Background and Objective Previous study showed
tenecteplase and alteplaxe were equovalent for 30-day
mortality in the
treatment of acute
myocardial infarction . The purpose of this open-label, randomized, multi-center, angiographic trial was to assess the
efficacy and
safety of
tenecteplase compared with
alteplase in
Chinese patients with acute
myocardial infarction .
Methods We recruited
patients with acute ST-elevation
myocardial infarction presenting within 6 hours of symptom onset from October, 2002 to March,2004, in 5
hospitals in
Beijing . After giving
informed consent ,
patients were randomly assigned a single-bolus
injection of
tenecteplase (30-50 mg according to
body weight ) or front loaded
alteplase (100 mg), and underwent
coronary angiography at 90 min after starting the study
drug . All
patients received
aspirin and
heparin (target
activated partial thromboplastin time 50-70 s). The primary
efficacy end point was the rate of TIMI grade 3 flow at 90 minutes. Other
efficacy end points included TIMI grade 2/3 flow at 90 minutes.
Safety end points included all
stroke ,
intracranial hemorrhage (ICH), moderate/severe
hemorrhage (except for ICH), all-cause
mortality at 30-days, and major non-fatal
cardiac events at 30 days. Results Overall 110
patients were eligible for
statistical analysis , with 58
patients assigned to receive
tenecteplase and 52
patients to
alteplase .
Tenecteplase produced a rate of TIMI grade 3 flow at 90 minutes after the start of thrombolysis(68.4%)
similar to that of
alteplase (66.7%, P=1.0); the rates of TIMI grade 2 or 3 were
similar for
patients treated with
tenecteplase versus
alteplase (89.5% versus 80.4%, respectively, P=0.278). At 30 days, rates for all
strokes were
similar for the two groups (5.17% for
tenecteplase and 1.92% for
alteplase , P=0.62); rates of ICH were 3.45% and 1.92% (
tenecteplase and rt-PA,P=1.00) respectively. The rate of moderate/severe
hemorrhage was 8.62% with
tenecteplase and 5.77% with
alteplase (P=0.72); total
mortality was almost identical in the two groups (13.8% versus 9.6%, respectively, P=0.565) while the rates of non-fatal cardiac
complications were 10.35% and 11.54% (
tenecteplase and
alteplase , P=1.0). Conclusions The
efficacy of a single-bolus, weightadjusted
tenecteplase fibrinolytic regimen is equivalent to front-loaded
alteplase in terms of the rates of TIMI grade 3 flow, and TIMI 2 or 3 flow, but the 30-day
mortality and ICH in both groups was so high that the use of
tenecteplase is not permitted in
China . These negative
safety results might be due to the high rate of
percutaneous coronary intervention (PCI) and high
dose of bolus
heparin and suboptimal concomitant medical
therapy during
hospitalization , so further studies are needed to confirm the
safety for
tenecteplase in
Chinese patients .