Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors

Andexanet alfa, a catalytically inactive decoy of factor Xa, successfully reversed the factor Xa inhibitory effects of rivaroxaban and apixaban in a small study involving patients with acute major bleeding. In randomized clinical trials, factor Xa inhibitors have been shown to be safe and effective...

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Bibliographic Details
Published in:The New England journal of medicine Vol. 375; no. 12; pp. 1131 - 1141
Main Authors: Connolly, Stuart J, Milling, Truman J, Eikelboom, John W, Gibson, C. Michael, Curnutte, John T, Gold, Alex, Bronson, Michele D, Lu, Genmin, Conley, Pamela B, Verhamme, Peter, Schmidt, Jeannot, Middeldorp, Saskia, Cohen, Alexander T, Beyer-Westendorf, Jan, Albaladejo, Pierre, Lopez-Sendon, Jose, Goodman, Shelly, Leeds, Janet, Wiens, Brian L, Siegal, Deborah M, Zotova, Elena, Meeks, Brandi, Nakamya, Juliet, Lim, W. Ting, Crowther, Mark
Format: Journal Article
Language:English
Published: United States Massachusetts Medical Society 22.09.2016
Subjects:
Acute Disease
Aged
Aged, 80 and over
Bleeding
Cardiovascular diseases
Cardiovascular Diseases - complications
Coagulation
Drug therapy
Enoxaparin - adverse effects
Enzymes
Factor Xa - adverse effects
Factor Xa - therapeutic use
Factor Xa Inhibitors - adverse effects
Factor Xa Inhibitors - metabolism
Factor Xa Inhibitors - therapeutic use
Female
Gastrointestinal Hemorrhage - chemically induced
Gastrointestinal Hemorrhage - drug therapy
Hemorrhage
Hemorrhage - chemically induced
Hemorrhage - drug therapy
Hemostasis
Humans
Infusions, Intravenous
Intracranial Hemorrhages - chemically induced
Intracranial Hemorrhages - diagnosis
Intracranial Hemorrhages - drug therapy
Male
Prospective Studies
Pyrazoles - adverse effects
Pyridones - adverse effects
Recombinant Proteins - adverse effects
Recombinant Proteins - therapeutic use
Rivaroxaban - adverse effects
Thrombosis - etiology
ISSN:0028-4793, 1533-4406
Online Access:Get full text
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Summary:Andexanet alfa, a catalytically inactive decoy of factor Xa, successfully reversed the factor Xa inhibitory effects of rivaroxaban and apixaban in a small study involving patients with acute major bleeding. In randomized clinical trials, factor Xa inhibitors have been shown to be safe and effective for the treatment and prevention of venous thromboembolism and for stroke prevention in patients with atrial fibrillation. 1 – 4 However, factor Xa inhibitors have been associated with major and even fatal bleeding events. 1 – 4 Such episodes of acute major bleeding may be difficult to treat because there is no reversal agent. Andexanet alfa (andexanet) has been designed and developed specifically to reverse the effects of both direct and indirect factor Xa inhibitors. It is a recombinant, modified human factor Xa decoy protein that binds factor Xa . . .
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A complete list of the investigators in the Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXA Inhibitors (ANNEXA-4) study is provided in the Supplementary Appendix, available at NEJM.org.
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMoa1607887