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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

Authors :
Jacques Bouget
Frédéric Balusson
Sandrine Kerbrat
Pierre-Marie Roy
Damien Viglino
Karine Lacut
Laure Pavageau
Emmanuel Oger
Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES)
Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)
CHU Pontchaillou [Rennes]
Centre Hospitalier Universitaire d'Angers (CHU Angers)
PRES Université Nantes Angers Le Mans (UNAM)
Centre Hospitalier Universitaire [Grenoble] (CHU)
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)
National Clinical Research Hospital Program of the French Ministry of Health [PHRC-12-009-0243]
Source :
European Journal of Clinical Pharmacology, European Journal of Clinical Pharmacology, 2022, 78 (7), pp.1137-1144. ⟨10.1007/s00228-022-03318-x⟩
Publication Year :
2021

Abstract

International audience; 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.

Details

ISSN :
14321041 and 00316970
Volume :
78
Issue :
7
Database :
OpenAIRE
Journal :
European journal of clinical pharmacology
Accession number :
edsair.doi.dedup.....8b9ad32df9d598b496c5726403763f04
Full Text :
https://doi.org/10.1007/s00228-022-03318-x⟩