Warren Alpert Medical School of Brown University, Providence, RI, USA.
Division of Hematology/Oncology, Warren Alpert Medical School of Brown University, Rhode Island Hospital, 593 Eddy St, Providence, RI, 02903, USA.
J Thromb Thrombolysis. 2023 Jul;56(1):121-127. doi: 10.1007/s11239-023-02826-6. Epub 2023 May 23.
Antiphospholipid syndrome (APS) is an acquired hypercoagulable state necessitating long-term anticoagulation for secondary thrombosis prevention. Anticoagulation guidelines are predominantly based on data in high risk, triple positive patients, and favor Vitamin K antagonists over other forms of anticoagulation. The efficacy of alternative anticoagulants for secondary thrombosis prevention in low risk, single and double positive APS remains uncertain. This study aimed to assess the incidence of recurrent thrombosis and major bleeding for patient with low risk APS on long-term anticoagulation. We performed a retrospective cohort study of patients who met revised criteria for thrombotic APS between January, 2001 and April, 2021 and received care through the Lifespan Health System. Primary outcomes included recurrent thrombosis and WHO Grades 3 and 4 major bleeding. A total of 190 patients were followed over a median duration of 3.1 years. At time of APS diagnosis, 89 patients were treated with warfarin and 59 patients with a direct oral anticoagulant (DOAC). There were similar rates of recurrent thrombosis in low risk patients on warfarin versus DOACs (adjusted IRR 6.91; 95% CI 0.90-53.40, p = 0.064). Major bleeding events only occurred in low risk patients on warfarin (n = 8, log-rank p = 0.13). In conclusion, despite the choice of anticoagulation, patients with low risk APS had similar rates of recurrent thrombosis suggesting DOACs may be a potential treatment option for this cohort. There was a non-significant increase in major bleeding rates in low risk patients on warfarin versus DOACs. Study limitations include a retrospective study design and small event numbers.
抗磷脂综合征（APS）是一种获得性高凝状态，需要长期抗凝以预防继发血栓形成。抗凝指南主要基于高危、三联阳性患者的数据，并且倾向于维生素 K 拮抗剂优于其他形式的抗凝。在低危、单阳性和双阳性 APS 患者中，替代抗凝剂预防继发血栓形成的疗效仍不确定。本研究旨在评估低危 APS 患者长期抗凝治疗后的复发性血栓形成和大出血发生率。我们对 2001 年 1 月至 2021 年 4 月期间符合血栓性 APS 修订标准并通过 Lifespan 健康系统接受治疗的患者进行了回顾性队列研究。主要结局包括复发性血栓形成和世界卫生组织 3 级和 4 级大出血。共有 190 名患者的中位随访时间为 3.1 年。在 APS 诊断时，89 名患者接受华法林治疗，59 名患者接受直接口服抗凝剂（DOAC）治疗。低危患者在华法林与 DOAC 治疗组的复发性血栓形成率相似（调整后的 IRR 6.91；95%CI 0.90-53.40，p=0.064）。大出血事件仅发生在华法林治疗的低危患者中（n=8，对数秩检验 p=0.13）。总之，尽管抗凝药物选择不同，但低危 APS 患者的复发性血栓形成率相似，这表明 DOAC 可能是该队列的潜在治疗选择。与 DOAC 相比，华法林治疗的低危患者大出血发生率有升高的趋势，但无统计学意义。研究局限性包括回顾性研究设计和小事件数量。
