Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large-Vessel Occlusion Stroke
Authors:   MARVEL Trial Authors for the MARVEL Investigators, 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 , Nguyen Thanh N. , Saver Jeffrey L. , Nogueira Raul G. , Li Fengli , Zi Wenjie 
Published: February 2024

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.

Interventions

Eligible 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 Registration

ChiCTR.org.cn Identifier: ChiCTR2100051729