What’s inside the “FAME”PCI CABG Angio-guided PCI FFR-guided PCI p = 0.002 p = 0.02 1 Year...
Transcript of What’s inside the “FAME”PCI CABG Angio-guided PCI FFR-guided PCI p = 0.002 p = 0.02 1 Year...
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What’s inside the “FAME” ?
Chang-Wook Nam, MD, PhD
Keimyung University Dongsan medical center, Daegu, Korea
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Fractional Flow Reserve
versus
Angiography for
Multivessel
Evaluation
Past of FAME
Current FAME
Future of FAME
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Past of FAME
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VS.Angiography FFR
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Pijl NH, JACC 2007;49:2105
PCI of moderate coronary stenosis without
functional significance does not improve outcome
or anginal status and does not reduce the use of
anti-anginal medication.
The DEFER Study
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Randomized
FFR-GuidedAngio-Guided
Composite of death,
MI and repeat revasc.
(MACE) at 1 year
Primary Endpoint
Cost-Effectiveness, MACE
and functional status at 2 years
Key Secondary Endpoints
Flow Chart
PCI performed on
indicated lesions
PCI performed on
indicated lesions
only if FFR ≤0.80
Patient with stenoses ≥ 50%
in at least 2 of the 3
major epicardial vessels
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Angio-Guided
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FFR-Guided
FFR 0.87
FFR 0.89
FFR 0.88
FFR 0.50
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1 Year Event-Free Survival
FFR-guided
30 days
2.9% 90 days
3.8% 180 days
4.9% 360 days
5.1%
Angio-guided
Absolute Difference in MACE-Free Survival
Tonino PA, NEJM 2009;360:213-24.
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Angio Better FFR Better
FFR
Less
Costly
Angio
Less
Costly
QALY
US
D
Bootstrap Simulation
1 Year Economic Evaluation
Fearon WF, Circ 2010;29.
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Why FFR-guided PCI is better?
Large portion of intermediate lesions
Lesser intervention
Lesser adverse events
% Diameter Stenosis of
Indicated Lesions
PCI: 33.7 %
Defer: 66.3%
31.3%65.1%
1.2 %2.4%
Nam CW, JACC interv 2010;3:812-7
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VS.Angiography FFR
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FFR-Guided
Angio-Guidaed
730 days
4.5%
2 Year Event-Free Survival
Pijl NH, JACC 2010;56:177-84
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2 Year Outcome of Deferred Lesions
94% (482)
513 Deferred Lesions in
509 FFR-Guided Patients
MI 6% (31)4.3% (22)
peri-procedural MI
1.6% (8) due to
new or stent
related lesionsOnly 1/513 or 0.2% of
deferred lesions
resulted in a late
myocardial infarction
Late MI 1.7% (9)
Pijl NH, JACC 2010;56:177-84
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2 Year Outcome of Deferred Lesions
89.7% (460)
513 Deferred Lesions in
509 FFR-Guided Patients
TVR 10.3% (53)7.2% (37) in New lesion
or in Restenotic lesion
1.2% (6) w/o FFR or
despite FFR> 0.80
Only 1.9 % (10/513) of
deferred lesions clearly
progressed requiring
repeat revascularization
3.1% (16)
Pijl NH, JACC 2010;56:177-84
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VS.CABG FFR-guided PCI
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SYNTAX FAME
Cu
mu
lati
ve M
AC
E a
t 1
-year
(%)
PCI
CABGAngio-guided PCI
FFR-guided PCI
p = 0.002 p = 0.02
1 Year Outcomes of SYNTAX and FAME
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SYNTAX FAME
Cu
mu
lati
ve M
AC
E a
t 2
-year
(%) PCI
CABGAngio-guided PCI
FFR-guided PCI
p < 0.001 p = 0.08
2 Year Outcomes of SYNTAX and FAME
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PCICABG
Pati
en
ts, %
Pati
en
ts, %
Death/CVA/MI MACCERevasc
P=0.11 P<0.001 P<0.001
Death/MI MACERevasc
P=0.02 P=0.30 P=0.08
SYNTAX (n=1095) FAME (n=1005)
AngiographyFFR
TCT 2009
Why CABG is better in multi-vessel CAD?
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Critical Area
before Red Zone
PCI betterPCI worse
Why CABG is better in multi-vessel CAD?
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0 12 24
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%
)
20
40
0
0 12 24
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%
)
20
40
0
0 12 24
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%
)
20
40
P<0.001P=0.06P=0.63
MACCE to 2 Years by SYNTAX Score Tertile
TCT 2009
Low Scores
(0-22)
Intermediate Scores
(22-33)
High Scores
(33≤)
PCI (N=299)CABG (N=275)
The Selection of Patients with Multi-vessel CAD can Improve Outcomes
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Wijns W, EHJ 2010;31:2501–2555.
Current Guidelines for MVD
But, can YOU
seriously believe
CORONARY
ANGIOGRAPHY ?
The Selection of Patients with Multi-vessel CAD can Improve Outcomes
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“FFR-guided SYNTAX score (FSS)” would
predict 1-year clinical outcome better than the
“classic SYNTAX score (SS)” in patients with
multi-vessel coronary artery disease
undergoing percutaneous coronary intervention
Current FAME
FFR-Guided SYNTAX Score
for Risk Assessment
in Multi-vessel Coronary Artery Disease
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FFR 0.86
FFR 0.86
FFR 0.90
FFR 0.90
FFR 0.92
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Randomized
FFR-GuidedAngio-Guided
Composite of death,
MI and repeat revasc.
(MACE) at 1 year
Primary Endpoint
Cost-Effectiveness, MACE
and functional status at 2 years
Key Secondary Endpoints
Flow Chart
PCI performed on
indicated lesions
PCI performed on
indicated lesions
only if FFR ≤0.80
Patient with stenoses ≥ 50%
in at least 2 of the 3
major epicardial vessels
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Classic SYNTAX score
Low SYNTAX score
Medium SYNTAX score
High SYNTAX score
37(23%)
25(15%)
101
(62%)
98
(59%)
69
(41%)
FFR-guided SYNTAX score
32%
Proportion of study population
167
(34%)
167
(34%)
163
(32%)
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FFR-guided SYNTAX score
Low SYNTAX score
Medium SYNTAX score
High SYNTAX score
Classic SYNTAX score
Proportion of study population
167
(34%)
167
(34%)
163
(32%)
106
(21%)290
(59%)
101
(20%)
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Cu
mu
lati
ve
Ra
te (
%)
P<0.001
P=0.001
Low risk
Medium risk
High risk
Cumulative MACE rate
Classic SYNTAX score FFR-guided SYNTAX score
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P=0.005Low risk
Medium risk
High risk
Cu
mu
lati
ve
Ra
te (
%)
Classic SYNTAX score FFR-guided SYNTAX score
Cumulative Death or MI rate
Low risk
Medium risk
High risk
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SYNTAX 1 Y FAME 1 Y
Cu
mu
lati
ve M
AC
E a
t 1-y
ea
r (%
)
PCI
CABGHigh FSS
Low-med FSS
p = 0.002
Outcomes of SYNTAX and FAME
p < 0.001
p < 0.001
SYNTAX 2 Y
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FAME II
Future of FAME
VS.OMT FFR-guided PCI
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COURAGE
Years
0 1 2 3 4 5 6
0.0
0.5
0.6
0.7
0.8
0.9
1.0
PCI + OMT
Optimal Medical Therapy (OMT)
Hazard ratio: 1.05
95% CI (0.87-1.27)
P = 0.62
7
Background
Boden WE, NEJM 2007;356:1503–1516.
Su
rviv
al
Fre
e o
f D
ea
th o
r M
I
BARI 2D PCI Stratum
Srinivas V et al ACC 2010
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32.4%
p=0.001
16.2%
De
ath
or
MI
(%)
% Ischemia Reduction ≥5% Myocardium (n=105 Moderate-to-Severe Pre-Rx Ischemia)
COURAGE nuclear substudy
Shaw et al. Circ 2008;117:1283
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FAME II Hypothesis
The overall hypothesis of the FAME II trial
is that FFR-guided PCI plus optimal
medical treatment is superior to optimal
medical treatment alone in patients with
stable coronary disease
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Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
Stable patients scheduled for one-,
two- or three vessel DES stenting
FFR in all indicated stenoses
There is at least one Stenosis
With FFR ≤ 0.80
1:1 Randomization
PCI+OMT OMT
Cohort A
There is no Stenosis
with an FFR ≤ 0.80
OMT
Cohort B
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FAME III
Future of FAME
VS.CABG FFR-guided PCI
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Fractional Flow Reserve
versus
Angiography for
Multivessel
Evaluation
Past of FAME: FAME original
Current FAME: FAME SYNTAX
Future of FAME: FAME II & III
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If FFR is applicable in the patients with multi-
vessel CAD, the number of lower-risk patients
who usually are recommended PCI can be
dramatically increased.
CABG could be highly recommendable in the
high-risk patients with multi-vessel CAD classified
by FFR to hopefully improve outcomes.
Therefore, the selection of target vessels, the
method for revascularization, and the
determination of prognosis in patients with multi-
vessel CAD are improved by FFR-guided risk in
daily practice.
Take Home Messages