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

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.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.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).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.

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Journal
Thrombosis and Haemostasis
Published
2025-01-16
DOI
https://doi.org/10.1055/a-2497-4089
Citations
1
Primary Topic
Venous Thromboembolism Diagnosis and Management
Type
article
Field-Weighted Citation Impact
1.87

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article

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

Michiel Coppens, Marc Schindewolf, Cihan Ay, Bernd Brüggenjürgen et al.
1 citations
Thrombosis and Haemostasis
Venous Thromboembolism Diagnosis and Management
1.87
article

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

Michiel Coppens, Marc Schindewolf, Cihan Ay, Bernd Brüggenjürgen, Pierre Hainaut, Seán Gaine, Peter Bramlage, David Jiménez, Giancarlo Agnelli, Pierre Lévy, Petra Laeis, Alexander T. Cohen, José Souza, Eva‐Maria Fronk, Ulrich Hoffmann
article en
1 citations

Abstract

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.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.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).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.

Thrombosis and HaemostasisVol. 125(09)
University of Bern (CH), Cliniques Universitaires Saint-Luc (BE), Daiichi Sankyo (Germany) (DE), King's College London (GB), Universidad de Alcalá (ES), Guy's and St Thomas' NHS Foundation Trust (GB), Instituto Cajal (ES), Université Paris Sciences et Lettres (FR), University of Perugia (IT), University Hospital of Bern (CH), Mater Misericordiae University Hospital (IE), Medizinische Hochschule Hannover (DE), IPPMed (Germany) (DE), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (ES), Amsterdam University Medical Centers (NL), Université Paris Dauphine-PSL (FR), Medical University of Vienna (AT), Ludwig-Maximilians-Universität München (DE), University of Amsterdam (NL)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, GlaxoSmithKline, Sanofi, Gilead Sciences, Biogen, Alexion Pharmaceuticals, F. Hoffmann-La Roche, United Therapeutics Corporation, CSL Behring, Boston Scientific Corporation, Daiichi-Sankyo, Novo Nordisk, Astellas Pharma, Swedish Orphan Biovitrum, LEO Pharma, Spark Therapeutics, Daiichi Sankyo Europe
Openalex Percentile: Top 23%
Venous Thromboembolism Diagnosis and Management
1.87
DOIOpen Access PDFOpenAlex
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