Abstract

Introduction: Multiple randomized controlled trials demonstrated better functional outcomes with endovascular therapy (EVT). Potential heterogeneity in EVT treatment effect by sex is an important question as several social and biological factors are shown to differentially affect stroke outcomes between men and women. We aimed to evaluate if clinical outcomes and thrombectomy treatment effect differed by sex among patients with large ischemic stroke. Methods: In the SELECT2 RCT, baseline characteristics and outcomes were compared between men and women. The primary outcome was a shift in modified Rankin Scale score, with functional independence (mRS 0-2), independent ambulation (mRS 0-3) and symptomatic ICH as secondary outcomes. Effect modification was examined using multiplicative sex-by-treatment interaction term. Additionally, repeated measure mixed effect models were used to evaluate if recovery in functional status differed by sex at discharge/ 5 to7-day, 30-day, and 90-day follow-up. Results: Of 352 enrolled patients, 71/145 (49%) of women and 109/207 (53%) of men underwent EVT. EVT was uniformly associated with better functional outcomes without evidence of treatment effect modification [Men - aGenOR: 1.66(1.24-2.23) vs women - aGenOR: 1.73(1.22-2.45), p-int: 0.94], functional independence [men - aRR: 1.99(0.99-4.02) vs women - aRR: 5.04(1.59-16.02), p-int: 0.20] and independent ambulation [men - aRR: 1.98(1.29-3.03) vs women - aRR: 2.44(1.40-4.24), p-int: 0.67]. There were no significant differences between the two cohorts’ recovery at discharge/5 to 7-day, 30-day, and 90-day follow-up (figure). Conclusions: EVT was associated with higher rates of functional independence and independent ambulation in both men and women, without significant heterogeneity in treatment effect or recovery arc between discharge and 90-day follow-up. Trial Registration: NCT03876457

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