Where to after ILUMIEN III and DOCTORS? Ziad A Ali MD DPhil - PowerPoint PPT Presentation

Where to after ILUMIEN III and DOCTORS? Ziad A Ali MD DPhil Columbia University Medical Center Cardiovascular Research Foundation

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company • • Grant/Research Support NIH/NHLBI, St Jude Medical (now Abbott), Cardiovascular Systems Inc • • St Jude Medical, Acist, Cardiovascular Consulting Fees/Honoraria Systems Inc, Boston Scientific • • Equity Shockwave Medical

The ILUMIEN Series of Trials

OCT Evidence Future OCTOBER Present – 2015 OCT optimized bifurcation event reduction Past ILUMIEN I : OCT stent guidance parameters ILUMIEN IV CLI-OPCI : and impact on decision making. Randomized controlled outcomes OCT improves outcomes ILUMIEN II vs. angiography Other areas under OCT vs. IVUS comparison of consideration: OPUS-Class Study stent expansion  Bifurcation Reliability of OCT measurement ILUMIEN III  BVS vs. IVUS and angiography OCT/IVUS Angio prospective  PVD OCT Safety and Efficacy randomized trial Nonocclusive OCT study DOCTORS OCT Optimization impact on FFR

OPUS-CLASS (Phantom vs OCT vs IVUS) Are OCT and IVUS measurements the same? 9% 8% 5% Minimum Lumen Diameter (mm) 10 3 Minimum Lumen Area (mm 2 ) * * ** 8 2 6 4 1 2 0 0 Phantom FD-OCT IVUS FD-OCT IVUS QCA Kubo et al. iJACC 2013;6(10):1095-1104

CLIO-PCI III Registry n=919 113 events P<0.0001 @ 1 year P<0.0001 % P<0.0001 P<0.0001 Independent predictors of MACE were in-stent MLA <4.5mm 2 , distal edge dissection, distal reference narrowing MLA <4.5mm 2 , and proximal reference narrowing MLA <4.5mm 2 . Prati et al. iJACC 2015 8(11):1297-305

ILUMIEN I:Pre-PCI OCT Impact PRE-PCI n=467 Stent length Longer 43% 98 98% Shorter 25% 91% % Stent diameter Larger 8 % Smaller 31% 57% YES FFR OCT Change in strategy Pre-PCI OCT impacted on procedure planning in 57% of cases

ILUMIEN I: Post-PCI OCT Impact Post-PCI n=467 Variable Core Lab (%) Operator (%) Dissection 28 3 98% Malapposition 32 14 83% Underexpansion 41 8 Dissection+malap 9 1 position Dissection+under 9 1 expansion Malapp + tissue 11 1 protrusion 27% Dissection+malap 4 0 YES p+underexpansion FFR OCT Post Thrombus or 26 1 Optimization tissue protrusion Post-PCI OCT impacted on procedure in 27% of cases, reducing malapposition from 51% to 19% and edge dissection 16% to 5%

ILUMIEN I - Pre-PCI OCT Impact Group N Post- PCI Strategy decision by OCT PCI guidance Pre / MLA Pre- and /or Post-PCI Post mm 2 - - 137 6.1 ± 2.5 No Pre-PCI Change Based on OCT and No Optimization post-PCI + - 165 5.2 ± 2.1 Pre-PCI Change Based on OCT and No Optimization post-PCI - + 41 5.3 ± 1.8 No Pre-PCI Change Based on OCT and Optimization post-PCI + + 65 5.0 ± 2.0 Pre-PCI Change Based on OCT and Optimization post-PCI Stents without optimization (-/-) were larger than the optimized (+/+) stents W Wijns. Eur Heart J. 2015;36(47):3346-55.

ILUMIEN II 1 ° Endpoint: Post-PCI stent expansion ILUMIEN I ADAPT-DES 418 pts enrolled 2,179 pts enrolled in IVUS substudy No QCA available (n=1043) STEMI (n=378) In-stent restenosis (n=191) No reference available (n=179) Poor quality (n=45) Left main (n=99) Not received by core lab (n=12) Lesions excluded: Lesions excluded: Poor image quality or media issue BRS (n=5) (n=77) Inconsistent data (n=2) Chronic total occlusion (n=75) Saphenous vein graft (n=66) Unreliable pullback (n=66) Randomly chosen 1 lesion per patient Not received by core lab (n=12) Overall study population (n=940) 354 patients, 354 lesions 586 patients, 586 lesions 1:1 Propensity matching RVD, lesion length, calcification, reference segment availability 1:1 Propensity matched groups (n=572) 286 patients, 286 lesions 286 patients, 286 lesions

ILUMIEN II – Stent Expansion Maehara et al. JACC Interv 2015;8:1704-14

If Stent Expansion is the same why does OCT guidance lead to a smaller MLA compared to angiography?

Visual Estimation Oversizes vs OCT Reference Segment Reference Segment Lumen-guided = 2.5mm stent Lumen-guided = 2.5mm stent (mm) 3.0 2.5 2.0 1.5 1.0 0.5 EEL-guided = 3.0mm stent 5.0 10.0 15.0 20.0 25.0 30.0 (mm) EEL-guided = 3.0mm stent NP NP o d ND ND p r 2.4 mm RVD by QCA 2.2mm 2 gain by EEL-guidance

Visual Estimation Oversizes vs OCT Reference Segment Lumen-guided = 2.25mm stent (mm) 3.0 2.5 2.0 1.5 1.0 0.5 EEL-guided = 3.25mm stent 5.0 10.0 15.0 20.0 25.0 30.0 (mm) NP NP p o d ND ND r 2.6 mm RVD by QCA 4.3 mm 2 gain by EEL-guidance

OCT vs IVUS

Randomized comparison of IVUS vs OCT-guided stenting Minimum Stent Area (mm 2 ) 8 10 7.1mm 2 Mean Stent Area (mm 2 ) 8.7mm 2 6.1mm 2 7.5mm 2 4 5 n=70 0 0 IVUS OCT IVUS OCT Border Visibility: Reference segment 62.9%, MLA 8.6% OCT IVUS Stent Sizing by Angiography 0% 37% Stent Sizing by Lumen 0% 63% Stent Sizing by Vessel Wall 100% 0% Stent Deployment Pressure 14.2±3.4 9.8±2.4 Postdilation 86% 60% Postdilation pressure 16.1±4.7 13.5±3.4 Habara et al. Circ Cardiovasc Interv 2012;5:193-201

OPINION Procedural Characteristics and Results OFDI IVUS P (n=54) (n=49) Acute procedural 2.92 ± 0.38 3.00 ± 0.37 Stent diameter, mm 0.007 3.1 ± 0.8 3.3 ± 1.2 Max. balloon diameter, mm 0.058 Follow-up OCT (8 months) 4.8 (3.3 – 5.9) 5.0 (4.4 – 6.2) Min lumen area, mm 2 0.18 6.3 (4.8 – 7.4) 6.3 (5.4 – 7.9) Mean lumen area, mm 2 0.24 5.4 (3.8 – 6.0) 5.8 (5.2 – 7.6) Min stent area, mm 2 0.024 6.7 (4.9 – 7.8) 7.2 (6.2 – 8.7) Mean stent area, mm 2 0.055 Kubo et al. iJACC 2017;S1936-878X

Why does OCT guidance lead to a smaller MLA compared to IVUS?

IVUS oversizes versus OCT Are OCT and IVUS measurements the same? 9% 8% 5% Minimum Lumen Diameter (mm) 10 3 Minimum Lumen Area (mm 2 ) * * ** 8 2 6 4 1 2 0 0 Phantom FD-OCT IVUS FD-OCT IVUS QCA Kubo et al. iJACC 2013;6(10):1095-1104

Comparison of OCT vs IVUS Stent Sizing OCT IVUS Habrara et al. Lumen Vessel Wall OPINION Lumen Vessel Wall

Proximal Reference: Lumen vs EEL n=100 Lumen EEL P 3.14 ± 0.61 4.08 ± 0.66 Mean Vessel Diameter (mm) <0.001 Undersize by ≥0.25 mm, % 98 (98) 0 (0) <0.001 Undersize by ≥0.50 mm, % 93 (93) 0 (0) <0.001 Undersize by ≥1.00mm, % 38 (38) 0 (0) <0.001 Mean difference proximal reference = 0.94 ± 0.34mm

Distal Reference: Lumen vs EEL n=100 Lumen EEL P 2.68 ± 0.53 3.44 ± 0.58 Mean Vessel Diameter (mm) <0.001 Undersize by ≥0.25 mm, % 98 (98) 0 (0) <0.001 Undersize by ≥0.50 mm, % 84 (84) 0 (0) <0.001 Undersize by ≥1.00mm, % 21 (21) 0 (0) <0.001 Mean difference distal reference = 0.76 ± 0.30mm

Stent Diameter: Upsize Lumen vs Downsize EEL n=100 Lumen EEL P 2.70 ± 0.44 3.33 ± 0.47 Mean Lumen Diameter (mm) <0.001 Undersize by ≥0.25 mm, % 10 (10) 0 (0) <0.001 Undersize by ≥0.50 mm, % 34 (34) 0 (0) <0.001 Undersize by ≥0.75mm, % 31 (31) 0 (0) <0.001 Undersize by ≥1.00 mm, % 16 (16) 0 (0) <0.001 Mean stent diameter difference = 0.63 ± 0.35mm

Comparison of OCT vs IVUS vs Angiography Largest Lumen- MSA/ EEL-Guided Guided MLA + ILUMIEN I Angio + Habrara et al. IVUS + IVUS OPINION + ILUMIEN III = • In all previous studies comparing stent sizing using lumen-guided OCT to IVUS or angiography, MSA/MLA has been inferior to the comparator. • In the only study using EEL-based OCT stent sizing, ILUMIEN III, MSA was non-inferior to IVUS with a trend towards superiority against angiography

ILUMIEN III: OPTIMIZE PCI HYPOTHESIS Using a novel stent sizing protocol, OCT-guided PCI will be non-inferior to IVUS-guided PCI and superior to angiography-guided PCI in achieving acute post-PCI MSA.

Protocol Exclusion: Inclusion Angiography • Left main • Single native vessel • Ostial RCA • One or more target lesions • CTO • RVD 2.25mm - 3.50mm Identification of • Planned bifurcation • Length < 40mm study lesion • eGFR <30ml/min Randomization to OCT-, IVUS- or angiography- guided PCI Angiography Pre-PCI OCT Pre-PCI IVUS OCT Stent Sizing Guidance, IVUS guided PCI, per Angiography guided PCI, per “local standard practice” “local standard practice” per study protocol IVUS guided optimization, per OCT guided Optimization per Angiographic optimization, “local standard practice” per “local standard practice” study protocol Post-PCI OCT, blinded Post-PCI OCT, blinded Post-PCI OCT to investigator to investigator Procedure Complete

OCT Stent Sizing Algorithm Pre-PCI OCT Can ≥ 180 ◦ of the EEL be identified at both proximal and distal reference segments Yes No 84% 16% Reference stent Reference stent diameter decided by diameter decided by OCT measurement of OCT automation based smallest mean EEL to on smallest mean EEL diameter at lumen diameter at reference site reference site Lumen EEL Reference stent length decided by OCT Automation