Evidence map›Paper›PMID 32627222›Full record

ArticleBritish journal of clinical pharmacology2021

Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation.

Patrick C Souverein, Hendrika A van den Ham, Consuelo Huerta, Elisa Martín Merino, Dolores Montero, Luz M León-Muñoz, Sven Schmiedl, Andreas Heeke, Marietta Rottenkolber, Morten Andersen and 4 more

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
3.4field-weighted citation impact, top 6% 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

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. What Anticoagulants Should We Use to Treat Atrial Fibrillation?Deutsches Arzteblatt international · 2026
    Article
  7. Article
  8. Article
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  11. Observational
  12. Observational
  13. Review
  14. Article
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  16. Article
  17. [Pathophysiology of bleeding].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2021
    Review
  18. Article
  19. Article
  20. 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

14 authors at 6 institutions in 5 countries.

Patrick C SouvereinDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.ORCID 0000-0002-7452-0477
Hendrika A van den HamDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.ORCID 0000-0003-1339-9818
Consuelo HuertaPharmacoepidemiology and Pharmacovigilance Division, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.ORCID 0000-0003-4012-7826
Elisa Martín MerinoPharmacoepidemiology and Pharmacovigilance Division, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
Dolores MonteroPharmacoepidemiology and Pharmacovigilance Division, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
Luz M León-MuñozPharmacoepidemiology and Pharmacovigilance Division, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
Sven SchmiedlPhilipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.
Andreas HeekeAOK NORDWEST, Dortmund, Germany.
Marietta RottenkolberDiabetic Research Group, Medizinische Klinik und Poliklinik IV, Klinikum der Universitaet Muenchen, Munich, Germany.
Morten AndersenPharmacovigilance Research Group, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.ORCID 0000-0001-7029-2860
Mia AakjaerPharmacovigilance Research Group, Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
Marie L De BruinCopenhagen Centre of Regulatory Science, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0001-9197-7068
Olaf H KlungelDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.
Helga GardarsdottirDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.ORCID 0000-0001-5623-9684
Agencia Española de Medicamentos y Productos Sanitarios · ESUtrecht University · NLUniversity of Copenhagen · DKKrankenhaus Nordwest · DELMU Klinikum · DEWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe introduction of direct oral anticoagulants (DOACs) has broadened the treatment arsenal for nonvalvular atrial fibrillation, but observational studies on the benefit-risk balance of DOACs compared to vitamin K antagonists (VKAs) are needed. The aim of this study was to characterize the risk of major bleeding in DOAC users using longitudinal data collected from electronic health care databases from 4 different EU-countries analysed with a common study protocol.

methodsA cohort study was conducted among new users (≥18 years) of DOACs or VKAs with nonvalvular atrial fibrillation using data from the UK, Spain, Germany and Denmark. The incidence of major bleeding events (overall and by bleeding site) was compared between current use of DOACs and VKAs. Cox regression analysis was used to calculate hazard ratios and 95% confidence intervals (CI) and adjust for confounders. RESULTS/

conclusionOverall, 251 719 patients were included across the 4 study cohorts (mean age ~75 years, % females between 41.3 and 54.3%), with overall hazard ratios of major bleeding risk for DOACs vs VKAs ranging between 0.84 (95% CI: 0.79-0.90) in Denmark and 1.13 (95% CI 1.02-1.25) in the UK. When stratifying according to the bleeding site, risk of gastrointestinal bleeding was increased by 48-67% in dabigatran users and 30-50% for rivaroxaban users compared to VKA users in all data sources except Denmark. Compared to VKAs, apixaban was not associated with an increased risk of gastrointestinal bleeding in all data sources and seemed to be associated with the lowest risk of major bleeding events compared to dabigatran and rivaroxaban.

Indexed as

Atrial FibrillationStrokeAdministration, OralAgedAnticoagulantsCohort StudiesDabigatranFemaleGermanyHemorrhageHumansMaleRivaroxabanSpainVitamin KAnticoagulantsDabigatranRivaroxabanVitamin Katrial fibrillationcohort studymajor bleedingnon-vitamin K antagonist oral anticoagulantspharmacoepidemiologyvitamin K antagonists

Identifiers

PMID32627222
PMCPMC9328267
OpenAlexW3038569180

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.