Parsels Katie A, Seabury Robert W, Zyck Stephanie, Miller Christopher D, Krishnamurthy Satish, Darko William, Probst Luke A, Latorre Julius Gene, Cwikla Gregory M, Feldman Elizabeth A
Upstate University Hospital, Department of Pharmacy, Syracuse, NY, USA.
Upstate University Hospital, Department of Pharmacy, Syracuse, NY, USA; Upstate Medical University, Department of Medicine, Syracuse, NY, USA.
Am J Emerg Med. 2022 May;55:16-19. doi: 10.1016/j.ajem.2022.02.036. Epub 2022 Feb 24.
There is limited information directly comparing andexanet alfa (AA) versus four-factor prothrombin complex concentrate (4F-PCC) in intracranial hemorrhage (ICH) on apixaban or rivaroxaban.
The objective of this study was to compare the effectiveness and safety of AA versus 4F-PCC in ICH on apixaban or rivaroxaban.
This retrospective, matched, cohort analysis was conducted at a single healthcare system. Patients were matched based on baseline ICH volume. The primary outcome was good or excellent ICH hemostasis, which was defined as a 35% or less increase in ICH volume within 24 h following AA or 4F-PCC administration. The secondary outcome was thrombotic events within 14 days following AA or 4F-PCC administration.
In total, 26 AA and 26 4F-PCC patients were included in this matched cohort analysis. Both groups had comparable rates of good or excellent ICH hemostasis (AA: 92.3% vs. 4F-PCC: 88.5%, p = 1.000). Thrombotic events within 14-days were not significantly different (AA: 26.9% vs. 4F-PCC: 11.5%, p = 0.159).
This study found no significant differences in good or excellent ICH hemostasis within 24-h or new thrombotic events within 14-days in a cohort given AA or 4F-PCC for ICH while on apixaban or rivaroxaban. However, this single-center analysis is underpowered due to sample size constraints, therefore further high-quality research comparing AA safety and effectiveness versus 4F-PCC is needed.
关于在使用阿哌沙班或利伐沙班的颅内出血（ICH）患者中，直接比较andexanet alfa（AA）与四因子凝血酶原复合物浓缩剂（4F-PCC）的信息有限。
本研究的目的是比较AA与4F-PCC在使用阿哌沙班或利伐沙班的ICH患者中的有效性和安全性。
本回顾性、匹配队列分析在单一医疗系统中进行。患者根据基线ICH体积进行匹配。主要结局是良好或优异的ICH止血，定义为在给予AA或4F-PCC后24小时内ICH体积增加35%或更少。次要结局是在给予AA或4F-PCC后14天内的血栓形成事件。
在这个匹配队列分析中，总共纳入了26例接受AA治疗的患者和26例接受4F-PCC治疗的患者。两组良好或优异的ICH止血率相当（AA组：92.3% vs. 4F-PCC组：88.5%，p = 1.000）。14天内的血栓形成事件无显著差异（AA组：26.9% vs. 4F-PCC组：11.5%，p = 0.159）。
本研究发现，在使用阿哌沙班或利伐沙班的情况下，给予AA或4F-PCC治疗的ICH患者队列中，24小时内良好或优异的ICH止血情况以及14天内新的血栓形成事件均无显著差异。然而，由于样本量限制，这项单中心分析的效能不足，因此需要进一步开展高质量研究来比较AA与4F-PCC的安全性和有效性。
