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

Cohen, Alexander T; Hoffmann, Ulrich; Hainaut, Philippe; Gaine, Sean; Ay, Cihan; Coppens, Michiel; Schindewolf, Marc; Jimenez, David; Brüggenjürgen, Bernd; Levy, Pierre; Laeis, Petra; Fronk, Eva-Maria; Zierhut, Wolfgang; Malzer, Thomas; Manu, Marius Constantin; Reimitz, Paul-Egbert; Bramlage, Peter; Agnelli, Giancarlo (2020). ETNA VTE Europe: A contemporary snapshot of patients treated with edoxaban in clinical practice across eight European countries. European journal of internal medicine, 82, pp. 48-55. Elsevier 10.1016/j.ejim.2020.08.014

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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.

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