한국인 급성 심근경색증 환자에서 Tenecteplase(TNK-tPA)와 Alteplase(rt-PA)의 효과 비교(무작위, 다기관, 관상동맥 조영술을 이용한 임상 시험)

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 groups：TNK-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.