Direct oral anticoagulants versus vitamin K antagonists in patients with thrombotic antiphospholipid syndrome: A prospective observational analysis.

Background: The role of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in the treatment of venous thromboembolism (VTE) in patients with antiphospholipid syndrome remains uncertain.

Methods: We conducted a prospective observational study on APS patients with VTE treated with VKAs or DOACs in a tertiary hospital from 2010 to 2023. Clinical characteristics, recurrent arterial or VTE events, and hemorrhagic complications were analyzed over a one-year follow-up.

Results: Fifty APS patients were included: 31 (62%) treated with VKAs and 19 (38%) with DOACs. Thrombotic recurrences occurred in 5 VKA patients (16.1%) and 3 DOAC patients (15.8%). Major bleeding occurred in 2 VKA patients (6.45%) and none in the DOAC group. There were no significant differences in thrombotic recurrence (OR 1.01; 95% CI: 0.19-5.46) or major bleeding (OR 1.09; 95% CI: 0.14-8.52) between groups.

Conclusions: In APS patients with VTE, DOACs showed similar rates of recurrent thrombosis and major bleeding compared to VKAs. Future studies should therefore focus on the role of DOACs in APS patients with varying clinical and serological profiles.