PB0555 - Efficacy and safety of 4-factor prothrombin complex concentrate for management for direct Xa inhibitor-induced major bleeding

Monday, June 26, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Paul P. Dobesh, PharmD, FACC, FAHA, FACC, BCPS, BCCP

Professor of Pharmacy Practice and Science
University of Nebraska Medical Center College of Pharmacy
Omaha, Nebraska, United States

Co-Author(s)

EL

Emilie A. Langenhan

Pharmacy Program Coordinator - Anticoagulation
Nebraska Medicine
Omaha, Nebraska, United States
HB

Heidi L. Brink

Cardiology Pharmacy Coordinator
Nebraska Medicine
Omaha, Nebraska, United States
JK

Jordan D. Kuck

Clinical Pharmacist
University of Nebraska Medical Center College of Pharmacy
Omaha, Nebraska, United States
AR

Adam L. Roskam

Clinical Pharmacist
University of Nebraska Medical Center College of Pharmacy
Omaha, Nebraska, United States
MS

Madison J. Suckstorf

Clinical Pharmacist
University of Nebraska Medical Center College of Pharmacy
Omaha, Nebraska, United States
CS

Cora K. Svoboda

Clinical Pharmacist
University of Nebraska Medical Center College of Pharmacy
Omaha, Nebraska, United States

Background: With the widespread use of direct Xa inhibitors, an effective and safe reversal agent is needed. Many institutions continue to use a 4-factor prothrombin complex concentrate (4F-PCC) due to lower cost and potential logistical variables, despite the lack of a plausible pharmacologic mechanism of action. Most data examining the use of 4F-PCC come from studies of 100 patients or less.

Aims: Assess the hemostatic efficacy and safety of 4F-PCC in management of direct Xa inhibitor-induced bleeding in real-world practice.

Methods: This retrospective, observational study included all patients who received 4F-PCC at our academic medical center for a major bleed while receiving a direct Xa inhibitor between 11/2014 to 5/2022. Patients receiving other anticoagulants or those undergoing surgery without bleeding were excluded. Patient demographics, medication use, laboratory values, hemostatic efficacy, and outcomes were collected from the electronic medical record. Hemostatic efficacy was defined using standard criteria. All descriptive data are presented as mean ± standard deviation.

Results: We identified 256 patients receiving 4F-PCC for management of direct Xa inhibitor-induced major bleeding. Bleeding was 55% intracranial, 29% gastrointestinal, 11% compartmental, and 5% unknown. Information on patient characteristics is found in Table 1. The 4F-PCC dose was 3199±1160 units at 37.8±12.6 units/kg. 4F-PCC stopped bleeding in 56% of patients while 24% required surgery. Hemostatic efficacy with 4F-PCC occurred within 32.6±39.7 hours and achieved in 59% of patients at 24 hours (Table 2). PRBCs were used in 32% and FFP and/or platelets in 25% of patients, respectively. Fatal bleeding occurred in 20% of patients and 5.1% had a thrombotic event at 30 days.

Conclusion(s): 4F-PCC provided a hemostatic efficacy of 59% at 24 hours. Thrombotic events were rare. 4F-PCC may not be optimal for management of direct Xa inhibitor-induced major bleeding.