PMID- 37265385
OWN - NLM
STAT- MEDLINE
DCOM- 20240206
LR  - 20240305
IS  - 2542-5641 (Electronic)
IS  - 0366-6999 (Print)
IS  - 0366-6999 (Linking)
VI  - 137
IP  - 3
DP  - 2024 Feb 5
TI  - Tenecteplase versus alteplase in treatment of acute ST-segment elevation 
      myocardial infarction: A randomized non-inferiority trial.
PG  - 312-319
LID - 10.1097/CM9.0000000000002731 [doi]
AB  - 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).
CI  - Copyright (c) 2024 The Chinese Medical Association, produced by Wolters Kluwer, 
      Inc. under the CC-BY-NC-ND license.
FAU - Zhao, Xingshan
AU  - Zhao X
AD  - Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, 
      The Fourth Clinical Medical College of Peking University, Beijing 100035, China.
FAU - Zhu, Yidan
AU  - Zhu Y
AD  - Peking University Clinical Research Institute, Peking University First Hospital, 
      Beijing 100191, China.
FAU - Zhang, Zheng
AU  - Zhang Z
AD  - Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, 
      Gansu 730013, China.
FAU - Tao, Guizhou
AU  - Tao G
AD  - Department of Cardiology, The First Affiliated Hospital of Liaoning Medical 
      University, Jinzhou, Liaoning 110002, China.
FAU - Xu, Haiyan
AU  - Xu H
AD  - Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular 
      Diseases, Chinese Academy of Medical Science and Peking Union Medical College, 
      Beijing 100037, China.
FAU - Cheng, Guanchang
AU  - Cheng G
AD  - Department of Cardiology, Huaihe Hospital of Henan University, Kaifeng, Henan 
      450001, China.
FAU - Gao, Wen
AU  - Gao W
AD  - Department of Cardiology, Bayannur Hospital, Bayannur, Inner Mongolia 015208, 
      China.
FAU - Ma, Liping
AU  - Ma L
AD  - Department of Cardiology, Puyang People's Hospital, Puyang, Henan 457099, China.
FAU - Qi, Liping
AU  - Qi L
AD  - Department of Cardiology, Xingtai Third Hospital, Xingtai, Hebei 054099, China.
FAU - Yan, Xiaoyan
AU  - Yan X
AD  - Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, 
      The Fourth Clinical Medical College of Peking University, Beijing 100035, China.
FAU - Wang, Haibo
AU  - Wang H
AD  - Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, 
      The Fourth Clinical Medical College of Peking University, Beijing 100035, China.
FAU - Xia, Qingde
AU  - Xia Q
AD  - Department of Cardiology, Lintao County People's Hospital, Dingxi, Gansu 730599, 
      China.
FAU - Yang, Yuwang
AU  - Yang Y
AD  - Department of Cardiology, Dancheng County People's Hospital, Zhoukou, Henan 
      477150, China.
FAU - Li, Wanke
AU  - Li W
AD  - Department of Cardiology, The First People's Hospital of Lingbao, Sanmenxia, 
      Henan 472500, China.
FAU - Rong, Juwen
AU  - Rong J
AD  - Department of Cardiology, Shanyin County People's Hospital, Shuozhou, Shanxi 
      036999, China.
FAU - Wang, Limei
AU  - Wang L
AD  - Department of Cardiology, Uxin Banner People's Hospital, Ordos, Inner Mongolia 
      017399, China.
FAU - Ding, Yutian
AU  - Ding Y
AD  - Department of Cardiology, Lingqiu County People's Hospital, Datong, Shanxi 
      034499, China.
FAU - Guo, Qiang
AU  - Guo Q
AD  - Department of Cardiology, Huaibin County People's Hospital, Xinyang, Henan 
      464411, China.
FAU - Dang, Wanjun
AU  - Dang W
AD  - Department of Cardiology, Tianzhu County People's Hospital, Wuwei, Gansu 733200, 
      China.
FAU - Yao, Chen
AU  - Yao C
AD  - Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, 
      The Fourth Clinical Medical College of Peking University, Beijing 100035, China.
FAU - Yang, Qin
AU  - Yang Q
AD  - Guangzhou Recomgen Biotech Co., Ltd, Guangzhou, Guangdong 510530, China.
FAU - Gao, Runlin
AU  - Gao R
AD  - Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular 
      Diseases, Chinese Academy of Medical Science and Peking Union Medical College, 
      Beijing 100037, China.
FAU - Wu, Yangfeng
AU  - Wu Y
AD  - Peking University Clinical Research Institute, Peking University First Hospital, 
      Beijing 100191, China.
FAU - Qiao, Shubin
AU  - Qiao S
AD  - Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular 
      Diseases, Chinese Academy of Medical Science and Peking Union Medical College, 
      Beijing 100037, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02835534
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20230602
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
RN  - EC 3.4.21.68 (Tissue Plasminogen Activator)
RN  - WGD229O42W (Tenecteplase)
RN  - 0 (Fibrinolytic Agents)
SB  - IM
MH  - Humans
MH  - Tissue Plasminogen Activator/therapeutic use/adverse effects
MH  - Tenecteplase/therapeutic use
MH  - *ST Elevation Myocardial Infarction/drug therapy
MH  - Fibrinolytic Agents/therapeutic use
MH  - *Myocardial Infarction/drug therapy
MH  - Treatment Outcome
PMC - PMC10836890
COIS- Qin Yang reported being as the chief executive officer for Recomlyse, the 
      marketed product of thrombolytic agent in the Guangzhou Recomgen Biotech Co., 
      Ltd. Haiyan Xu, Yangfeng Wu, Xingshan Zhao, and Shubin Qiao reported receiving 
      honoraria for steering committee membership from the Guangzhou Recomgen Biotech 
      Co., Ltd. The remaining authors have no disclosure to report.
EDAT- 2023/06/02 13:15
MHDA- 2024/02/06 06:42
PMCR- 2024/02/05
CRDT- 2023/06/02 09:43
PHST- 2022/05/27 00:00 [received]
PHST- 2024/02/06 06:42 [medline]
PHST- 2023/06/02 13:15 [pubmed]
PHST- 2023/06/02 09:43 [entrez]
PHST- 2024/02/05 00:00 [pmc-release]
AID - 00029330-202402050-00009 [pii]
AID - CMJ-2022-1479 [pii]
AID - 10.1097/CM9.0000000000002731 [doi]
PST - ppublish
SO  - Chin Med J (Engl). 2024 Feb 5;137(3):312-319. doi: 10.1097/CM9.0000000000002731. 
      Epub 2023 Jun 2.