New
glycoprotein (
GP) IIb-IIIa antagonist preparation
framon (
Monafram), is the F(ab')(2) fragment of a
monoclonal antibody FRaMon directed against
GP IIb-IIIa. This preparation blocks
GP IIb-IIIa binding with
fibrinogen and inhibits platelet aggregation both in vitro and upon
intravenous administration. Safety and ability of
framon to prevent thrombotic complications in high risk coronary angioplasty (CA) was evaluated in the present study.
FRAMON was injected intravenously into 153 patients just before the start of procedure as a single bolus at the dose of 0.25 mg/kg. Control group was formed of 126 patients who underwent angioplasty without
GP IIb-IIIa blockers. After
framon administration there were no
allergic reactions or major bleedings, deep
thrombocytopenia (< 50000/microl) developed in 1 patient (< 1%), and
antibodies against
framon were detected in less than 5% of patients. Number of unfavorable outcomes (cardiovascular death,
myocardial infarction, angina recurrence) within 1 month after CA was 3 times higher in control group than in the group of patients treated with
framon (11.4% and 3.3%, respectively, p = 0.018). The effect of
framon was most strongly pronounced within the first day after procedure -- administration of the
drug reduced number of acute
thromboses from 6.5% to 0.7% (p = 0.013). Significant differences between numbers of end points was still preserved at 6 months after procedure (25.7 and 14.2% in control and
framon groups, respectively, p = 0.023). The data obtained proved safety and clinical efficacy of
framon administration in coronary angioplasty with high risk of thrombotic complications.