Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis

作者：Xuan Sun, Yiming Deng, Yong Zhang, Ming Yang, Dapeng Sun, Thanh N. Nguyen, Xu Tong, Guangge Peng, Aihua Liu, Yun Xu, WU Yun-hu, Xiaokun Geng, Yang Wang, Tianxiao Li, Shihui Xing, Wei Wu, Yunxiang Ji, Hua Yang, Shouchun Wang, Xiaoping Gao, Weimin Yang, Xingquan Zhao, Liping Liu, Ning Ma, Feng Gao, Dapeng Mo, Xiaochuan Huo, Ligang Song, Xiaoqing Li, Jingbo Zhang, Hongwei He, Ming Lv, Shiqing Mu, Wengui Yu, David S Liebeskind, Sepideh Amin‐Hanjani, Yongjun Wang, Yilong Wang, Zhongrong Miao, BASIS Investigators, Yifeng Du, Hui-Sheng Chen, Peiming Wang, Yajie Liu, Hongbo Zheng, Wenhua Liu, Wenfeng Cao, Guisheng Jiang, Jianfeng Han, Ya Peng, Jun Wang, Shiyong Zhang, Gesheng Wang, Liyu Wang, Jin Wu, Guifu Li, Mingze Chang, Jing Jing, N. D. Qi, Zhenwei Zhao, Kehui Dong, Huaizhang Shi, Jin Shi, Yiling Cai, Yuesong Pan · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.12829 · 被引用次数：91 · 研究领域：Cerebrovascular and Carotid Artery Diseases、Acute Ischemic Stroke Management、Moyamoya disease diagnosis and treatment

Importance: Previous randomized clinical trials did not demonstrate the superiority of endovascular stenting over aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis (sICAS). However, balloon angioplasty has not been investigated in a randomized clinical trial. Objective: To determine whether balloon angioplasty plus aggressive medical management is superior to aggressive medical management alone for patients with sICAS. Design, Setting, and Participants: A randomized, open-label, blinded end point clinical trial at 31 centers across China. Eligible patients aged 35 to 80 years with sICAS defined as recent transient ischemic attack (<90 days) or ischemic stroke (14-90 days) before enrollment attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery receiving treatment with at least 1 antithrombotic drug and/or standard risk factor management were recruited between November 8, 2018, and April 2, 2022 (final follow-up: April 3, 2023). Interventions: Submaximal balloon angioplasty plus aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control. Main Outcomes and Measures: The primary outcome was a composite of any stroke or death within 30 days after enrollment or after balloon angioplasty of the qualifying lesion or any ischemic stroke in the qualifying artery territor...