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Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large-Vessel Occlusion Stroke

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Shan, Yuanjun, Pu, Jie, Ni, Yang, Liu, Zongtao, Zou, Xin, Wu, Changchuan, Liu, Jiazuo, Qi, Li, Chen, Junbin, Wang, Pengfei, Luan, Jianfang, Liu, Da, Song, Bo, Hao, Yonggang, Qiu, Tao, Wang, Kuiyun, Li, Zuopeng, Liu, Junsheng, Li, Zhenqiang, Li, Yanling, Yang, Shuang, Lin, Xiaoli, Cheng, Wen, Chen, Anqiang, Yan, Shiqiang, Liu, Shudong, Du, Jie, Chen, Zhuo, Yao, Li, Kong, Deyan, Wang, Hongjun, Wang, Shouchun, Zhu, Xunfeng, Wan, Yue, Zhao, Haojin, Mou, Qingchun, Dai, Ling, Yu, Shui, Ju, Dongsheng, Huang, Wenguo, Huang, Yihong, Kong, Weilin, Sun, Wenzhe, Shi, Xiaolei, Yang, Shihai, Wang, Zhixi, Tian, Yan, Chen, Yangmei, Liu, Chen, Xu, Rufu, Yang, Qingwu, Guo, Changwei, Yue, Chengsong, Song, Jiaxing, Yang, Jie, Peng, Zhouzhou, Yu, Nizhen, Huang, Jiacheng, Li, Linyu, Huang, Jiandi, Chen, Yifei, Zheng, Chong, Jiang, Shunfu, Ruan, Zhongfan, Zhang, Min, Song, Dengwen, Luo, Xiaojun, Tian, Yaoyu, Yang, Mei, Deng, Shenglin, Wei, Shirong, Wu, Youlin, Tang, Yufeng, Yang, De, Tan, Xiaolin, Zeng, Guoyong, Cheng, Daoyou, Liu, Wenhua, He, Wencheng, Cai, Tieying, Pan, Chengde, Liao, Jiasheng, Lei, Bo, Pu, Shengxiong, Jin, Zhenglong, Li, Jinglun, Xia, Zhongbin, Zhang, Guling, Luo, Jun, Sun, Yaxuan, Xiong, Xiaoping, Wang, Jian, Li, Bo, Peng, Yuqi, Chen, Kechun, Shan, Yuanjun, Zhou, Peiyang, Huang, Xinyuan, Luo, Shiwei, Zhang, Jie, Liu, Chang, Jiang, Lin, Yang, Dahong, Tian, Yan, Hu, Jinrong, Qiu, Zhongming, Ma, Jinfu, Xu, Xu, Fan, Shitao, Liu, Xiang, Xie, Dongjing, Niu, Jianqin, Zheng, Hongting, Ouyang, Qin, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Nguyen, Thanh N., Saver, Jeffrey L., Nogueira, Raul G., Li, Fengli and Zi, Wenjie (2024) 'Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large-Vessel Occlusion Stroke'. JAMA, Vol 331, Issue 10, pp. 840-849.

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Abstract

Importance
It is uncertain whether intravenous methylprednisolone improves outcomes for patients with acute ischemic stroke due to large-vessel occlusion (LVO) undergoing endovascular thrombectomy.
Objective
To assess the efficacy and adverse events of adjunctive intravenous low-dose methylprednisolone to endovascular thrombectomy for acute ischemic stroke secondary to LVO.
Design, Setting, and Participants
This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 82 hospitals in China, enrolling 1680 patients with stroke and proximal intracranial LVO presenting within 24 hours of time last known to be well. Recruitment took place between February 9, 2022, and June 30, 2023, with a final follow-up on September 30, 2023.InterventionsEligible patients were randomly assigned to intravenous methylprednisolone (n = 839) at 2 mg/kg/d or placebo (n = 841) for 3 days adjunctive to endovascular thrombectomy.
Main Outcomes and Measures
The primary efficacy outcome was disability level at 90 days as measured by the overall distribution of the modified Rankin Scale scores (range, 0 [no symptoms] to 6 [death]). The primary safety outcomes included mortality at 90 days and the incidence of symptomatic intracranial hemorrhage within 48 hours.
Results
Among 1680 patients randomized (median age, 69 years; 727 female [43.3%]), 1673 (99.6%) completed the trial. The median 90-day modified Rankin Scale score was 3 (IQR, 1-5) in the methylprednisolone group vs 3 (IQR, 1-6) in the placebo group (adjusted generalized odds ratio for a lower level of disability, 1.10 [95% CI, 0.96-1.25]; P = .17). In the methylprednisolone group, there was a lower mortality rate (23.2% vs 28.5%; adjusted risk ratio, 0.84 [95% CI, 0.71-0.98]; P = .03) and a lower rate of symptomatic intracranial hemorrhage (8.6% vs 11.7%; adjusted risk ratio, 0.74 [95% CI, 0.55-0.99]; P = .04) compared with placebo.
Conclusions and Relevance
Among patients with acute ischemic stroke due to LVO undergoing endovascular thrombectomy, adjunctive methylprednisolone added to endovascular thrombectomy did not significantly improve the degree of overall disability.Trial RegistrationChiCTR.org.cn Identifier: ChiCTR2100051729

Item Type:	Article
Subjects:	QV Pharmacology > QV 4 General works WL Nervous System > WL 20 Research (General)
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1001/jama.2024.0626
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	21 Mar 2024 13:55
Last Modified:	21 Mar 2024 13:55
URI:	https://archive.lstmed.ac.uk/id/eprint/24232

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