Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction:A randomized non-inferiority trial  

作　　者：Xingshan Zhao Yidan Zhu Zheng Zhang Guizhou Tao Haiyan Xu Guanchang Cheng Wen Gao Liping Ma Liping Qi Xiaoyan Yan Haibo Wang Qingde Xia Yuwang Yang Wanke Li Juwen Rong Limei Wang Yutian Ding Qiang Guo Wanjun Dang Chen Yao Qin Yang Runlin Gao Yangfeng Wu Shubin Qiao 

机构地区：[1]Department of Cardiology,Beijing Jishuitan Hospital,Capital Medical University,The Fourth Clinical Medical College of Peking University,Beijing 100035,China [2]Peking University Clinical Research Institute,Peking University First Hospital,Beijing 100191,China [3]Department of Cardiology,The First Hospital of Lanzhou University,Lanzhou,Gansu 730013,China [4]Department of Cardiology,The First Affiliated Hospital of Liaoning Medical University,Jinzhou,Liaoning 110002,China [5]Department of Cardiology,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100037,China [6]Department of Cardiology,Huaihe Hospital of Henan University,Kaifeng,Henan 450001,China [7]Department of Cardiology,Bayannur Hospital,Bayannur,Inner Mongolia 015208,China [8]Department of Cardiology,Puyang People’s Hospital,Puyang,Henan 457099,China [9]Department of Cardiology,Xingtai Third Hospital,Xingtai,Hebei 054099,China [10]Department of Cardiology,Lintao County People’s Hospital,Dingxi,Gansu 730599,China [11]Department of Cardiology,Dancheng County People’s Hospital,Zhoukou,Henan 477150,China [12]Department of Cardiology,The First People’s Hospital of Lingbao,Sanmenxia,Henan 472500,China [13]Department of Cardiology,Shanyin County People’s Hospital,Shuozhou,Shanxi 036999,China [14]Department of Cardiology,Uxin Banner People’s Hospital,Ordos,Inner Mongolia 017399,China [15]Department of Cardiology,Lingqiu County People’s Hospital,Datong,Shanxi 034499,China [16]Department of Cardiology,Huaibin County People’s Hospital,Xinyang,Henan 464411,China [17]Department of Cardiology,Tianzhu County People’s Hospital,Wuwei,Gansu 733200,China [18]Guangzhou Recomgen Biotech Co.,Ltd,Guangzhou,Guangdong 510530,China

出　　处：《Chinese Medical Journal》2024年第3期312-319,共8页中华医学杂志（英文版）

基　　金：supported by the Guangzhou Recomgen Biotech Co.,Ltd.The funder had no role in the design and conduct of the study;collection,management,analysis,and interpretation of the data

摘　　要：Background:A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator(rhTNK-tPA)has previously shown its preliminary efficacy in ST elevation myocardial infarction(STEMI)patients.This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase(rt-PA)in Chinese patients with STEMI.Methods:In this multicenter,randomized,open-label,non-inferiority trial,patients with acute STEMI were randomly assigned(1:1)to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min.The primary endpoint was recanalization defined by thrombolysis in myocardial infarction(TIMI)flow grade 2 or 3.The secondary endpoint was clinically justified recanalization.Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events(MACCEs)and safety endpoints.Results:From July 2016 to September 2019,767 eligible patients were randomly assigned to receive rhTNK-tPA(n=384)or rt-PA(n=383).Among them,369 patients had coronary angiography data on TIMI flow,and 711 patients had data on clinically justified recanalization.Both used a–15%difference as the non-inferiority efficacy margin.In comparison to rt-PA,both the proportion of patients with TIMI grade 2 or 3 flow(78.3%[148/189]vs.81.7%[147/180];differences:–3.4%;95%confidence interval[CI]:–11.5%,4.8%)and clinically justified recanalization(85.4%[305/357]vs.85.9%[304/354];difference:–0.5%;95%CI:–5.6%,4.7%)in the rhTNK-tPA group were non-inferior.The occurrence of 30-day MACCEs(10.2%[39/384]vs.11.0%[42/383];hazard ratio:0.96;95%CI:0.61,1.50)did not differ significantly between groups.No safety outcomes significantly differed between groups.Conclusion:rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery,a validated surrogate of clinical outcomes,among Chinese patients with acute STEMI.Trial registration:www.ClinicalTrials.gov(No

关 键 词：Thrombolytic therapy rhTNK-tPA Randomized controlled trial ST elevation myocardial infarction 

分 类 号：R542.22[医药卫生—心血管疾病]