HTUPA as a new thrombolytic agent for acute myocardial infarction: A multicenter, randomized study

• Published in: International journal of cardiology Vol. 172; no. 2; pp. 326 - 331
• Main Authors: Sun, Yingxian, Liu, Xingli, Guo, Liang, Pang, Wenyue, Guo, Xiaofan, Sun, Zhaoqing, Li, Zhanquan, Cui, Xiaoying, Li, Hui, Tao, Guizhou, Wang, Lanfeng, Zhou, Changyong, Liu, Ying, Shan, Hongwei, Wang, Manqing, Liu, Mingxin, Li, Jia, Yin, Lei, Hu, Dayi
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 15.03.2014; Elsevier
• Subjects: Acute myocardial infarction; Adult; Aged; Anticoagulants - therapeutic use; Aspirin - therapeutic use; Biological and medical sciences; Blood Pressure - physiology; Cardiology. Vascular system; Cardiovascular; China; Coronary Angiography; Coronary heart disease; Electrocardiography; Female; Fibrinolytic Agents - therapeutic use; Heart; Heart Rate - physiology; Heparin - therapeutic use; HTUPA; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - diagnostic imaging; Myocardial Infarction - drug therapy; Myocardial Infarction - physiopathology; Myocarditis. Cardiomyopathies; Patency; rt-PA; Stroke Volume - physiology; Thrombolysis; Treatment Outcome; Urokinase-Type Plasminogen Activator - therapeutic use; Vascular Patency; Patency; HTUPA; Acute myocardial infarction; Thrombolysis; rt-PA; Myocardial infarction; Agent; Acute; Multicenter study; Cardiovascular disease; Coronary heart disease; Myocardial disease; Fibrinolysis; Randomization; Clinical trial; Cardiology; Fibrinolytic
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2013.12.018

Abstract Background It is necessary to develop a new thrombolytic agent which can be used by a single bolus at first aid sites to decrease the time to reperfusion in clinical practice. HTUPA, a genetically engineered new thrombolytic with a longer half-life, is well qualified. We aim to compare the thrombolytic efficacy and safety of human tissue urokinase type plasminogen activator (HTUPA) to recombinant tissue plasminogen activator (rt-PA) in Chinese patients with acute myocardial infarction (AMI). Methods AMI patients (n = 221) were randomized to rt-PA (a standard protocol) or HTUPA (25 mg bolus) treatment groups. All patients also received oral aspirin and intravenous heparin. Coronary angiography was performed 90 min after therapy initiation to determine infarct-related coronary artery (IRA) patency. Clinical outcomes and changes of clotting variables, heart rate, blood pressure, left ventricular ejection fraction (LVEF), and electrocardiogram were evaluated. Results Patent IRA [thrombolysis in myocardial infarction (TIMI) grade 2 or 3] was observed in 77% of HTUPA-treated patients, compared to 76% of rt-PA-treated patients ( P = 0.76). TIMI grade 3 patency rates were 52% and 44% in the HTUPA and rt-PA groups, respectively ( P = 0.37). The total patency rate was 77% (86/111 patients) in the HTUPA group and 73% (80/110 patients) in the rt-PA group ( P = 0.41). Adverse events were infrequent in both groups, and no significant differences were detected in mortality, re-occlusion rate, revascularization rate, adverse effects, clotting index, LVEF, or electrocardiogram between the two groups. Conclusions Intravenous HTUPA had a safe and efficacious profile as good as rt-PA in patients with AMI.