News | October 15, 2008

FAME Data Demonstrates 30 Percent Reduction in Composite Events When Using Routine FFR Guidance in Multi-Vessel Disease

October 16, 2008 - The one-year follow-up of the FAME study (FFR vs. angiography for multivessel evaluation) was presented at TCT 2008 and confirms the beneficial clinical and economic impact of FFR when used routinely to guide treatments of multi-vessel disease.

“The FAME study is among the most important studies in today's DES therapy era,” said Morton Kern, M.D., professor of medicine and associate chief, Division of Cardiology, University of California, Irvine. “FAME demonstrates that when physicians employ FFR to guide multi-vessel PCI treatment, their patients benefit both clinically and economically. The FFR-guided interventions for multi-vessel disease are also cost effective for hospitals and payers. FAME confirms the benefits of routine FFR for the multi-vessel patient just as the earlier deferral versus performance of PTCA in Patients Without Documented ischemia (DEFER) study demonstrated in single-vessel disease, but does so in a larger patient population and in a randomized fashion,"

FAME randomized 1005 patients diagnosed with multi-vessel coronary artery disease at 20 European and U.S. centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current DES regimens. FAME’s objective was to compare angiographic guidance to FFR guidance and to determine which coronary lesions required revascularization. FAME demonstrated that FFR- guidance in routine multi-vessel PCI resulted in clinically-superior outcomes and reduced the composite of death, documented myocardial infarction, and repeat revascularization by 30 percent at one year. The study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease is cost beneficial to the hospital and payers by reducing procedural costs ($5,332 vs. $6,007), lowering average length of hospitalization (3.4 days vs. 3.7 days), and reducing the number of drug eluting-stents necessary per patient (1.9 vs. 2.7). The data also showed that the implementation of FFR did not add time to the multi-vessel PCI procedure.

DEFER is a study demonstrating that patients with intermediate disease not treated with PCI based on FFR guidance achieved long-term outcomes out to five years equivalent to patients who underwent PCI for similar intermediate lesions. DEFER outlines a revascularization strategy for angiographically equivocal stenoses that deploys FFR technology to identify and treat only those lesions producing reversible ischemia. The Journal of the American College of Cardiology has recognized the five-year follow-up results of the DEFER trial as one of the studies with the greatest impact on clinical cardiology in 2007. (JACC Vol. 51, No. 4, 2008 Jan. 29, 2008:490-512)

For more information: www.volcanocorp.com

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