PB0472 - Use of andexanet alfa and 4-factor prothrombin complex concentrate for reversal therapy in severe hemorrhage: a single-centre cohort study

Sunday, June 25, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Elena Campello, MD, PhD (she/her/hers)

Assistant Professor
Department of Medicine, University of Padova, Italy
Padova, Veneto, Italy

Co-Author(s)

AA

Alessandra Aquilone

Resident in internal MEedicine
Department of Medicine, University of Padova, Italy
Padova, Veneto, Italy
NP

Nicola Perin

Resident in internal MEedicine
Department of Medicine, University of Padova, Italy
Padova, Veneto, Italy
Chiara Simion, MD

Resident in Geriatrics
Department of Medicine, University of Padova, Italy
Padova, Veneto, Italy
LS

Luca Spiezia

Associate Professor
Department of Medicine, University of Padova, Italy
Padova, Veneto, Italy
SP

Susanna Paccagnella

Pharmacist
Hospital Pharmacy, University-Hospital of Padova
Padova, Veneto, Italy
VC

Vito Cianci

Medical Doctor
Emergency-Urgency Department, University-Hospital of Padova
Padova, Veneto, Italy
FV

Francesca Venturini

Pharmacist
Hospital Pharmacy, University-Hospital of Padova
Padova, Veneto, Italy
Paolo Simioni, MD, PhD (he/him/his)

Full Professor
Department of Medicine, Thrombotic and Haemorrhagic Diseases Unit, University of Padua Medical School, Padua (Italy)
Padua, Veneto, Italy

Background: Andexanet alfa (AA) is the first specific reversal agent for the factor Xa (FXa) inhibitors rivaroxaban and apixaban in case of life-threatening or uncontrolled bleeding. 4-factor prothrombin complex concentrate (4F-PCC) has been commonly used as a reversal strategy.

Aims: To describe the clinical and safety outcomes between AA and 4F-PCC for the reversal of apixaban or rivaroxaban in the setting of severe hemorrhage.

Methods: This is a prospective cohort study including all adult patients admitted to our Emergency Department between 2021 and 2022 with severe traumatic or spontaneous FXa-related hemorrhage who received AA or 4F-PCC as reversal strategy. Our primary analysis evaluated the achievement of hemostatic efficacy through radiologic/endoscopic procedures. Secondary outcomes included 30-day mortality and disability, length of hospital stay, incidence of thromboembolic event and costs.

Results: A total of 38 patients (median age 79 years [34-97], M=19) were included, of which 14 (37%) received AA and 24 (63%) received 4F-PCC. Patients characteristics and outcomes are reported in Table 1. The achieved hemostatic efficacy, evaluated after a radiologic or endoscopic procedure repeated within 24 hours after the reversal strategy, was excellent in 10 (71.5%) patients in the AA group vs. and in 15 (62.5%) patients in the 4F-PCC group (p=0.22). 2 patients (14%) treated with AA died during hospitalization vs. 6 (25%) within the 4F-PCC group (p=0.47). The intra-hospital mortality considering only cerebral hemorrhages was also similar between groups (33.3% vs 31.2%, respectively). Overall, 19 patients (50%) were discharged with anticoagulant therapy, 10 with low-molecular weight heparin, 6 with a direct oral anticoagulant, and 2 with Warfarin. None of the patients had thromboembolic events. Costs were higher with AA vs. 4F-PCC.

Conclusion(s): Real-world data confirm excellent hemostatic effect of AA, with low intra-hospital mortality and permanent disability. No thrombotic events were recorded. Cost is the main current issue.