http://www.theheart.org/web_slides/1416535.do A trial to compare Fractional Flow Reserve versus Angiography for Guiding PCI in Patients with Multivessel Coronary Artery Disease II

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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