Expanding Global Access to Lifesaving Stroke Care
Summary
- Acute ischemic stroke caused by large‑vessel occlusion is among the most devastating neurological emergencies, but access to mechanical thrombectomy remains scarce in many low‑ and middle‑income countries.
- The Miller School of Medicine’s Dr. Dileep Yavagal conducted research that offers compelling evidence that a locally priced, high‑performance stent retriever can deliver excellent outcomes.
- The trial’s efficient execution across varied hospital environments, including centers with limited angiography resources, shows that high‑quality endovascular programs can be established and sustained with workflow optimization and team training.
Acute ischemic stroke caused by large‑vessel occlusion (LVO) is among the most devastating neurological emergencies. But access to mechanical thrombectomy, the standard of care, remains scarce in many low‑ and middle‑income countries.
A new multicenter trial led by Dileep R. Yavagal, M.D., professor of neurology and neurosurgery at the University of Miami Miller School of Medicine, offers compelling evidence that a locally priced, high‑performance stent retriever can deliver excellent outcomes and help bridge this global care gap. The GRASSROOT Trial, conducted across eight stroke centers in India, evaluated the Supernova stent retriever and found high rates of successful reperfusion with low complication rates—results that may accelerate adoption and reimbursement in resource‑constrained settings.
“The GRASSROOT clinical trial confirms that cutting-edge novel stroke device trials can be executed with world-class clinical trial rigor and results in low- and middle-income countries,” said Dr. Yavagal. “The partnership between academic neurointerventionalists in the U.S. and Indian counterparts can be a great example for future neurointerventional and stroke clinical trial collaborations across the globe.”
The Prevalence of Stroke
Worldwide, stroke affects approximately 12 million people annually and causes more than seven million deaths. LVO strokes account for up to 30% of acute ischemic stroke cases and frequently lead to severe disability or death unless timely mechanical thrombectomy is available.
Unfortunately, low‑ and middle‑income countries face both infrastructure and cost barriers. India, for example, has only 0.26 endovascular thrombectomy–capable centers per million people. Single‑use thrombectomy devices typically cost about $5,000, a prohibitive figure in low‑ and middle‑income countries.
GRASSROOT was designed to address these realities by testing a de novo, value‑priced device engineered for top‑tier performance at lower cost.
Study Design and Methodology
GRASSROOT was a pragmatic, prospective, single‑arm trial enrolling 32 consecutive adults with imaging‑confirmed LVO in the internal carotid terminus, M1/M2 middle cerebral artery or basilar artery within 24 hours of symptom onset. Baseline severity was substantial.
More study details:
• Operators used the Supernova stent retriever as the initial device, performing up to three passes, typically with balloon‑guide or distal aspiration to minimize embolization.
• Primary safety outcomes were symptomatic intracranial hemorrhage (sICH) within 24 hours and all‑cause mortality at 90 days
• The primary efficacy outcome was angiographic reperfusion. Functional independence served as a secondary efficacy endpoint.
• An independent imaging core lab and clinical events committee adjudicated outcomes. Statistical superiority was tested against conservative performance goals derived from historical device data.
Key Results
The Supernova achieved successful reperfusion in 93.8% of participants, surpassing the efficacy benchmark. Near‑complete reperfusion occurred in 75% of participants. Notably, first‑pass substantial reperfusion was observed in 68.8% of participants, a rate that compares favorably with leading devices and contemporary studies. The median procedure time was 51 minutes, with the median number of passes one. Importantly, no embolization to previously uninvolved territories and no device‑related serious adverse events were reported.
Safety outcomes were equally encouraging:
• 90‑day all‑cause mortality was 9.4%
• sICH occurred in 3.1% and the composite primary safety endpoint (sICH within 24 hours or 90‑day mortality) was 9.4%—significantly below the 30.4% performance goal.
• Asymptomatic hemorrhage occurred in 15.6% of participants and decompressive hemicraniectomy for malignant edema was required in 6.3%.
• Clinically, patients improved markedly. Median NIH Stroke Scale/Score fell from 14 at baseline to seven at discharge and four at 90 days. Fifty percent of participants achieved functional independence at 90 days.
Implications for Patient Care
For low‑ and middle‑income countries, the GRASSROOT findings are pivotal. A device that matches top‑tier performance while enabling value‑based pricing can catalyze broader mechanical thrombectomy adoption, increase procedure volumes and justify investment in stroke‑ready infrastructure and training.
The trial’s efficient execution across varied hospital environments, including centers with limited angiography resources, shows that high‑quality endovascular programs can be established and sustained with workflow optimization and team training. These results provide a strong evidence base for policymakers, payers and hospital leaders to expand EVT capacity, streamline reimbursement and standardize emergency pathways so more patients can receive timely mechanical thrombectomy.
In low‑ and middle‑income countries, where fewer than 2% of eligible stroke patients receive mechanical thrombectomy, a high‑performing, lower‑cost device is a practical lever to expand access and improve outcomes.
Tags: Department of Neurological Surgery, Department of Neurology, Dr. Dileep Yavagal, neurology, stroke, stroke outcomes, thrombectomy