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Thromb Haemost 2023; 123(04): 427-437
DOI: 10.1055/s-0042-1760365
Stroke, Systemic or Venous Thromboembolism

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

Carla Schenker 
1   Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
,
Odile Stalder
2   CTU Bern, University of Bern, Bern, Switzerland
,
Marie Méan
3   Division of Internal Medicine, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland
,
Tobias Tritschler
1   Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
,
Marc Righini
4   Division of Angiology and Hemostasis, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland
,
Nicolas Rodondi
1   Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
5   Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
,
Drahomir Aujesky
1   Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
› Author Affiliations Funding The SWITCO65+ is entirely funded by grants from the Swiss National Science Foundation (grant no. 33CSCO-122659/139470). CanVECTOR Network; the Network receives grant funding from the Canadian Institutes of Health Research (CDT-142654).
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Abstract

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.

Keywords

venous thromboembolism - anticoagulation - bleeding risk - exclusion criteria - elderly

Authors Contribution

Concept and design: C.S., O.S., M.M., D.A. Data acquisition: M.M., M.R., N.R., D.A. Statistical analysis: O.S. Drafting of the manuscript: C.S., D.A. Critical revision of the manuscript for important intellectual content: all authors. Final approval of the manuscript: all authors.


Supplementary Material



Publication History

Received: 02 May 2022

Accepted: 16 November 2022

Article published online:
09 January 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
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