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Intravascular Ultrasound and Near-infrared spectroscopy of non-culprit, non-steno7c segments for the predic7on of MACE Results from ATHEROREMO Rohit M. Oemrawsingh, MD MSc Op7cs in Cardiology, Zurich April 20th, 2018 Disclosures Conflict

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Intravascular Ultrasound and Near-infrared spectroscopy

f non-culprit, non-steno7c segments

for the predic7on of MACE Results from ATHEROREMO

Rohit M. Oemrawsingh, MD MSc Op7cs in Cardiology, Zurich April 20th, 2018

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Disclosures

§ Conflict of interest: NONE à Netherlands Heart Founda6on, non-commercial charity (grant no. NHS 2007B012 and NHS 2009B091 ) § Funding ATHEROREMO à European Commission, Seventh Framework Programme theme FP7-HEALTH-2007-2.4.2-1

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PRESENTATION OUTLINE

§ (RF)IVUS and risk predic6on (n=581) § NIRS and risk predic6on (n=203 for 1 year FU, n=275 for 4 year FU)

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ATHEROREMO

European Collaborative Project

n Inflammation and Vascular Wall Remodeling

in Atherosclerosis

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Background

§ ATHEROREMO à European collabora6ve research programme studying the rela6on of gene$c profile and novel circula$ng biomarkers with coronary plaque phenotype as determined by intravascular ultrasound and NIRS

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Objec7ves

§ To assess the prognos'c value of coronary plaque detec6on, as evaluated with RF-IVUS and NIRS à adverse cardiovascular

utcome

§ To inves6gate whether imaging of a single segment without significant luminal narrowing of a non-culprit coronary artery could be used for the purpose of risk stra6fica6on

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Methods I

§ Prospec6ve, single-center, observa6onal study § With an indica6on, as determined by their trea'ng physician, for diagnos6c CAG and/or PCI § Real world se`ng of everyday clinical prac6ce, in which pa6ents with both stable angina and ACS present for coronary angiography. § Approved by the Medical Ethics Commiaee of the Erasmus MC and performed in accordance to the Declara6on of Helsinki. Wriaen informed consent was provided by all pa6ents.

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Methods II

§ RF- IVUS and NIRS target segment of the non-culprit coronary artery of at least 40 mm in length and without significant luminal narrowing (< 50 % stenosis) as assessed by on-line angiography § Selec6on of the non-culprit vessels was predefined in the study protocol

1. Lee anterior descending artery
2. Right coronary artery
3. Lee circumflex artery

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Methods III

§ Focus on predic6ng type 1 MI during FU, not on TLR events § In case of follow-up angiography, events were classified either as a definite culprit lesion-related (CLR) event (ISR or ST)or as related to a coronary site that was not treated during the index procedure (non-culprit lesion-related event) § In case angiographic informa6on on the endpoint related coronary site was not available ( e.g. in case of death), the event was classified as indeterminate

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RF-IVUS

European Collaborative Project

n Inflammation and Vascular Wall Remodeling

in Atherosclerosis

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Results

Patient characteristics (n=581) Age 61.6 years Men 75.6 % Diabetes 17.0 % Hypertension 51.6 % History of MI 31.7 % Indication for angiography: ACS 54.7 % Stable CAD 45.3 % Multi-vessel disease 39.6 % PCI performed 88.0 %

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Results

Imaged non-culprit coronary artery Left anterior descending 36.1 % Left circumflex 33.6 % Right coronary artery 30.3 % Median segment length 44.3 [33.8-55.4] mm

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High-risk coronary lesions

Virtual Histology- derived TCFA lesion Lesion with plaque burden ≥70% Lesion with minimal luminal area ≤4.0mm2

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Results

Presence of high-risk lesions ≥1 VH-TCFA lesion 41.7 % ≥1 lesion with plaque burden ≥70% 21.3 % ≥1 minimal luminal area ≤4.0mm2 31.3 % Imaged non-culprit coronary artery Left anterior descending 36.1 % Left circumflex 33.6 % Right coronary artery 30.3 % Median segment length 44.3 [33.8-55.4] mm

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Results

1-year MACE (definite culprit lesion-related events not counted) Death 17 Acute coronary syndrome 11 Unplanned coronary revascularization 17 MACE 45 Death or acute coronary syndrome 28

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Results

MACE P Presence of VH-TCFA HR 1.98 (1.09-3.60) 0.026 Lesion with plaque burden ≥70% HR 2.90 (1.60-5.25) <0.001 Lesion with minimal luminal area ≤4mm2 HR 1.23 (0.67-2.26) 0.50

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Results

MACE P Presence of VH-TCFA HR 1.98 (1.09-3.60) 0.026 Lesion with plaque burden ≥70% HR 2.90 (1.60-5.25) <0.001 Lesion with minimal luminal area ≤4mm2 HR 1.23 (0.67-2.26) 0.50 Death or ACS P Presence of Vh-TCFA HR 2.51 (1.15-5.49) 0.021 Lesion with plaque burden ≥70% HR 2.01 (0.92-4.39) 0.079 Lesion with minimal luminal area ≤4mm2 HR 1.14 (0.53-2.49) 0.73

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Results

5 10 15 20 25 Present Absent TCFA TCFA+MLA≤4mm2 TCFA+PB≥70% TCFA+PB≥70%+ MLA≤4mm2 10.8 5.6 15.1 6.9 20.5 6.1 23.1 6.8 0.024 0.025 <0.001 <0.001 41.7 11.9 10.5 6.0 P value Prevalence (%) Hazard ratio (95% CI) 1.96 (1.08-3.53) 2.26 (1.09-4.69) 3.47 (1.86-6.49) 3.70 (1.72-7.95) Major adverse cardiac events (%)

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Results

5 10 15 20 Presence of TCFA with PB≥70% (large TCFA) No TCFA Presence of TCFA with PB<70% (small TCFA) Large TCFA vs no TCFA p=0.011 Small TCFA vs no TCFA p=0.49 3 6 Death, ACS or revascularization (%) 5 10 15 20 6 9 12 Large TCFA vs no TCFA p<0.001 Small TCFA vs no TCFA p=0.033 months

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NIRS

European Collaborative Project

n Inflammation and Vascular Wall Remodeling

in Atherosclerosis

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Background

§ NIRS is based on diffuse reflectance spectroscopy § A FDA-approved NIRS system (InfraReDx) performs 1000 chemical measurements per 12.5 mm § Each measurement interrogates 1-2 mm2 of vessel wall § Tissue scaaering and absorp6on of light in the NIR result in a wavelenght dependent return of light which can be displayed as an image map à chemogram § Cholesterol (monohydrate and ester) are both abundant in necro6c cores and has prominent molecular features in the NIR region

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Chemograms as result of near-infrared spectroscopy

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Gardner CM et al. JACC Cardiovasc Imaging. 2008;1:638–648

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§ J Am Coll Cardiol. 2014 Dec 16;64(23):2510-8

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Methods

§ NIRS target segment of the non-culprit coronary artery of at least 40 mm in length and without significant luminal narrowing (< 50 % stenosis) as assessed by on-line angiography § Primary endpoint à composite of all-cause mortality, non-fatal ACS, stroke and unplanned PCI during one-year follow-up, exclusive of events related to the culprit lesion at the index angiography § Secondary endpoints included 1) the composite of all-cause mortality and non-fatal ACS 2) the composite of all-cause mortality, non-fatal ACS and stroke 3) the composite of all-cause mortality, non-fatal ACS and unplanned PCI.

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Baseline characteris7cs

203

April 16, 2009 – January 28, 2011

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Baseline characteris7cs

Age, years 63.4 ±10.9 Male, n (%) 148 (72.9) Diabetes Mellitus, n (%) 41 (20.2) Hypertension, n (%) 114 (56.2) Hypercholesterolemia, n (%) 115 (56.7) Smoking, n (%) 50 (24.6) Posi6ve family history, n (%) 120 (59.1) Previous MI, n (%) 79 (38.9) Previous PCI, n (%) 78 (38.4) Previous CABG, n (%) 6 (3.0) Previous stroke, n (%) 6 (3.0) Peripheral artery disease, n (%) 11 (5.4) History of renal insufficiency, n (%) 12 (5.9) History of heart failure, n(%) 9 (4.4)

SLIDE 30 Median total cholesterol (IQR) 4.20 (3.60-5.20) Median low-density lipoprotein (IQR) 2.47 (1.95-3.21) Median high-density lipoprotein (IQR) 1.14 (0.92-1.36) Median triglycerides (IQR) 1.26 (0.91-1.80) Sta6n, n (%) 181 (89.1) Indica'on for coronary angiography ACS, n (%) 95 (46.8) PCI / stent implanta6on, n (%) 179 (88.2) Extent of coronary artery disease No significant stenosis, n (%) 16 (7.9) 1-vessel disease, n (%) 106 (52.2) 2-vessel disease, n (%) 58 (28.6) 3-vessel disease, n (%) 23 (11.3)

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Median LCBI

43

LCBI < Median N= 101 LCBI ≥ Median N=102 P value Age, years 64.8 ±10.8 62.1 ±11.0 0.08 Male, n (%) 67 (66.3) 81 (79.4) 0.041 Median LCBI 15.0 (6.0-27.0) 88.5 (58.8-120.3) <0.001 History of hypercholesterolemia, stroke or PAD were iden6fied as predictors of con6nuous LCBI

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Primary endpoint

Adjusted HR: 4.04 95% CI: 1.3-12.3 P=0.01

SAP and ACS patients (p-value for heterogeneity=0.14)

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Secondary endpoint: All-cause mortality and non-fatal ACS

Adjusted HR: 8.91 95% CI: 1.1-72.3 P=0.04

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Secondary endpoint: All-cause mortality, non-fatal ACS and stroke

Adjusted HR: 10.59 95% CI: 1.4-83.3 P=0.03

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Secondary endpoint: All-cause mortality, non- fatal ACS, unplanned PCI

Adjusted HR: 3.56 95% CI: 1.1-11.2 P=0.03

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No. of patients

AR 581 Baseline IVUS-VH IBIS-3 192 Baseline NIRS

389

128 275 pa6ents available for analysis

45 in both studies

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Baseline characteristics

Atheroremo IBIS-3 median Age, year 63.3 60.2 Man 72% 84% Diabetes 21% 21% Smoker 24% 29% Statin user 89% 95% Indication: STEMI 13% 12% NSTEMI 33% 27% SAP 54% 61% Multiple vessel disease 48% 42%

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Distribution LCBI region of interest 40

N=275

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Distribution LCBI max 4mm 227

N=275

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Conclusion

§ IVUS plaque characteris6cs and LCBI in a non-steno'c target segment of a non-culprit vessel reflect larger coronary vulnerability § No claims on sensi'vity or specificity given the number of events § Key ques6on remains: NPV or PPV? § Neither on temporal plaque stability

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Conclusion

Strenghts § Prospec6ve data, applicable to both SAP and ACS pa6ents § Blinded Clinical Event Commiaee and blinded core lab for RF- IVUS and NIRS analysis Limita'ons § Sample size § Single center by virtue of design § Single vessel imaging

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FUTURE DEVELOPMENTS

in terms of risk predic6on with NIRS

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PROSPECT-2

§ Inves6gator ini6ated, mul6center ( 16 Scandinavian sites), prospec6ve registry § 900 ACS pa6ents: three vessel NIRS and IVUS imaging § 2 year follow-up, Primary endpoint: Non-Culprit lesion related Major Adverse Cardiac Event

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The Lipid-Rich Plaque Study

§ Inves6gator ini6ated, mul6center (100 centers) , prospec6ve

bserva6onal registry

§ 1562 SAP, UAP and ACS pa6ents: 50 mms of NIRS pullback of segments without prior or index-PCI § Imaging from 2 or 3 na6ve coronary arteries § 2 year follow-up, primary endpoint: Non-Culprit lesion related Major Adverse Cardiac Event § Final data collec6on 2018

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PACMAN AMI

§ Inves6gator ini6ated, mul6center, placebo controlled RCT inves6ga6ng alirocumab § 220 ACS pa6ents § Mul6vesssel IVUS NIRS and OCT

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Vielen Dank !

r.oemrawsingh@erasmusmc.nl