ETNA VTE Europe: A contemporary snapshot of patients treated with edoxaban in clinical practice across eight European countries

Published:August 18, 2020DOI:https://doi.org/10.1016/j.ejim.2020.08.014

      Highlights

      • Edoxaban has proven its efficacy and safety in the ENGAGE AF-TIMI 48 and HOKUSAI-VTE clinical trials.
      • Patients in clinical practice are older, more likely female and with a higher prevalence of chronic venous insufficiency than those in the European cohort of the HOKUSAI-VTE trial. Bodyweight and creatinine clearance were substantially lower.
      • Edoxaban dosing was adherent to label in 90% of patients, with higher (60 mg) and lower than recommended doses (30 mg) used in 6.6% and 3.3% of the patients, respectively.
      • Heparin lead-in was used in 84.7% of patients. Edoxaban was used more frequently in patients with pulmonary embolism (PE) than deep-vein thrombosis (DVT) (91.3 vs. 80.1%; p<0.0001).
      • Patients using edoxaban in routine clinical practice differ from those in prior randomised controlled trials but edoxaban use proved to be largely appropriate.

      Abstract

      Introduction

      Edoxaban has proven its efficacy and safety in the ENGAGE AF-TIMI 48 and HOKUSAI-VTE clinical trials. Clinical practice patients, however, may differ from those enolled in clinical trials. We aimed to compare patients from the HOKUSAI-VTE clinical trial with those treated in clinical practice.

      Materials and Methods

      ETNA-VTE-Europe is a prospective, non-interventional post-authorisation safety study conducted in eight European countries.

      Results

      A total of 2,879 patients presenting with acute symptomatic venous thromboembolism (VTE) were enrolled at 339 sites. Of the 2,680 patients with complete data, 23.6% reported prior VTE and 2.8% had a history of bleeding. Patients in ETNA-VTE were older (65vs.57 years), more likely to be female (46.5vs.39.8%) and had a higher prevalence of chronic venous insufficiency (11.1vs.1.6%) than those in the European cohort of the HOKUSAI-VTE trial (n=1,512). Bodyweight and creatinine clearance were substantially lower in clinical practice. Edoxaban dosing was adherent to label in 90% of patients, with higher (60 mg) and lower than recommended doses (30 mg) used in 6.6% and 3.3% of the patients, respectively. Heparin lead-in was used in 84.7% of the patients overall, and was more frequently used in patients with PE than patients with DVT only (91.3% vs. 80.1%; p<0.0001).

      Conclusions

      These data reinforce the largely appropriate use of edoxaban in routine clinical practice, where the study population differs from those in prior randomised controlled trials.

      ClinicalTrials.gov Identifier

      NCT02943993

      Keywords

      Abbreviations:

      CI (confidence interval), CRNM (clinically relevant non-major bleeding), DACH (Austria, Switzerland and Germany), DOAC (direct oral anticoagulant), DVT (deep vein thrombosis), NVAF (non-valvular atrial fibrillation), PASS (post-authorisation safety study), PE (pulmonary embolism), UK/IE (United Kingdom/Ireland), VTE (venous thromboembolism)
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