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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dc.contributor.authorRamacciotti, Eduardo
dc.contributor.authorBarile Agati, Leandro
dc.contributor.authorCalderaro, Daniela
dc.contributor.authorAguiar, Valéria Cristina Resende
dc.contributor.authorSpyropoulos, Alex C
dc.contributor.authorde Oliveira, Caroline Candida Carvalho
dc.contributor.authorLins dos Santos, Jessica
dc.contributor.authorVolpiani, Giuliano Giova
dc.contributor.authorSobreira, Marcone Lima [UNESP]
dc.contributor.authorJoviliano, Edwaldo Edner
dc.contributor.authorBohatch Júnior, Milton Sérgio
dc.contributor.authorda Fonseca, Benedito Antônio Lopes
dc.contributor.authorRibeiro, Maurício Serra
dc.contributor.authorDusilek, Cesar
dc.contributor.authorItinose, Kengi
dc.contributor.authorSanches, Suzanna Maria Viana
dc.contributor.authorde Almeida Araujo Ramos, Karine
dc.contributor.authorde Moraes, Nara Franzin
dc.contributor.authorTierno, Paulo Fernando Guimarães Morando Marzocchi
dc.contributor.authorde Oliveira, André Luiz Malavasi Longo
dc.contributor.authorTachibana, Adriano
dc.contributor.authorChate, Rodrigo Caruso
dc.contributor.authorSantos, Marcus Vinícius Barbosa
dc.contributor.authorde Menezes Cavalcante, Bruno Bezerra
dc.contributor.authorMoreira, Ricardo Cesar Rocha
dc.contributor.authorChang, Chiann
dc.contributor.authorTafur, Alfonso
dc.contributor.authorFareed, Jawed
dc.contributor.authorLopes, Renato D
dc.contributor.authorBenevenuto Caltabiano, Tania
dc.contributor.authorHattori, Breno
dc.contributor.authorda Silva Jardim, Marcello
dc.contributor.authorMarinho, Igor
dc.contributor.authorSilva Marinho, Ivan
dc.contributor.authorMara Melo Batista, Liane
dc.contributor.authorRivabem, Lucas
dc.contributor.authorAlberto Kenji Nakashima, Carlos
dc.contributor.authorCarla Gois Franco, Ana
dc.contributor.authorde Oliveira Pereira, Renata Fernanda
dc.contributor.authorStrack Neves, Giana Caroline
dc.contributor.authorde Castro e Souza, Izara
dc.contributor.authorMoraes Ribas, Bruno
dc.contributor.authorRamos Tristão, Flavia
dc.contributor.authorBarbosa Santos, Marcus Vinicius
dc.contributor.institutionScience Valley Research Institute
dc.contributor.institutionSanto André
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionZucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research
dc.contributor.institutionI M Sechenov First Moscow State Medical University
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionHospital do Rocio
dc.contributor.institutionSalvador
dc.contributor.institutionHospital Municipal de Barueri
dc.contributor.institutionSão Paulo State Public Women's Health Reference Center
dc.contributor.institutionHospital Israelita Albert Einstein
dc.contributor.institutionInstitute of Teaching and Research Hapvida
dc.contributor.institutionHospital Nossa Senhora das Graças
dc.contributor.institutionNorthshore University Health System
dc.contributor.institutionHemostasis and Thrombosis Research Laboratories at Loyola University Medical Center
dc.contributor.institutionDuke University School of Medicine
dc.date.accessioned2022-04-29T08:46:13Z
dc.date.available2022-04-29T08:46:13Z
dc.date.issued2022-01-01
dc.description.abstractBackground: 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.en
dc.description.affiliationScience Valley Research Institute
dc.description.affiliationHospital e Maternidade Christóvão da Gama Grupo Leforte Santo André
dc.description.affiliationUnidade de Medicina Interdisciplinar em Cardiologia Instituto do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo
dc.description.affiliationZucker School of Medicine at Hofstra/Northwell and the Feinstein Institutes for Medical Research
dc.description.affiliationDepartment of Obstetrics and Gynecology I M Sechenov First Moscow State Medical University
dc.description.affiliationUniversidade Estadual Paulista
dc.description.affiliationHospital das Clínicas de Ribeirão Preto São Paulo University Medical School Ribeirão Preto
dc.description.affiliationHospital do Rocio, Campo Largo
dc.description.affiliationInstituto Couto Maia Salvador
dc.description.affiliationHospital Municipal de Barueri
dc.description.affiliationSão Paulo State Public Women's Health Reference Center
dc.description.affiliationHospital Israelita Albert Einstein
dc.description.affiliationInstituto do Coração Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo
dc.description.affiliationInstitute of Teaching and Research Hapvida
dc.description.affiliationHospital Nossa Senhora das Graças
dc.description.affiliationDepartment of Statistics Institute of Mathematics and Statistics University of São Paulo
dc.description.affiliationNorthshore University Health System
dc.description.affiliationHemostasis and Thrombosis Research Laboratories at Loyola University Medical Center
dc.description.affiliationDuke Clinical Research Institute Duke University School of Medicine
dc.description.affiliationUnespUniversidade Estadual Paulista
dc.format.extent50-59
dc.identifierhttp://dx.doi.org/10.1016/S0140-6736(21)02392-8
dc.identifier.citationThe Lancet, v. 399, n. 10319, p. 50-59, 2022.
dc.identifier.doi10.1016/S0140-6736(21)02392-8
dc.identifier.issn1474-547X
dc.identifier.issn0140-6736
dc.identifier.scopus2-s2.0-85121910783
dc.identifier.urihttp://hdl.handle.net/11449/231577
dc.language.isoeng
dc.relation.ispartofThe Lancet
dc.sourceScopus
dc.titleRivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trialen
dc.typeArtigo

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