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.