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Therapeutics/Prevention
Randomised controlled trial
New reversal agent for factor Xa inhibitors shows promise
  1. Kamrouz Ghadimi,
  2. Ian J Welsby
  1. Divisions of Cardiothoracic Anesthesiology & Critical Care Medicine, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA
  1. Correspondence to : Dr Ian J Welsby, Divisions of Cardiothoracic Anesthesiology & Critical Care Medicine, Department of Anesthesiology, Duke University Medical Center, 2301 Erwin Road, HAFS 5691H, Durham, NC 27710, USA; welsb001{at}mc.duke.edu

https://doi.org/10.1136/ebmed-2016-110390

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    Commentary on: Siegal DM, Curnette JT, Connolly SJ, et al. Andexanet alfa for the reversal of Factor Xa inhibitor activity. N Engl J Med 2015;373:2413–24.

    Context

    Direct oral anticoagulants (DOACs) have emerged as alternatives to vitamin K-antagonists (eg, warfarin) for the long-term management of stroke prevention for non-valvular atrial fibrillation or venous thromboembolic disease. Favourable side-effect profiles and absence of therapeutic monitoring are important benefits of these newer agents. Warfarin is readily reversed with fresh frozen plasma (FFP) or prothrombin complex concentrates.1 The first reversal agent for DOACs, idarucizumab recently received Food and Drug Administration approval as the reversal of the direct thrombin inhibitor, dabigatran. A reversal agent for the factor Xa-inhibitors, Andexanet Alfa is the subject of a recent Phase 3a trial and the core topic of this commentary.2

    Methods

    In a two-part, randomised, placebo-controlled study, healthy, older volunteers were established on 5 mg of apixaban twice daily or 20 mg of rivaroxaban daily. Andexanet alfa was then administered as a …

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    Footnotes

    • Contributors KG and IJW have contributed to the literature and writing of this manuscripts.

    • Competing interests KG is a Co-Investigator in a prospective, open-label study of Andexanet-Alfa in patients receiving factor Xa inhibitors with acute major bleeding, sponsored by Portola Pharmaceuticals (NCT02329327). IJW is the Principal Investigator in a prospective, open-label study of Andexanet Alfa in patients receiving factor Xa inhibitors with acute major bleeding, sponsored by Portola Pharmaceuticals (NCT02329327) and has recently received grant support from CSL Behring and Terumo BCT.

    • Provenance and peer review Commissioned; internally peer reviewed.