A fter Stent Implantation in Patients with Coronary Artery Disease Giora Weisz MD On behalf of the COLOR Investigators C OLOR Background The clinical impact of lipidrich plaque LRP in patients with coronary atherosclerosis undergoing PCI is poorly understood ID: 606407
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A Prospective, Multicenter Registry Evaluating the Relationship Between Lipid-Rich Plaque and Two-year Outcomes After Stent Implantation in Patients with Coronary Artery Disease
Giora Weisz, MDOn behalf of the COLOR Investigators
COLORSlide2Slide3
Background
The clinical impact of lipid-rich plaque (LRP) in patients with coronary atherosclerosis undergoing PCI is poorly understoodAutopsy-based studies suggested that LRP may be associated with increased PCI risk and subsequent eventsCatheter-based near-infrared spectroscopy (NIRS) can identify the presence and extent of LRP in the coronary artery
Prior case reports and small studies have suggested an association between LRP as assessed by NIRS and peri-procedural outcomes after PCISlide4
Intra-Coronary Near Infrared Spectroscopy (NIRS)
NIRS-IVUS combined imaging catheter
3.2F Catheter
Monorail
0.014” Guide Wire Compatible
No Occlusion of Blood Flow
Validated Lipid Core Plaque Detection Algorithm
FDA/CE cleared
1100
1200
1300
1400
1500
1600
1700
1800
1900
Cholesterol
Cholesteryl Linoleate
Cholesteryl
Oleate
Collagen
1.0
0.8
0.6
0.4
0.2
Absorbance
Wavelength (nm)Slide5
Generation of Chemogram
Spectral pullback map
Each point = 1 spectrum
Lipid-rich plaque probability map
Each point = 1 lipid-rich plaque score
Lipid-rich plaque probability map
Fill in grid by image processing
Chemogram
Block Chemogram
Distal
Proximal
LCBI =
Proportion of
pixels indicating lipid in the region of interest x 1000
MaxLCBI
4mm
= maximum LCBI in any 4-mm segmentSlide6
NIRS/IVUS
LCBI = Proportion of pixels indicating lipid in the region of interest
x 1000MaxLCBI4mm = maximum LCBI in any 4-mm segmentSlide7
Chemogram
-Histology
Validation
Gardner CM et al.
JACC
Cardiovasc
Imaging
2008;1:638-648Slide8
Primary Objective
To evaluate the association of coronary lipid rich plaque as imaged by NIRS with peri-procedural and long-term events after PCI
C
OLORSlide9
Clinical Outcomes
COLOR Registry
ClinicalTrials.gov
NCT00831116
2
yr
Follow-up
Patient
s w
ith Clinical Indication for Coronary Angiography and Possible Revascularization
(22 US sites)
NIRS
only
NIRS/IVUSSlide10
Major Inclusion
Criteria
Clinical indication for coronary catheterization and possible revascularization
No contraindication for intravascular imaging
At least one
c
hemogram
is obtained within a native coronary artery
Patient life expectancy
is at least 2
years
Post heart-transplant patients were excluded from this analysis (n=100)Slide11
Event related to the culprit PCI segment imaged by NIRS
Culprit Related Event
Clinical symptom + any of the followings.
>20% DS progression from baseline to event or rupture/thrombus
Objective evidence of ischemia (positive stress test)
≥50% DS at FU with or without revascularization
<50% DS at FU with revascularization
Non-Culprit Related EventSlide12
Primary endpoint
Composite MACE Secondary endpoint
The components of MACECardiac death
Myocardial infarction
(SCAI definition for
peri
-PCI MI)
Stent thrombosis
Revascularization for progressive or UAP
Hospitalization
for
progressive or UAP
EndpointsSlide13
Top 10 Enrolling Sites
1. Annapoorna
Kini
,
Mount Sinai Hospital, NY
460
2.
Giora
Weisz
,
Columbia University Medical Center
4193. Emmanouil
Brilakis, Veterans Affairs North Texas Health Care
189
4. David
Rizik, Scottsdale Healthcare Shea 1885. Kendrick Shunk, San Francisco Veterans Affairs Medical Center 1416. Eric Powers, Medical University of South Carolina Hospital 767. Jonathan Tobis, University of California Los Angeles Medical Center 758. Brijeshwar Maini, Pinnacle Health Heart & Vascular Institute 709. Simon Dixon, William Beaumont Hospital 5810. Nabil Dib, Mercy Gilbert Medical Center 50 Between February 2009 and February 2014, 1899 pts were enrolled at 22 US sitesSlide14
Study Organization
Principal InvestigatorGiora Weisz, MD
Shaare Zedek Medical Center
Columbia
University Medical
Center
Executive
Committee
Akiko Maehara
,
MD
; Gregg
W. Stone,
MD, Gary Mintz, MD; Giora Weisz, MD.NIRS/IVUS/Angio/CEC AnalysisMyong Hwa Yamamoto, MD; Mitsuaki Matsumura, MS; Tomotaka Dohi, MD; Yang Cao, MD; Chee Yang Chin, MD; Akiko Fujino, MD; Kosaku Goto
, MD; Sung Sik Kim, MD; Song-Yi Kim, Tadayuki Kadohira, MD; Kohei Koyama, MD; Cheolmin Lee, MD; Fuyu Qiu
, MD; Peiren Shan, MD; Lei Song, MD; Cristiano F Souza, MD; Bin Wang, MD; Da Yin, MD; Wenbin Zhang, MD; Bo Zheng, MD. Cardiovascular Research
Foundation.
Clinical Event CommitteeIoanna Kosmidou, MD, PhD; Sorin
J. Brener, MD. Angiographic Core LabPhilippe Généreux, MD; Maria Corral, MD; Champika Djurkovic, MD; Mitchel Lustre, MD; Douey Wright, MD. Cardiovascular Research FoundationNIRS/IVUS Core LabAkiko Maehara, MD; Marek Gacki, MD. Cardiovascular Research Foundation. Stephen J. Nicholls, MBBS, PhD; Jordan Andrews, BS; Alex Janssen, BS; Tracy Nguyen, BS; Nisha Schwarz PhD. South Australian Health and Medical Research Institute. Data Management and BiostatisticsAaron Crowley, MA; Ovidiu Dressler, MD, Thomas McAndrew, PhD. Cardiovascular Research Foundation SponsorJames E. Muller, MD; Priti Shah; Michael Hendricks, BS; Sean Madden, PhD; InfraReDxSlide15
Non-culprit NIRS
(1072 lesions in 927 pts)
Pre-PCI Culprit NIRS
(1265 lesions in 1168 pts)
COLOR Registry
ClinicalTrials.gov
NCT00831116
Excluded:
No NIRS or poor quality n=185
Planned CABG n=7
Median
Follow-up
731d (IQR 711, 746)
Patient
s w
ith Clinical Indication for Coronary Angiography and Possible Revascularization
N=
1899 NIRS only n=705NIRS/IVUS n=1194Primary EndpointMACE (cardiac death, myocardial infarction, stent thrombosis, revascularization, hospitalization) Slide16
Patient Characteristics
N=1899
Baseline Characteristics
n=1899
Age, years
63.7
±
10.7
Female/Male
24.7%
/ 75.3%
Hypertension
89.9%
Diabetes Mellitus
38.2%
-
IDDM
5.9% - NIDDM32.3%Dyslipidemia90.4%Current Smoking20.7%PVD9.9%Family Hx55.2%Prior MI29.7%Prior PCI51.3%Prior CABG8.9%
Laboratory data - Total cholesterol154.5 ± 43.8 - LDL86.2 ± 35.7 - HDL40.6 ± 12.9 - TG141.6 ± 105.4Medical Therapyn=1899Aspirin96.6%ADP receptor antagonist Plavix76.7%
Prasugrel or Ticagrelor12.2%Statin91.3%Clinical Presentationn=1899 - STEMI1.7% - Non-STEMI9.3% - Unstable angina49.3% - Stable angina39.7%Slide17
2-year Outcomes
All
Culprit lesion
related
Non-culprit
lesion related
Indeterminate
Cardiac death
2.4% (43)
0.3% (6)
0% (0)
2.1% (37)
MI
2.4% (44)
1.6% (30)
0.6% (10)
0.3% (5)
Stent thrombosis
0.8% (15)0.5% (10)0.3% (5)0% (0)Revascularization
8.3% (147)4.5% (80)5.4% (96)0 % (0)Hospitalization11.5% (202)4.9% (86)8.2% (144)0.3% (6)Composite MACE14.1% (253)6.0% (108)8.3% (145)2.4% (42)Composite MACE(n=1168 PCI pts)
15.4% (170)7.0% (77)9.4% (102)2.3% (24)KM estimates Slide18
Number at risk:
All
CL related
NCL related
Indeterminate
1,899
1,716
1,578
1,488
911
1,899
1,766
1,651
1,571
977
1,899
1,759
1,630
1,542
943
1,8991,8101,714
1,6451,019MACE (%)03
6
9
12
15
Time in
Days
0
180
365
550
730
All patients
6.5%
9.7%
12.0%
14.1%
2.9%
4.2%
5.4%
6.0%
Culprit
lesion
3.1%
5.2%
6.7%
8.3%
Non-culprit lesion
1.1%
1.6%
2.0%
2.4%
Indeterminate
2-Year OutcomesSlide19
Pre-PCI Culprit NIRS
(1265 lesions in 1168 pts)
COLOR Registry
ClinicalTrials.gov
NCT00831116
Median
Follow-up
731d (IQR 711, 746)
Patient
s w
ith Clinical Indication for Coronary Angiogram and Possible Revascularization
N=
1899
Primary Endpoint
MACE (cardiac death, myocardial infarction, stent thrombosis, revascularization, hospitalization) Slide20
Culprit Lesion Related Data
Patients: 68/1168 (5.8%)Lesions: 70/1265 (5.5%)LCBI, median (IQR
)=98 (36, 178)maxLCBI4mm, median (IQR)=304 (139, 482)
NIRS-related complications: 10 (0.5%)Slide21
E
vent
No-event
p-value
Age, years
61.4±7.9
63.9
±
10.6
<0.01
Female
19.5%
23.2%
0.45
Hypertension
94.8%
90.2%
0.18
Diabetes Mellitus48.1%38.7%0.10 - IDDM9.1%6.1%0.32 - NIDDM39.0%
32.6%0.25Dyslipidemia96.1%91.5%0.16Current Smoking34.7%21.4%<0.01PVD16.9%9.0%0.02Family history63.6%54.1%0.10Prior MI32.5%29.5%
0.58Prior PCI59.7%53.4%0.28Prior CABG18.2%9.2%0.01Laboratory data Total cholesterol155.4±42.0153.0±44.10.67 LDL86.8±38.085.6±36.70.81
HDL38.3±12.439.6±11.60.45 TG157.8±104.9143.0±111.50.30PCI Patient CharacteristicsSlide22
632
605
584
571
544
524
521
514
313
633
606
600
584
571
538
532
531
356
Number at risk:
< 304
≥ 304Hazard Ratio = 0.83 [0.52, 1.30]
P-Value = 0.41MACE (%)024
6
8
10
Time in Days
0
180
365
550
730
maxLCBI
4mm
< 304 [median]
maxLCBI
4mm
≥
304 [median]
6.3%
5.4%
Culprit lesion related MACE by maxLCBI
4mmSlide23
Relationship Between NIRS and Culprit-lesion related MACE
P value = 0.41
AUC [95% CI] =
0.53 [0.46,0.60]
Sensitivity
0.00
0.25
0.50
0.75
1.00
1-Specificity
0.00
0.25
0.50
0.75
1.00
P value = 0.42
AUC [95% CI] =
0.53 [0.46,0.60]
Sensitivity
0.00
0.250.500.75
1.00
1-Specificity
0.00
0.25
0.50
0.75
1.00
maxLCBI
4mm
Total lesion LCBISlide24
Lesion Level Multivariable Model
HR [95% CI]
P
-value
Max LCBI
4mm
(per 100)
1.08
[
0.97,
1.20
]
0.17
Diabetes
mellitus
1.31
[
0.80, 2.12]0.28ACS0.91 [0.43, 1.91]0.80Lesion length (per mm)1.02 [1.00, 1.04]0.02 RVD (per mm)0.66 [0.41, 1.06]0.08 In-stent restenosis lesion1.02 [0.55, 1.88]0.96 2nd generation DES
0.58 [0.34, 0.99]0.046 Prasugrel or ticagrelor0.85 [0.41, 1.78]0.67Culprit-lesion related MACESlide25
0 – 30 days
HR [95% CI]
P
-value
Max LCBI
4mm
per 100
1.07 [
0.83,
1.38
]
0.59
Diabetes
mellitus
0.69
[
0.24, 2.01
]
0.50ACS0.86 [0.19, 3.93]0.84Lesion length, mm1.02 [0.99, 1.05]0.17 RVD, mm0.87 [0.34, 2.22]0.76 In-stent restenosis0.33 [0.05, 2.22]0.26 2nd generation DES
0.76 [0.27, 2.18]0.62 Prasugrel or ticagrelor0.43 [0.06, 3.34]0.4231 days – 2 yearsHR [95% CI]P-valueMax LCBI4mm per 1001.08 [0.96, 1.22]0.20Diabetes mellitus1.57 [0.90, 2.75]0.12ACS0.93
[0.40, 2.17]0.87Lesion length, mm1.02 [1.00, 1.04]0.06 RVD, mm0.60 [0.35, 1.03]0.06 In-stent restenosis1.24 [0.63, 2.44]0.53 2nd generation DES0.54 [0.29, 1.00]0.05 Prasugrel or ticagrelor0.98 [0.44, 2.20]0.97
Lesion Level Multivariable ModelCulprit-lesion related MACESlide26
Limitations
Voluntary registry, not consecutive patients. Selection bias cannot be excludedOperators not blinded to NIRS/IVUS imaging which may have affected treatment strategy
Imaging was not done routinely post-PCIAngiographic follow-up was not performedOnly few lesions responsible for non-culprit lesion-related events were imaged at baseline, precluding in-depth analysisSlide27
Conclusions
In the present large-scale registry, non-culprit lesion-related events were more common than culprit-lesion-related post-PCI events during 2-year follow-upPCI of NIRS-defined LRPs was safe, and
was not associated with increased peri-procedural or late adverse outcomes compared to PCI of non-LRPsThe Clinical significance of NIRS-defined non-culprit LRPs will be determined by two ongoing prospective outcome studies (LRP study and PROSPECT-II)Slide28
A Prospective, Multicenter Registry Evaluating the Relationship Between Lipid-Rich Plaque and Two-year Outcomes After Stent Implantation in Patients with Coronary Artery Disease
Giora Weisz, MDOn behalf of the COLOR Investigators
COLOR