Journal article
Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study.
- Cohen AT 1Guy's and St Thomas' NHS Foundation Trust, King's College London, London, UK.
- Ay C 2Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
- Hainaut P 3Department of General Internal Medicine, Cliniques Universitaires Saint Luc, UCL, Bruxelles, Belgium.
- Décousus H 4Centre Hospitalier Universitaire de Saint-Etienne, Saint-Priest En Jarez, France.
- Hoffmann U Division of Angiology, Medical Clinic IV, University Hospital, Ludwig-Maximilians-University, Munich, Germany.
- Gaine S 6National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland.
- Coppens M 7Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
- da Silva PM 8Department of Internal Medicine, Arterial Investigation Unit, Hospital de Santa Marta, Lisbon, Portugal.
- Castro DJ 9Respiratory Department, Ramón y Cajal Hospital, Madrid, Spain.
- Amann-Vesti B 10Division of Angiology, University Hospital Zurich, Zurich, Switzerland.
- Brüggenjürgen B 11Institute for Health Economics, Steinbeis-University, Berlin, Germany.
- Levy P 12LEGOS, Université Paris - Dauphine, Paris, France.
- Bastida JL 13University of Castilla-La Mancha, Talavera de la Reina, Toledo, Spain.
- Vicaut E 14Department of Medicine, Université Paris Descartes, Paris, France.
- Laeis P 15Daiichi Sankyo Europe GmbH, Munich, Germany.
- Fronk EM 15Daiichi Sankyo Europe GmbH, Munich, Germany.
- Zierhut W 15Daiichi Sankyo Europe GmbH, Munich, Germany.
- Malzer T 15Daiichi Sankyo Europe GmbH, Munich, Germany.
- Bramlage P Institute for Pharmacology and Preventive Medicine, Berlin, Germany.
- Agnelli G 17Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy.
- 2018-05-03
Published in:
- Thrombosis journal. - 2018
Anticoagulation
Direct oral anticoagulant (DOAC/NOAC)
Edoxaban
Registry
Venous thromboembolism (VTE)
English
Background
Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104-183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available.
Methods
ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial.
Conclusions
ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention.
Trial registration
ClinicalTrials.gov Identifier: NCT02943993.
Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104-183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available.
Methods
ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial.
Conclusions
ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention.
Trial registration
ClinicalTrials.gov Identifier: NCT02943993.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12959-018-0163-7
- PMID 29719492
- Persistent URL
- https://sonar.ch/global/documents/145439
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