A Comparison of Tenecteplase(TNK-tPA) and Alteplase(rt-PA) in Korean Patients with Acute Myocardial Infarction(A Randomized, Multi-Centered Coronary Angiographic Trial)

ABSTRACT

BACKGROUND AND OBJECTIVES: This is a comparative, randomized, multi-centered, angiographic trial for the comparison of TNK-tPA with rt-PA, in Korean patients with an acute myocardial infarction (AMI). SUBJECTS AND METHODS: Fifty four patients that were eligible for thrombolysis, diagnosed with an AMI, were randomized into two groupsTNK-tPA (single bolus injection, 25-50 mg weight adjusted;n=25) or rt-PA (accelerated intravenous infusion, up to 100 mg;n=29) at the emergency room. The primary endpoint was the percentage of patients with a TIMI (Thrombolysis In Myocardial Infarction) III flow 90 min following the administration of the study drug. The secondary endpoints were an infarct-related artery patency at 90 min, the percentage of patients with ST segment resolution at 60 and 180 min, and at 30 days mortality. RESULTS: The baseline demographic data, including age, sex and body weight, and a medical history of prior myocardial infarction and risk factors were no different between the TNK-tPA and rt-PA groups. The pain-to-needle and door-to-needle times were also no different. The ST segment resolution was no different between the two groups. A TIMI grade 3, on a coronary angiogram, 90 min following the drug administration, was observed in 19 (76.0%) of the TNK-tPA and 17 (58.6%) of the rt-PA (p=0.24) patients. However, a TIMI grade more than 2 was higher in the TNK-tPA (100%;25/25) than in rt-PA group (72.4%;21/29)(p=0.0052). The in-hospital adverse events, and clinical outcomes at 30 days, were no different between the two groups. CONCLUSION: TNK-tPA is more convenient, and may be a preferred thrombolytic agent, for the revascularization of an AMI.