Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures.

Autor: Bradshaw PG; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Keegan SP; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Droege ME; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Dykes NJH; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Ernst NE; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Foertsch MJ; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Makley AT; Department of Surgery, Division of Trauma, University of Cincinnati, Cincinnati, Ohio, USA., Mueller EW; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Philpott CD; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Srinivasan V; Department of Emergency Medicine, University of Washington School of Medicine, Seattle, Washington, USA., Winter JB; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA., Goodman MD; Department of Surgery, Division of Trauma, University of Cincinnati, Cincinnati, Ohio, USA., Droege CA; Department of Pharmacy, UC Health - University of Cincinnati Medical Center, Cincinnati, Ohio, USA.; University of Cincinnati James L. Winkle College of Pharmacy, Cincinnati, Ohio, USA.
Jazyk: angličtina
Zdroj: Pharmacotherapy [Pharmacotherapy] 2022 Oct; Vol. 42 (10), pp. 780-791. Date of Electronic Publication: 2022 Sep 23.
DOI: 10.1002/phar.2727
Abstrakt: Background: Outcomes following andexanet alfa reversal of factor Xa inhibitors in patients requiring urgent or emergent invasive procedures are lacking. This study aimed to describe efficacy and safety outcomes following andexanet alfa administration within 24 h of an invasive procedure.
Methods: This single-center, observational, retrospective study included patients who received andexanet alfa within 24 h of an invasive or surgical procedure. The primary outcome was hemostatic efficacy graded as excellent, good, or poor using similar definitions to the ANNEXA-4 criteria. Secondary outcomes included hospital discharge disposition, intensive care unit (ICU) and hospital length of stay, 30-day mortality, 30-day thromboischemic event rates, and serum coagulation assay changes pre- and postreversal.
Results: Forty-four patients met inclusion criteria; of these, 27 (62.8%) received apixaban and 16 (37.2%) were treated with rivaroxaban prior to admission. The indications for reversal were categorized as intracranial (n = 20 [45.5%]) or extracranial (n = 24 [54.5%]) sites. Majority of patients required emergent operative procedures (18 [40.9%]), followed by invasive device placement (10 [22.7%]) or arterial embolization (9 [20.5%]). Thirty-eight (86.4%) patients were able to be adequately graded for hemostatic efficacy. Overall, 30 (78.9%) patients achieved excellent or good hemostasis within 24 h after periprocedural administration of andexanet alfa (19 [82.6%] apixaban vs. 11 [78.6%] rivaroxaban; 12 [80.0%] intracranial events vs. 18 [78.3%] extracranial events). Discharge disposition was most often to a short- or long-term care facilities (27 [61.4%]). Thirty-day mortality and thromboischemic complications occurred in 15 (34.1%) and 12 (27.3%) patients, respectively. Prothrombin time and antifactor Xa assay results were significantly decreased after andexanet alfa administration (p < 0.05) while thromboelastogram assay values (reaction time, kinetic time, and activated clotting time) showed nonsignificant changes pre- versus postreversal.
Conclusion: Andexanet alfa may be used for urgent or emergent reversal of apixaban and rivaroxaban peri-procedurally with promising hemostatic outcomes. Further prospective, comparative clinical research is warranted.
(© 2022 The Authors. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy published by Wiley Periodicals LLC on behalf of Pharmacotherapy Publications, Inc.)
Databáze: MEDLINE
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