Major bleeding complications in patients treated with direct oral anticoagulants: One-year observational study in a Paris Hospital

Curr Res Transl Med. 2016 Jul-Sep;64(3):129-133. doi: 10.1016/j.retram.2016.02.003. Epub 2016 Jun 1.

Abstract

Direct oral anticoagulants (DAOC) are indicated for the treatment of venous thromboembolism and the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation. Given their advantages and friendly use for patient, the prescription of long term DOAC therapy has rapidly increased both as first line treatment while initiating anticoagulation and as a substitute to vitamins K antagonist (VKA) in poorly controlled patients. However, DOAC therapy can also be associated with significant bleeding complications, and in the absence of specific antidote at disposal, treatment of serious hemorrhagic complications under DOAC remains complex. We report and discuss herein five cases of major hemorrhagic complications under DOAC, which were reported to the pharmacological surveillance department over one year at Saint-Louis University Hospital (Paris, France). We further discuss the need for careful assessment of the risk/benefit ratio at time of starting DOAC therapy in daily clinical practice.

Keywords: Contraindications; Direct oral anticoagulants; Major hemorrhage; Precautions for use; Risk/benefit ratio.

Publication types

  • Observational Study

MeSH terms

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Amiodarone / adverse effects
  • Amiodarone / therapeutic use
  • Cardiovascular Diseases / complications
  • Dabigatran / administration & dosage
  • Dabigatran / adverse effects*
  • Erythrocyte Transfusion
  • Factor Xa Inhibitors / administration & dosage
  • Factor Xa Inhibitors / adverse effects*
  • Female
  • Gastrointestinal Hemorrhage / chemically induced
  • Hemorrhage / chemically induced*
  • Hemorrhage / epidemiology
  • Hemorrhage / therapy
  • Hospitals, University
  • Humans
  • Intracranial Hemorrhages / chemically induced
  • Kidney Diseases / complications
  • Male
  • Paris / epidemiology
  • Pharmacovigilance
  • Risk Factors
  • Rivaroxaban / administration & dosage
  • Rivaroxaban / adverse effects*

Substances

  • Factor Xa Inhibitors
  • Rivaroxaban
  • Dabigatran
  • Amiodarone