Advancing Stroke Treatment: Approval of Mechanical Thrombectomy by the Ministry of Health in Brazil

06 Dec 2023

The 24th of November of 2023 became a historical milestone for patients with stroke in Brazil. On that day, the Ministry of Health (MoH) published Order 1.996/2023, adding mechanical thrombectomy (MT) to the list of procedures covered by the Brazilian Public Health System (Sistema Único de Saúde – SUS). This achievement crowns the efforts of a tireless network of stroke neurologists and neurointerventionalists, nearly a decade after the initial spark.

In 2013, following 3 international MT negative trials, Dr. Raul Nogueira, a Brazilian stroke neurologist and neurointerventionalist based in the USA, designed a clinical trial (RESILIENT Trial) for testing MT in acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). He proposed to Dr. Sheila Martins, a Brazilian stroke neurologist, at that time, advisor of the Ministry of Health, and now, president of the WSO, to work together to implement the trial in the public health system in Brazil. Stroke was, in that time, the second cause of death and the leading cause of disability in Brazil. The MoH, who published Orders 664 and 665 one year before, which included the reimbursement of alteplase for AIS and established criteria to subsidize the implementation of stroke centers, was approached by Dr Sheila Martins for funding to this national randomized clinical trial. The MoH accepted the proposal in 2014 and negotiated with Medtronic and Penumbra to donate the devices. Concurrently, the MoH established the National Stroke Research Network, under the coordination of Dr. Octávio Marques Pontes Neto, Co-Chair of the WSO Education Committee.

Constraints in ethical and regulatory procedures delayed the trial’s commencement due to certain devices not being registered in Brazil. The 5 pivotal MT trials were published between October 2014 and April 2015, when the study was ready to start. With those results in hand, the Brazilian group, led by the Principal Investigators Sheila and Raul approached the MoH again, asking for the implementation of MT. The government was not satisfied with the findings of these studies, conducted in high-income countries, because several questions arose for this costly procedure: would the national pre-hospital delays in diagnosis, triage, and transportation, the vulnerability of our population, the low-resource in-hospital setting, the lack of access to post-procedural care and rehabilitation, and the lack of trained neurointerventionalists affect the results? Were the findings translatable for low- and middle-income countries? Was the procedure cost-effective in a public healthcare setting?

In this sense, the RESILIENT trial was demanded by the Brazilian MoH. The stroke neurologists and neurointerventionalists worked hard to reorganize and train the stroke services and the network to be prepared for the new treatment. Raul Nogueira and the President of the Brazilian Society of Neurointervention, Francisco Mont’Alverne, together with the experient neurointerventionalists Daniel Abud, Michel Frudit, Pedro Magalhães, and Leandro Barbosa provided training to the entire group for the procedure, offering 24/7 telemedicine support in real time for complex cases. The study's executive committee and working group, including Gisele Sampaio Silva, a member of the WSO Executive Board, Maramelia Miranda-Alves, Fabrício Lima, Leticia Costa Rebello, and the WSO Future Leaders Ana Claudia de Souza, and Leonardo Carbonera were available to discuss cases and assist in patient selection. The study had a special international collaboration for the Data Safe Monitoring Board (DSMB) composed by Jeff Saver, Joe Broderick, Carlos Molina, and Jamary Oliveira Filho; Clinical Events Committee composed by Diogo Hausen and Guilherme Dabus, and images adjudication by David Liebskind.

The RESILIENT trial recruited its first of 221 patients in February 2017, and the trial was terminated after the first interim analysis, as results overwhelmingly favored the MT group. The network celebrated the accomplishment: the findings were published in the New England Journal of Medicine in 2020. The extensive list of investigators that made it possible is available here. Furthermore, the procedure was proven cost-effective in a lifetime horizon in a beautiful study led by Ana Claudia de Souza.

The National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) recommended, in 2021, the incorporation of MT in SUS – promptly followed by the favorable decision of the Secretary of Science, Technology, Innovation, and Strategic Health Supplies of the MoH, to make MT available up to 24h of symptoms for patients with AIS due to LVO.

Public resources are limited, which was the main reason for the gap between the decision to implement MT and its practical implementation in SUS. The articulation with the Federal Government, led by the Brazilian Stroke Society, Brazilian Stroke Network and Brazilian Academy of Neurology, among other societies, politicians, and professionals, was critical, as well as the openness of the MoH to the dialogue. Order 1.996/2023 establishes the reimbursement standards, enables 12 public stroke centers to start offering the procedure promptly, and paves the way for additional stroke centers to submit their interest.

The legacies of the RESILIENT trial are outstanding. For the scientific field, a research network was created and is pushing forward relevant randomized clinical trials that inspire other low- and middle-income countries to do the same. In terms of populational health, it aims to substantially reduce the burden of stroke in the country and serve as inspiration to societies and governments worldwide to implement MT for AIS.

The success of the implementation of MT in SUS is a history of translation from research to practice; from impact factor to populational impact; from dream to reality.

Resources:

1. BRASIL, Ministério da Saúde. PORTARIA GM-MS Nº 1.996, DE 24 DE NOVEMBRO DE 2023.

2. BRASIL, Ministério da Saúde. PORTARIA Nº 664, DE 12 DE ABRIL DE 2012

3. BRASIL, Ministério da Saúde. PORTARIA Nº 665, DE 12 DE ABRIL DE 2012

4. Martins SO, Mont’Alverne F, Rebello LC, et al. Thrombectomy for stroke in the public health care system of Brazil. New England Journal of Medicine 2020; 382: 2316–2326.

5. de Souza AC, Martins SO, Polanczyk CA, et al. Cost-effectiveness of mechanical thrombectomy for acute ischemic stroke in Brazil: Results from the RESILIENT trial. International Journal of Stroke 2022; 17: 855–862.

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