1. In this randomized controlled trial, patients with acute strokes secondary to large infarctions had improved disability outcomes with endovascular therapy compared to those with medical therapy alone.
2. Endovascular therapy was also associated with a higher risk of intracranial hemorrhage as a complication.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Endovascular therapy has become the standard of care to treat ischemic stroke due to large-vessel occlusion. Current clinical guidelines only recommend this procedure in small to medium-sized infarcts, excluding larger infarctions. Several trials have demonstrated that endovascular therapy resulted in better outcomes in treating large cerebral infarcts but also more intracranial hemorrhages compared to medical therapy alone. The current trial was conducted in China to evaluate the effectiveness and safety of endovascular therapy, compared to medical management alone, to treat large infarcts caused by acute large-vessel occlusion in the anterior circulation. At 90 days, endovascular therapy resulted in significantly improved functional outcomes (assessed by the modified Rankin scale). The study was halted early due to the superiority of endovascular therapy compared to medical management. Endovascular therapy was associated with an increased risk of intracranial hemorrhage, symptomatic or otherwise. The study was limited by the low proportion of patients receiving intravenous thrombolysis and its specific validity within the study population. The trial demonstrated the superiority of endovascular therapy in treating large-infarct strokes over medical therapy alone. This, however, was accompanied by a higher risk of intracranial hemorrhage.
Click here to read the study in NEJM
Relevant Reading: Endovascular therapy for acute stroke with a large ischemic region
In-Depth [randomized controlled trial]: The current study was a multicenter, randomized, open-label clinical trial with a blinded end-point assessment conducted in China to evaluate the effectiveness and safety of endovascular therapy in treating large infarcts caused by acute large-vessel occlusion. Patients between 18 and 80 years of age who had an acute ischemic stroke within the preceding 24 hours with a score of 6 to 30 on the National Institutes of Health Stroke Scale, a pre-stroke score of 0 or 1 on the modified Rankin scale, and large-vessel occlusion of the initial segment of the middle cerebral artery and/or the intracranial segment of the distal internal carotid artery were eligible. Exclusion criteria included signs of herniation, mass effect, high risk of hemorrhage, and multiple occlusions. Overall, 456 patients were randomized to undergo endovascular therapy and receive medical management (endovascular-therapy group) or medical management alone (medical-management group). The primary outcome was the score on the modified Rankin scale at 90 days. At 90 days, the endovascular-therapy group had significant improvements in the primary outcome compared to the medical-management group (generalized odds ratio, 1.37; 95% Confidence Interval [CI], 1.11 to 1.69; p=0.004). The proportion of patients with a score between 0 and 3 on the modified Rankin scale at 90 days was 47.0% and 33.3%, respectively (Relative Risk [RR], 1.50; 95% CI, 1.17 to 1.91), favoring the endovascular-therapy group. Symptomatic intracranial hemorrhage within 24 hours following randomization was reported in 6.1% of the endovascular-therapy group and 2.7% of the medical-management group (RR, 2.07; 95% CI, 0.79 to 5.41; p=0.12). Any intracranial hemorrhage within the same timeframe occurred in 49.1% of the endovascular-therapy group and 17.3% of the medical-management group (RR, 2.71; 95% CI, 1.91 to 3.84; p<0.001). The trial was stopped early due to the superiority of endovascular therapy. These results provided further evidence to support the use of endovascular therapy in treating large-infarct acute stroke over medical therapy alone.
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