Arrhythmias & electrophysiology

Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria

EuropacePublished Post-hoc analysis of the ATHENA randomised trial

Primary result · CV death, stroke, or hospitalisation for HF or ACSResult — go to the resultHazard ratio 0.71 95% CI 0.54–0.94

Study context

Population
Patients with early AF/atrial flutter and CV comorbidities meeting EAST-AFNET 4 inclusion criteriaearly AF
Participants
1,810 patients
Comparison
Dronedarone vs placebo
  • Dronedaronen = 924
  • Placebon = 886reference
Primary endpoint
Co-primary: (i) CV death, stroke, or hospitalisation for worsening heart failure (HF) or acute coronary syndrome (ACS); (ii) nights spent in hospital per year
Methodological detailsplacebo-controlled, EAST-AFNET 4 criteria
  • Placebo-controlled
  • EAST-AFNET 4 criteria

Primary result

As reported in the abstract

CV death, stroke, or hospitalisation for HF or ACS

Hazard ratio

0.71

95% CI 0.54–0.94

P = 0.014

Events by treatment group

Dronedarone

87

events

Placebo

117

events

Dronedarone vs Placebo
HR 0.71 (95% CI 0.54–0.94); P = 0.014

Secondary outcomes

Sinus rhythm · 12 months

Safety

Events

OutcomeDronedaronePlacebo
Primary safety outcome: death, stroke, or prespecified serious AESIs related to rhythm control therapy6071
  • Primary safety outcome: death, stroke, or prespecified serious adverse events of special interest (AESIs) related to rhythm control therapy: patients with ≥1 event

Primary safety outcome: death, stroke, or prespecified serious AESIs related to rhythm control therapy

Not different between groups

Original publication

Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. Europace. Published 29 April 2025. doi:10.1093/europace/euaf080

Summarised from the published abstract; every number is checked against it

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