Mechanical thrombectomy for acute ischemic stroke in a low- and middle-income country: primary outcomes from the GRASSROOT Trial.

BACKGROUND AND AIMS: Access to mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion (LVO) is severely restricted in resource-constrained environments, largely owing to the prohibitive cost of existing approved devices.

OBJECTIVE

The GRASSROOT Trial is the first prospective thrombectomy study in a low- and middle-income country (LMIC) setting assessing the safety and efficacy of the novel Supernova stent retriever-engineered for highest-level performance across diverse patient populations.

METHODS

A prospective, single-arm, multicenter trial conducted in India enrolled patients with AIS due to internal carotid artery terminus, M1/M2 middle cerebral artery, or basilar artery occlusions presenting within 24 hours of symptom onset. Primary safety endpoints were symptomatic intracranial hemorrhage (sICH) within 24 hours and all-cause mortality at 90 days. Primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) score ≥2b), with a 90-day modified Rankin Scale (mRS) score of 0-2 serving as the secondary efficacy endpoint.

RESULTS

Thirty-two consecutive eligible patients (mean age 58±16 years; 31% female; median National Institutes of Health Stroke Scale (NIHSS) score 14 (IQR 9-18), Alberta Stroke Program Early CT Score 8 (IQR 7-10)) were enrolled. Successful reperfusion (mTICI≥2b) after 1-3 passes of the Supernova stent retriever (median=1 (1-3)) was achieved in 30 (93.8%) patients without need for adjunctive rescue therapy. At 90 days, mortality was 9.4%, sICH 3.1%, and functional independence (mRS score 0-2) 50%. The median NIHSS score improved from 14 at baseline to 7 at discharge and to 4 at 90 days. First pass recanalization was observed in 22 (68.8%) patients. No device-related complications or deficiencies were observed.

CONCLUSIONS

The GRASSROOT Trial demonstrates excellent safety and efficacy of the Supernova stent retriever in large vessel occlusions. High rate of first pass reperfusion together with value-based pricing could facilitate a significant advancement in acute stroke thrombectomy access in India and other LMICs.

TRIAL REGISTRATION NUMBER: NCT06249776.