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Fractional Flow Reserve guided
Intervention:
Should it be routine or
individualized according to very
specific need in MVD?
Prof.Dr. Amr Zaki
Alexandria University
The answer is;
it should be individualized
2
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 FFR – guided PCI improves outcomes by
adding functional information to the
anatomic information obtained from the
angiogram.
3
 DES → ↓↓ TVR
 A large and growing number of patients
with MVD are undergoing PCI.
4
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 SS is an anatomic scoring system based
on coronary angiogram;
it
1 - Qualifies lesion complexity
2 - Predicts outcome after PCI in
patients with MVD
5
 Not all angiographically significant
LESIONS turned to be hemodynamically
significant.
6
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Thus the clinical guide of FFR helps in
a. Intermediate lesions
b. Serial Lesions
c. Ostial Lesions
d. Side Branch Lesions
e. MVD
f. In stent Restenosis
7
Intermediate stenoses (40-60%)
baseline hyperemia
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Serial stenoses
1 2 3 4
By performing a pullback over the stenoses the
”culprit lesion” can be identified.
Left Main Stenosis
LM
LAD
Surgery or not?
Measure pressure and the
patient might avoid CABG
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6
Side branch lesions
Measurement of FFR in side branch lesions suggests that
most of these lesions do NOT have functional significance,
despite morphologic appearance.
When in doubt, measure FFR.
Koo et al. J Am Coll Cardiol. 2005;46: 633-7
MVD - Multivessel Disease
 Measure all suspected lesions
 Use long-lasting hyperemic stimulus – time for pullback
 Place stents only in stenoses where FFR is below 0.75
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Where to intervene?
LAD D 1
D 2
RCA
Where to intervene?
RCA
FFR = 0.94 >0.75
FFR = 0.89 >0.75
FFR = 0.90 >0.75
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Where to intervene?
RCA
FFR = 0.41 <0.75
Where to intervene?
FFR = 0.67 <0.75
After balloon inflation
3.0 balloon 12 atm (mid-RCA)
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9
Where to intervene?
After stent 3.5 mm (mid-RCA)
FFR = 0.80Not optimal post stent result
Where to intervene?
Stent 3.5 mm (mid-RCA) + Stent 3.5 mm
(prox-RCA)
FFR = 0.94Optimal post stent result
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10
Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls.
Fractional Flow Reserve
versus
Angiography for
Multivessel
Evaluation
FRACTIONAL FLOW RESERVE
versus ANGIOGRAPHY
FOR GUIDING PCI IN PATIENTS WITH
MULTIVESSEL CORONARY ARTERY DISEASE
Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls.
FAME study: Study Population
The FAME study was designed to reflect daily practice
in performing PCI in patients with multivessel disease
Inclusion criteria:
• ALL patients with multivessel disease
• At least 2 stenoses ≥ 50% in 2 or 3 major epicardial
coronary arteries amenable for stenting
Exclusion criteria:
• Left main disease or previous bypass surgery
• STEMI within last 5 days
• Extremely tortuous or calcific coronaries
Note: patients with previous PCI were not excluded
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11
Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls.
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
Ref. NEJM Vol 360, No 3, pp 213-
ANGIO-group
N=496
FFR-group
N=509
P-value
Events at 1 year, No (%)
Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02
FAME study: Adverse Events at 1 year
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Ref. NEJM Vol 360, No 3, pp 213-
ANGIO-group
N=496
FFR-group
N=509
P-value
Events at 1 year, No (%)
Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02
Death 15 (3.0) 9 (1.8) 0.19
Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04
CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08
FAME study: Adverse Events at 1 year
Ref. NEJM Vol 360, No 3, pp 213-
ANGIO-group
N=496
FFR-group
N=509
P-value
Events at 1 year, No (%)
Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02
Death 15 (3.0) 9 (1.8) 0.19
Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04
CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08
Total no. of MACE 113 76 0.02
FAME study: Adverse Events at 1 year
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Ref. NEJM Vol 360, No 3, pp 213-
ANGIO-group
N=496
FFR-group
N=509
P-value
Events at 1 year, No (%)
Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02
Death 15 (3.0) 9 (1.8) 0.19
Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04
CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08
Total no. of MACE 113 76 0.02
Myocardial infarction, specified
All myocardial infarctions 43 (8.7) 29 (5.7) 0.07
Small periprocedural CK-MB 3-5 x N 16 12
Other infarctions (“late or large”) 27 17
FAME study: Adverse Events at 1 year
Ref. NEJM Vol 360, No 3, pp 213-
FFR-guided
30 days
2.9% 90 days
3.8% 180 days
4.9% 360 days
5.3%
Angio-guided
absolute difference in MACE-free survival
FAME study: Event-free Survival
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14
Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls.
FAME study: CONCLUSIONS (1)
Routine measurement of FFR during PCI with DES
in patients with multivessel disease, when
compared to current angiography guided strategy
• reduces the rate of the composite endpoint of
death, myocardial infarction, re-PCI and CABG
at 1 year by ~ 30%
• reduces mortality and myocardial infarction at
1 year by ~ 35 %
Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls.
FAME study: CONCLUSIONS (2)
Routine measurement of FFR during PCI with DES
in patients with multivessel disease, when
compared to current angiography guided strategy,
furthermore:
• is cost-saving and does not prolong the procedure
• reduces the number of stents used
• decreases the amount of contrast agent used
• results in a similar, if not better, functional status
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15
Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls.
Routine measurement of FFR during DES-stenting
in patients with multivessel disease is superior
to current angiography guided treatment.
It improves outcome of PCI significantly
It supports the evolving paradigm of
“Functionally Complete Revascularization”,
i.e. stenting of ischemic lesions and
medical treatment of non-ischemic ones.
FAME study: CONCLUSIONS (3)
 Functional SYNTAX score for Risk
Assessment in Multivessel coronary
artery disease
JACC volume 58,Issue 12 ,Sept 2011
30
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16
 Aim of FSS Study
To determine whether an FFR- guided
SYNTAX score (FSS) and defined as a
recalculated SS counting only ischemia-
producing lesions as assessed by FFR is a
better predictor of 1 Year clinical outcome in
patients with MVD undergoing PCI ?
31
32
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17
33
The major findings in the current study are
that FSS:
1) Decreases the number of highest – risk
patients as assessed by the classic SS
2) Is better descimintor risk for MACE in
patients with MVD undergoing PCI
3) FSS is an independent predictor of a 1 year
MACE in these patients
34
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18
Conclusions
Compared with the classic SS, the FSS, which
is obtained by counting only ischemia – Providing
lesions, has better reproducability, has better
prognostic value , and increases the proportion of
patients with MVD who fall into the lowest risk for
adverse events after PCI
35
Why should it be individualized ?
 Is not a clinical scoring
 The study included patients with 2-Vessel
disease beside 3-Vessel disease
 This trial was not head to head comparison
with CABG
 FFR is time consuming
36
R&M Solutions
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19
THANK YOU
37
R&M Solutions
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Ffr ppt.

  • 1. 1 Fractional Flow Reserve guided Intervention: Should it be routine or individualized according to very specific need in MVD? Prof.Dr. Amr Zaki Alexandria University The answer is; it should be individualized 2 R&M Solutions www.rmsolutions.net
  • 2. 2  FFR – guided PCI improves outcomes by adding functional information to the anatomic information obtained from the angiogram. 3  DES → ↓↓ TVR  A large and growing number of patients with MVD are undergoing PCI. 4 R&M Solutions www.rmsolutions.net
  • 3. 3  SS is an anatomic scoring system based on coronary angiogram; it 1 - Qualifies lesion complexity 2 - Predicts outcome after PCI in patients with MVD 5  Not all angiographically significant LESIONS turned to be hemodynamically significant. 6 R&M Solutions www.rmsolutions.net
  • 4. 4 Thus the clinical guide of FFR helps in a. Intermediate lesions b. Serial Lesions c. Ostial Lesions d. Side Branch Lesions e. MVD f. In stent Restenosis 7 Intermediate stenoses (40-60%) baseline hyperemia R&M Solutions www.rmsolutions.net
  • 5. 5 Serial stenoses 1 2 3 4 By performing a pullback over the stenoses the ”culprit lesion” can be identified. Left Main Stenosis LM LAD Surgery or not? Measure pressure and the patient might avoid CABG R&M Solutions www.rmsolutions.net
  • 6. 6 Side branch lesions Measurement of FFR in side branch lesions suggests that most of these lesions do NOT have functional significance, despite morphologic appearance. When in doubt, measure FFR. Koo et al. J Am Coll Cardiol. 2005;46: 633-7 MVD - Multivessel Disease  Measure all suspected lesions  Use long-lasting hyperemic stimulus – time for pullback  Place stents only in stenoses where FFR is below 0.75 R&M Solutions www.rmsolutions.net
  • 7. 7 Where to intervene? LAD D 1 D 2 RCA Where to intervene? RCA FFR = 0.94 >0.75 FFR = 0.89 >0.75 FFR = 0.90 >0.75 R&M Solutions www.rmsolutions.net
  • 8. 8 Where to intervene? RCA FFR = 0.41 <0.75 Where to intervene? FFR = 0.67 <0.75 After balloon inflation 3.0 balloon 12 atm (mid-RCA) R&M Solutions www.rmsolutions.net
  • 9. 9 Where to intervene? After stent 3.5 mm (mid-RCA) FFR = 0.80Not optimal post stent result Where to intervene? Stent 3.5 mm (mid-RCA) + Stent 3.5 mm (prox-RCA) FFR = 0.94Optimal post stent result R&M Solutions www.rmsolutions.net
  • 10. 10 Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls. Fractional Flow Reserve versus Angiography for Multivessel Evaluation FRACTIONAL FLOW RESERVE versus ANGIOGRAPHY FOR GUIDING PCI IN PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASE Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls. FAME study: Study Population The FAME study was designed to reflect daily practice in performing PCI in patients with multivessel disease Inclusion criteria: • ALL patients with multivessel disease • At least 2 stenoses ≥ 50% in 2 or 3 major epicardial coronary arteries amenable for stenting Exclusion criteria: • Left main disease or previous bypass surgery • STEMI within last 5 days • Extremely tortuous or calcific coronaries Note: patients with previous PCI were not excluded R&M Solutions www.rmsolutions.net
  • 11. 11 Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls. 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 Ref. NEJM Vol 360, No 3, pp 213- ANGIO-group N=496 FFR-group N=509 P-value Events at 1 year, No (%) Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02 FAME study: Adverse Events at 1 year R&M Solutions www.rmsolutions.net
  • 12. 12 Ref. NEJM Vol 360, No 3, pp 213- ANGIO-group N=496 FFR-group N=509 P-value Events at 1 year, No (%) Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02 Death 15 (3.0) 9 (1.8) 0.19 Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04 CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08 FAME study: Adverse Events at 1 year Ref. NEJM Vol 360, No 3, pp 213- ANGIO-group N=496 FFR-group N=509 P-value Events at 1 year, No (%) Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02 Death 15 (3.0) 9 (1.8) 0.19 Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04 CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08 Total no. of MACE 113 76 0.02 FAME study: Adverse Events at 1 year R&M Solutions www.rmsolutions.net
  • 13. 13 Ref. NEJM Vol 360, No 3, pp 213- ANGIO-group N=496 FFR-group N=509 P-value Events at 1 year, No (%) Death, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.02 Death 15 (3.0) 9 (1.8) 0.19 Death or myocardial infarction 55 (11.1) 37 (7.3) 0.04 CABG or repeat PCI 47 (9.5) 33 (6.5) 0.08 Total no. of MACE 113 76 0.02 Myocardial infarction, specified All myocardial infarctions 43 (8.7) 29 (5.7) 0.07 Small periprocedural CK-MB 3-5 x N 16 12 Other infarctions (“late or large”) 27 17 FAME study: Adverse Events at 1 year Ref. NEJM Vol 360, No 3, pp 213- FFR-guided 30 days 2.9% 90 days 3.8% 180 days 4.9% 360 days 5.3% Angio-guided absolute difference in MACE-free survival FAME study: Event-free Survival R&M Solutions www.rmsolutions.net
  • 14. 14 Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls. FAME study: CONCLUSIONS (1) Routine measurement of FFR during PCI with DES in patients with multivessel disease, when compared to current angiography guided strategy • reduces the rate of the composite endpoint of death, myocardial infarction, re-PCI and CABG at 1 year by ~ 30% • reduces mortality and myocardial infarction at 1 year by ~ 35 % Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls. FAME study: CONCLUSIONS (2) Routine measurement of FFR during PCI with DES in patients with multivessel disease, when compared to current angiography guided strategy, furthermore: • is cost-saving and does not prolong the procedure • reduces the number of stents used • decreases the amount of contrast agent used • results in a similar, if not better, functional status R&M Solutions www.rmsolutions.net
  • 15. 15 Ref. NEJM Vol 360, No 3, pp 213-224. Slides courtesy Nico H J Pijls. Routine measurement of FFR during DES-stenting in patients with multivessel disease is superior to current angiography guided treatment. It improves outcome of PCI significantly It supports the evolving paradigm of “Functionally Complete Revascularization”, i.e. stenting of ischemic lesions and medical treatment of non-ischemic ones. FAME study: CONCLUSIONS (3)  Functional SYNTAX score for Risk Assessment in Multivessel coronary artery disease JACC volume 58,Issue 12 ,Sept 2011 30 R&M Solutions www.rmsolutions.net
  • 16. 16  Aim of FSS Study To determine whether an FFR- guided SYNTAX score (FSS) and defined as a recalculated SS counting only ischemia- producing lesions as assessed by FFR is a better predictor of 1 Year clinical outcome in patients with MVD undergoing PCI ? 31 32 R&M Solutions www.rmsolutions.net
  • 17. 17 33 The major findings in the current study are that FSS: 1) Decreases the number of highest – risk patients as assessed by the classic SS 2) Is better descimintor risk for MACE in patients with MVD undergoing PCI 3) FSS is an independent predictor of a 1 year MACE in these patients 34 R&M Solutions www.rmsolutions.net
  • 18. 18 Conclusions Compared with the classic SS, the FSS, which is obtained by counting only ischemia – Providing lesions, has better reproducability, has better prognostic value , and increases the proportion of patients with MVD who fall into the lowest risk for adverse events after PCI 35 Why should it be individualized ?  Is not a clinical scoring  The study included patients with 2-Vessel disease beside 3-Vessel disease  This trial was not head to head comparison with CABG  FFR is time consuming 36 R&M Solutions www.rmsolutions.net