MUNICH, Germany, Sept. 3 A sub-analysis of theTRITON-TIMI 38 clinical trial showed that treatment with prasugrel comparedwith clopidogrel significantly reduced the risk of new or recurrent heartattacks (7.4 percent vs. 9.7 percent, p<0.0001), regardless of whether theevents occurred around the time of an artery-opening procedure known aspercutaneous coronary intervention (PCI), or if they occurred spontaneouslyduring the longer-term maintenance phase. The analysis was presented today atthe European Society of Cardiology (ESC) in Munich, Germany.
The sub-analysis assessed the effect of prasugrel on new or recurrentheart attacks, occurring in the acute setting and during long-term medicaltreatment (up to 15 months) in 13,608 acute coronary syndromes (ACS) patientswho were managed with PCI. New or recurrent heart attacks were classifiedaccording to the ESC Universal Definition of Myocardial Infarction asspontaneous (Type 1) or procedure-related (Type 4 or 5).(1) The analysisshowed that prasugrel consistently and significantly reduced spontaneous (Type1) heart attacks by 29 percent compared with clopidogrel (2.5 percent vs. 3.4percent, p=0.0015) and procedure-related recurrent heart attacks (Type 4 or 5)24 percent in prasugrel-treated patients compared with those takingclopidogrel (4.9 percent vs. 6.4 percent, p=0.0002).
Long-term treatment with prasugrel, continuing after 30 days for up to 15months, significantly reduced the risk for patients who suffer any form ofheart attack by 23 percent compared with clopidogrel (2.9 percent vs. 3.7percent, p=0.01). In the sub-analysis, prasugrel was also shown to reduce therisk of a future severe heart attack (ST elevation myocardial infarction(STEMI), a more severe form of ACS with a higher risk of death) by more than50 percent compared with clopidogrel (p=0.0001).
The main TRITON-TIMI 38 clinical trial, for which overall results werepreviously published in the New England Journal of Medicine in November 2007(Vol. 357 No.20), compared prasugrel with clopidogrel (Plavix(R)/Iscover(R))in patients with ACS undergoing PCI. In the primary analysis of the trial,prasugrel reduced the risk of the composite of cardiovascular death, heartattack or stroke by 19 percent, with an increased risk of major bleedingcompared with clopidogrel (2.4 percent vs. 1.8 percent).(2)
Heart attacks are a major manifestation of coronary heart disease, aglobal health problem. About 7.2 million people die each year from coronaryheart disease worldwide.(3) In the United States, the annual rate of heartattack is 920,000, with 600,000 being first-time attacks and 320,000 repeatattacks.(4)
"In this new sub-analysis of TRITON-TIMI 38, we found that the reductionof heart attacks seen with prasugrel compared with clopidogrel was consistentacross the spectrum of heart attacks based on type, timing and magnitude,"said David Morrow, M.D., M.P.H., associate professor of medicine at HarvardMedical School and the Brigham and Women's Hospital, Boston, USA, andinvestigator with the Thrombolysis in Myocardial Infarction (TIMI) StudyGroup.
About TRITON-TIMI 38
TRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-headclinical trial comparing the effects of prasugrel versus clopidogrel inpatients with ACS who were managed with PCI, a procedure to open blockages inheart arteries including the use of coronary stenting. The study enrolled13,608 patients at 707 trial sites in 30 countries.
The primary endpoint of the study was to compare the effects of prasugrelto clopidogrel on the combined incidence of cardiovascular death, non-fatalheart attack and non-fatal stroke during a median period of at least 12 monthsfollowing PCI. Patients were randomly assigned to one of two treatment groupsand given a loading dose of either prasugrel 60 mg or the approved loadingdose of clopidogrel 300 mg anytime betw