Best medical therapy versus intravenous thrombolysis for minor stroke: a patient-level pooled analysis of ARAMIS and TRUST trials

Background Trials failed to demonstrate superiority of intravenous thrombolysis (IVT) versus best medical therapy (BMT) in minor stroke; however, modest sample sizes raised concerns. This study aimed to compare the efficacy and safety of IVT with BMT in minor stroke based on pooled cohorts from clinical trials.Methods This was a pooled analysis using individual participant data from two randomised controlled trials. Patients with acute minor ischaemic stroke presented within 4.5 hours of symptom onset in the full analysis set were included and classified into IVT and BMT groups. In IVT group, patients received intravenous alteplase or urokinase. In BMT group, patients received standard care based on current guidelines. Primary outcome was excellent functional outcome at 90 days, defined as modified Rankin Scale scoring 0 or 1. Safety outcome was symptomatic intracranial haemorrhage within 36 hours.Results A total of 1417 patients were included (median age, 64 years; male, 915 (64.6%)) and assigned into IVT group (707 patients) and BMT (710 patients). The proportion of 90-day excellent functional outcome was similar between groups (89.4% vs 89.4%, adjusted OR, 1.054 (95% CI 0.741 to 1.500), p=0.770). Compared with BMT, symptomatic intracranial haemorrhage was numerically higher in the IVT but not statistically significant (0.7% vs 0.3%, adjusted OR, 2.125 (95% CI 0.506 to 11.929), p=0.310).Conclusions Among patients with acute minor ischaemic stroke presented within 4.5 hours of symptom onset, no statistically significant difference was observed between IVT and BMT regarding excellent functional outcome at 90 days.Trial registration number ClinicalTrials.gov Identifier: NCT03661411 and NCT04420351.