Hays William Blake, Billups Kelsey, Nicholson Jessica, Bailey Abby M, Gregory Haili, Weeda Erin R, Weant Kyle A
Department of Pharmacy, Indiana University Health West Hospital, Avon, IN, USA.
Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA.
J Thromb Thrombolysis. 2025 Feb;58(2):276-283. doi: 10.1007/s11239-024-03052-4. Epub 2024 Oct 28.
Multiple agents exist for the reversal of oral Factor Xa inhibitor (FXa) associated bleeding, including Coagulation FXa Recombinant, Inactivated zhzo (andexanet alfa) and 4-factor prothrombin complex concentrate (4F-PCC). While classified as a 3F-PCC product, Profilnine contains up to 35 IU of Factor VII (per 100 IU of Factor IX) in addition to therapeutic levels of Factors II, IX, and X, and has demonstrated a similar impact on prothrombin time and blood product usage in non-warfarin related bleeding. This was a retrospective, multicenter study at four medical centers of adult patients who presented with major bleeding associated with oral FXa inhibitors and received either 4F-PCC (n = 64) or 3F-PCC (n = 61). The primary outcome was hemostatic effectiveness. Secondary outcomes included the incidence of thromboembolism, in-hospital mortality, and length of stay. The most common indication for reversal was intracranial bleeding. For the primary outcome, 84% of all patients were rated as effective with no difference noted between the groups (p = 0.81). No significant difference between groups was found in the multivariable analysis adjusting for baseline differences between groups including race, total body weight, type of bleeding, and the use of antiplatelet therapy. There was no difference in the length of stay, in-hospital mortality, or the incidence of thromboembolism between the groups. Overall, no significant differences were found in the effectiveness or safety of 4F-PCC and 3F-PCC use in the management of oral FXa inhibitor-associated bleeding. Further investigations are warranted to explore the use of 3F-PCC for this indication and its safety and effectiveness.
有多种药物可用于逆转口服Xa因子抑制剂（FXa）相关的出血，包括凝血因子Xa重组剂、灭活的zhzo（andexanet alfa）和四因子凝血酶原复合物浓缩剂（4F-PCC）。虽然Profilnine被归类为三因子凝血酶原复合物浓缩剂产品，但除了治疗水平的凝血因子II、IX和X外，每100国际单位的凝血因子IX中还含有高达35国际单位的凝血因子VII，并且在非华法林相关出血中，其对凝血酶原时间和血液制品使用的影响相似。这是一项在四个医疗中心进行的回顾性多中心研究，研究对象为出现与口服FXa抑制剂相关的大出血并接受4F-PCC（n = 64）或三因子凝血酶原复合物浓缩剂（3F-PCC，n = 61）治疗的成年患者。主要结局指标是止血效果。次要结局指标包括血栓栓塞的发生率、住院死亡率和住院时间。最常见的逆转指征是颅内出血。对于主要结局指标，所有患者中有84%被评定为有效，两组之间未发现差异（p = 0.81）。在对包括种族、总体重、出血类型和抗血小板治疗使用情况等组间基线差异进行调整的多变量分析中，两组之间未发现显著差异。两组在住院时间、住院死亡率或血栓栓塞发生率方面没有差异。总体而言，在口服FXa抑制剂相关出血的管理中，使用4F-PCC和3F-PCC的有效性或安全性方面未发现显著差异。有必要进行进一步研究，以探索3F-PCC用于该指征的情况及其安全性和有效性。
