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CC BY-NC-ND 4.0 · Thromb Haemost 2025; 125(09): 880-892
DOI: 10.1055/a-2497-4089
Stroke, Systemic or Venous Thromboembolism

Treatment of Venous Thromboembolism with Edoxaban over 18 Months: Results from ETNA-VTE Europe

Giancarlo Agnelli 
1   Internal Emergency and Vascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy
,
Ulrich Hoffmann
2   Division of Angiology, Medical Clinic IV, Ludwig-Maximilians-University, University Hospital, Munich, Germany
,
Philippe Hainaut
3   Department of General Internal Medicine, Cliniques Universitaires Saint Luc, UCL, Bruxelles, Belgium
,
Sean Gaine
4   National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland
,
Cihan Ay
5   Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria
,
Michiel Coppens
6   Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
7   Amsterdam Cardiovascular Sciences, Pulmonary Hypertension and Thrombosis, Amsterdam, The Netherlands
,
Marc Schindewolf
8   Division of Angiology, Swiss Cardiovascular Center, University of Bern, Inselspital, Bern University Hospital, Bern, Switzerland
,
David Jimenez 
9   Respiratory Department, Ramón y Cajal Hospital, Madrid, Spain
10   Medicine Department, Universidad de Alcala, Madrid, Spain
11   CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain
,
Eva-Maria Fronk
12   Daiichi Sankyo Europe GmbH, Munich, Germany
,
José Souza
12   Daiichi Sankyo Europe GmbH, Munich, Germany
,
Petra Laeis
12   Daiichi Sankyo Europe GmbH, Munich, Germany
,
Peter Bramlage 
13   Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
,
Bernd Brüggenjürgen
14   Orthopedic Department, Medical School Hannover (MHH) at DIAKOVERE Annastift, Hannover, Germany
,
Pierre Levy
15   LEDa-LEGOS, Université Paris–Dauphine, PSL University, Paris, France
,
Alexander T. Cohen
16   Guy's and St Thomas' NHS Foundation Trust, King's College London, United Kingdom
,
on behalf of the ETNA-VTE-Europe investigators› Author Affiliations
Funding Daiichi Sankyo Europe GmbH, Munich, Germany.
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Abstract

Background

The benefits and risks of extending anticoagulant treatment beyond the first 3 to 6 months in patients with venous thromboembolism (VTE) in clinical practice are not well understood.

Methods

ETNA-VTE Europe is a prospective, noninterventional, post-authorization study in unselected patients with VTE treated with edoxaban in eight European countries for up to 18 months. Recurrent VTE, major bleeding, and all-cause death were the primary study outcomes.

Results

The median age of the 2,644 patients was 65 years; 46.6% were female, and 22.8% had a history of VTE. The median treatment duration was 50.6 weeks (interquartile range: 23.4–77.7). VTE recurrence occurred in 100 patients (3.8% at an annual rate of 2.7%/year); 37 patients (1.4%) were on edoxaban at the time of the event, with a corresponding annualized rate of 1.6%/year. Major bleeding was experienced by 37 patients (1.4%) during edoxaban treatment, corresponding to an annualized rate of 1.5%/year. Overall, 95 patients died (3.6%; annualized rate 2.6%/year), with the majority for reasons other than VTE- and cardiovascular (CV)-related causes. Out of 15 deaths (1.9%; annualized rate 2.1%/year) that occurred during edoxaban treatment, 1 was related to VTE and 11 related to CV (annualized rate 0.0%/year and 0.5%/year).

Conclusions

ETNA-VTE Europe provides evidence for the real-world effectiveness of edoxaban treatment (up to 18 months) based on a low rate of VTE recurrence, all-cause death, and major bleeding, and is aligned with the results of the randomized clinical trial reassuring the use of edoxaban in the treatment of VTE in routine clinical practice.

Keywords

venous thromboembolism - pulmonary embolism - edoxaban - clinical outcomes - safety

Ethical Approval Statement

Approval from the responsible Ethics Committees and Institutional Review Boards was obtained prior to protocol implementation. Informed consent was obtained from all patients prior to enrolment, and compliance with the Declaration of Helsinki was ensured throughout the study.


Data Availability Statement

Available from the corresponding author upon reasonable request with the level of detail required.


Authors' Contribution

All authors have contributed to the design of the registry and/or the preparation of the manuscript. E.M.F. was responsible for the analysis of data. G.A. and P.B. drafted the first version of the manuscript and the remaining authors made substantial revisions to the manuscript. All authors have approved the version to be published. Apart from the selection of the countries, all design aspects were decided by the scientific Steering Committee and executed by independent Contract Research Organizations.


Supplementary Material



Publication History

Received: 14 May 2024

Accepted: 02 December 2024

Article published online:
16 January 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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