Raul G Nogueira1, Fabricio O Lima2,3, Octávio M Pontes-Neto4, Gisele S Silva5,6, Francisco José Mont'Alverne7, Daniel G Abud8, Michel Frudit9, Paulo Passos10, Diogo C Haussen1, Guilherme Dabus11, Gabriel R de Freitas12, Jamary Oliveira-Filho13, Daniel C Bezerra14, David S Liebeskind15, Mario B Wagner16, José Ef Passos17, Carlos A Molina18, Joseph Broderick19, Jeffrey L Saver15, Sheila O Martins10,20. 1. Department of Neurology, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, 12239Emory University School of Medicine, Atlanta, GA, USA. 2. Neurology Service, 365090Hospital Geral de Fortaleza, Fortaleza-CE, Brazil. 3. Department of Neurology, 28128Universidade de Fortaleza, Fortaleza-CE, Brazil. 4. Stroke Service-Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil. 5. Neurology and Neurosurgery Department, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil. 6. Academic Research Organization, 37896Hospital Israelita Albert Einstein São Paulo, São Paulo, Brazil. 7. Neurointerventional Radiology Service, 365090Hospital Geral de Fortaleza, Fortaleza-CE, Brazil. 8. Department of Internal Medicine, Radiology Division, Hospital das Clínicas-Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Sao Paulo, Brazil. 9. Neurointerventional Radiology Service, Federal University of São Paulo, São Paulo, Brazil. 10. 156417Hospital Moinhos de Vento, Porto Alegre, Brazil. 11. Miami Cardiac and Vascular Institute and Baptist Neuroscience Center, Miami, FL, USA. 12. 519983D'Or Institute for Research and Education, 28110Universidade Federal Fluminense, Rio de Janeiro, Brazil. 13. Postgraduate Program in Health Sciences, 28111Federal University of Bahia School of Medicine, Salvador, BA, Brazil. 14. Department of Neurology, Hospital Pró-Cardíaco, Rio de Janeiro, Brazil. 15. Department of Neurology and Comprehensive Stroke Center, 8783University of California Los Angeles David Geffen School of Medicine, Los Angeles, CA, USA. 16. School of Medicine, 28124Federal University of Rio Grande do Sul, Porto Alegre, Brazil. 17. Administrative Director of the National Council of Municipal Health Secretariats, Bauru, São Paulo. 18. Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain. 19. Department of Neurology and Rehabilitation Medicine, 12303University of Cincinnati College of Medicine, Cincinnati, OH, USA. 20. Neurology Service, Hospital de Clínicas de Porto Alegre, 28124Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
Abstract
BACKGROUND: RESILIENT is a prospective, multicenter, randomized phase III trial to test the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone in patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country. METHODS: Subjects must fulfill the following main inclusion criteria: symptom onset ≤8 h, age ≥18 years, baseline NIHSS ≥8, evidence of intracranial ICA or proximal MCA (M1 segment) occlusion, ASPECTS ≥6 on CT or >5 on DWI-MRI and be either ineligible for or unresponsive to intravenous alteplase. The primary end-point is the distribution of disability levels (on the modified Rankin Scale, mRS) at 90 days under the intention-to-treat principle. RANDOMIZATION: Randomization is performed under a minimization process using age, baseline NIHSS, intravenous alteplase use, occlusion site and center. DESIGN: The trial is designed with an expectation of a 10% difference in the proportion of favorable outcome (mRS 0-2 at 90 days) common odds ratio of 1.615. PRIMARY OUTCOME: Projected sample size is 690 subjects with pre-planned interim analyses at 174, 346, and 518 subjects. SECONDARY OUTCOMES: Secondary end-points include: 90-day functional independence (mRS ≤2), mRS shift stratified for treatment with IV rt-PA at 90 days, infarct volume on 24 h CT or MRI, early dramatic response (NIHSS 0-2 or improvement ≥8 points) at 24 h, vessel recanalization evaluated by CTA or MRA at 24 h, and the post-procedure rate of successful reperfusion (defined as a modified Treatment in Cerebral Infarction 2b or greater). Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage at 24 h and procedure-related complications.
RCT Entities:
BACKGROUND: RESILIENT is a prospective, multicenter, randomized phase III trial to test the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone in patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country. METHODS: Subjects must fulfill the following main inclusion criteria: symptom onset ≤8 h, age ≥18 years, baseline NIHSS ≥8, evidence of intracranial ICA or proximal MCA (M1 segment) occlusion, ASPECTS ≥6 on CT or >5 on DWI-MRI and be either ineligible for or unresponsive to intravenous alteplase. The primary end-point is the distribution of disability levels (on the modified Rankin Scale, mRS) at 90 days under the intention-to-treat principle. RANDOMIZATION: Randomization is performed under a minimization process using age, baseline NIHSS, intravenous alteplase use, occlusion site and center. DESIGN: The trial is designed with an expectation of a 10% difference in the proportion of favorable outcome (mRS 0-2 at 90 days) common odds ratio of 1.615. PRIMARY OUTCOME: Projected sample size is 690 subjects with pre-planned interim analyses at 174, 346, and 518 subjects. SECONDARY OUTCOMES: Secondary end-points include: 90-day functional independence (mRS ≤2), mRS shift stratified for treatment with IV rt-PA at 90 days, infarct volume on 24 h CT or MRI, early dramatic response (NIHSS 0-2 or improvement ≥8 points) at 24 h, vessel recanalization evaluated by CTA or MRA at 24 h, and the post-procedure rate of successful reperfusion (defined as a modified Treatment in Cerebral Infarction 2b or greater). Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage at 24 h and procedure-related complications.