Intravenous alteplase compared with standard medical treatment for stroke aged over 70 years: a secondary analysis of the HOPE randomised clinical trial.

BACKGROUND: Data regarding intravenous alteplase in elderly patients with acute ischaemic stroke during 4.5 to 24 hours of onset are limited. This study aimed to investigate the effectiveness and safety of intravenous alteplase in patients aged over 70 years between 4.5 and 24 hours enrolled from the Treatment With Intravenous Alteplase in Ischemic Stroke Patients With Onset Time Between 4.5 and 24 Hours (HOPE) trial. METHODS: The HOPE trial included patients within 4.5 to 24 hours of stroke onset who had salvageable tissue. Participants were 1:1 randomised to alteplase group or standard medical treatment group. In this post hoc study, patients aged over 70 years were included. The primary outcome was the proportion of non-disabled functional outcome, defined as 90-day modified Rankin Score of 0-1. Safety outcomes included 90-day mortality and 36-hour symptomatic intracranial haemorrhage (sICH). RESULTS: Totally, 198 patients in the HOPE trial who were aged over 70 years were included in this post hoc analysis. The median age was 80 years, and the median National Institutes of Health Stroke Scale score was 11, with 99 (50.0%) receiving alteplase and 99 (50.0%) receiving standard medical treatment. The primary outcome occurred in 38.4% in the alteplase group and 18.2% in the standard medical treatment group (adjusted risk ratio, 2.14 [95% CI 1.34 to 3.41]). A significantly higher rate of sICH within 36 hours occurred in the alteplase group (4.0% vs 1.0%, adjusted risk ratio, 5.49; 95% CI 1.71 to 17.64). However, the mortality between the two groups was not significantly different (17.2% vs 16.2%, adjusted risk ratio, 0.94; 95% CI 0.50 to 1.77). CONCLUSIONS: This secondary analysis suggests that the evidence trends towards safety and effectiveness of intravenous alteplase in patients aged over 70 years during 4.5 to 24 hours after stroke onset.