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Results of the TRILOGY ACS Angiographic Cohort presented at TCT 2012

Study finds that prasugrel may reduce cardiovascular events among patients managed medically after an angiogram for acute coronary syndrome

Miami, FL, USA (October 24, 2012) – A study has found that the anti-clotting medication prasugrel reduced cardiovascular events among patients who present with an acute coronary syndrome and are managed medically after an angiogram is performed to determine coronary anatomy. Results of the TRILOGY ACS trial, Angiographic Cohort were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 platelet inhibitor is beneficial in patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI). Because a substantial fraction of these patients do not undergo revascularization after angiography, their optimal DAPT strategy is unknown.

The TRILOGY ACS trial compared prasugrel with aspirin versus clopidogrel with aspirin in the primary cohort of 7,243 UA/NSTEMI patients less than 75 years old who were medically managed without revascularization and had at least one high-risk criterion. The primary results of this study, presented at the European Society of Cardiology earlier this year, did not show any benefit for prasugrel with aspirin versus clopidogrel.

Patients were enrolled in 52 countries from June 2008 through September 2011 with median follow-up of 17 months. Those who weighed more than 60 kg were treated with a 10 mg maintenance dose of prasugrel versus 75 mg of clopidogrel; patients less than 60 kg received 5 mg of prasugrel.

Angiography was not required for enrollment, but if performed, evidence of coronary disease had to be demonstrated (at least one lesion > 30 percent stenosis or prior percutaneous coronary intervention/ coronary artery bypass graft surgery). Approximately 43% of the patients had angiography performed and coronary anatomy determined before being triaged to medical therapy. The results of this angiographic cohort were presented for the first time today at TCT.

Overall, in the TRILOGY ACS Trial, prasugrel did not reduce cardiovascular events among patients managed medically for ACS.

However, when treated with prasugrel compared to clopidogrel, patients who were triaged to medical therapy in the trial following angiography tended to have:

• Lower rates of the combined endpoint of cardiovascular disease/heart attack/stroke
• Lower rates of heart attack, stroke alone, and recurrent ischemic events
• Higher rates of bleeding

"Though hypothesis-generating, these results are consistent with previous trials and suggest that when angiography is performed and coronary disease is confirmed, the benefits and risks of intensive antiplatelet therapy exist whether medical therapy or percutaneous coronary intervention is elected," said Stephen D. Wiviott, MD. Dr. Wiviott is a senior investigator with the TIMI Study Group, associate physician, Cardiovascular Division at Brigham and Women’s Hospital, and associate professor of Medicine at Harvard Medical School.

The results of the TRILOGY ACS Angiographic Cohort trial will be presented on Wednesday October 24 at 12:32 PM EST in the Main Arena (Hall D) of the Miami Beach Convention Center.

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The trial was funded by Eli Lilly & Company and Daiichi Sankyo. Dr. Wiviott reported grant/research support from Eli Lilly & Company, AstraZeneca, Merck, and Eisai; and consulting fees/honoraria from Eli Lilly & Company, Daiichi Sankyo, AstraZeneca, BMS, Sanofi-Aventis, and Eisai.

About CRF

The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field.

For more information, visit www.crf.org

Cardiovascular Research Foundation, 24.10.2012 (tB).