Outcomes of 4-factor Prothrombin Complex Concentrate in Patients With Liver Disease and Nonvitamin K Antagonist-Related Coagulopathy: A Retrospective Study

Autor: Paarth B. Dodhiawala BS, Kyle Pribyl MD, Jared Larson PharmD, Victor Vakayil MD, MS, Malavika Chandrashekar DO, Amanda Lord PharmD, Julie Welbig MS, MLS (ASCP), SBB, Nicole D. Zantek MD, PhD, David Martin MD, James V. Harmon MD, PhD
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Clinical and Applied Thrombosis/Hemostasis, Vol 29 (2023)
Druh dokumentu: article
ISSN: 1938-2723
10760296
DOI: 10.1177/10760296231198038
Popis: The administration of 4-factor prothrombin complex concentrate (4F-PCC) has expanded beyond its Food and Drug Administration (FDA)-approved indication for the emergent reversal of vitamin K antagonists (VKAs). Therefore, this study aimed to evaluate the risks and benefits associated with the expanded use of 4F-PCC. We conducted a single-center retrospective review of 4F-PCC administrations at our university hospital. Of the 159 patients who received 4F-PCC, 76% (n = 121) and 24% (n = 38) received it for the FDA-approved indication in the vitamin K-related coagulopathy (VKA) group and for expanded use in the nonvitamin K-related coagulopathy (nVKA) group, respectively. The expanded use of 4F-PCC was associated with a less robust reduction in the international normalized ratio (INR) (INR of −0.7 ± 1.3 vs INR of −1.6 ± 1.8, P = .002), and fewer patients in the nVKA group achieved a postadministration INR of less than1.5 (11% vs 79%, P = .001) than those in the VKA group. Furthermore, the 30-day mortality rate was significantly higher in the nVKA cohort than in the VKA cohort (42% vs 20%, P = .04). Notably, based on our data, underlying differences in the patient’s comorbidities, particularly advanced liver disease, may have contributed to the observed outcome variations, including mortality rate. Therefore, factors, including comorbidities and the underlying etiology of coagulopathy, should be considered when deciding on the expanded use of 4F-PCC. Further research is needed to better understand the potential risks and benefits of 4F-PCC in expanded use scenarios, and the clinical decision to use 4F-PCC outside its FDA-approved indication should be made carefully, considering this information.
Databáze: Directory of Open Access Journals
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