IVUS and DES in Complex PCIMLA = 4.83 mm2 Drug-eluting Stent Stanford 0 10 20 30 40 1 year 2 years 4...

Stanford

IVUS and DES in Complex PCIIVUS and DES in Complex PCI

•• Alan C. Yeung, MDAlan C. Yeung, MD•• Interventional Cardiology Professor of Interventional Cardiology Professor of

MedicineMedicine•• Stanford University School of MedicineStanford University School of Medicine

Stanford

Intravascular Ultrasound ImagingIntravascular Ultrasound Imaging

Korea, 2005

……the inside view of DESthe inside view of DES……

Stanford

Everyone gets a Everyone gets a stentstent(mechanical)(mechanical)

Plaque ResidualPlaque Residual

Stanford

CRUISE: Final MSA to Predict TLRCRUISE: Final MSA to Predict TLR

Morino Y, Fitzgerald PJ, et al. Am J Cardiol 2001

Final MSAFinal MSA

SpecificitySpecificity

SensitivitySensitivity

6.56.5

(%)(%)

00

2020

4040

6060

8080

100100

5.05.0 10.010.0 13.013.0 ((mmmm22))

Stanford

•• Mechanical Mechanical ScaffoldScaffold

•• Biological Biological SolutionSolution

RevolutionalRevolutional Technologies: Technologies: Drug Eluting StentsDrug Eluting Stents

StentStent as a Drugas a Drug--Delivery PlatformDelivery Platform

Stanford

BaselineBaseline 6M follow6M follow--upup

DES Trial: Case Example DES Trial: Case Example Bare metal stent Bare metal stent

Stanford

BaselineBaseline

66--month follow upmonth follow up

DES:DES: Case ExampleCase ExampleBare metal stent Bare metal stent

(%(%neointimalneointimal volume=50%, volume=50%, late lumen area loss=5.72mmlate lumen area loss=5.72mm2 2 ))

Stanford

DES:DES: Case ExampleCase ExampleDrugDrug--eluting stent eluting stent

BaselineBaseline 6M follow6M follow--upup

Stanford

BaselineBaseline

66--month follow upmonth follow up

DES:DES: Case ExampleCase ExampleDrugDrug--eluting stent eluting stent

(%(%neointimalneointimal volume= 0 %, volume= 0 %, late lumen area loss= 0 mmlate lumen area loss= 0 mm2 2 ))

Stanford

0102030405060708090

100

3.5

4.0

4.5

5.5

6.0

6.5

7.0

7.5

8.0

8.5

Optimal Threshold of MSA for Long-Term Stent PatencyFollowing Sirolimus-Eluting Stent Implantation

(%)

(mm2)

SES

5.0

sensitivityspecificity

0102030405060708090

100

3.5

4.0

4.5

5.0

5.5

6.0

7.0

7.5

8.0

8.5

(%)

(mm2)

BMS

6.5

JACC, 2004 (Sonoda et al)

StanfordStanford

POSTPOSTPOST 4 months4 months4 months 1 year1 year1 year

% NIV = 0 %MLA = 5.13 mm2

% % NIV = 0 %NIV = 0 %MLA = 5.13 mmMLA = 5.13 mm22

% NIV = 1.3 %MLA = 5.09 mm2

% % NIV = 1.3 %NIV = 1.3 %MLA = 5.09 mmMLA = 5.09 mm22

% NIV = 3.5 %MLA = 4.83 mm2

% % NIV = 3.5 %NIV = 3.5 %MLA = 4.83 mmMLA = 4.83 mm22

DrugDrug--eluting eluting StentStent

StanfordStanford

00

1010

2020

3030

4040

1 year1 year 2 years2 years 4 years4 years

Chronological Change of NIHChronological Change of NIH

Changes in % Neointimal VolumeChanges in % Neointimal Volume

Kuroda, et al.Kuroda, et al. StanfordStanfordBMSBMS

6 months6 months

??4.34.3

0.30.32.32.3

6.36.3 7.47.4

3.13.11.91.9

Sirolimus Studies *SirolimusSirolimus Studies *Studies *

* Stanford Database 2004* * Stanford Database 2004Stanford Database 2004

StanfordStanford

Clinical Use of IVUS in DES Clinical Use of IVUS in DES stentingstenting

•• Improve precision: length, diameterImprove precision: length, diameter•• OstialOstial location, side branch involvement location, side branch involvement

(e.g. left main)(e.g. left main)•• BMS and DES failureBMS and DES failure

Stanford

•• Length = 22.5 mmLength = 22.5 mm•• Plaque: fibrofattyPlaque: fibrofatty

OnOn--Line IVUS: Line IVUS: Length AssessmentLength Assessment

Stanford

<-------------------------8.1 mm8.1 mm

LMLM

Diag.Diag.

OnOn--Line IVUS: Length AssessmentLine IVUS: Length Assessment

Stanford

Longitudinal ReconstructionLongitudinal Reconstruction

LADLAD

CxCx

Left Left MainMain

Ostial DiseaseOstial Disease

Stanford

Stanford

Case 4M: C.C.

• 88 year old woman with left main disease, referred for CABG

• Recurrent SOB, all SVG has failed.

• H/O anterior (apex HK to AK) infarction, EF 35 to 40% range

Stanford

Stanford

9 months

Copyright © 2004 by Boston Scientific Corporation or its affiliates. All rights reserved. 26

IVUS Issues in DES

Bifurcation stenosis treated with two Cypher™ Stents without IVUS guidance

Seven-Month Follow-Up

DES “failure” 2º chronic LAD stent underexpansion just

distal to the diagonal


IVUS Issues in DES• DES failure 2o intimal hyperplasia

After 3x18 mm Cypher™ Stents Three Months Later IVUS

Stent CSA = 7.4 mm2

MLA= 1.8 mm2


IVUS Issues in DES• DES failure 2o stent underexpansion

Pre-InterventionS/P 3-18 mm Long

Cypher™ Stents

Three Months Later

Stent CSA = 4.5 mm2


IVUS Issues in DES• DES failure 2o stent underexpansion in a diabetic

Post 3.0x18 and 3.0x8

Cypher™ Stents

Eight Months Later

Proximal

Distal

Stent CSA = 5.2 mm2

MLA= 3.7 mm2

StanfordStanford

Quantitative IVUS AnalysisQuantitative IVUS Analysis

Neointimal Area (mmNeointimal Area (mm22))

Stent Area (mmStent Area (mm22))

Lumen Area (mmLumen Area (mm22))

StanfordStanford

CrossCross--Sectional (2Sectional (2--D) AnalysisD) AnalysisENDEAVOR IENDEAVOR IENDEAVOR I

Minimal Luminal Area (MLA)

Maximal Neointimal Area (Max.NIA)

Maximal % Neointimal Area Obstruction (Max.%NIA)

Minimal Luminal Area (MLA)Minimal Luminal Area (MLA)

Maximal Maximal NeointimalNeointimal Area (Max.NIA)Area (Max.NIA)

Maximal % Maximal % NeointimalNeointimal Area Obstruction (Max.%NIA)Area Obstruction (Max.%NIA)

IVUS can precisely evaluate:IVUS can precisely evaluateIVUS can precisely evaluate::

LA :LA :LA :

NIA :NIA :NIA :

%NIA

= NIA*100 / stent area :

%NIA %NIA

= NIA*100 / = NIA*100 / stentstent area : area : *100*100*100

StanfordStanford

Maximal % Maximal % NeointimalNeointimal Area Obstruction (Max.%NIA)Area Obstruction (Max.%NIA)Example TrialExample TrialExample Trial

0

24

6

810

12

14

1618

20

0

24

6

810

12

14

1618

20

(Number of patients)

(Number of (Number of patients)patients)

101010 202020 303030 404040 505050 606060 707070 808080 909090 100100100

(%)(%)(%)

Mean ± SD: 23.5 ± 15.1 %Median (25,75): 19.6 (13.1, 31.6)Mean Mean ±± SD: 23.5 SD: 23.5 ±± 15.1 %15.1 %Median (25,75): 19.6 (13.1, 31.6)Median (25,75): 19.6 (13.1, 31.6)

*100*100*100

RSRSRS

StanfordStanford

Volumetric IVUS AnalysisVolumetric IVUS Analysis

Volume = Volume = ΣΣ AAi i = A= A11+ A+ A22 ++⋅⋅⋅⋅⋅⋅⋅⋅⋅⋅⋅⋅+ A+ Ann--11 + A+ An n i=1i=1

nnSimpsonSimpson’’s Methods Method

VolumesVolumes: Stent, Lumen, Neointima (mm: Stent, Lumen, Neointima (mm33))

Volume IndexVolume Index = Volume / length (mm= Volume / length (mm33/mm)/mm)

% Neointimal Volume% Neointimal Volume = Neointima / Stent (%)= Neointima / Stent (%)

StanfordStanford

00

55

1010

1515

00 1010 2020 3030 4040 5050 6060 7070 8080 90900

5

10

15

20

0 1 2 3 4 5 6 7 8 9

Per

cent

of T

otal

Cas

es

Neointimal Volume Index (mmNeointimal Volume Index (mm22/mm)/mm) % Neointimal Volume (%)% Neointimal Volume (%)

n=1421

2.552.55±±1.351.35 3232±±1616

Bare Metal StentsBare Metal Stents

Statistical Distributions of NIHStatistical Distributions of NIH

(%) (%)

MeanMean±±SDSD MeanMean±±SDSD

StanfordStanford

0

10

20

30

40

50

0

10

20

30

40

50

101010

000

202020

303030

404040

505050

(N of patients)

(N of (N of patients)patients)

Mean ± SD: 33.1 ± 14.0 %Median (25,75): 30.8 (21.9, 44.5) %Mean Mean ±± SD: 33.1 SD: 33.1 ±± 14.0 %14.0 %Median (25,75): 30.8 (21.9, 44.5) %Median (25,75): 30.8 (21.9, 44.5) %


Volumetric Analysis Vs. CrossVolumetric Analysis Vs. Cross--sectional Analysissectional Analysis

% NIV at 8M-FU% % NIV at NIV at 8M8M--FUFU Max.%NIA at 8M-FUMax.%NIA at Max.%NIA at 8M8M--FUFUSIRIUS Trial BMS ArmSIRIUS Trial BMSSIRIUS Trial BMS ArmArm

(n=45)((n=45)n=45) (n=45)((n=45)n=45)

101010 202020 303030 404040 505050 606060 707070 808080

(%)(%)(%)909090101010 202020 303030 404040 505050 606060

(%)(%)(%)707070

RSRSRS

StanfordStanford

0

10

20

30

40

50

0

10

20

30

40

50

101010

000

202020

303030

404040

505050

(N of patients)

(N of (N of patients)patients)



Volumetric Analysis Vs. CrossVolumetric Analysis Vs. Cross--sectional Analysissectional Analysis

SIRIUS Trial Cypher® ArmSIRIUS Trial SIRIUS Trial CypherCypher®® ArmArm

% NIV at 8M-FU% % NIV at NIV at 8M8M--FUFU Max.%NIA at 8M-FUMax.%NIA at Max.%NIA at 8M8M--FUFU

101010 202020 303030 404040 505050 606060(%)(%)(%)

707070

(n=51)((n=51)n=51) (n=51)((n=51)n=51)

101010 202020 303030 404040 505050 606060 707070 808080

(%)(%)(%)909090

RSRSRS

StanfordStanford

SirolimusSirolimusABTABT--578 578

(PC(PC--only)only)PaclitaxelPaclitaxel

(Non(Non--Polymer)Polymer)

% Neointimal Volume (%)% Neointimal Volume (%)

DrugDrug--Eluting StentsEluting Stents

Impact of Biological ModificationImpact of Biological Modification

00

2020

4040

6060

8080

100100

00 1010 2020 3030 4040 5050 6060 00 1010 2020 3030 4040 5050 6060 00 1010 2020 3030 4040 5050 6060

(%)(%)

StanfordStanford

33--D Intravascular Ultrasound DrugD Intravascular Ultrasound Drug--Eluting Stents: Eluting Stents: NeointimalNeointimal VolumeVolume

1010 2020 3030 40400

20

40

0

60

80

100

(%)

Neointimal Volume (%)Neointimal Volume (%)

Frequency Distributions:Frequency Distributions:

ControlControlDrug ADrug A

Drug BDrug B

DES TrialsSirolimusSirolimus

TaxusTaxus

ProgramProgram

AB

T 578 ProgramA

BT 578 Program

Evirolim

usE

virolimus

ProgramProgram

StanfordStanford

Stent Trials: Frequency Distributions of NIHStent Trials: Frequency Distributions of NIH

20

40

0

60

80

100(%)

NeointimalNeointimal Volume (%)Volume (%)

30

1:1 Randomization1:1 Randomization


Randomized TrialsRandomized TrialsDES + BMSDES + BMS

StanfordStanford

NeointimalNeointimal Volume ObstructionVolume Obstruction

0

10

20

30

40

50

DELIVERDELIVER (N=70)(N=70)

% NIV = 29.42

Median (%) = 26.98

% NIV = 29.42% NIV = 29.42

Median (%) = 26.98Median (%) = 26.98

5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80

(% o

f cas

es)

%%NeointimalNeointimal Volume ObstructionVolume Obstruction


StanfordStanford

NeointimalNeointimal Volume ObstructionVolume Obstruction

0

10

20

30

40

50

5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80

DELIVERDELIVER (N=70)(N=70)

% NIV = 29.42

Median (%) = 26.98

% NIV = 29.42% NIV = 29.42

Median (%) = 26.98Median (%) = 26.98

(% o

f cas

es)

%%NeointimalNeointimal Volume ObstructionVolume Obstruction

StanfordStanford

%%NeointimalNeointimal VolumeVolume

%%NeointimalNeointimal VolumeVolume

0

10

20

30

40

50

(N=165)

5 10 15 20 25 30 35 40 45 50 55 60 65 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 8070 75 80

(Pat

ient

s)

%NIH = 24.1±14.9Median (%) = 22.0%NIH = 24.1±14.9Median (%) = 22.0


LLL = 0.72 ± 0.41Median(25, 75) = 0.63(0.43, 0.93)LLL = 0.72 ± 0.41

Median(25, 75) = 0.63(0.43, 0.93)

Stanford

STEALTH 1 IVUS ResultsSTEALTH 1 IVUS Results~~ Distribution ofDistribution of %%NeointimalNeointimal Volume Volume ~~

((NeointimalNeointimal Volume / Stent Volume)Volume / Stent Volume)

0

10

20

30

40

50

60

70(% of cases)

%NIV = 10.0 ± 13.5

Median: 3.225% Quartile: 1.075% Quartile: 12.6

(%Neointimal Volume)5 10 15 20 30 40 50 60 70 8025 35 45 55 65 75

*overall results

0

*out of 81 patients with follow-up 3D analysis


StanfordStanford

0

10

20

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70

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0 10 20 30 40 50 60 70 800

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20

30

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0 10 20 30 40 50 60 70 80

Max. %NIA (%)Max. %NIA (%)Max. %NIA (%)

%NIV (%)%NIV (%)%NIV (%)

(n=87)(n=87)(n=87)

Relationship between Volume and Area Relationship between Volume and Area ObstructionObstruction

FocalFocal

DiffuseDiffuse

StanfordStanford

0

10

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20

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0 10 20 30 40 50 60 70 80


%NIV (%)%NIV (%)%NIV (%)

(n=87)(n=87)(n=87)

%NIV: 13.7 %

Max%NIA: 19.6 %

%NIV: 13.7 %%NIV: 13.7 %

Max%NIA: 19.6 %Max%NIA: 19.6 %

Relationship between Volume and Area ObstructionRelationship between Volume and Area Obstruction

StanfordStanford

0

10

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80

0 10 20 30 40 50 60 70 800

10

20

30

40

50

60

70

80

0 10 20 30 40 50 60 70 80


(n=87)(n=87)(n=87)

%NIV: 12.6 %

Max%NIA: 54.2 %

%NIV: 12.6 %%NIV: 12.6 %


%NIV (%)%NIV (%)%NIV (%)


StanfordStanford

0

10

20

30

40

50

60

70

80

0 10 20 30 40 50 60 70 800

10

20

30

40

50

60

70

80

0 10 20 30 40 50 60 70 80


(n=87)(n=87)(n=87)

%NIV (%)%NIV (%)%NIV (%)

%NIV: 45.8 %

Max%NIA: 55.1 %

%NIV: 45.8 %%NIV: 45.8 %



StanfordStanford

0

10

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0 10 20 30 40 50 60 70 800

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20

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0 10 20 30 40 50 60 70 80

Max.

%NIA (%)

Max.Max.

%NIA (%)%NIA (%)

(n=87)(n=87)(n=87)

%NIV (%)%NIV (%)%NIV (%)

FocalFocal

DiffuseDiffuse


AAA

BBB CCC

AAA

BBB

CCC

Stanford

Intravascular Ultrasound: The view Intravascular Ultrasound: The view from within from within ……

* Magnitude of IH

* Statistical Distribution

* Distribution of IH in stent

* Safety issues

The changing landscape by DESThe changing landscape by DES……

…the edges are important …incomplete apposition

Stanford

FollowFollow--up Incomplete (up Incomplete (++ remodeling)remodeling)

BaselineBaseline

FollowFollow--up IAup IA(remodeling)(remodeling)

FollowFollow--up IAup IA(no remodeling)(no remodeling)

Stanford

LateLate Incomplete AppositionIncomplete Apposition

Follow-upFollowFollow--upupBaselineBaselineBaseline

DrugDrug--elutingeluting stentstent groupgroup

Stanford

RapaRapa--eluting eluting stentstent: IH distribution: IH distribution

Mid-stentlocation of late

IA …asymmetric IH

distribution

8.9 %

Stanford

DrugDrug--eluting eluting stentstent: IH distribution: IH distribution

(more even (more even distibutiondistibution……fills in gaps)fills in gaps)

Ptx / Express II

Incidence of LIA = 1.2 %

.. drug and platform

Stanford

Intravascular Ultrasound: The view Intravascular Ultrasound: The view from within from within ……

* Clinical Subset adjunct

* Clinical efficacy and safety

* New Applications

IVUS and DES in Complex PCIMLA = 4.83 mm2 Drug-eluting Stent Stanford 0 10 20 30 40 1 year 2 years 4...

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Transcript of IVUS and DES in Complex PCIMLA = 4.83 mm2 Drug-eluting Stent Stanford 0 10 20 30 40 1 year 2 years 4...