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 

作者机构：Department of CardiologyBeijing Jishuitan HospitalCapital Medical UniversityThe Fourth Clinical Medical College of Peking UniversityBeijing 100035China Peking University Clinical Research InstitutePeking University First HospitalBeijing 100191China Department of CardiologyThe First Hospital of Lanzhou UniversityLanzhouGansu 730013China Department of CardiologyThe First Affiliated Hospital of Liaoning Medical UniversityJinzhouLiaoning 110002China Department of CardiologyFuwai HospitalNational Center for Cardiovascular DiseasesChinese Academy of Medical Science and Peking Union Medical CollegeBeijing 100037China Department of CardiologyHuaihe Hospital of Henan UniversityKaifengHenan 450001China Department of CardiologyBayannur HospitalBayannurInner Mongolia 015208China Department of CardiologyPuyang People’s HospitalPuyangHenan 457099China Department of CardiologyXingtai Third HospitalXingtaiHebei 054099China Department of CardiologyLintao County People’s HospitalDingxiGansu 730599China Department of CardiologyDancheng County People’s HospitalZhoukouHenan 477150China Department of CardiologyThe First People’s Hospital of LingbaoSanmenxiaHenan 472500China Department of CardiologyShanyin County People’s HospitalShuozhouShanxi 036999China Department of CardiologyUxin Banner People’s HospitalOrdosInner Mongolia 017399China Department of CardiologyLingqiu County People’s HospitalDatongShanxi 034499China Department of CardiologyHuaibin County People’s HospitalXinyangHenan 464411China Department of CardiologyTianzhu County People’s HospitalWuweiGansu 733200China Guangzhou Recomgen Biotech Co.LtdGuangzhouGuangdong 510530China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2024年第137卷第3期

页      面：312-319页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

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 

主　　题：Thrombolytic therapy rhTNK-tPA Randomized controlled trial ST elevation myocardial infarction 

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)*** 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 ***: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 *** primary endpoint was recanalization defined by thrombolysis in myocardial infarction(TIMI)flow grade 2 or *** secondary endpoint was clinically justified *** endpoints included 30-day major adverse cardiovascular and cerebrovascular events(MACCEs)and safety ***: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 *** used a–15%difference as the non-inferiority efficacy *** 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 *** 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 *** safety outcomes significantly differed between ***: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 ***