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.