columbia university medical center cardiovascular research ...€¦ · oct ivus angio p p (n=158)...

Columbia University Medical CenterColumbia University Medical Center

Cardiovascular Research FoundationCardiovascular Research Foundation

Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest

Within the past 12 months, I or my spouse/partner have had a financialWithin the past 12 months, I or my spouse/partner have had a financialinterest/arrangement or affiliation with the organization(s) listed below.interest/arrangement or affiliation with the organization(s) listed below.

•• Grant/ResearchGrant/Research SupportSupport •• NIH/NHLBI,NIH/NHLBI, St Jude Medical,St Jude Medical,

Affiliation/Financial Relationship Company•• Grant/ResearchGrant/Research SupportSupport

•• Consulting Fees/Consulting Fees/HonorariaHonoraria

•• NIH/NHLBI,NIH/NHLBI, St Jude Medical,St Jude Medical,Cardiovascular SystemsCardiovascular Systems IncInc

•• St Jude Medical,St Jude Medical, AcistAcist, Astra Zeneca,, Astra Zeneca,Canon, Cardiovascular SystemsCanon, Cardiovascular Systems IncInc

•• EquityEquity •• Shockwave Medical,Shockwave Medical, VitaBxVitaBx Inc.Inc.

BEFORE THE CASEBEFORE THE CASE

“Why do“Why do II need to image?need to image?I have great results.”I have great results.”I have great results.”I have great results.”

T W EN T E5-Years: ClinicalEvents

R ES O L U T E ZES X IEN CEV EESHazardR atio

(95% CI)L og-R ank

P

Death,any 62 (9.0) 80 (11.6) 0.77(0.55 – 1.07) 0.12

Cardiacdeath 25 (3.7) 35 (5.2) 0.71 (0.42 – 1.18) 0.18Cardiacdeath 25 (3.7) 35 (5.2) 0.71 (0.42 – 1.18) 0.18

M yocardialinfarction,any 49 (7.2) 52 (7.7) 0.94 (0.63 – 1.38) 0.73

T argetvesselm yocardialinfarction 46 (6.8) 45 (6.6) 1.02 (0.67– 1.53) 0.94

R evascularization,any 95 (14.1) 105 (15.9) 0.90 (0.68– 1.18) 0.43

T argetvesselrevascularization(T VR ) 60 (8.9) 69 (10.5) 0.86 (0.61 – 1.22) 0.41

T argetlesionrevascularization(T L R ) 47(7.0) 50 (7.7) 0.94 (0.63 – 1.40) 0.77

T argetvesselfailure(T VF) 110 (16.1) 123 (18.1) 0.89 (0.69 – 1.15) 0.36

T argetlesionfailure(T L F) 102 (15.0) 110 (16.2) 0.93 (0.71 – 1.21) 0.58

M ajoradversecardiacevents(M ACE) 138(19.9) 157(22.7) 0.88(0.70 – 1.10) 0.26

P atient-oriented com positeendpoint(P O CE) 176 (25.4) 196 (28.4) 0.89 (0.73 – 1.10) 0.27P atient-oriented com positeendpoint(P O CE) 176 (25.4) 196 (28.4) 0.89 (0.73 – 1.10) 0.27

Definite-or-probablestentthrom bosis 13 (1.9) 14 (2.1) 0.92 (0.43 – 1.96) 0.83

Definitestentthrom bosis 7(1.0) 4 (0.6) 1.74 (0.51 – 5.94) 0.37

Dataarefrequencies(% )andHazard R atio(95% ConfidenceInterval).T argetvesselandtargetlesionrevascularizationsw ereclinically indicated.

“Where is the data?”“Where is the data?”

10HR: 0.65 [95% CI: 0.54, 0.78]P < 0.001 7.45%7.45%

MACE (Definite/Probable ST,MACE (Definite/Probable ST,Cardiac Death, MI)Cardiac Death, MI)

Two year followTwo year follow--up dataup datafrom ADAPTfrom ADAPT--DES (3361DES (3361

MA

CE

(%)

MA

CE

(%)

5

P < 0.001

4.90%4.90%

7.45%7.45%

IVUS UsedIVUS Used

IVUS Not UsedIVUS Not Used

from ADAPTfrom ADAPT--DES (3361DES (3361ptspts treated with IVUStreated with IVUS--guidanceguidance vsvs 52215221 ptspts

treated withtreated with

3361 3206 3117 2988 1739

Number at risk:

IVUS Used

0

Time in MonthsTime in Months0 6 12 18 24

treated withtreated withangiographic guidance)angiographic guidance)

Definite/Probable STDefinite/Probable ST

Defi

nit

e/P

rob

ab

leS

T(%

)

HR: 0.47 [95% CI: 0.28, 0.80]

2

Myo

card

ial

Infa

rcti

on

(%)

10

HR: 0.62 [95% CI: 0.49, 0.77]

Myocardial InfarctionMyocardial Infarction

3361 3206 3117 2988 1739

5221 4912 4740 4537 2177

IVUS Used

IVUS Not Used

Defi

nit

e/P

rob

ab

leS

T(%

)

HR: 0.47 [95% CI: 0.28, 0.80]P = 0.004

0.55%

1.16%1

IVUS UsedIVUS Used

IVUS Not UsedIVUS Not Used

Myo

card

ial

Infa

rcti

on

(%)

5

HR: 0.62 [95% CI: 0.49, 0.77]P < 0.001

3.47%

5.59%

IVUS Not UsedIVUS Not Used

Defi

nit

e/P

rob

ab

leS

T(%

)

Time in Months3361 3260 3182 3065 1791

Number at risk:

IVUS Used

0.55%

00 6 12 18 24

IVUS UsedIVUS Used

Myo

card

ial

Infa

rcti

on

(%)

0

Time in Months3361 3209 3120 2991 1739

Number at risk:

IVUS Used

0 6 12 18 24

IVUS UsedIVUS Used

3361 3260 3182 3065 1791

5221 5019 4886 4713 2279

IVUS Used

IVUS Not Used

3361 3209 3120 2991 1739

5221 4916 4744 4541 2179

IVUS Used

IVUS Not Used

Maehara et al. J Am Coll Cardiol 2013;62:B21-B22

“That’s a registry.“That’s a registry.Where is the RCT data?”Where is the RCT data?”Where is the RCT data?”Where is the RCT data?”

IVUS XPLIVUS XPL –– Primary EndpointPrimary Endpoint

NNTIVUS XPL = 1/34IVUS XPL = 1/34WOSCOPS = 1/45HTN Diuretics = 1/86HTN BB = 1/140ASA = 1/400ASA = 1/400

“That“That’’s just one study.”s just one study.”

Meta-Analysis of 20DES Studies

Compared withCompared with angiographicangiographic

DES Studies(n=29,068) MACE

P Agostoni

P Roy

SJ Park

2005

2008

2009

0.40 (0.05, 2.91)

0.90 (0.71, 1.15)

0.64 (0.39, 1.05)

0.17

11.13

2.75Compared withCompared with angiographicangiographicguidanceguidance, IVUS, IVUS--guided DESguided DESimplantation was associatedimplantation was associatedwith reduced rates of:with reduced rates of:

SJ Park

J Jakabcin

JS Kim

BE Claessen

SH Hur

K W Park

SL Chen

2009

2010

2011

2011

2011

2011

2012

0.64 (0.39, 1.05)

0.92 (0.37, 2.28)

0.73 (0.44, 1.20)

0.77 (0.56, 1.06)

0.76 (0.62, 0.93)

1.07 (0.86, 1.33)

0.80 (0.54, 1.18)

2.75

1.58

2.68

12.41

19.70

2.79

4.31with reduced rates of:with reduced rates of:

•• DeathDeathHR 0.62 (0.54HR 0.62 (0.54--0.71), p<0.0010.71), p<0.001

SL Chen

ADAPT-DES

Chieffo A

RESET

YJ Youn

YW Yoon

SG Ahn

2012

2012

2012

2013

2011

2013

2013

0.80 (0.54, 1.18)

0.67 (0.53, 0.84)

0.73 (0.41, 1.28)

0.59 (0.28, 1.24)

0.71 (0.40, 1.25)

1.06 (0.54, 2.08)

0.24 (0.07, 0.80)

4.31

12.49

2.07

1.20

2.10

1.46

0.45

•• MACEMACEHR 0.77HR 0.77 (0.71(0.71--0.830.83), p<0.001), p<0.001

•• StentStent thrombosisthrombosis

SG Ahn

IRIS_DES

Hernandez

SJ Hong

XF Gao

Overall

2013

2013

2014

2014

2014

0.24 (0.07, 0.80)

0.64 (0.44, 0.94)

0.73 (0.55, 1.53)

0.92 (0.55, 1.53)

0.54 (0.40, 0.73)

0.77 (0.71, 0.83)

0.45

4.60

8.54

2.54

7.05

100

•• StentStent thrombosisthrombosisHR 0.59 (0.47HR 0.59 (0.47--0.73), p<0.0010.73), p<0.001

Zhang Y et al.

0.1 .1 1 10 100Favors IVUS Favors Non-IVUS

Zhang Y et al.BMC Cardiovasc Dis 2015;15:153

“That“That’’s just one metas just one meta--analysis.”analysis.”

More MetaMore Meta--AnalysesAnalyses

JACC Cardiovasc Interv 2014; 7: 233-43.

Circ Cardiovasc Interv. 2016 Apr;9(4):e003700

Am J Cardiol 2014; 113: 1338-47.

Am J Cardiol 2014; 113: 1338-47.

“Those are simple lesions.”“Those are simple lesions.”

8 trials, 3276 randomized pts (3 studies 1st gen DES, 3studies

Meta-analysis in Complex Lesions8 trials, 3276 randomized pts (3 studies 1st gen DES, 3studies

2nd gen DES, 2 studies not stated)

Mean FU 1.4 ± 0.5 years

MACEMACEIVUS

guided PCIStudy or

Angiographyguided PCI Risk Ratio Risk RatioStudy or

Subgroup Events Total Events Total WeightRisk Ratio

M-H, Random 95% CIRisk Ratio

M-H, Random 95% CI

MACEAIR-CTO, 2015AVIO, 2013CTO-IVUS, 2015HOME DES IVUS, 2010

2524511

115142201105

29331412

115142201105

23.2%22.9%5.1%8.5%

0.86 [0.54, 1.38]0.73 [0.45, 1.17]0.36 [0.13, 0.97]0.92 [0.42, 1.98]HOME DES IVUS, 2010

IVUS-XPL, 2015RESET, 2013Tan et al, 2015Zhang et al, 2016Subtotal (95%)

11191283

1057002696142

1635

123920179

1057002746242

1641

8.5%17.6%10.5%8.8%3.3%

100.0%

0.92 [0.42, 1.98]0.49 [0.28, 0.83]0.61 [0.30, 1.23]0.48 [0.22, 1.03]0.33 [0.10, 1.15]0.64 [0.51, 0.80]Subtotal (95%)

Total eventsHeterogeneity: Tau2=0.00; Chi2=6.67, df=7 (P=0.46); 12=0%Test for overall effect: Z=3.88, P=0.0001

107 173

1635 1641 100.0% 0.64 [0.51, 0.80]

0.02

Favors IVUS-

0.1 1 10

Favors angiography-

50

Bavishi C and Stone GW. AHJ 2017;185:26-34

Favors IVUS-guidance

Favors angiography-guidance

“Its too expensive, and not really worth it.”“Its too expensive, and not really worth it.”

IVUSIVUS –– Cost EffectivenessCost Effectiveness

From the healthcare payerFrom the healthcare payerFrom the healthcare payerFrom the healthcare payerperspective, IVUS is aperspective, IVUS is adominant treatment option,dominant treatment option,providing improvedproviding improved

Mean ICER

providing improvedproviding improvedoutcomes at lower costs,outcomes at lower costs,with greater economicwith greater economicbenefit in higher riskbenefit in higher riskbenefit in higher riskbenefit in higher risksubgroups (diabetes, renalsubgroups (diabetes, renalinsufficiency, ACS)insufficiency, ACS)

Incremental QALYsinsufficiency, ACS)insufficiency, ACS)

Incremental QALYs

Assumptions: hypothetical population of 1000 pts with an average age of 60, all of whom underwent PCI withDES, guided either by IVUS and angiography, or angiography alone with 1.6% probability of MI and 2.7%

Eur J Health Econ. 2016 Mar;17(2):185-93

DES, guided either by IVUS and angiography, or angiography alone with 1.6% probability of MI and 2.7%probability of repeat revascularization in one year

DURING THE CASEDURING THE CASE

“It takes too long.”“It takes too long.”

Procedural CharacteristicsProcedural Characteristics

OCTOCT IVUSIVUS AngioAngio PP PPOCTOCT(n=158)(n=158)

IVUSIVUS(n=146)(n=146)

AngioAngio(n=146)(n=146)

PPOCT vsOCT vsIVUSIVUS

PPOCT vsOCT vsAngioAngio

Radial Access 66% 60% 62% 0.26 0.50Radial Access 66% 60% 62% 0.26 0.50

Stents per lesion 1 [1, 1] 1 [1, 1] 1 [1, 1] 0.58 0.93

Stent length, mm 23 [15, 32] 24 [16, 32] 20 [16, 30] 1.00 0.27

Maximal stent diameter, mm3.00

[2.75, 3.50]3.00

[2.75, 3.50]3.00

[2.75, 3.50]0.36 0.39

Post-dilatation balloons used, n 2 [1, 3] 2 [1, 3] 1 [1, 2] 0.80 0.0005

Maximum balloon size, mm 3.5 [3.0, 4.0] 3.5 [3.0, 4.0] 3.0 [3.0, 3.5] 0.94 0.0007

Maximum inflation pressure, atm 18 [16, 20] 20 [16, 20] 18 [16, 20] 0.48 0.02

Procedure duration, min 71 [57,101] 73 [54,97] 58 [39,78] 0.99 <0.0001

Radiation dose, Gy 1.3 [0.85, 2.0] 1.2 [0.74, 2.3] 1.2 [0.70, 2.0] 0.87 0.39

Contrast volume, mL 222 [164, 285] 190 [140, 250] 183 [140, 250] 0.004 0.001

“I mean the pullback takes too long”“I mean the pullback takes too long”

Rapid PullbackRapid Pullback

Conventional 10mm/sec

“Its too complicated.”“Its too complicated.”

ImagingImagingffor the Engineeror the Engineer

TransducerTransducerFrequencyFrequency

PulsePulse DurationDuration

and Lengthand LengthSignalSignal

ProcessingProcessing

ffor the Engineeror the Engineer

FrequencyFrequency

TransducerTransducer

BandwidthBandwidth

and Lengthand Length ProcessingProcessing

GrayscaleGrayscaleBandwidthBandwidth

Image QualityImage Quality MinimizingMinimizingPenetrationPenetration

GrayscaleGrayscale

TransducerTransducer

artifactsartifactsFocusingFocusing

Signal/Noise RatioSignal/Noise Ratio TransducerTransducershapeshape

PulsePulse

ShapeShape

SheathSheath

MaterialMaterialShapeShape MaterialMaterial

8 simple steps8 simple steps

OCT ImagingOCT Imaging

Pre-InterventionAssessment

Stent DeploymentComplication

and Post ProceduralAssessments

AssessmentAssessments

1. Assess plaque composition2. Identify reference segments

4. Confirm Landing Zones5. Determine expansion/MSA

6. Identify edge dissections7. Determine apposition2. Identify reference segments

3. Choose stent size5. Determine expansion/MSA 7. Determine apposition

8. Identify tissue protrusion

“I don’t know what I am looking at.”“I don’t know what I am looking at.”

Of course you don’t…..Of course you don’t…..

Normal Vessel 2017Normal Vessel 2017

AdventitiaThin intima

Adventitia Thin intimaAdventitia

MediaMedia

High resolution imaging allows clear delineation of healthyHigh resolution imaging allows clear delineation of healthyvessel layers

CY Chan & ZA Ali. JACC Int 2016; 27;9(12):1305-6.

OCT Image InterpretationOCT Image Interpretation

Fibrous Plaque Fibro-fatty Plaque Calcium

Red Thrombus White Thrombus Tissue Protrusion

IVUS Image InterpretationIVUS Image Interpretation

Fibrous Plaque Fibro-fatty Plaque Calcium

Red Thrombus White Thrombus Tissue Protrusion

DissectionsDissections

Intimal Medial Intramural Hematoma

“I don’t know where I am in the artery.”“I don’t know where I am in the artery.”

Where am I?Where am I?

?

?

“I don’t know when, and when not, to use it.”“I don’t know when, and when not, to use it.”“I don’t know when, and when not, to use it.”“I don’t know when, and when not, to use it.”

Which Patients Benefit from Imaging Guidance?Which Patients Benefit from Imaging Guidance?

46 year old with HTN, HL and CCS II stable angina46 year old with HTN, HL and CCS II stable angina

Direct Stent 4.0x15mm EES

Which Patients Benefit from Imaging Guidance?Which Patients Benefit from Imaging Guidance?

Risk of Restenosis in 2Risk of Restenosis in 2ndnd Generation DESGeneration DES

1.01.0

EESEES ZESZESMSA 7.0mm2MSA 6.8mm2

0.5

Reste

nosis

%

0.5

Reste

nosis

%

0.0

0.5

Reste

nosis

%

0.0

Reste

nosis

%

0 1 2 3 4 5 6 7 8 9 10 11 120.0

MSA 5.4mm2MSA 5.3mm2

0 1 2 3 4 5 6 7 8 9 10 11 120.0

4.0 EES area expansion = π(r2)3.14(22)12.6mm2

Even 70% expansion = 8.8mm2

Song et al.Song et al. CathetCathet CardiovascCardiovasc IntervInterv 2014;83:8732014;83:873--88

Even 70% expansion = 8.8mm2

Patient ComorbiditiesPatient Comorbidities

In whom is the risk of TVF the highest?In whom is the risk of TVF the highest?

• Diabetes Mellitus

• End Stage Renal Disease

• Previous Stent Failure

• Co-morbidity necessitating the use of BMS• Co-morbidity necessitating the use of BMS

IndependentIndependent RiskRisk FactorsFactors forfor RestenosisRestenosis

14

7

16

Hypertension

Diabetes

AHA B2/C

3370 patients

5

14

5

14

CTO

AHA B2/C

>28mm lesion

ISR

11Severe stenosis

5>28mm lesion

5Stent Expansion

61

29

84

Stent length

<2.5mm Ref

BMS vs DES

5

0 20 40 60 80 1001 5

odds ratio relative power (χ2)

2 3 4

61BMS vs DES

0

odds ratio relative power (χ2)

Kastrati et al., Am J Cardiol 2000

AFTER THE CASEAFTER THE CASE

“I knew I should have imaged….”“I knew I should have imaged….”

Intravascular ImagingIntravascular Imaging

•• Angiography has limitationsAngiography has limitations

•• The benefits of intravascular imagingThe benefits of intravascular imaging•• The benefits of intravascular imagingThe benefits of intravascular imagingon PCI outcomes are irrefutableon PCI outcomes are irrefutable

•• Choice of imaging modality isChoice of imaging modality isdependent upon the lesion and thedependent upon the lesion and thedependent upon the lesion and thedependent upon the lesion and thequestion to be answeredquestion to be answered

•• NO MORE EXCUSES!!!!!!!NO MORE EXCUSES!!!!!!!