Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial - Université de Lorraine Accéder directement au contenu
Article Dans Une Revue EClinicalMedicine Année : 2023

Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial

1 DCAC - Défaillance Cardiovasculaire Aiguë et Chronique
2 Innovte - F-Crin INvestigation Network On Venous Thrombo-Embolism [CHU Saint-Etienne]
3 Centre régional de compétence des Maladies systémiques et auto-immunes rares de l'adulte et Maladies vasculaires rares
4 APEMAC - Adaptation, mesure et évaluation en santé. Approches interdisciplinaires
5 Service des Maladies Infectieuses et Tropicales [CHRU Nancy]
6 IThEM - U1140 - Innovations thérapeutiques en hémostase = Innovative Therapies in Haemostasis
7 HEGP - Hôpital Européen Georges Pompidou [APHP]
8 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
9 Service de Cardiologie [CHRU Nancy]
10 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
11 CHR de Metz-Thionville
12 Centre Hospitalier Agen-Nérac
13 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
14 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
15 Université Paris-Saclay
16 HPPIT - Hypertension pulmonaire : physiopathologie et innovation thérapeutique
17 CHV - Centre Hospitalier de Versailles André Mignot
18 Department of Cardiology, University Hospital Jean Minjoz
19 UFC - Université de Franche-Comté
20 CHU Amiens-Picardie
21 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
22 UNEOS
23 Département Maladies Infectieuses et Tropicales, Hôpital Universitaire, Montpellier, France
24 CHU - Hôpital Lapeyronie [Montpellier]
25 IDESP - Institut Desbrest de santé publique
26 RID-AGE - Facteurs de Risque et Déterminants Moléculaires des Maladies liées au Vieillissement - U 1167
27 CeRAINO - Centre National de Référence des Maladies Auto-Immunes Systémiques Rares du Nord et Nord-Ouest de France
28 HUS - Les Hôpitaux Universitaires de Strasbourg
29 Hôpitaux Civils de Colmar
30 Service d’Hématologie Biologique [CHU Lariboisière]
31 EnVI - Endothélium, valvulopathies et insuffisance cardiaque
32 UA - Université d'Angers
33 CHU d'Angers [Département Urgences]
34 SAINBIOSE - Santé Ingénierie Biologie Saint-Etienne
35 Service de Chirurgie Vasculaire [CHU Saint-Etienne]
36 CIC-EC 1408 - Centre d'Investigation Clinique - Epidémiologie Clinique [CHU Saint-Etienne]
37 CIC-P - Centre d'investigation clinique plurithématique Pierre Drouin [Nancy]
38 INI-CRCT - Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy]
39 Centre Hospitalier Princesse Grace
40 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale
41 UL - Université de Lorraine
42 MPI - Département Méthodologie Promotion Investigation [CHRU Nancy]
Simon Soudet
  • Fonction : Auteur
François Maurier
  • Fonction : Auteur

Résumé

Background: Venous thromboembolism is a major complication of coronavirus disease 2019 (COVID-19). We hypothesized that a weight-adjusted intermediate dose of anticoagulation may decrease the risk of venous thromboembolism COVID-19 patients. Methods: In this multicenter, randomised, open-label, phase 4, superiority trial with blinded adjudication of outcomes, we randomly assigned adult patients hospitalised in 20 French centers and presenting with acute respiratory SARS-CoV-2. Eligible patients were randomly assigned (1:1 ratio) to receive an intermediate weight-adjusted prophylactic dose or a fixed-dose of subcutaneous low-molecular-weight heparin during the hospital stay. The primary outcome corresponded to symptomatic deep-vein thrombosis (fatal) pulmonary embolism during hospitalization (COVI-DOSE ClinicalTrials.gov number: NCT04373707). Findings: Between May 2020, and April 2021, 1000 patients underwent randomisation in medical wards (noncritically ill) (80.1%) and intensive care units (critically ill) (19.9%); 502 patients were assigned to receive a weight-adjusted intermediate dose, and 498 received fixed-dose thromboprophylaxis. Symptomatic venous thromboembolism occurred in 6 of 502 patients (1.2%) in the weight-adjusted dose group and in 10 of 498 patients (2.1%) in the fixed-dose group (subdistribution hazard ratio, 0.59; 95% CI, 0.22-1.63; P = 0.31). There was a twofold increased risk of major or clinically relevant nonmajor bleeding: 5.9% in the weight-adjusted dose group and 3.1% in the fixed-dose group (P = 0.034). Interpretation: In the COVI-DOSE trial, the observed rate of thromboembolic events was lower than expected in patients hospitalized for COVID-19 infection, and the study was unable to show a significant difference in the risk of venous thromboembolism between the two low-molecular-weight-heparin regimens.
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hal-04141301 , version 1 (26-06-2023)

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Stéphane Zuily, Benjamin Lefèvre, Olivier Sanchez, Ombeline Empis de Vendin, Guillaume de Ciancio, et al.. Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial. EClinicalMedicine, 2023, 60, pp.102031. ⟨10.1016/j.eclinm.2023.102031⟩. ⟨hal-04141301⟩
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