Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials

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Introduction: The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization. Methods: Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status. Results: Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P =.02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P <.01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups. Conclusion: Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.


  • Munveer Thind
  • Harry J. Crijns
  • Gerald V. Naccarelli
  • James A. Reiffel
  • Valérie Corp dit Genti
  • Mattias Wieloch
  • Andrew Koren
  • Peter R. Kowey
External organisations
  • Pennsylvania State University College of Medicine
  • Columbia University
  • Lankenau Institute for Medical Research
  • Maastricht University Medical Centre
  • Maastricht University
  • Sanofi-Synthelabo, Inc.
  • Sanofi-Aventis
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems


  • antiarrhythmic drug, atrial fibrillation, atrial flutter, cardioversion, dronedarone
Original languageEnglish
JournalJournal of Cardiovascular Electrophysiology
Publication statusE-pub ahead of print - 2020 Feb 21
Publication categoryResearch