Coronary stenting the appropriate use of FFR Morton

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 2 D images of angiogram to accurately depict the 3 D 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

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. Aortic, Pa Resting pressures FFR= Pd/Pa = 65/90 = 0. 72 Coronary, Pd Adenosine

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 -3 cm 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 Hemodynamic Artifacts: Technical • loose connections • Damped pressure waveforms. • Improper zero • Guide obstruction • Calibration offset • Contrast media Anatomic • Extreme tortuosity • Very small guide (<5 F) • Inability to wire vessel • Pressure signal drift • Spasm • Side holes and ostial Mechanical ‘pseudostenosis’ Wire/artery impact Pharmacologic • Inadequate hyperemia

Rely on FFR Effect of Wire Introducer

Rely on FFR – No Guide Catheter Side Holes or Damping From Nico Pijls

Rely on FFR – Avoid Signal Drift True Gradient Notch No notch Notch

Severe stenosis filters high frequency components – No dichrotic notch No notch Distal wave form is one key to drift

IV vs IC Pharmacologic Hyperemic agents

Q: Why can we not use IVUS/OCT for functional assessment? A: A single cross-sectional area does not mean the same thing everywhere. 5 < 4 mm² = significant stenosis ? Ref Diam (mm) 4 3 2 50 25 % Stenosis for an Cross Sectional Area of 4 mm² 0

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. )

Coronary Physiologic (FFR) Criteria and Clinical Outcome Studies 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 >0. 80 (Key Study: FAME I, II) (Key Study: Hamilos for LM) (Key Study: Koo BW et al) Endpoint of stenting *(IVUS better post stent) >0. 94*

62 yo Man, RCA stent occl 2 yr ago with return of CP LAD FFR=0. 86, 0. 87 Now 1 V CAD and new approach

DEFER Study – 5 year data JACC

RW. 59 yo man with Angina, inferior perf defect 3 V 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 Tonino et al, NEJM 2009, Pijls et al, JACC 2010 Angio-guided % 10 12. 7 P= 0. 03 8. 4 5 0 FFR-guided Death or MI 2 year 9. 5 6. 1 MI 2 year(exclusion of small periprocedural infarction)

Fearon WF et al. Circ 2010; 122: 25450 -2550 Incremental Cost [$] Economic Evaluation of FFR-guided PCI in pts with MVD. CABG ROTO BMS Balloon FFR Guidance Saves Resources DES FFR Guidance Improves Outcomes Incremental QALY

Angiographic 3 - or 2 -Vessel Disease does NOT equal Physiologic 3 - or 2 V CAD FAME: Angiography vs FFR Tonino, P. A. L. et al. J Am Coll Cardiol 2010; 55: 2816 -2821 3 V CAD Angio = 14% physiol 2 V 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 Registry Randomised Trial At least 1 stenosis with FFR ≤ 0. 80 When all FFR >0. 80 Randomisation 1: 1 PCI + OMT OMT 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 24 years

FAME II Rate of Any Revascularisation Cumulative incidence (%) 60 RCT: OMT vs. RCT: PCI+OMT = 12. 1% vs. 1. 7% 50 HR (95% CI): 7. 63 (3. 24 -18. 0); logrank p<. 0001 40 30 20 10 RCT: PCI+OMT vs. REGISTRY: OMT, p=0. 54 0 0 1 3 4 5 6 7 8 9 10 12 10 18 1 8 18 1 Months after randomisation No. at risk RCT: OMT only 339 RCT: PCI+OMT 352 REGISTRY: OMT only 131 2 238 256 88 123 144 41 119 141 40 115 140 40 112 139 40 83 114 35 20 25 4 25

71 yo Man with typical angina, pos stress, CAD risk factors What’s your best approach?

FFR CFX=0. 88

LAD Xience 3. 5 x 18. 2 nd 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 Asymptomatic Patients FFR FFR FFR FFR

Revascularization Approaches per AUC 2 v CAD with prox LAD 3 v CAD Isolated LM LM and other CAD FFR reduces uncertainty and documents appropriateness

The Mandate for Physiologic Guidance arises from a decade of outcomes studies and is supported by guidelines Class IA Guidelines - ESC Class IIa Guidelines - ACC/ AHA/ SCAI