Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction: A randomized non-inferiority trial
10.1097/CM9.0000000000002731
- VernacularTitle:Tenecteplase versus alteplase in treatment of acute ST-segment elevation myocardial infarction: A randomized non-inferiority trial
- Author:
Xingshan ZHAO
1
;
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
Author Information
1. Department of Cardiology, Beijing Jishuitan Hospital, Capital Medical University, The Fourth Clinical Medical College of Peking University, Beijing 100035, China
- Keywords:
Thrombolytic therapy;
rhTNK-tPA;
Randomized controlled trial;
ST elevation myocardial infarction
- From:
Chinese Medical Journal
2024;137(3):312-319
- CountryChina
- Language:Chinese
-
Abstract:
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).
