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dc.contributor.authorde Groot, Joris R.
dc.contributor.authorWeiss, T. W.
dc.contributor.authorKelly, Peter
dc.contributor.authorMonteiro, Pedro
dc.contributor.authorDeharo, Jean Claude
dc.contributor.authorde Asmundis, C.
dc.contributor.authorLópez-de-Sá, Esteban
dc.contributor.authorWaltenberger, Johannes
dc.contributor.authorSteffel, Jan
hal.structure.identifierLaboratoire d'Economie de Dauphine [LEDa]
dc.contributor.authorLévy, Pierre
dc.contributor.authorBakhai, Ameet
dc.contributor.authorZierhut, Wolfgang
dc.contributor.authorLaeis, Petra
dc.contributor.authorManu, M. C.
dc.contributor.authorReimitz, Paul-Egbert
dc.contributor.authorDe Caterina, R.
dc.contributor.authorKirchhof, Paulus
dc.date.accessioned2022-01-04T15:25:10Z
dc.date.available2022-01-04T15:25:10Z
dc.date.issued2021
dc.identifier.issn2055-6845
dc.identifier.urihttps://basepub.dauphine.psl.eu/handle/123456789/22402
dc.language.isoenen
dc.subjectNon-vitamin K oral anticoagulanten
dc.subjectEdoxabanen
dc.subjectReal-worlden
dc.subjectRegistryen
dc.subjectAtrial fibrillationen
dc.subjectmortalityen
dc.subjectstroke prevention, cerebrovascular accidenten
dc.subject.ddc334en
dc.subject.classificationjelI12en
dc.titleEdoxaban for stroke prevention in atrial fibrillation in routine clinical care: 1-year follow-up of the prospective observational ETNA-AF-Europe studyen
dc.typeArticle accepté pour publication ou publié
dc.description.abstractenAims : Non-vitamin K oral anticoagulants are safe and effective for stroke prevention in patients with atrial fibrillation (AF). Data on the safety and efficacy of edoxaban in routine care are limited in Europe. We report 1-year outcomes in patients with AF treated with edoxaban in routine care. Methods and results : ETNA-AF-Europe is a prospective, multicentre, post-authorization, observational study enrolling patients treated with edoxaban in 10 European countries, the design of which was agreed with the European Medicines Agency as part of edoxaban’s post-approval safety plan. Altogether 13 092 patients in 852 sites completed the 1-year follow-up [mean age: 73.6 ± 9.5 years ; 57% male, mean follow-up: 352 ± 49 days (median: 366 days)]. Most patients had associated comorbidities (mean CHA2DS2-VASc score: 3.1 ± 1.4). Stroke or systemic embolism was reported in 103 patients (annualized event rate : 0.82%/year), and major bleeding events were reported in 132 patients (1.05%/year). Rates of intracranial haemorrhage were low [30 patients (0.24%/year)]. Death occurred in 442 patients (3.50%/year); cardiovascular (CV) death occurred in 206 patients (1.63%/year). The approved dosing of edoxaban was chosen in 83%. All-cause and CV mortality were higher in patients receiving edoxaban 30 mg vs. 60 mg, in line with the higher age and more frequent comorbidities of the 30 mg group. Major bleeding was also numerically more common in patients receiving edoxaban 30 mg vs. 60 mg. Conclusion : The rates of stroke, systemic embolism, and major bleeding are low in this large unselected cohort of high-risk AF patients routinely treated with edoxaban.en
dc.relation.isversionofjnlnameEuropean Heart Journal - Cardiovascular Pharmacotherapy
dc.relation.isversionofjnlvol7en
dc.relation.isversionofjnlissueFI1en
dc.relation.isversionofjnldate2021
dc.relation.isversionofjnlpagesf30-f39en
dc.relation.isversionofdoi10.1093/ehjcvp/pvaa079en
dc.relation.isversionofjnlpublisherOxford University Pressen
dc.subject.ddclabelEconomie socialeen
dc.relation.forthcomingnonen
dc.description.ssrncandidatenon
dc.description.halcandidateouien
dc.description.readershiprechercheen
dc.description.audienceInternationalen
dc.relation.Isversionofjnlpeerreviewedouien
dc.date.updated2022-01-04T15:02:44Z
hal.identifierhal-03510844
hal.version1
dc.subject.classificationjelHALI.I1.I12en
hal.date.transferred2022-01-04T15:25:13Z
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