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

Mate Vamos, Hugh Calkins, Peter R. Kowey, Christian T. Torp-Pedersen, Valérie Corp dit Genti, Mattias Wieloch, Andrew Koren, Stefan H. Hohnloser

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)291-297
Number of pages7
JournalClinical Cardiology
Volume43
Issue number3
DOIs
StatePublished - Mar 1 2020

Keywords

  • ablation
  • antiarrhythmic drug
  • atrial fibrillation
  • atrial flutter
  • dronedarone

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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