BACKGROUND AND PURPOSE: Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. METHODS: STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. RESULTS: A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction > /=2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. CONCLUSIONS: This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Background -Endovascular treatment with mechanical thrombectomy (MT) is beneficial for acute stroke patients suffering a large vessel occlusion, though treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared to direct presentation. Methods -STRATIS was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke due to anterior-circulation large vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without IV-tPA, and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed 1) real-world time metrics of stroke care delivery, 2) outcome differences between direct and transfer patients undergoing MT, and 3) the potential impact of local hospital bypass. Results -A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct vs. 311.5 minutes for transfer patients (p < 0.001). Clinical outcomes were better in the direct group with 60.0% (299/498) achieving functional independence, compared to 52.2% (213/408) in the transfer group (odds ratio 1.38, 95%CI 1.06-1.79; p=0.02). Likewise, excellent outcome (modified Rankin Score 0-1) was achieved in 47.4% (236/498) of direct patients vs. 38.0% (155/408) of transfer patients (odds ratio 1.47, 95%CI 1.13-1.92; p=0.005). Mortality did not differ between the two groups (15.1% for direct, 13.7% for transfer; p=0.55). IV-tPA did not impact outcomes. Hypothetical bypass modeling for all transferred patients suggested that IV-tPA would be delayed by 12 minutes but MT would be performed 91 minutes sooner if patients were routed directly to endovascular-capable centers. If bypass is limited to a 20-mile radius from onset, then IV-tPA would be delayed by 7 minutes and MT performed 94 minutes earlier. Conclusions -In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large vessel occlusion and direct routing to endovascular-capable centers for severe stroke patients may improve outcomes. Clinical Trial Registration -URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.