Faculty of Medicine, University of Aarhus, Aarhus, Denmark.
Centre for Haemostasis and Thrombosis, Guy's & St Thomas NHS Foundation Trust, London, UK.
Lupus. 2024 Nov;33(13):1446-1454. doi: 10.1177/09612033241285225. Epub 2024 Sep 16.
Vitamin-K antagonists (VKA) are considered the first-line anticoagulants for thrombotic antiphospholipid syndrome (TAPS), particularly with triple positivity or arterial events. However, thrombotic recurrence remains high despite anticoagulation and other clinical issues may arise. Long-term parenteral anticoagulants may therefore be considered, however little is known about the viability of fondaparinux in this setting.
We describe the efficacy and safety of long-term fondaparinux for TAPS (>3-months duration) treated at a single centre in the UK. Clinical features and the outcomes of recurrence and bleeding were reviewed using electronic patient records.
46 patients were identified with history of either venous or arterial TAPS and a total 175 patient-years using fondaparinux (median duration 2.7 years/patient (IQR 1.4-4.8)). 43 (93%) had VKA as first-line anticoagulation with a median duration of 6.5 years (IQR 4.0 - 9.8). All patients received fondaparinux as second-to fourth-line anticoagulation.Thrombosis recurrence occurred in 1 (1%) patient (0.6 events/100-patient years). Major, clinically relevant non-major (CRNM) or minor bleeding occurred in 2 (7%), 5 (10.9%) and 8 (17.4%) patients respectively. Major/CRNM bleeding rates were 1.1 and 2.9 events/100-patient-years. Age >65years was associated with bleeding ( = .047) and concurrent antiplatelets were associated with major/CRNM bleeding ( = .011). Logistic regression showed increasing age was associated with bleeding (OR = 1.097, = .009).
We suggest that fondaparinux may be used for TAPS when VKA is not appropriate. Thrombotic recurrence was infrequent, and the number of major bleeding events appeared comparable to conventional therapies.
维生素 K 拮抗剂 (VKA) 被认为是血栓性抗磷脂综合征 (TAPS) 的一线抗凝药物，特别是在三联阳性或动脉事件中。然而，尽管进行了抗凝治疗，血栓复发仍然很高，并且可能出现其他临床问题。因此，可能需要考虑长期的肠外抗凝剂，但是对于在这种情况下使用磺达肝素的可行性知之甚少。
我们描述了在英国的一家中心使用长期磺达肝素治疗 TAPS（持续时间> 3 个月）的疗效和安全性。使用电子病历回顾了复发和出血的临床特征和结果。
共确定了 46 例有静脉或动脉 TAPS 病史的患者，使用磺达肝素的总患者人数为 175 人年（中位数持续时间为 2.7 年/患者（IQR 1.4-4.8））。43 例（93%）患者一线抗凝治疗使用 VKA，中位持续时间为 6.5 年（IQR 4.0-9.8）。所有患者均接受磺达肝素作为二线至四线抗凝治疗。有 1 例（1%）患者发生血栓复发（0.6 例/100 人年）。2 例（7%）、5 例（10.9%）和 8 例（17.4%）患者分别发生重大、临床相关非重大（CRNM）或轻微出血。重大/CRNM 出血率分别为 1.1 和 2.9 例/100 人年。年龄>65 岁与出血相关（ =.047），同时使用抗血小板药物与重大/CRNM 出血相关（ =.011）。Logistic 回归显示，年龄增加与出血相关（OR = 1.097， =.009）。
我们建议，当 VKA 不适用时，磺达肝素可用于 TAPS。血栓复发罕见，且大出血事件数量似乎与传统治疗相当。
