Evidence map›Paper›PMID 40295782›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2025

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

Paulus Kirchhof, A John Camm, Harry J G M Crijns, Jonathan P Piccini, Christian Torp-Pedersen, David S McKindley, Mattias Wieloch, Stefan H Hohnloser

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00174785 phase3completednot on this map

A Placebo-controlled,Double-blind,Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg Bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation/Atrial Flutter (AF/AFL)

TypeinterventionalSponsorSanofiRan2005 to 2008Enrolled4,628ConditionsAtrial Fibrillation, Atrial FlutterArmsdronedarone (SR33589), placebo
NCT01288352 phase4completednot on this map

Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST).

TypeinterventionalSponsorAtrial Fibrillation NetworkRan2011 to 2020Enrolled2,789ConditionsAtrial Fibrillation, StrokeArmsearly standardised rhythm control
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Interactions of blood biomolecules with early rhythm control in atrial fibrillation patients: exploratory analysis of the EAST-AFNET 4 biomolecule study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  2. Comparison of the effectiveness and safety of dronedarone and amiodarone for preventing recurrence after catheter ablation of atrial fibrillation: an open-label randomized controlled trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  3. Article
  4. Article
  5. Practical compendium of antiarrhythmic drugs: a clinical consensus statement of the European Heart Rhythm Association of the European Society of Cardiology.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Review
  6. Towards personalized therapy for atrial fibrillation: the rhythmic climbing of dronedarone.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Paulus KirchhofDepartment of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0002-1881-0197
A John CammInstitute of Molecular and Clinical Sciences, St. George's University of London, London, UK.ORCID 0000-0002-2536-2871
Harry J G M CrijnsMaastricht University Medical Centre and Cardiovascular Research Institute, Maastricht, The Netherlands.ORCID 0000-0003-1073-5337
Jonathan P PicciniDuke University Medical Center and the Duke Clinical Research Institute, Durham, NC, USA.ORCID 0000-0003-0772-2404
Christian Torp-PedersenDepartment of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-2892-6131
David S McKindleySanofi, Bridgewater, NJ, USA.ORCID 0000-0002-4402-6814
Mattias WielochSanofi, Paris, France.ORCID 0000-0002-7425-6549
Stefan H HohnloserDepartment of Cardiology, J.W. Goethe University, Theodor-W.-Adorno-Platz 1, 60629 Frankfurt am Main, Germany.ORCID 0000-0001-5030-3315

Funding

Sanofi
6 · The paper itself

Abstract

aimsThis 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 outcomes. METHODS AND

resultsThe co-primary outcomes were (i) a composite of cardiovascular death, stroke, or hospitalisation due to worsening of heart 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).

conclusionThese data support the use of dronedarone for early rhythm control therapy in selected patients with early AF.

trial registrationATHENA: ClinicalTrials.gov identifier NCT00174785. EAST-AFNET 4: ClinicalTrials.gov identifier NCT01288352.

Indexed as

Anti-Arrhythmia AgentsAtrial FibrillationAtrial FlutterDronedaroneHeart RateAcute Coronary SyndromeAgedComorbidityDouble-Blind MethodFemaleHeart FailureHospitalizationHumansMaleMiddle AgedRisk FactorsAnti-Arrhythmia AgentsDronedaroneAtrial fibrillationAtrial flutterDronedaroneEarly rhythm control

Identifiers

PMID40295782
PMCPMC12037275

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.