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

Abstract:

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.

journal_name

Autoimmun Rev

journal_title

Autoimmunity reviews

authors

Noel N,Dutasta F,Costedoat-Chalumeau N,Bienvenu B,Mariette X,Geffray L,Sene D,Chaidi RB,Michot JM,Fain O,Darnige L,Ankri A,Cacoub P,Piette JC,Saadoun D

doi

10.1016/j.autrev.2015.03.007

subject

Has Abstract

pub_date

2015-08-01 00:00:00

pages

680-5

issue

8

eissn

1568-9972

issn

1873-0183

pii

S1568-9972(15)00069-5

journal_volume

14

pub_type

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