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

Schenker, Carla; Stalder, Odile; Méan, Marie; Tritschler, Tobias; Righini, Marc; Rodondi, Nicolas; Aujesky, Drahomir (2023). Bleeding Risk in Elderly Patients with Venous Thromboembolism Who Would Have Been Excluded from Anticoagulation Trials. Thrombosis and haemostasis, 123(4), pp. 427-437. Thieme 10.1055/s-0042-1760365

[img]
Preview
Text
Schenker_ThrombHaemost_2022_AAM.pdf - Accepted Version
Available under License Creative Commons: Attribution-Noncommercial (CC-BY-NC).

Download (308kB) | Preview
[img] Text
Schenker_ThrombHaemost_2023.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (1MB)

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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine

UniBE Contributor:

Schenker, Carla, Stalder, Odile, Tritschler, Tobias, Rodondi, Nicolas, Aujesky, Drahomir

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2567-689X

Publisher:

Thieme

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Pubmed Import

Date Deposited:

20 Jan 2023 12:34

Last Modified:

20 Feb 2024 14:15

Publisher DOI:

10.1055/s-0042-1760365

PubMed ID:

36649737

BORIS DOI:

10.48350/177607

URI:

https://boris.unibe.ch/id/eprint/177607

Actions (login required)

Edit item Edit item
Provide Feedback