LB 02.2 - Prevention of Symptomatic Venous Thromboembolism with Low-Molecular-Weight Heparin in Hospitalized Older Adult Medical Patients: a Randomized Placebo-Controlled Trial

Tuesday, June 27, 2023

11:00 – 11:15 ET

Room: 517

Session Available As: Live-Streamed and On-Demand

Co-Author(s)

DM

Dominique Mottier

Professor
Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, INSERM UMR 1304 -GETBO, CIC INSERM 1412, F-CRIN INNOVTE
Brest, Bretagne, France
PG

Philippe Girard

MD
Département Thoracique, Institut Mutualiste Montsouris; Paris, FCRIN INNOVTE, France.
Paris, Ile-de-France, France
Francis Couturaud, PhD (he/him/his)

MD, PhD
Centre Hospitalo-Universitaire de Brest, Département de Médecine Interne et Pneumologie, INSERM U1304, CIC INSERM 1412, Univ_Brest, Brest, FCRIN INNOVTE, France.
Brest, Bretagne, France
EL

Emmanuelle Le Moigne

MD
INSERM U1304-GETBO, Univ Brest, FCRIN INNOVTE, Brest, France
Brest, Bretagne, France
NP

Nicolas Paleiron

MD, MS
Service de pneumologie-allergologie-cancérologie thoracique, HIA Sainte Anne, Toulon, FCRIN INNOVTE, France
Toulon, Provence-Alpes-Cote d'Azur, France
DG

Dewi Guellec

Physician
Service de rhumatologie, Centre d’Investigation Clinique INSERM UMR 1412, LBAI 37613, Centre Hospitalo-Universitaire de Brest
Brest, Bretagne, France
OS

Olivier Sanchez

MD, PhD
Georges Pompidou European Hospital, Paris, France
Paris, Ile-de-France, France
VC

Viriginie Cogulet

Pharmacist
Service de la pharmacie, Centre Hospitalo-Universitaire, Brest
Brest, Bretagne, France
SL

Silvy Laporte

PharmD, PhD
Department of Clinical Pharmacology and Clinical Research Unit, University Hospital of Saint-Etienne; UMR 1059 DVH-Sainbiose, Jean Monnet University, Saint-Etienne; INSERM F-CRIN INNOVTE Network France
Saint Etienne, Rhone-Alpes, France
GM

Gisèle Marhic

Research coordinator
Centre d’Investigation Clinique – INSERM 1412 – Centre Hospitalier Universitaire, Brest
Brest, Bretagne, France
PM

Patrick Mismetti

Professor
Service de Médecine et Thérapeutique, Unité de Pharmacologie Clinique, Centre Hospitalo-Universitaire de Saint-Etienne, Hôpital Nord, SAINBIOSE INSERM U 1059, Université Jean Monnet, F-CRIN INNOVTE, Saint-Etienne
Saint-Etienne, Rhone-Alpes, France
EP

Emilie Presles

Msc
Department of Clinical Pharmacology and Clinical Research Unit, University Hospital of Saint-Etienne;
Saint Etienne, Rhone-Alpes, France
Helia Robert-Ebadi, MD

MD
Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland
Geneva, Geneve, Switzerland
Isabelle MAHE, MD, PhD (she/her/hers)

MD,PhD
Paris Cité University, APHP, Hôpital Louis Mourier, Colombes, Internal Medicine Department, INSERM UMR_S1140, and F-CRIN InnoVTE, France
Colombes, Ile-de-France, France
LP

Ludovic Plaisance

MD
APHP, Louis Mourier Hospital, Internal Medicine Department
Colombes, Ile-de-France, France
Jean-Luc Reny, MD, PhD (he/him/his)

Co-head of Geneva Platelet Group
Geneva Platelet Group, Faculty of Medicine, University of Geneva
Geneva, Geneve, Switzerland
Marc Righini, MD

MD
Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland
Geneve, Geneve, Switzerland

Presenting Author(s)

Gregoire Le Gal, MD PhD

MD, PhD
Ottawa Hospital Research Institute, University of Ottawa, Canada
Ottawa, Ontario, Canada

Background: Admission to hospital is a major risk factor for venous thromboembolism. The wide use of thromboprophylaxis in medically ill admitted patients has recently been challenged. Age might be the strongest thrombosis risk factor, but is also associated with bleeding. Whether thromboprophylaxis with low-molecular weight heparin significantly prevents symptomatic venous thromboembolism in older adults, remains debated.

Aims: To test the superiority of Enoxaparin 40 mg daily versus placebo for the prevention of symptomatic venous thromboembolism in older adult patients hospitalized for an acute medical condition.

Methods: In a prospective, randomized, placebo-controlled, double-blind, multicenter trial, older adults (>70 years) patients hospitalized for an acute medical condition were randomized to receive low-molecular-weight heparin enoxaparin 40mg daily or placebo for 6-14 days. Randomization was stratified by creatinine clearance, antiplatelet use and center. The primary efficacy outcome was the incidence of symptomatic venous thromboembolism at day 30. The primary safety outcome was major bleeding using the International Society on Thrombosis and Haemostasis criteria.

Results: Inclusions started in September 2015. The trial was prematurely discontinued in September 2020 due to drug supply issues, after 2,559 patients had undergone randomization at 47 centers. Median age was 82 years. In the intention-to-treat population, the primary efficacy outcome occurred in 22/1,278 (1.8%) patients in the enoxaparin arm and in 27/1,263 (2.2%) patients in the placebo arm (Subdistribution hazard ratio [SubHR] 0.81, 95% confidence interval [CI] 0.46-1.42; P=0.46). The incidence of major bleeding was not different between groups (0.9% vs 1.0%, SubHR 0.91, 95%CI 0.40-2.06).

Conclusion(s): In this trial of thromboprophylaxis in older adult medical inpatients, enoxaparin use did not significantly reduce the risk of symptomatic VTE at one month and did not increase the risk of major bleeding. The study was underpowered due to its premature discontinuation (NCT02379806).