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.NCT02835534).
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;
Department of Cardiology,Beijing Jishuitan Hospital,Capital Medical University,The Fourth Clinical Medical College of Peking University,Beijing 100035,ChinaPeking University Clinical Research Institute,Peking University First Hospital,Beijing 100191,ChinaDepartment of Cardiology,The First Hospital of Lanzhou University,Lanzhou,Gansu 730013,ChinaDepartment of Cardiology,The First Affiliated Hospital of Liaoning Medical University,Jinzhou,Liaoning 110002,ChinaDepartment of Cardiology,Fuwai Hospital,National Center for Cardiovascular Diseases,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100037,ChinaDepartment of Cardiology,Huaihe Hospital of Henan University,Kaifeng,Henan 450001,ChinaDepartment of Cardiology,Bayannur Hospital,Bayannur,Inner Mongolia 015208,ChinaDepartment of Cardiology,Puyang People’s Hospital,Puyang,Henan 457099,ChinaDepartment of Cardiology,Xingtai Third Hospital,Xingtai,Hebei 054099,ChinaDepartment of Cardiology,Lintao County People’s Hospital,Dingxi,Gansu 730599,ChinaDepartment of Cardiology,Dancheng County People’s Hospital,Zhoukou,Henan 477150,ChinaDepartment of Cardiology,The First People’s Hospital of Lingbao,Sanmenxia,Henan 472500,ChinaDepartment of Cardiology,Shanyin County People’s Hospital,Shuozhou,Shanxi 036999,ChinaDepartment of Cardiology,Uxin Banner People’s Hospital,Ordos,Inner Mongolia 017399,ChinaDepartment of Cardiology,Lingqiu County People’s Hospital,Datong,Shanxi 034499,ChinaDepartment of Cardiology,Huaibin County People’s Hospital,Xinyang,Henan 464411,ChinaDepartment of Cardiology,Tianzhu County People’s Hospital,Wuwei,Gansu 733200,ChinaGuangzhou Recomgen Biotech Co.,Ltd,Guangzhou,Guangdong 510530,China
临床医学
Thrombolytic therapy;rhTNK-tPA;Randomized controlled trial;ST elevation myocardial infarction
《Chinese Medical Journal》 2024 (003)
P.312-319 / 8
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
10.1097/CM9.0000000000002731
评论