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

Autor: Laure Pavageau, Jacques Bouget, Karine Lacut, Pierre-Marie Roy, Damien Viglino, Frédéric Balusson, Emmanuel Oger
Přispěvatelé: Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), CHU Grenoble, Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Centre hospitalier universitaire de Nantes (CHU Nantes), PHRC-12-009-0243, Direction de l’hospitalisation et de l’offre de Soins, Jonchère, Laurent, Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC)
Rok vydání: 2020
Předmět:
Male
Critical Care and Emergency Medicine
Databases
Factual
Epidemiology
[SDV]Life Sciences [q-bio]
030204 cardiovascular system & hematology
Cardiovascular Medicine
Antiplatelet Therapy
Vascular Medicine
Cohort Studies
0302 clinical medicine
Medical Conditions
Risk Factors
Outcome Assessment
Health Care
Medicine and Health Sciences
Medicine
030212 general & internal medicine
Prospective Studies
Prospective cohort study
Aged
80 and over
education.field_of_study
Aspirin
Multidisciplinary
Pharmaceutics
Mortality rate
Incidence
Hazard ratio
Middle Aged
Clopidogrel
3. Good health
[SDV] Life Sciences [q-bio]
Oral Antiplatelet Therapy
Cardiovascular Diseases
Drug Therapy
Combination
Female
France
Gastrointestinal Hemorrhage
Intracranial Hemorrhages
medicine.drug
Cohort study
Research Article
Adult
medicine.medical_specialty
Adolescent
Death Rates
Science
Population
Cardiology
Hemorrhage
03 medical and health sciences
Young Adult
Signs and Symptoms
Drug Therapy
Population Metrics
Internal medicine
Humans
education
Aged
Population Biology
business.industry
Biology and Life Sciences
Cardiovascular Disease Risk
Medical Risk Factors
Clinical Medicine
business
Platelet Aggregation Inhibitors
Zdroj: PLoS ONE
PLoS ONE, Public Library of Science, 2020, 15 (8), pp.e0237022. ⟨10.1371/journal.pone.0237022⟩
PLoS ONE, Vol 15, Iss 8, p e0237022 (2020)
PLoS ONE, 2020, 15 (8), pp.e0237022. ⟨10.1371/journal.pone.0237022⟩
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0237022⟩
Popis: International audience; Background - Major 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 findings - A 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. Conclusion - The incidence of major bleeding and mortality was low. In monotherapy, low-dose aspirin was the safest therapeutic option whatever the indication. Trial registration - NCT02886533.
Databáze: OpenAIRE
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