1. OCT-Guided PCI What needs to be done to establish criteria?
Ziad A Ali MD DPhil
Columbia University Medical Center
Cardiovascular Research Foundation

2. 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
Consulting Fees/Honoraria
NIH/NHLBI, St Jude Medical, Cardiovascular Systems Inc
St Jude Medical, ACIST, Canon, Medtronic.
Equity
Shockwave Medical, VitaBx Inc.
I have the following conflicts of interest to disclose. This study was funded by St Jude Medical.

3. Clinical Evidence Future Present–2015 Past ILUMIEN IV
OCT vs Angiography Randomized Outcomes Trial
Other areas under consideration:
Non-contrast flush media
BVS
Virtual OFFR
Present–2015
Past
ILUMIEN I:
Define and evaluate OCT stent guidance parameters and determine impact on physician decision making.
ILUMIEN II
OCT vs. IVUS propensity matched comparison of stent expansion.
ILUMIEN III
OCT vs IVUS vs Angiography prospective randomized trial to evaluate OCT EEL-guided PCI
CLI-OPCI I and II:
OCT improves outcomes vs. angiography
OPUS-Class Study
Reliability of OCT measurement vs. IVUS and angiography
OCT Safety and Efficacy
Non-occlusive OCT study
The clinical evidence for the role of OCT in daily clinical practice is mounting. Early studies have reinforced the role of OCT in physician decision making.
In 2015, a series of three key clinical studies were initiated. ILUMIEN I showed that OCT influenced physician decision making in 65% of patients (pre- and-post-PCI).
As important, ILUMIEN II confirmed OCT’s ability to achieve comparable stent expansion vs. IVUS while offering superior resolution.
ILUMIEN III will be a randomized trial comparing angiography, IVUS and OCT. The primary efficacy endpoint is to measure post-PCI MSA assessed by OCT in each randomized arm and to test the noninferiority of OCT-guided stenting vs. IVUS-guided stenting, the superiority of OCT-guided stenting vs. angiography-guided stenting, and the superiority of OCT-guided stenting vs. IVUS-guided stenting.
Future studies include an ILUMIEN IV study. The protocol is still under development.
CONFIDENTIAL. FOR INTERNAL USE ONLY

4. OPUS-CLASS Phantom vs OCT vs IVUS ex vivo in vivo * ** *1 2 3
Minimum Lumen Diameter (mm)
FD-OCT
IVUS
QCA 9% 5% * ** 2 6 10
Minimum Lumen Area (mm2) 8% 4 8 *
Phantom
FD-OCT
IVUS
Kubo et al. iJACC 2013;6(10):

5. CLI-OPCI
n=919
113 1 year
P<0.0001 %
P<0.0001
P<0.0001
P<0.0001
Independent predictors of MACE were in-stent MLA <4.5mm2, distal edge dissection, distal reference narrowing, and proximal reference narrowing.
Prati et al. iJACC (11):

6. ILUMIEN I - Pre-PCI OCT Impact
PRE-PCI n=467
98%
Stent length
Longer 43%
Shorter 25%
Stent diameter
Larger 8 %
Smaller 31%
91%
57%
YES
FFR
OCT
Change in strategy
WIjns et al. EHJ :

7. ILUMIEN I - Pre-PCI OCT Impact PCI Strategy decision by OCT guidance
Pre- and /or Post-PCI
Group
Pre / Post N
Post-PCI MLA
mm2
No Pre-PCI Change Based on OCT and
No Optimization post-PCI
- -
137
6.1±2.5
Pre-PCI Change Based on OCT and No Optimization post-PCI
+ -
165
5.2±2.1
No Pre-PCI Change Based on OCT and Optimization post-PCI
- + 41
5.3±1.8
Pre-PCI Change Based on OCT and Optimization post-PCI
+ + 65
5.0±2.0
Stents without optimization (-/-) were larger than the optimized (+/+) stents
WIjns et al. EHJ :

8. Randomized comparison of IVUS vs OCT-guided stenting with blinded cross-over imaging
Border Visibility: At reference segments 62.9%
At MLA 8.6%
Reference stent diameter decided by mean lumen diameter of proximal and distal reference site
Decided by angiography
63% OCT
100% IVUS
37% OCT 8 10
7.1mm2
8.7mm2
6.1mm2
7.5mm2
Minimum Stent Area (mm2) 4
Mean Stent Area (mm2) 5
IVUS
OCT
IVUS
OCT
Habara et al. Circ Cardiovasc Interv 2012;5:

9. Procedural characteristics
OFDI and IVUS criteria for PCI
OFDI-guided PCI
IVUS-guided PCI
Determination of stent diameter
By measuring lumen diameter at proximal and distal reference sites
By measuring vessel diameter at proximal and distal reference sites
Procedural characteristics
OFDI
IVUS
p-value
Stent diameter, mm
2.92 ± 0.38
3.00 ± 0.37
0.007
Max. balloon diameter, mm
3.1 ± 0.8
3.3 ± 1.2
0.058
Min stent area, mm2
5.2 ± 1.6
6.1 ± 2.3
0.088
Mean stent area, mm2
6.6 ± 1.7
7.5 ± 2.5
0.054
Kubo et al. EuroPCR 2016

10. The problem with lumen guided sizing
Reference Segment
Reference Segment
Lumen-guided = 2.5mm stent
Lumen-guided = 2.5mm stent
EEL-guided = 3.0mm stent
EEL-guided = 3.0mm stent
2.4 mm RVD by QCA
2.2mm2 gain by EEL-guidance

11. The problem with lumen guided sizing
Reference Segment
Lumen-guided = 2.25mm stent
EEL-guided = 3.25mm stent
2.6 mm RVD by QCA
4.3 mm2 gain by EEL-guidance

12. Sizing Between Devices
MLD 3.0mm
Histology
MLD 3.0mm
OCT
3.0mm Stent
7.1mm2
MLD 3.3mm
IVUS
3.25mm stent
8.5mm2

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

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

15. OCT Stent Optimization Algorithm
Optimal, > 95%
Acceptable, 90 to <95%
Unacceptable, <90%
Target MSA (in both proximal and distal halves of the stent relative to the closest reference segment)
Stent Implantation
Angiographic success?
0% diameter stenosis
Target MSA criteria achieved?
Final OCT imaging
Post-dilation No
Post-PCI OCT

16. ILUMIEN III Endpoints OCT (n=140) IVUS (n=135) Angio P
OCT vs IVUS
OCT vs Angio
Minimal stent area, mm2
5.79 [4.54,7.34]
5.89 [4.67,7.80]
5.49
[4.39, 6.59]
0.42
0.12
Min stent expansion, %
88 ± 17
87 ± 16
83 ± 13
0.77
0.02
Mean stent expansion, %
106
[98, 120]
[97, 117]
101
[92, 110]
0.63
0.001
Optimal Expansion >95%
26%
25%
17%
0.84
0.07
Acceptable 90 - <95%
16%
12%
3.7%
0.0008
Unacceptable <90%
59%
63%
79%
0.45
0.0002
Dissection, any
28%
40%
44%
0.04
0.006
Major
14%
19%
0.009
0.25
Minor
13%
Malapposition, any
41%
38%
0.62
0.002
11%
21%
31%
<0.0001
18%
0.01
0.60

17. ILUMIEN IV
Multicenter Randomized Outcomes Trial comparing OCT- vs Angiography- guided PCI.
≈ 3000 patients
> 100 sites globally
Complex patients and complex lesions