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Design and Rationale of the Non-Interventional, Edoxaban Treatment in RoutiNe Clinical PrActice in Patients with Venous ThromboEmbolism in Europe (ETNA-VTE-Europe) Study

dc.contributor.authorCohen, A
dc.contributor.authorAy, C
dc.contributor.authorHainaut, P
dc.contributor.authorDécousus, H
dc.contributor.authorHoffmann, U
dc.contributor.authorGaine, S
dc.contributor.authorCoppens, M
dc.contributor.authorMarques da Silva, P
dc.contributor.authorJimenez Castro, D
dc.contributor.authorAmann-Vesti, B
dc.contributor.authorBrüggenjürgen, B
dc.contributor.authorLevy, P
dc.contributor.authorBastida, J
dc.contributor.authorVicaut, E
dc.contributor.authorLaeis, P
dc.contributor.authorFronk, EM
dc.contributor.authorZierhut, W
dc.contributor.authorMalzer, T
dc.contributor.authorBramlage, P
dc.contributor.authorAgnelli, G
dc.date.accessioned2018-12-20T12:16:29Z
dc.date.available2018-12-20T12:16:29Z
dc.date.issued2018
dc.description.abstractBACKGROUND: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationThromb J. 2018 May 1;16:9.pt_PT
dc.identifier.doi10.1186/s12959-018-0163-7pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/3149
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBioMed Centralpt_PT
dc.subjectHSM MEDpt_PT
dc.subjectVenous Thromboembolismpt_PT
dc.subjectEuropept_PT
dc.subjectAnticoagulationpt_PT
dc.subjectDirect oral anticoagulant (DOAC/NOAC)pt_PT
dc.subjectEdoxabanpt_PT
dc.subjectRegistrypt_PT
dc.titleDesign and Rationale of the Non-Interventional, Edoxaban Treatment in RoutiNe Clinical PrActice in Patients with Venous ThromboEmbolism in Europe (ETNA-VTE-Europe) Studypt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1pt_PT
oaire.citation.startPage9pt_PT
oaire.citation.titleThrombosis Journalpt_PT
oaire.citation.volume16pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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