MUNICH and SAN DIEGO, - Volcano Corporation (NASDAQ: VOLC) a worldwide leader in precision guided therapy tools, today celebrated the publication of the results of the FAME 2 trial in the New England Journal of Medicine (NEJM). Volcano also announced participation in the next major international functionally-guided study—ISCHEMIA that will include the newest PrimeWire® PRESTIGE PLUS Pressure Guidewires.
Ever since the COURAGE trial demonstrated that not every patient entering the cath lab benefits from stenting, the interventional cardiology community has been exploring more precise ways to identify which patients will benefit most from PCI, and which patients should instead be treated with optimal medical therapy (OMT) alone.
The initial FAME study published in the NEJM showed that PCI outcomes can be improved by guiding a stent strategy using Fractional Flow Reserve (FFR) instead of angiography alone as was practiced in COURAGE. The results of the FAME study showed that the number of vessels that actually needed treatment was dramatically less than previously thought, and therefore reduced the complexity of the initial angiographic diagnosis.
FAME 2 (Fractional Flow Reserve-Guided PCI vs. Medical Therapy in Stable Coronary Disease) is the second FFR-guided randomized clinical trial to be published in the NEJM. It demonstrates that using stents to treat patients with proven ischemia by FFR does in fact deliver better outcomes than OMT alone in the combined endpoint of death, myocardial infarction (MI) and urgent revascularization. It is important to note that the FAME 2 trial was halted early by the Independent Data Safety Monitoring Board because it determined it was unethical to continue enrolling patients in the medical therapy only arm due to the increased risk of these significant adverse events.
PR Newswire