Mixed Data From IMPACT-II Trial Of Integrelin

Mixed results from the IMPACT-II trial of Cor Therapeutics' glycoprotein IIb/IIIa receptor antagonist Integrelin were presented at the European Society of Cardiology meeting. The drug demonstrated a significant effect on the primary composite endpoint of all-cause mortality/myocardial/need for revascularization/stent placement at 24 hours, but appeared to have no preventive effects on the rate of restenosis.

IMPACT-II enrolled 4,010 patients at 82 sites, and included an angiographic substudy involving 900 patients looking at restenosis rates. The patients were a mixed population, with 40% of them at high risk of needing cardiac interventions. There were three study arms: high-dose Integrelin (135mcg/kg bolus then 0.75mcg/kg/min for 24 hours); low-dose Integrelin (135mcg/kg bolus and 0.3mcg/kg/min for 24 hours); or placebo.

Compared to placebo, Integrelin achieved a 31% reduction in the primary composite endpoint, which was significant and consistent over all components. At 30 days the reduction was 18%. The top-line data are given in the table below: