AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca - LARVOL DELTA

TFPIα activity suppression by Andexanet alfa is partially restored by protein S and factor V-short (BSH 2025) - No abstract available

Cardiovascular • Hematological Disorders • Thrombosis • PROS1

Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation) (clinicaltrials.gov) - P=N/A | N=300 | Recruiting | Sponsor: AstraZeneca | Trial completion date: May 2025 ➔ Nov 2025 | Trial primary completion date: May 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date

CuratED: The emergency medicine pharmacotherapy literature of 2024. (PubMed, Am J Emerg Med) - "Covered topics include guideline updates on seizure prophylaxis in traumatic brain injury, corticosteroid use in sepsis and acute respiratory distress and antibiotic prophylaxis in trauma. Additional topics include updates on thrombolytic therapy for acute ischemic stroke, including tenecteplase versus alteplase, anticoagulation reversal strategies with andexanet alpha and prothrombin complex concentrate, and the use of tranexamic acid in traumatic brain injury, ketamine versus etomidate for intubation in critically ill adults, expert consensus on heart failure hospitalization management, geriatric emergency medication safety recommendations, and emerging data on dual antiplatelet therapy for stroke management."

Journal • Review • Acute Respiratory Distress Syndrome • Cardiovascular • CNS Disorders • Congestive Heart Failure • Epilepsy • Heart Failure • Infectious Disease • Ischemic stroke • Septic Shock • Vascular Neurology

Andexanet alfa for reversal of intracerebral haemorrhage resulting in ST-segment myocardial infarction: a case report. (PubMed, Eur Heart J Case Rep) - "A 76-year-old male presented with atrial fibrillation with rapid ventricular response and was started on Eliquis after a successful direct current cardioversion. Current European Society of Cardiology Guidelines do not have recommendations for the use of andexanet alfa for the reversal of anticoagulation due to its uncertain risk profile. This case emphasizes the increased risk of thrombotic complications associated with andexanet alfa and highlights the importance of the continued need to research its use, which may help elucidate or revise current guidelines."

Journal • Atrial Fibrillation • Cardiovascular • Myocardial Infarction • Renal Disease • Respiratory Diseases • Septic Shock

Safety of direct oral anticoagulants reversal agents in older patients: an analysis of individual case safety reports of adverse drug reaction from VigiBase®. (PubMed, Aging Clin Exp Res) - "Clinicians should pay particular attention when managing individuals needing these drugs, especially if vulnerable and requiring polytherapy."

Adverse drug reaction • Journal • Retrospective data • Cardiovascular

Rapid Determination of Xa Inhibitor Activity in Blood Using a Microfluidic Device that Measures Platelet Deposition and Fibrin Generation Under Flow. (PubMed, TH Open) - "The assay simultaneously measured whole blood clotting dynamics on collagen/tissue factor (TF; wall shear rate, 200 -1 ) under four ex vivo conditions: no-treatment control, high dose Factor Xa inhibition, low dose or high dose FXa reversal agent (andexanet alfa). For a threshold of 100 nM DOAC, the area under the curve (AUC) was found to be 0.881 for apixaban and 0.933 for rivaroxaban. Microfluidic testing of whole blood can provide a rapid estimate of DOAC levels over the on-therapy range."

Journal • Atrial Fibrillation • Cardiovascular • Venous Thromboembolism

Reversal of Factor Xa Inhibitor-Related Intracranial Hemorrhage: A Multicenter, Retrospective, Observational Study Comparing the Efficacy and Safety of Andexanet and Prothrombin Complex Concentrates. (PubMed, Crit Care Med) - "Despite statistically higher odds of achieving hemostatic efficacy with andexanet, we also observed higher odds of a TE with no difference in discharge outcomes observed between groups. When those with more severe neurologic injuries were excluded, efficacy and safety outcomes were similar between treatments."

Journal • Observational data • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Andexanet Alfa in Urgent Cardiac Surgery: A Case Report of Edoxaban Reversal for Acute Hemopericardium. (PubMed, Am J Case Rep) - "BACKGROUND Antidotes to non-vitamin K oral anticoagulants (NOAK) like idarucizumab and andexanet alfa have been approved for reversing the effects of dabigatran and apixaban/rivaroxaban, respectively. Successful management was achieved through a multidisciplinary approach. Further research is needed to evaluate the safety and efficacy of andexanet alfa in patients on edoxaban therapy."

Journal • Cardiovascular • Hematological Disorders

Results of intracranial hemorrhage treatment using andexanet alfa at our hospital (JSNE 2025) - No abstract available

Clinical • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Relationship between cerebral infarction onset and PT-INR after administration of andexanet alfa (JSNE 2025) - No abstract available

CNS Disorders

"Reversal of direct oral anticoagulants: Guidance from the SSC of the ISTH": Reply. (PubMed, J Thromb Haemost) - No abstract available

Journal

Use of Andexanet Alpha Versus Standard of Care Among Patients Hospitalized With Upper and Lower Gastrointestinal Bleeding: A Retrospective, Multicenter, Comparative Effectiveness Study (ATS 2025) - No abstract available

HEOR • Retrospective data • Gastroenterology • Gastrointestinal Disorder

Efficacy and safety of andexanet alfa for factor Xa inhibitor-associated intracranial haemorrhage. (PubMed, J Neurol Neurosurg Psychiatry) - "The present meta-analysis suggests AA is associated with improved haemostatic efficacy compared with usual care, with no significant differences observed in functional and safety outcomes. These findings indicate that AA may have a role in the management of factor Xa inhibitor-associated ICH, although further high-quality studies are needed to better define its net clinical benefit."

Clinical • Journal • Cerebral Hemorrhage

Real-world andexanet alfa utilization and the association between delay in administration due to hospital transfer and all-cause inpatient mortality. (PubMed, Res Pract Thromb Haemost) - "Cases with hospital transfer had an 82% increased odds of all-cause inpatient mortality (95% CI, 17%-183%) but did not reach statistical significance when the population was limited to intracranial hemorrhage (odds ratio, 1.51; 95% CI, 0.88-2.60). Delay in administering andexanet alfa due to hospital transfer may be associated with increased all-cause mortality."

Journal • Real-world evidence • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Andexanet Alfa Versus 4F-PCC for Direct Anticoagulation Reversal in Intracranial Hemorrhage: A Quality Improvement (QI) Analysis (AAN 2025) - "57 patients were on apixaban, 14 on rivaroxaban, and 1 on fondaparinux. The findings of our analysis indicate that 4F-PCC and andexanet alfa are similarly effective in DOAC reversal for patients with ICH at our institution."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders

Spontaneous hemorrhage arising from a proximal descending branch of the suprascapular artery. (PubMed, Am J Emerg Med) - "There are no prior case reports of spontaneous suprascapular artery hemorrhage, though rupture secondary to an inciting traumatic event has been described. This case highlights the importance of maintaining a high index of suspicion for vascular injury in patients with an enlarging soft tissue mass, as early diagnosis and intervention are crucial for achieving a favorable outcome."

Journal • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Peripheral Arterial Disease

Risk Factors for Thromboischemic Complications After Andexanet Alfa Reversal of Factor Xa Inhibitors (SCCM 2025) - "Most patients were prescribed apixaban (97 (66.4%) for atrial fibrillation (95 [65.1%] and received low-dose AA (127 [86.9%]) for an intracranial bleed (106 [72.6%]). Patients with a BMI > 40 kg/m2 are at a higher risk for TE post-reversal with AA. Further research is warranted to identify ideal populations for reversal with AA while minimizing risk of TE."

Clinical • Atrial Fibrillation • Cardiovascular • CNS Disorders • Ischemic stroke • Myocardial Infarction • Oncology • Respiratory Diseases • Venous Thromboembolism

RETHINKING REVERSAL: THE UNDERAPPRECIATED RISK OF THROMBOTIC COMPLICATIONS AFTER ANDEXANET ALFA USE (SCCM 2025) - "Introduction: Current paradigms call for early reversal of apixaban in anticoagulation-associated traumatic intracranial hemorrhage (tICH) to prevent worse outcomes associated with hematoma expansion. Emerging evidence suggests that reversal itself can constitute a prothrombotic event, a possible etiology in our patient as she had been anticoagulated and lacked intracardiac thrombi or right to left shunt. This case report shows that reversal carries significant risk of morbidity, and thus more nuanced guidelines around the decision to reverse might be beneficial while further safety data is obtained."

Atrial Fibrillation • Bladder Cancer • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Dyslipidemia • Genito-urinary Cancer • Hematological Disorders • Hypertension • Musculoskeletal Diseases • Oncology • Pain • Solid Tumor • Subarachnoid Hemorrhage

COMPARISON OF REVERSAL AGENTS FOR DIRECT ORAL ANTICOAGULANT-ASSOCIATED LIFE-THREATENING BLEEDS (SCCM 2025) - "Andexanet alfa may be associated with increased rates of effective hemostatic control. However, there was no difference in mortality or length of stay between groups. Andexanet alfa was associated with longer times to administration and demonstrated a trend toward increased rates of thromboembolism although this finding was not statistically significant."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Gastrointestinal Disorder • Hematological Disorders

Pro: The Patient With the Recent Intake of DOACs Problems Are Solved With the Approval of Reversal Agents. (PubMed, J Cardiothorac Vasc Anesth) - No abstract available

Journal • Cardiovascular

Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Feb 2025 ➔ May 2025 | Trial primary completion date: Feb 2025 ➔ May 2025

HEOR • Real-world evidence • Trial completion date • Trial primary completion date • Hematological Disorders

Con: The Patient With Recent Intake of Direct Oral Anticoagulants-Problems Are Not Solved With the Approval of Reversal Agents. (PubMed, J Cardiothorac Vasc Anesth) - No abstract available

Journal

Reversal of Direct Oral Anticoagulants (DOACs) for Critical Bleeding or Urgent Procedures. (PubMed, J Clin Med) - "We present here a narrative review of the literature on the reversal of DOAC-associated bleeding or for urgent procedures. The totality of the reversal literature synthesized here yields several clear (1) targeted DOAC reversal with specific agents demonstrates superior efficacy for both bleeding and urgent surgical indications when compared to the use of non-specific agents, such as prothrombin complex concentrates (PCCs); (2) at the same time, high-quality data suggest potentially increased thrombotic risks, particularly for ischemic stroke, when using the specific targeted agent andexanet; (3) in all cases of life-threatening bleeding, timely reversal is of the essence; (4) in particular, there is growing consensus that DOAC-associated intracranial hemorrhage (ICH) should be reversed promptly, with a goal door-to-reversal time of 60 min; (5) future research will focus on optimizing clinical pathways for reversal to address "calls to action" from..."

Clinical • Journal • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Thrombosis

Association of Biomarkers with risk of Hematoma Expansion and Arterial Thromboembolic Events in Acute Factor Xa Inhibitor-Associated Intracerebral Hemorrhage: The ANNEXa-I Biomarker Substudy (ISC 2025) - "We examined the association between change from baseline to 1 hour in anti-FXa level and endogenous thrombin potential (ETP) and outcome in patients with apixaban- or rivaroxaban-associated intracerebral hemorrhage (ICH). We compared the effects of andexanet with usual care on change in biomarker levels between baseline and 1 hour using Wilcoxon rank sum test. In patients with factor Xa inhibitor-associated ICH, andexanet compared with usual care produces greater reduction in anti-FXa and greater increase in ETP at 1 hour. Both reduction in anti-FXa and increase in ETP between baseline and 1 hour are independent predictors of HE but do not predict ATE."

Biomarker • Late-breaking abstract • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

Restarting anticoagulation in FXa inhibitor associated intracerebral hemorrhage treated with andexanet reduces thrombotic events (ISC 2025) - "Treatment with prophylactic or therapeutic anticoagulation is associated with a reduced risk of thrombotic events in patients with FXa inhibitor-associated major bleeding receiving andexanet."

Late-breaking abstract • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke • Myocardial Infarction • Venous Thromboembolism