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Long-Term Follow-Up of Extracranial-Intracranial Bypass Surgery for Symptomatic Cerebral Artery Occlusion

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机构: [1]Department of Neurosurgery, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University, National Center for Neurological Disorders, Beijing, China. [2]Department of Neurosurgery, Huashan Hospital, Fudan University, National Center for Neurological Disorders, Shanghai, China. [3]Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China. [4]Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Tianjin, China. [5]Department of Neurosurgery, Huanhu Hospital, Tianjin, China. [6]Department of Neurosurgery, Liaocheng People's Hospital, Shandong First Medical University, Liaocheng, China. [7]Department of Neurosurgery, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [8]Department of Neurosurgery, The First Hospital of China Medical University, Liaoning, China. [9]Department of Neurosurgery, The Affiliated Cardiovascular Hospital of Shanxi Medical University and Shanxi Cardiovascular Hospital (Institute), Taiyuan, China. [10]Department of Neurology, The Ninth Medical Center, Chinese PLA General Hospital, Beijing, China. [11]Department of Neurosurgery, The Second Hospital of Lan Zhou University, Lanzhou, China. [12]Department of Neurosurgery, Qilu Hospital of Shandong University, Jinan, Qilu Hospital of Shandong University Dezhou Hospital, Dezhou, China. [13]Department of Neurosurgery, The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China. [14]Department of Neurosurgery, The First Affiliated Hospital of XinJiang Medical University, Urumqi, China. [15]Department of Neurosurgery, Nanjing Drum Tower Hospital, Neurosurgical Institute of Nanjing University, Nanjing University Medical School, Nanjing, China. [16]Department of Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [17]Department of Interventional Neuroradiology, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University, National Center for Neurological Disorders, Beijing, China. [18]Department of Radiology and Medical Imaging, University of Virginia School of Medicine, Charlottesville.
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Previous trials have shown no significant benefit of extracranialintracranial (EC-IC) bypass surgery vsmedical therapy in symptomatic patients with hemodynamically compromised internal carotid artery or middle carotid artery occlusion.1-3 CMOSS (Carotid and Middle Cerebral Artery Occlusion Surgery Study) was a multicenter, randomized clinical trial that compared EC-IC bypass surgery plus medical treatment vs medical treatment alone.1,4 The primary outcome was neutral at the 2-year follow up1 ; the present report includes the longer-term follow-up results. Methods | After finishing the initial preplanned follow-up, the study protocol was amended and approved for long-term follow-up of up to 10 years by institutional research ethics board at each center (Supplement 1). An addendum consent was required. Among 330 patients initially randomized, 324 patients were eligible and followed up through June 12, 2024. The primary outcome was a composite of any stroke or death within 30 days or ischemic stroke ipsilateral to the occluded artery beyond 30 days after randomization. Analyses were conducted in all eligible randomized participants and also in a perprotocol set; secondary outcomes and sensitivity analyses to address missing data were performed (eMethods in Supplement 2). The difference in the primary outcome was tested using a log-rank test, with the center as a stratification factor. P < .05 was considered statistically significant. χ2 or Fisher exact tests were used for categorical variables,ttests orWilcoxon rank tests were used for continuous variables, and KaplanMeier analysis was used for the risk of time-to-event outcomes. All statistical tests were 2-sided and completed using SAS, version 9.4 (SAS Institute).

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大类 | 1 区 医学
小类 | 1 区 医学:内科
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大类 | 1 区 医学
小类 | 1 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Department of Neurosurgery, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University, National Center for Neurological Disorders, Beijing, China.
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通讯机构: [1]Department of Neurosurgery, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University, National Center for Neurological Disorders, Beijing, China. [17]Department of Interventional Neuroradiology, Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University, National Center for Neurological Disorders, Beijing, China.
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