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abelacimab预防静脉血栓栓塞
Abelacimab for Prevention of Venous Thromboembolism


Peter Verhamme ... 其他 • 2021.08.12
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新型抗凝药物abelacimab有效预防术后静脉血栓栓塞

 

郭建明,郭连瑞*

首都医科大学宣武医院血管外科*通讯作者

 

骨科患者术后VTE的风险很高,术后静脉血栓发生多被认为是由手术部位暴露的组织因子激活外源性凝血途径导致的1,而内源性凝血途径在术后静脉血栓形成发病机制中的重要性尚不确定。

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摘要


背景

凝血因子XI在术后静脉血栓栓塞发病机制中的作用尚不明确。abelacimab是一种单克隆抗体,可与凝血因子XI结合并将其锁定在酶原(非活性前体)构象。

 

方法

在此项开放标签的平行组试验中,我们将接受全膝关节置换术的412例患者随机分组,四组分别接受三种abelacimab方案之一(30 mg、75 mg或150 mg)(术后单次静脉给药)或40 mg依诺肝素(每日一次皮下给药)。主要效力结局是静脉血栓栓塞(检测方式是对接受手术的腿进行强制性静脉造影或者对有症状事件进行客观确认)。主要安全性结局是由截至术后30日的大出血或临床相关非大出血构成的复合结局。

 

结果

30 mg abelacimab组102例患者中的13例(13%)、75 mg abelacimab组99例患者中的5例(5%)、150 mg abelacimab组98例患者中的4例(4%)和依诺肝素组101例患者中的22例(22%)发生了静脉血栓栓塞。30 mg abelacimab方案不劣于依诺肝素,75 mg和150 mg abelacimab方案优于依诺肝素(P<0.001)。30 mg、75 mg和150 mg abelacimab组,以及依诺肝素组分别有2%、2%、0例和0例患者发生了出血。

 

结论

本试验表明,凝血因子XI在术后静脉血栓栓塞发生过程中起重要作用。全膝关节置换术后,通过abelacimab单次静脉给药抑制凝血因子XI可有效预防静脉血栓栓塞,并且出血风险低(由Anthos Therapeutics资助,ANT-005在TKA EudraCT注册号为2019-003756-37)。





作者信息

Peter Verhamme, M.D., B. Alexander Yi, M.D., Ph.D., Annelise Segers, M.D., Janeen Salter, B.S.N., Daniel Bloomfield, M.D., Harry R. Büller, M.D., Gary E. Raskob, Ph.D., and Jeffrey I. Weitz, M.D. for the ANT-005 TKA Investigators*
From KU Leuven Department of Cardiovascular Sciences, Vascular Medicine and Hemostasis, Leuven, Belgium (P.V.); Anthos Therapeutics, Cambridge, MA (B.A.Y., J.S., D.B.); International Trial Expertise Advisory and Services (A.S.) and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam (H.R.B.) — both in Amsterdam; Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City (G.E.R.); and the Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada (J.I.W.). Address reprint requests to Dr. Weitz at the Thrombosis and Atherosclerosis Research Institute, 237 Barton St. East, Hamilton, ON, Canada L8L 2X2, or at weitzj@taari.ca. *A complete list of investigators and committees in the ANT-005 TKA (Total Knee Arthroplasty) trial is provided in the Supplementary Appendix, available at NEJM.org.

 

参考文献

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