FAME II trial - Summary & Trial
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The FAME II trial compared the clinical outcomes and cost-effectiveness of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) versus OMT alone in patients with multivessel coronary artery disease. Results indicated that patients with hemodynamically relevant disease who received PCI had significantly lower rates of urgent revascularization compared to those treated solely with OMT. Commentary highlighted the importance of treating ischemia and relieving symptoms promptly for patients with stable CAD.
FAME II trial - Summary & Trial
- 1. FAME II (Fractional Flow Reserve versus Angiography for Guiding PCI in Patients with Multivessel Coronary Artery Disease II)
- 2. FAME II B De Bruyne (OLV Clinic, Aalst, Belgium) EuroPCR 2012 • A trial to compare the clinical outcomes, safety and cost-effectiveness of FFR- guided PCI plus OMT vs OMT alone in patients with stable CAD • Population: 1219 patients found on FFR to have hemodynamically relevant disease (and were scheduled for one-, two-, or three-vessel stenting), and another 166 patients from a separate registry, FFR having failed to detect important stenosis • Primary outcome: Major adverse cardiac event rate (MACE)—a composite of all-cause death, documented MI, unplanned hospitalization leading to urgent revascularization—at 24 months FFR=fractional flow reserve; OMT=optimal medical treatment; PCI=percutaneous coronary intervention; CAD=coronary artery disease
- 3. FAME II: Results • After one year: The rate of urgent revascularization among OMT-treated patients with no hemodynamically significant disease was nearly identical to the low rate of urgent revascularizations among patients with hemodynamically relevant disease who were randomized to PCI, at approximately 0.6% Patients who had hemodynamically significant disease on FFR who were randomized to OMT had urgent revascularization rates of 6% at follow-up (HR 11.2, log-rank p<0.0001 vs PCI-treated patients) Rates of any revascularization showed an even more striking difference between the randomized groups, at 12.1% vs 1.7% (HR 7.63, log-rank p<0.0001)
- 4. FAME II: Commentary* "This should be considered as a complement to, an extension of COURAGE." - Dr Bernard De Bruyne "This extends observations that we have already made and reminds us we should be treating ischemia, not lesions." - Dr David Holmes "The thing we tend to forget is that we are not only dealing with repeat revascularizations, we are also dealing with relieving symptoms. If you want your angina to go away tomorrow, rather than in three months with OMT, you will ask for a stent." - Dr Ron Waksman *All comments from FAME II: FFR pinpoints stable CAD patients who fare worse with OMT (http://www.theheart.org/article/1398627.do)
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