Evidence map›Paper›PMID 32764775›Full record

ArticlePloS one2020

Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study.

Jacques Bouget, Frédéric Balusson, Damien Viglino, Pierre-Marie Roy, Karine Lacut, Laure Pavageau, Emmanuel Oger

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02886533 (Major Bleeding Risk Associated With Antithrombotics), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.9field-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.

NCT02886533 completednot on this map

Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study

TypeobservationalSponsorRennes University HospitalRan2013 to 2015Enrolled6,484ConditionsMajor HaemorrhageArmsAntithrombotic
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

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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

7 authors at 5 institutions in 1 country.

Jacques BougetEA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Univ Rennes, CHU Rennes, Rennes, France.
Frédéric BalussonEA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Univ Rennes, CHU Rennes, Rennes, France.
Damien ViglinoEmergency Department, Grenoble-Alpes University Hospital, Grenoble, France.
Pierre-Marie RoyEmergency Department, Centre Hospitalier Universitaire, Institut MITOVASC, Université d'Angers, Angers, France.
Karine LacutCIC 1412, Université de Bretagne Loire, Université de Brest, INSERM CIC 1412, CHRU de Brest, Brest, France.
Laure PavageauEmergency Department, University Hospital, Nantes, France.
Emmanuel OgerEA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Univ Rennes, CHU Rennes, Rennes, France.ORCID 0000-0001-9837-2977
Centre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Nantes · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor bleedings other than gastrointestinal (GI) and intracranial (ICH) and mortality rates associated with antiplatelet drugs in real-world clinical practice are unknown. The objective was to estimate major bleeding risk and mortality among new users of antiplatelet drugs in real-world clinical practice. METHODS AND

findingsA population-based prospective cohort using the French national health data system (SNIIRAM), identified 69,911 adults living within five well-defined geographical areas, who were new users of antiplatelet drugs in 2013-2015 and who had not received any antithrombotics in 2012. Among them, 63,600 started a monotherapy and 6,311 a dual regimen. Clinical data for all adults referred for bleeding was collected from all emergency departments within these areas, and medically validated. Databases were linked using common key variables. The main outcome measure was time to major bleeding (GI, ICH and other bleedings). Secondary outcomes were death, and event-free survival (EFS). Hazard ratios (HR) were derived from adjusted Cox proportional hazard models. We used Inverse Propensity of Treatment Weighting as a stratified sensitivity analysis according to the antiplatelet monotherapy indication: primary prevention without cardiovascular (CV) risk factors, with CV risk factors, and secondary prevention. We observed 250 (0.36%) major haemorrhages, 81 ICH, 106 GI and 63 other types of bleeding. Incidences were twice as high in dual therapy as in monotherapy. Compared to low-dose aspirin (≤ 100 mg daily), high-dose (> 100 up to 325 mg daily) was associated with an increased risk of ICH (HR = 1.80, 95%CI 1.10 to 2.95). EFS was improved by high-dose compared to low-dose aspirin (1.41, 1.04 to 1.90 and 1.32, 1.03 to 1.68) and clopidogrel (1.30, 0.73 to 2.3 and 1.7, 1.24 to 2.34) respectively in primary prevention with and without CV risk factors.

conclusionThe incidence of major bleeding and mortality was low. In monotherapy, low-dose aspirin was the safest therapeutic option whatever the indication.

trial registrationNCT02886533.

Indexed as

AdolescentAdultAgedAged, 80 and overAspirinClopidogrelCohort StudiesDatabases, FactualDrug Therapy, CombinationFemaleFranceGastrointestinal HemorrhageHemorrhageHumansIncidenceIntracranial HemorrhagesAspirinClopidogrelPlatelet Aggregation Inhibitors

Identifiers

PMID32764775
PMCPMC7413418
OpenAlexW3047981275

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.