[Glycoprotein IIb-IIIa antagonist Monafram in primary angioplasty of patients with acute coronary syndrome without st segment elevation].
Glycoprotein (GP) llb-llla anagonist monafram is the F(ab)2 fragments of anti GP llb llla monoclonal antibody FraMon (CRC64). Efficacy and safety of monafram in primary coronary angioplasty of patients with acute coronary syndrome without ST segment elevation (non ST ACS) was evaluated in this study. Monafram was introduced intravenously to 284 patients just before angioplasty at standard dosage - 0.25 mg/kg as single i.v. bolus. Control group included 203 patients. All patients received aspirin (loading dose 300 mg and then 75 mg daily) and more than 90% - clopidogrel (loading dose 300-600 mg and then 75 mg daily). Within 30 days of follow up period monafram decreased by more than 2.5 fold the total amount of unfavorable outcomes (cardiovascular death, myocardial infarction and indications for repeat revascularization due to angina recurrence) - from 19.2% to 7.4% (p<0.001). The rate of indications for revascularization was most strongly decreased - by more than 7 times - from 7.9% to 1.1% (p<0.001). The number of myocardial infarctions was reduced by more than 2 times - from 8.4% to 3.9% (p=0.057). The amount of lethal outcomes did not differ between two groups (2.9% and 2.4% in the control and monafram groups, respectively). In the control group 8.9% patients received monafram during primary angioplasty due to urgent indications. Monafram did not cause any allergic reaction in all tested patients. Major bleeding was registered in one (less than 0.5%) and deep thrombocytopenia (<20000 platelets per 1 ul) - in 3 (1.1%) out of 284 patients. The data obtained indicated that monafram decreased the number of thrombotic complications in non ST ACS patients undergoing angioplasty upon the dual antiplatelet therapy (aspirin+clopidogrel) and without significant increase of dangerous side effects.
Pevzner
D V
DV
Staroverov
I I
II
Samko
A N
AN
Frolova
N S
NS
Mazurov
A V
AV
Ruda
M Ya
MY
D054058:Acute Coronary Syndrome / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects; D000077144:Clopidogrel; D004562:Electrocardiography; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000503:physiopathology / Q000628:therapy; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D012307:Risk Factors; D055502:Secondary Prevention; D013921:Thrombocytopenia / Q000139:chemically induced; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D005343:Fibrinolytic Agents; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; C525918:monafram; D006493:Heparin; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin