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Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery
Date:11/16/2010

ly to undergo urgent CABG surgery. The risk of bleeding is increased in patients receiving Effient who undergo CABG. If possible, Effient should be discontinued at least seven days prior to CABG.(4)

Study MethodologyTRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-head clinical trial comparing the effects of Effient versus clopidogrel in patients with ACS who were managed with PCI, a procedure to open blockages in heart arteries, including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke during at least 12 months following PCI. Patients were randomly assigned to one of two treatment groups and given a loading dose of either Effient 60 mg or the FDA-approved loading dose of clopidogrel 300 mg, followed by a daily maintenance dose of either Effient 10 mg or clopidogrel 75 mg. All patients also received a daily dose of aspirin (75 mg to 325 mg).

This retrospective analysis included newly collected data on 346 patients who underwent isolated CABG following withdrawal of study drug, either Effient (n=173) or clopidogrel n=173), during the TRITON-TIMI 38 study.(2) Possible baseline imbalances between arms were adjusted using European System for Cardiac Operative Risk Evaluation (EuroSCORE) and Society of Thoracic Surgeons (STS) scoring, two widely accepted and standardized methods of calculating cardiac operative mortality risk.(2) Bleeding was measured by chest tube blood loss, a standard method used by surgeons.(2) Despite the adjustment for predicted risk of mortality at the time of CABG, this non-randomized comparison between Effient and clopidogrel may be subject to potential residual biases.(2)

About EffientDaiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE:

SOURCE Eli Lilly and Company
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