Stanford

FFR-Guided PCIFFR-Guided PCI

William F. Fearon, M.D.Associate Professor

Division of Cardiovascular MedicineStanford University Medical Center

4th Imaging and Physiology SummitOctober 29th, 2010Seoul, Korea

Stanford

Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest

I, William Fearon, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Stanford receives research support from St. Jude Medical.

Stanford

Why do we need FFR?Why do we need FFR?

• Importance of ischemia

• Limitations of noninvasive testing

• Limitations of angiography

• Limitations of IVUS/OCT

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Importance of IschemiaImportance of Ischemia

0.30.8

2.3

4.6

0

0.9 1.1 1.3

0

1

2

3

4

5

Nl Mild Abnl Mod Abnl Sev Abnl

Nuclear Scan Result

Car

diac

Dea

th (%

/yr)

Medical Therapy Revascularization

Hachamovitch et al. Circulation 1998;97:535-543

Nuclear perfusion scans performed in > 5000 patients

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COURAGE Nuclear SubstudyCOURAGE Nuclear Substudy

Shaw et al. Circulation 2008;117:1283

Comparison of death/MI in patients with mod-severe pre-treatment ischemia

StanfordJAMA 2008;300:1765

Stanford

FFR vs. Nuclear Perfusion Scan in MVDFFR vs. Nuclear Perfusion Scan in MVD

Melikian et al. J Am Coll Cardiol Int 2010;3:307-14

67 patients with angiographic 2 or 3 vessel CAD

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FFR vs. Nuclear Perfusion Scan in MVDFFR vs. Nuclear Perfusion Scan in MVD

Melikian et al. J Am Coll Cardiol Int 2010;3:307-14

67 patients with angiographic 2 or 3 vessel CAD

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Limitation of AngiographyLimitation of Angiography

0 10 20 30 40 50 60 70 80 90 1000.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Diameter Stenosis (%)

FFR

Courtesy of Bernard De Bruyne, MD, PhD

Comparison of QCA to FFR in over 3,000 lesions

(-) Ischemia

(+) Ischemia

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FFR should not guide ALL PCI!FFR should not guide ALL PCI!70 year old man with angina and anterior ischemia

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When should we use FFR?When should we use FFR?

• In patients with coronary narrowings in the 50-90% range and unclear, equivocal or absent noninvasive stress imaging studies.

– Most commonly in patients with multivessel CAD.

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Which Lesions Need FFR?Which Lesions Need FFR?1329 lesions in the FFR-guided arm of the FAME Study

~35%

~20%

J Am Coll Cardiol 2010;55:2816-21.

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Why should FFR Guide PCI?Why should FFR Guide PCI?

• Improves outcomes• Saves money• PCI of intermediate lesions is not benign• Medical treatment of hemodynamically

insignificant lesions is safe• FFR-guided PCI can simplify a procedure

and may increase PCI volume

Stanford

Why should FFR Guide PCI?Why should FFR Guide PCI?

• Improves outcomes• Saves money• PCI of intermediate lesions is not benign• Medical treatment of hemodynamically

insignificant lesions is safe• FFR-guided PCI can simplify a procedure

and may increase PCI volume

StanfordNew Engl J Med 2009;360:213-24.

FAME Study: One Year OutcomesFAME Study: One Year Outcomes

3

8.7 9.511.1

18.3

1.8

5.7 6.5 7.3

13.2

0

5

10

15

20

Death MI RepeatRevasc

Death/MI MACE

Angio-Guided FFR-Guided

p=0.02p=0.04

%

~40%

~35% ~30% ~35%

~30%

Over 1,000 patients with MVD undergoing PCI and randomized to FFR or angiographic guidance alone

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FAME Study: Two Year OutcomesFAME Study: Two Year Outcomes

FFRFFR--GuidedGuided

AngioAngio--GuidedGuided

730 days730 days4.5%4.5%

J Am Coll Cardiol 2010;56:177-184

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FAME: 1 Year Economic EvaluationFAME: 1 Year Economic Evaluation

USD

Bootstrap SimulationBootstrap Simulation

Fearon, et al. Circulation 2010; (in press)-5000

-4000

-3000

-2000

-1000

0

1000

2000

3000

4000

-0.050 -0.025 0.000 0.025 0.050 0.075 0.1

Increm. QALY

Incr

em. C

ost [

$]

FFR Guidance Improves outcomes

FFR Guidance Saves Resources

ICER of 50,000 $ / QALY1 Year CostsAngio ~ $16,700 / patientFFR ~ $14,300 / patient

FFR BetterAngio Better

Angio Less

Costly

FFR Less

Costly

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Why should FFR Guide PCI?Why should FFR Guide PCI?

• Improves outcomes• Saves money• PCI of intermediate lesions is not benign• Medical treatment of hemodynamically

insignificant lesions is safe• FFR-guided PCI can simplify a procedure

and may increase PCI volume

Stanford

Should we perform PCI in all intermediate lesions?

Should we perform PCI in all intermediate lesions?

Moses JW, et al. J Am Coll Cardiol 2006;47:2164-71.

92 lesions with QCA < 50% stenosis treated with DES

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What is the Expected MACE in DES-Treated Intermediate Lesions?

What is the Expected MACE in DES-Treated Intermediate Lesions?

Moses JW, et al. J Am Coll Cardiol 2006;47:2164-71.

1 year events in 92 intermediate lesions treated with DES

1 Year Cardiac Death and MI rate of 3.4%

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5 Year Cardiac Death / MI in DEFER study5 Year Cardiac Death / MI in DEFER study

Pijls et al. J Am Coll Cardiol 2007;49:2105-11

3.3

7.9

15.7

0

5

10

15

20 %

P=0.20

P< 0.003

P< 0.005

DEFER PERFORM REFERENCEFFR ≥ 0.75 FFR < 0.75

181 patients with intermediate lesions and FFR ≥0.75 randomized to PCI or deferral

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2 Year Outcome of Deferred Lesions in FAME2 Year Outcome of Deferred Lesions in FAME

513 Deferred Lesions in513 Deferred Lesions in509 FFR509 FFR--Guided PatientsGuided Patients

2 Years2 Years

31 31 Myocardial InfarctionsMyocardial Infarctions 2222PeriPeri--proceduralprocedural

99Late Myocardial InfarctionsLate Myocardial Infarctions

88Due to a New Lesion Due to a New Lesion

or Stentor Stent--RelatedRelated

11Myocardial Infarction due toMyocardial Infarction due to

an Originally Deferred Lesionan Originally Deferred Lesion

Only 1/513 or 0.2% of deferred Only 1/513 or 0.2% of deferred lesions resulted in a late lesions resulted in a late

myocardial infarctionmyocardial infarction

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Why should FFR Guide PCI?Why should FFR Guide PCI?

• Improves outcomes• Saves money• PCI of intermediate lesions is not benign• Medical treatment of hemodynamically

insignificant lesions is safe• FFR-guided PCI can simplify a procedure

and may increase PCI volume

Stanford

Recent Case: “Mr. H.”Recent Case: “Mr. H.”

• 79 year old retired physicist with angina• Risk factors include HTN and dyslipidemia• Stress echo revealed anteroseptal and

apical ischemia• Referred for coronary angiography on

September 10th, 2010…

Stanford

Stanford

Stanford

Stanford

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How should we handle this case?How should we handle this case?

Wijns W, Kolh P, et al. Eur Heart J 2010; in press

Recently published European guidelines for revascularizationRecently published European guidelines for revascularization

Calculated Calculated SYNTAX SYNTAX score = 25.5score = 25.5

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PCI vs. CABG Outcomes Based on Syntax ScorePCI vs. CABG Outcomes Based on Syntax Score

Serruys et al. N Engl J Med 2009;360:961-72

Worse outcomes with PCI vs CABG with higher SYNTAX scoreWorse outcomes with PCI vs CABG with higher SYNTAX score

>22

≥33

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PCI vs. CABG Outcomes Based on Syntax ScorePCI vs. CABG Outcomes Based on Syntax Score

Serruys et al. N Engl J Med 2009;360:961-72

Similar outcomes with PCI vs CABG with lower SYNTAX scoreSimilar outcomes with PCI vs CABG with lower SYNTAX score

0-22

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FFR of RCA = 0.91

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How should we handle this case?How should we handle this case?

Wijns W, Kolh P, et al. Eur Heart J 2010; in press

Recently published European guidelines for revascularizationRecently published European guidelines for revascularization

Recalculated Recalculated SYNTAX SYNTAX score after score after FFR = 18.5FFR = 18.5

Stanford

Stanford

e-mail from Mr. H.e-mail from Mr. H.

Sept. 19th, 2010:

Dr. Fearon....this is from New Mexico. Yesterday we were walking around on the base of the Santa Fe ski area at over 10,300 feet. Not too strenuous but then not too much air there. Feeling great and just wanted to tell you and say thanks...Bill

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3VD (14%)0VD (9%)

1VD (34%) 2VD (43%)

Angiographic3 VesselDisease

Anatomic vs. Functional CADAnatomic vs. Functional CAD

Tonino et al., JACC 2010;55:2816-21

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Change in SYNTAX score after FFRChange in SYNTAX score after FFR

166(34%)

170(35%)

160(32%)

CW Nam, MD (preliminary data)

Without FFR

SYNTAX score in roughly 500 FAME patients before and after FFR

281(57%)

119(24%)

95(19%)

With FFR

Lowest Tertile

Middle Tertile

Highest Tertile

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Impact of FFR on SYNTAX ScoreImpact of FFR on SYNTAX ScorePrognostic value of SYNTAX score improves after incorporating FFR

N=281 N=119 N=95N=166 N=170 N=160

P<0.001

CW Nam, MD (preliminary data)

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2009 U.S. PCI Guidelines Update2009 U.S. PCI Guidelines Update

1. FFR can be useful to determine if PCI is warranted, particularlyif the noninvasive test is absent or equivocal. It is reasonableto use FFR for assessing the need for PCI of intermediate lesions (IIa)

2. FFR is not warranted to assess an angiographically significant stenosis if there is angina present and an unequivocally positive stress test in a concordant vascular distribution (III)

Circulation 2009;120:2271-2306

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2010 European PCI Guidelines2010 European PCI Guidelines

Wijns W, Kolh P, et al. Eur Heart J 2010; in press

FFR Receives IA Recommendation

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Should FFR Guide PCI?Should FFR Guide PCI?

• Yes, in most cases, FFR will:– Simplify your procedure– Save money– And most importantly, improve your patient’s

outcome!