Session Title: Antiphospholipid Syndrome
Session Type: Abstract Submissions (ACR)
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. Our aim was to report on the safety and the efficacy of new oral direct inhibitors of thrombin and factor Xa (ODIs) in antiphospholipid syndrome (APS).
Descriptive analysis of patients with APS enrolled in a French multicentre observational cohort between January 2012 and March 2014 and receiving ODIs. Clinical, biological, and therapeutic data were retrospectively analyzed. The main primary outcome was the occurrence of a thrombotic recurrence. Secondary outcomes included adverse effects – notably hemorrhagic episodes, and biological tolerance. Kaplan-Meier survival analyses were performed to take into account censored data, using therapeutic interruptions/modifications as events.
Twenty-four patients with APS (primary in 11) received ODIs. The median [IQR] age at APS diagnosis was 41 [23-50] years, and the median duration of disease was 3 [1-11] years at introduction of the anti-thrombotic agent. Antiphospholipid antibodies (Abs) included anticardiolipin Abs (n=21/24, IgG isotype in 20), lupus anticoagulant (n=16/22), and IgG anti-ß2glycoprotein I Abs (n=6/24).
ODIs included dabigatran (n=11), and rivaroxaban (n=13). Nineteen patients had been previously treated with VKA (n=18), 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=16), recurrent thrombosis (n=1), VKA’s associated bleeding event (n=1), atrial fibrillation (n=1). Five patients received ODIs as first-line therapy. After a median follow-up of 15 [8-21] 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. Overall, the event-free survival rate was of 86.6% at 12 months using Kaplan-Meier curve analysis.
ODIs might be an alternative therapeutic option in APS, especially for patients with INR lability. Prospective studies are warranted to evaluate their safety in this condition.
J. M. Michot,
J. C. Piette,
« Back to 2014 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-of-new-oral-direct-inhibitors-of-thrombin-and-factor-xa-in-antiphospholipid-syndrome/