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...
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
To treat or not to treat?
Is this lesion producing Ischemia? Is PCI appropriate for situation?
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
Uncertainty in Critical
Angiographic Based Decisions
• Intermediate Stenosis, no evidence
ischemia
• Left Main Stenosis
• Multivessel CAD
• Serial Lesions
• Ostial and Branch Disease
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
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
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’
Rely on FFR
Effect of Wire Introducer
Rely on FFR – No Guide Catheter Side Holes or
Damping
From Nico Pijls
Notch
Notch
Notch
No notch
Rely on FFR – Avoid Signal Drift
Drift Drift True Gradient
Distal wave form is one key to drift
Severe stenosis filters high
frequency components – No
dichrotic notch
Notch
No notch
IV vs IC Pharmacologic Hyperemic agents
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.
Single anatomic parameters do
not predict FFR with confidence
IVUS v FFR
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.)
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
62 yo Man, RCA stent occl 2yr ago with return of CP
LAD FFR=0.86, 0.87
Now 1V CAD and
new approach
DEFER Study – 5 year data
JACC
2007;49:2105
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?
JACC 2010;56:177
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
-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
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
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
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
71 yo Man with typical angina, pos stress, CAD risk factors
What’s your best approach?
FFR CFX
FFR CFX=0.88
LAD Xience 3.5x18. 2nd LAD lesion? All done?
?
FFR = 0.68
Physiologic Guidance
1. Appropriate need
for Stents
2. Objective info re
ischemia
3. Eliminates operator
uncertainty
Chest pain, No objective evidence ischemia
FFR
FFR FFR
FFR FFR FFR
FFR
FFR
FFR FFR FFR
FFR FFR
Asymptomatic Patients
Revascularization Approaches per AUC
FFR reduces uncertainty and documents appropriateness
2v CAD with prox LAD
3v CAD
Isolated LM
LM and other CAD
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