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

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

Author information

1
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaire Paris Sud, CHU Bicêtre, Service de Médecine Interne et Immunologie Clinique, Le Kremlin Bicêtre, France; Université Paris Sud, UMR 1184, Le Kremlin Bicêtre, France.
2
Hôpital d'Instruction des Armées Percy, Service de Médecine Interne, Clamart, France.
3
AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, Service de Médecine Interne Pôle médecine, Paris, France; Université René Descartes, Paris 5, France. Electronic address: nathalie.costedoat@gmail.com.
4
CHRU de Caen, Service de Médecine Interne, Caen, France.
5
Université Paris Sud, UMR 1184, Le Kremlin Bicêtre, France; AP-HP, Hôpitaux Universitaires Paris Sud, CHU Bicêtre, Service de Rhumatologie, Le Kremlin Bicêtre, France.
6
CH Lisieux, Service de Médecine Interne, Lisieux, France.
7
AP-HP, Groupe Hospitalier Lariboisière-Fernand Widal, Service de Médecine Interne 2, Paris, France.
8
CHU Poitiers, Service de Médecine Interne, Poitiers, France.
9
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaire Paris Sud, CHU Bicêtre, Service de Médecine Interne et Immunologie Clinique, Le Kremlin Bicêtre, France.
10
AP-HP, CHU Saint Antoine, Service de Médecine Interne, France.
11
AP-HP, Hôpital Européen Georges Pompidou, Service d'Hématologie Biologique, Paris, France.
12
AP-HP, Hôpital Pitié-Salpétrière, Service d'Hématologie Biologique, France.
13
AP-HP, Hôpital Pitié-Salpêtrière, Centre national de référence maladies auto-immunes systémiques rares, Département de Médecine Interne et Immunologie Clinique, Paris, France; DHU Inflammation, Immunopathologie, Biothérapie, Université Pierre et Marie Curie, Faculté Paris 6, France.
14
AP-HP, Hôpital Pitié-Salpêtrière, Centre national de référence maladies auto-immunes systémiques rares, Département de Médecine Interne et Immunologie Clinique, Paris, France; DHU Inflammation, Immunopathologie, Biothérapie, Université Pierre et Marie Curie, Faculté Paris 6, France. Electronic address: david.saadoun@psl.aphp.fr.

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.

KEYWORDS:

Antiphospholipid syndrome; Dabigatran; Oral direct inhibitors; Rivaroxaban; Thrombosis

PMID:
25864630
DOI:
10.1016/j.autrev.2015.03.007
[Indexed for MEDLINE]

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