Evidence map›Paper›PMID 38938310›Full record

ArticleJACC. Advances2023

Sex Differences Among Patients Receiving Edoxaban vs Vitamin K Antagonist for Atrial Fibrillation After TAVR.

Roxana Mehran, Alessandro Spirito, James Jin, Cathy Chen, Julia Seeger, Julia Mascherbauer, Pascal Vranckx, Raul Moreno, Irene M Lang, Anil Duggal and 10 more

Abstract read
In one paragraph

Article in JACC. Advances, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

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

4 citing papers in PubMed.

  1. Trial
  2. Understanding Aortic Stenosis and Transcatheter Aortic Valve Replacement in Women.Structural heart : the journal of the Heart Team · 2025
    Review
  3. JACC. Advances · 2023
    Article
  4. 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

20 authors.

Roxana MehranThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Alessandro SpiritoThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
James JinDaiichi Sankyo, Basking Ridge, New Jersey, USA.
Cathy ChenDaiichi Sankyo, Basking Ridge, New Jersey, USA.
Julia SeegerDepartment of Cardiology and Intensive Care, Medical Campus Lake Constance, Friedrichshafen, Germany.
Julia MascherbauerDepartment of Internal Medicine 3, Karl Landsteiner University of Health Sciences, University Hospital St. Pölten, Krems, Austria.
Pascal VranckxDepartment of Cardiology, Jessa Hospital, Hasselt, Belgium.
Raul MorenoDepartment of Cardiology, University Hospital La Paz, Madrid, Spain.
Irene M LangDivision of Cardiology, Department of Internal Medicine II, Vienna General Hospital, Medical University, Vienna, Austria.
Anil DuggalDaiichi Sankyo, Basking Ridge, New Jersey, USA.
Yusuke WatanabeDepartment of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
Piera CapranzanoDivision of Cardiology, Policlinico Hospital, University of Catania, Catania, Italy.
Annapoorna S KiniThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Verena VeulemansDepartment of Cardiology, Pulmonology, and Angiology, University Hospital Düsseldorf, Düsseldorf, Germany.
Elena TessitoreDepartment of Cardiology, HUG, Geneva, Switzerland.
Kentaro HayashidaDepartment of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Martin UnverdorbenDaiichi Sankyo, Basking Ridge, New Jersey, USA.
Nicolas M Van MieghemDepartment of Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands.
Christian HengstenbergDivision of Cardiology, Department of Internal Medicine II, Vienna General Hospital, Medical University, Vienna, Austria.
George D DangasThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In the ENVISAGE-TAVI AF (Edoxaban vs Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation-Atrial Fibrillation) trial, edoxaban was noninferior to vitamin K antagonists (VKA) for a composite outcome of ischemic and bleeding complications but increased major bleeding in patients with atrial fibrillation after successful transcatheter aortic valve replacement. Women are at higher risk of bleeding and stroke than men after transcatheter aortic valve replacement. It is unclear whether the effect of edoxaban on these complications varies in relation to sex. Objectives: This study was to assess the effect of edoxaban vs VKA according to sex in the ENVISAGE-TAVI AF trial. Methods: The primary outcomes were net adverse cardiovascular events (NACE) and major bleeding, assessed considering the effective time on study medication (safety analysis). Results: Out of 1,377 patients, 658 (47.8%) were women. Risks for ischemic and major bleeding outcomes were similar between women and men. Edoxaban compared to VKA was associated with a similar risk of NACE in women (HR: 1.16; 95% CI: 0.81-1.65) and men (HR: 1.08; 95% CI: 0.76-1.53; Conclusions: Edoxaban compared to VKA was associated with a similar risk of NACE and higher risk of major bleeding in both sexes. The increase in bleeding complications with edoxaban was attenuated in women.

Indexed as

atrial fibrillationedoxabanoutcomessexTAVR

Identifiers

PMID38938310
PMCPMC11198645

What OpenQuestion holds

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Registered trials

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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.