MR CLEAN
Trial question
What is the role of intraarterial treatment in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 500
500 patients (208 female, 292 male).
Inclusion criteria: patients with AIS caused by a proximal intracranial occlusion of the anterior circulation.
Key exclusion criteria: arterial BP > 185/110 mmHg, blood glucose < 2.7 or > 22.2 mmol/L, intravenous treatment with thrombolytic therapy.
Interventions
N=233 intervention (intraarterial treatment within 6h of symptom onset with intraarterial thrombolysis, mechanical treatment, or both plus usual care with intravenous administration of alteplase).
N=267 control (usual care alone with intravenous administration of alteplase).
Primary outcome
Modified Rankin Scale scores at 90 days
3 points
4 points
4.0 points
3.0 points
2.0 points
1.0 points
0.0 points
Intervention
Control
Significant
decrease ▼
Significant decrease in mRS scores at 90 days (3 points vs. 4 points; aOR 0.6, 95% CI 0.43 to 0.83).
Secondary outcomes
Significant increase in mRS score of 0-2 at 90 days (32.6% vs. 19.1%; aOR 2.16, 95% CI 1.39 to 3.38).
Significant increase in Barthel index of 19 or 20 at day 90 (46% vs. 29.8%; aOR 2.1, 95% CI 1.4 to 3.2).
Significant increase in no intracranial occlusion on follow-up CT angiography (75.4% vs. 32.9%; aOR 6.88, 95% CI 4.34 to 10.94).
Safety outcomes
No significant difference in mortality or the occurrence of symptomatic intracerebral hemorrhage.
Significant difference in clinical signs of new ischemic stroke in a different vascular territory (5.6% vs. 0.4%).
Conclusion
In patients with AIS caused by a proximal intracranial occlusion of the anterior circulation, intervention was superior to control with respect to mRS scores at 90 days.
Reference
Berkhemer OA, Fransen PS, Beumer D et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20.
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