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Radi Medical Systems AB Patient Enrollment Complete in First Trial to Compare Physiologic Guidance vs. Angiographic Guidance of Stent Deployment in Patients with Multivessel Disease


10/22/2007 8:15:19 AM

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:

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, functional class at one year, number of anti-anginal drugs after one year, overall MACE rate at one month post-procedure and at six months, two, three and five years.

"With drug-eluting stents (DES) and lower restenosis rates, interventional cardiologists are performing PCI more often in patients with increasingly complex CAD, including multivessel disease," said Dr. De Bruyne. "Furthermore, some physicians are stenting all intermediate lesions with DES regardless of the physiologic significance of those lesions. DES are expensive and have been associated with potential late complications. Therefore, the objective of FAME is to help us identify an approach to PCI that will improve overall clinical outcomes and reduce healthcare expenditure."

In addition to Dr. De Bruyne, the FAME study's investigators are represented by Nico H. J. Pijls, M.D., Ph.D.; Pim Tonino, M.D.; Uwe Siebert, M.D., M.Sc., M.P.H., Sc.D.; and William Fearon, M.D. A paper outlining the rationale and design of the trial is published in the October issue of American Heart Journal (American Heart Journal Vol.154, No. 4, pp.632-636). For more information about the FAME study, visit http://clinicaltrials.gov/ct/gui/show/NCT00267774?order=17 .

david.schull@russopartnersllc.combenjamin.carmichael@russopartnersllc.com

CONTACT: David Schull, david.schull@russopartnersllc.com, or Benjamin
Carmichael, benjamin.carmichael@russopartnersllc.com, both of Russo
Partners for Radi Medical Systems AB, +1-212-845-4271, +1-858-717-2310
during TCT 2007

Web site: http://clinicaltrials.gov/ct/gui/show/NCT00267774?order=17/


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