Produção Nacional
Revisado por pares
Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trial
2023; Elsevier BV; Volume: 60; Linguagem: Inglês
10.1016/j.eclinm.2023.102004
ISSN2589-5370
AutoresÁlvaro Avezum, Haliton Alves de Oliveira, Precil Diego Miranda de Menezes Neves, Lucas Bassolli de Oliveira Alves, Alexandre Biasi Cavalcanti, Régis Goulart Rosa, Viviane Cordeiro Veiga, Luciano César Pontes Azevedo, Sérgio Luiz Zimmermann, Odílson Marcos Silvestre, Raphael Cruz Seabra Prudente, Adrian Kormann, Frederico Rafael Moreira, Ícaro Boszczowski, Edgar de Brito Sobrinho, André da Silva e Souza, Renato Seligman, Bruno de Souza Paolino, Álvaro Razuk, Audes D. M. Feitosa, Pedro Luiz Monteiro Belmonte, Priscila Freitas das Neves Gonçalves, Mauro Esteves Hernandes, Ariovaldo Leal Fagundes, José Maria Sarmet Esteves, Alexandre Pereira Tognon, John W. Eikelboom, Otávio Berwanger, Renato D. Lópes, Gustavo B.F. Oliveira,
Tópico(s)Thermal Regulation in Medicine
ResumoSummary Background COVID-19 progression is associated with an increased risk of arterial and venous thrombosis. Randomised trials have demonstrated that anticoagulants reduce the risk of thromboembolism in hospitalised patients with COVID-19, but a benefit of routine anticoagulation has not been demonstrated in the outpatient setting. Methods We conducted a randomised, open-label, controlled, multicentre study, evaluating the use of rivaroxaban in mild or moderate COVID-19 patients. Adults ≥18 years old, with probable or confirmed SARS-CoV-2 infection, presenting within ≤7 days from symptom onset with no clear indication for hospitalization, plus at least 2 risk factors for complication, were randomised 1:1 either to rivaroxaban 10 mg OD for 14 days or to routine care. The primary efficacy endpoint was the composite of venous thromboembolic events, need of mechanical ventilation, acute myocardial infarction, stroke, acute limb ischemia, or death due to COVID-19 during the first 30 days. ClinicalTrials.gov: NCT04757857. Findings Enrollment was prematurely stopped due to sustained reduction in new COVID-19 cases. From September 29th, 2020, through May 23rd, 2022, 660 patients were randomised (median age 61 [Q1-Q3 47–69], 55.7% women). There was no significant difference between rivaroxaban and control in the primary efficacy endpoint (4.3% [14/327] vs 5.8% [19/330], RR 0.74; 95% CI: 0.38–1.46). There was no major bleeding in the control group and 1 in the rivaroxaban group. Interpretation On light of these findings no decision can be made about the utility of rivaroxaban to improve outcomes in outpatients with COVID-19. Metanalyses data provide no evidence of a benefit of anticoagulant prophylaxis in outpatients with COVID-19. These findings were the result of an underpowered study, therefore should be interpreted with caution. Funding COALITION COVID-19 Brazil and Bayer S.A.
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