Abstract
BackgroundThe role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established.HypothesisWe hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone.MethodsWe 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.ResultsIn 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.ConclusionIn 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.
Highlights
Antiarrhythmic drugs (AADs) have commonly been used as first-line treatment for maintenance of sinus rhythm in individuals with paroxysmal and persistent atrial fibrillation (AF), and form a class IA recommendation in the American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) AF guidelines.[1,2] Real-world data indicate an increasing use of catheter ablation for rhythm management of AF,[3,4] driven by improvements in ablation techniques and outcomes.[5]
Among the 128 patients who were in sinus rhythm at baseline, AF/atrial flutter (AFL) recurrence occurred in 36 of 63 patients (57.1%) treated with dronedarone and 46 of 65 patients (70.8%) treated with placebo (Table 3)
Median time to first atrial fibrillation/atrial flutter (AF/AFL) recurrence was longer (561 days [95% confidence interval (CI): 342, 778] vs 180 days [95% CI: 61, 429]) and risk of first AF/AFL recurrence was lower in patients treated with dronedarone compared with placebo (HR: 0.65 [95% CI: 0.42, 1.00], P < .05; Table 3; Figure 1)
Summary
Antiarrhythmic drugs (AADs) have commonly been used as first-line treatment for maintenance of sinus rhythm in individuals with paroxysmal and persistent atrial fibrillation (AF), and form a class IA recommendation in the American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) AF guidelines.[1,2] Real-world data indicate an increasing use of catheter ablation for rhythm management of AF,[3,4] driven by improvements in ablation techniques and outcomes.[5]. There is a substantial gap in scientific evidence regarding the impact of ablation on the effectiveness and safety of AADs in the post-ablation setting. Dronedarone is an AAD that has been shown to reduce the rate of hospitalization because of cardiovascular (CV) events in patients with paroxysmal or persistent AF or atrial flutter (AFL) in a randomized, double-blind, placebo-controlled phase 3 study (“A Trial with Dronedarone to Prevent Hospitalization or Death in Patients with Atrial Fibrillation” [ATHENA; NCT00174785]).[12] The aim of the current analysis was to assess the efficacy and safety of dronedarone among patients with prior ablation who received treatment in the ATHENA study
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