Effect of sex differences on prognosis of intravenous thrombolysis: data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China)

BACKGROUND AND PURPOSE: Previous studies have reported conflicting results as to whether women have poorer functional outcome than men after thrombolytic therapy. This study aims to investigate the relationship between sex differences and the prognosis of intravenous thrombolysis in Chinese patients with acute ischaemic stroke. METHODS: The patients enrolled in this study were from the Chinese Acute Ischemic Stroke Thrombolysis Monitoring and Registration study. The primary outcome was poor functional outcome, defined as a 3-month modified Rankin score of 3–6. The safe outcome was symptomatic intracranial haemorrhage (SICH) and mortality within 7 days and 90 days. Multiple Cox regression model was used to correct the potential covariates to evaluate the association between sex disparities and prognosis. Furthermore, the interaction of preonset Rankin scores, baseline National Institute of Health Stroke Scale (NIHSS) scores and Trial of Org 10172 in Acute Stroke Treatment (TOAST) types was statistically analysed. RESULTS: A total of 1440 patients were recruited, including 541 women and 899 men. The baseline information indicated that women were older at the time of onset (66.2±11.2 years vs 61.0±11.3 years, p<0.001), and more likely to have a history of atrial fibrillation (25.3% vs 11.2%, p<0.001), and had a higher NIHSS score on admission (12.3±6.8 vs 11.6±6.7, p=0.04). According to the prognosis analysis of unsatisfactory functional recovery, there was no significant difference between women and men (45.9% vs 37.1%; adjusted OR 1.01, 95% CI 0.75 to 1.37). As for the safe outcome, the proportion of SICH and mortality in women is relatively high but did not reach statistical significance. There was no significant interaction with sex, age, preonset Rankin score, NIHSS score, TOAST classification and the prognosis of intravenous thrombolysis. CONCLUSIONS: For Chinese patients with ischaemic stroke, although women are older and more severe at the time of onset, the prognosis after intravenous thrombolysis is not significantly different from men.