S. Vanderschueren et al., RANDOMIZED CORONARY PATENCY TRIAL OF DOUBLE-BOLUS RECOMBINANT STAPHYLOKINASE VERSUS FRONT-LOADED ALTEPLASE IN ACUTE MYOCARDIAL-INFARCTION, The American heart journal, 134(2), 1997, pp. 213-219
One hundred two patients with evolving myocardial infarction of 6 hour
s' duration were given aspirin and intravenous heparin and randomly al
located to intravenous front-loaded, weight-adjusted rTPA administrati
on over a 90-minute period (52 patients) or to two 15 mg doses of reco
mbinant staphylokinase, 30 minutes apart (50 patients). Thrombolysis i
n Myocardial Infarction (TIMI) perfusion grade 3 at 90 minutes was ach
ieved in 68% (95% confidence interval, 55% to 81%) of patients treated
with staphylokinase versus 57% (95% confidence interval, 43% to 72%)
of patients treated with rTPA (p = not significant). Double-bolus stop
hylokinase was significantly more fibrin-specific than accelerated rTP
A with residual fibrinogen at 90 minutes of 105% +/- 4.1% and 68% +/-
75%, respectively (p < 0.0001). Thirteen patients in each study group
underwent angioplasty of the culprit coronary artery within the first
24 hours because of suboptimal recanalization (TIMI <3). In the patien
ts without prior coronary intervention, TIMI 3 at 24 hours was 100% af
ter staphylokinase administration (n = 35) versus 79% after rTPA (n =
34) (p = 0.005). The distribution of inhospital events did not signifi
cantly differ between both groups. One patient receiving rTPA died in
the hospital from ischemic stroke. Staphylokinase administration did n
ot induce allergic reactions, but significant staphylokinase-neutraliz
ing activity (>5 mu g/ml) and specific anti-staphylokinase IgG develop
ed in 73% of patients after 2 weeks. Thus two 75 mg doses of staphylok
inase induce early, complete, and sustained coronary artery patency at
least as frequently as accelerated rTPA without associated fibrinogen
degradation but with subsequent induction of circulating neutralizing
antibodies.