Article Impact Level: HIGH Data Quality: STRONG Summary of New England Journal of Medicine, 388(22), 2025–2036. https://doi.org/10.1056/NEJMoa2214299 Dr. Wenjie Zi et al.
Points
- A multicenter trial evaluated the effectiveness of tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, in acute ischemic stroke patients without complete occlusion of large or medium-sized vessels.
- Patients were randomly assigned to receive either intravenous tirofiban or oral aspirin, with the primary endpoint being an excellent outcome on the modified Rankin scale at 90 days.
- The tirofiban group showed a higher percentage of patients with an excellent outcome (29.1%) than the aspirin group (22.2%), indicating a greater likelihood of positive results with tirofiban.
- Secondary endpoints generally supported the primary analysis, although mortality rates did not differ significantly between the two groups.
- The incidence of symptomatic intracranial hemorrhage was low but slightly higher in the tirofiban group (1.0%) compared to the aspirin group (0%), suggesting careful consideration of the potential risks associated with tirofiban use.
Summary
This multicenter trial aimed to evaluate the efficacy of the glycoprotein IIb/IIIa receptor inhibitor tirofiban in patients with acute ischemic stroke without evidence of complete occlusion in large or medium-sized vessels. The study enrolled patients from China who presented with ischemic stroke, a National Institutes of Health Stroke Scale score of 5 or more, and at least one moderately to severely weak limb.
Patients meeting specific criteria were randomly assigned to receive either intravenous tirofiban (plus oral placebo) or oral aspirin (100 mg per day, plus intravenous placebo) for two days, followed by oral aspirin until day 90. The primary endpoint was an excellent outcome defined as a score of 0 or 1 on the modified Rankin scale at 90 days. Secondary endpoints included functional independence and quality-of-life measures. Safety endpoints encompassed mortality and symptomatic intracranial hemorrhage.
Of the 606 patients assigned to the tirofiban group and 571 patients to the aspirin group, the majority had small infarctions presumed to be atherosclerotic. At 90 days, the percentage of patients achieving an excellent outcome was 29.1% in the tirofiban group, compared to 22.2% in the aspirin group (adjusted risk ratio: 1.26; 95% confidence interval: 1.04 to 1.53, P=0.02). Although not consistent with the primary analysis, results for secondary endpoints generally aligned with the primary efficacy endpoint. The mortality rate did not significantly differ between the tirofiban and aspirin groups. However, the incidence of symptomatic intracranial hemorrhage was 1.0% in the tirofiban group, while no cases were reported in the aspirin group.
In this trial involving patients with recent-onset or progressing stroke symptoms and nonoccluded large and medium-sized cerebral vessels, intravenous tirofiban administration was associated with a greater likelihood of achieving an excellent outcome than low-dose aspirin. The incidence of symptomatic intracranial hemorrhage was low but slightly higher with tirofiban. These findings support the potential efficacy of tirofiban in improving outcomes for acute ischemic stroke patients without large or medium-sized vessel occlusion, suggesting its relevance for further investigation and consideration in clinical practice.
Link to the article: https://www.nejm.org/doi/10.1056/NEJMoa2214299
References Zi, W., Song, J., Kong, W., Huang, J., Guo, C., He, W., Yu, Y., Zhang, B., Geng, W., Tan, X., Tian, Y., Liu, Z., Cao, M., Cheng, D., Li, B., Huang, W., Liu, J., Wang, P., Yu, Z., … Yang, Q. (2023). Tirofiban for stroke without large or medium-sized vessel occlusion. New England Journal of Medicine, 388(22), 2025–2036. https://doi.org/10.1056/NEJMoa2214299
