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andexanet alfa和四因子凝血酶原复合物浓缩剂用于逆转阿哌沙班和利伐沙班在颅内出血患者中的作用。

Andexanet alfa and four-factor prothrombin complex concentrate for reversal of apixaban and rivaroxaban in patients diagnosed with intracranial hemorrhage.

作者信息

Vestal Mark L, Hodulik Kimberly, Mando-Vandrick Jennifer, James Michael L, Ortel Thomas L, Fuller Matthew, Notini Maria, Friedland Mark, Welsby Ian J

机构信息

Department of Pharmacy, Duke University Medical Center, Durham, NC, USA.

Department of Pharmacy, Duke Regional Hospital, 3643 North Roxboro Street, Durham, NC, 27704, USA.

出版信息

J Thromb Thrombolysis. 2022 Jan;53(1):167-175. doi: 10.1007/s11239-021-02495-3. Epub 2021 Jun 8.

Abstract

Limited data exists regarding the clinical outcomes of andexanet alfa and four factor prothrombin complex concentrate (4F-PCC) for reversal of apixaban or rivaroxaban in the setting of intracranial hemorrhage (ICH). The objective of this study was to evaluate clinical outcomes of 4F-PCC and andexanet alfa for reversal of ICH associated with oral factor Xa inhibitors. This was a retrospective, single-center, case series evaluating hemostatic efficacy of patients receiving andexanet alfa) or 4F-PCC for reversal of apixaban or rivaroxaban after ICH. Secondary endpoints included in-hospital mortality, thrombotic complications, timing of reversal agents, intensive care unit and hospital length of stay, patient disposition, and 30-day readmission rate. During the study period, 21 patients received andexanet alfa and 35 received 4F-PCC. Hemostatic efficacy occurred in 64.7% of patients receiving andexanet alfa and 54.8% of receiving 4F-PCC. Thirty-day all-cause mortality was 45.2% for 4F-PCC and 30% for andexanet alfa. Thrombotic events were higher with 4F-PCC (31.4%) compared to andexanet alfa (14.3%). Median time from presentation to administration of reversal agent was 2.67 [1.75-4.13] hours with andexanet alfa and 1.73 [1.21-3.55] hours with 4F-PCC. Discharge to skilled nursing facilities and 30-day readmission were similar between groups. In this cohort, reversal with andexanet alfa and 4F-PCC differed in terms ofhemostatic efficacy and thrombotic events after ICH in patients anticoagulated with apixaban or rivaroxaban.

摘要

关于在颅内出血(ICH)情况下使用andexanet alfa和四因子凝血酶原复合物浓缩物(4F-PCC)来逆转阿哌沙班或利伐沙班的临床结果,现有数据有限。本研究的目的是评估4F-PCC和andexanet alfa用于逆转与口服Xa因子抑制剂相关的ICH的临床结果。这是一项回顾性、单中心病例系列研究,评估接受andexanet alfa或4F-PCC以逆转ICH后阿哌沙班或利伐沙班的患者的止血效果。次要终点包括住院死亡率、血栓形成并发症、逆转剂使用时间、重症监护病房和住院时间、患者出院情况以及30天再入院率。在研究期间,21例患者接受了andexanet alfa,35例接受了4F-PCC。接受andexanet alfa的患者中有64.7%出现止血效果,接受4F-PCC的患者中有54.8%出现止血效果。4F-PCC组的30天全因死亡率为45.2%,andexanet alfa组为30%。与andexanet alfa(14.3%)相比,4F-PCC组的血栓形成事件发生率更高(31.4%)。接受andexanet alfa的患者从出现症状到使用逆转剂的中位时间为2.67[1.75 - 4.13]小时,接受4F-PCC的患者为1.73[1.21 - 3.55]小时。两组之间转至专业护理机构的出院情况和30天再入院率相似。在该队列中,对于接受阿哌沙班或利伐沙班抗凝的ICH患者,andexanet alfa和4F-PCC在止血效果和血栓形成事件方面存在差异。

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