Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial

Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.

Abstract

Treatment with apixaban versus placebo for 12 months significantly reduced symptomatic recurrent venous thromboembolism (VTE) or all-cause death without increasing the rate of major bleeding in the AMPLIFY-EXT trial. This analysis examined the effects of apixaban versus placebo on the rate of all-cause hospitalisations, time to first hospitalisation, and predictors of first hospitalisation in patients with VTE enrolled in AMPLIFY-EXT. Treatment with apixaban 2.5 mg and 5 mg twice daily significantly reduced the rate of all-cause hospitalisations versus placebo (hazard ratio [95% confidence interval], 0.64 [0.43, 0.95]; p=0.026 and 0.54 [0.36, 0.82]; p=0.004, respectively). Apixaban prolonged mean time to first hospitalisation versus placebo by 43 and 49 days for the 2.5-mg and 5-mg twice-daily groups, respectively. Median length of hospital stay during the first hospitalisation was longer for placebo than for apixaban 2.5 mg or 5 mg twice daily (7.0, 5.0, and 4.5 days, respectively). Treatment with apixaban was a significant predictor of lower rates of hospitalisations versus placebo, and severe/moderate renal impairment was a significant predictor of an increased rate. This study supports extended use of apixaban for reducing all-cause hospitalisations and extending time to first hospitalisation in patients with VTE enrolled in AMPLIFY-EXT (www.clinicaltrials.gov registration: #NCT00633893).

Keywords: Apixaban; extended anticoagulation; hospitalisation; venous thromboembolism.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Blood Coagulation / drug effects*
  • Double-Blind Method
  • Drug Administration Schedule
  • Factor Xa Inhibitors / administration & dosage*
  • Factor Xa Inhibitors / adverse effects
  • Female
  • Hemorrhage / chemically induced
  • Hospitalization*
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Pyrazoles / administration & dosage*
  • Pyrazoles / adverse effects
  • Pyridones / administration & dosage*
  • Pyridones / adverse effects
  • Recurrence
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Venous Thromboembolism / diagnosis
  • Venous Thromboembolism / drug therapy*
  • Venous Thromboembolism / mortality

Substances

  • Factor Xa Inhibitors
  • Pyrazoles
  • Pyridones
  • apixaban

Associated data

  • ClinicalTrials.gov/NCT00633893