Cubilier Edouard, Chergui Youcef, Garrouste Cyril, Ramos Ines, Philipponnet Carole, Atenza Alba, Greze Clarisse, Aniort Julien, Uro-Coste Charlotte, Heng Anne-Elisabeth
Nephrology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
Biostatistics Unit, DRCI, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.
Kidney Int Rep. 2025 Mar 3;10(5):1468-1475. doi: 10.1016/j.ekir.2025.02.028. eCollection 2025 May.
Nephrotic syndrome (NS) is a pathological state of the glomerular filtration barrier associated with an increased venous and arterial thrombotic risk. Current guidelines suggest heparin-based or vitamin K antagonist (VKA) regimens for thromboprophylaxis in such patients. Although widely prescribed for other indications, direct oral anticoagulants (DOACs) are not recommended in NS because of limited pharmacological and safety reports. This study aimed to compare DOACs and VKAs for thromboprophylaxis in NS, specifically regarding thrombotic events (TEs) and bleeding events (BEs).
We conducted a retrospective monocentric analysis of recorded NS episodes that required prophylactic anticoagulation between January 2006 and December 2023. We included 133 NS episodes of which 51 were treated with DOACs and 82 with VKAs. The primary endpoint was a composite endpoint, including thrombosis occurrence and major or clinically significant BEs during thromboprophylaxis. The secondary endpoints consisted of relevant features potentially involved when each primary endpoint was considered independently.
Patient characteristics, underlying NS etiology, personal thrombotic and bleeding risk factors, and biological parameters were globally similar in both groups. The primary endpoint appeared similar in both groups ( = 0.481). The secondary endpoints were mostly hypothesis-generating because of the low TE ( = 2) and BE ( = 7) occurrences.
This study provides reassuring clinical data on DOAC use in NS thromboprophylaxis compared with VKAs, the recommended therapy, and calls for confirmation in randomized controlled trials (RCTs) and larger pharmacological studies.
肾病综合征(NS)是一种肾小球滤过屏障的病理状态,与静脉和动脉血栓形成风险增加相关。当前指南建议对此类患者采用基于肝素或维生素K拮抗剂(VKA)的方案进行血栓预防。尽管直接口服抗凝剂(DOAC)因其他适应症而被广泛处方,但由于药理学和安全性报告有限,不建议在NS中使用。本研究旨在比较DOAC和VKA在NS血栓预防中的效果,特别是关于血栓事件(TE)和出血事件(BE)。
我们对2006年1月至2023年12月期间需要预防性抗凝的NS发作记录进行了回顾性单中心分析。我们纳入了133例NS发作,其中51例接受DOAC治疗,82例接受VKA治疗。主要终点是一个复合终点,包括血栓形成的发生以及血栓预防期间的重大或具有临床意义的BE。次要终点包括在独立考虑每个主要终点时可能涉及的相关特征。
两组患者的特征、潜在的NS病因、个人血栓形成和出血风险因素以及生物学参数总体相似。两组的主要终点似乎相似(P = 0.481)。由于TE(n = 2)和BE(n = 7)发生率较低,次要终点大多是产生假设性的。
与推荐疗法VKA相比,本研究提供了关于DOAC用于NS血栓预防的令人安心的临床数据,并呼吁在随机对照试验(RCT)和更大规模的药理学研究中进行确认。