Arrhythmias & electrophysiology

Dronedarone vs Sotalol Among Patients With Atrial Fibrillation: A Meta-Analysis of Retrospective Observational Databases

JACC Clin ElectrophysiolPublished prespecified noninterventional meta-analysis of 4 retrospective observational cohort studies

Authors' conclusion

In this retrospective meta-analysis, dronedarone exhibited significantly lower rates of CV hospitalization and ventricular arrhythmias compared with sotalol. These findings provide real-world evidence to support selection of the most appropriate first-line AAD for rhythm control in patients with AF.

Study context

Population
AAD-naive patients with Atrial Fibrillation (AF), from Optum Clinformatics Data Mart, Merative MarketScan, Veterans Health Administration Electronic Health Record, and the Swedish National Patient Register4 retrospective observational cohort studies from 4 databases
Comparison
Dronedarone vs sotalol
Outcome
Primary outcomes, tested hierarchically: Cardiovascular (CV) hospitalization, then ventricular arrhythmias
Methodological detailsone master protocol, target trial emulation, active comparator, new user design, as-treated approach, propensity score matching, negative control outcomes, fixed effects models
  • One master protocol
  • Target trial emulation
  • Active comparator, new user design
  • As-treated approach
  • Propensity score matching
  • Negative control outcomes
  • Fixed effects models

Pooled result

As reported in the abstract

dronedarone vs sotalolPooled hazard ratio (95% CI)
CV hospitalization
0.91(0.85–0.97)
Ventricular arrhythmias
0.77(0.69–0.85)

Further pooled results

Cohort balance after propensity score matching (PSM)

Mean age range
62.5-70.9 years
Mean CHA2DS2-VASc score range
1.81-3.15
  • Well balanced within databases before and after PSM

Negative control outcomes

Little-to-no evidence of residual confounding

Original publication

Dronedarone vs Sotalol Among Patients With Atrial Fibrillation: A Meta-Analysis of Retrospective Observational Databases. JACC Clin Electrophysiol. Published 23 April 2025. doi:10.1016/j.jacep.2025.02.029

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