Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases
Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct
First author：X. Huo, G. Ma
Corresponding author：Z. Ren, Yongjun Wang, and Z. Miao
essential_information
- Person in charge：X. Huo, G. Ma
- Data Sources： OTHERS
- Number of papers：OTHERS20230047
- Published time：2023-02-09
2023-02-09
Published articles
Journal：The New England Journal of Medicine
Publication type: Original Contributions
IF(IF): 176.079
PMID: 36762852 Link To Pubmed Full text Download
Background And Purpose
The role of endovascular therapy for acute stroke with a large infarction has not been extensively studied in differing populations
Method
We conducted a multicenter, prospective, open-label, randomized trial in China involving patients with acute large-vessel occlusion in the anterior circulation and an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower values indicating larger infarction) or an infarct-core volume of 70 to 100 ml. Patients were randomly assigned in a 1:1 ratio within 24 hours from the time they were last known to be well to undergo endovascular therapy and receive medical management or to eceive medical management alone. The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability), and the primary objective was to determine whether a shift in the distribution of the scores on the modified Rankin scale at 90 days had occurred between the two groups. Secondary outcomes included scores of 0 to 2 and 0 to 3 on the modified Rankin scale. The primary safety outcome was symptomatic intracranial hemorrhage within 48 hours after randomization
Conclusion
In a trial conducted in China, patients with large cerebral infarctions had better outcomes with endovascular therapy administered within 24 hours than with medical management alone but had more intracranial hemorrhages.
Main results
A total of 456 patients were enrolled; 231 were assigned to the endovascular-therapy group and 225 to the medical-management group. Approximately 28% of the patients in both groups received intravenous thrombolysis. The trial was stopped early owing to the efficacy of endovascular therapy after the second interim analysis. At 90 days, a shift in the distribution of scores on the modified Rankin scale toward better outcomes was observed in favor of endovascular therapy over medical management alone generalized odds ratio, 1.37; 95% confidence interval, 1.11 to 1.69; P=0.004). Symptomatic intracranial hemorrhage occurred in 14 of 230 patients (6.1%) in the endovascular-therapy group and in 6 of 225 patients (2.7%) in the medical-management group; any intracranial hemorrhage occurred in 113 (49.1%) and 39 (17.3%), respectively. Results for the secondary outcomes generally supported those of the primary analysis