Evidence map›Paper›PMID 32415705›Full record

ArticleBritish journal of clinical pharmacology2020

Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3-year period population-based prospective cohort study.

Jacques Bouget, Frédéric Balusson, Maxime Maignan, Laure Pavageau, Pierre-Marie Roy, Karine Lacut, Lucie-Marie Scailteux, Emmanuel Nowak, Emmanuel Oger

Abstract readMulticenter Study
In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–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

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Inhibiting the P2YJACC. Basic to translational science · 2024
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  6. Review
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  9. Observational
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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

9 authors.

Jacques BougetUniv Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Rennes, France.
Frédéric BalussonUniv Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Rennes, France.
Maxime MaignanEmergency Department, University Hospital, Grenoble, France.
Laure PavageauEmergency Department, University hospital, Nantes, France.
Pierre-Marie RoyEmergency Department, University hospital, Angers, France.
Karine LacutCIC 1412, Université de Bretagne Loire, Université de Brest, INSERM, CHRU de Brest, Brest, France.
Lucie-Marie ScailteuxUniv Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Rennes, France.ORCID 0000-0001-7047-9107
Emmanuel NowakCIC 1412, Université de Bretagne Loire, Université de Brest, INSERM, CHRU de Brest, Brest, France.
Emmanuel OgerUniv Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Rennes, France.ORCID 0000-0001-9837-2977

Funding

French Ministry of Health, National Clinical Research Hospital Program (PHRC) PHRC-12-009-0243
6 · The paper itself

Abstract

aimsThe objective was to compare major bleeding risk of direct oral anticoagulants (DOACs; per type and dose) with vitamin K antagonists (VKAs), irrespective of indication, using real-world data.

methodsA population-based prospective cohort study, using the French national health data system (SNIIRAM), identified 47 469 adults living within 5 well-defined geographical areas, who were new users of oral anticoagulants in the period 2013-2015: 20 205 VKA users, 19 579 rivaroxaban users, 4225 dabigatran users and 3460 apixaban users. From all emergency departments within these areas, clinical data for all adults referred for bleeding was collected and medically validated. The databases were linked for common key variables. The main outcome measure was major bleeding: intracranial haemorrhage, major gastrointestinal bleeding and other major bleeding events. Hazard ratios were derived from adjusted Cox proportional hazard models. We used propensity score weighting as a sensitivity analysis, with separate analyses according to indications (atrial fibrillation or venous thromboembolism).

resultsCompared to VKAs, high and low-dose DOACs were associated with a reduced risk of intracranial haemorrhage (adjusted hazard ratio 0.55, 95% confidence interval 0.37-0.82 and 0.54, 0.26-1.12 respectively), and a reduced risk of other major bleeding events (0.41, 0.29-0.58 and 0.41, 0.22-0.79 respectively), irrespective of duration and indication. Neither DOAC dose evidenced any significant difference from VKAs in terms of risk of major gastrointestinal bleeding.

conclusionThere is a clear benefit of using DOACs with regard to intracranial haemorrhage. The study provides new insight into major gastrointestinal and other major bleeding events.

Indexed as

AnticoagulantsAtrial FibrillationHemorrhageStrokeAdministration, OralAdultAgedCohort StudiesDabigatranFemaleHumansProspective StudiesRivaroxabanVitamin KAnticoagulantsDabigatranRivaroxabanVitamin Kmajor bleedingoral anticoagulantreal-world data

Identifiers

PMID32415705
PMCPMC7688535

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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.