• Jianmin Liu, Yu Zhou, Lei Zhang, Zifu Li, Wenhuo Chen, Yueqi Zhu, Xiaoxi Yao, Liyong Zhang, Shen Liu, Ya Peng, Ming Wei, Quanbin Zhang, Hansheng Shu, Shouchun Wang, Wenhua Liu, Shu Wan, Tong Li, Yibin Fang, Hongxing Han, Guang Zhang, Li'an Huang, Feng Wang, Guangsen Cheng, Lianbo Gao, Hongchao Shi, Jintao Han, Yun Luo, Shuai Li, Chuwei Cai, Rong Yin, Zhenglong Jin, Chengwei Shao, Bing Tian, Yongxin Zhang, Qiang Li, Yingying Zhang, Ping Zhang, Binben Li, Pengfei Xing, Hongjian Shen, Xuan Zhu, Xiaoxi Zhang, Weilong Hua, Fang Shen, Meihua Huyan, Rundong Chen, Qiao Zuo, Qinghai Huang, Yi Xu, Benqiang Deng, Rui Zhao, Mayank Goyal, Yongwei Zhang, Pengfei Yang, and PROTECT-MT Investigators.
• Center for Clinical Neuroscience, Changhai Hospital, Naval Medical University, Shanghai, China; Oriental Pan-Vascular Devices Innovation College, University of Shanghai for Science and Technology, Shanghai, China; Institute of Neuroscience, Key Laboratory of Molecular Neurobiology of Ministry of Education and the Collaborative Innovation Center for Brain Science, Naval Medical University, Shanghai, China. Electronic address: liu118@vip.163.com.
• Lancet. 2024 Nov 20.

BackgroundThe effectiveness of using a balloon guide catheter during endovascular thrombectomy in patients with acute ischaemic stroke due to large vessel occlusion of the anterior circulation remains uncertain. We aimed to assess the effectiveness and safety of using a balloon guide catheter during endovascular thrombectomy, compared with using a conventional guide catheter, in this patient population.MethodsWe conducted a multicentre, open-label, blinded-endpoint, randomised controlled trial at 28 hospitals in China. Adults aged 18 years or older with acute ischaemic stroke who were able to receive endovascular thrombectomy within 24 h after symptom onset, according to local guidelines, were eligible. Patients were randomly assigned (1:1) to the balloon guide catheter group or the conventional guide catheter group using a central internet-based system with a minimisation algorithm. The treating physicians and patients were aware of treatment allocation, but clinical outcomes were collected by local trained physicians who were masked. Neurological assessments were performed at baseline, 24 h after randomisation, and at 7 days or hospital discharge (whichever occurred first). The primary outcome was functional recovery, assessed by change in modified Rankin Scale (mRS) scores (ranging from 0 [no symptoms] to 6 [death]) at 90 days in the intention-to-treat population and obtained from structured interviews. Treatment effect was estimated using ordinal logistic regression with adjustment for site and baseline prognostic factors (time from symptom onset to randomisation, the preferred thrombectomy strategy, baseline National Institutes of Health Stroke Scale score, prestroke function [estimated mRS score], and age). This trial is registered with ClinicalTrials.gov, NCT05592054 (terminated).FindingsBetween Feb 7 and Nov 13, 2023, 1698 patients were assessed for eligibility and 329 were randomly assigned to the balloon guide catheter group (n=164) or conventional guide catheter group (n=165) when the trial was paused and subsequently terminated on April 18, 2024, due to safety concerns. The median age was 69 years (IQR 59-76). Of 329 patients, 201 (61%) were male and 128 (39%) were female. Participants in the balloon guide catheter group had significantly worse scores on the mRS at 90 days than those in the conventional guide catheter group (adjusted common odds ratio 0·66 [95% CI 0·45-0·98]; p=0·037). All-cause mortality at 90 days was numerically higher in the balloon guide catheter group than in the conventional guide catheter group (39 [24%] vs 26 [16%]). There were no statistically significant differences between groups in intracranial haemorrhage, symptomatic intracranial haemorrhage, or other serious adverse events.InterpretationCompared with conventional guide catheters, the use of balloon guide catheters led to worse functional recovery in patients receiving endovascular thrombectomy for intracranial large vessel occlusion. Future studies are needed to confirm these results.FundingNational Natural Science Foundation of China, Shanghai Hospital Development Center, Biopharma Industry Promotion Center Shanghai, and Ton-bridge Medical Technology.TranslationFor the Chinese translation of the abstract see Supplementary Materials section.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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