EXPECTS
Trial question
What is the effect of early administration of alteplase in patients with mild posterior circulation stroke who did not receive thrombectomy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 234
234 patients (81 female, 153 male).
Inclusion criteria: patients with mild posterior circulation stroke after 4.5-24 hours of onset who did not receive thrombectomy.
Key exclusion criteria: intended to proceed to endovascular treatment; contraindications to alteplase; infarction of the anterior circulation; pregnancy; life expectancy < 3 months; likelihood of nonadherence to the trial protocol or follow-up.
Interventions
N=117 alteplase (at a dose of 0.9 mg/kg of body weight within 4.5-24 hours after onset of symptoms).
N=117 standard care (standard medical treatment within 4.5-24 hours after onset of symptoms).
Primary outcome
Functional independence at day 90, modified Rankin Scale score < 3
89.6%
72.6%
89.6 %
67.2 %
44.8 %
22.4 %
0.0 %
Alteplase
Standard
care
Significant
increase ▲
NNT = 5
Significant increase in functional independence at day 90, mRS score < 3 (89.6% vs. 72.6%; RR 1.16, 95% CI 1.03 to 1.3).
Secondary outcomes
No significant difference in mRS score < 2 at day 90 (73.9% vs. 60.7%; RR 1.16, 95% CI 0.98 to 1.36).
No significant difference in major neurologic improvement at 24 hours (36.2% vs. 35.9%; RR 0.97, 95% CI 0.69 to 1.37).
No significant difference in major neurologic improvement at 7 days (56% vs. 48.7%; RR 1.11, 95% CI 0.87 to 1.42).
Safety outcomes
No significant differences in death at day 90, symptomatic ICH and parenchymal hematoma within 36 hours after randomization.
Conclusion
In patients with mild posterior circulation stroke after 4.5-24 hours of onset who did not receive thrombectomy, alteplase was superior to standard care with respect to functional independence at day 90, mRS score < 3.
Reference
Shenqiang Yan, Ying Zhou, Maarten G Lansberg et al. Alteplase for Posterior Circulation Ischemic Stroke at 4.5 to 24 Hours. N Engl J Med. 2025 Apr 3;392(13):1288-1296.
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