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.
"The FAME 2 study is important because it shows COURAGE and angiography alone are not enough. FAME 2 demonstrates that when deciding between OMT and interventional therapy you need to know if there is ischemia. This will help lead to the right therapy for the right patient," commented
FAME 2 showed that patients receiving PCI with proven ischemia by FFR had 66% fewer primary endpoint events including death, MI and urgent vascularization's than those patients treated with medical therapy alone (percentage of patients who had a primary endpoint event: 4.3% in the PCI group and 12.7% in the medical-therapy group; hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P < 0.001). The Registry arm also showed that patients with a negative FFR suggesting absence of ischemia did very well being treated with just medical therapy and no further intervention (primary endpoint event rate of 3.0%).
"The evidence continues to mount that using the physiology or the functional evaluation of a lesion is better than relying on angiography alone," added
The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) is a randomized controlled trial that will study 8,000 patients with stable ischemic heart disease (SIHD) and moderate to severe ischemia. Patients will be randomized between invasive revascularization therapies including PCI and more conservative treatment focused on optimal medical therapy. The study, funded by one of the largest grants ever awarded by the NIH for a comparative effectiveness trial, will enlist the collaboration of more than 150 medical centers around the U.S. and hundreds of sites in 33 countries worldwide. The ISCHEMIA trial enriches the population of patients enrolled by requiring documented proof of ischemia using non-invasive methods prior to enrollment and FFR as appropriate during the procedure.
"PCI outcomes have improved in the years since COURAGE, with second generation DES now standard of care and dramatic increases in the use of FFR and IVUS," continued Burnett. "Volcano now has close to 5,000 multi-modality FFR & Imaging capable systems installed around the world, and the use of FFR has more than tripled in the past three years. We are excited to support the ISCHEMIA trial by contributing our precision guided therapy tools like FFR and IVUS, and to better understand which therapy is right for each patient, especially when practicing modern day Functional PCI."
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