- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Effectivity of Andexanet Alfa for the Reversal of Factor Xa Inhibitors under Hemodilution (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1879; Andexanet spiking of non-anticoagulated blood samples prolonged RVV test’s clotting time (CT) (Figure 2). Hemodilution prolonged clotting parameters further and reduced mean clot firmness (MCF).
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Differential Neutralization of Unfractionated Heparin and Enoxaparin by Andexanet Alfa (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1131; The ANOVA test yielded a significant result when comparing the means of UFH treated at various andexanet alfa concentrations. The Tukey Post-Hoc test revealed significant differences between the UFH and UFH treated with andexanet alfa at all concentrations tested except at 6.25 μg/ml.
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Real-world Use of Andexanet Alfa for Anti-Xa Inhibitor Reversal: A Case Series (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_734; Median patient age was 68 (interquartile range: 58-75), 60% were female, 80% were white, and 66% were receiving apixaban. The most common indication for andexanet was intracranial bleeding (73.3%).
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Effects of andexanet alfa on different thrombin generation and anti-Xa-methods in vitro. (ExCel Center, ICC Capital Suite Room 10&11) - May 13, 2022 - Abstract #ISTH2022ISTH_361; An overshoot of baseline TG levels was noticed after adding andexanet, which was reversed by a TFPI-antibody. Small differences were found between the CAT-1 and ST Genesia measurement.
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Journal: Differential Neutralization of Unfractionated Heparin and Enoxaparin by Andexanet Alfa. (Pubmed Central) - May 12, 2022 Small differences were found between the CAT-1 and ST Genesia measurement. Andexanet partially neutralized UFH and LMWH with variability between assays, necessitating investigation into assay-dependent differences.
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Case series of the first use of Andexanet Alfa at Salisbury NHS Foundation Trust () - Apr 25, 2022 - Abstract #BSH2022BSH_250; Accordingly, SFTs are implementing quality assured DOAC specific Anti-Xa assays to appropriately assess DOAC levels in the setting of Andexanet Alfa use. SFT has now incorporated the NICE Guidance into its practice since May 2021 and now only uses Andexanet Alfa for reversing anticoagulation from apixaban or rivaroxaban in adults with life threatening or uncontrolled bleeding in the gastrointestinal tract.
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Journal: Difficulties Detecting Clinically Relevant Factor Xa Inhibitor Levels Prior to Reversal With Andexanet Alfa for Intracranial Hemorrhage. (Pubmed Central) - Apr 15, 2022 These cases highlight the challenges clinicians are facing when using andexanet alfa for emergent rivaroxaban or apixaban reversal when the timing of last dose is unknown, or patients fall outside of the recommended timeframe for use and clinically relevant drug levels are still suspected. Based on our experiences, we encourage other institutions to evaluate their abilities to rapidly and accurately detect the presence of clinically relevant rivaroxaban and apixaban levels when utilizing andexanet alfa.
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Clinical, Journal: Apixaban and rivaroxaban anti-Xa level utilization for guidance of administration of andexanet alfa: a case series. (Pubmed Central) - Apr 7, 2022 In this cohort, reversal with andexanet alfa and 4F-PCC differed in terms ofhemostatic efficacy and thrombotic events after ICH in patients anticoagulated with apixaban or rivaroxaban. In our case series, obtaining anti-Xa DOAC levels prior to administration of andexanet alfa was achievable and facilitated use of reversal agents in patients with major bleeding or emergent procedural need.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, Feiba (human plasma derived anti-inhibitor coagulant complex) / Takeda
FEIBA AND ANDEXANET ALFA FOR THE REVERSAL OF APIXABAN AND RIVAROXABAN IN UNCONTROLLED HEMORRHAGE ([VIRTUAL]) - Mar 23, 2022 - Abstract #SCCM2022SCCM_1891; The overall rates of effective hemostasis, mortality, thrombosis, and hemorrhagic complication were similar in the FEIBA and andexanet alfa groups after propensity matching. Due to our small population size, larger prospective studies are needed to evaluate the use of FEIBA versus andexanet alfa to determine effectiveness between agents.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
COMPARISON OF 4F-PCC AND ANDEXANET ALFA FOR REVERSAL OF APIXABAN- AND RIVAROXABAN-ASSOCIATED ICH ([VIRTUAL]) - Mar 23, 2022 - Abstract #SCCM2022SCCM_1730; Due to our small population size, larger prospective studies are needed to evaluate the use of FEIBA versus andexanet alfa to determine effectiveness between agents. In patients who experienced an ICH while taking apixaban or rivaroxaban, 4F-PCC and andexanet alfa were found to have similar rates of excellent or good hemostatic efficacy.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
FOUR-FACTOR PCC VERSUS ANDEXANET ALFA FOR ORAL FACTOR XA INHIBITOR-ASSOCIATED MAJOR BLEEDS ([VIRTUAL]) - Mar 23, 2022 - Abstract #SCCM2022SCCM_1334; This study showed no statistical difference in the rates of clinical hemostasis, in-hospital mortality, thromboembolism, or blood product consumption in the studied population. 4F-PCC and andexanet alfa have shown to be equally effective for treating factor Xa-associated major bleeding events with no difference in thromboembolism
- |||||||||| tranexamic acid oral / Generic mfg.
Journal: Direct (new) oral anticoagulants (DOACs): Drawbacks, bleeding and reversal. (Pubmed Central) - Mar 16, 2022 Management recommendations for hemorrhage associated with DOAC use vary, depending on the class of the culprit agent (direct thrombin inhibitor vs. FXa inhibitor), the clinical status of the patient (mild/ moderate vs. severe/life-threatening), and capabilities of the institution. Specific reversal agents (i.e., idarucizumab and andexanet alfa) can be used if available, while prothrombin complex concentrates, fresh frozen plasma and/ or tranexamic acid can also be employed as nonspecific replacement agents in the management of DOAC-related bleeding diathesis.
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Budget Impact of Andexanet ALFA for Gastrointestinal Bleeding Associated with Factor Xa Inhibitors from a US Hospital Perspective (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1458; Further research is warranted to confirm the mortality differences between reversal/replacement agents for DOAC-related bleeding. Our analysis suggests that appropriate utilization of andexanet for reversal of FXa inhibitors in the setting of major gastrointestinal bleeding may result in net reductions in hospitalization costs from a US acute care hospital perspective.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Surgery: Annexa-S: Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery (clinicaltrials.gov) - Mar 7, 2022 P2, N=10, Terminated, Our analysis suggests that appropriate utilization of andexanet for reversal of FXa inhibitors in the setting of major gastrointestinal bleeding may result in net reductions in hospitalization costs from a US acute care hospital perspective. N=100 --> 10 | Trial completion date: Oct 2022 --> Jan 2022 | Recruiting --> Terminated | Trial primary completion date: Sep 2022 --> Nov 2021; Limited value as a single-arm study
- |||||||||| Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Review, Journal: Review of Target-Specific Anticoagulation Reversal Agents. (Pubmed Central) - Mar 4, 2022 In addition, for agents that continue to lack a targeted reversal agent (eg, low-molecular-weight heparin, antiplatelets, and new antithrombotics), it is imperative that research continues to evaluate improved reversal strategies. This review focuses on target-specific anticoagulation reversal agents currently available in the United States (protamine, idarucizumab, and andexanet alfa) and summarizes agents that are in the pipeline for these anticoagulants and antiplatelets.
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Journal: Case Report: Extended Duration Andexanet Alfa Infusion in a Surgical Trauma Patient. (Pubmed Central) - Mar 3, 2022 Modifications to the andexanet infusion may be required in surgical patients requiring rivaroxaban reversal for a prolonged procedure. Further data are needed to determine the optimal approach to infusion modification.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Clinical, Clinical data, Journal, Real-world evidence: Hematoma Expansion and Clinical Outcomes in Patients With Factor-Xa Inhibitor-Related Atraumatic Intracerebral Hemorrhage Treated Within the ANNEXA-4 Trial Versus Real-World Usual Care. (Pubmed Central) - Feb 19, 2022 P=N/A, P3 As compared with usual care, andexanet alfa was associated with a lower rate of HE in atraumatic factor-Xa inhibitor-related ICH, however, without translating into significantly improved clinical outcomes. A comparative trial is needed to confirm the benefit on limiting HE and to explore clinical outcomes across patient subgroups and by time to treatment.
- |||||||||| Savaysa (edoxaban) / Daiichi Sankyo, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca, Bevyxxa (betrixaban) / AstraZeneca
Differential Neutralization of Apixaban, Betrixaban, Edoxaban, and Rivaroxaban by Andexanet Alfa as measured by Whole Blood Thromboelastographic Analysis (hall 1; hall 2; hall 3; hall 4; hall 5) - Feb 16, 2022 - Abstract #GTH2022GTH_283; Edoxaban exhibited the strongest anticoagulant effect followed by Betrixaban and Rivaroxaban whereas Apixaban showed much weaker anticoagulant effects. AA FC=100 ug/mL showed much stronger, consistent, and complete neutralization effects of all of the 4 FXa Inhibitors when compared to AA at FC=50 ug/mL.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Differential Neutralization of Unfractionated Heparin and Enoxaparin by Andexanet Alfa (hall 1; hall 2; hall 3; hall 4; hall 5) - Feb 16, 2022 - Abstract #GTH2022GTH_173; In ACT, there appears to be stronger neutralization of UFH at the concentrations tested. Study of the andexanet alfa and anticoagulant interaction in other assays may further clarify the mechanism and/or behavior of neutralization.
- |||||||||| AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
Trial completion date, Trial primary completion date: Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor (clinicaltrials.gov) - Jan 26, 2022 P4, N=1200, Recruiting, However, there were no differences in thrombotic events, length of ICU, and hospital stay between patients treated with AA and 4F-PCC. Trial completion date: Nov 2023 --> Jul 2024 | Trial primary completion date: Mar 2023 --> May 2024
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