Sheila O Martins1, Francisco Mont'Alverne1, Letícia C Rebello1, Daniel G Abud1, Gisele S Silva1, Fabrício O Lima1, Bruno S M Parente1, Guilherme S Nakiri1, Mário B Faria1, Michel E Frudit1, João J F de Carvalho1, Eduardo Waihrich1, José A Fiorot1, Fabrício B Cardoso1, Raquel C T Hidalgo1, Viviane F Zétola1, Fernanda M Carvalho1, Ana C de Souza1, Francisco A Dias1, Diego Bandeira1, Maramélia Miranda Alves1, Mário B Wagner1, Leonardo A Carbonera1, Jamary Oliveira-Filho1, Daniel C Bezerra1, David S Liebeskind1, Joseph Broderick1, Carlos A Molina1, José E Fogolin Passos1, Jeffrey L Saver1, Octávio M Pontes-Neto1, Raul G Nogueira1. 1. From the Departments of Neurology (S.O.M., A.C.S., L.A.C.), Interventional Neuroradiology (M.B.F.), and Social Medicine (M.B.W.), Federal University of Rio Grande do Sul, and Hospital de Clínicas de Porto Alegre (S.O.M., A.C.S., L.A.C., M.B.W.), Porto Alegre, the Departments of Interventional Neuroradiology (F.M.A., D.B.) and Neurology (F.O.L., J.J.F.C., F.M.C., D.B.), Hospital Geral de Fortaleza, and the Department of Post-Graduate Medical Sciences, University of Fortaleza, Fortaleza (F.M.C.), the Departments of Neurology (L.C.R.) and Neurosurgery (B.S.M.P., E.W.), Instituto Hospital de Base do Distrito Federal, Brasilia, the Stroke Neurology Division, Departments of Interventional Neuroradiology (D.G.A., G.S.N.) and Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, the Departments of Neurology (G.S.S., M.M.A.) and Interventional Neuroradiology (M.E.F.), Universidade Federal de São Paulo and Academic Research Organization, Hospital Israelita Albert Einstein (G.S.S.), the Department of Neurology, Universidade Estadual de Campinas (F.B.C.), and the Department of Neurology and Interventional Neuroradiology, Hospital de Base de São José do Rio Preto (R.C.T.H.), São Paulo, the Department of Neurology, Hospital Estadual Central de Vitória, Vitória (J.A.F.), the Department of Neurology, Universidade Federal do Paraná, Curitiba (V.F.Z.), the Postgraduate Program in Health Sciences, Federal University of Bahia School of Medicine, Salvador (J.O.-F.), the Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro (D.C.B.), and Administrative Director of the National Council of Municipal Health Secretariats, Bauru (J.E.F.P.) - all in Brazil; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (D.S.L., J.L.S.); the Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati (J.B.); the Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona (C.A.M.); and the Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University School of Medicine, Atlanta (R.G.N.).
Abstract
BACKGROUND: Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries. METHODS: We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. RESULTS: A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P = 0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group. CONCLUSIONS: In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.).
RCT Entities:
BACKGROUND: Randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion. These trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries. METHODS: We studied the safety and efficacy of thrombectomy in the public health system of Brazil. In 12 public hospitals, patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. RESULTS: A total of 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; P = 0.001), favoring thrombectomy. The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6). Asymptomatic intracranial hemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group; symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group. CONCLUSIONS: In this randomized trial conducted in the public health care system of Brazil, endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone. (Funded by the Brazilian Ministry of Health; RESILIENT ClinicalTrials.gov number, NCT02216643.).
Authors: Peter B Sporns; Heather J Fullerton; Sarah Lee; Helen Kim; Warren D Lo; Mark T Mackay; Moritz Wildgruber Journal: Nat Rev Dis Primers Date: 2022-02-24 Impact factor: 52.329