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

Paulus Kirchhof1,2,3, A John Camm4, Harry J G M Crijns5

  • 1Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Insights

Dronedarone significantly reduced cardiovascular events in early atrial fibrillation (AF) patients. Early rhythm control with dronedarone is supported for selected early AF patients.

Area of Science:

  • Cardiology
  • Pharmacology

Background:

  • The ATHENA trial (NCT00174785) investigated dronedarone for atrial fibrillation (AF).
  • The EAST-AFNET 4 trial (NCT01288352) established criteria for early rhythm control in AF.

Purpose of the Study:

  • To assess if dronedarone (400 mg twice daily) improves cardiovascular outcomes in early atrial fibrillation/atrial flutter (AF) patients with comorbidities.
  • To evaluate dronedarone's efficacy and safety based on EAST-AFNET 4 inclusion criteria and outcomes.

Main Methods:

  • Post-hoc analysis of the ATHENA trial involving 1810 patients with early AF.
  • Co-primary outcomes included a composite of cardiovascular death, stroke, or hospitalizations for heart failure/acute coronary syndrome, and nights in hospital per year.
  • Secondary outcome was sinus rhythm at 12 months; primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm control therapy.

Main Results:

  • Dronedarone significantly reduced the composite of cardiovascular death, stroke, or hospitalizations (HR 0.71; P=0.014).
  • No difference in hospital nights between groups.
  • More patients on dronedarone achieved sinus rhythm (69.2%) versus placebo (60.8%).
  • No significant difference in primary safety events between dronedarone and placebo groups.

Conclusions:

  • Dronedarone demonstrated efficacy in reducing cardiovascular events in early AF patients.
  • The findings support early rhythm control therapy with dronedarone in selected early AF patients.
Abstract

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