NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank

Am Heart J. 2016 Jul:177:74-86. doi: 10.1016/j.ahj.2016.04.010. Epub 2016 Apr 23.

Abstract

Four non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) have been approved in the United States for treatment of atrial fibrillation (AF) and venous thromboembolic disease. They have been as or more effective than the prior standards of care, with less fatal or intracranial bleeding, fewer drug and dietary interactions, and greater patient convenience. Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention. Accordingly, a Cardiac Research Safety Consortium "think tank" meeting was held in February 2015 to address these concerns. This manuscript reports on the discussions held and the conclusions reached at that meeting.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal, Humanized
  • Antidotes / therapeutic use*
  • Antithrombins / therapeutic use
  • Arginine / analogs & derivatives
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / drug therapy*
  • Congresses as Topic
  • Dabigatran / therapeutic use
  • Drug Monitoring
  • Factor Xa
  • Factor Xa Inhibitors / therapeutic use*
  • Humans
  • Partial Thromboplastin Time
  • Piperazines
  • Product Surveillance, Postmarketing
  • Pyrazoles / therapeutic use
  • Pyridines / therapeutic use
  • Pyridones / therapeutic use
  • Recombinant Proteins
  • Rivaroxaban / therapeutic use
  • Stroke / etiology
  • Stroke / prevention & control*
  • Thiazoles / therapeutic use
  • Thrombin Time
  • Venous Thromboembolism / drug therapy
  • Venous Thromboembolism / prevention & control*

Substances

  • Antibodies, Monoclonal, Humanized
  • Antidotes
  • Antithrombins
  • Factor Xa Inhibitors
  • PRT064445
  • Piperazines
  • Pyrazoles
  • Pyridines
  • Pyridones
  • Recombinant Proteins
  • Thiazoles
  • apixaban
  • Arginine
  • idarucizumab
  • Rivaroxaban
  • Factor Xa
  • Dabigatran
  • edoxaban
  • PER977