Coronary stenting: the appropriate use of FFR€¦ · 3V CAD – CABG vs PCI? FFR=0.71 2 Questions...
Transcript of Coronary stenting: the appropriate use of FFR€¦ · 3V CAD – CABG vs PCI? FFR=0.71 2 Questions...
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Coronary stenting: the appropriate use of
FFR
Morton J. Kern, MD
Professor of Medicine Chief of Cardiology LBVA Associate Chief Cardiology University California Irvine
Orange, California
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To treat or not to treat?
Is this lesion producing Ischemia? Is PCI appropriate for situation?
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The rationale for using coronary physiology is the inability of
the 2D images of angiogram to accurately depict the 3D
lesion characteristics limiting flow.
75% Dia
20% Dia
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Uncertainty in Critical
Angiographic Based Decisions
• Intermediate Stenosis, no evidence
ischemia
• Left Main Stenosis
• Multivessel CAD
• Serial Lesions
• Ostial and Branch Disease
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Aortic, Pa
Coronary, Pd
FFR= Pd/Pa = 65/90 = 0.72
Measurement of FFR correlates to the
results of stress testing and ischemia out
of the lab.
FFR is a ‘stress test’ for that artery in
the lab at time of cath.
Adenosine Resting pressures
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5 Steps to Accurate FFR
1.Zero guide and wire on table to atmosphere
2. Insert wire into guide and match wire/guide
pressures in aorta
3.Cross lesion 2-3cm distal
4.Turn on IV adenosine 2-4 minutes
5.Confirm accuracy with pressure pull back
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Rely on FFR Avoid pitfalls of pressure and FFR
Technical • loose connections • Improper zero • Calibration offset
Anatomic • Extreme tortuosity • Inability to wire vessel • Spasm
Mechanical Wire/artery impact Pharmacologic
• Inadequate hyperemia
Hemodynamic Artifacts:
• Damped pressure waveforms.
• Guide obstruction
• Contrast media
• Very small guide (<5F)
• Pressure signal drift
• Side holes and ostial ‘pseudostenosis’
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Rely on FFR
Effect of Wire Introducer
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Rely on FFR – No Guide Catheter Side Holes or
Damping
From Nico Pijls
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Notch
Notch
Notch
No notch
Rely on FFR – Avoid Signal Drift
Drift Drift True Gradient
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Distal wave form is one key to drift
Severe stenosis filters high
frequency components – No
dichrotic notch
Notch
No notch
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IV vs IC Pharmacologic Hyperemic agents
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Ref
Diam
(mm)
% Stenosis for an
Cross Sectional Area of 4 mm²
< 4 mm² =
significant stenosis ?
0 25 50 2
3
4
5
Q: Why can we not use IVUS/OCT for functional assessment?
A: A single cross-sectional area does not mean the same thing
everywhere.
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Single anatomic parameters do
not predict FFR with confidence
IVUS v FFR
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When can you NOT rely on FFR?
False Negative FFR 1. Pressure Damping 2. No hyperemia - wrong drug, not mixed not delivered (IV?) or side holes 3. STEMI, culprit. STEMI – non-culprit OK 4. LM + LAD when FFRepicardial <0.6 5. Serial lesion FFR of individual lesion (only gradient useful) False Positive FFR 1. Technical errors (Pressure signal drift,zero, etc.)
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Application FFR
Ischemia detection, >15 studies Pos <0.75
Neg >0.80
Deferred angioplasty, >8 studies
(Key Study: Defer)
>0.75
Multivessel FFR guided PCI, LM,
Ostial, Jailed Side Branch
(Key Study: FAME I, II)
(Key Study: Hamilos for LM)
(Key Study: Koo BW et al)
>0.80
Endpoint of stenting
*(IVUS better post stent)
>0.94*
Coronary Physiologic (FFR) Criteria and Clinical
Outcome Studies
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62 yo Man, RCA stent occl 2yr ago with return of CP
LAD FFR=0.86, 0.87
Now 1V CAD and
new approach
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DEFER Study – 5 year data
JACC
2007;49:2105
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RW. 59 yo man with Angina, inferior perf defect 3V CAD – CABG vs PCI?
FFR=0.71
2 Questions How Accurate is Stress Test? If PCI needed, FFR directed?
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JACC 2010;56:177
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FAME study: Death and MI after 2 Years
10
0
5
2 year
12.7
8.4
%
FFR-guided
Angio-guided
P= 0.03
9.5
6.1
P= 0.03
2 year(exclusion of small
periprocedural infarction)
Tonino et al, NEJM 2009, Pijls et al, JACC 2010
Death or MI MI
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-6000
-5000
-4000
-3000
-2000
-1000
0
1000
2000
3000
4000
5000
6000
-0.100 -0.075 -0.050 -0.025 0.000 0.025 0.050 0.075 0.100
Increm. QALYIn
cre
m. C
os
t [$
]
FFR Guidance Improves outcomes
FFR Guidance
Saves Resources
ICER of 50,000 $ / QALY
Incremental
QALY
FFR Guidance
Improves Outcomes
FFR Guidance
Saves
Resources
Incre
men
tal
Co
st
[$]
DES
CABG
ROTO
BMS
Balloon
Economic Evaluation of
FFR-guided PCI in pts with
MVD.
Fearon WF et al. Circ
2010;122:25450-2550
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FAME: Angiography vs FFR
Tonino, P. A. L. et al. J Am Coll Cardiol 2010;55:2816-2821
Angiographic 3- or 2-Vessel Disease does NOT equal Physiologic 3- or 2V CAD
3V CAD Angio = 14% physiol 2V CAD Angio= 43% physiol
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FAME II – Ischemia directed
PCI+OMT vs OMT alone
Stable patients scheduled for 1, 2 or 3 vessel DES stenting
FFR in all target lesions
When all FFR >0.80
OMT
At least 1 stenosis
with FFR ≤ 0.80
Randomisation 1:1
PCI + OMT OMT
Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
Randomised Trial Registry
24
50% randomly
assigned to FU
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25
Rate of Any Revascularisation
131 88 41 40 40 40 35 4 1 1 1 1 REGISTRY:OMT only 352 256 144 141 140 139 114 25 18 18 18 18 RCT:PCI+OMT 339 238 123 119 115 112 83 20 10 10 10 8 RCT:OMT only
No. at risk Months after randomisation
0
10
20
30
40
50
60
0 1 2 3 4 5 6 7 8 9 10 12
RCT:PCI+OMT vs. REGISTRY:OMT, p=0.54
RCT:OMT vs. RCT:PCI+OMT = 12.1% vs. 1.7%
HR (95% CI): 7.63 (3.24-18.0); logrank p<.0001
Cu
mu
lati
ve i
nc
iden
ce (
%)
FAME II
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71 yo Man with typical angina, pos stress, CAD risk factors
What’s your best approach?
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FFR CFX
FFR CFX=0.88
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LAD Xience 3.5x18. 2nd LAD lesion? All done?
?
FFR = 0.68
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Physiologic Guidance
1. Appropriate need
for Stents
2. Objective info re
ischemia
3. Eliminates operator
uncertainty
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Chest pain, No objective evidence ischemia
FFR
FFR FFR
FFR FFR FFR
FFR
FFR
FFR FFR FFR
FFR FFR
Asymptomatic Patients
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Revascularization Approaches per AUC
FFR reduces uncertainty and documents appropriateness
2v CAD with prox LAD
3v CAD
Isolated LM
LM and other CAD
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Class IIa Guidelines - ACC/ AHA/ SCAI
Class IA Guidelines - ESC
The Mandate for Physiologic Guidance arises from
a decade of outcomes studies and is supported by
guidelines