Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study
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Key result
ETNA-VTE-Europe registry evaluates 18-month real-world safety and effectiveness of edoxaban in acute VTE.
- n=2,700
Why the study?
Current safety and efficacy data for edoxaban in VTE treatment are derived from clinical trials, with no information about treatment durations beyond 12 months.
What are the real-world safety and effectiveness outcomes of edoxaban in patients with acute symptomatic VTE over 18 months?
Population
Estimated cohort of 2700 patients with acute symptomatic VTE in Europe
Comparison
Edoxaban treatment in routine clinical practice without comparator
Design
18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study
Follow-up
18 months
Authors
Discussion
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Implication
May guide edoxaban use in acute VTE; leaves open confirmation of real-world safety and effectiveness.
Study Design
Type
Observational (n=2,700)
Multicenter
Yes
Structured PICO
What are the real-world safety and effectiveness outcomes of edoxaban in patients with acute symptomatic VTE over 18 months?
P
Population
An estimated 2,700 patients with acute symptomatic venous thromboembolism treated with edoxaban in routine clinical practice across 8 European countries, to be followed for 18 months.
E
Exposure
Edoxaban prescribed in routine clinical practice.
O
Outcome
18-month rate of symptomatic VTE recurrence, and real-world rates of bleeding and adverse drug reactions.safety
The ETNA-VTE-Europe study is designed to evaluate the real-world safety and effectiveness of edoxaban over 18 months in patients with acute symptomatic VTE.
Limitations
- Lack of stringent inclusion/exclusion criteria, blinding, and site/protocol standardisation typical of RCTs
- Heterogeneous timing and length of edoxaban exposure
- Potential incompleteness, insufficient detail, or inaccuracy of patient data
- Single-arm design precludes direct comparisons with other anticoagulants
Cite This Study
Cohen et al. (2018) conducted an observational in Venous Thromboembolism (VTE) (n=2,700). Edoxaban was evaluated on 18-month rate of symptomatic VTE recurrence. ETNA-VTE-Europe is a prospective, non-interventional registry designed to evaluate the 18-month safety and effectiveness of edoxaban in approximately 2,700 patients with acute VTE.
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