HTUPA as a new thrombolytic agent for acute myocardial infarction: A multicenter, randomized study.
Int J Cardiol. 2013 Dec 22;
Authors: Sun Y, Liu X, Guo L, Pang W, Guo X, Sun Z, Li Z, Cui X, Li H, Tao G, Wang L, Zhou C, Liu Y, Shan H, Wang M, Liu M, Li J, Yin L, Hu D
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 (25mg bolus) treatment groups. All patients also received oral aspirin and intravenous heparin. Coronary angiography was performed 90min 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.
PMID: 24525155 [PubMed - as supplied by publisher]