Bleeding Risk in Elderly Patients with Venous Thromboembolism Who Would Have Been Excluded from Anticoagulation Trials.

Détails

ID Serval
serval:BIB_1D43CF5B1EBF
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Bleeding Risk in Elderly Patients with Venous Thromboembolism Who Would Have Been Excluded from Anticoagulation Trials.
Périodique
Thrombosis and haemostasis
Auteur⸱e⸱s
Schenker C., Stalder O., Méan M., Tritschler T., Righini M., Rodondi N., Aujesky D.
ISSN
2567-689X (Electronic)
ISSN-L
0340-6245
Statut éditorial
Publié
Date de publication
04/2023
Peer-reviewed
Oui
Volume
123
Numéro
4
Pages
427-437
Langue
anglais
Notes
Publication types: Multicenter Study ; Journal Article
Publication Status: ppublish
Résumé
Older patients with venous thromboembolism (VTE) are underrepresented in clinical anticoagulation trials. We examined to which extent elderly patients with VTE would be excluded from such trials and compared the bleeding risk between hypothetically excluded and enrolled patients. We studied 991 patients aged ≥65 years with acute VTE in a prospective multicenter cohort. We identified 12 landmark VTE oral anticoagulation trials from the eighth and updated ninth American College of Chest Physician Guidelines. For each trial, we abstracted the exclusion criteria and calculated the proportion of our study patients who would have been excluded from trial participation. We examined the association between five common exclusion criteria (hemodynamic instability, high bleeding risk, comorbidity, co-medication, and invasive treatments) and major bleeding (MB) within 36 months using competing risk regression, adjusting for age, sex, and periods of anticoagulation. A median of 31% (range: 20-52%) of our patients would have been excluded from participation in the landmark trials. Hemodynamic instability (sub-hazard ratio [SHR]: 2.2, 95% CI: 1.1-4.7), comorbidity (SHR: 1.5, 95% CI: 1.1-2.2), and co-medication (SHR: 1.5, 95% CI: 1.0-2.3) were associated with MB. Compared to eligible patients, those with ≥2 exclusion criteria had a twofold (SHR: 2.16, 95% CI: 1.38-3.39) increased risk of MB. Overall, about one-third of older patients would not be eligible for participation in guideline-defining VTE anticoagulation trials. The bleeding risk increases significantly with the number of exclusion criteria present. Thus, results from such trials may not be generalizable to older, multimorbid, and co-medicated patients.
Mots-clé
Aged, Humans, Venous Thromboembolism/diagnosis, Venous Thromboembolism/drug therapy, Venous Thromboembolism/epidemiology, Anticoagulants/adverse effects, Prospective Studies, Blood Coagulation, Hemorrhage/chemically induced, Hemorrhage/epidemiology, Hemorrhage/drug therapy
Pubmed
Web of science
Création de la notice
23/01/2023 10:19
Dernière modification de la notice
10/05/2023 6:55
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