Rauch Sebastian, Müller Hans-Peter, Dreyhaupt Jens, Ludolph Albert C, Kassubek Jan, Althaus Katharina
Department of Neurology, University of Ulm, 89081 Ulm, Germany.
Institute of Epidemiology and Medical Biometry, University of Ulm, 89081 Ulm, Germany.
J Clin Med. 2022 Jun 13;11(12):3399. doi: 10.3390/jcm11123399.
Background: Intracranial hemorrhage (ICH) is associated with high mortality and morbidity, especially in patients under anticoagulative treatment. Andexanet alfa (AA) is a modified recombinant form of human factor Xa (FXa) developed for reversal of FXa-inhibitors, e.g., in the event of ICH, but experience is still limited. Methods: This monocentric retrospective observational cohort study included 46 patients with acute FXa-inhibitor-associated non-traumatic ICH (FXa-I-ICH) of whom 23 were treated with AA within 12 h after symptom onset, compared to 23 patients with usual care (UC). Volumetrically analyzed hematoma expansion (HE) in brain imaging, clinical outcome and incidence of adverse events were analyzed. Results: All patients (mean age 79.8 ± 7.2 years) were effectively anticoagulated. The cohort included severely ill patients with large hematoma volumes (median 20.4, IQR 7.8−39.0 mL). Efficacy, as assessed by HE in imaging, was very good in the AA-group. There was no (0.0%) relevant HE (>33%) in contrast to UC-group (26.1%). Nevertheless, we observed a high incidence of thromboembolic events (30.4% vs. 4.4%) and non-favorable outcomes (death/palliative condition) in 43.5% vs. 26.1%. Conclusions: There was no HE in the volumetric neuroimaging assessment in the AA-group, but clinical outcomes remained often worse. Large randomized trials for the use of AA in patients with acute FXa-inhibitor-associated ICH are needed to investigate the clinical outcome in consideration of the rates of thromboembolism.
颅内出血（ICH）与高死亡率和高发病率相关，尤其是在接受抗凝治疗的患者中。安多凝血素α（AA）是一种经过修饰的重组人凝血因子Xa（FXa），用于逆转FXa抑制剂的作用，例如在发生ICH的情况下，但相关经验仍然有限。方法：这项单中心回顾性观察队列研究纳入了46例急性FXa抑制剂相关的非创伤性ICH（FXa-I-ICH）患者，其中23例在症状出现后12小时内接受了AA治疗，与23例接受常规治疗（UC）的患者进行比较。分析了脑成像中血肿体积的变化（HE）、临床结局和不良事件的发生率。结果：所有患者（平均年龄79.8±7.2岁）均接受了有效的抗凝治疗。该队列包括病情严重、血肿体积大的患者（中位数20.4，四分位数间距7.8−39.0 mL）。通过成像中的HE评估，AA组的疗效非常好。与UC组（26.1%）相比，AA组没有（0.0%）发生相关的血肿扩大（>33%）。然而，我们观察到血栓栓塞事件的发生率较高（30.4%对4.4%），且AA组的不良结局（死亡/姑息状态）发生率为43.5%，高于UC组的26.1%。结论：AA组在容积神经影像学评估中没有出现血肿扩大，但临床结局通常仍然较差。需要开展大型随机试验，研究AA在急性FXa抑制剂相关ICH患者中的应用，以考虑血栓栓塞发生率来研究临床结局。
