Real World Evidence for Management of Severe Bleeding in the Anticoagulated Patient: Impact of Specific Reversal Therapy for Intracranial Hemorrhage and Gastrointestinal Bleeding

July 28, 2023

Moderator: W. Brian Gibler, MD, FACEP, FACC, FAHA
Other Participants: Paul P. Dobesh, PharmD, FACC, FAHA, FCCP, BCPS, BCCP; Gregory J. Fermann, MD; Natalie Kreitzer, MD, MS

Recent Real World Evidence from a large observational study of 4,395 patients from 354 hospitals across the United States presented at the Society for Academic Emergency Medicine and International Society of Thrombosis and Hemostasis meetings has provided critical information for clinicians caring for patients with severe gastrointestinal and intracranial bleeding. With large gastrointestinal bleeding and intracranial hemorrhage cohorts, this study has demonstrated that andexanet alfa is superior to 4-Factor PCCs in managing severe bleeding in patients anticoagulated with Factor Xa inhibitors. In addition, patients with heart failure, liver failure, and chronic kidney disease (CKD) typically excluded from a randomized controlled trial showed benefit in this observational study. In addition, ANEXXA-I, a randomized controlled trial of andexanet alfa versus 4-Factor PCCs for treatment in intracranial hemorrhage, was stopped by the data safety and monitoring board of the trial due to efficacy of the andexanet alfa treatment arm.

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