ANGEL-ASPECT
Trial question
What is the role of endovascular therapy in patients with AIS with large infarction?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 455
455 patients (176 female, 279 male)
Inclusion criteria: adult patients aged 18-80 years with ischemic stroke within the previous 24 hours
Key exclusion criteria: midline shift or clinical signs of herniation; mass effect; high risk of hemorrhage; acute bilateral strokes; or multiple intracranial occlusions
Interventions
N=230 endovascular therapy (mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty or stenting plus medical management)
N=225 medical management (standard guideline-directed medical therapy alone)
Primary outcome
Modified Rankin scale score at day 90
4
4
4.0
3.0
2.0
1.0
0.0
Endovascular therapy
Medical management
Significant increase ▲
Significant increase in mRS score at day 90 (4 vs. 4 ; OR 1.37, 95% CI 1.11 to 1.69)
Secondary outcomes
Borderline significant increase in mRS score of 0-2 at day 90 (30% vs. 11.6%; RR 2.62, 95% CI 1.69 to 4.06)
Borderline significant increase in mRS score of 0-3 at day 90 (47% vs. 33.3%; RR 1.5, 95% CI 1.17 to 1.91)
Borderline significant increase in target artery recanalization at 36 hours (85.8% vs. 36.4%; RR 2.46, 95% CI 1.96 to 3.08)
Safety outcomes
No significant differences in symptomatic ICH within 48 hours, death within 90 days, decompressive hemicraniectomy during hospitalization.
Significant difference in any ICH within 48 hours (49.1% vs. 17.3%).
Conclusion
In adult patients aged 18-80 years with ischemic stroke within the previous 24 hours, endovascular therapy was superior to medical management with respect to mRS score at day 90.
Reference
Xiaochuan Huo, Gaoting Ma, Xu Tong et al. Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct. N Engl J Med. 2023 Apr 6;388(14):1272-1283.
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