Evidence map›Paper›PMID 31872901›Full record

Trial reportClinical cardiology2020

Efficacy and safety of dronedarone in patients with a prior ablation for atrial fibrillation/flutter: Insights from the ATHENA study.

Mate Vamos, Hugh Calkins, Peter R Kowey, Christian T Torp-Pedersen, Valérie Corp Dit Genti, Mattias Wieloch, Andrew Koren, Stefan H Hohnloser

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
0.6field-weighted citation impact, top 26% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. 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
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  5. Trial
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  7. Article
  8. Article
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  10. Selected Advances in the Anti-arrhythmic Management of Atrial Fibrillation: 2023.The Journal of innovations in cardiac rhythm management · 2024
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  12. Article
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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 at 5 institutions in 6 countries.

Mate VamosJ.W. Goethe University, Department of Cardiology, Division of Clinical Electrophysiology, Frankfurt, Germany.
Hugh CalkinsJohns Hopkins University, Department of Medicine, Cardiology, Baltimore, Maryland.
Peter R KoweyLankenau Heart Institute, Department of Cardiology, Wynnewood, Pennsylvania.
Christian T Torp-PedersenNordsjaellands Hospital, Department of Cardiology and Epidemiology, Hillerød, Denmark.
Valérie Corp Dit GentiSanofi-Aventis, Paris, France.
Mattias WielochSanofi-Aventis, Paris, France.
Andrew KorenSanofi US Inc., Bridgewater, New Jersey.
Stefan H HohnloserJ.W. Goethe University, Department of Cardiology, Division of Clinical Electrophysiology, Frankfurt, Germany.
Goethe University Frankfurt · DELund University · SEJohns Hopkins University · USLankenau Heart Institute · USNordsjællands Hospital · DK

Funding

Sanofi GPP3Sanofi US Inc
6 · The paper itself

Abstract

backgroundThe role of antiarrhythmic drugs for atrial fibrillation/atrial flutter (AF/AFL) after catheter ablation is not well established. HYPOTHESIS: We hypothesized that changing the myocardial substrate by ablation may alter the responsiveness to dronedarone.

methodsWe assessed the efficacy and safety of dronedarone in the treatment of paroxysmal/persistent atrial fibrillation/atrial flutter (AF/AFL) post-ablation, based on a post hoc analysis of the ATHENA study. A total of 196 patients (dronedarone 90, placebo 106) had an ablation for AF/AFL before study entry. In these patients, the effect of treatment on the first hospitalization because of cardiovascular (CV) events/all-cause death was assessed, as was AF/AFL recurrence in individuals with sinus rhythm at baseline. The safety of dronedarone vs placebo was also determined.

resultsIn patients with prior ablation, dronedarone reduced the risk of AF/AFL recurrence (hazard ratio [HR]: 0.65 [95% confidence interval [CI]: 0.42, 1.00]; P < .05) as well as the median time to first AF/AFL recurrence (561 vs 180 days) compared with placebo. The HR for first CV hospitalization/all-cause death with dronedarone vs placebo was 0.98 (95% CI: 0.62, 1.53; P = .91). Rates of treatment-emergent adverse events were 83.1% vs 75.5% and rates of serious TEAEs were 27.0% vs 18.9% in the dronedarone and placebo groups, respectively. One death occurred with dronedarone (not treatment-emergent) and five occurred with placebo.

conclusionIn patients with prior ablation for AF/AFL, dronedarone reduced the risk of AF/AFL recurrence compared with placebo, but not the risk of first CV hospitalization/all-cause death. Safety outcomes were consistent with those of the overall ATHENA study.

Indexed as

Catheter AblationAgedAged, 80 and overAnti-Arrhythmia AgentsAtrial FibrillationAtrial FlutterDouble-Blind MethodDronedaroneFemaleHeart RateHospitalizationHumansMaleMiddle AgedRecurrenceRisk AssessmentAnti-Arrhythmia AgentsDronedaroneablationantiarrhythmic drugatrial fibrillationatrial flutterdronedarone

Identifiers

PMID31872901
PMCPMC7068068
OpenAlexW2998263402

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.