Efficacy and safety of dronedarone in patients with a prior ablation for atrial fibrillation/flutter: Insights from the ATHENA study

Clin Cardiol. 2020 Mar;43(3):291-297. doi: 10.1002/clc.23309. Epub 2019 Dec 24.

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.

Keywords: ablation; antiarrhythmic drug; atrial fibrillation; atrial flutter; dronedarone.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Arrhythmia Agents / adverse effects
  • Anti-Arrhythmia Agents / therapeutic use*
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / mortality
  • Atrial Fibrillation / physiopathology
  • Atrial Fibrillation / therapy*
  • Atrial Flutter / diagnosis
  • Atrial Flutter / mortality
  • Atrial Flutter / physiopathology
  • Atrial Flutter / therapy*
  • Catheter Ablation* / adverse effects
  • Catheter Ablation* / mortality
  • Double-Blind Method
  • Dronedarone / adverse effects
  • Dronedarone / therapeutic use*
  • Female
  • Heart Rate / drug effects*
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Recurrence
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Arrhythmia Agents
  • Dronedarone