DOACs Use in Extreme Body-weighted Patients: Results from the Prospective START-register

Overview

Journal Intern Emerg Med

Publisher Springer

Specialties Emergency Medicine
General Medicine

Date 2023 Jun 10

PMID 37301770

Authors

Matteo Guarascio

Lorenza Bertu

Marco Paolo Donadini

Emilia Antonucci

Gualtiero Palareti

Walter Ageno

Affiliations

Soon will be listed here.

Abstract

Background: Direct oral anticoagulants (DOACs) are widely used for the treatment of venous thromboembolism (VTE) and for stroke prevention in atrial fibrillation (AF). However, evidence in obese and underweight patients is limited. We assessed the safety and effectiveness of DOACs and vitamin K antagonists (VKAs) in patients ≥ 120 kg or ≤ 50 kg enrolled in an observational prospective cohort study, the START-Register.

Methods: Adult patients started on anticoagulant therapy were followed up for a median of 1.5 years (IQR 0.6-2.8). Primary efficacy outcome was the occurrence of VTE recurrence, stroke and systemic embolism. Primary safety outcome was major bleeding (MB).

Results: 10,080 AF and VTE patients were enrolled between March 2011 and June 2021, 295 patients weighted ≤ 50 kg and 82 patients ≥ 120 kg. Obese patients were significantly younger than underweight patients. Rates of thrombotic events were low and similar between DOACs and VKAs in underweight patients (1 event on DOACs therapy [0.9% 95% CI 0.11-5.39] and 2 on VKAs [1.1% 95% CI 0.01-47.68]) and in overweight patients (0 events on DOACs, 1 on VKAs [1.6%, 95% CI 0.11-5.79]. Two MB events occurred on DOACs (1.9%, 95% CI 0.38-6.00) and 3 on VKAs (1.6%, 95% CI 0.04-22.06) in the underweight group; 1 MB on DOACs (5.3% 95% CI 0.33-16.68) and 2 on VKAs (3.3%, 95% CI 0.02-130.77) in the overweight group.

Conclusions: DOACs seem to be effective and safe also for the treatment of patients with extreme body weights, both underweight and overweight. Further prospective studies are needed to support these findings.

Citing Articles

Plasma Concentrations of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Different Degrees of Obesity.

Menichelli D, Pannunzio A, Baldacci E, Cammisotto V, Castellani V, Mormile R Clin Pharmacokinet. 2025; .

PMID: 39937335 DOI: 10.1007/s40262-025-01474-8.

Efficacy and Safety of Direct Oral Anticoagulants versus Warfarin in Obese Patients (BMI ≥ 30 kg/m) with Atrial Fibrillation or Venous Thromboembolism: An Updated Systematic Review and Meta-Analysis.

Karakasis P, Ktenopoulos N, Pamporis K, Sagris M, Soulaidopoulos S, Gerogianni M J Clin Med. 2024; 13(13).

PMID: 38999350 PMC: 11242099. DOI: 10.3390/jcm13133784.

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