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.