Full Length ArticleThe use of direct oral anticoagulants in 56 patients with antiphospholipid syndrome

•This is the largest case series and the longest follow-up of DOACs (mainly rivaroxaban) in APS patients.•DOACs could be used in the patients with APS if the patient prefers this type of anticoagulant therapy.•Elevated FVIII on the day of the switch to DOACs could correlate with a higher risk of VTE recurrence in APS.•The 6% risk of recurrent VTE on DOACs cannot be neglected.

IntroductionAntiphospholipid syndrome (APS) is a common acquired thrombophilia associated with a high thrombotic risk, in which vitamin K antagonists (VKA) represent the mainstay of therapy. Case series involving up to 35 patients with APS suggested limited efficacy and safety of direct oral anticoagulants (DOACs).Material and methodsIn the prospective case series we followed 56 consecutive patients with APS (44 women and 12 men, aged from 22 to 64 years), including 33 (60%) associated with systemic lupus erythematosus (SLE) and 16 (28.6%) with triple APS who were treated with DOACs due to their preferences or unstable anticoagulation with VKA. DOACs were started at least 3 months since the thromboembolic event in patients with D-dimer below 500 ng/ml.ResultsForty-nine (87.5%) patients were treated with rivaroxaban, 4 (7.3%) with dabigatran and 3 (5.4%) with apixaban. During follow-up of 2 to 43 (mean 22) months, 6 (10.7%, 5.8 per 100 patient-years) patients (4 women and 2 men, 4 with triple positive APS) experienced recurrent thrombosis, including deep vein thrombosis (n = 4, including 2 episodes preceded by nonadherence), superficial vein thrombosis (n = 1) and non-ST elevation myocardial infarction (n = 1). The recurrence rate of VTE on DOACs was 5.8 per 100 patient-years. Two patients (3.6%) experienced severe bleeding.ConclusionsThis case-series suggests that DOACs are safe in patients with APS. These findings need to be confirmed in larger studies.