{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,28]],"date-time":"2026-02-28T04:32:15Z","timestamp":1772253135220,"version":"3.50.1"},"reference-count":36,"publisher":"Sociedade Brasileira de Cardiologia","issue":"3","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arq. Bras. Cardiol."],"abstract":"<jats:p>Resumo  Fundamento: Os ensaios cl\u00ednicos demonstraram a seguran\u00e7a da Edoxabana, um anticoagulante oral n\u00e3o dependente de vitamina K (NOAC), e a sua efic\u00e1cia na preven\u00e7\u00e3o de acidente vascular cerebral e embolia sist\u00e9mica em pacientes com fibrila\u00e7\u00e3o atrial n\u00e3o valvar (FANV) e tamb\u00e9m na preven\u00e7\u00e3o e tratamento de tromboembolismo venoso. No entanto, pesquisas adicionais s\u00e3o necess\u00e1rias para avaliar a seguran\u00e7a e a efic\u00e1cia da Edoxabana em um cen\u00e1rio real na popula\u00e7\u00e3o brasileira.  Objetivo: A fim de compreender os riscos e benef\u00edcios do uso da Edoxabana em cen\u00e1rios cl\u00ednicos de rotina, o estudo EdoBRA est\u00e1 sendo conduzido para obter informa\u00e7\u00f5es sobre a seguran\u00e7a e efic\u00e1cia do uso da Edoxabana em pacientes n\u00e3o pr\u00e9-selecionados com FANV no Brasil.  M\u00e9todos: O estudo EdoBRA \u00e9 um estudo multic\u00eantrico, prospectivo e observacional, realizado em 36 centros no Brasil. S\u00e3o eleg\u00edveis para este estudo pacientes com FANV, \u2265 18 anos de idade, tratados com Edoxabana dispon\u00edvel comercialmente, que iniciaram o tratamento por pelo menos 14 dias e n\u00e3o mais do que 90 dias antes da data de inclus\u00e3o no estudo, e que n\u00e3o est\u00e3o participando de nenhum outro estudo de interven\u00e7\u00e3o. Ao todo, 700 pacientes devem ser inscritos e acompanhados por um ano, com coletas de dados programadas para o per\u00edodo basal e 3, 6 e 12 meses ap\u00f3s a inscri\u00e7\u00e3o no estudo. O objetivo prim\u00e1rio de seguran\u00e7a \u00e9 o sangramento clinicamente relevante (de acordo com crit\u00e9rios da Sociedade Internacional de Trombose e Hemostasia - ISTH), e o objetivo secund\u00e1rio de efic\u00e1cia s\u00e3o desfechos cardiovasculares relevantes relacionados \u00e0 FANV.  Conclus\u00e3o: O estudo observacional EdoBRA gerar\u00e1 informa\u00e7\u00f5es adicionais relevantes sobre a Edoxabana enquanto NOAC em diversos aspectos do manejo de pacientes no atendimento cl\u00ednico de rotina, como perfil de seguran\u00e7a e efetividade em pacientes com FANV no Brasil.<\/jats:p>","DOI":"10.36660\/abc.20230392","type":"journal-article","created":{"date-parts":[[2024,6,4]],"date-time":"2024-06-04T13:09:54Z","timestamp":1717506594000},"source":"Crossref","is-referenced-by-count":0,"title":["Desenho de Estudo de um Estudo Observacional Brasileiro sobre o uso de Edoxabana em Pacientes com Fibrila\u00e7\u00e3o Atrial (EdoBRA)"],"prefix":"10.36660","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1187-8690","authenticated-orcid":false,"given":"Dalton Bertolim","family":"Pr\u00e9coma","sequence":"first","affiliation":[{"name":"Hospital Angelina Caron,  Brasil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael Paletta da","family":"Silva","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Brasil Farmac\u00eautica,  Brasil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allyson","family":"Nakamoto","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Brasil Farmac\u00eautica,  Brasil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Viviane Mariz","family":"Omar","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Brasil Farmac\u00eautica,  Brasil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danilo","family":"Lopes","sequence":"additional","affiliation":[{"name":"Daiichi Sankyo Brasil Farmac\u00eautica,  Brasil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos\u00e9 Francisco Kerr","family":"Saraiva","sequence":"additional","affiliation":[{"name":"Pontif\u00edcia Universidade Cat\u00f3lica de Campinas,  Brasil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"22636","published-online":{"date-parts":[[2024]]},"reference":[{"issue":"5 Pt 2","key":"ref1","first-page":"821","article-title":"Atrial Fibrillation: The Most Common Arrhythmia","volume":"37","author":"Le Heuzey JY","year":"2008","journal-title":"Presse Med"},{"issue":"5","key":"ref2","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1093\/eurheartj\/ehaa612","article-title":"2020 ESC Guidelines for the Diagnosis and Management of Atrial Fibrillation Developed in Collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the Diagnosis and Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Developed with the Special Contribution of the European Heart Rhythm Association (EHRA) of the ESC","volume":"42","author":"Hindricks G","year":"2021","journal-title":"Eur Heart J"},{"issue":"1","key":"ref3","doi-asserted-by":"crossref","first-page":"384","DOI":"10.1186\/s12872-021-02019-0","article-title":"Demographic, Clinical, and Functional Determinants of Antithrombotic Treatment in Patients with Nonvalvular Atrial Fibrillation","volume":"21","author":"Mostaza JM","year":"2021","journal-title":"BMC Cardiovasc Disord"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"441","DOI":"10.2147\/IJGM.S62819","article-title":"Burden of Disease from Atrial Fibrillation in Adults from Seven Countries in Latin America","volume":"7","author":"Cubillos L","year":"2014","journal-title":"Int J Gen Med"},{"issue":"4","key":"ref5","doi-asserted-by":"crossref","first-page":"1","DOI":"10.5935\/abc.20160055","article-title":"II Diretrizes Brasileiras de Fibrila\u00e7\u00e3o Atrial","volume":"106","author":"Magalh\u00e3es LP","year":"2016","journal-title":"Arq Bras Cardiol"},{"issue":"6","key":"ref6","first-page":"576","article-title":"Stroke Prevention in Atrial Fibrillation: Focus on Latin America","volume":"107","author":"Massaro AR","year":"2016","journal-title":"Arq Bras Cardiol"},{"issue":"23","key":"ref7","doi-asserted-by":"crossref","first-page":"2933","DOI":"10.1161\/CIRCULATIONAHA.111.069450","article-title":"Symptoms and Functional Status of Patients with Atrial Fibrillation: State of the Art and Future Research Opportunities","volume":"125","author":"Rienstra M","year":"2012","journal-title":"Circulation"},{"issue":"6","key":"ref8","doi-asserted-by":"crossref","first-page":"677","DOI":"10.1016\/S0002-9149(03)00821-X","article-title":"Impact of a Practice Guideline for Patients with Atrial Fibrillation on Medical Resource Utilization and Costs","volume":"92","author":"Zimetbaum P","year":"2003","journal-title":"Am J Cardiol"},{"issue":"5","key":"ref9","first-page":"109","article-title":"Atrial Fibrillation: A Leading Cause of Heart Failure-Related Hospitalizations; 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