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New Analysis of Data Presented at AHA Regarding Effect of Effient® (Prasugrel) on Cardiovascular Events in STEMI Patients According to Timing of PCI
Date:11/16/2011

on if primary PCI was intended or at the time of secondary PCI. The primary endpoint of the analysis was a reduction in the composite of CV death, MI and stroke.

In this analysis, TIMI major non-CABG bleeding events at 15 months occurred in 3 percent of prasugrel-treated primary PCI patients and 1.9 percent of clopidogrel-treated patients (HR=1.52, p=0.13); TIMI non-CABG major or minor bleeding occurred in this patient group in 5 percent of clopidogrel-treated patients and 6 percent of prasugrel-treated patients (HR=1.33, p=0.12). In secondary PCI patients, TIMI major non-CABG bleeding events occurred in 2.5 percent of clopidogrel-treated patients and 0.9 percent of prasugrel-treated patients (HR=0.39, p=0.07); TIMI non-CABG major or minor bleeding events occurred in 5 percent of clopidogrel-treated patients compared to 3 percent of prasugrel-treated patients (HR=0.57, p=0.09).(1) TIMI major non-CABG bleeding events associated with prasugrel as compared to clopidogrel were consistent in the STEMI cohort compared to the overall trial. Within the PCI subgroup, the hazard of bleeding with primary PCI at 15 months was HR 1.52 [CI 0.87-2.65] and for secondary PCI at 15 months was HR 0.39 [CI 0.14-1.11].(1)

Overall TRITON-TIMI 38 Study Methodology

TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg loading dose [LD], followed by a 10-mg once-daily maintenance dose) plus aspirin (ASA) with Plavix (clopidogrel) (300-mg LD, followed by a 75-mg once-daily maintenance dose) plus ASA in 13,608 patients with ACS managed with percutaneous coronary intervention (PCI), a procedure to open blockages in heart arteries, including the use of coronary stenting. The median duration of study treatment was 14.5 months.(2)

The primary endpoint of the study was the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke in patients followed for 6-15 months following PCI. The study showed that treatment with Effie
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SOURCE Eli Lilly and Company
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