Clinical use of low-dose parenteral anticoagulation, incidence of major bleeding and mortality: a multi-centre cohort study using the French national health data system.

Szczegóły
Abstrakt

Tytuł:: Clinical use of low-dose parenteral anticoagulation, incidence of major bleeding and mortality: a multi-centre cohort study using the French national health data system.
Autorzy:: Bouget J; Université de Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, 35043, Rennes, France. .; Emergency Department, Rennes University Hospital, 35033, Rennes, France. .
Balusson F; Université de Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, 35043, Rennes, France.
Kerbrat S; Université de Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, 35043, Rennes, France.
Roy PM; Emergency Department, Institut MITOVASC, Centre Hospitalier Universitaire, Université d'Angers, 49033, Angers, France.; F-CRIN INNOVTE, Saint-Étienne, France.
Viglino D; Emergency Department, Grenoble-Alpes University Hospital, 38043, Grenoble, France.
Lacut K; Université de Bretagne Loire, Université de Brest, INSERM CIC 1412, CHRU de Brest, CIC 1412, 29200, Brest, France.
Pavageau L; Emergency Department, University Hospital, 44093, Nantes, France.
Oger E; Université de Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, 35043, Rennes, France.
Źródło:: European journal of clinical pharmacology [Eur J Clin Pharmacol] 2022 Jul; Vol. 78 (7), pp. 1137-1144. Date of Electronic Publication: 2022 Apr 06.
Typ publikacji:: Journal Article; Multicenter Study
Język:: English
Imprint Name(s):: Original Publication: Berlin, New York, Springer.
MeSH Terms:: Heparin, Low-Molecular-Weight*/adverse effects
Venous Thromboembolism*/drug therapy
Venous Thromboembolism*/epidemiology
Venous Thromboembolism*/prevention & control
Adult ; Anticoagulants/adverse effects ; Cohort Studies ; Enoxaparin/therapeutic use ; Fondaparinux/therapeutic use ; Hemorrhage/chemically induced ; Hemorrhage/epidemiology ; Heparin/therapeutic use ; Humans ; Incidence ; Polysaccharides/therapeutic use ; Prospective Studies ; Tinzaparin/therapeutic use
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Grant Information:: PHRC-12-009-0243 National Clinical Research Hospital Program of the French Ministry of Health
Contributed Indexing:: Keywords: Fondaparinux; Low-molecular weight heparin; Major bleeding; Mortality; Unfractionated heparin
Molecular Sequence:: ClinicalTrials.gov NCT02886533
Substance Nomenclature:: 0 (Anticoagulants)
0 (Enoxaparin)
0 (Heparin, Low-Molecular-Weight)
0 (Polysaccharides)
7UQ7X4Y489 (Tinzaparin)
9005-49-6 (Heparin)
J177FOW5JL (Fondaparinux)
Entry Date(s):: Date Created: 20220407 Date Completed: 20220613 Latest Revision: 20220613
Update Code:: 20240105
DOI:: 10.1007/s00228-022-03318-x
PMID:: 35385975
: Czasopismo naukowe

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Purpose: Low-dose parenteral anticoagulation has demonstrated its efficacy for venous thromboembolism prophylaxis in randomized trials. However, current practice is not widely documented. In ambulatory settings, we aimed to provide an overview of the clinical use of low-dose parenteral anticoagulation in France and to assess the incidence of major bleeding and death rates.
Methods: A population-based prospective cohort study using the French national health data system (SNIIRAM) identified 142,815 adults living in five well-defined geographical areas who had a course of low-dose parenteral anticoagulants (a total of 150,389 courses) in the period 2013-2015. The main outcome measures were the types of low-dose parenteral anticoagulant, the duration and the clinical context. Adjusted incidence rate ratios (IRR) were derived from Poisson models.
Results: Enoxaparin was the most frequently prescribed anticoagulant (58.9%) followed by tinzaparin (27.3%) and fondaparinux (10.9%). Patients receiving unfractionated heparin (N = 766, 0.53%) were older, more frequently had renal disease (48.75%) and had a higher modified HAS-B(L)ED score (≥ 3 in 61.6%) than patients receiving low-molecular weight heparin (LMWH). Surgical thrombo-prophylaxis was the most frequent indication (47.6%), followed by medical prophylaxis (29.9%). Course durations were in line with regulatory agency specifications. Only 43 (0.028%) major bleeding events and 478 (0.32%) deaths were observed. Adjusted IRRs for major bleeding or death were not significantly different for dalteparin/nadroparin, tinzaparin or fondaparinux compared to enoxaparin.
Conclusion: Very low incidence rates of major bleeding and all-cause mortality were observed. Our study confirms the safety of LMWHs and fondaparinux in thrombo-prophylaxis in ambulatory settings.
Trial Registration: ClinicalTrials.gov identifier: NCT02886533.
(© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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