[Results of clinical trials of a novel glycoprotein IIb-IIIa antagonist framon in high-risk coronary angioplasty].
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.
Mazurov
A V
AV
Pevzner
D V
DV
Staroverov
I I
II
Samko
A N
AN
Antonova
O A
OA
Ivanov
V A
VA
Abugov
S A
SA
Gontuar
M G
MG
Chestukhin
V V
VV
Vlasik
T N
TN
Ruda
M Ia
MIa
D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000276:immunology; D003328:Coronary Thrombosis / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000276:immunology* / Q000627:therapeutic use*; D007275:Injections, Intravenous; D039661:Integrin beta3 / Q000276:immunology* / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D040201:Platelet Membrane Glycoprotein IIb / Q000276:immunology* / Q000378:metabolism*; D011971:Receptors, Immunologic / Q000008:administration & dosage / Q000276:immunology* / Q000627:therapeutic use*; D012307:Risk Factors
D000911:Antibodies, Monoclonal; C052643:F(ab')2 receptor; D007155:Immunologic Factors; D039661:Integrin beta3; D040201:Platelet Membrane Glycoprotein IIb; D011971:Receptors, Immunologic