Real-world utilization of andexanet alfa

Brown, Caitlin S.; Scott, Rachael; Sridharan, Meera; Rabinstein, Alejandro A.

doi:10.1016/j.ajem.2019.12.008

Cited by 36 publications

(53 citation statements)

References 14 publications

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“…We report a 19% incidence of ischemic complications, which falls within the 0% to 31% range reported in previous andexanet alfa reversal studies 17,18,20‐22 . Importantly, andexanet alfa is not a procoagulant agent, but a decoy molecule that temporarily impairs anti‐FXa activity.…”

Section: Discussionsupporting

confidence: 79%

“…We found andexanet alfa reversal for FXa inhibitor‐associated extracranial bleeding had a lower rate of hemostatic effectiveness compared with previous studies on DOAC‐associated bleeding. In prior studies evaluating reversal of FXa inhibitor‐associated bleeding with andexanet alfa, hemostatic effectiveness ranged from 57% to 91%, compared to 48% in our cohort 17,18,20‐22 . The relatively low rate of hemostatic effectiveness found in our study is potentially explained through differences in patient selection, as patients requiring surgical intervention were excluded in the ANNEXA‐4 trial 20 .…”

Section: Discussionmentioning

confidence: 60%

“…Clinician judgment of what constitutes life‐threatening bleeding forms the basis for patient selection at BWH and other centers that described their protocol, which more closely mirror the prescribing information published by the manufacturer (Figure 2). 17,21,22 All discussed protocols stated that indications not specified in the protocol may qualify for use of andexanet alfa after hematology or pharmacy consult and approval.…”

Section: Discussionmentioning

confidence: 99%

“…A plethora of single‐arm cohort studies of 4F‐PCC reversal for FXa‐associated bleeding have reported effectiveness rates of 69%‐95%, defined using the Sarode et al criteria or significant intracranial hemorrhage progression 25‐32 . The Sarode et al criteria were also used by most studies on real‐world use of andexanet alfa reversal 18‐22 . However, these criteria require standardized patient selection to be able to compare the hemostatic effectiveness of andexanet and 4F‐PCC, as selection bias is present otherwise.…”

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Evaluation of oral factor Xa inhibitor‐associated extracranial bleeding reversal with andexanet alfa

Nederpelt

Naar

Sylvester

et al. 2020

Journal of Thrombosis and Haemostasis

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Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 60%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of oral factor Xa inhibitor‐associated extracranial bleeding reversal with andexanet alfa

Nederpelt

Naar

Sylvester

et al. 2020

Journal of Thrombosis and Haemostasis

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“…A single institutional experience of the use of andexanet alfa in 13 patients demonstrated effective hemostasis in 77% of the patients with a 31% incidence of thromboembolic events and a 15% mortality rate. There are few other single institutional case series on its use in a limited number of patients from large tertiary hospitals [ 20 - 21 ]. We hereby report the utilization of andexanet alfa in a rural community hospital through a retrospective review of patients at Guthrie Robert Packer Hospital who received andexanet from June 2019 to March 2020 for the reversal of life-threatening bleeding associated with rivaroxaban or apixaban.…”

Section: Introductionmentioning

confidence: 99%

Institutional Experience of Using Andexanet Alfa

Khadka¹,

Kasireddy²,

Dhakal³

2020

Cureus

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Given their ease of use, safety, and efficacy, direct-acting oral anticoagulants (DOACs) are nowadays widely used in patients with atrial fibrillation or venous thromboembolism, with or without an association with malignancy. Andexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that reverses the inhibition of factor Xa. After Food and Drug Administration (FDA) approval in May 2018, andexanet has been used for life-threatening bleeding in patients treated with apixaban or rivaroxaban. In this article, we present a single institutional retrospective review of patients receiving andexanet alfa at Guthrie Robert Packer Hospital. A total of four patients in a period of 10 months received andexanet for intracranial bleeding, 50% (2) had excellent hemostasis, 30 days mortality was 75% (3), and 25% (1) had a thromboembolic event. Anticoagulation was never started in all patients. This review tends to show the real-world utilization data of andexanet in a community hospital setting.

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Evaluation of Direct Oral Anticoagulant Reversal Agents in Intracranial Hemorrhage

et al. 2022

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ImportanceDirect oral anticoagulant (DOAC)–associated intracranial hemorrhage (ICH) has high morbidity and mortality. The safety and outcome data of DOAC reversal agents in ICH are limited.ObjectiveTo evaluate the safety and outcomes of DOAC reversal agents among patients with ICH.Data SourcesPubMed, MEDLINE, The Cochrane Library, Embase, EBSCO, Web of Science, and CINAHL databases were searched from inception through April 29, 2022.Study SelectionThe eligibility criteria were (1) adult patients (age ≥18 years) with ICH receiving treatment with a DOAC, (2) reversal of DOAC, and (3) reported safety and anticoagulation reversal outcomes. All nonhuman studies and case reports, studies evaluating patients with ischemic stroke requiring anticoagulation reversal or different dosing regimens of DOAC reversal agents, and mixed study groups with DOAC and warfarin were excluded.Data Extraction and SynthesisPreferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used for abstracting data and assessing data quality and validity. Two reviewers independently selected the studies and abstracted data. Data were pooled using the random-effects model.Main Outcomes and MeasuresThe primary outcome was proportion with anticoagulation reversed. The primary safety end points were all-cause mortality and thromboembolic events after the reversal agent.ResultsA total of 36 studies met criteria for inclusion, with a total of 1832 patients (967 receiving 4-factor prothrombin complex concentrate [4F-PCC]; 525, andexanet alfa [AA]; 340, idarucizumab). The mean age was 76 (range, 68-83) years, and 57% were men. For 4F-PCC, anticoagulation reversal was 77% (95% CI, 72%-82%; I2 = 55%); all-cause mortality, 26% (95% CI, 20%-32%; I2 = 68%), and thromboembolic events, 8% (95% CI, 5%-12%; I2 = 41%). For AA, anticoagulation reversal was 75% (95% CI, 67%-81%; I2 = 48%); all-cause mortality, 24% (95% CI, 16%-34%; I2 = 73%), and thromboembolic events, 14% (95% CI, 10%-19%; I2 = 16%). Idarucizumab for reversal of dabigatran had an anticoagulation reversal rate of 82% (95% CI, 55%-95%; I2 = 41%), all-cause mortality, 11% (95% CI, 8%-15%, I2 = 0%), and thromboembolic events, 5% (95% CI, 3%-8%; I2 = 0%). A direct retrospective comparison of 4F-PCC and AA showed no differences in anticoagulation reversal, proportional mortality, or thromboembolic events.Conclusions and RelevanceIn the absence of randomized clinical comparison trials, the overall anticoagulation reversal, mortality, and thromboembolic event rates in this systematic review and meta-analysis appeared similar among available DOAC reversal agents for managing ICH. Cost, institutional formulary status, and availability may restrict reversal agent choice, particularly in small community hospitals.

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Real-world utilization of andexanet alfa

Cited by 36 publications

References 14 publications

Evaluation of oral factor Xa inhibitor‐associated extracranial bleeding reversal with andexanet alfa

Evaluation of oral factor Xa inhibitor‐associated extracranial bleeding reversal with andexanet alfa

Institutional Experience of Using Andexanet Alfa

Evaluation of Direct Oral Anticoagulant Reversal Agents in Intracranial Hemorrhage

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