Real-World Outcomes of Mechanical Thrombectomy in Trial-Eligible Patients

Introduction/Purpose Landmark thrombectomy trials (MR CLEAN, DEFUSE‐3, DAWN) established the foundation of modern stroke care, defining time windows, imaging criteria, and benchmarks for functional independence. Nearly a decade later, real‐world practices include broader and more heterogeneous patient populations, raising questions about whether these trial‐level outcomes remain reproducible outside controlled settings. This study compared contemporary outcomes in trial‐eligible patients to original benchmarks. Materials/Methods We conducted a retrospective cohort analysis of consecutive adults treated with mechanical thrombectomy between January 2022 and June 2024. Patients were assigned to MR CLEAN, DEFUSE‐3, or DAWN groups based strictly on trial inclusion criteria to ensure comparability. Demographic, clinical, and imaging data were collected, including baseline NIHSS, prestroke mRS, and occlusion site. The primary endpoint was functional independence (mRS 0‐2) at 90 days. Secondary outcomes included mortality, reperfusion success (TICI ≥2b), and hemorrhage. Real‐world outcomes were compared with published trial results using two‐sample z‐tests, odds ratios, and ordinal shift analyses. Results Of 483 screened patients, 335 (69%) met at least one trial's eligibility criteria (216 MR CLEAN, 72 DEFUSE‐3, 37 DAWN). Cohorts reflected typical practice demographics (mean age 68.5 ± 13.7 years; 48% male; hypertension 74%; diabetes 27%). At 90 days, functional independence occurred in 34% of MR CLEAN, 32% of DEFUSE‐3, and 22% of DAWN patients, compared with 33%, 45%, and 49% in the original trials. Despite high reperfusion rates (>86% across cohorts), 90‐day mortality was consistently higher than reported in the trials. Subgroup analysis revealed significantly worse outcomes in patients ≥80 years, with lower functional independence and increased mortality. Conclusion Real‐world MR CLEAN outcomes closely replicate trial results, but extended‐window DEFUSE‐3 and DAWN cohorts underperform, underscoring the challenges of broader eligibility. These findings highlight the importance of patient selection, age stratification, and workflow optimization to sustain trial‐level efficacy in everyday practice.