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