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PACULit Literature Updates September 2025: Emergency Medicine & Critical Care

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  1. Use of a drug-related problem oriented medical record in the medication review of critically ill patients Randomized clinical trial
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  2. PACULit Daily Literature Update: Stress hyperglycemia ratio as a biomarker for early mortality risk stratification in cardiovascular disease a propensity matched analysis
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  3. PACULit Daily Literature Update: Initial serum electrolyte imbalances and mortality in patients with traumatic brain injury a retrospective study
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  4. PACULit Daily Literature Update: AsNeeded AlbuterolBudesonide in Mild Asthma
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  5. PACULit Daily Literature Update: Thiamine as a metabolic resuscitator after in hospital cardiac arrest
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  6. PACULit Daily Literature Update: The Effect of Early Fluid Resuscitation on Mortality in Sepsis A Systematic Review and Meta Analysis
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  7. PACULit Daily Literature Update: Inhaled isoflurane for sedation of mechanically ventilated children in intensive care (IsoCOMFORT): a multicentre, randomised, active-control, assessor-masked, non-inferiority phase 3 trial
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  8. PACULit Daily Literature Update: Prevalence risk factors and consequences of early clinical deterioration under noninvasive ventilation in emergency department patients a prospective multicentre observational study of the French IRU Network
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  9. PACULit Daily Literature Update: Evaluation of Stress Dose Hydrocortisone Tapers in Septic Shock
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  10. Opportunistic Screening for Atrial Fibrillation With Continuous ECG Monitoring in the Emergency Department
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  11. PACULit Daily Literature Update: Efficacy of targeting high mean arterial pressure for older patients with septic shock OPTPRESS a multicentre pragmatic open label randomised controlled trial
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  12. PACULit Daily Literature Update: Evaluation of Etomidate Use and Association with Mortality Compared with Ketamine among Critically Ill Patients
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  13. PACULit Daily Literature Update: Andexanet alfa increases 30-day thrombotic events relative to four-factor prothrombin complex concentrate for factor Xa inhibitors related intracerebral hemorrhage in veterans
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  14. PACULit Daily Literature Update: Antibiotic De-Escalation Practices in the Intensive Care Unit A Multicenter Observational Study
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  15. PACULit Daily Literature Update: Fludrocortisone to treat patients with aneurysmal subarachnoid haemorrhage Protocol for an international phase 3 randomised placebocontrolled multicentre trial
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  16. PACULit Daily Literature Update: Early intramuscular adrenaline administration is associated with improved survival from out-of-hospital cardiac arrest
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  17. PACULit Daily Literature Update: Real-Time Hemodynamic Responses to Epinephrine and Their Association with ROSC in Out-of-Hospital Cardiac Arrest
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  18. Reevaluating bicarbonate therapy in pediatric DKA A propensity scorematched analysis of neurological and respiratory outcomes
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  19. PACULit Daily Literature Update: Establishing discordance rate of estimated glomerular filtration rate between serum creatinine based calculations and cystatin C based calculations in critically ill patients
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  20. Alteplase for Posterior Circulation Ischemic Stroke at 45 to 24 Hours
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  21. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
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  22. ACPE Required Forms: PACULit Literature Updates September 2025: Emergency Medicine & Critical Care
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Daily Literature Update

Andexanet alfa increases 30-day thrombotic events relative to four-factor prothrombin complex concentrate for factor Xa inhibitors related intracerebral hemorrhage in veterans

Rech MA, Budde E, Evans CT, et al. Andexanet alfa increases 30-day thrombotic events relative to four-factor prothrombin complex concentrate for factor Xa inhibitors-related intracerebral hemorrhage in veterans. Am J Emerg Med. 2025 Jul;97:97-102. doi: 10.1016/j.ajem.2025.07.037. PMID:40700941.

Study Type: National retrospective cohort study within the Veteran Health Administration (2018–2024)

Population: Veterans with factor Xa inhibitor-related intracerebral hemorrhage (n=350 on fXa inhibitors; AA n=129, 4F-PCC n=221)

Intervention: Andexanet alfa (AA) versus 4-factor prothrombin complex concentrate (4F-PCC) for reversal

Outcomes: Primary effectiveness: 90-day mortality; Primary safety: 30-day thrombotic events (venous thromboembolism, pulmonary embolism, acute ischemic stroke, myocardial infarction) validated by manual chart review

Key Findings

  • No significant difference in 90-day mortality: AA 30.9% vs 4F-PCC 36.6% (p=0.35)
  • Significantly higher 30-day thrombotic events with AA (11.4%) vs 4F-PCC (2.4%) (p<0.01)
  • Acute ischemic stroke particularly more common in AA group
  • AA group more likely on apixaban (87.8% vs 77.2%, p=0.03) in matched cohort

Context & Related Research

  • Systematic review/meta-analysis: No mortality difference but higher thrombotic events with AA vs 4F-PCC (PMID:39379749)
  • ASTRO-DE prospective study, 2023: AA reduced hematoma expansion but increased thromboembolic risk (PMID:39834067)
  • Several observational studies: Consistently highlight thrombotic risks with AA in factor Xa inhibitor-related ICH reversal
  • Guidelines: Urge careful balancing of bleeding vs thrombotic risks when selecting reversal agents

Strengths & Limitations

Strengths Limitations
Large national veteran cohort with manual validation of thrombotic events Retrospective design; potential for residual confounding despite propensity matching
Propensity score matching for demographic and clinical balance Limited generalizability beyond predominantly male veteran population
Focused on clinically relevant safety endpoints with chart review Potential coding inaccuracies and treatment selection bias

Clinical Implications & Impact

Pharmacists should carefully assess thrombotic risk when recommending reversal agents for factor Xa inhibitor-associated ICH, recognizing that andexanet alfa may increase 30-day thrombotic events, especially acute ischemic stroke, without survival benefit over 4F-PCC. Collaborative risk-benefit discussions with multidisciplinary teams and vigilant monitoring for thrombosis in patients receiving AA are essential.

Conclusion

In veterans with factor Xa inhibitor-related intracerebral hemorrhage, andexanet alfa did not reduce 90-day mortality compared to four-factor prothrombin complex concentrate but was associated with a significantly higher rate of 30-day thrombotic events, particularly acute ischemic stroke.

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Citations

  • Rech MA et al. Am J Emerg Med. 2025 Jul;97:97-102. PMID:40700941
  • Yahn BA et al. Systematic review/meta-analysis on AA vs 4F-PCC. 2023; PMID:39379749
  • Meinel T et al. ASTRO-DE prospective study. 2023; PMID:39834067
  • Additional observational studies on thrombotic risk with andexanet alfa, various years.

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