The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design
Why the study?
Additional research was needed to evaluate the effects, safety, and effectiveness of edoxaban in routine clinical practice in patients with nonvalvular AF or VTE.
What are the safety and effectiveness outcomes of edoxaban in routine clinical practice for patients with AF or VTE?
Population
Targeted >31 000 patients (>26 000 AF, >4500 VTE) receiving edoxaban in routine clinical practice
Comparison
Edoxaban in routine clinical care (single-arm registry program)
Design
Prospective multinational noninterventional registry program
Follow-up
2 years for AF and 1 year for VTE
Authors
Discussion
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Member takes
Implication
Supports edoxaban safety in routine AF practice with low event rates; extends RCT data to unselected patients but leaves practice change open.
Structured PICO
What are the safety and effectiveness outcomes of edoxaban in routine clinical practice for patients with AF or VTE?
P
Population
Targeted >31,000 patients (AF >26,000; VTE >4,500) receiving edoxaban in routine clinical practice across Europe, Japan, and East and Southeast Asia.
I
Intervention
Edoxaban in routine clinical practice
O
Outcome
Safety and effectiveness outcomes including crude rates of bleeding and thromboembolic eventssafety
The ETNA program will provide large-scale, prospective, real-world data on the safety and effectiveness of edoxaban in patients with AF or VTE.
Cite This Study
Caterina et al. (2019) studied this question.