Elsebaie Maha A T, Wickham Zoe, DeBragga Stephanie, Fedewa Stacey, Amgad Mohamed, Park Jane Jungyoon, Li Allen, Eshaghpour Ali, Li Juan, Crowther Mark, Gaddh Manila
Department of Hematology and Medical Oncology, University of Chicago, Chicago, Illinois, USA.
Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia, USA.
Res Pract Thromb Haemost. 2025 Apr 17;9(4):102856. doi: 10.1016/j.rpth.2025.102856. eCollection 2025 May.
Direct oral anticoagulants (DOACs) have become firstline treatment for many thrombotic conditions, but their use in antiphospholipid syndrome (APS) patients remains controversial.
This multicenter, retrospective cohort study conducted at Emory and McMaster University Medical Centers aimed to explore pattern of DOAC use among APS patients and compare the efficacy and safety of DOACs vs warfarin.
We included APS patients aged ≥18 years who experienced acute thrombosis between 2012 and 2018 and initiated DOACs or warfarin. Clinical endpoints were recurrent thrombosis, clinically relevant bleeding, and a composite of thrombosis and bleeding (net clinical benefit). Cox proportional hazards models estimated hazard ratios (HRs) for the clinical endpoints and defined DOAC or warfarin exposure as time-varying to account for anticoagulant switching.
A total of 152 patients were identified: 77 initiated treatment with warfarin and 75 with DOACs. Sixty patients switched anticoagulation therapy at least once. Twenty-four patients had triple-positive antiphospholipid antibodies anticoagulation class (DOAC vs warfarin) did not influence risk of recurrent thrombosis (HR, 0.91; 95% CI, 0.46-1.79) or net clinical benefit (HR, 0.81; 95% CI, 0.46-1.43). Conversely, DOACs were associated with 57% reduction in risk of clinically relevant bleeding (HR, 0.43; 95% CI, 0.20-0.95). The risk of recurrent venous or arterial thrombosis was comparable between DOAC and warfarin cohorts.
This study demonstrated comparable efficacy and improved safety of DOACs over warfarin in a predominantly lower-risk APS population. Caution is advised, particularly in APS patients with triple-positive antiphospholipid antibodies or history of arterial thrombosis.
直接口服抗凝剂（DOACs）已成为许多血栓形成疾病的一线治疗药物，但其在抗磷脂综合征（APS）患者中的应用仍存在争议。
这项在埃默里大学和麦克马斯特大学医学中心进行的多中心回顾性队列研究旨在探讨APS患者使用DOACs的模式，并比较DOACs与华法林的疗效和安全性。
我们纳入了2012年至2018年间发生急性血栓形成并开始使用DOACs或华法林的年龄≥18岁的APS患者。临床终点为复发性血栓形成、临床相关出血以及血栓形成和出血的综合指标（净临床获益）。Cox比例风险模型估计临床终点的风险比（HRs），并将DOAC或华法林暴露定义为随时间变化，以考虑抗凝剂的转换。
共确定了152例患者：77例开始使用华法林治疗，75例使用DOACs治疗。60例患者至少更换过一次抗凝治疗。24例患者抗磷脂抗体呈三阳性。抗凝类别（DOAC与华法林）不影响复发性血栓形成风险（HR，0.91；95%CI，0.46-1.79）或净临床获益（HR，0.81；95%CI，0.46-1.43）。相反，DOACs与临床相关出血风险降低57%相关（HR，0.43；95%CI，0.20-0.95）。DOAC组和华法林组复发性静脉或动脉血栓形成的风险相当。
本研究表明，在主要为低风险的APS人群中，DOACs与华法林疗效相当，但安全性更高。建议谨慎使用，尤其是在抗磷脂抗体呈三阳性或有动脉血栓形成病史的APS患者中。
