Paige Bradshaw, BCCCP, PharmD
Clinical Pharmacy Specialist - Critical Care/Emergency Medicine
University of Cincinnati Medical Center
Mason, Ohio
Disclosure information not submitted.
Carolyn Philpott, PharmD, BCCCP
Clinical Pharmacy Specialist
University of Cincinnati Medical Center, United States
Disclosure information not submitted.
Chris Droege, PharmD, BCCCP, FCCM
UC Health/University of Cincinnati Medical Center
Cincinnati
Disclosure information not submitted.
Molly Droege, PharmD
Clinical Pharmacy Specialist
UC Health/University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Disclosure information not submitted.
Neil Ernst, PharmD
Clinical Pharmacy Specialist
University of Cincinnati Medical Center, United States
Disclosure information not submitted.
Madeline Foertsch, PharmD, BCCCP
Clinical Pharmacy Specialist
University of Cincinnati Medical Center, United States
Disclosure information not submitted.
Nicole Harger, Pharm.D., BCCCP
Clinical Pharmacy Specialist - Emergency Medicine
UC Health-University of Cincinnati Medical Center, United States
Disclosure information not submitted.
Vasisht Srinivasan, MD
Dept of Emergency Medicine
University of Washington School of Medicine, United States
Disclosure information not submitted.
Jessica Winter, Pharm.D., BCCCP, BCPS
Clinical Pharmacy Specialist
University of Cincinnati Medical Center, United States
Disclosure information not submitted.
Shaun Keegan, Pharm.D., BCPS
Clinical Pharmacy Specialist
University of Cincinnati Medical Center, United States
Disclosure information not submitted.
Title: Reversal of direct factor Xa inhibitors with andexanet alfa prior to invasive or surgical procedures
Introduction: The objective of this study is to describe the hemostatic outcomes of patients who received andexanet alfa (AA) within 24 hours of an invasive or surgical procedure while also reporting the effects of AA on coagulation lab trends in patients prescribed apixaban and rivaroxaban.
Methods: This single-centre, observational study included patients who received AA within 24 hours of an invasive or surgical procedure. The primary outcome graded the level of achieved hemostasis 24 hours after AA as “excellent”, “good”, or “poor” using similar definitions to ANEXXA-4. Secondary outcomes included in-hospital morbidity data, discharge disposition, blood product transfusion trends, 30-day mortality, and 30-day ischemic event rates. Coagulation labs (prothrombin time (PT), anti-Xa concentrations, and thromboelastography (TEG) values) were evaluated for all patients who had pre- and post levels within 24 hours of AA administration.
Results: Thirty patients underwent surgery or an invasive procedure within 24 hours of AA administration (apixaban, n=18 (62%); rivaroxaban, n=11 (38%)). The indications for reversal were categorized as intracranial bleeding (n=13 (43%)) or extracranial (n=17 (57%). In patients able to be assessed per study definitions for hemostatic efficacy, 76% of all patients achieved “excellent” or “good” hemostasis (intracranial, n=7 (87.5%); extracranial, n=12 (70.6%)). Eight (26.7%) patients required blood product transfusions prior to AA administration and 10 (33.3%) patients required intra-procedure blood product. There was no significant differences in blood product transfusion needs before versus after AA administration (p >0.05). Coagulation lab assays showed nonsignificant changes, however TEG-R time trended toward and TEG-ACT was statistically different for pre- and post-reversal. The median hospital LOS was 12.5 days (IQR 6-19.5 days) while seven (23.3%) patients died prior to discharge. Discharge disposition of survivors was most often to a SNF, LTAC, or inpatient rehabilitation (n=19 (63.3%)). Ten (33.3%) patients experienced an ischemic complication within 30 days.
Conclusion: AA may be utilized for urgent or emergent reversal of apixaban and rivaroxaban peri-procedurally with promising hemostatic outcomes. Further prospective, comparative research is warranted.