An angiographic trial to evaluate the efficacy and safety of tenecteplase in Chinese patients with acute myocardial infarction
10.3760/cma.j.issn.0253-3758.2009.06.008
- VernacularTitle:急性心肌梗死患者替奈普酶溶栓疗效和安全性评价
- Author:
Feng LIANG
1
;
Li-Zhong WANG
;
Da-Yi HU
;
Xu-Bo SHI
;
Jia-Ping WEI
;
Hong ZHAO
;
Lei WANG
;
San-Qing JIA
;
Hong-Yu WANG
;
Ru-Hui LIU
;
Yun-Dai CHEN
;
Yan-Ling LU
Author Information
1. 首都医科大学大兴医院
- Keywords:
Myocardial infarction;
Tissue plasminogen activator;
Treatment outcome
- From:
Chinese Journal of Cardiology
2009;37(6):514-517
- CountryChina
- Language:Chinese
-
Abstract:
Objective In this randomized,open-label,multicenter,angiographic trial,we compared the efficacy and safety of tenecteplase(TNK-tPA)with alteplase(rt-PA)in Chinese patients with acute myocardial infarction.Method Patients with acute ST-elevation myocardial infarction and pain to hospital time within 6 hours from October 2002,to March 2004 were randomly assigned a body weight adjusted bolus of TNK-tPA(0.53 ms/kg over more than 10 s,n=58) or front loaded rt-PA(≤100 mg,n=52).Coronary angeography was performed at 90 min after initiating study drugs.All patients received aspirin and heparin(target activated partial thromboplastin time:50-70 s).The primary end point of the trial was the rate of TIMI grade 3 flow at 90 minutes.Other end points included the rate of TIMI grade 2/3 flow at 90 minutes,all cause mortality at 30 days,the moderate/severe hemorrhage without intracranial hemorrhage(ICH) and ICH within 30 days.Results TIMI grade 3 flow at 90 minutes(68.4%vs.66.7%,P=1.00),TIMI grade 2 or 3 at 90 minutes(89.5%vs.80.4%,P=0.278).total mortality at 30 days(13.8%vs.9.6%,P=0.565),the rate of moderate/severe hemorrhage(8.6%vs.5.8%,P=0.72)and incidence of ICH(3.5%vs.1.9%.P=1.00)were all similar in TNK-tPA treated patients compared to rt-PA treated patients.Conclusion The efficacy of single-bolus,weight-adjusted TNK-tPA fibrinolytic regimen is equivalent to front-loaded alteplase in terms of the rates of TIMI grade 3 flow,TIMI 2 or 3 flow.Incidences of moderate/severe hemorrhage,ICH and 30-days mortality were similar in TNK-tPA and rt-PA treated patients.