Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large-Vessel Occlusion Stroke The MARVEL Randomized Clinical Trial

作者全名："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; Nguyen, Thanh N.; Saver, Jeffrey L.; Nogueira, Raul G.; Li, Fengli; Zi, Wenjie"

作者地址："[Yang, Qingwu; Guo, Changwei; Yue, Chengsong; Song, Jiaxing; Yang, Jie; Peng, Zhouzhou; Yu, Nizhen; Huang, Jiacheng; Li, Linyu; Huang, Jiandi; Jiang, Lin; Yang, Dahong; Tian, Yan; Hu, Jinrong; Qiu, Zhongming; Ma, Jinfu; Xu, Xu; Fan, Shitao; Liu, Xiang; Xie, Dongjing; Li, Fengli; Zi, Wenjie] Third Mil Med Univ, Mil Med Univ 3, Xinqiao Hosp, Dept Neurol, 183 Xinqiao Main St, Chongqing 400037, Peoples R China; [Yang, Qingwu; Guo, Changwei; Yue, Chengsong; Song, Jiaxing; Yang, Jie; Peng, Zhouzhou; Yu, Nizhen; Huang, Jiacheng; Li, Linyu; Huang, Jiandi; Jiang, Lin; Yang, Dahong; Tian, Yan; Hu, Jinrong; Qiu, Zhongming; Ma, Jinfu; Xu, Xu; Fan, Shitao; Liu, Xiang; Xie, Dongjing; Li, Fengli; Zi, Wenjie] Third Mil Med Univ, Army Med Univ, Affiliated Hosp 2, 183 Xinqiao Main St, Chongqing 400037, Peoples R China; [Chen, Yifei] Kunming Med Univ, Dept Neurol, Affiliated Hosp 1, Kunming, Peoples R China; [Zheng, Chong] Fujian Med Univ, Dept Neurol, Longyan Affiliated Hosp 1, Longyan, Peoples R China; [Jiang, Shunfu] Jingdezhen 1 Peoples Hosp, Dept Neurol, Jingdezhen, Peoples R China; [Ruan, Zhongfan] Univ South China, Affiliated Hosp 1, Dept Neurol, Hengyang, Peoples R China; [Zhang, Min] Jiangmen Cent Hosp, Dept Neurol, Jiangmen, Peoples R China; [Song, Dengwen] Hosp 302 Attached Guizhou Aviat Grp, Dept Neurol, Anshun, Peoples R China; [Luo, Xiaojun] Guangyuan Cent Hosp, Dept Cerebrovasc Dis, Guangyuan, Peoples R China; [Tian, Yaoyu] Qian Xi Nan Peoples Hosp, Dept Neurol, Xingyi, Peoples R China; [Yang, Mei] Dali Bai Autonomous Prefecture Peoples Hosp, Dept Neurol, Dali, Peoples R China; [Deng, Shenglin] Peoples Hosp Wushen Cty, Dept Neurol, Guangan, Peoples R China; [Wei, Shirong] Youjiang Med Univ Nationalities, Peoples Hosp Hechi, Dept Neurol, Hechi, Peoples R China; [Wei, Shirong] Youjiang Med Univ Nationalities, Hechi Hosp, Hechi, Peoples R China; [Wu, Youlin] Chongzhou Hosp, Dept Neurol, Chongzhou, Peoples R China; [Tang, Yufeng] Mianyang Cent Hosp, Dept Neurol, Mianyang, Peoples R China; [Yang, De] Chongqing Univ, Fuling Hosp, Dept Neurol, Chongqing, Peoples R China; [Tan, Xiaolin] Meishan Second Peoples Hosp, Dept Neurol, Meishan, Peoples R China; [Zeng, Guoyong] Ganzhou Peoples Hosp, Dept Neurol, Ganzhou, Peoples R China; [Cheng, Daoyou] Xingyi Peoples Hosp, Dept Neurol, Xingyi, Peoples R China; [Liu, Wenhua] Wuhan Hosp Tradit Chinese & Western Med, Dept Ophthalmol, Wuhan, Peoples R China; [He, Wencheng] Guiping Peoples Hosp, Dept Neurol, Guiping, Peoples R China; [Cai, Tieying] Yunyang Cty Peoples Hosp, Dept Neurol, Yunyang, Peoples R China; [Pan, Chengde] Peoples Hosp Chongqing Banan Dist, Dept Neurol, Banan, Peoples R China; [Liao, Jiasheng] Suining First Peoples Hosp, Dept Neurol, Suining, Peoples R China; [Lei, Bo] Peoples Hosp Leshan, Dept Cerebrovasc Dis, Leshan, Peoples R China; [Pu, Shengxiong] North Sichuan Med Coll, Affiliated Hosp, Dept Neurol, Nanchong, Peoples R China; [Jin, Zhenglong] Jiangmen Wuyi Hosp Tradit Chinese Med, Dept Neurol, Jiangmen, Peoples R China; [Li, Jinglun] Southwest Med Univ, Dept Neurol, Affiliated Hosp, Luzhou, Peoples R China; [Xia, Zhongbin] Jiujiang Univ, Affiliated Hosp, Dept Neurol, Jiujiang, Peoples R China; [Zhang, Guling] Peoples Hosp Danzhai, Dept Neurol, Danzhi, Peoples R China; [Luo, Jun] Sichuan Mianyang 404 Hosp, Dept Neurol, Mianyang, Peoples R China; [Sun, Yaxuan] Shanxi Prov Peoples Hosp, Dept Neurol, Taiyuan, Peoples R China; [Xiong, Xiaoping] Chongqing Univ Qianjiang Hosp, Dept Neurol, Qianjiang Dist, Peoples R China; [Wang, Jian] Yaan Peoples Hosp, Dept Neurol, Yaan, Peoples R China; [Li, Bo] Bazhong Cent Hosp, Dept Neurol, Bazhong, Peoples R China; [Peng, Yuqi] Sichuan Sci City Hosp, Dept Urol, Mianyang, Peoples R China; [Chen, Kechun] Zhangjiagang First Peoples Hosp, Dept Neurol, Zhangjiagang, Peoples R China; [Shan, Yuanjun] Xiangzhou Dist Peoples Hosp, Dept Neurol, Xiangyang, Peoples R China; [Zhou, Peiyang] Xiangyang 1 Peoples Hosp, Dept Neurol, Xiangyang, Peoples R China; [Huang, Xinyuan] Guizhou Med Univ, Dept Neurol, Baiyun Hosp, Guiyang, Peoples R China; [Luo, Shiwei] Jieyang Peoples Hosp, Dept Neurol, Jieyang, Peoples R China; [Zhang, Jie] Zhejiang Prov Peoples Hosp, Bijie Hosp, Dept Neurol, Bijie, Peoples R China; [Liu, Chang] Chongqing Med Univ, Dept Neurol, Affiliated Hosp 2, Chongqing, Peoples R China; [Niu, Jianqin] Army Med Univ, Dept Histol & Embryol, Chongqing, Peoples R China; [Zheng, Hongting] Third Mil Med Univ, Army Med Univ, Xinqiao Hosp, Dept Endocrinol, Chongqing, Peoples R China; [Zheng, Hongting] Third Mil Med Univ, Army Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China; [Ouyang, Qin] Army Med Univ, Dept Med Chem, Chongqing, Peoples R China; [Wang, Duolao] Univ Liverpool Liverpool Sch Trop Med, Global Hlth Trials Unit, Liverpool, England; [Nguyen, Thanh N.] Boston Med Ctr, Dept Neurol, Radiol, Boston, MA USA; [Saver, Jeffrey L.] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA USA; [Nogueira, Raul G.] Univ Pittsburgh, UPMC Stroke Inst, Dept Neurol & Neurosurg, Pittsburgh, PA USA"

通信作者："Li, FL; Zi, WJ (通讯作者)，Third Mil Med Univ, Mil Med Univ 3, Xinqiao Hosp, Dept Neurol, 183 Xinqiao Main St, Chongqing 400037, Peoples R China.; Li, FL; Zi, WJ (通讯作者)，Third Mil Med Univ, Army Med Univ, Affiliated Hosp 2, 183 Xinqiao Main St, Chongqing 400037, Peoples R China."

来源：JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001160881500002

JCR分区：Q1

影响因子：63.1

年份：2024

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：　

摘要："ImportanceIt is uncertain whether intravenous methylprednisolone improves outcomes for patients with acute ischemic stroke due to large-vessel occlusion (LVO) undergoing endovascular thrombectomy. ObjectiveTo 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 ParticipantsThis 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 MeasuresThe 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. ResultsAmong 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 RelevanceAmong 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"

基金机构："National Natural Science Foundation of China [82071323, 82271349]; Chongqing Science and Health Joint Project [2023GGXM007]; National Natural Science Foundation of China Major Program [82090040]"

基金资助正文："This study was supported bythe National Natural Science Foundation of China (No. 82071323 and 82271349), Chongqing Science and Health Joint Project (No. 2023GGXM007), and the National Natural Science Foundation of China Major Program (No. 82090040). The study drug was provided by Chongqing Lummy Pharmaceutical Co Ltd."