Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases

J Comp Eff Res. 2018 Nov;7(11):1063-1071. doi: 10.2217/cer-2018-0054. Epub 2018 Aug 13.

Abstract

Aim: This study aimed to evaluate the risk of major bleeding among two cohorts of nonvalvular atrial fibrillation patients newly initiating a vitamin K antagonist (VKA) or apixaban in a real-world setting in Italy.

Patients & methods: A retrospective study using a large administrative database of Italian local health units was performed, using data from ten local health units and patients were included from the date of new initiation of apixaban or VKAs from January 2012 to June 2015.

Results: Risk of major bleeding was calculated using an adjusted Cox regression model. Compared with VKA, apixaban had a significantly lower risk of major bleeding (hazard ratio = 0.44 [95% CI: 0.12-0.97]).

Conclusion: In this analysis, apixaban was associated with a lower risk of major bleeding compared with VKA.

Keywords: cardiology/cardiovascular; cohort studies; comparative effectiveness research.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects*
  • Atrial Fibrillation / drug therapy*
  • Databases, Factual
  • Evidence-Based Medicine
  • Factor Xa Inhibitors / administration & dosage*
  • Factor Xa Inhibitors / adverse effects*
  • Female
  • Hemorrhage / chemically induced*
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Proportional Hazards Models
  • Pyrazoles / administration & dosage*
  • Pyrazoles / adverse effects*
  • Pyridones / administration & dosage*
  • Pyridones / adverse effects*
  • Retrospective Studies
  • Risk
  • Vitamin K / antagonists & inhibitors*

Substances

  • Anticoagulants
  • Factor Xa Inhibitors
  • Pyrazoles
  • Pyridones
  • Vitamin K
  • apixaban