Zhongrong Miao1, Yong Zhang2, Jie Shuai2, Changchun Jiang2, Qiyi Zhu2, Kangning Chen2, Li Liu2, Baomin Li2, Xiangqun Shi2, Lianbo Gao2, Yajie Liu2, Feng Wang2, Yongli Li2, Tieyan Liu2, Hongbo Zheng2, Yilong Wang2, Yongjun Wang2. 1. From the Departments of Interventional Neuroradiology (Z.M.) and Neurology (Yilong Wang, Yongjun Wang), Beijing Tiantan Hospital, Capital Medical University, China National Clinical Research Center for Neurological Diseases, Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China; Department of Neurology, The Affiliated Hospital of Qingdao University Medical College, Qingdao, China (Y.Z.); Department of Neurology, Xin Qiao Hospital, Third Military Medical University, Chongqing, China (J.S.); Department of Neurology, Baotou Central Hospital, Baotou, China (C.J.); Department of Neurology, Linyi People's Hospital, Linyi, China (Q.Z.); Department of Neurology, Xi Nan Hospital, Third Military Medical University, Chongqing, China (K.C.); Department of Neurology, The Hospital of Chifeng City, Chifeng, China (L.L.); Department of Neurosurgery, The PLA General Hospital, Beijing, China (B.L.); Department of Neurology, The Lanzhou General Hospital of PLA, Lanzhou, China (X.S.); Department of Neurology, The Affiliated Fourth Hospital of China Medical University, Shenyang, China (L.G.); Department of Neurology, Zhujiang Hospital, Southern Medical University, Guangzhou, China (Yajie Liu); Department of Interventional Therapy, The First Affiliated Hospital of Dalian Medical University, Dalian, China (F.W.); Department of Neurosurgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, China (Yongli Li); Department of Interventional Radiology, Cangzhou Central Hospital, Cangzhou, China (T.L.); and Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (H.Z.). zhongrongm@163.com. 2. From the Departments of Interventional Neuroradiology (Z.M.) and Neurology (Yilong Wang, Yongjun Wang), Beijing Tiantan Hospital, Capital Medical University, China National Clinical Research Center for Neurological Diseases, Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China; Department of Neurology, The Affiliated Hospital of Qingdao University Medical College, Qingdao, China (Y.Z.); Department of Neurology, Xin Qiao Hospital, Third Military Medical University, Chongqing, China (J.S.); Department of Neurology, Baotou Central Hospital, Baotou, China (C.J.); Department of Neurology, Linyi People's Hospital, Linyi, China (Q.Z.); Department of Neurology, Xi Nan Hospital, Third Military Medical University, Chongqing, China (K.C.); Department of Neurology, The Hospital of Chifeng City, Chifeng, China (L.L.); Department of Neurosurgery, The PLA General Hospital, Beijing, China (B.L.); Department of Neurology, The Lanzhou General Hospital of PLA, Lanzhou, China (X.S.); Department of Neurology, The Affiliated Fourth Hospital of China Medical University, Shenyang, China (L.G.); Department of Neurology, Zhujiang Hospital, Southern Medical University, Guangzhou, China (Yajie Liu); Department of Interventional Therapy, The First Affiliated Hospital of Dalian Medical University, Dalian, China (F.W.); Department of Neurosurgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, China (Yongli Li); Department of Interventional Radiology, Cangzhou Central Hospital, Cangzhou, China (T.L.); and Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (H.Z.).
Abstract
BACKGROUND AND PURPOSE: Although recent trials have suggested that stenting is worse than medical therapy for patients with severe symptomatic intracranial atherosclerotic stenosis, it is not clear whether this conclusion applies to a subset of patients with hypoperfusion symptoms. To justify for a new trial in China, we performed a multicenter prospective registry study to evaluate the safety and efficacy of endovascular stenting within 30 days for patients with severe symptomatic intracranial atherosclerotic stenosis. METHODS: Patients with symptomatic intracranial atherosclerotic stenosis caused by 70% to 99% stenosis combined with poor collaterals were enrolled. The patients were treated either with balloon-mounted stent or with balloon predilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome within 30 days is stroke, transient ischemic attack, and death after stenting. The secondary outcome is successful revascularization. The baseline characteristics and outcomes of the 2 treatment groups were compared. RESULTS: From September 2013 to January 2015, among 354 consecutive patients, 300 patients (aged 58.3±9.78 years) were recruited, including 159 patients treated with balloon-mounted stent and 141 patients with balloon plus self-expanding stent. The 30-day rate of stroke, transient ischemic attack, and death was 4.3%. Successful revascularization was 97.3%. Patients treated with balloon-mounted stent were older, less likely to have middle cerebral artery lesions, more likely to have vertebral artery lesions, more likely to have Mori A lesions, less likely to have Mori C lesions, and likely to have lower degree of residual stenosis than patients treated with balloon plus self-expanding stent. CONCLUSIONS: The short-term safety and efficacy of endovascular stenting for patients with severe symptomatic intracranial atherosclerotic stenosis in China is acceptable. Balloon-mounted stent may have lower degree of residual stenosis than self-expanding stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01968122.
BACKGROUND AND PURPOSE: Although recent trials have suggested that stenting is worse than medical therapy for patients with severe symptomatic intracranial atherosclerotic stenosis, it is not clear whether this conclusion applies to a subset of patients with hypoperfusion symptoms. To justify for a new trial in China, we performed a multicenter prospective registry study to evaluate the safety and efficacy of endovascular stenting within 30 days for patients with severe symptomatic intracranial atherosclerotic stenosis. METHODS:Patients with symptomatic intracranial atherosclerotic stenosis caused by 70% to 99% stenosis combined with poor collaterals were enrolled. The patients were treated either with balloon-mounted stent or with balloon predilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome within 30 days is stroke, transient ischemic attack, and death after stenting. The secondary outcome is successful revascularization. The baseline characteristics and outcomes of the 2 treatment groups were compared. RESULTS: From September 2013 to January 2015, among 354 consecutive patients, 300 patients (aged 58.3±9.78 years) were recruited, including 159 patients treated with balloon-mounted stent and 141 patients with balloon plus self-expanding stent. The 30-day rate of stroke, transient ischemic attack, and death was 4.3%. Successful revascularization was 97.3%. Patients treated with balloon-mounted stent were older, less likely to have middle cerebral artery lesions, more likely to have vertebral artery lesions, more likely to have Mori A lesions, less likely to have Mori C lesions, and likely to have lower degree of residual stenosis than patients treated with balloon plus self-expanding stent. CONCLUSIONS: The short-term safety and efficacy of endovascular stenting for patients with severe symptomatic intracranial atherosclerotic stenosis in China is acceptable. Balloon-mounted stent may have lower degree of residual stenosis than self-expanding stent. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01968122.