1. Compared to medical care alone, treatment of large cerebral infarctions had better functional outcomes with endovascular therapy.
2. Endovascular therapy of large cerebral infarctions had more intracranial hemorrhages when compared to medical care alone.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Endovascular therapy is one of the standard treatments for acute stroke caused by large-vessel occlusion, though patients with large infarctions have generally been excluded from clinical trials of endovascular therapy. This is in part due to concerns of bleeding in the area of infarction after reperfusion. However, a prior meta-analysis suggested that endovascular therapy may be associated with improved functional outcomes and lower mortality in those with large infarctions. Therefore, there is a gap in knowledge as to understanding the effect of endovascular therapy with medical therapy, as compared with medical care alone, in patients with an acute large ischemic stroke. This study found that for patients with acute stroke and a large ischemic region, functional outcomes were better with endovascular therapy than medical care alone, though endovascular therapy was associated with an increased incidence of intracranial hemorrhage. This study was limited by factors such as limited generalizability beyond the Japanese population, as well as relatively low use of tPA among enrolled patients and patients being enrolled based on judgment of neurologists regarding the indication for endovascular therapy. Nevertheless, these study’s findings are significant, as they demonstrate that endovascular therapy is superior to medical care alone for improving functional outcomes in patients with a large ischemic acute stroke, though endovascular therapy was associated with an increased incidence of intracranial hemorrhage.
Click to read the study in NEJM
Relevant Reading: In Stroke, When Is a Good Outcome Good Enough?
In-Depth [open label randomized control trial]: This multicenter, open-label, randomized clinical trial in Japan included 203 patients with occlusion of large cerebral vessels and sizable strokes on imaging. Patients who had a large acute ischemic stroke were 18 years or older, and if endovascular therapy could be initiated within 60 minutes after randomization were eligible for the study. Patients who had a clinically significant cerebral mass effect with midline shift or acute intracranial hemorrhage on CT or MRI were excluded from the study. Patients were assigned to either the endovascular therapy group or the medical care-only group. The primary outcome measured was a score of 0 to 3 on the modified Rankin scale (which is on a scale of 0 to 6) 90 days after the onset of stroke, with higher scores indicating greater disability. Outcomes in the primary analysis were analyzed via per-protocol population analyses and relative risks and an ordinal logistic model was used to analyze the primary, secondary, and safety outcomes between the trial groups without adjustment for stratification variables. Based on the analysis, the percentage of patients with a modified Rankin score of 0 to 3 at 90 days was 31% in the endovascular therapy group and 12.7% in the medical-care group (relative risk, 2.43; 95% Confidence Interval [CI], 1.35 to 4.37). An improvement of at least 8 points on the National Institutes of Health Stroke Scale (NIHSS) was seen in 31% of the patients receiving endovascular therapy and in 8.8% of patients receiving medical care alone (relative risk, 3.51; 95% CI, 1.76 to 7). The occurrence of any intracranial hemorrhage happened in 58% of the endovascular therapy patients and in 31.4% of the medical care only patients (P<0.001). Overall, this study demonstrated that endovascular therapy for patients with a large acute ischemic stroke provided improved functional outcomes compared to medical therapy alone, but had a higher incidence of intracranial hemorrhages.
Image: PD
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