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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Schindewolf, Marc

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1879-0828

Publisher:

Elsevier

Language:

English

Submitter:

Claudine Strametz

Date Deposited:

19 Oct 2020 10:01

Last Modified:

16 Dec 2020 01:32

Publisher DOI:

10.1016/j.ejim.2020.08.014

PubMed ID:

32826158

Uncontrolled Keywords:

Anticoagulation Direct oral anticoagulant (DOAC/NOAC) Edoxaban Registry Venous thromboembolism (VTE)

BORIS DOI:

10.7892/boris.146990

URI:

https://boris.unibe.ch/id/eprint/146990

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