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
Abbott), Cardiovascular Systems Inc
Systems Inc, Boston Scientific
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
CLI-OPCI:
OCT improves outcomes
OPUS-Class Study
Reliability of OCT measurement
OCT Safety and Efficacy
Nonocclusive OCT study
Past Present–2015 Future
OCTOBER
OCT optimized bifurcation event reduction
ILUMIEN IV
Randomized controlled outcomes
Other areas under consideration:
ILUMIEN I:
OCT stent guidance parameters and impact on decision making.
ILUMIEN II
OCT vs. IVUS comparison of stent expansion
ILUMIEN III
OCT/IVUS Angio prospective randomized trial
DOCTORS
OCT Optimization impact on FFR
2 6 10
Minimum Lumen Area (mm2)
8% 4 8
*
Phantom FD-OCT IVUS
1 2 3
Minimum Lumen Diameter (mm)
FD-OCT IVUS QCA
9% 5%
* **
Are OCT and IVUS measurements the same?
Kubo et al. iJACC 2013;6(10):1095-1104
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 MLA <4.5mm2, and proximal reference narrowing MLA <4.5mm2.
%
n=919 113 events @ 1 year Prati et al. iJACC 2015 8(11):1297-305
91% 98% 57% YES
98 %
Change in strategy OCT FFR
PRE-PCI n=467
Stent length
Longer 43% Shorter 25%
Stent diameter
Larger 8 % Smaller 31%
83% 98% Post Optimization OCT FFR
Post-PCI OCT impacted on procedure in 27% of cases, reducing malapposition from 51% to 19% and edge dissection 16% to 5% Post-PCI n=467
27% YES
Variable Core Lab (%) Operator (%) Dissection
28 3
Malapposition
32 14
Underexpansion
41 8
Dissection+malap position
9 1
Dissection+under expansion
9 1
Malapp + tissue protrusion
11 1
Dissection+malap p+underexpansion
4
Thrombus or tissue protrusion
26 1
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
W Wijns. Eur Heart J. 2015;36(47):3346-55.
1°Endpoint: Post-PCI stent expansion
ADAPT-DES
418 pts enrolled
Lesions excluded:
586 patients, 586 lesions
Lesions excluded:
ILUMIEN I
No QCA available (n=1043) STEMI (n=378) In-stent restenosis (n=191) No reference available (n=179) Left main (n=99) Poor image quality or media issue (n=77) Chronic total occlusion (n=75) Saphenous vein graft (n=66) Unreliable pullback (n=66) Not received by core lab (n=12) Poor quality (n=45) Not received by core lab (n=12) BRS (n=5) Inconsistent data (n=2)
2,179 pts enrolled in IVUS substudy
354 patients, 354 lesions Randomly chosen 1 lesion per patient 1:1 Propensity matching 286 patients, 286 lesions 286 patients, 286 lesions Overall study population (n=940) 1:1 Propensity matched groups (n=572)
RVD, lesion length, calcification, reference segment availability
Maehara et al. JACC Interv 2015;8:1704-14
Reference Segment
Lumen-guided = 2.5mm stent EEL-guided = 3.0mm stent
2.4 mm RVD by QCA
(mm) (mm) 5.0 10.0 15.0 20.0 25.0 30.0 0.5 1.0 1.5 2.0 2.5 3.0 NP NP ND NDReference Segment
Lumen-guided = 2.5mm stent EEL-guided = 3.0mm stent
2.2mm2 gain by EEL-guidance
Reference Segment
Lumen-guided = 2.25mm stent EEL-guided = 3.25mm stent
4.3 mm2 gain by EEL-guidance
(mm) (mm) 5.0 10.0 15.0 20.0 25.0 30.0 0.5 1.0 1.5 2.0 2.5 3.0 NP NP ND ND2.6 mm RVD by QCA
Randomized comparison of IVUS vs OCT-guided stenting
Habara et al. Circ Cardiovasc Interv 2012;5:193-201
Minimum Stent Area (mm2)
4 8
IVUS OCT
7.1mm2 6.1mm2 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
Mean Stent Area (mm2)
5 10
IVUS OCT
8.7mm2 7.5mm2
n=70
Border Visibility: Reference segment 62.9%, MLA 8.6%
OFDI (n=54) IVUS (n=49) P Acute procedural Stent diameter, mm 2.92 ± 0.38 3.00 ± 0.37 0.007
3.1 ± 0.8 3.3 ± 1.2 0.058 Follow-up OCT (8 months) Min lumen area, mm2 4.8 (3.3–5.9) 5.0 (4.4–6.2) 0.18 Mean lumen area, mm2 6.3 (4.8–7.4) 6.3 (5.4–7.9) 0.24 Min stent area, mm2 5.4 (3.8–6.0) 5.8 (5.2–7.6) 0.024 Mean stent area, mm2 6.7 (4.9–7.8) 7.2 (6.2–8.7) 0.055
Kubo et al. iJACC 2017;S1936-878X
2 6 10
Minimum Lumen Area (mm2)
8% 4 8
*
Phantom FD-OCT IVUS
1 2 3
Minimum Lumen Diameter (mm)
FD-OCT IVUS QCA
9% 5%
* **
Are OCT and IVUS measurements the same?
Kubo et al. iJACC 2013;6(10):1095-1104
OCT IVUS Habrara et al. Lumen Vessel Wall OPINION Lumen Vessel Wall
n=100 Lumen EEL P Mean Vessel Diameter (mm) 3.14 ± 0.61 4.08 ± 0.66 <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
n=100 Lumen EEL P Mean Vessel Diameter (mm) 2.68 ± 0.53 3.44 ± 0.58 <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
n=100 Lumen EEL P Mean Lumen Diameter (mm) 2.70 ± 0.44 3.33 ± 0.47 <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
Lumen- Guided EEL-Guided Largest MSA/ MLA ILUMIEN I
Angio Habrara et al.
IVUS OPINION
IVUS ILUMIEN III
=
IVUS or angiography, MSA/MLA has been inferior to the comparator.
was non-inferior to IVUS with a trend towards superiority against angiography
Pre-PCI OCT Angiography OCT Stent Sizing Guidance, per study protocol OCT guided Optimization per study protocol Angiography guided PCI, per “local standard practice” Angiographic optimization, per “local standard practice”
Post-PCI OCT
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 Post-PCI OCT, blinded to investigator
Inclusion
Exclusion:
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
lumen diameter at reference site No Lumen Reference stent length decided by OCT Automation 84% 16%
Target MSA (in both proximal and distal halves of the stent relative to the closest reference segment)
Stent Implantation Angiographic success?
Target MSA criteria achieved? Final OCT imaging Post-dilation No Post-PCI OCT Post-dilation Post-PCI OCT Target MSA criteria achieved? Post-dilation
Ali et al. Lancet 2016;2618-28
0.0
IVUS better OCT better
NI margin
97.5% one-sided CI: [-0.70, - ] Pnoninferiority = 0.001 Psuperiority = 0.12
Ali et al. Lancet 2016;2618-28
OCT (n=140) IVUS (n=135) Angio (n=140) P
OCT vs IVUS
P
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] 106 [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% 0.42 0.0008 Unacceptable <90% 59% 63% 79% 0.45 0.0002 Dissection, any 28% 40% 44% 0.04 0.006 Major 14% 26% 19% 0.009 0.25 Minor 14% 13% 25% 0.84 0.02 Malapposition, any 41% 38% 59% 0.62 0.002 Major 11% 21% 31% 0.02 <0.0001 Minor 31% 18% 28% 0.01 0.60
Lumen- Guided EEL-Guided Largest MSA/ MLA ILUMIEN I
Angio Habrara et al.
IVUS OPINION
IVUS ILUMIEN III
=
IVUS or angiography, MSA/MLA has been inferior to the comparator.
was non-inferior to IVUS with a trend towards superiority against angiography
No patient developed acute renal failure
OCT (n=158) IVUS (n=146) Angio (n=146) P
OCT vs IVUS
P
OCT vs Angio
Procedural MACE 2.5% 0.7% 0.7% 0.37 0.37 Complications Dissection 1.3% 0.0% 0.7% 0.50 1.00 Perforation 0.0% 0.7% 0.0% 0.48
1.3% 0% 0.0% 0.50 0.50 Acute closure 0.6% 0.0% 0.0% 1.00 1.00 Intervention Additional stent 2.5% 0.7% 0.7% 0.37 0.37
148 patients IVUS-guided PCI
18 excluded 5 unable to pass catheter 7 uninterpretable image 6 no final OCT done
Followed OCT Protocol
(46.4%)
(53.6%)
450 randomized patients 158 patients OCT-guided PCI 148 patients Angiography-guided PCI
Number at risk: 146 141 141 141 53 Angiography 146 137 135 133 59 IVUS 158 152 152 150 59 OCT
P=0.33 1.4% 4.3% 2.6%
2 4 6 8 3 6 9 12
Angiography IVUS OCT
TLF (%)
Time Post Procedure (Months)
Meneveaux et al. Circulation 2016;134
46 year old with HTN, HL and CCS II stable angina
Direct Stent 4.0x15mm EES
High Risk Clinical and Lesion Characteristics
(cardiac death, TV-MI, or ID-TVR)
RR [95% CI] P Diabetes* 1.50 [1.28, 1.76] <0.0001 ACS NSTEMI* 1.42 [1.31, 1.54] <0.0001 Stent Length >28mm* 1.14 [1.06, 1.23] <0.001 Bifurcation# 1.31 [1.11, 1.56] 0.0019 Moderate to Severe Ca2+* 1.62 [1.37, 1.91] 0.06 Chronic Total Occlusion# 1.31 [0.99, 1.75] <0.0001 In-Stent Restenosis# 1.88 [1.57, 2.26] <0.0001
*Pooled analysis of 13,380 pts from contemporary DES trials
#ADAPT-DES
2556-3568 pts with high-risk clinical or angiographic features undergoing PCI at 125 centers in the US, Canada, Western Europe, and Asia-Pacific Follow-up: Minimum 1 year, maximum 2 years Primary endpoints: 1) Minimal stent area (MSA) by OCT (powered for superiority) 2) Target vessel failure (event-driven, powered for superiority) Principal Investigators: Ziad Ali and Ulf Landmesser Study Chair: Gregg W. Stone
HR clinical: Diabetes HR angio: Troponin+ ACS culprit Stent length ≥28 mm 2-stent bifurcation Severe calcification CTO Diffuse/MF ISR
Randomize 1:1 OCT-guided* PCI (modified ILUMIEN III protocol) Angiography-guided PCI Final OCT (blinded in angiography arm)
Sponsor: Abbott
Can the EEL be identified at the distal reference segment to allow vessel diameter measurement?
Reference stent diameter decided by OCT measurement of smallest mean EEL to EEL diameter at reference site rounded down to nearest stent size
Yes EEL
Reference stent diameter decided by OCT automation based on smallest mean lumen diameter at reference site rounded up to nearest stent size
No Lumen Pre-PCI OCT Reference stent length decided by OCT Automation 71% 29%
EEL
Final OCT imaging Stent Implantation using angiographic co-registration Angiographic success (≤0% visual diameter stenosis)? No Post-PCI OCT Post-dilation with NC balloon at ≥ 18 atm sized to the reference EEL of one
the stent with OCT-assessed underexpansion, rounded down to the nearest balloon diameter based on the post-PCI OCT No MSA ≥ 90% in the proximal segment of the stent relative to the proximal reference and distal segment of the stent relative to the distal reference? Post-dilation with NC balloon at ≥ 18 atm sized to the reference EEL of one
the stent with angiographic underexpansion, rounded down to the nearest balloon diameter based on the pre-PCI OCT Do both the proximal and distal reference segment lumens (within 5mm of the stent edge) each have a MLA of ≥4.5mm2 ? No Place an additional DES to treat the reference segment disease, unless anatomically prohibitive (e.g. diffuse disease or very small vessel) Yes, or maximal balloon and pressure used based
Yes, or maximal balloon and pressure used based on the post- PCI OCT
3.20mm 3.49mm 3.54mm
Site Analysis Core Lab Analysis
Mean diameter: 3.52mm Stent size: 3.00mm
IEL EEL Media Intima
Adventitia