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TRITON-TIMI 38 Stent Analysis Favors Prasugrel
Date:3/29/2008

Regardless of stent timing and type, prasugrel bests clopidogrel

CHICAGO, March 29 /PRNewswire/ -- Prasugrel has been shown to block platelet activity in patients with acute coronary syndromes (ACS) more effectively than clopidogrel, and to cut by more than half the risk of thrombosis, or blood clotting, inside the coronary stent. Now a new analysis of data from the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel (TRITON-TIMI 38) reveals that the investigational drug maintains its edge over clopidogrel regardless of the type of stent, the amount of time since the stenting procedure, or the way stent thrombosis is defined.

The results of the TRITON-TIMI 38 analysis are being reported today in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC). The study will be simultaneously published online in The Lancet.

For the main TRITON-TIMI 38 study, researchers recruited 13,608 patients with ACS who needed stenting from 707 medical centers in 30 countries. Patients were randomly assigned to anti-platelet therapy consisting of either a 300-mg loading dose of clopidogrel before the procedure, followed by a maintenance dose of 75 mg daily for one year, or to a loading dose of 60 mg of prasugrel, followed by 10 mg daily for one year. Both medications prevent unwanted blood clotting by inhibiting the ability of platelets to clump together.

Stephen D. Wiviott, MD, Brigham and Women's Hospital, Boston, led the new stent analysis. Of the 12,844 patients who ultimately were treated with at least one coronary stent, 6,461 patients received only bare-metal stents (BMS), and 5,743 patients received only drug-eluting stents (DES). Overall, prasugrel reduced both early stent thrombosis -- within 30 days of stenting -- when compared with clopidogrel (0.64 percent vs. 1.56 percent, hazard ratio 0.41, p<0.001) -- and late stent thrombosis -- more than 30 days after stenting (0.49 percent vs. 0.82 percent, hazard ratio 0.60, p=0.035). For bare-metal stents, the respective rates of stent thrombosis with prasugrel and clopidogrel were 1.3 percent vs. 2.4 percent, hazard ratio 0.52, p=0.009, and for drug-eluting stents, 0.8 percent vs. 2.3 percent, hazard ratio 0.36, p<0.001. Prasugrel's advantage remained highly statistically significant across a broad array of patient and procedural characteristics.

Dr. Wiviott will present the results of the "Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel" (TRITON-TIMI 38) stent substudy on Saturday, March 29 at 9:00 a.m. CDT in the Grand Ballroom, S100. The study will be simultaneously published online in The Lancet.

About SCAI

Headquartered in Washington, DC, the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in over 60 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's annual meeting has become the leading venue for education, discussion, and debate about the latest developments in this dynamic medical specialty.

About ACC

The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care.


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