Safety and efficacy of oral direct inhibitors of thrombin and factor Xa in antiphospholipid syndrome

Background: Long-term anticoagulation is recommended in antiphospholipid syndrome with thrombosis in order to prevent recurrences. While the current mainstay relies on vitamin K antagonists, their long-term maintenance may remain challenging. Objectives: To report on the safety and the efficacy of oral direct inhibitors of thrombin and factor Xa (ODIs) in antiphospholipid syndrome (APS). Methods: We performed a descriptive analysis of patients with APS enrolled in a French multicentre observational cohort between January 2012 and March 2014 and receiving ODIs. The main outcomes were the occurrence of a thrombotic recurrence or bleeding events. Results: Twenty-six patients with APS (primary in 12) received ODIs. Twenty patients had been previously treated with VKA (n = 19), or fondaparinux (n = 1) for a median duration of 3 years. ODIs were introduced as second-line therapy because of INR lability/therapeutic simplification (n = 17), recurrent thrombosis (n = 1), VKA's associated bleeding event (n = 1), and atrial fibrillation (n = 1). Six patients received ODIs as first-line therapy. After a median [IQR] follow-up of 19 [8-29] months, one relapse of arterial thrombosis, two bleeding events (hypermenorrhea and rectal bleeding under rivaroxaban) and one recurrent migraine were reported, leading to discontinuation of therapy in these 4 patients. Conclusion: ODIs might be an alternative therapeutic option in APS. Prospective studies are warranted to evaluate their safety in this condition. (C) 2015 Elsevier B.V. All rights reserved.