Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial

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Autor(es): dc.contributorScience Valley Research Institute-
Autor(es): dc.contributorSanto André-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorZucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research-
Autor(es): dc.contributorI M Sechenov First Moscow State Medical University-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorHospital do Rocio-
Autor(es): dc.contributorSalvador-
Autor(es): dc.contributorHospital Municipal de Barueri-
Autor(es): dc.contributorSão Paulo State Public Women's Health Reference Center-
Autor(es): dc.contributorHospital Israelita Albert Einstein-
Autor(es): dc.contributorInstitute of Teaching and Research Hapvida-
Autor(es): dc.contributorHospital Nossa Senhora das Graças-
Autor(es): dc.contributorNorthshore University Health System-
Autor(es): dc.contributorHemostasis and Thrombosis Research Laboratories at Loyola University Medical Center-
Autor(es): dc.contributorDuke University School of Medicine-
Autor(es): dc.creatorRamacciotti, Eduardo-
Autor(es): dc.creatorBarile Agati, Leandro-
Autor(es): dc.creatorCalderaro, Daniela-
Autor(es): dc.creatorAguiar, Valéria Cristina Resende-
Autor(es): dc.creatorSpyropoulos, Alex C-
Autor(es): dc.creatorde Oliveira, Caroline Candida Carvalho-
Autor(es): dc.creatorLins dos Santos, Jessica-
Autor(es): dc.creatorVolpiani, Giuliano Giova-
Autor(es): dc.creatorSobreira, Marcone Lima-
Autor(es): dc.creatorJoviliano, Edwaldo Edner-
Autor(es): dc.creatorBohatch Júnior, Milton Sérgio-
Autor(es): dc.creatorda Fonseca, Benedito Antônio Lopes-
Autor(es): dc.creatorRibeiro, Maurício Serra-
Autor(es): dc.creatorDusilek, Cesar-
Autor(es): dc.creatorItinose, Kengi-
Autor(es): dc.creatorSanches, Suzanna Maria Viana-
Autor(es): dc.creatorde Almeida Araujo Ramos, Karine-
Autor(es): dc.creatorde Moraes, Nara Franzin-
Autor(es): dc.creatorTierno, Paulo Fernando Guimarães Morando Marzocchi-
Autor(es): dc.creatorde Oliveira, André Luiz Malavasi Longo-
Autor(es): dc.creatorTachibana, Adriano-
Autor(es): dc.creatorChate, Rodrigo Caruso-
Autor(es): dc.creatorSantos, Marcus Vinícius Barbosa-
Autor(es): dc.creatorde Menezes Cavalcante, Bruno Bezerra-
Autor(es): dc.creatorMoreira, Ricardo Cesar Rocha-
Autor(es): dc.creatorChang, Chiann-
Autor(es): dc.creatorTafur, Alfonso-
Autor(es): dc.creatorFareed, Jawed-
Autor(es): dc.creatorLopes, Renato D-
Autor(es): dc.creatorBenevenuto Caltabiano, Tania-
Autor(es): dc.creatorHattori, Breno-
Autor(es): dc.creatorda Silva Jardim, Marcello-
Autor(es): dc.creatorMarinho, Igor-
Autor(es): dc.creatorSilva Marinho, Ivan-
Autor(es): dc.creatorMara Melo Batista, Liane-
Autor(es): dc.creatorRivabem, Lucas-
Autor(es): dc.creatorAlberto Kenji Nakashima, Carlos-
Autor(es): dc.creatorCarla Gois Franco, Ana-
Autor(es): dc.creatorde Oliveira Pereira, Renata Fernanda-
Autor(es): dc.creatorStrack Neves, Giana Caroline-
Autor(es): dc.creatorde Castro e Souza, Izara-
Autor(es): dc.creatorMoraes Ribas, Bruno-
Autor(es): dc.creatorRamos Tristão, Flavia-
Autor(es): dc.creatorBarbosa Santos, Marcus Vinicius-
Data de aceite: dc.date.accessioned2025-08-21T16:12:26Z-
Data de disponibilização: dc.date.available2025-08-21T16:12:26Z-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2021-12-31-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1016/S0140-6736(21)02392-8-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/231577-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/231577-
Descrição: dc.descriptionBackground: Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown. Methods: In this open-label, multicentre, randomised trial conducted at 14 centres in Brazil, patients hospitalised with COVID-19 at increased risk for venous thromboembolism (International Medical Prevention Registry on Venous Thromboembolism [IMPROVE] venous thromboembolism [VTE] score of ≥4 or 2–3 with a D-dimer >500 ng/mL) were randomly assigned (1:1) to receive, at hospital discharge, rivaroxaban 10 mg/day or no anticoagulation for 35 days. The primary efficacy outcome in an intention-to-treat analysis was a composite of symptomatic or fatal venous thromboembolism, asymptomatic venous thromboembolism on bilateral lower-limb venous ultrasound and CT pulmonary angiogram, symptomatic arterial thromboembolism, and cardiovascular death at day 35. Adjudication was blinded. The primary safety outcome was major bleeding. The primary and safety analyses were carried out in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04662684. Findings: From Oct 8, 2020, to June 29, 2021, 997 patients were screened. Of these patients, 677 did not meet eligibility criteria; the remaining 320 patients were enrolled and randomly assigned to receive rivaroxaban (n=160 [50%]) or no anticoagulation (n=160 [50%]). All patients received thromboprophylaxis with standard doses of heparin during hospitalisation. 165 (52%) patients were in the intensive care unit while hospitalised. 197 (62%) patients had an IMPROVE score of 2–3 and elevated D-dimer levels and 121 (38%) had a score of 4 or more. Two patients (one in each group) were lost to follow-up due to withdrawal of consent and not included in the intention-to-treat primary analysis. The primary efficacy outcome occurred in five (3%) of 159 patients assigned to rivaroxaban and 15 (9%) of 159 patients assigned to no anticoagulation (relative risk 0·33, 95% CI 0·12–0·90; p=0·0293). No major bleeding occurred in either study group. Allergic reactions occurred in two (1%) patients in the rivaroxaban group. Interpretation: In patients at high risk discharged after hospitalisation due to COVID-19, thromboprophylaxis with rivaroxaban 10 mg/day for 35 days improved clinical outcomes compared with no extended thromboprophylaxis. Funding: Bayer.-
Descrição: dc.descriptionScience Valley Research Institute-
Descrição: dc.descriptionHospital e Maternidade Christóvão da Gama Grupo Leforte Santo André-
Descrição: dc.descriptionUnidade de Medicina Interdisciplinar em Cardiologia Instituto do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo-
Descrição: dc.descriptionZucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research-
Descrição: dc.descriptionDepartment of Obstetrics and Gynecology I M Sechenov First Moscow State Medical University-
Descrição: dc.descriptionUniversidade Estadual Paulista-
Descrição: dc.descriptionHospital das Clínicas de Ribeirão Preto São Paulo University Medical School Ribeirão Preto-
Descrição: dc.descriptionHospital do Rocio, Campo Largo-
Descrição: dc.descriptionInstituto Couto Maia Salvador-
Descrição: dc.descriptionHospital Municipal de Barueri-
Descrição: dc.descriptionSão Paulo State Public Women's Health Reference Center-
Descrição: dc.descriptionHospital Israelita Albert Einstein-
Descrição: dc.descriptionInstituto do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo-
Descrição: dc.descriptionInstitute of Teaching and Research Hapvida-
Descrição: dc.descriptionHospital Nossa Senhora das Graças-
Descrição: dc.descriptionDepartment of Statistics Institute of Mathematics and Statistics University of São Paulo-
Descrição: dc.descriptionNorthshore University Health System-
Descrição: dc.descriptionHemostasis and Thrombosis Research Laboratories at Loyola University Medical Center-
Descrição: dc.descriptionDuke Clinical Research Institute Duke University School of Medicine-
Descrição: dc.descriptionUniversidade Estadual Paulista-
Formato: dc.format50-59-
Idioma: dc.languageen-
Relação: dc.relationThe Lancet-
???dc.source???: dc.sourceScopus-
Título: dc.titleRivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

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