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Randomization of Endovascular Treatment with Stent-retriever/Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke due to Large VEssel OcclusioN Trial in the Extended Time Window
Description
Background and Purpose: The lack of available advanced imaging techniques for stroke is a major challenge for implementing endovascular therapy in an extended time window. This clinical trial in a public hospital setting in Brazil aimed to assess whether mechanical thrombectomy (MT) was superior to best medical treatment (BMT) in achieving better outcomes for ischemic stroke patients caused by large vessel occlusion (LVO) in the anterior circulation within 8-24 hours last time seen well.

Methods: Participants aged ≥18years had to meet inclusion criteria, including NIHSS scores and involvement in Cortical ASPECTS areas (score 5-10) based on age. Treatment selection was based exclusively on Non-Contrast-CT and CT angiography. The primary outcome was disability at 90 days, evaluated by the distribution of scores on the modified Rankin scale.

Results: A total of 245 patients were randomized to MT + best medical management (126) or best medical management alone (119) 8-12 hours from time last seen well across 12 public health centers in Brazil. The median NIHSS score at baseline was 16 and median ASPECTS was 7-8. The proportional odds assumption was violated for the primary outcome. For the key secondary clinical outcome, MT performed up to 24 hours after last known well had an adjusted odds ratio of 2.66 (95% CI 1.35-5.25, p=0.012) for functional independence at 90 days compared to best medical therapy. Significantly more MT patients showed functional independence at 90 days versus medical management, 25.4% versus 14.3%. In the subgroup analysis, patients aged ≤68years had a higher effect size of MT (36% MTgroup vs 14% BMT, OR 3.5, CI95% 1.6-7.6,p=0.001) compared to >68years (5% MT vs 12% BMT, OR 0.4, CI95% 0.73-2.2, p=0.28). Higher age and baseline NIHSS scores were predictors of bad outcomes.

Conclusion: RESILIENT-Extend trial is pivotal in expanding the treatment window for thrombectomy globally with simplified selection criteria, potentially altering guidelines.

Event Type
General Session
TimeTuesday, October 15th11:42am - 12:00pm PDT
LocationHarbor Ballrooms D-I
Focus Areas
Ischemic Stroke