Evidence map›Paper›PMID 32790837›Full record

Observational studyEuropean heart journal. Cardiovascular pharmacotherapy2021

Edoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe study.

Joris R de Groot, Thomas W Weiss, Peter Kelly, Pedro Monteiro, Jean Claude Deharo, Carlo de Asmundis, Esteban López-de-Sá, Johannes Waltenberger, Jan Steffel, Pierre Levy and 7 more

Open access · bronzeAbstract readObservational Study
In one paragraph

Observational study in European heart journal. Cardiovascular pharmacotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 3% 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

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  11. Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.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 · 2024
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  18. Outcomes of patients with atrial fibrillation on oral anticoagulation with and without heart failure: the ETNA-AF-Europe registry.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 · 2023
    Observational
  19. Article
  20. The influence of atrial high-rate episodes on stroke and cardiovascular death: an update.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 · 2023
    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

17 authors at 14 institutions in 11 countries.

Joris R de GrootDepartment of Cardiology, Amsterdam University Medical Centres/University of Amsterdam, Spui 21 1012 WX Amsterdam, The Netherlands.
Thomas W WeissInstitute for Cardiometabolic Diseases, Karl Landsteiner Society, St. Pölten, Austria.
Peter KellyDepartment of Neurology, HRB Stroke Clinical Trials Network Ireland, University College Dublin/Mater Misericordiae University Hospital, Eccles St, Northside, Dublin, Ireland.
Pedro MonteiroDepartment of Cardiology, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto 3000-075, Coimbra, Portugal.
Jean Claude DeharoAP-HM, Aix Marseille University, Hôpital Timone, Cardiologie, Rythmologie, 264 rue Saint-Pierre, 13005, Marseille, France.
Carlo de AsmundisDepartment of Cardiology, Universitair Ziekenhuis Brussels, Ninoofsesteenweg 134, 1700 Dilbeek, Belgium.
Esteban López-de-SáCardiological Intensive Care Unit, Cardiology Service, Hospital Universitario La Paz, IDIPAZ, CIBER-CV, Madrid, Spain.
Johannes WaltenbergerDepartment of Cardiovascular Medicine, University of Munster, Schlossplatz 2, 48149 Münster, Germany.
Jan SteffelDepartment of Cardiology, University Hospital of Zurich, Rämistrasse 100, 8091 Zurich, Switzerland.
Pierre LevyDepartment of Economics, Université Paris-Dauphine, PSL Research University, LEDa-LEGOS, Paris, France.
Ameet BakhaiDepartment of Cardiology, Royal Free London NHS Foundation Trust, Pond Street, London NW3 2QG, UK.
Wolfgang ZierhutDaiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munich, Germany.
Petra LaeisDaiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munich, Germany.
Marius Constantin ManuDaiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munich, Germany.
Paul-Egbert ReimitzDaiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 Munich, Germany.
Raffaele De CaterinaChair of Cardiology, University of Pisa, Lungarno Antonio Pacinotti, 43, 56126 Pisa, Italy.
Paulus KirchhofInstitute of Cardiovascular Sciences, University of Birmingham, SWBH and UHB NHS Trusts, IBR 136, Wolfson Drive, Birmingham B15 2TT, UK.
Daiichi Sankyo (Germany) · DEAix-Marseille Université · FRAtrial Fibrillation NETwork · DEHospitais da Universidade de Coimbra · PTHospital Universitario La Paz · ESKarl Landsteiner Society · ATRoyal Free London NHS Foundation Trust · GBUniversitair Ziekenhuis Brussel · BEUniversité Paris Sciences et Lettres · FRUniversity College Dublin · IEUniversity Hospital of Zurich · CHUniversity of Amsterdam · NLUniversity of Münster · DEUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsNon-vitamin K oral anticoagulants are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report 1-year outcomes in patients with AF treated with edoxaban in routine care. METHODS AND

resultsETNA-AF-Europe is a prospective, multicentre, post-authorization, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban's post-approval safety plan. Altogether 13 092 patients in 852 sites completed the 1-year follow-up [mean age: 73.6 ± 9.5 years; 57% male, mean follow-up: 352 ± 49 days (median: 366 days)]. Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualized event rate: 0.82%/year), and major bleeding events were reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low [30 patients (0.24%/year)]. Death occurred in 442 patients (3.50%/year); cardiovascular (CV) death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and CV mortality were higher in patients receiving edoxaban 30 mg vs. 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg vs. 60 mg.

conclusionThe rates of stroke, systemic embolism, and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.

Indexed as

Atrial FibrillationStrokeAgedAged, 80 and overEuropeFactor Xa InhibitorsFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesPyridinesThiazolesedoxabanFactor Xa InhibitorsPyridinesThiazolesAtrial fibrillationEdoxabanNon-vitamin K oral anticoagulantReal-worldRegistry

Identifiers

PMID32790837
PMCPMC8117428
OpenAlexW3049055344

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.