Evidence map›Paper›PMID 40273298›Full record

Observational studyEuropean heart journal. Cardiovascular pharmacotherapy2025

Albumin level and risk of major bleeding in patients with atrial fibrillation on direct oral anticoagulants.

Shun Sasaki, Daisuke Sakamoto, Yuki Matsuoka, Katsuki Okada, Akihiro Sunaga, Daisaku Nakatani, Hidetaka Kioka, Takashi Kanda, Hitoshi Minamiguchi, Ryuta Watanabe and 5 more

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study in European heart journal. Cardiovascular pharmacotherapy, 2025. 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. Article
  2. Review
  3. Article
  4. Our knowledge about atrial fibrillation steadily increases.European heart journal. Cardiovascular pharmacotherapy · 2025
    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

15 authors.

Shun SasakiDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.ORCID 0000-0002-9561-0201
Daisuke SakamotoDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
Yuki MatsuokaDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
Katsuki OkadaDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.ORCID 0000-0002-1725-781X
Akihiro SunagaDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
Daisaku NakataniDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.ORCID 0000-0002-1534-2033
Hidetaka KiokaDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
Takashi KandaCardiovascular Division, Osaka Keisatsu Hospital, 2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan.
Hitoshi MinamiguchiCardiovascular Division, Osaka Keisatsu Hospital, 2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan.ORCID 0000-0002-3319-6316
Ryuta WatanabeDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, 30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610, Japan.
Kouichi NagashimaDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, 30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610, Japan.
Yoshiharu HiguchiCardiovascular Division, Osaka Keisatsu Hospital, 2-6-40 Karasugatsuji, Tennoji-ku, Osaka 543-8922, Japan.
Yasuo OkumuraDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, 30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610, Japan.ORCID 0000-0002-2960-4241
Yohei SotomiDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.ORCID 0000-0002-7564-2978
Yasushi SakataDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.

Funding

JSPS KAKENHI JP22K16073
6 · The paper itself

Abstract

aimsThe pharmacological effect of direct oral anticoagulants (DOACs) is influenced by binding status with albumin. This study aimed to assess the association between albumin levels and bleeding risk in atrial fibrillation (AF) patients treated with DOACs. METHODS AND

resultsWe conducted DIRECT-Extend registry (N = 7512), a pooled database combining three large-scale observational study of AF patients treated with DOAC. The primary endpoint was major bleeding as defined by International Society on Thrombosis and Haemostasis criteria. Multivariable Cox hazard model was used to assess the impact of albumin level on major bleeding. Out of the overall cohort, 2523 patients [73 (IQR 66-80) years, 1620 (64.2%) males] with albumin data available at enrolment were analyzed in this study. Median follow-up duration was 532 days (IQR 94-1405 days). The entire cohort was divided into tertiles based on albumin levels (lower tertile: <3.7 g/dL, middle tertile: 3.7-4.1 g/dL, and higher tertile: ≥4.1 g/dL). The incidences of major bleeding increased as albumin levels decreased; 56 patients (6.8%), 81 patients (9.7%), and 113 patients (13.1%) in the higher, middle, and lower tertiles, respectively. (Log-rank test P < 0.0001). A lower albumin level was independently associated with a higher incidence of major bleeding (adjusted hazard ratio 0.61, 95% confidence interval 0.47-0.80, P < 0.01), which was consistently observed in all DOACs (P-value for interaction >0.05).

conclusionA lower albumin level was independently associated with a higher bleeding risk in AF patients using DOACs. Careful attention should be paid to hypoalbuminemia when prescribing DOACs.

Indexed as

AntithrombinsAtrial FibrillationFactor Xa InhibitorsHemorrhageHypoalbuminemiaSerum Albumin, HumanStrokeAdministration, OralAgedAged, 80 and overBiomarkersDatabases, FactualFemaleHumansIncidenceMaleALB protein, humanAntithrombinsBiomarkersFactor Xa InhibitorsSerum Albumin, HumanAlbuminAnti-coagulationAtrial fibrillationDOACHigh bleeding riskProtein binding

Identifiers

PMID40273298
PMCPMC12343015

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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.