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

Preview	Text Schenker_ThrombHaemost_2022_AAM.pdf - Accepted Version Available under License Creative Commons: Attribution-Noncommercial (CC-BY-NC). Download (308kB) | Preview
	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.

Interest & Impact

Downloads

51 since deposited on 20 Jan 2023
45 in the past 12 months

Citations

5 Citations in Web of Science ®
6 Citations in Scopus

Search

in Google Scholar™

Services

Actions (login required)

Edit item

Actions (login required)

Edit item