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Войти в исследования European stroke journal · 2026
Effect of Admission Diabetes History on Safety and Efficacy of Early Tirofiban Infusion after Intravenous Thrombolysis in Ischaemic Stroke: a post-hoc analysis of the ASSET-IT trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Wang Li, Tao Chunrong, Luo Cong, Chen Yuerong, Zhu Yuyou, Xu Pengfei, Li Rui, Liu Tianlong, Zhang Chao, Song Jianlong, Cui Jiangping, Sun Jun, Hu Wei, Liu Xinfeng
Аннотация
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.
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.