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

Nicolas Noel, Fabien Dutasta, Nathalie Costedoat-Chalumeau, Boris Bienvenu, Xavier Mariette, Loik Geffray, Damien Sene, Rafik Bekhadj Chaidi, Jean-Marie Michot, Olivier Fain, Luc Darnige, Annick Ankri, Patrice Cacoub, Jean-Charles Piette, David Saadoun

Journal: Autoimmunity reviews 2015;14(8):680-5

PMID: 25864630

Full Text on Elsevier Science View on PubMed

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.

Address: 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.; Hôpital d'Instruction des Armées Percy, Service de Médecine Interne, Clamart, France.; 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: [email protected].; CHRU de Caen, Service de Médecine Interne, Caen, France.; Université Paris Sud, UMR 1184, Le Kremlin Bicêtre, France; AP-HP, Hôpitaux Universitaires Paris Sud, CHU Bicêtre, Service de Rhumatologie, Le Kremlin Bicêtre, France.; CH Lisieux, Service de Médecine Interne, Lisieux, France.; AP-HP, Groupe Hospitalier Lariboisière-Fernand Widal, Service de Médecine Interne 2, Paris, France.; CHU Poitiers, Service de Médecine Interne, Poitiers, France.; Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaire Paris Sud, CHU Bicêtre, Service de Médecine Interne et Immunologie Clinique, Le Kremlin Bicêtre, France.; AP-HP, CHU Saint Antoine, Service de Médecine Interne, France.; AP-HP, Hôpital Européen Georges Pompidou, Service d'Hématologie Biologique, Paris, France.; AP-HP, Hôpital Pitié-Salpétrière, Service d'Hématologie Biologique, France.; 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.; 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: [email protected].

DOI: 10.1016/j.autrev.2015.03.007

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MeSH Terms: Administration, Oral, Anticoagulants, Antiphospholipid Syndrome, Factor Xa, Factor Xa Inhibitors, Hemorrhage, Humans, Thrombin