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.
Autoimmun Rev. 2015 Aug;14(8):680-5. doi: 10.1016/j.autrev.2015.03.007. Epub 2015 Apr 9.
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.
To report on the safety and the efficacy of oral direct inhibitors of thrombin and factor Xa (ODIs) in antiphospholipid syndrome (APS).
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.
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.
ODIs might be an alternative therapeutic option in APS. Prospective studies are warranted to evaluate their safety in this condition.
为了预防复发，抗磷脂综合征合并血栓形成者推荐长期抗凝治疗。目前的主要治疗方法依赖于维生素 K 拮抗剂，但长期维持治疗可能仍然具有挑战性。
报告口服直接凝血酶和 Xa 因子抑制剂（ODI）在抗磷脂综合征（APS）中的安全性和疗效。
我们对 2012 年 1 月至 2014 年 3 月期间参加法国多中心观察性队列的 APS 患者进行了描述性分析，这些患者接受了 ODI 治疗。主要结局是血栓复发或出血事件的发生。
26 例 APS 患者（原发性 12 例）接受了 ODI 治疗。20 例患者曾因 INR 不稳定/治疗简化（n=17）、复发性血栓形成（n=1）、VKA 相关出血事件（n=1）和心房颤动（n=1）而接受 VKA 或磺达肝素钠治疗，中位数治疗时间为 3 年。ODI 被引入二线治疗。在中位数[IQR]为 19[8-29]个月的随访中，有 1 例动脉血栓形成复发，2 例出血事件（月经过多和利伐沙班下直肠出血）和 1 例复发性偏头痛，导致 4 例患者停止治疗。
ODI 可能是 APS 的另一种治疗选择。需要前瞻性研究来评估其在这种情况下的安全性。
