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Endovascular Therapy for Acute Stroke With Large Ischemic Region
Quick Takes
- The percentage of patients with large ischemic regions of acute stroke who had good functional status at 90 days with respect to the primary outcome was significantly higher with endovascular therapy plus medical care than with standard medical care alone.
- However, there were significantly more intracranial hemorrhages in the endovascular-therapy group than in the medical-care group, but the difference in the percentage of patients with symptomatic intracranial hemorrhage was not significant.
- Since this is one study with a relatively small number of patients, we should await results of other ongoing randomized trials such as SELECT2 (NCT03876457) and ANGEL-ASPECT (NCT04551664) to have a definitive answer to the potential benefit of endovascular therapy for acute stroke with a large ischemic core.
Study Questions:
What is the effect of endovascular therapy with medical care, as compared with medical care alone, in patients with acute ischemic stroke caused by large-vessel occlusion and a large ischemic region?
Methods:
The investigators conducted a multicenter, open-label, randomized clinical trial (RESCUE-Japan LIMIT) in Japan, involving patients with occlusion of large cerebral vessels and sizable strokes on imaging, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) value of 3–5 (on a scale from 0–10, with lower values indicating larger infarction). Patients were randomly assigned in a 1:1 ratio to receive endovascular therapy with medical care or medical care alone within 6 hours after they were last known to be well or within 24 hours if there was no early change on fluid-attenuated inversion recovery images. Alteplase (0.6 mg/kg of body weight) was used when appropriate in both groups.
The primary outcome was a modified Rankin scale score of 0–3 (on a scale from 0–6, with higher scores indicating greater disability) at 90 days. Secondary outcomes included a shift across the range of modified Rankin scale scores toward a better outcome at 90 days and an improvement of ≥8 points in the National Institutes of Health Stroke Scale (NIHSS) score (range, 0–42, with higher scores indicating greater deficit) at 48 hours. The effects of endovascular therapy, as compared with medical care alone, are presented as relative risks (RRs) with 95% confidence intervals (CIs). The shift of modified Rankin scale toward a better functional outcome was estimated with the use of an ordinal logistic model, and a common odds ratio with 95% CIs was derived after verification of the proportional odds assumption.
Results:
A total of 203 patients underwent randomization; 101 patients were assigned to the endovascular-therapy group and 102 to the medical-care group. Approximately 27% of patients in each group received alteplase. The percentage of patients with a modified Rankin scale score of 0–3 at 90 days was 31.0% in the endovascular-therapy group and 12.7% in the medical-care group (RR, 2.43; 95% CI, 1.35-4.37; p = 0.002). The ordinal shift across the range of modified Rankin scale scores generally favored endovascular therapy. An improvement of ≥8 points on the NIHSS score at 48 hours was observed in 31.0% of the patients in the endovascular-therapy group and 8.8% of those in the medical-care group (RR, 3.51; 95% CI, 1.76-7.00), and any intracranial hemorrhage occurred in 58.0% and 31.4%, respectively (p < 0.001).
Conclusions:
The authors concluded that patients with large cerebral infarctions had better functional outcomes with endovascular therapy than with medical care alone but had more intracranial hemorrhages.
Perspective:
This trial reports that the percentage of patients with large ischemic regions of acute stroke, as gauged by an ASPECTS value of 3–5, who had good functional status at 90 days with respect to the primary outcome was significantly higher with endovascular therapy plus medical care than with standard medical care alone. However, there were significantly more intracranial hemorrhages in the endovascular-therapy group than in the medical-care group, but the difference in the percentage of patients with symptomatic intracranial hemorrhage was not significant. The results of this small study suggest that patients with large core infarcts have just as much benefit from endovascular therapy as patients with smaller infarcts. Since this is one study with a relatively small number of patients, we should await results of other ongoing randomized trials such as SELECT2 (NCT03876457) and ANGEL-ASPECT (NCT04551664) to have a definitive answer to this question.
Clinical Topics: Dyslipidemia, Noninvasive Imaging, Prevention, Vascular Medicine, Lipid Metabolism, Interventions and Imaging
Keywords: Brain Ischemia, Cerebral Infarction, Diagnostic Imaging, Endovascular Procedures, Intracranial Hemorrhages, Ischemic Stroke, Secondary Prevention, Stroke, Tissue Plasminogen Activator, Vascular Diseases
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