Evaluation of standard versus reduced dose apixaban for the treatment of venous thromboembolism in patients with severe renal disease (ESRD-VTE)

Thromb Res. 2022 Dec:220:91-96. doi: 10.1016/j.thromres.2022.10.014. Epub 2022 Oct 24.


Background: There are no clear dosing recommendations when using apixaban for venous thromboembolism (VTE) treatment in patients with severe or end-stage renal disease; clinical trials excluded patients with a creatinine clearance (CrCl) <25 mL/min or on dialysis. This study compares bleeding rates in patients with severe or end-stage renal disease taking standard versus reduced dose apixaban for VTE treatment.

Materials and methods: This was a multicenter, retrospective cohort study using electronic medical records between January 1, 2013, and August 31, 2021. This study included patients 18 years or older who had severe or end-stage renal disease when prescribed apixaban for VTE treatment. Severe or end-stage renal disease was defined as at least one of the following: CrCl <25 mL/min, SCr >2.5 mg/dL, CKD stage 4 or 5, or on dialysis. The primary endpoint was rate of clinically relevant bleeding within six months of starting apixaban. Secondary endpoints were VTE recurrence within six months of starting apixaban, time to clinically relevant bleed, and time to VTE recurrence.

Results: A total of 203 patients were included in the final analysis (n = 125 on 5 mg; n = 78 on 2.5 mg). Clinically relevant bleeding rate was significantly higher in the standard dose group (14.4 % vs 3.8 %, p = 0.02). Rates of VTE recurrence appear similar (6.4 % vs 7.7 %, p = 0.21).

Conclusions: A reduced dose of apixaban may be considered when treating VTE in patients with severe or end-stage renal disease.

Keywords: Anticoagulation; Apixaban; Renal disease; Venous thromboembolism; dialysis.

Publication types

  • Multicenter Study

MeSH terms

  • Anticoagulants / therapeutic use
  • Hemorrhage / chemically induced
  • Hemorrhage / drug therapy
  • Humans
  • Kidney Failure, Chronic* / complications
  • Pyridones / adverse effects
  • Retrospective Studies
  • Venous Thromboembolism* / chemically induced
  • Venous Thromboembolism* / drug therapy


  • apixaban
  • Anticoagulants
  • Pyridones