Combined therapy effective in treatment of percutaneous coronary intervention

Clear platelets II, designed to evaluate the effects of the addition of Integrilin to an anti-thrombotic regimen of aspirin, clopidogrel and bivalirudin in elective percutaneous coronary intervention (PCI) patients, demonstrated that when added to bivalirudin, Integrilin significantly decreased platelet aggregation in response to multiple stimuli, thereby producing increased platelet inhibition. Results were statistically significant for all measurements of platelet aggregation induced by multiple agonists.

Clear Platelets II was a randomized two-center, open-label study enrolling 200 patients undergoing elective PCI with stenting who were given high-dose clopidogrel (600mg) in the absence of chronic clopidogrel therapy and aspirin (325mg, and then randomized to either a bivalirudin alone or bivalirudin plus Integrilin.

The primary outcome of the study was to compare the antiplatelet effects of bivalirudin versus bivalirudin plus Integrilin 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.

In the secondary outcome of 30-day clinical events, the rate of periprocedural myocardial infarction in the bivalirudin plus Integrilin treatment arm was 2% versus 9% in the bivalirudin alone treatment arm. Bivalirudin plus Integrilin compared to bivalirudin alone produced greater relative inhibition of platelet aggregation.

Paul Gurbel, director of the Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, said: “The results reflect the importance of a GP IIb-IIIa inhibitor in reducing platelet aggregation. This pharmacodynamic study supports the role of inhibition of platelet aggregation in patients undergoing elective coronary stenting.”