It is a clinical trial, from the Ministry of Health of Brazil (DECIT / SAS) in partnership with CNPq, coordinated by Hospital de Clínicas de Porto Alegre, randomized, prospective, multicentric, controlled, open, with blind outcome with sequential design. Patients with acute ischemic stroke eligible for endovascular treatment are selected for the study, who according to local guidelines are randomized into one of two treatment arms. Randomization is 1: 1 for mechanical thrombectomy with the self-expanding stent retriever approved in Brazil Solitaire FR® versus clinical treatment alone. For the primary outcome, the subjects were followed for 90 days after randomization. Simulated endovascular procedure (Sham) was not performed due to the morbidity of the arteriography and the futility and difficulty of keeping investigators blind to the allocation. Randomization was done through an internet system developed by HCPA (http://resilient.org.br/). Patients were followed up daily during the hospitalization period. Follow-up data were collected at 24 hours, 7 days (or at the time of death or hospital discharge if they occurred earlier), 90 days, 6 months and 1 year. The 90th day evaluation was conducted personally by a trained and blind team member to allocate the treatment in question. Brain imaging exams (CT or MRI) were performed according to standardized techniques at admission, in 24 hours and at a later stage. The aim of the study was to assess whether mechanical thrombectomy with stent-retriever and / or thrombus aspiration is superior to clinical treatment alone in achieving more favorable neurological evolution in 90 days in subjects presenting with acute ischemic stroke with occlusion of large vessels in anterior circulation in patients seen in the public health system. Between 2014 and 2015, 5 randomized clinical trials were published comparing mechanical thrombectomy associated with the best clinical treatment versus the best isolated clinical treatment. These studies have proven the superiority of endovascular treatment with a number necessary to treat between 3 and 7 to achieve a favorable outcome.
The RESILIENT clinical study was published this week in the New England Journal of Medicine, the world’s leading medical journal. To access the publication click here
Highlights of scientific production:
1: Pontes-Neto OM, Cougo P, Martins SC, Abud DG, Nogueira RG, Miranda M, Castro-Afonso LH, Rebello LC, Caldas JG, Bazan R, Bezerra DC, Rezende MT, Freitas GR, Longo A, Magalhães P, Carvalho JJ, Montalverne FJ, Lima FO, Andrade GH, Massaro AR, Oliveira-Filho J, Gagliardi R, Silva GS. Brazilian guidelines for endovascular treatment of patients with acute ischemic stroke. Arq Neuropsiquiatr. 2017 Jan;75(1):50-56. doi: 10.1590/0004-282X20160174. PubMed PMID: 28099563.
Link: http://www.scielo.br/pdf/anp/v75n1/0004-282X-anp-75-01-0050.pdf
2: Martins SO, Mont’Alverne F, Rebello LC, Abud DG, Silva GS, Lima FO, Parente BSM, Nakiri GS, Faria MB, Frudit ME, Carvalho JF, Waihrich Eduardo, Fiorot JA, Cardoso FB, Hidalgo RCT, Zétola VF, Carvalho FM, Souza AC, Dias FA, Bandeira D, Alves MM, Wagner MB, Carbonera LA, Oliveira-Filho J, Bezerra DC, Liebeskind DS, Broderick J, Molina CA, Passos JEF, Saver JL, OM Pontes-Neto, Nogueira RG. Thrombectomy for Stroke in the Public Health Care System of Brazil. New England Journal of Medicine. 2020 Jun; 382:2316-2326. doi : 10.1056/NEJMoa2000120
Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2000120