Evidence map›Paper›PMID 33587659›Full record

ArticleCirculation2021

Comparison of the Efficacy and Safety Outcomes of Edoxaban in 8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial.

Thomas A Zelniker, Maddalena Ardissino, Felicita Andreotti, Michelle L O'Donoghue, Ophelia Yin, Jeong-Gun Park, Sabina A Murphy, Christian T Ruff, Hans J Lanz, Elliott M Antman and 3 more

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  7. Review
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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

13 authors at 7 institutions in 6 countries.

Thomas A ZelnikerDivision of Cardiology, Medical University of Vienna, Austria (T.A.Z.).
Maddalena ArdissinoDepartment of Medicine, Imperial College, London, United Kingdom (M.A.).
Felicita AndreottiFondazione Policlinico Universitario Gemelli IRCCS, Rome, Italy (F.A.).
Michelle L O'DonoghueTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Ophelia YinDaiichi Sankyo Inc, Basking Ridge, NJ (O.Y.).
Jeong-Gun ParkTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Sabina A MurphyTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Christian T RuffTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Hans J LanzDaiichi Sankyo Europe GmbH, Munich, Germany (H.J.L.).
Elliott M AntmanTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Eugene BraunwaldTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Robert P GiuglianoTIMI Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.L.O., J.-G.P., S.A.M., C.T.R., E.M.A., E.B., R.P.G.).
Piera Angelica MerliniDepartment of Cardiology, Niguarda Hospital, Milan, Italy (P.A.M.).
Brigham and Women's Hospital · USAgostino Gemelli University Polyclinic · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITDaiichi Sankyo (Germany) · DEDaiichi Sankyo (United States) · USImperial College London · GBMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFemale sex is an independent risk factor for stroke and systemic embolic events in patients with atrial fibrillation. This study aimed to examine the efficacy and safety profile of edoxaban in women versus men.

methodsThe ENGAGE AF-TIMI 48 trial (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) randomly assigned 21 105 patients (8040 women) with atrial fibrillation and CHADS

resultsIn comparison with men, women were older, had lower body weight, were more likely to have hypertension and renal dysfunction, but less likely to smoke, drink alcohol, or have diabetes or coronary artery disease. Pretreatment endogenous factor Xa activity was significantly higher in women than in men (92.5% versus 86.1%,

conclusionsDespite many differences in baseline characteristics between women and men and higher baseline endogenous factor Xa levels in women, the intensity of anticoagulation achieved with edoxaban between the sexes was similar. Treatment with higher-dose edoxaban regimen resulted in an even greater reduction in hemorrhagic stroke and several serious bleeding outcomes in women than in men, whereas the efficacy profile was similar between sexes.

Indexed as

AgedAtrial FibrillationFactor Xa InhibitorsFemaleHumansMaleMiddle AgedPyridinesThiazolesedoxabanFactor Xa InhibitorsPyridinesThiazolesanticoagulantsatrial fibrillationedoxabanfactor Xa inhibitorswarfarinwomen

Identifiers

PMID33587659
PMCPMC7884089
OpenAlexW3132577593

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.