Abstract
IntroductionThe 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.MethodsTime to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status.ResultsOf 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.ConclusionPatients 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.
Highlights
The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF
In the European Trial in AF or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm (EURIDIS; NCT00259428) and the American‐Australian‐African Trial with Dronedarone in AF Patients for the Maintenance of Sinus Rhythm (ADONIS; NCT00259376), dronedarone significantly increased the time to first documented AF/atrial flutter (AFL) recurrence and reduced ventricular rate during recurrence compared with placebo
In this analysis of the EURIDIS and ADONIS studies, we evaluated patient characteristics, patterns of AF/AFL recurrences, clinical outcomes, and safety in patients with nonpermanent AF/AFL by baseline cardioversion status
Summary
Antiarrhythmic drugs (AADs) are typically not recommended after the first diagnosis of atrial fibrillation (AF). In the European Trial in AF or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm (EURIDIS; NCT00259428) and the American‐Australian‐African Trial with Dronedarone in AF Patients for the Maintenance of Sinus Rhythm (ADONIS; NCT00259376), dronedarone significantly increased the time to first documented AF/atrial flutter (AFL) recurrence and reduced ventricular rate during recurrence compared with placebo.8 In these trials, patients in AF/AFL were included if they reverted to sinus rhythm or had successful cardioversion within 5 days before randomization.. Patients in AF/AFL were included if they reverted to sinus rhythm or had successful cardioversion within 5 days before randomization.8 In this pooled analysis of EURIDIS and ADONIS, we assessed whether baseline characteristics and treatment outcomes differed by baseline cardioversion status Dronedarone is an AAD indicated to reduce risk of hospitalization for AF in patients in sinus rhythm with a history of paroxysmal/ persistent AF. In the European Trial in AF or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm (EURIDIS; NCT00259428) and the American‐Australian‐African Trial with Dronedarone in AF Patients for the Maintenance of Sinus Rhythm (ADONIS; NCT00259376), dronedarone significantly increased the time to first documented AF/atrial flutter (AFL) recurrence and reduced ventricular rate during recurrence compared with placebo. In these trials, patients in AF/AFL were included if they reverted to sinus rhythm or had successful cardioversion within 5 days before randomization. In this pooled analysis of EURIDIS and ADONIS, we assessed whether baseline characteristics and treatment outcomes differed by baseline cardioversion status
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