Post‐Market Registry of Stroke Patients Treated With Medtronic Neurothrombectomy Devices in Southeast Asia: PROSPR‐SEA

Background Southeast Asia accounts for approximately 10% of stroke‐related mortalities worldwide, yet there are limited data regarding mechanical thrombectomy (MT) outcomes in this region. PROSPR‐SEA (Post‐Market Registry of Stroke Patients Treated With Medtronic Neurothrombectomy Devices to Collect Real‐World Data in Southeast Asia) assessed post‐market clinical outcomes of MT using the Solitaire Revascularization Device in southeast Asia. Methods PROSPR‐SEA is a prospective, multicenter, nonrandomized, observational registry of patients who underwent MT using Solitaire as first line treatment at 1 of 10 centers in Vietnam, Thailand, and Singapore between January 2018 and July 2019. The primary end point was functional independence (modified Rankin scale 0–2) at 90 days. Safety end points included symptomatic intracerebral hemorrhage, emboli in new territory at 24 hours, and all‐cause mortality at 90 days. Secondary end points were successful revascularization (modified thrombolysis in cerebral infarction ≥2b), workflow metrics, National Institutes of Health Stroke Scale score at discharge, and patient disposition at 90 days. Results A total of 183 patients (64.9±13.7, 49.7% [91/183] female) were included in the study and underwent MT; 79.2% (145/183) had occlusions in the middle cerebral artery. Median baseline National Institutes of Health Stroke Scale was 15.0 (range 1–31) and median baseline Alberta Stroke Program Early CT Score was 8.0 (range 0–10). Functional independence at 90 days was achieved in 62.2% (112/180). Mean puncture‐to‐revascularization time was 53.3±53.9 minutes, and mean onset‐to‐revascularization time was 330.0±110.4 minutes. Revascularization was successful in 94.0% (172/183) of patients. Median National Institutes of Health Stroke Scale improved at discharge (−8.0, range −22, 25) and 90 days (−13.0, range −22, 0). Within 24 hours, symptomatic intracerebral hemorrhage occurred in 7.7% (14/183) and emboli in new territory in 3.3% (6/183). At 90 days, the all‐cause mortality rate was 7.7% (14/183). Most patients were discharged to home by 90 days (84.1%, 154/183). Conclusion PROSPR‐SEA demonstrated high rates of positive functional outcomes and procedural success with a low mortality rate and indicates that the technical and clinical outcomes of landmark MT trials using Solitaire as the first‐line device are reproducible in real‐world southeast Asian settings