Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial

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Autor(es): dc.contributorDuke University Medical Center-
Autor(es): dc.contributorBrazilian Clinical Research Institute-
Autor(es): dc.contributorHCor Research Institute-
Autor(es): dc.contributorHospital Samaritano Paulista-
Autor(es): dc.contributorHospital Israelita Albert Einstein-
Autor(es): dc.contributorUniversidade de São Paulo (USP)-
Autor(es): dc.contributorScience Valley Research Institute-
Autor(es): dc.contributorHemostasis & Thrombosis Research Laboratories at Loyola University Medical Center-
Autor(es): dc.contributorHospital Estadual Dr Jayme Santos Neves-
Autor(es): dc.contributorHospital Cárdio Pulmonar-
Autor(es): dc.contributorEscola Bahiana de Medicina-
Autor(es): dc.contributorUniversidade Federal da Bahia (UFBA)-
Autor(es): dc.contributorHospital Vera Cruz-
Autor(es): dc.contributorHospital Da Bahia-
Autor(es): dc.contributorHospital Naval Marcílio Dias-
Autor(es): dc.contributorHospital Santa Paula-
Autor(es): dc.contributorSanta Casa de Misericórdia de Votuporanga-
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.contributorBrazilian Research in Intensive Care Network-
Autor(es): dc.contributorBP—A Beneficência Portuguesa de São Paulo-
Autor(es): dc.contributorUniversidade Estadual de Londrina (UEL)-
Autor(es): dc.contributorHospital Felício Rocho-
Autor(es): dc.contributorSanta Casa de Misericórdia da Bahia–Hospital Santa Izabel-
Autor(es): dc.contributorCentro Universitário Faculdade de Tecnologia e Ciências-
Autor(es): dc.contributorHospital Moinhos de Vento-
Autor(es): dc.contributorInstituto Dante Pazzanese de Cardiologia-
Autor(es): dc.contributorHospital de Amor de Barretos (Pio XII)-
Autor(es): dc.contributorHospital de Base de São José do Rio Preto-
Autor(es): dc.contributorInstituto Socrates Guanaes-
Autor(es): dc.contributorHospital Sírio Libanês Research and Education Institute-
Autor(es): dc.contributorHospital Alemão Oswaldo Cruz-
Autor(es): dc.creatorLopes, Renato D-
Autor(es): dc.creatorde Barros e Silva, Pedro Gabriel Melo-
Autor(es): dc.creatorFurtado, Remo H M-
Autor(es): dc.creatorMacedo, Ariane Vieira Scarlatelli-
Autor(es): dc.creatorBronhara, Bruna-
Autor(es): dc.creatorDamiani, Lucas Petri-
Autor(es): dc.creatorBarbosa, Lilian Mazza-
Autor(es): dc.creatorde Aveiro Morata, Júlia-
Autor(es): dc.creatorRamacciotti, Eduardo-
Autor(es): dc.creatorde Aquino Martins, Priscilla-
Autor(es): dc.creatorde Oliveira, Aryadne Lyrio-
Autor(es): dc.creatorNunes, Vinicius Santana-
Autor(es): dc.creatorRitt, Luiz Eduardo Fonteles-
Autor(es): dc.creatorRocha, Ana Thereza-
Autor(es): dc.creatorTramujas, Lucas-
Autor(es): dc.creatorSantos, Sueli V-
Autor(es): dc.creatorDiaz, Dario Rafael Abregu-
Autor(es): dc.creatorViana, Lorena Souza-
Autor(es): dc.creatorMelro, Lívia Maria Garcia-
Autor(es): dc.creatorde Alcântara Chaud, Mariana Silveira-
Autor(es): dc.creatorFigueiredo, Estêvão Lanna-
Autor(es): dc.creatorNeuenschwander, Fernando Carvalho-
Autor(es): dc.creatorDracoulakis, Marianna Deway Andrade-
Autor(es): dc.creatorLima, Rodolfo Godinho Souza Dourado-
Autor(es): dc.creatorde Souza Dantas, Vicente Cés-
Autor(es): dc.creatorFernandes, Anne Cristine Silva-
Autor(es): dc.creatorGebara, Otávio Celso Eluf-
Autor(es): dc.creatorHernandes, Mauro Esteves-
Autor(es): dc.creatorQueiroz, Diego Aparecido Rios-
Autor(es): dc.creatorVeiga, Viviane C-
Autor(es): dc.creatorCanesin, Manoel Fernandes-
Autor(es): dc.creatorde Faria, Leonardo Meira-
Autor(es): dc.creatorFeitosa-Filho, Gilson Soares-
Autor(es): dc.creatorGazzana, Marcelo Basso-
Autor(es): dc.creatorLiporace, Idelzuíta Leandro-
Autor(es): dc.creatorde Oliveira Twardowsky, Aline-
Autor(es): dc.creatorMaia, Lilia Nigro-
Autor(es): dc.creatorMachado, Flávia Ribeiro-
Autor(es): dc.creatorde Matos Soeiro, Alexandre-
Autor(es): dc.creatorConceição-Souza, Germano Emílio-
Autor(es): dc.creatorArmaganijan, Luciana-
Autor(es): dc.creatorGuimarães, Patrícia O-
Autor(es): dc.creatorRosa, Regis G-
Autor(es): dc.creatorAzevedo, Luciano C P-
Autor(es): dc.creatorAlexander, John H-
Autor(es): dc.creatorAvezum, Alvaro-
Autor(es): dc.creatorCavalcanti, Alexandre B-
Autor(es): dc.creatorBerwanger, Otavio-
Data de aceite: dc.date.accessioned2025-08-21T16:26:22Z-
Data de disponibilização: dc.date.available2025-08-21T16:26:22Z-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2022-04-29-
Data de envio: dc.date.issued2021-06-12-
Fonte completa do material: dc.identifierhttp://dx.doi.org/10.1016/S0140-6736(21)01203-4-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/228961-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/228961-
Descrição: dc.descriptionBackground: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. Methods: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3–0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. Findings: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59–1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61–8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. Interpretation: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. Funding: Coalition COVID-19 Brazil, Bayer SA.-
Descrição: dc.descriptionDuke Clinical Research Institute Duke University Medical Center-
Descrição: dc.descriptionBrazilian Clinical Research Institute-
Descrição: dc.descriptionHCor Research Institute-
Descrição: dc.descriptionHospital Samaritano Paulista-
Descrição: dc.descriptionAcademic Research Organization Hospital Israelita Albert Einstein-
Descrição: dc.descriptionInstituto do Coração Universidade de São Paulo-
Descrição: dc.descriptionInstituto do Câncer do Estado de São Paulo Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo-
Descrição: dc.descriptionScience Valley Research Institute-
Descrição: dc.descriptionHemostasis & Thrombosis Research Laboratories at Loyola University Medical Center-
Descrição: dc.descriptionHospital Estadual Dr Jayme Santos Neves-
Descrição: dc.descriptionHospital Cárdio Pulmonar-
Descrição: dc.descriptionEscola Bahiana de Medicina-
Descrição: dc.descriptionUniversidade Federal da Bahia-
Descrição: dc.descriptionHospital Vera Cruz-
Descrição: dc.descriptionHospital Da Bahia-
Descrição: dc.descriptionHospital Naval Marcílio Dias-
Descrição: dc.descriptionHospital Santa Paula-
Descrição: dc.descriptionSanta Casa de Misericórdia de Votuporanga-
Descrição: dc.descriptionHospital das Clínicas da Faculdade de Medicina de Botucatu-
Descrição: dc.descriptionBrazilian Research in Intensive Care Network-
Descrição: dc.descriptionBP—A Beneficência Portuguesa de São Paulo-
Descrição: dc.descriptionHospital Universitário da Universidade Estadual de Londrina-
Descrição: dc.descriptionHospital Felício Rocho-
Descrição: dc.descriptionSanta Casa de Misericórdia da Bahia–Hospital Santa Izabel-
Descrição: dc.descriptionCentro Universitário Faculdade de Tecnologia e Ciências-
Descrição: dc.descriptionHospital Moinhos de Vento-
Descrição: dc.descriptionInstituto Dante Pazzanese de Cardiologia-
Descrição: dc.descriptionHospital de Amor de Barretos (Pio XII)-
Descrição: dc.descriptionHospital de Base de São José do Rio Preto-
Descrição: dc.descriptionAnesthesiology Pain and Intensive Care Department Federal University of São Paulo-
Descrição: dc.descriptionInstituto Socrates Guanaes-
Descrição: dc.descriptionHospital Sírio Libanês Research and Education Institute-
Descrição: dc.descriptionInternational Research Center Hospital Alemão Oswaldo Cruz-
Descrição: dc.descriptionHospital das Clínicas da Faculdade de Medicina de Botucatu-
Formato: dc.format2253-2263-
Idioma: dc.languageen-
Relação: dc.relationThe Lancet-
???dc.source???: dc.sourceScopus-
Título: dc.titleTherapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial-
Tipo de arquivo: dc.typelivro digital-
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