Intra-Arterial Urokinase After Endovascular Reperfusion for Acute Ischemic Stroke

被引:2
|
作者
Liu, Chang [1 ,2 ,3 ]
Guo, Changwei [2 ,3 ]
Li, Fengli [2 ,3 ]
Yu, Nizhen [2 ,3 ]
Huang, Jiacheng [1 ,2 ,3 ]
Peng, Zhouzhou [2 ,3 ]
Kong, Weilin [4 ]
Song, Jiaxing [1 ,2 ,3 ]
Liu, Xiang [2 ,3 ]
Fan, Shitao [2 ,3 ]
Yue, Chengsong [2 ,3 ]
Chen, Boyu [5 ]
Zheng, Chong [6 ]
Yuan, Xingyun [7 ]
Sheng, Jian [8 ]
Wu, Youlin [9 ]
Sun, Bo [10 ]
Zhao, Zengqiang [11 ]
Zhu, Minzhen [12 ]
Han, Ling [13 ]
Shi, Qiang [14 ]
Xia, Zhongbin [15 ]
Shang, Xianjin [16 ]
Li, Fengguang [17 ]
Li, Rongzong [18 ]
Yue, Feixue [19 ]
Jiang, Shunfu [20 ]
Song, Dengwen [21 ]
Song, Min [1 ]
Shan, Yuanjun [22 ]
Ding, Chawen [23 ]
Yao, Li [24 ]
Yang, Yong [25 ]
Chen, Junbin [26 ]
He, Wencheng [27 ]
Pan, Feibao [28 ]
Zhang, Wensheng [11 ]
Cai, Tieying [29 ]
Han, Shibo [30 ]
Li, Wei [10 ]
Li, Gongbo [1 ]
Gong, Chen [1 ]
Huang, Liping [1 ]
Huang, Cheng [2 ,3 ]
Wang, Duolao [31 ]
Kaesmacher, Johannes [32 ,33 ,34 ]
Nguyen, Thanh N. [35 ]
Nogueira, Raul G. [36 ]
Saver, Jeffrey L. [37 ]
Zi, Wenjie [2 ,3 ]
机构
[1] Second Affiliated Hosp Chongqing Med Univ, Dept Neurosurg, Chongqing 400042, Peoples R China
[2] Army Med Univ, Mil Med Univ 3, Xinqiao Hosp, Dept Neurol, 183 Xinqiao Main St, Chongqing 400037, Peoples R China
[3] Army Med Univ, Mil Med Univ 3, Affiliated Hosp 2, 183 Xinqiao Main St, Chongqing 400037, Peoples R China
[4] Gen Hosp Southern Theatre Command, Dept Neurosurg, Guangzhou, Peoples R China
[5] Kunming Med Univ, Qujing 1 Hosp Affiliated Hosp, Affiliated Hosp 1, Kunming, Peoples R China
[6] Longyan First Affiliated Hosp Fujian Med Univ, Dept Ultrasonog, Longyan 364000, Fujian, Peoples R China
[7] First Peoples Hosp Xianyang, Dept Neurol, Xianyang, Shaanxi, Peoples R China
[8] Peoples Hosp Qiandongnan Autonomous Prefecture, Dept Neurosurg, Kaili, Guizhou, Peoples R China
[9] Chongzhou Hosp, Dept Neurol, Chongzhou, Sichuan, Peoples R China
[10] Nanjing Med Univ, Affiliated Huaian 1 Peoples Hosp, Affiliated Huaian No 1 Peoples Hosp, Huaian, Peoples R China
[11] First Affiliated Hosp Hainan Med Univ, Dept Cardiothorac Surg, Haikou 570102, Hainan, Peoples R China
[12] Heyuan Hosp, Heyuan Peoples Hosp, Guangdong Prov Peoples Hosp, Dept Neurol, Heyuan, Guangdong, Peoples R China
[13] Changsha Hosp Tradit Chinese Med, Hosp Changsha 8, Dept Neurosurg, Changsha, Peoples R China
[14] Zigong First peoples Hosp, Dept Neurol, Zigong, Sichuan, Peoples R China
[15] Jiujiang Univ, Affiliated Hosp, Dept Neurol, Jiujiang, Jiangxi, Peoples R China
[16] Wannan Med Coll, Yijishan Hosp, Dept Neurol, Wuhu, Anhui, Peoples R China
[17] Wuhan Puren Hosp, Dept Neurol, Wuhan, Hubei, Peoples R China
[18] 924th Hosp Peoples Liberat Army, Dept Neurol, Guilin, Guangxi, Peoples R China
[19] First Hosp Jilin Univ, Dept Neurol, Changchun, Jilin, Peoples R China
[20] Jingdezhen 1 Peoples Hosp, Dept Neurol, Jingdezhen 333000, Jiangxi, Peoples R China
[21] Aviat Grp, Dept Neurol, Hosp 302, Anshun, Guizhou, Peoples R China
[22] Xiangzhou Dist Peoples Hosp, Dept Neurol, Xiangyang, Hubei, Peoples R China
[23] ChongGang Gen Hosp, Dept Neurol, Chongqing, Peoples R China
[24] Xian XD Grp Hosp, Dept Neurol, Xian, Shaanxi, Peoples R China
[25] South China Univ Technol, Guangzhou Peoples Hosp 1, Sch Med, Dept Neurol, Guangzhou, Guangdong, Peoples R China
[26] Shantou Univ, Affiliated Yuebei Peoples Hosp, Coll Med, Med Coll, Shaoguan, Peoples R China
[27] Guiping Peoples Hosp, Dept Ophthalmol, Guiping 537200, Guangxi, Peoples R China
[28] Suining Cent Hosp, Dept Neurol, Suining, Peoples R China
[29] Yunyang Cty Peoples Hosp, Dept Neurol, Chongqing, Peoples R China
[30] Dali Bai Autonomous Prefecture Peoples Hosp, Dept Neurol, Dali, Yunnan, Peoples R China
[31] Univ Liverpool Liverpool Sch Trop Med, Global Hlth Trials Unit, Liverpool, England
[32] Univ Bern, Univ Hosp Bern, Inselspital, Dept Diagnost & Intervent Neuroradiol, Bern, Switzerland
[33] CHRU Tours, Diagnost & Intervent Neuroradiol, CIC IT 1415, Tours, France
[34] Studium Loire Valley Inst Adv Studies, Orleans, France
[35] Boston Univ, Boston Med Ctr, Chobanian & Avedisian Sch Med, Dept Radiol, Boston, MA USA
[36] Univ Pittsburgh, Sch Med, UPMC Stroke Inst, Dept Neurol, Pittsburgh, PA USA
[37] David Geffen Sch Med UCLA, Dept Neurol, Los Angeles, CA 90024 USA
基金
中国博士后科学基金; 中国国家自然科学基金;
关键词
RANDOMIZED-TRIAL; THROMBECTOMY; EFFICACY; METAANALYSIS; SAFETY;
D O I
10.1001/jama.2024.23480
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ImportancePersisting or new thrombi in the distal arteries and the microcirculation have been reported to limit the benefits of successful endovascular thrombectomy for patients with acute ischemic stroke. It remains uncertain whether intra-arterial thrombolysis by urokinase following near-complete to complete reperfusion by thrombectomy improves outcomes among patients with ischemic stroke due to large vessel occlusion. ObjectiveTo assess the efficacy and adverse events of intra-arterial urokinase after near-complete to complete reperfusion by thrombectomy for acute ischemic stroke due to large vessel occlusion. Design, Setting, and ParticipantsThis investigator-initiated, randomized, open-label, blinded-end point trial was implemented at 35 hospitals in China, enrolling 535 patients with proximal intracranial large vessel occlusion presenting within 24 hours of time last known well, who achieved near-complete or complete reperfusion by endovascular thrombectomy and did not receive intravenous thrombolysis prior to the procedure. Recruitment took place between November 15, 2022, and March 29, 2024, with final follow-up on July 4, 2024. InterventionsEligible patients were randomly assigned to the intra-arterial urokinase group (a single dose of intra-arterial 100 000 IU urokinase injected in the initial target territory; n = 267) or control group (without intra-arterial thrombolysis; n = 267). Main Outcomes and MeasuresThe primary efficacy outcome was the percentage of patients achieving survival without disability (modified Rankin Scale score of 0 or 1) at 90 days. The primary safety outcomes were mortality at 90 days and incidence of symptomatic intracranial hemorrhage within 48 hours. ResultsA total of 535 patients were enrolled (median age, 69 years; 223 [41.8%] female) and 532 (99.6%) completed the trial. The percentage of patients with survival without disability at 90 days was 45.1% (120/266) in the intra-arterial urokinase group and 40.2% (107/266) in the control group (adjusted risk ratio, 1.13 [95% CI, 0.94-1.36]; P = .19). Mortality at 90 days (18.4% vs 17.3%, respectively; adjusted hazard ratio, 1.06 [95% CI, 0.71-1.59]; P = .77) and incidence of symptomatic intracranial hemorrhage (4.1% vs 4.1%, respectively; adjusted risk ratio, 1.05 [95% CI, 0.45-2.44]; P = .91) were not significantly different between groups. Conclusions and RelevanceAmong patients with acute ischemic stroke due to large vessel occlusion, adjunct intra-arterial urokinase after near-complete to complete reperfusion by endovascular thrombectomy did not significantly increase the likelihood of survival without disability at 90 days. Trial RegistrationChiCTR.org.cn Identifier: ChiCTR2200065617
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页数:10
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