(769) Comparison of 4-Factor Prothrombin Complex Concentrates for Direct Xa Inhibitor Intracranial Bleed

Sunday, February 23, 2025

11:00am – 12:00pm Eastern Time

Location: Connections Central - RST 01

First Author(s)

VN

Vivian X. Nguyen, PharmD

Riverside Methodist Hospital, USA

Co-Author(s)

MS

Maureen Smythe, PharmD, FCCP

Clinical Pharmacy Specialist (Anticoagulation)/ Professor (Clinical)
Wayne State University/Corewell Health William Beaumont University Hospital, Royal Oak, United States
JH

Janet Hoffman, PharmD

Pharmacist Specialist (Drug Information)
Corewell Health William Beaumont University Hospital, Royal Oak, United States
JK

John M. Koerber, PharmD

Pharmacist Specialist (Investigational Drug)
Beaumont Hospital - Royal Oak, United States
EP

Ekaterina Pechenko, PharmD

PGY-1 Pharmacy Resident
Corewell Health William Beaumont University Hospital, Dearborn, United States
JB

Jason R. Batke, MD

Hospitalist
Corewell Health William Beaumont University Hospital, Royal Oak,, United States
AK

Anant Krishnan, MD

Neuroradiologist
Corewell Health William Beaumont University Hospital, Royal Oak, United States

Introduction: Both four-factor prothrombin complex concentrate (4FPCC) and activated 4FPCC (a4FPCC) can be used for direct Xa inhibitor bleeding however comparison data are limited. This study aimed to compare patient outcomes of 4FPCC and a4FPCC for apixaban- and rivaroxaban-related intracranial hemorrhage (ICH).

Methods: This single-center, retrospective cohort study included adult patients who received either a4FPCC from August 2016 to July 2019 or 4FPCC from June 2021 to June 2023. Those with emergent surgical reversal without bleed were excluded. The primary efficacy and safety outcomes were hemostatic efficacy (modified ANNEXA-4 criteria) and thrombosis with at least a possible/probable relationship to reversal at 30 days, respectively. Reversal-related thrombosis was adjudicated by two physicians using the World Health Organization causality categories. Secondary outcomes were mortality, anticoagulation resumption at discharge, and readmission.

Results: Forty-eight 4FPCC and 34 a4FPCC patients were included. More patients in the 4FPCC cohort were prescribed apixaban (75% vs. 44.1%, p=0.006) and a higher median PCC dose (50 vs. 43.5 units/kg, p< 0.0001). No difference was observed in hemostatic efficacy (4FPCC, 84.4% vs. a4FPCC, 69%, p=0.15), 30-day thrombosis with at least a possible/probable relationship to reversal (4FPCC, 8.3% vs. a4FPCC 8.8%, p=1), or any secondary outcomes. Within the 4FPCC cohort, three cases of ischemic stroke, one superficial vein thrombosis, one deep vein thrombosis (DVT), and one pulmonary embolism were confirmed (one patient experienced multiple thrombotic events). Within the a4FPCC cohort, one case of ischemic stroke, one DVT, and one arterial thrombus were confirmed.

Conclusions: There was no difference in hemostatic efficacy and thrombosis with at least a possible/probable relationship to reversal at 30 days between the two groups. Larger prospective randomized studies are necessary to determine the efficacy and thromboembolism rate of 4FPCC and a4FPCC for the management of apixaban- and rivaroxaban-related ICH.