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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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العنوان: 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
المؤلفون: Estêvão Lanna Figueiredo, Dario Rafael Abregu Diaz, Alexandre Biasi Cavalcanti, Aline de Oliveira Twardowsky, Alexandre de Matos Soeiro, Marianna Deway Andrade Dracoulakis, Renato D. Lopes, Vinicius Santana Nunes, Anne Cristine Silva Fernandes, Júlia de Aveiro Morata, Mauro E. Hernandes, Gilson Soares Feitosa-Filho, Manoel Fernandes Canesin, Lilia Nigro Maia, Vicente C.S. Dantas, Viviane C Veiga, Ana Thereza Rocha, Otavio Gebara, Remo H.M. Furtado, Lilian Mazza Barbosa, Sueli V Santos, Leonardo Meira de Faria, Lorena Souza Viana, Aryadne Lyrio de Oliveira, Flávia Ribeiro Machado, Idelzuíta Leandro Liporace, Diego Aparecido Rios Queiroz, Fernando Carvalho Neuenschwander, Regis Goulart Rosa, Mariana Silveira de Alcântara Chaud, Livia Maria Garcia Melro, Ariane Vieira Scarlatelli Macedo, Patrícia O. Guimarães, Priscilla de Aquino Martins, John H. Alexander, Eduardo Ramacciotti, Luiz Eduardo Fonteles Ritt, Alvaro Avezum, Luciano Cesar Pontes Azevedo, Lucas Tramujas, Luciana Armaganijan, Rodolfo Godinho Souza Dourado Lima, Bruna Bronhara, Germano Emílio Conceição-Souza, Marcelo Basso Gazzana, Pedro Gabriel Melo de Barros e Silva, Otavio Berwanger, Lucas P. Damiani
المساهمون: Duke University Medical Center, Brazilian Clinical Research Institute, HCor Research Institute, Hospital Samaritano Paulista, Hospital Israelita Albert Einstein, Universidade de São Paulo (USP), Science Valley Research Institute, Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Hospital Estadual Dr Jayme Santos Neves, Hospital Cárdio Pulmonar, Escola Bahiana de Medicina, Universidade Federal da Bahia (UFBA), Hospital Vera Cruz, Hospital Da Bahia, Hospital Naval Marcílio Dias, Hospital Santa Paula, Santa Casa de Misericórdia de Votuporanga, Universidade Estadual Paulista (UNESP), Brazilian Research in Intensive Care Network, BP—A Beneficência Portuguesa de São Paulo, Universidade Estadual de Londrina (UEL), Hospital Felício Rocho, Santa Casa de Misericórdia da Bahia–Hospital Santa Izabel, Centro Universitário Faculdade de Tecnologia e Ciências, Hospital Moinhos de Vento, Instituto Dante Pazzanese de Cardiologia, Hospital de Amor de Barretos (Pio XII), Hospital de Base de São José do Rio Preto, Instituto Socrates Guanaes, Hospital Sírio Libanês Research and Education Institute, Hospital Alemão Oswaldo Cruz
المصدر: Lancet (London, England)
Scopus
Repositório Institucional da UNESP
Universidade Estadual Paulista (UNESP)
instacron:UNESP
سنة النشر: 2021
مصطلحات موضوعية: Adult, Male, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Endpoint Determination, Population, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Rivaroxaban, Elevated D-dimer, law, Internal medicine, Correspondence, medicine, Humans, 030212 general & internal medicine, Enoxaparin, education, Blood Coagulation, Aged, education.field_of_study, business.industry, Heparin, SARS-CoV-2, Anticoagulants, COVID-19, Articles, General Medicine, Middle Aged, Patient Discharge, COVID-19 Drug Treatment, Hospitalization, Treatment Outcome, Relative risk, Female, Open label, business, Brazil, medicine.drug
الوصف: Made available in DSpace on 2022-04-29T08:29:34Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-06-12 Background: 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. Duke Clinical Research Institute Duke University Medical Center Brazilian Clinical Research Institute HCor Research Institute Hospital Samaritano Paulista Academic Research Organization Hospital Israelita Albert Einstein Instituto do Coração Universidade de São Paulo Instituto do Câncer do Estado de São Paulo Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo Science Valley Research Institute Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center Hospital Estadual Dr Jayme Santos Neves Hospital Cárdio Pulmonar Escola Bahiana de Medicina Universidade Federal da Bahia Hospital Vera Cruz Hospital Da Bahia Hospital Naval Marcílio Dias Hospital Santa Paula Santa Casa de Misericórdia de Votuporanga Hospital das Clínicas da Faculdade de Medicina de Botucatu Brazilian Research in Intensive Care Network BP—A Beneficência Portuguesa de São Paulo Hospital Universitário da Universidade Estadual de Londrina Hospital Felício Rocho Santa Casa de Misericórdia da Bahia–Hospital Santa Izabel Centro Universitário Faculdade de Tecnologia e Ciências Hospital Moinhos de Vento Instituto Dante Pazzanese de Cardiologia Hospital de Amor de Barretos (Pio XII) Hospital de Base de São José do Rio Preto Anesthesiology Pain and Intensive Care Department Federal University of São Paulo Instituto Socrates Guanaes Hospital Sírio Libanês Research and Education Institute International Research Center Hospital Alemão Oswaldo Cruz Hospital das Clínicas da Faculdade de Medicina de Botucatu
تدمد: 1474-547X
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5bfabd0d574887435b7d90aaad9e1ccc
https://pubmed.ncbi.nlm.nih.gov/34627488
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....5bfabd0d574887435b7d90aaad9e1ccc
قاعدة البيانات: OpenAIRE
الوصف
تدمد:1474547X