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XARELTO®

(rivaroxaban)

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XARELTO® (rivaroxaban)

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SPECIFIC RESPONSE

XARELTO - Reversal Agents in Human Studies - Andexanet alfaa (PRT064445) - Milling et al (2023)

Last updated : 05/16/2024

Milling et al (2023) conducted a multicenter, prospective, open-label, single-cohort study that evaluated andexanet alfa (low- or high- dose) in 479 patients, >18 years of age, that presented with acute major bleeding and had received 1 of the following within 18 hours: apixaban, XARELTO, edoxaban, or enoxaparin.1

Study Design1

Study Population

  • Efficacy population: Patients treated with XARELTO and a baseline anti–factor Xa activity of ≥75 ng/mL, with confirmed major bleeding at presentation (n=176 [36.7%]).
    • Patients on low-dose factor Xa inhibitors for the management of coronary or peripheral vascular disease were excluded.
  • Safety population: All patients given any amount of andexanet alfa (XARELTO, n=132 [37.7%]).
  • In XARELTO-treated patients (n=132), the median anti–factor Xa activity decreased from 214.6 ng/mL at baseline to 10.8 ng/mL at nadir (median reduction, 94%; 95% CI, 94-93).
  • Hemostatic efficacy for patients on XARELTO was 81% (95% CI, 73-87).
  • For all 4 inhibitors evaluated, within 2 minutes after andexanet alfa bolus completion, there was a decrease in anti–factor Xa activity, which was sustained until the end of continuous infusion.
  • A significant difference in anti–factor Xa activity across subgroups by race was not observed.
    • There was a significant correlation between hemostatic efficacy and lower mortality in all patients (P<0.001).
    • Hemostatic efficacy was good or excellent in 80% of patients (95% CI, 75-84) overall.

aAndexxa® (coagulation factor Xa [recombinant], inactivated-zhzo) is a product of AstraZeneca. Please refer to the Andexxa Prescribing Information for complete product information or call AstraZeneca at 1-800-236-9933.
bAcute major bleeding was defined as ≥1 of the following:

  • Potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise
  • Bleeding associated with a drop in hemoglobin of ≥2 g/dL (or a hemoglobin level of ≤8 g/dL if baseline hemoglobin was unavailable)
  • Bleeding in a critical area or organ

cTwo possible andexanet alfa dosing regimens (low- or high- dose) were evaluated based on the factor Xa inhibitor the patient received, dose, and time since the patient’s last dose (<8 hours,="" ≥8="" hours,="" or="">

CI, confidence interval; IV, intravenous.

CI, confidence interval; IV, intravenous.

Reference

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1. Milling TJ Jr, Middeldorp S, Xu L, et al. Final study report of andexanet alfa for major bleeding with factor Xa inhibitors. Circulation. 2023;147(13):1026-1038.