title: Efficacy of prothrombin complex concentrates for the emergency reversal of dabigatran-induced anticoagulation.
abstract: Dabigatran is effective in decreasing the risk of ischaemic stroke in patients with atrial fibrillation. However, like all anticoagulants, it is associated with a risk of bleeding. In cases of trauma or emergency surgery, emergency reversal of dabigatran-induced anticoagulation may be required. A specific reversal agent for dabigatran, idarucizumab, has been approved by the US Food and Drug Administration. Alternative reversal agents are available, such as prothrombin complex concentrates (PCCs) and activated PCCs (aPCCs). In this review we evaluate the role of PCCs and aPCCs in the reversal of dabigatran anticoagulation and consider which tests are appropriate for monitoring coagulation in this setting. Pre-clinical studies, small clinical studies and case reports indicate that PCCs and aPCCs may be able to reverse dabigatran-induced anticoagulation in a dose-dependent manner. However, dosing based on coagulation parameters can be difficult because available assays may not provide adequate sensitivity and specificity for measuring anticoagulation induced by dabigatran or the countering effects of PCCs/aPCCs. In addition, PCCs or aPCCs can potentially provoke thromboembolic complications. Despite these limitations and the fact that PCCs and aPCCs are not yet licensed for dabigatran reversal, their use appears to be warranted in patients with life-threatening haemorrhage if idarucizumab is not available.
authors.affiliation: Department of Anesthesiology, RWTH Aachen University Hospital, Pauwelsstrasse 30, 52074, Aachen, Germany. ogrottke@ukaachen.de.
authors.forename: Oliver
authors.initials: O
authors.lastname: Grottke
authors.affiliation: The Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: James
authors.initials: J
authors.lastname: Aisenberg
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Bernstein
authors.affiliation: Emergency Department and SAMU, Lille University Hospital, Lille, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Goldstein
authors.affiliation: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Menno V
authors.initials: MV
authors.lastname: Huisman
authors.affiliation: Department of Neurology, Weill Cornell Medical College, New York, NY, USA.
authors.forename: Dara G
authors.initials: DG
authors.lastname: Jamieson
authors.affiliation: Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Jerrold H
authors.initials: JH
authors.lastname: Levy
authors.affiliation: Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.
authors.forename: Charles V
authors.initials: CV
authors.lastname: Pollack
authors.affiliation: Hofstra North Shore/LIJ School of Medicine, Lenox Hill Hospital, New York, NY, USA.
authors.forename: Alex C
authors.initials: AC
authors.lastname: Spyropoulos
authors.affiliation: University of Heidelberg, Heidelberg, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Steiner
authors.affiliation: Departments of Medicine and Neurology, University of Washington, Seattle, WA, USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Del Zoppo
authors.affiliation: McMaster University, Hamilton, Ontario, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Eikelboom
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000188:drug therapy; D001777:Blood Coagulation / Q000187:drug effects; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D000069604:Dabigatran / Q000009:adverse effects* / Q000627:therapeutic use / Q000633:toxicity; D006801:Humans; D013918:Thrombin Time
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D000069604:Dabigatran
keywords: Activated prothrombin complex concentrate; Anticoagulation; Bleeding; Dabigatran; Prothrombin complex concentrate; Trauma