Definition of factor Xa inhibitor-related, life-threatening gastrointestinal bleeding and guidance on when to use reversal therapy: A Delphi panel - Fermann, G. J.; Cash, B. D.; Coelho-Prabhu, N.; Maegele, M.; Bingisser, R.; Sehgal, V.; Cohen, A. T.; Golden, A. H.; Russo, J.; Price, M.; Mangel, A.; Koch, B.; et al. (J Am Coll Emerg Physicians Open, 2023)
OBJECTIVE: To define and contextualize life-threatening gastrointestinal (GI) bleeding in the setting of factor Xa (FXa) inhibitor therapy and to derive a consensus-based, clinically oriented approach to the administration of FXa inhibitor reversal therapy. METHODS: We convened an expert panel of clinicians representing specialties in emergency medicine, gastroenterology, vascular medicine, and trauma surgery. Consensus was reached among the clinician panelists using the Delphi technique, which consisted of 2 survey questionnaires followed by virtual, real-time consensus-building exercises. RESULTS: Hypovolemia and hemodynamic instability were considered the most important clinical signs of FXa inhibitor-related, life-threatening GI bleeds. Clinician panelists agreed that potentially life-threatening GI bleeding should be determined on the basis of hemodynamic instability, signs of shock, individual patient characteristics, and clinical judgment. Last, the panel agreed that all patients with life-threatening, FXa inhibitor-associated GI bleeding should be considered for FXa inhibitor reversal therapy; the decision to reverse FXa inhibition should be individualized, weighing the risks and benefits of reversal; and when reversal is elected, therapy should be administered within 1 h after initial emergency department evaluation, when possible. CONCLUSIONS: Consensus-based definitions of life-threatening GI bleeding and approaches to FXa inhibitor reversal centered on hemodynamic instability, signs of shock, individual patient characteristics, and clinical judgment. The results from this Delphi panel may inform clinical decision-making for the treatment of patients experiencing GI bleeding associated with FXa inhibitor use in the emergency department setting.
Keywords: journalArticle; AstraZeneca; AstraZeneca, Bayer AG, Bristol-Myers Squibb, and Pfizer; AstraZeneca, Bristol-Myers Squibb, and Pfizer; AstraZeneca. Nayantara Coelho-Prabhu has served as a consultant for Boston; CellPhire, Acasti Pharma, and Octapharma; Fujifilm. Roland Bingisser has served as a consultant for AstraZeneca, SpinChip,; Health Solutions, an independent nonprofit research organization, which was; Medtronic. Alexander T. Cohen has received grants or contracts from Alexion,; Scientific and Alexion and has received research funding from Cook Endoscopy and; Truman J. Milling Jr. has served as a consultant for AstraZeneca, CSL Behring,; Zeneca, and on Speaker's Bureau for Astra Zeneca, and has received research; a consultant for Apollo Endosurgery, Pentax, Medtronic, Pharmacosmos, Microtech,; and AstraZeneca; and Phillips point-of-care systems; and has received educational grants from Apollo Endosurgery, Pentax, and; and may hold shares and/or stock options in the company. Mary J. Christoph was an; and payments or; and serves as an editor for medStandards. Vinay Sehgal has served as; anticoagulant reversal; at the time this research was conducted. Bruce Koch is an employee of AstraZeneca; consulting fees from Alexion,; employee of AstraZeneca at the time this research was conducted and may hold; factor Xa inhibitor; gastrointestinal hemorrhage; has received fees for presentations from; has served on advisory boards for Pharmacosmos and Microtech; honoraria from Alexion, AstraZeneca, Bayer AG, Bristol-Myers Squibb, and Pfizer; of Health. Brooks D. Cash and Marc Maegele have served as consultants for; on which they work. Allen Mangel was a full-time employee of RTI Health Solutions; retained by Alexion, AstraZeneca Rare Disease, to conduct the research that is; scientific advisory board for Milestone Pharmaceuticals, as a consultant to Astra; shares and/or stock options in the company. Gregory J. Fermann has served on the; support from Siemens, Abbott, InCarda Therapeutics, and the National Institutes; the subject of this manuscript. Their compensation is unconnected to the studies