Early tirofiban after intravenous thrombolysis improved 90-day functional outcomes in stroke patients without diabetes (69.0% vs 55.8%) but not in those with diabetes (P=.009 for interaction).
RCT (n=832)
randomised
Yes
Does early tirofiban infusion after intravenous thrombolysis improve excellent functional outcomes at 90 days in patients with acute ischaemic noncardioembolic stroke, and does diabetes status modify this effect?
Early tirofiban administration after intravenous thrombolysis for acute ischemic stroke may improve functional outcomes specifically in patients without diabetes, suggesting a differential treatment effect based on diabetes status.
p-value: p=.009 for treatment-by-diabetes interaction
INTRODUCTION: This study aimed to investigate how diabetes mellitus (DM) influences the efficacy of early tirofiban administration after intravenous thrombolysis in patients with acute ischaemic noncardioembolic stroke. PATIENTS AND METHODS: This was a post-hoc analysis of the ASSET-IT (Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis) trial. Patients were categorised into DM and non-DM groups based on baseline diabetes history. The primary efficacy outcome was an excellent functional outcome at 90 days, defined as an mRS score of 0-1. Safety outcomes included sICH within 36 h, any ICH and all-cause mortality within 90 days. The effect of diabetes on treatment outcomes was assessed using multivariable regression models adjusting for relevant confounders. RESULTS: A total of 832 patients at 38 centres were randomised in the ASSET-IT trial (414 to tirofiban, 418 to placebo). The median age was 69 years (IQR, 59-76); 301 (36.2%) were women. Overall, 191 patients (23.0%) had diabetes mellitus. Among patients without diabetes, an excellent functional outcome at 90 days occurred in 69.0% of patients in the tirofiban group and 55.8% in the placebo group, whereas among patients with diabetes, the corresponding rates were 55.0% and 52.0%, respectively. The nominal P value for the treatment-by-diabetes interaction was .009. The 90-day mortality was higher in the DM group receiving tirofiban (6.6% vs 2.0%; RR, 3.79; 95% CI, 0.84-17.05; P = .082) but not in the non-DM group (3.4% vs 4.4%; RR, 0.82; 95% CI, 0.40-1.70; P = .597). CONCLUSION: Exploratory post-hoc findings from the ASSET-IT trial suggest that the association between early tirofiban administration after intravenous thrombolysis and 90-day functional outcomes may differ according to diabetes status. These hypothesis-generating observations require confirmation in prospective studies with pre-specified subgroup analyses.
Wang et al. (Wed,) conducted a rct in acute ischaemic noncardioembolic stroke (n=832). Early tirofiban infusion vs. Placebo was evaluated on Excellent functional outcome at 90 days (mRS score of 0-1) (p=.009 for treatment-by-diabetes interaction). Early tirofiban after intravenous thrombolysis improved 90-day functional outcomes in stroke patients without diabetes (69.0% vs 55.8%) but not in those with diabetes (P=.009 for interaction).