Fixed-Dose Four-Factor Prothrombin Complex Concentrate for Reversal of Anticoagulation: Evaluation of Efficacy, Safety, and Cost Savings.

IF 1.3 Q4 HEMATOLOGY
Journal of hematology Pub Date : 2025-08-07 eCollection Date: 2025-08-01 DOI:10.14740/jh2078
Amer Al Homssi, Ryan Lokkesmoe, Ryan Powers, Benjamin Jung, Farheen Chunara, Aniko Szabo, Lisa Baumann Kreuziger
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引用次数: 0

Abstract

Background: Four-factor prothrombin complex concentrate (4F-PCC) is used for warfarin reversal and off-label management of bleeding in patients taking direct oral anticoagulants (DOACs). Dosing strategies that optimize hemostatic efficacy and cost, such as fixed dosing of 4F-PCC, are still under evaluation. The objective of this study was to retrospectively evaluate the efficacy, safety, and cost savings of fixed-dosing of 4F-PCC (1,500 IU for warfarin, 2,000 IU for DOACs).

Methods: Patients records from October 1, 2018, to April 30, 2021, at three hospitals within the Froedtert Health System were retrospectively reviewed for individuals who received fixed-dosing of 4F-PCC. Safety and efficacy were reflected in 30-day bleeding and thrombosis events, the need for repeat doses, and all-cause mortality. Cost savings were defined as the difference in the cost between the administration of fixed-dosing and the projected weight- and international normalized ratio (INR)-based dosing based on the package insert for warfarin reversal or 50 IU/kg in patients treated with DOACs.

Results: A total of 592 patients received fixed-dosing of 4F-PCC during the prespecified period, of whom 541 received it for warfarin reversal (n = 414) or DOACs (n = 127) management in emergency settings. INR below 2 was achieved in 89% of patients on warfarin. Less than 5% in either group required repeat doses of 4F-PCC. Within 30 days, both groups had similar bleeding (12%) and thrombotic (5%) events. All-cause 30-day mortality rates in patients treated with warfarin and DOACs were 24% and 30%, respectively. The median cost savings of fixed-dosing per patient on warfarin and DOACs were $1,567 and $3,936, respectively, with annualized median hospital cost savings of $176,239 and $146,733, respectively.

Conclusions: Fixed-dosing of 4F-PCC had significantly less cost than adjusted dose and is associated with similar rates of thrombosis and death compared to other studies.

用于抗凝逆转的固定剂量四因子凝血酶原复合物浓缩物:疗效、安全性和成本节约的评估。
背景:四因子凝血酶原复合物浓缩物(4F-PCC)用于直接口服抗凝剂(DOACs)患者的华法林逆转和超说明书出血管理。优化止血效果和成本的给药策略,如4F-PCC的固定剂量,仍在评估中。本研究的目的是回顾性评价固定剂量4F-PCC(华法林1500 IU, DOACs 2000 IU)的疗效、安全性和成本节约。方法:回顾性分析Froedtert卫生系统内三家医院2018年10月1日至2021年4月30日的患者记录,其中包括接受固定剂量4F-PCC的患者。安全性和有效性反映在30天出血和血栓事件、需要重复给药和全因死亡率上。成本节约被定义为固定给药剂量与基于华法林逆转或50 IU/kg doac治疗患者的包装说明书的基于预计体重和国际标准化比例(INR)的给药剂量之间的成本差异。结果:共有592名患者在预定期间接受了固定剂量的4F-PCC,其中541名患者在紧急情况下接受华法林逆转(n = 414)或DOACs (n = 127)管理。89%的华法林患者INR低于2。两组中需要重复剂量4F-PCC的患者均少于5%。在30天内,两组有相似的出血(12%)和血栓(5%)事件。接受华法林和doac治疗的患者的全因30天死亡率分别为24%和30%。华法林和doac的固定剂量每位患者的成本节约中位数分别为1567美元和3936美元,年化医院成本节约中位数分别为176239美元和146733美元。结论:与其他研究相比,固定剂量的4F-PCC的成本明显低于调整剂量,并且与类似的血栓和死亡率相关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of hematology
Journal of hematology HEMATOLOGY-
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