MR CLEAN-LATE (2-year follow-up)
Trial question
What is the role of endovascular treatment in patients with AIS within the late window?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 502
502 patients (261 female, 241 male).
Inclusion criteria: adult patients with an AIS due to a large vessel occlusion in the anterior circulation and at least some collateral flow in the affected middle cerebral artery territory on CTA.
Key exclusion criteria: mRS score > 2; cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of large recent infarction on neuroimaging in the territory of the middle cerebral artery; clinical evidence of hemorrhagic diathesis.
Interventions
N=255 endovascular treatment (endovascular treatment with best medical treatment).
N=247 medical treatment alone (best medical treatment alone).
Primary outcome
Median modified Rankin Scale score at 2 years
4 points
6 points
6.0 points
4.5 points
3.0 points
1.5 points
0.0 points
Endovascular
treatment
Medical treatment
alone
Significant
decrease ▼
Significant decrease in median mRS score at 2 years (4 points vs. 6 points; OR 0.7, 95% CI 0.5 to 1).
Secondary outcomes
No significant difference in death at 2 years (34% vs. 41%; HR 0.81, 95% CI 0.6 to 1.08).
Safety outcomes
No significant difference in major vascular events.
Conclusion
In adult patients with an AIS due to a large vessel occlusion in the anterior circulation and at least some collateral flow in the affected middle cerebral artery territory on CTA, endovascular treatment was superior to medical treatment alone with respect to median mRS score at 2 years.
Reference
Ilse Huijberts, Florentina M E Pinckaers, Susanne G H Olthuis et al. Collateral-based selection for endovascular treatment of acute ischaemic stroke in the late window (MR CLEAN-LATE): 2-year follow-up of a phase 3, multicentre, open-label, randomised controlled trial in the Netherlands. Lancet Neurol. 2024 Sep;23(9):893-900.
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