Scientific article
Open access

Bleeding risk in elderly patients with venous thromboembolism who would have been excluded from anticoagulation trials

Published inThrombosis and haemostasis, vol. 123, no. 4, p. 427-437
Publication date2023-04
First online date2023-01-09

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.

  • 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
Citation (ISO format)
SCHENKER, Carla et al. Bleeding risk in elderly patients with venous thromboembolism who would have been excluded from anticoagulation trials. In: Thrombosis and haemostasis, 2023, vol. 123, n° 4, p. 427–437. doi: 10.1055/s-0042-1760365
Main files (2)
Article (Published version)
Article (Accepted version)
ISSN of the journal0340-6245

Technical informations

Creation02/08/2024 10:40:27 AM
First validation04/16/2024 6:48:31 AM
Update time04/16/2024 6:48:31 AM
Status update04/16/2024 6:48:31 AM
Last indexation05/06/2024 6:23:40 PM
All rights reserved by Archive ouverte UNIGE and the University of GenevaunigeBlack