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Addition of INTEGRILIN(R) (Eptifibatide) to Bivalirudin Plus Standard of Care Inhibits Platelet Aggregation in Patients Undergoing Elective Coronary Stenting
Date:11/5/2007

h stenting who were given high-dose clopidogrel (600 mg) in the absence of chronic clopidogrel therapy and aspirin (325 mg) and then randomized to either a bivalirudin alone (n=102) or bivalirudin + INTEGRILIN(R) (n=98). The primary outcome of the study was to compare the antiplatelet effects of bivalirudin vs. bivalirudin plus INTEGRILIN(R) in patients being treated with clopidogrel and aspirin at the time of elective percutaneous intervention. Secondary outcomes were the release of markers of myocardial necrosis, inflammatory markers and in- hospital, 30-day, and 1-year clinical outcomes.

All patients post-stenting received standard antiplatelet treatment (75 mg clopidogrel and 325 mg aspirin daily). Patients had serial assessment of platelet reactivity, myocardial necrosis markers, and inflammatory markers at baseline, 2 hours, 8 hours, and 18-24 hours post-stenting. Blood work was processed at The Sinai Center for Thrombosis Research and the University of Oklahoma Health Science Center. Platelet reactivity was measured by aggregometry and flow cytometry. Thrombelastography measured the characteristics of maximum platelet-fibrin clot strength and time to initial platelet-clot formation. Clinical outcomes were recorded using a standard case report form. Patients were followed to 30 days, and will be further followed to one year. In the secondary outcome of 30-day clinical events, the rate of periprocedural myocardial infarction in the bivalirudin plus INTEGRILIN(R) treatment arm was 2% vs. 9% in the bivalirudin alone treatment arm. Statistical significance of these findings has not yet been confirmed.

Bivalirudin plus INTEGRILIN(R) compared to bivalirudin alone produced greater relative inhibition of platelet aggregation induced by 5 or 20 uM ADP, 15 or 25 uM TRAP, or collagen (p<0.01 for all). Platelet reactivity and maximum platelet-fibrin clot strength were higher in patients with myocardial infarction.

This is the first study in PCI patients
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SOURCE Schering-Plough Corporation
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