近日，美国布列根和妇女医院Christian T. Ruff团队比较了房颤患者接受阿贝西单抗与利伐沙班治疗后对出血事件的影响。该研究于2025年1月23日发表在《新英格兰医学杂志》上。

阿贝西单抗是一种全人源单克隆抗体，可结合无活性形式的因子XI并阻断其激活。与直接口服抗凝剂相比，阿贝西单抗在房颤患者中的安全性尚不清楚。

将房颤和中高卒中风险患者以1:1:1的比例随机分配，接受盲法皮下注射阿贝西单抗（150 mg或90 mg，每月一次）或开放标签口服利伐沙班（20 mg，每日一次）。主要终点是严重或临床相关的非重大出血。

共有1287名患者接受了随机分组；中位年龄为74岁，44%为女性。3个月时，剂量为150 mg的阿贝西单抗组的游离因子XI水平的中位降低率为99%（四分位数间距，98至99），剂量为90 mg的阿贝西单抗组为97%（四分位间距，51至99）。根据独立数据监测委员会的建议，该试验提前停止，因为使用阿贝西单抗后出血事件的减少幅度大于预期。与利伐沙班每100人年8.4起事件相比，150 mg阿贝西单抗的严重或临床相关非重大出血的发生率为每100人-年3.2起事件，90 mg阿贝西单抗为每100人-年2.6起事件。三组不良事件的发生率和严重程度似乎相似。

研究结果表明，在中高程度中风风险的房颤患者中，与利伐沙班治疗相比，阿贝西单抗治疗导致游离因子XI水平显著降低，出血事件减少。

附：英文原文

Title: Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation

Author: Christian T. Ruff, Siddharth M. Patel, Robert P. Giugliano, David A. Morrow, Bruce Hug, Julia F. Kuder, Erica L. Goodrich, Shih-Ann Chen, Shaun G. Goodman, Boyoung Joung, Robert G. Kiss, Jindrich Spinar, Wojciech Wojakowski, Jeffrey I. Weitz, Sabina A. Murphy, Stephen D. Wiviott, Sanobar Parkar, Daniel Bloomfield, Marc S. Sabatine

Issue&Volume: 2025-01-23

Abstract:

BACKGROUND

Abelacimab is a fully human monoclonal antibody that binds to the inactive form of factor XI and blocks its activation. The safety of abelacimab as compared with a direct oral anticoagulant in patients with atrial fibrillation is unknown.

METHODS

Patients with atrial fibrillation and a moderate-to-high risk of stroke were randomly assigned, in a 1:1:1 ratio, to receive subcutaneous injection of abelacimab (150 mg or 90 mg once monthly) administered in a blinded fashion or oral rivaroxaban (20 mg once daily) administered in an open-label fashion. The primary end point was major or clinically relevant nonmajor bleeding.

RESULTS

A total of 1287 patients underwent randomization; the median age was 74 years, and 44% were women. At 3 months, the median reduction in free factor XI levels with abelacimab at a dose of 150 mg was 99% (interquartile range, 98 to 99) and with abelacimab at a dose of 90 mg was 97% (interquartile range, 51 to 99). The trial was stopped early on the recommendation of the independent data monitoring committee because of a greater-than-anticipated reduction in bleeding events with abelacimab. The incidence rate of major or clinically relevant nonmajor bleeding was 3.2 events per 100 person-years with 150-mg abelacimab and 2.6 events per 100 person-years with 90-mg abelacimab, as compared with 8.4 events per 100 person-years with rivaroxaban (hazard ratio for 150-mg abelacimab vs. rivaroxaban, 0.38 [95% confidence interval {CI}, 0.24 to 0.60]; hazard ratio for 90-mg abelacimab vs. rivaroxaban, 0.31 [95% CI, 0.19 to 0.51]; P<0.001 for both comparisons). The incidence and severity of adverse events appeared to be similar in the three groups.

CONCLUSIONS

Among patients with atrial fibrillation who were at moderate-to-high risk for stroke, treatment with abelacimab resulted in markedly lower levels of free factor XI and fewer bleeding events than treatment with rivaroxaban.

DOI: NJ202501233920409

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2406674