Factor VIII Inhibitor Bypassing Activity (FEIBA) Reversal for Apixaban and Rivaroxaban in Patients With Acute Intracranial and Nonintracranial Hemorrhage.

MedStar author(s):
Citation: Annals of Pharmacotherapy. 55(12):1455-1466, 2021 12.PMID: 33843267Institution: MedStar Montgomery Medical CenterForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aftercare | *Rivaroxaban | Blood Coagulation Factors | Hemorrhage | Humans | Patient Discharge | Pyrazoles | Pyridones | Retrospective Studies | Rivaroxaban/ae [Adverse Effects]Year: 2021ISSN:
  • 1060-0280
Name of journal: The Annals of pharmacotherapyAbstract: BACKGROUND: The clinical use of factor VIII inhibitor bypassing activity (FEIBA) for factor Xa (FXa) inhibitor reversal is derived from small studies with notable variation in patient eligibility for use, dosage regimens, concurrent supportive care, and outcome measures. Consequently, additional effectiveness and safety data are warranted to expand the literature evaluating FEIBA for FXa inhibitor reversal.CONCLUSION AND RELEVANCE: The combined ICH and non-ICH overall rates of effective hemostasis, TEE, and mortality were comparable to preexisting studies of FEIBA for factor Xa inhibitor reversal. The limitations inherent to the study design warrant a randomized controlled trial with an active comparator to confirm these observations.METHODS: This case series evaluated patients between January 1, 2014 through July 1, 2019 who received at least one FEIBA R dose for apixaban or rivaroxaban reversal secondary to acute ICH or non-ICH. Patient demographics, FEIBA R dosages, adjunct treatments, effectiveness, and safety outcomes were retrospectively collected from electronic medical record review. Modified hemostasis outcomes, adapted from criteria previously published by Sarode et al., TEE, and mortality between apixaban and rivaroxaban in the ICH and non-ICH populations were evaluated.OBJECTIVE: This study sought to determine the incidence of observed effective hemostasis within 24 hours of post-FEIBA R administration as well as in-hospital and 30-day post-discharge incidences of thromboembolic event (TEE) and mortality between apixaban and rivaroxaban in the intracranial hemorrhage (ICH) and non-ICH populations.RESULTS: Among the 104 patients evaluated, 62 received apixaban and 42 rivaroxaban. Thirty apixaban and 25 rivaroxaban users experienced ICH, whereas 32 apixaban and 17 rivaroxaban users experienced non-ICH. Among the combined ICH and non-ICH populations, effective hemostasis occurred in 89%, TEE in 8%, and mortality in 13%. No statistically significant differences were observed within ICH and non-ICH populations receiving apixaban or rivaroxaban regarding effective hemostasis, TEE, or mortality.All authors: Coffeen SN, Hunt AR, Ice C, Parker J, Shiltz DLOriginally published: Annals of Pharmacotherapy. :10600280211004583, 2021 Apr 10Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier: Date added to catalog: 2021-06-07
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 33843267 Available 33843267

BACKGROUND: The clinical use of factor VIII inhibitor bypassing activity (FEIBA) for factor Xa (FXa) inhibitor reversal is derived from small studies with notable variation in patient eligibility for use, dosage regimens, concurrent supportive care, and outcome measures. Consequently, additional effectiveness and safety data are warranted to expand the literature evaluating FEIBA for FXa inhibitor reversal.

CONCLUSION AND RELEVANCE: The combined ICH and non-ICH overall rates of effective hemostasis, TEE, and mortality were comparable to preexisting studies of FEIBA for factor Xa inhibitor reversal. The limitations inherent to the study design warrant a randomized controlled trial with an active comparator to confirm these observations.

METHODS: This case series evaluated patients between January 1, 2014 through July 1, 2019 who received at least one FEIBA R dose for apixaban or rivaroxaban reversal secondary to acute ICH or non-ICH. Patient demographics, FEIBA R dosages, adjunct treatments, effectiveness, and safety outcomes were retrospectively collected from electronic medical record review. Modified hemostasis outcomes, adapted from criteria previously published by Sarode et al., TEE, and mortality between apixaban and rivaroxaban in the ICH and non-ICH populations were evaluated.

OBJECTIVE: This study sought to determine the incidence of observed effective hemostasis within 24 hours of post-FEIBA R administration as well as in-hospital and 30-day post-discharge incidences of thromboembolic event (TEE) and mortality between apixaban and rivaroxaban in the intracranial hemorrhage (ICH) and non-ICH populations.

RESULTS: Among the 104 patients evaluated, 62 received apixaban and 42 rivaroxaban. Thirty apixaban and 25 rivaroxaban users experienced ICH, whereas 32 apixaban and 17 rivaroxaban users experienced non-ICH. Among the combined ICH and non-ICH populations, effective hemostasis occurred in 89%, TEE in 8%, and mortality in 13%. No statistically significant differences were observed within ICH and non-ICH populations receiving apixaban or rivaroxaban regarding effective hemostasis, TEE, or mortality.

English

Powered by Koha