Four hundred seventy-three patients with acute myocardial infarction (
AMI) were treated with either saruplase (80 mg/hour, n = 236) or altep
lase (100 mg every 3 hours, n = 237). Comedication included heparin an
d acetylsalicylic acid. Angiography was performed at 45 and 60 minutes
after the start of thrombolytic therapy. When flow was insufficient,
angiography was repeated at 90 minutes. Coronary angioplasty was then
performed if Thrombolysis In Myocardial Infarction (TIMI) trial 0 to 1
flow was seen. Control angiography was at 24 to 40 hours. Baseline ch
aracteristics were similar. Angiography showed comparable and remarkab
ly high early potency rates (TIMI 2 or 3 flow) in both treatment group
s: at 45 minutes, 74.6% versus 68.9% (p = 0.22); and at 60 minutes 79.
9% versus 75.3% (p = 0.26). Patency rates at 90 minutes before additio
nal interventions were also comparable (79.9% and 81.4%). Angiographic
reocclusion rates were not significantly different: 1.2% versus 2.4%
(p = 0.68). After rescue angioplasty, angiographic reocclusion rates o
f 22.0% and 15.0% were observed. Safety data were similar for both gro
ups. Thus, (1) early patency rates were high for saruplase and altepla
se treatment, (2) reocclusion rates for both drugs were remarkably low
, and (3) complication rates were similar. Thus, saruplase seems to be
as safe and effective as alteplase. (C) 1997 by Excerpta Medica, Inc.