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

Autoimmun Rev. 2015 Aug;14(8):680-5. doi: 10.1016/j.autrev.2015.03.007. Epub 2015 Apr 9.


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 3years. 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.

Keywords: Antiphospholipid syndrome; Dabigatran; Oral direct inhibitors; Rivaroxaban; Thrombosis.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Administration, Oral
  • Anticoagulants / therapeutic use
  • Antiphospholipid Syndrome / drug therapy*
  • Factor Xa / metabolism
  • Factor Xa Inhibitors / administration & dosage
  • Factor Xa Inhibitors / adverse effects
  • Factor Xa Inhibitors / therapeutic use*
  • Hemorrhage / chemically induced
  • Humans
  • Thrombin / antagonists & inhibitors*


  • Anticoagulants
  • Factor Xa Inhibitors
  • Thrombin
  • Factor Xa