European stroke journal · 2025
Effects of sex on imaging-based intravenous thrombolysis for ischaemic stroke with unknown onset time: a pooled analysis of clinical trials.
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Fukuda-Doi Mayumi, Koga Masatoshi, Thomalla Götz, Jensen Märit, Inoue Manabu, Yoshimura Sohei, Miwa Kaori, Gerloff Christian, Davis Stephen M, Donnan Geoffrey A, Ma Henry, Hacke Werner, Ringleb Peter, Wu Ona, Schwamm Lee H, Warach Steven, Toyoda Kazunori
Аннотация
INTRODUCTION: The effects of imaging-based intravenous thrombolysis on outcomes based on patient sex remain unclear. We aimed to investigate whether outcomes among patients with stroke with an unknown onset time and treated with imaging-based intravenous thrombolysis are influenced by their sex.
PATIENTS AND METHODS: This study was a pooled analysis of individual patient-level data acquired from the Evaluation of unknown Onset Stroke thrombolysis trials. Patients treated with imaging-based intravenous thrombolysis for stroke with an unknown onset time were included. The primary outcome was a favourable outcome (modified Rankin Scale score 0-1) at 90 days. The sex-based difference in outcomes was studied using mixed-effect logistic or ordinal regression models, considering potential heterogeneity across trials.
RESULTS: Out of 509 patients in total, 204 (40.1%) were women. Compared with men, women were older and more likely to have atrial fibrillation. Baseline National Institutes of Health Stroke Scale score was higher and hours from last-known-well to treatment were longer for women than for men. Favourable outcomes occurred less often among women than among men. However, multivariate adjustment revealed a non-significant association between female sex and favourable outcome (adjusted odds ratio: 1.04 [95% confidence interval: 0.66-1.52], p = 0.98).
DISCUSSION AND CONCLUSION: Pooled data from the included clinical trials showed that women with ischaemic stroke with an unknown onset time had worse functional outcomes following imaging-based intravenous thrombolysis than did men. However, this sex-based difference can be explained by the higher age and more severe clinical status at onset among women.
PATIENTS AND METHODS: This study was a pooled analysis of individual patient-level data acquired from the Evaluation of unknown Onset Stroke thrombolysis trials. Patients treated with imaging-based intravenous thrombolysis for stroke with an unknown onset time were included. The primary outcome was a favourable outcome (modified Rankin Scale score 0-1) at 90 days. The sex-based difference in outcomes was studied using mixed-effect logistic or ordinal regression models, considering potential heterogeneity across trials.
RESULTS: Out of 509 patients in total, 204 (40.1%) were women. Compared with men, women were older and more likely to have atrial fibrillation. Baseline National Institutes of Health Stroke Scale score was higher and hours from last-known-well to treatment were longer for women than for men. Favourable outcomes occurred less often among women than among men. However, multivariate adjustment revealed a non-significant association between female sex and favourable outcome (adjusted odds ratio: 1.04 [95% confidence interval: 0.66-1.52], p = 0.98).
DISCUSSION AND CONCLUSION: Pooled data from the included clinical trials showed that women with ischaemic stroke with an unknown onset time had worse functional outcomes following imaging-based intravenous thrombolysis than did men. However, this sex-based difference can be explained by the higher age and more severe clinical status at onset among women.