Real-World Outcomes of the Solitaire™ and React™ Devices from India’s First Multicenter Mechanical Thrombectomy Registry

Introduction: There is a low utilization of mechanical thrombectomy (MT) in India and lack of a nationwide registry or data. This registry aimed to study the systems of care, functional outcomes, and cost effectiveness of MT treatment in patients with acute ischemic stroke (AIS). Methods: Patients were treated with Solitaire™ X and/or React™ catheter as the primary device/s. Subjects with AIS due to large vessel occlusion, within 24 hours of symptom onset with the Alberta Stroke Program Early CT Score (ASPECTS) score >5 and the National Institutes of Health Stroke Scale (NIHSS) ≥6 were included. An independent Core lab and clinical events committee assessed outcomes. Good functional outcome was defined as modified Rankin score of 0-2 at 90 days. Successful revascularization was defined as the modified Thrombolysis in Cerebral Infarction (mTICI) ≥ 2b. Performance measures included door to needle time, door to groin puncture time, and groin puncture to recanalization time. A cost-effectiveness model was also developed. Results: Of the 200 patients screened, 190 (mean age, 59.6±14.35 years) were included. The mean baseline NIHSS score was 14.7 ± 5.38, median door to needle time was 50 (10-173) mins, door to groin puncture time was 99 (11- 478) mins, and groin puncture to revascularization time was 40 (10-170) mins. The first pass mTICI≥2b was 127 (66.8%) and the final pass mTICI≥2b was attained in 167 (87.9%). A good functional outcome was seen in 123 (65.8%) patients. Symptomatic intracranial hemorrhage occurred in 4 (2.1%). Device and/or procedure-related serious adverse events occurred in 27 (14.2%). Combined therapy of MT and Intravenous Tissue Plasminogen Activator [IV-tPA]was cost-effective compared with MT alone with an expected gain of 1.5 QALYs. Conclusions: This study results are comparable with global clinical registries and randomized clinical trials with favorable functional outcomes and excellent first pass and final recanalization. Combined therapy (MT + IV-tPA) was cost-effective compared to MT or IV-tPA alone.