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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

  • Pharmacoepidemiology and Prescription
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Abstract

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.

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Funding

This study was supported by the National Clinical Research Hospital Program of the French Ministry of Health, No. PHRC-12–009-0243.

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Authors and Affiliations

  1. Université de Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, 35043, Rennes, France

    Jacques Bouget, Frédéric Balusson, Sandrine Kerbrat & Emmanuel Oger

  2. Emergency Department, Rennes University Hospital, 35033, Rennes, France

    Jacques Bouget

  3. Emergency Department, Institut MITOVASC, Centre Hospitalier Universitaire, Université d’Angers, 49033, Angers, France

    Pierre-Marie Roy

  4. F-CRIN INNOVTE, Saint-Étienne, France

    Pierre-Marie Roy

  5. Emergency Department, Grenoble-Alpes University Hospital, 38043, Grenoble, France

    Damien Viglino

  6. Université de Bretagne Loire, Université de Brest, INSERM CIC 1412, CHRU de Brest, CIC 1412, 29200, Brest, France

    Karine Lacut

  7. Emergency Department, University Hospital, 44093, Nantes, France

    Laure Pavageau

Authors
  1. Jacques Bouget
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  2. Frédéric Balusson
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  4. Pierre-Marie Roy
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  6. Karine Lacut
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  7. Laure Pavageau
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  8. Emmanuel Oger
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Contributions

Jacques Bouget: methodology, writing–original draft, writing–review and editing, validation, Frédéric Balusson: formal analysis, writing–review and editing, validation, Sandrine Kerbrat: formal analysis, writing–review and editing, validation, Pierre-Marie Roy: investigation, writing–review and editing, Damien Viglino: investigation, writing–review and editing, Karine Lacut: investigation, writing–review and editing, Laure Pavageau: investigation, writing–review and editing, Emmanuel Oger: methodology, formal analysis, writing–original draft, writing–review and editing, validation.

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Correspondence to Jacques Bouget.

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Bouget, J., Balusson, F., Kerbrat, S. et al. 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. Eur J Clin Pharmacol 78, 1137–1144 (2022). https://doi.org/10.1007/s00228-022-03318-x

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  • DOI: https://doi.org/10.1007/s00228-022-03318-x

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