麻豆传媒

The benefits of stroke thrombectomy could be reproduced in a resource-limited healthcare system, a randomized trial in Brazil showed.

Within the public health system there, adding endovascular treatment to standard care for large vessel occlusion strokes resulted in less disability as shown by a better distribution of modified Rankin scale (mRS) scores at 90 days (common OR 2.28, 95% CI 1.41-3.69).

Moreover, 35.1% of thrombectomy recipients had good outcomes (0-2 mRS scores) at that point, compared with 20.0% of controls receiving standard care alone (difference 15.1 percentage points, 95% CI 2.6-27.6), reported Raul Nogueira, MD, of Grady Memorial Hospital in Atlanta, and collaborators.

Rates of 90-day mortality were 24.3% and 30.0% for the thrombectomy and control arms (HR 0.73, 95% CI 0.45-1.19), the group reported in their paper .

"While there was a lower overall likelihood of good outcome and higher mortality rates as compared to previous trials in high-income countries, the overall benefit of thrombectomy as shown on the shift across all modified Rankin Scale scores was similar," commented Amrou Sarraj, MD, of UTHealth McGovern Medical School in Houston.

"Additionally, the likelihood of achieving functional independence largely mirrored the MR CLEAN trial," according to Sarraj.

And that was despite differences at every step of stroke care compared with the high-income countries where trials were conducted, Nogueira's group noted.

Lack of such confirmatory data from developing nations might have been one reason that "[d]espite its apparent efficacy, the use of thrombectomy has remained limited in many regions of the world or has been delayed in adoption," Nogueira's group wrote.

"Further work is still needed in these countries to bridge the remaining gaps, but the results help further open the doors for millions of people with limited healthcare system resources to receive this life-saving treatment. It is a major step in the right direction in these countries," Sarraj told 麻豆传媒.

The represented a collaborative effort by the Brazilian government and academic physicians to evaluate whether the treatment should be incorporated into the country's Universal Public Health Care System. In Brazil, thrombectomy costs over $8,000 more per patient upfront than medical therapy alone.

The study randomized acute stroke patients to standard care with or without thrombectomy at 18 Brazilian sites in 2017-2019 -- well before the . Participants had to have a proximal intracranial occlusion in the anterior circulation and be treated within 8 hours of symptom onset.

From 20 sites initially considered for the trial, 12 certified stroke centers ended up making the cut and participating. Only one center had had prior experience with endovascular stroke treatment, though all trial operators were fellowship-trained neurointerventionalists with at least five thrombectomies (at any center) under their belt, Nogueira and colleagues said.

During the roll-in phase of the trial, hospitals that had no previous experience with thrombectomy were required to perform three to five such procedures and have them evaluated. The 79 patients treated during this period were not included in the primary analysis.

Notably, RESILIENT leaders had intended to include 690 study participants. An interim analysis, conducted after 174 people reached 90-day follow-up, favored early efficacy of thrombectomy, and thus enrollment was stopped.

In the final intention-to-treat analysis, 221 individuals were randomized. NIH Stroke Scale scores were a median of 18. Patients had a median age of 66 years, and just over half of participants were women. Around 70% of both groups received IV alteplase (Activase).

In the thrombectomy arm, 82.0% of patients achieved substantial reperfusion. Median time from arrival in the emergency department to the start of IV alteplase was 34 minutes. Time from arrival to arterial puncture was 116 minutes.

Symptomatic intracranial hemorrhage (ICH) was observed in 4.5% of either group. Asymptomatic ICH occurred in 51.4% of thrombectomy patients and 24.5% of controls -- higher than previously seen in other studies, Nogueira's group noted.

"Because most of our follow-up imaging at 24 hours to determine whether there had been an intraparenchymal hemorrhage was performed with CT, it was difficult to distinguish contrast staining from hemorrhagic conversion, and this may have resulted in the overestimation of the number of minor hemorrhages," the authors noted.

Nevertheless, RESILIENT provides "high-level evidence" that thrombectomy may have benefits in developing countries, Sarraj told 麻豆传媒.

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