Evidence map›Paper›PMID 31436835›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 Cardiology2019

Determinants of left atrium thrombi in scheduled cardioversion: an ENSURE-AF study analysis.

Jose L Merino, Gregory Y H Lip, Hein Heidbuchel, Aron-Ariel Cohen, Raffaele De Caterina, Joris R de Groot, Michael D Ezekowitz, Jean-Yves Le Heuzey, Sakis Themistoclakis, James Jin and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02072434 (A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.1field-weighted citation impact, top 7% 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.

NCT02072434 phase3completednot on this map

A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

TypeinterventionalSponsorDaiichi SankyoRan2014 to 2016Enrolled2,199ConditionsAtrial FibrillationArmsEdoxaban, Warfarin, Enoxaparin
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 28 citations in OpenAlex.

  1. Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Trial
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  14. Cardioversion of atrial fibrillation and atrial flutter revisited: current evidence and practical guidance for a common procedure.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 · 2020
    Article
  15. Article
  16. Heart Failure and the Non-Resolution of Atrial Thrombus Detected in Anticoagulated Patients with Non-Valvular Atrial Fibrillation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Observational
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

14 authors at 12 institutions in 10 countries.

Jose L MerinoArrhythmia and Robotic Electrophysiology Unit, Hospital Universitario La Paz, IDIPaz, Departamento de Medicina de la Universidad Autonoma de Madrid, P. Castellana, 261 (H. Gral, 1st Floor), Madrid, Spain.
Gregory Y H LipLiverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.
Hein HeidbuchelDepartment of Cardiology, Antwerp University and University Hospital, Wijlrijkstraat 10, Antwerp, Edegem, Belgium.
Aron-Ariel CohenService de cardiologie, INSERM 856 and Hôpital Saint Antoine, Hôpital Tenon; Sorbonne-Université (Université Pierre et Marie Curie, Paris VI), 1 rue Victor Cousin, Paris, France.
Raffaele De CaterinaChair of Cardiology, University of Pisa and Cardiology Division, Pisa University Hospital, Pisa, Italy.
Joris R de GrootDepartment of Cardiology, Amsterdam UMC, University of Amsterdam, Heart Center, Meibergdreef 9, AZ, Amsterdam, The Netherlands.
Michael D EzekowitzDepartment of Cardiovascular Medicine, Sidney Kimmel Jefferson Medical College at Thomas Jefferson University, 1025 Walnut St #100, Philadelphia, PA, USA; Lankenau Medical Center, 100 East Lancaster Avenue, Wynnewood, PA, USA and Bryn Mawr Hospital, 130 South Bryn Mawr Avenue Bryn Mawr, PA, USA.
Jean-Yves Le HeuzeyCardiology and Arrhythmology, Georges Pompidou Hospital, René Descartes University, 20 Rue Leblanc, Paris, France.
Sakis ThemistoclakisUnit of Electrophysiology and Cardiac Pacing, Dell'Angelo Hospital, Via Paccagnella, 11, Venice-Mestre, Italy.
James JinDaiichi Sankyo Pharma Development, 211 Mt Airy Rd, Basking Ridge, NJ, USA.
Michael MelinoDaiichi Sankyo Pharma Development, 211 Mt Airy Rd, Basking Ridge, NJ, USA.
Shannon M WintersDaiichi Sankyo, Inc., 211 Mt Airy Rd, Basking Ridge, NJ, USA.
Béla MerkelySemmelweis University Heart and Vascular Center, Városmajor u.68, Budapest, Hungary.
Andreas GoetteSt. Vincenz-Hospital, Paderborn, Am Busdorf 2, Paderborn, Nordrhein-Westfalen, Germany.
Daiichi Sankyo (United States) · USAmsterdam University Medical Centers · NLAntwerp University Hospital · BEHospital Universitario La Paz · ESInserm · FROspedale dell' Angelo · ITSemmelweis University · HUThomas Jefferson University · USUniversité Paris Cité · FRUniversity Hospital Magdeburg · DEUniversity of Liverpool · GBUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsENSURE-AF (NCT02072434) was the largest prospective randomized clinical trial of anticoagulation for cardioversion in atrial fibrillation (AF), which also provides the largest prospective dataset for transoesophageal echocardiography (TOE) prior to cardioversion. This ancillary analysis investigated determinants of TOE-detected left atrium thrombi (LAT) in patients scheduled for electrical cardioversion (ECV). METHODS AND

resultsThe ENSURE-AF multicentre PROBE evaluation trial compared edoxaban 60 mg once daily (QD) with enoxaparin/warfarin in 2199 subjects undergoing ECV of non-valvular AF. Patients were stratified by the use of TOE, anticoagulant experience, and selected edoxaban dose. Electrical cardioversion was cancelled or deferred when TOEdetected LAT. In total, 1183 subjects were stratified to the TOE arm and LAT was reported in 91 (8.2%). In univariate analysis, age ≥75 years (26.4% vs. 16.9%, P = 0.0308), lower weight (86.5 ± 15.0 vs. 90.7 ± 18.0 kg, P = 0.0309), lower creatinine clearance (80.1 ± 30.6 vs. 93.2 ± 33.9 mL/min, P = 0.0007), heart failure (59.3% vs. 43.0%, P = 0.0029), and diuretic treatment (53.9% vs. 40.1%, P = 0.0141) were more prevalent in the LAT group. Non-significant trends were seen for higher mean CHA2DS2-VASc score (3.0 ± 1.41 vs. 2.7 ± 1.48, P = 0.0571) and more prevalent anticoagulation use prior to enrolment (60.4% vs. 50.3%, P = 0.0795) in the LAT group. In logistic regression analysis, age (P = 0.0202) and heart failure (P = 0.0064) were independently associated with LAT.

conclusionElective ECV is commonly cancelled or deferred due to TOE-detected LAT in patients with non-valvular AF. Age ≥75 years and heart failure were associated with the presence of LAT.

Indexed as

AgedAnticoagulantsAtrial FibrillationDose-Response Relationship, DrugDrug Therapy, CombinationEchocardiography, TransesophagealElectric CountershockFactor Xa InhibitorsFemaleHeart AtriaHeart DiseasesHumansMaleProspective StudiesPyridinesThiazolesAnticoagulantsedoxabanFactor Xa InhibitorsPyridinesThiazolesWarfarinAnticoagulationAtrial fibrillationEdoxabanElectrical cardioversionLeft atrial thrombusTransoesophageal echochardiography

Identifiers

PMID31436835
PMCPMC6826208
OpenAlexW2969756980

What OpenQuestion holds

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LicenceCC BY-NC
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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.