OC 21.5 - Risk of anticoagulant-related bleeding in patients with venous thromboembolism. Results from a large non-interventional cohort.

Sunday, June 25, 2023

15:45 – 16:00 ET

Room: 516

Session Available As: Live-Stream and On-Demand

Presenting Author(s)

Leela Raj (she/her/hers)

BHSc
Schulich School of Medicine & Dentistr, London, Canada, Western University, U1304-GETBO, Brest, France
London, Ontario, Canada

Co-Author(s)

Claire de Moreuil, MD,PhD (she/her/hers)

Hospital Practioner in Internal Medicine
Internal medicine and Pneumology Department, Brest University Hospital, UMR 1304, GETBO
BREST, Bretagne, France
BE

Benjamin Espinasse

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

Raphaël Le Mao

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

Cecile Tromeur

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
MG

Marie Guegan

TEC
INSERM U1304-GETBO, Univ Brest, FCRIN INNOVTE, Brest, France
Brest, Bretagne, France
EL

Emmanuelle Le Moigne

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

Karine Lacut

MD, PhD
U1304-GETBO, Brest University, Department of internal medicine and chest disease, CHU Brest, Brest, France
Brest, Bretagne, France
CL

Christophe Leroyer

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
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

Background: Current findings on incidences and risk factors of anticoagulant-related bleeding in venous thromboembolism (VTE) patients are heterogenous. Furthermore, a significant amount of data stems from randomized trials which may underestimate the true impact of anticoagulant-related bleeding in VTE patients.

Aims: To assess the epidemiology and risk factors of anticoagulant-related major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) in a non-interventional cohort of VTE patients.

Methods: We performed a retrospective chart review of VTE patients in the EDITH observational prospective cohort included between May 2000 and July 2017, capturing all anticoagulant-related MB and CRNMB events. We performed a Cox regression analysis to identify predictors of anticoagulant-related bleeding. All patients provided written informed consent.

Results: Among the 4286 included patients, 268 (6.25%) experienced bleeding of any type under anticoagulant therapy. At 3, 6, 12, 24 months, cumulative incidences of CRNMB were 3.5%, 4.7%, 6.5% and 9.4%, respectively, and those of MB were 1.8%, 2.2%, 2.8% and 3.8%, respectively (Figure). Age >65 (HR 1.47, 95%CI 1.07-2.03), female sex (HR 1.64, 95%CI 1.21-2.23), stroke history (HR 1.96, 95%CI 1.23-3.12), low-molecular weight heparin (HR 1.56, 95%CI 1.10-2.22) and newly diagnosed cancer (HR 1.82, 95%CI 1.12-2.96) were independent predictors of both MB and CRNMB. Direct oral anticoagulants (HR 0.49, 95%CI 0.32-0.75), VTE family history (HR 0.66, 95%CI 0.47-0.93) and presence of minor factor < 1 month before VTE (HR 0.23, 95%CI 0.07-0.73) were protective against both MB and CRNMB in multivariable analysis (Table).

Conclusion(s): Anticoagulant-related bleeding remains a non-negligible effect of VTE treatment in practice today. While incidence of bleeding is highest in the first 3 months of treatment, it continues to increase linearly over time and must be monitored past the initial period. Women should be particularly monitored for anticoagulant-related bleeding. Furthermore, DOACs appear to reduce the risk of bleeding compared to VKAs.

Learning Objectives:

1. Upon completion, participant will be able to describe the current epidemiology of anticoagulant-related bleeding in VTE patients over a 2-year follow-up period. 2. Upon completion, participant will be able to recognize the risk factors and protective factors of anticoagulant-related bleeding in VTE patients.
3. Upon completion, participant will be able to compare and contrast the similarities and differences between the epidemiology of all anticoagulant-related bleeding and major anticoagulant-related bleeding in VTE patients. 4. Upon completion, participant will be able to compare and contrast the similarities and differences between the risk and protective factors of all anticoagulant-related bleeding and major anticoagulant-related bleeding in VTE patients.
5. Upon completion, participant will be able to integrate this knowledge into practice to maximize benefit of treatment and avoid VTE recurrence, while reducing risks of bleeding in VTE patients.