July 31, 2017
e-ASPECTS in thrombectomy trial in Brazil
Oxford – The only mechanical thrombectomy trial in a developing country is currently taking place in Brazil and it is being ably assisted by e-ASPECTS, which is being used to select those patients who are eligible for the treatment.
Accurate assessment of eligibility is vital because thrombectomy is only effective for patients who have ASPECTS scores of six or more within a 6-hour window. The stroke also needs to be confirmed as a large vessel occlusion by using CT angiography. This reproduces international recommendations.
Called RESILIENT, this three-year long randomized clinical trial has been initiated by the Ministry of Health and coordinated by the Hospital de Clinicas of Porto Alegre. Total recruitment is projected to be 690 patients in 15 hospitals.
It is hoped RESILIENT will prove that thrombectomy treatment for patients suffering from ischemic stroke with large vessel occlusion is effective and feasible in the public system.
Financial and logistical feasibility is an important part of a study in a country whose hospitals are challenged to offer the same treatments, technological platforms and human resource levels as those in more developed countries.
Some of the challenges Brazilian stroke healthcare faces are: purchase of expensive medical devices and the immediate availability of specialized interventional neuroradiologists and stroke physicians.
There are more than 400,000 strokes each year in Brazil with a population of 211 million. Stroke is the most common cause of disability and the second most common reason for death.
The principal Investigator for RESILIENT and the Technical Advisor to the Ministry of Health Dr Sheila Christina Ouriques Martins, from the Hospital de Clinicas de Porto Alegre. said “This trial is of great importance for Brazil and for developing countries because it will help us study the viability for its implementation. Previous randomized clinical trials have shown that thrombectomy in ischemic stroke decreases mortality and disabilities, but all these studies have been conducted in developed countries. The logistics in Brazil are difficult. We need experienced neuro-interventionists available 24x7. The RESILIENT trial was designed to evaluate not only whether thrombectomy is effective, but also whether it is feasible and cost effective for a public hospital in Brazil.”
Brainomix CEO and co-founder, Dr Michalis Papadakis said: “We are excited to be involved in this trial whose results will have significant implications for stroke healthcare in Brazil. If the results are positive, e-ASPECTS will be an important part of clinical practice in Brazil for selecting patients who are likely to benefit from mechanical thrombectomy.
The Secretary of Health of the Espírito Santo state published the following about e-ASPECTS in the Hospital Estadual Central (HEC), one of RESILIENT trial participants.