Koo Soo Jin, Hussain Yunus, Booth Deborah Y, Desai Payal, Oh Elly S, Rios Jose, Audley Kristen
J Am Pharm Assoc (2003). 2024 Mar-Apr;64(2):395-401. doi: 10.1016/j.japh.2023.11.015. Epub 2023 Nov 11.
Optimal reversal agent for direct oral anticoagulant (DOAC)-associated major bleeding has not been described. Before the approval of andexanet alfa (AA) in 2018, 4-factor prothrombin complex concentrate (4F-PCC) was recommended by major guidelines. Currently, AA is recommended as the first-line agent by most guidelines. With a paucity of literature comparing the 2 agents, there is clinical value in assessing hemostatic efficacy and safety of the 2 agents.
This study aimed to evaluate hemostatic efficacy and safety of AA and 4F-PCC in all DOAC-associated major bleedings.
A multicenter, retrospective chart review was performed of adult subjects who were admitted for a DOAC-associated major bleeding and received 4F-PCC from February 2018 to May 2019 or AA from May 2019 to September 2021. Some of the exclusion criteria included not receiving a DOAC, receiving multiple reversal agents during the same hospitalization, receiving reversal for any nonmajor bleeding indication, and not receiving the full dose of a reversal agent. The primary outcome was hemostatic efficacy 24 hours after the end of the reversal agent administration. Secondary outcomes included time to administration, hospital mortality, length of stay, need for surgery, and need for additional blood product. Safety outcome was incidence of thrombotic events.
There were 99 subjects included in the 4F-PCC group and 84 subjects in the AA group. Hemostatic efficacy was achieved in 69 subjects (69.7%) in the 4F-PCC group and 63 subjects (75%) in the AA group (P = 0.927). In-hospital mortality was seen in 20 subjects (20.2%) in the 4F-PCC group and 10 subjects (11.9%) in the AA group. Thrombotic events were seen in 7 subjects (7.1%) in the 4F-PCC group and 6 subjects (7.1%) in the AA group.
There were no significant differences in hemostatic efficacy, in-hospital mortality, and number of thrombotic events between 4F-PCC and AA.
直接口服抗凝剂（DOAC）相关的严重出血的最佳逆转剂尚未明确。在2018年andexanet alfa（AA）获批之前，主要指南推荐使用4因子凝血酶原复合物浓缩剂（4F-PCC）。目前，大多数指南推荐AA作为一线药物。由于比较这两种药物的文献较少，评估这两种药物的止血效果和安全性具有临床价值。
本研究旨在评估AA和4F-PCC在所有DOAC相关严重出血中的止血效果和安全性。
对2018年2月至2019年5月因DOAC相关严重出血入院并接受4F-PCC治疗，或2019年5月至2021年9月接受AA治疗的成年患者进行多中心回顾性病历审查。一些排除标准包括未接受DOAC治疗、在同一住院期间接受多种逆转剂治疗、因任何非严重出血指征接受逆转治疗以及未接受全剂量逆转剂治疗。主要结局是逆转剂给药结束后24小时的止血效果。次要结局包括给药时间、医院死亡率、住院时间、手术需求以及额外血液制品的需求。安全性结局是血栓事件的发生率。
4F-PCC组纳入99例患者，AA组纳入84例患者。4F-PCC组69例患者（69.7%）实现止血，AA组63例患者（75%）实现止血（P = 0.927）。4F-PCC组20例患者（20.2%）出现院内死亡，AA组10例患者（11.9%）出现院内死亡。4F-PCC组7例患者（7.1%）出现血栓事件，AA组6例患者（7.1%）出现血栓事件。
4F-PCC和AA在止血效果、院内死亡率和血栓事件数量方面无显著差异。
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