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!