Dronedarone provides effective early rhythm control : post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria
(2025) In Europace 27(4).- Abstract
Aims This post-hoc analysis of the ATHENA trial assessed whether dronedarone (400 mg twice daily) improved cardiovascular outcomes compared with placebo in patients with early atrial fibrillation/atrial flutter (AF) and cardiovascular comorbidities, based on EAST-AFNET 4 inclusion criteria and outcomesMethods The co-primary outcomes were (i) a composite of cardiovascular death, stroke, or hospitalisation due to worsening of heart and results failure (HF) or acute coronary syndrome (ACS) and (ii) nights spent in hospital per year. Sinus rhythm (SR) at 12 months was a secondary outcome. The primary safety outcome was a composite of death, stroke, or pre-specified serious adverse events of special interest (AESIs) related to... (More)
Aims This post-hoc analysis of the ATHENA trial assessed whether dronedarone (400 mg twice daily) improved cardiovascular outcomes compared with placebo in patients with early atrial fibrillation/atrial flutter (AF) and cardiovascular comorbidities, based on EAST-AFNET 4 inclusion criteria and outcomesMethods The co-primary outcomes were (i) a composite of cardiovascular death, stroke, or hospitalisation due to worsening of heart and results failure (HF) or acute coronary syndrome (ACS) and (ii) nights spent in hospital per year. Sinus rhythm (SR) at 12 months was a secondary outcome. The primary safety outcome was a composite of death, stroke, or pre-specified serious adverse events of special interest (AESIs) related to rhythm control therapy. 1810 patients with early AF were identified. Patients receiving dronedarone had fewer deaths from cardiovascular causes, strokes, or hospitalisations due to worsening of HF or ACS compared with patients receiving placebo [dronedarone (n = 924), 87 patients with ≥1 event; placebo (n = 886), 117 patients with ≥1 event; hazard ratio 0.71; 95% confidence interval 0.54–0.94; P = 0.014]. Number of nights spent in hospital did not differ between treatment groups. More patients receiving dronedarone (69.2%) were in SR at 12 months compared with placebo (60.8%). Primary safety events comprising death, stroke, or pre-specified serious AESIs related to rhythm control therapy were not different (dronedarone vs. placebo: 60 vs. 71 patients with ≥1 eventConclusion These data support the use of dronedarone for early rhythm control therapy in selected patients with early AF. Trial ATHENA: ClinicalTrials.gov identifier NCT00174785. EAST-AFNET 4: ClinicalTrials.gov identifier NCT01288352.
(Less)
- author
- Kirchhof, Paulus ; John Camm, A. ; Crijns, Harry J.G.M. ; Piccini, Jonathan P. ; Torp-Pedersen, Christian ; McKindley, David S. ; Wieloch, Mattias LU and Hohnloser, Stefan H.
- organization
- publishing date
- 2025-04-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Atrial fibrillation, Atrial flutter, Dronedarone, Early rhythm control
- in
- Europace
- volume
- 27
- issue
- 4
- article number
- euaf080
- publisher
- Oxford University Press
- external identifiers
-
- scopus:105003959953
- pmid:40295782
- ISSN
- 1099-5129
- DOI
- 10.1093/europace/euaf080
- language
- English
- LU publication?
- yes
- id
- 9f3860fc-50e4-4b02-83b8-85fa4896fb57
- date added to LUP
- 2025-08-13 13:09:13
- date last changed
- 2025-08-14 14:31:45
@article{9f3860fc-50e4-4b02-83b8-85fa4896fb57,
abstract = {{<p>Aims This post-hoc analysis of the ATHENA trial assessed whether dronedarone (400 mg twice daily) improved cardiovascular outcomes compared with placebo in patients with early atrial fibrillation/atrial flutter (AF) and cardiovascular comorbidities, based on EAST-AFNET 4 inclusion criteria and outcomesMethods The co-primary outcomes were (i) a composite of cardiovascular death, stroke, or hospitalisation due to worsening of heart and <sup>results</sup> failure (HF) or acute coronary syndrome (ACS) and (ii) nights spent in hospital per year. Sinus rhythm (SR) at 12 months was a secondary outcome. The primary safety outcome was a composite of death, stroke, or pre-specified serious adverse events of special interest (AESIs) related to rhythm control therapy. 1810 patients with early AF were identified. Patients receiving dronedarone had fewer deaths from cardiovascular causes, strokes, or hospitalisations due to worsening of HF or ACS compared with patients receiving placebo [dronedarone (n = 924), 87 patients with ≥1 event; placebo (n = 886), 117 patients with ≥1 event; hazard ratio 0.71; 95% confidence interval 0.54–0.94; P = 0.014]. Number of nights spent in hospital did not differ between treatment groups. More patients receiving dronedarone (69.2%) were in SR at 12 months compared with placebo (60.8%). Primary safety events comprising death, stroke, or pre-specified serious AESIs related to rhythm control therapy were not different (dronedarone vs. placebo: 60 vs. 71 patients with ≥1 event<sup>Conclusion</sup> These data support the use of dronedarone for early rhythm control therapy in selected patients with early AF. Trial ATHENA: ClinicalTrials.gov identifier NCT00174785. EAST-AFNET 4: ClinicalTrials.gov identifier NCT01288352.</p>}},
author = {{Kirchhof, Paulus and John Camm, A. and Crijns, Harry J.G.M. and Piccini, Jonathan P. and Torp-Pedersen, Christian and McKindley, David S. and Wieloch, Mattias and Hohnloser, Stefan H.}},
issn = {{1099-5129}},
keywords = {{Atrial fibrillation; Atrial flutter; Dronedarone; Early rhythm control}},
language = {{eng}},
month = {{04}},
number = {{4}},
publisher = {{Oxford University Press}},
series = {{Europace}},
title = {{Dronedarone provides effective early rhythm control : post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria}},
url = {{http://dx.doi.org/10.1093/europace/euaf080}},
doi = {{10.1093/europace/euaf080}},
volume = {{27}},
year = {{2025}},
}