June 11, 2020
Thrombectomy for Stroke Studied in the Public Health Care System of Brazil
June 11, 2020—In a randomized trial conducted in the public health care system of Brazil, investigators concluded that endovascular treatment within 8 hours after the onset of stroke symptoms in conjunction with standard care resulted in better functional outcomes at 90 days than standard care alone.
Findings from the RESILIENT study, which was funded by the Brazilian Ministry of Health, were published by Sheila O. Martins, MD, et al in The New England Journal of Medicine (NEJM; 2020;382:2316-2326).
The background of the study is that randomized trials involving patients with stroke have established that outcomes are improved with the use of thrombectomy for large-vessel occlusion; however, these trials were performed in high-resource countries and have had limited effects on medical practice in low- and middle-income countries.
As summarized in NEJM, the RESILIENT study of the safety and efficacy of thrombectomy was conducted at 12 public hospitals and enrolled 300 patients with a proximal intracranial occlusion in the anterior circulation that could be treated within 8 hours after the onset of stroke symptoms. The patients 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.
Of the 300 patients, 79 had undergone thrombectomy during an open-label roll-in period. A total of 300 patients were enrolled. Approximately 70% in the two groups received intravenous alteplase. The trial was stopped early because of efficacy when 221 of a planned 690 patients had undergone randomization (111 to the thrombectomy group and 110 to the control group). The common odds ratio for a better distribution of scores on the modified Rankin scale at 90 days was 2.28 (95% CI, 1.41-3.69; P = .001), favoring thrombectomy.
In NEJM, the investigators reported the following for patients in the thrombectomy group versus the control group:
- The percentage of patients with a score on the modified Rankin scale of 0 to 2, signifying an absence of or minor neurologic deficit, was 35.1% versus 20% (difference, 15.1 percentage points; 95% CI, 2.6-27.6).
- Asymptomatic intracranial hemorrhage occurred in 51.4% versus 24.5% of patients.
- Symptomatic intracranial hemorrhage occurred in 4.5% of the patients in each group.