Background The efficacy of mechanical thrombectomy for acute stroke due to large vessel occlusion (LVO) initiated beyond 6 hours of time last seen well (TLSW) has not been demonstrated by randomized trials.
Aim To establish whether subjects considered to have substantial areas of salvageable brain based on age-adjusted clinical core mismatch (CCM) who can undergo thrombectomy with the Trevo device within 6–24 hours from TLSW have better outcomes at 3 months compared to subjects treated with standard medical therapy alone. Age-adjusted CCM was defined by age (≤80 or>80 years), baseline NIHSS (10–20 or ≥21) and core size (0–20 cc’s in subjects older than 80 and, in subjects younger than 80, 0–30 cc’s with NIHSS 10–20 and 31–50 cc with NIHSS ≥21).
Method Prospective, randomized, multicenter, Bayesian adaptive-enrichment, open label trial with blinded endpoint assessment. Subjects were randomized in a 1:1 ratio to receive thrombectomy or medical management alone. Sequential interim analyses allowing adaptation of enrolment criteria or stopping new enrolment for futility or predicted success was planned to occur every 50 randomized patients starting at 150 to a maximum of 500 patients. The primary endpoint was the modified Rankin Scale (mRS) score at 90 days analyzed as a utility weighted score and (due to regulatory considerations) also as a dichotomized variable. The primary safety outcome was stroke-related mortality at 90 days.
Results Trial enrolment was stopped at the DSMB’s recommendation due to crossing of pre-specified probability thresholds for predicted success. Full results will be provided at the presentation.
Disclosures T. Jovin: None. R. Nogueira: None.
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