New England Journal of Medicine· 2015Q1· Clinical trial
Endovascular Therapy for Ischemic Stroke with Perfusion-Imaging Selection
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- 2015year
Short summary
Early endovascular thrombectomy using the Solitaire FR stent retriever significantly improved reperfusion, early neurologic recovery, and long-term functional outcomes in ischemic stroke patients compared to alteplase alone.
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Key points
- Early thrombectomy achieved 100% reperfusion vs 37% with alteplase alone.
- 80% of thrombectomy patients showed early neurologic improvement vs 37% with alteplase.
- 71% of thrombectomy patients were functionally independent at 90 days vs 40% with alteplase.
- The trial was stopped early due to demonstrated efficacy.
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: Trials of endovascular therapy for ischemic stroke have produced variable results. We conducted this study to test whether more advanced imaging selection, recently developed devices, and earlier intervention improve outcomes. METHODS: We randomly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke either to undergo endovascular thrombectomy with the Solitaire FR (Flow Restoration) stent retriever or to continue receiving alteplase alone. All the patients had occlusion of the internal carotid or middle cerebral artery and evidence of salvageable brain tissue and ischemic core of less than 70 ml on computed tomographic (CT) perfusion imaging. The coprimary outcomes were reperfusion at 24 hours and early neurologic improvement (≥8-point reduction on the National Institutes of Health Stroke Scale or a score of 0 or 1 at day 3). Secondary outcomes included the functional score on the modified Rankin scale at 90 days. RESULTS: The trial was stopped early because of efficacy after 70 patients had undergone randomization (35 patients in each group). The percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular-therapy group than in the alteplase-only group (median, 100% vs. 37%; P<0.001). Endovascular therapy, initiated at a median of 210 minutes after the onset of stroke, increased early neurologic improvement at 3 days (80% vs. 37%, P=0.002) and improved the functional outcome at 90 days, with more patients achieving functional independence (score of 0 to 2 on the modified Rankin scale, 71% vs. 40%; P=0.01). There were no significant differences in rates of death or symptomatic intracerebral hemorrhage. CONCLUSIONS: In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging, early thrombectomy with the Solitaire FR stent retriever, as compared with alteplase alone, improved reperfusion, early neurologic recovery, and functional outcome. (Funded by the Australian National Health and Medical Research Council and others; EXTEND-IA ClinicalTrials.gov number, NCT01492725, and Australian New Zealand Clinical Trials Registry number, ACTRN12611000969965.).
The authors' abstract, as published at the source. New England Journal of Medicine, 2015 · DOI ↗
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Field: Epidemiology
EpidemiologyMedicine