| Grant number: | 16/15236-8 |
| Support Opportunities: | Research Grants - Research in Public Policies for the National Health Care System (PP-SUS) |
| Start date: | December 01, 2016 |
| End date: | May 31, 2019 |
| Field of knowledge: | Health Sciences - Medicine - Medical Clinics |
| Agreement: | CNPq - PPSUS |
| Principal Investigator: | Octávio Marques Pontes-Neto |
| Grantee: | Octávio Marques Pontes-Neto |
| Host Institution: | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP (HCMRP). Secretaria da Saúde (São Paulo - Estado). Ribeirão Preto , SP, Brazil |
| Associated researchers: | Daniel Giansante Abud ; Francisco Antunes Dias ; Gisele Sampaio Silva ; João Pereira Leite ; Karina Tavares Weber ; Millene Rodrigues Camilo ; Rodrigo Bazan ; Sheila Cristina Ouriques Martins ; Taiza Elaine Grespan Santos Edwards |
Abstract
Stroke is the leading cause of disability and second most common cause of mortality worldwide. In Brazil, stroke has an estimated annual rate of 400.000 new cases each year with more than 100.000 deaths per year, and it is also the second most common cause of mortality in the country. Ischemic stroke represents 80% of all cases and it is due to occlusion of an intracranial artery. Among ischemic stroke patients, those with a basilar artery occlusion - a posterior circulation major vessel - have the most severe clinical profile and worst functional prognosis, frequently presenting with coma, locked-in state and death. Great recent advances in ischemic stroke treatment have been incorporated to clinical practice in last two decades, especially acute recanalization therapies. There are at least two acute stroke arterial recanalization treatments available supported by good quality randomized controlled trials: a. Intravenous thrombolysis with recombinant tissue plasminogen activator (TPA) within 4.5 hours of symptoms onset. b. Endovascular therapy (mechanical thrombectomy) with use of stent retrievers in proximal anterior circulation artery occlusion patients within 6 hours of symptoms onset. Several trials have evaluated intravenous thrombolysis in the first hours of symptoms onset of an ischemic stroke. In summary, these trials had shown that patients treated with intravenous thrombolysis with TPA within 4.5 hours of symptoms onset obtain less disability at 90 days despite a higher symptomatic intracranial hemorrhage rate, which is not related with elevated death rates. In this scenario, it is crucial to emphasize that most of intravenous thrombolysis studies have included indistinctly both anterior and posterior circulation stroke patients, and then these trials results may be extrapolated for treatment of basilar occlusion patients. Thus, intravenous thrombolysis with TPA is currently the recanalization strategy considered the gold standard for ischemic stroke treatment. In recent years, 5 randomized controlled trials including stroke patients with proximal arterial occlusion of the anterior circulation have been concluded and published. These trials have demonstrated a dramatic benefit of endovascular treatment with stent retrievers within 6 hours of symptoms onset when compared to medical management alone usually including intravenous thrombolysis. However, none of these trials included patients with stroke in the posterior circulation. In fact, patients with basilar occlusion were excluded from the trials purposely, since they have a very different clinical course from proximal anterior circulation occlusion patients. Therefore, it is still uncertain if endovascular treatment (intra-arterial thrombolysis or mechanical thrombectomy) when associated with current best medical management is safe and could result in additional benefit to functional prognosis in BAO patients. This is the major focus of the present study. BASICS is an international, multicenter, open label, academic, investigator-initiated randomized controlled phase III trial, with blind assessments (PROBE design) aiming to answer a key question regarding eligible patients for recanalization therapies in acute phase of an ischemic stroke secondary to basilar artery occlusion: does endovascular treatment improve functional outcome in a safe and cost effective way when to best medical management in BAO patients safer and with better efficacy compared to best medical management alone? BASICS is a randomised, multi-centre, open label, controlled phase III, treatment trial. Patients, aged 18 through 85 years, with CTA or MRA confirmed basilar occlusion treated with IVT will be randomised between additional IAT followed by maximum supportive care versus maximum supportive care alone. IVT has to be initiated within 4.5 hours from estimated time of basilar artery occlusion and IAT within 6 hours. Then main study endpoints are favourable outcome at 90 days (AU)
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