After receiving a standing ovation when presented at the European Stroke Organisation Conference (ESOC; 22–24 May, Milan, Italy) last year, the final results of RESILIENT have now been published in The New England Journal of Medicine.
The trial showed that among patients in the public healthcare system of Brazil who were treated within eight hours after a stroke due to a proximal occlusion in the anterior circulation, 90-day functional outcomes were better with thrombectomy plus standard care than with standard care alone. Specifically, the percentage of patients with a score on the modified Rankin Scale (mRS) 0–2 was 35.1% in the thrombectomy group, and 20% in the control.
Regarding safety outcomes, asymptomatic intracranial haemorrhage occurred in 51.4% of the patients in the thrombectomy group and 24.5% of those in the control group, while symptomatic intracranial haemorrhage occurred in 4.5% of the patients in each group.
“All previous randomised clinical trials of mechanical thrombectomy were performed in high-income countries, and for that reason, have minimal to no impact over the public healthcare policies of low- and mid-income countries,” Raul Nogueira, Grady Memorial Hospital, Atlanta, USA, tells NeuroNews. Nogueira, alongside Sheila Martins (Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil) is a principal investigator of the trial.
He adds that across the entirety of Latin America, there is only one thrombectomy-capable programme (in Santiago, Chile), currently being funded by a federal government. “This is the same reality of most of the developing countries around the world; thrombectomy is only available to those who can afford paying for private insurance or the treatment itself,” he says.
However, despite the highly positive results of the previous thrombectomy trials published in 2015, Nogueira disclosed that the Brazilian Government deemed the cost of thrombectomy too high, and its cost-effectiveness unproven. Yet, the country agreed to fund a clinical trial to assess whether incorporation of the treatment into the Brazilian Universal Public Healthcare System would be beneficial.
“The RESILIENT investigators hope that their study will not bring a life-changing treatment to the over 80% of Brazilians that cannot afford private health insurance,” Nogueira adds, as he tells the newspaper that he hopes the findings will influence governmental decisions across many other countries facing similar challenges in their public healthcare system.
The trial itself studied the safety and efficacy of thrombectomy in 12 public hospitals in Brazil. Patients with a proximal intracranial occlusion in the anterior circulation that could be treated within eight hours after the onset of stroke symptoms were randomly assigned in a 1:1 ratio to receive standard care plus mechanical thrombectomy (thrombectomy group) or standard care alone (control group). The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days.
In total, 300 patients were enrolled, including 79 who had undergone thrombectomy during an open-label roll-in period. Approximately 70% in the two groups received intravenous alteplase.
According to the authors, the trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomisation (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on mRS at 90 days was 2.28 (95% confidence interval [CI], 1.41 to 3.69; p=0.001), favouring thrombectomy. Again, the percentage of patients with an mRS score 0–2, signifying an absence of or minor neurologic deficit, was 35.1% in the thrombectomy group and 20.0% in the control group (difference, 15.1 percentage points; 95% CI, 2.6 to 27.6).