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Jie Qian
National Heart Center & FuWai Hospitall
FFR in Diffuse Multivessel Disease
Different Patients with the same symptom : angina
IVUS –based or FFR –Based PCI ?
Angio-based PCI
Why do we need functional evaluation ?
Limitations of coronary angiography
Limitations of noninvasive techniques
Cost issues ( Cost / Benefit )
Limitations of Angiography :
“Lumengram”: Disconnection with function & physiology
FAME study: (dis)congruence between QCA and FFRFAME study: (dis)congruence between QCA and FFR
Key paper: Tonino et al; JACC 2010; 55: 2816-2821
“I do not stent lesions of 50-70%”You are under-treating 40% of your patients
“I always stent lesions of 50-70%”You are over-treating 60% of your patients
“I only stent lesions > 70%”You are still over-treating 20% of your patients
IVUS does not solve this problem !(Key publication: Kang, Park, et al: Circulation Cardiov Interv 2011; 4: 65-71)
Limitations of noninvasive techniques
Often not performed
Can be inaccurate in multivessel disease
Generally “territory” specific, but not “vessel” specific
Can be “vessel” specific “ but not “lesion “ specific
Limitations of noninvasive techniques
143 patients with angiographically significant 3-vessel disease ( > 70% diameter stenosis)
18
36 36
10
0
5
10
15
20
25
30
35
40
No Defect 1-Vesselpattern
2-Vesselpattern
3-Vesselpattern
Tallium Scan Findings %
Lima et al , J Am Cll Cardiol 2003; 42:63-70
Stress
Rest
Infero-lateral inducible ischemia
75 yrs male,
Hyperlipidemia .Hypertension and diabetes
Typical chest pain on exerction despite optimal medical therapy .
FFR= 0.82
Following stent implantation at prox LCX
FFR= 0.72FFR= 0.97
Functional Evaluation is not mandatory for every patient :
Intermediate Lesion :
Chest pain , without non invasive ischemic test
Simple functional evaluation would provide better management …
The angio-guided approach : is it the optimal approach ?
Anatomic ScoringFor Each Lesion Segment
– Location– Length– Calcification– Tortuosity– Bifurcation– Diffuse Disease– Occlusion– Thrombus
SYNTAX Score
SYNTAX Score = 18 SYNTAX Score = 41
0 6 12
20
40
0
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%
)
TAXUS™ Express2™ Stent (n=181)CABG (n=171)
MACCE to 12 Months by SYNTAX Score™ TercileLow Scores (0-22) 3VD Subset
Calculated by core laboratory; ITT population
P=0.66*
17.3%
15.2%
Event Rate ± 1.5 SE, *Fisher exact testPresenter: See Glossary
0 6 12
20
40
0
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%
)
TAXUS™ Express2™ Stent (n=207)CABG (n=208)
MACCE to 12 Months by SYNTAX Score™ TercileIntermediate Scores (23-32) 3VD Subset
P=0.02*
18.6%
10.0%
Calculated by core laboratory; ITT populationEvent Rate ± 1.5 SE, *Fisher exact testPresenter: See Glossary
0 6 12
20
40
0
Months Since Allocation
Cu
mu
lati
ve E
ven
t R
ate
(%
)
TAXUS™ Express2™ Stent (n=155)CABG (n=166)
MACCE to 12 Months by SYNTAX Score™ TercileHigh Scores (33) 3VD Subset
P=0.002*
21.5%
8.8%
Calculated by core laboratory; ITT populationEvent Rate ± 1.5 SE, *Fisher exact testPresenter: See Glossary
48% of patients received ≥5 stents
Max #14 stents!
Stent Number and Length Higher in the SYNTAX Trial
0
5
10
15
20
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Pat
ien
ts (
%)
Total Number of Stents Implanted per Patient
Multivessel disease: 96.2%* 3-vessel disease: 90.8%Avg. stents per patient: 4.6 ± 2.3 Avg. stented length: 86.1 mm
*3VD+LM/3VD+LM/2VD+LM/1VD
Linear Increase in MACCE by Number of Stentsin the SYNTAX Trial
0,00
0,05
0,10
0,15
0,20
0,25
0,30
12m
MA
CC
E in
TA
XU
S A
rm
1 2 3 4 5 6 7 8+Number of Stents Implanted
12m MACCE Probability
12m MACCE Rate
4.6 StentsSYNTAX Average
17.8%
1.5 Stents“Typical” RealWorld Average
1 stent5.6%
Avg. in pts with5-8+ stentsin SYNTAX19.6%
1 432 5 6 7 8
Functional SYNTAX Score •497 patients , FFR-guided arm of FAME Study•2-3 vessel disease •Angio Syntax Score : Conventional fashion •Functional ( FFR) Syntax Score : counting only the lesions with FFR < 0.80
Angio SYNTAX Functional ( FFR ) SYNTAX
FFR reclassifies > 30% !Fearon WF et al , TCT-MD 2011
Funtctional SYNTAX Score desciminates Risk of Death/MI and Risk of Total MACE
Death / MI Total MACE
Fearon WF et al , TCT-MD 2011
Is it safe to defer treatment ?
DEFER Study : 5-year Follow-up ( Death / MI )
27
9
0
5
10
15
20
25
30
35
FFR < 0.75 FFR > 0.75
MA
CE
at
1 ye
ar
%
p<0.05
Chamuleau et al , AJC 2002;89:377-80
Risk of deferring PCI if FFR < 0.75
FFR-Guided PCI in Multivessel Disease
137 patients , non-randomized
Wongpraparut et al , AJC 2005; 96:877-884
Angiography-guided PCI FFR-guided PCI
Measure FFR in all indicated stenoses
Stent all indicated stenoses
Stent only those stenoses with FFR ≤ 0.80
Randomization
Indicate all stenoses ≥ 50% considered for stenting
Patient with stenoses ≥ 50% in at least 2 of the 3 major
epicardial vessels
1-year follow-up
FLOW CHART
FAME study: PRIMARY ENDPOINT
Composite of death, myocardial infarction, or repeat revascularization (“MACE”) at 1 year
ANGIO-group
N=496
FFR-group
N=509P-value
Events at 1 year, No (%)
Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.020.02
Death 15 (3.0) 9 (1.8) 0.190.19
Death or myocardial infarction 55 (11.1) 37 (7.3) 0.040.04
CABG or repeat PCI 47 (9.5) 33 (6.5) 0.080.08
Total no. of MACE 113 76 0.020.02
Myocardial infarction, specified
All myocardial infarctions 43 (8.7) 29 (5.7) 0.070.07
Small periprocedural CK-MB 3-5 x N 16 12
Other infarctions (“late or large”) 27 17
FAME study: Adverse Events at 1 year
FFR-guided
30 days2.9% 90 days
3.8% 180 days4.9% 360 days
5.3%
Angio-guided
absolute difference in MACE-free survival
FAME study: Event-free Survival
Adverse Events at 2 Years
Angio-Guidedn = 496
FFR- Guidedn = 509
P Value
Total no. of MACE 139 105
Individual Endpoints
Death 19 (3.8) 13 (2.6) 0.25
Myocardial Infarction 48 (9.7) 31 (6.1) 0.03
CABG or repeat PCI 61 (12.3) 53 (10.4) 0.35
Composite Endpoints
Death or Myocardial Infarction 63 (12.7) 43 (8.4) 0.03
Death, MI, CABG, or re-PCI 110 (22.2) 90 (17.7) 0.07
FAME study: 2-year Event-free Survival FAME study: 2-year Event-free Survival
Stent length / Number of stent
&
restenosis – stent thrombosis
5,3
8,5
17,4
0
5
10
15
20
< 20 20 ~ 40 > 40
%
P<0.001
Stent Length is Independent Predictor of Restenosis.Lee CW et al. Am J Cardiol 2006;97:506-511
mm
Non-Q-Wave MI Data from DES studies suggest Non-Q-Wave MI rates increase as total stented length increases.
TAXUS VMultiplestents7.3
1,5 0,81,9
2,73,4
4,7 4,6 4,8
6,87,3
16,1
0
2
4
6
8
10
12
14
16
18
TAXUS II RAVEL SIRIUS TAXUSIV
E-SIRIUS REALITYCYPHER
REALITYTAXUS
TAXUS V TAXUSVI
TAXUS VMultiplestents
WHCMultiplestents
15 mm Mean Stent length ( mm) 65 mm
Non
Q w
ave M
I
25mm 30mm 40 mm
TAXUS stent
Cyphert stent
Full Metal Jacket.Ielasi, Colombo et al. Ital J Inv Cardiol 2009; 3 Suppl: 111
• 658 full metal jacket lesions (≥60mm) in 617 patients.
• 33% DM, 33 had prior PCI, 33% CTO.• 39 months mean follow up (2 yr in 91% pts).• Mortality 7.3%• MI during follow up: 3.5%• TLR: 23.4%• Stent thrombosis (Def or Probable): 2.6% (10/17
while on DAP).
Longer Stents have more Thrombosis. Roy et al. AJC 2009; 803:801-5
• Independent Predictors of Cumulative ST.
• ISRS (OR 2.7, p<0.001)
• Number of stents (OR 1.7, p<0.001)• Clopridogrel Cessation (OR 1.7, p<0.001)• Diabetes (OR 1.5, p 0.2)• Renal Insufficiency (OR 1.4, p 0.4)
Pressure wire assessment in MVD and diffuse disease is technically easy and offers more accurate functional evaluation of coronary stenoses.
Defering treatment of intermediate lesions when the FFR>0.80 seems safe and effective
Reducing the number and length of stents /vessel and or /patient is translated in less MACE on long term outcome
Conclusions
THANKS!