Abstract Number: PB0413
Meeting: ISTH 2020 Congress
Theme: Coagulation and Natural Anticoagulants » Regulation of Coagulation
Background: In 2018, the FDA approval coagulation factor Xa [(recombinant) Andexanet alfa (AA)] for reversal of life-threatening or uncontrolled bleeding in patients receiving apixaban or rivaroxaban.
Aims: To describe our experience with AA for reversal of apixaban and rivaroxaban in patients diagnosed with ICH.
Methods: This retrospective, single-center, observational study included adult patients with ICH who received AA for reversal of apixaban or rivaroxaban between July 1, 2018 and September 1, 2019. See figure 1 for dosing guidelines. Patients were excluded if they received multiple doses of AA during the same encounter, or both four-factor prothrombin complex concentrate (4F-PCC) and AA. The primary endpoint of this study was the incidence of hemostatic treatment failure, indicated by progression of hematoma on neuroimaging within 24 hours of AA administration. Notable secondary endpoints included in-hospital mortality, incidence of thrombotic complications within 30 days, ICU and hospital length of stay (LOS), patient disposition, and change in National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) at presentation and discharge.
Results: During the study period, 19 eligible patients receiving 20 doses (1 high-dose (800 mg bolus, followed by 8 mg/min) and 19 low-doses (400 mg bolus, followed by 4 mg/min)) of AA. 15 patients had repeat neuroimaging within 24 hours after AA was administered with 7/15 (46.7%) noted to have progression of hematoma. 2 patients (10.5%) developed thrombotic complications (deep vein thrombosis, ST-elevation myocardial infarction, and ischemic stroke), and one patient developed ventricular tachycardia with chest pain (Patient not included due to not receiving the full infusion of AA). Additional secondary endpoints are noted in table 1.
Conclusions: In our patient population, rates of hemostatic treatment failure were higher compared to the ANEXXA-4 study. However, our definition of failure based on hematoma expansion differs from the ANNEXA-4 hemostatic efficacy scale.
[Andexanet alfa Dosing Guidelines]
n=19 | |
In-hospital mortality, n (%) | 3 (15.8) |
Discharge disposition, n (%) Hospice Skilled Nursing Facility Home | 2 (10.5) 7 (36.8) 7 (36.8) |
ICU length of stay (days), median (IQR) | 3.74 (2.30-7.13) |
Hospital length of stay (days), median (IQR) | 7.83 (4.37-15.89) |
Confirmatory anticoagulation lab obtained (n=17) Time to confirmatory result (hours), median (IQR) | 1.00 (0.62-1.42) |
Resumption of DVT prophylaxis (n=13) Time to resumption of DVT prophylaxis (hours), median (IQR) | 69.10 (47.95-69.90) |
Resumption of systemic anticoagulation (n=8) Time to resumption of systemic anticoagulation (days), median (IQR) | 26.5 (14-35) |
Admission NIHSS, median (IQR), n=13 Admission mRS, median (IQR), n=11 Discharge NIHSS, median (IQR), n=7 Discharge mRS, median (IQR), n=7 | 10 (3-14) 1 (0-4) 6 (4-9.5) 4 (3.5-4) |
[Secondary Endpoints]
To cite this abstract in AMA style:
Vestal M, Hodulik K, Mando-Vandrick J, Friedland M, Ortel T, Welsby I. Coagulation Factor Xa [(Recombinant) Andexxa®] for Reversal of Apixaban and Rivaroxaban in Patients Diagnosed with Intracranial Hemorrhage [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/coagulation-factor-xa-recombinant-andexxa-for-reversal-of-apixaban-and-rivaroxaban-in-patients-diagnosed-with-intracranial-hemorrhage/. Accessed March 21, 2024.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/coagulation-factor-xa-recombinant-andexxa-for-reversal-of-apixaban-and-rivaroxaban-in-patients-diagnosed-with-intracranial-hemorrhage/