Reversal Agent Results in Promising Hemostatic Outcomes Within 24 Hours of Surgery

Most patients achieved good or excellent hemostasis after being treated with andexanet alfa within 24 hours of an invasive surgical procedure, according to findings published in Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy.

Andexanet alfa is a modified, recombinant, human coagulation Factor Xa protein that can be used as an antidote to the blood thinners apixaban and rivaroxaban.

“Outcomes following andexanet alfa reversal of factor Xa inhibitors in patients requiring urgent or emergent invasive procedures are lacking,” researchers said.

The single-center, observational, retrospective study enrolled 44 patients treated with andexanet alfa within 24 hours of an invasive surgical procedure. Before surgery, 27 (62.8%) patients received apixaban and 16 (37.2%) patients received rivaroxaban.

The most common surgery types were emergent operative procedures (18 patients; 40.9%), invasive device placement (10 patients; 22.7%), and arterial embolization (9 patients; 20.5%). Anticoagulant reversal was indicated for bleeding in 20 (45.5%) intracranial sites and 24 (54.5%) extracranial sites.

“The primary outcome was hemostatic efficacy graded as excellent, good, or poor using similar definitions to the ANNEXA-4 criteria,” researchers said. “Secondary outcomes included hospital discharge disposition, intensive care unit and hospital length of stay, 30-day mortality, 30-day thromboischemic event rates, and serum coagulation assay changes pre- and postreversal.”

Investigators were able to grade the hemostatic outcomes of 38 (86.4%) patients in the study. Of these, 30 (78.9%) patients achieved good or excellent hemostasis within 24 hours of receiving andexanet alfa (19 [82.6%] apixaban vs 11 [78.6%] rivaroxaban; 12 [80.0%] intracranial events vs 18 [78.3%] extracranial events).

The rate of 30-day mortality was 34.1%, or 15 patients. Additionally, 12 (27.3%) patients experienced thromboischemic complications. Andexanet alfa was associated with significant reductions in prothrombin time and antifactor Xa assay results (P < .05) but no significant change in thromboelastogram assay values.

“Andexanet alfa may be used for urgent or emergent reversal of apixaban and rivaroxaban periprocedurally with promising hemostatic outcomes. Further prospective, comparative clinical research is warranted,” researchers concluded.

Reference:
Bradshaw PG, Keegan SP, Droege ME, et al. Reversal of apixaban and rivaroxaban with andexanet alfa prior to invasive or surgical procedures. Pharmacotherapy. Published online September 8, 2022. doi:10.1002/phar.2727