Safety Outcomes of Apixaban Compared With Warfarin in Patients With End-Stage Renal Disease

Ann Pharmacother. 2017 Jun;51(6):445-450. doi: 10.1177/1060028017694654. Epub 2017 Feb 1.

Abstract

Background: Current guidelines make no specific recommendations on the selection of direct oral anticoagulants for the prevention and treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) receiving hemodialysis. Based on these guidelines, warfarin remains the anticoagulant of choice in these patients.

Objective: To compare bleeding rates in patients receiving apixaban or warfarin with ESRD undergoing chronic hemodialysis.

Methods: This was a single-center, retrospective, institutional review board-approved cohort analysis. Patients with ESRD undergoing chronic hemodialysis and receiving anticoagulation therapy with either apixaban or warfarin were included in this study. All data were collected from paper charts and electronic medical records and included documentation of bleeding events and related interventions. The primary outcome of this study was clinically relevant major bleeding events. Secondary outcomes included clinically relevant nonmajor bleeding events and minor bleeding events.

Results: A total of 160 patients were included in this study (warfarin group, n = 120; apixaban group, n = 40). There were 7 major bleeding events in the warfarin group compared with zero in the apixaban group ( P = 0.34). There were similar rates of clinically relevant nonmajor bleeding events (12.5% vs 5.8%, P = 0.17) and minor bleeding (2.5% vs 2.5%, P = 0.74) events in patients receiving apixaban and warfarin.

Conclusions: There were no observed differences in bleeding rates in patients receiving apixaban compared with those receiving warfarin. Apixaban may be a cautious consideration in hemodialysis patients until there is further insight into the effect of subsequent, multiple doses on drug accumulation and clinical outcomes.

Keywords: apixaban; atrial fibrillation; bleeding; end-stage renal disease; hemodialysis; hemorrhage; venous thromboembolism; warfarin.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / adverse effects*
  • Anticoagulants / therapeutic use
  • Female
  • Hemorrhage / chemically induced*
  • Humans
  • Kidney Failure, Chronic / drug therapy
  • Male
  • Middle Aged
  • Pyrazoles / adverse effects*
  • Pyridones / adverse effects*
  • Retrospective Studies
  • Venous Thromboembolism / drug therapy
  • Warfarin / adverse effects*
  • Warfarin / therapeutic use

Substances

  • Anticoagulants
  • Pyrazoles
  • Pyridones
  • apixaban
  • Warfarin