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Patient Enrollment Complete in First Trial to Compare Physiologic Guidance vs. Angiographic Guidance of Stent Deployment in Patients with Multivessel Disease
Date:10/22/2007

WASHINGTON, Oct. 22 /PRNewswire/ -- Patient enrollment is complete in the first randomized, prospective, multicenter trial that will compare the clinical outcomes and cost-effectiveness of a physiologic-guided percutaneous coronary intervention (PCI) strategy to an angiographic-guided one in patients with multivessel coronary artery disease (CAD). Bernard De Bruyne, M.D., Ph.D., presented the study update today at the Transcatheter Cardiovascular Therapeutics symposium (TCT 2007) in Washington.

One thousand patients at 20 centers worldwide are participating in the FAME (Fractional flow reserve vs. Angiography for Multivessel Evaluation) study. Participants enrolled in the study meet the following criteria:

-- Coronary lesions in at least two of the three major cardiac vessels

have narrowings of greater than or equal to 50 percent by visual

assessment.

-- The lesions require stenting, according to the investigator.

-- The vessels are large enough to accommodate drug-eluting stents.

After an investigator's visual assessment of an angiogram and notation of which lesions appear to require stenting, patients will be assigned randomly to one of the two PCI strategies. Patients assigned to angiographic guidance will undergo stenting as planned, while patients assigned to physiologic guidance will have fractional flow reserve (FFR) measured in diseased vessels with a coronary pressure wire using a system provided by Radi Medical Systems AB. If FFR is less than or equal to 0.80, meaning the coronary pressure or flow beyond the narrowing is less than or equal to 80% of what it should be, the lesion will be stented.

The study's primary endpoint is a composite of major adverse cardiac events (MACE), including death, myocardial infarction and repeat coronary revascularization at one year. Secondary endpoints include global cost effectiveness after one year, cardiac death and myocardial infarction rate at one year, fu
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SOURCE Radi Medical Systems AB
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