TOKYO and INDIANAPOLIS--27 Feb--PRNewswire-AsiaNet/InfoQuest
Results from a pre-specified analysis of the landmark Phase III TRITON-TIMI 38 study showed that patients with the most severe form of acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) achieved a significant reduction in relative risk of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke at both 30 days and 15 months when treated with prasugrel compared with clopidogrel (Plavix(R)/Iscover(R)). These data appear in the February 28 issue of the
medical journal The Lancet.
This analysis of the TRITON-TIMI 38 study showed a significant reduction in cardiovascular events in patients with acute ST elevation myocardial infarction (STEMI, or high-risk heart attack) treated with prasugrel compared with clopidogrel as early as 30 days (32 percent reduction, p=0.0017) and continued for up to 15 months (21 percent reduction, p=0.0221). In addition, a similar safety profile was seen in both the prasugrel and clopidogrel groups. Although the overall study population, which included patients with unstable angina,
NSTEMI (non-STEMI) and STEMI, showed a significant increase in TIMI major bleeding for patients on prasugrel, in the STEMI subpopulation, there was no significant increase of non-CABG (coronary artery bypass grafting) related TIMI major or minor bleeding during the trial period. This analysis of 3,534 STEMI
patients, who were enrolled in the TRITON-TIMI 38 trial, represented the first large analysis evaluating prasugrel as well as clopidogrel in this patient population undergoing PCI.
"Patients with ST elevation myocardial infarction are at higher risk of early cardiovascular events and death than patients with unstable angina," said Professor Gilles Montalescot, key study investigator and professor of cardiology at Pitie-Salpetriere Hospital, Paris. "Our analysis showed that treatment with prasugrel significantly reduced the risk of cardiovascular events compared with clopidogrel -- without an increase in major bleeding -- which is certainly good news for this group of high-risk patients."
About the Analysis
This pre-specified analysis of the landmark Phase III TRITON-TIMI 38 trial assessed the effect of prasugrel versus clopidogrel in the STEMI population undergoing PCI, an interventional procedure to re-open clogged arteries.
Patients were recruited when they presented within 12 hours of symptom onset (primary PCI) or when they presented from 12 hours to 14 days after the onset of symptoms (secondary PCI).
In the sub-analysis, prasugrel reduced the key secondary combined endpoint of cardiovascular death, non-fatal heart attack or urgent target vessel revascularization (UTVR) -- an emergency procedure used to open blockages in arteries when a heart attack is occurring or imminent -- by 21 percent compared with clopidogrel (9.6 percent prasugrel vs. 12 percent clopidogrel, p=0.0250) through 15 months. Treatment with prasugrel also reduced the risk of stent thrombosis in the STEMI sub-population by 42 percent compared with clopidogrel (1.6 percent vs. 2.8 percent, p=0.0232) through 15 months. In both primary and secondary PCI patients, a greater reduction of cardiovascular events was seen with prasugrel versus clopidogrel.
In this sub-analysis of the STEMI population, there was no significant difference between prasugrel and clopidogrel in non-CABG, TIMI major and life-threatening bleeding through 15 months. For the combined endpoint of non-CABG, TIMI major and minor bleeding, there was no difference between the two groups both at 30 days (3 percent prasugrel vs. 3.3 percent clopidogrel, p=0.6170) and 15 months (5.1 percent prasugrel vs. 4.7 percent clopidogrel, p=0.6494). In addition, there was no significant difference between
life-threatening bleeding between prasugrel versus clopidogrel at 15 months (1.3 percent vs. 1.1 percent, respectively, p=0.75).
About TRITON-TIMI 38
The main TRITON-TIMI 38 clinical trial, previously published in the New England Journal of Medicine in November 2007 (Vol. 357 No.20), compared prasugrel with clopidogrel in patients with ACS undergoing PCI. In the primary analysis of the study, prasugrel reduced the relative risk of the combined endpoint of cardiovascular death, heart attack, or stroke by 19 percent (Absolute Risk Reduction 2.2 percent; p