recurrence (561 vs 180 days) compared with placebo. The HR for first CV hospitalization/all‐cause death with dronedarone vs placebo was 0.98 (95% CI: 0.62, 1.53; P = .91). Rates of treatment‐emergent adverse events were 83.1% vs 75.5% and rates of serious TEAEs were 27.0% vs 18.9% in the dronedarone and placebo groups, respectively. One death occurred with dronedarone (not treatment‐emergent) and five occurred with placebo. Conclusion In patients with prior ablation for AF/AFL, dronedarone reduced the risk of AF/AFL recurrence compared with placebo, but not the risk of first CV hospitalization/all‐cause death. Safety outcomes were consistent with those of the overall ATHENA study.