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Giora Weisz , MD On behalf of the COLOR Investigators

Investigating lipid-rich plaque impact on two-year outcomes post-stent implantation in coronary artery disease patients undergoing PCI. NIRS technology used to assess plaque characteristics and predict events.

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Giora Weisz , MD On behalf of the COLOR Investigators

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  1. COLOR 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, MD On behalf of the COLOR Investigators

  2. Background • The clinical impact of lipid-rich plaque (LRP) in patients with coronary atherosclerosis undergoing PCI is poorly understood • Autopsy-based studies suggested that LRP may be associated with increased PCI risk and subsequent events • Catheter-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 PCI

  3. Intra-Coronary Near Infrared Spectroscopy (NIRS) 1.0 Cholesterol 0.8 Cholesteryl Oleate Absorbance 0.6 Collagen 0.4 Cholesteryl Linoleate 0.2 1100 1200 1300 1400 1500 1600 1700 1800 1900 Wavelength (nm) • 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

  4. Spectral pullback map Lipid-rich plaque probability map Lipid-rich plaque probability map Chemogram Block Chemogram Each point = 1 spectrum Each point = 1 lipid-rich plaque score Fill in grid by image processing Generation of Chemogram Distal Proximal LCBI = Proportion of pixels indicating lipid in the region of interest x 1000 MaxLCBI4mm = maximum LCBI in any 4-mm segment

  5. NIRS/IVUS LCBI = Proportion of pixels indicating lipid in the region of interest x 1000 MaxLCBI4mm = maximum LCBI in any 4-mm segment

  6. Chemogram-Histology Validation Gardner CM et al. JACC Cardiovasc Imaging 2008;1:638-648

  7. COLOR Primary Objective To evaluate the association of coronary lipid rich plaque as imaged by NIRS with peri-procedural and long-term events after PCI

  8. COLOR Registry Patients with Clinical Indication for Coronary Angiography and Possible Revascularization (22 US sites) NIRS/IVUS NIRS only 2 yr Follow-up Clinical Outcomes ClinicalTrials.govNCT00831116

  9. Major Inclusion Criteria • Clinical indication for coronary catheterization and possible revascularization • No contraindication for intravascular imaging • At least one chemogram 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)

  10. Culprit Related Event Event related to the culprit PCI segment imaged by NIRS Non-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

  11. Endpoints Primary endpoint Composite MACE Secondary endpoint The components of MACE • Cardiac death • Myocardial infarction (SCAI definition for peri-PCI MI) • Stent thrombosis • Revascularization for progressive or UAP • Hospitalization for progressive or UAP

  12. Top 10 Enrolling Sites Between February 2009 and February 2014, 1899 pts were enrolled at 22 US sites 1. AnnapoornaKini, Mount Sinai Hospital, NY460 2. GioraWeisz, Columbia University Medical Center 419 3. EmmanouilBrilakis, Veterans Affairs North Texas Health Care 189 4. David Rizik,Scottsdale Healthcare Shea188 5. Kendrick Shunk, San Francisco Veterans Affairs Medical Center141 6. Eric Powers,Medical University of South Carolina Hospital76 7. Jonathan Tobis, University of California Los Angeles Medical Center75 8. BrijeshwarMaini, Pinnacle Health Heart & Vascular Institute70 9. Simon Dixon, William Beaumont Hospital58 10. Nabil Dib, Mercy Gilbert Medical Center50

  13. Principal Investigator Giora Weisz, MD ShaareZedek Medical Center Columbia University Medical Center Executive Committee Akiko Maehara, MD; Gregg W. Stone, MD, Gary Mintz, MD; GioraWeisz, MD. NIRS/IVUS/Angio/CEC Analysis Myong Hwa Yamamoto, MD; Mitsuaki Matsumura, MS; TomotakaDohi, MD; Yang Cao, MD; Chee Yang Chin, MD; Akiko Fujino, MD; KosakuGoto, MD; Sung Sik Kim, MD; Song-Yi Kim, Tadayuki Kadohira, MD; Kohei Koyama, MD; Cheolmin Lee, MD; FuyuQiu, 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 Committee IoannaKosmidou, MD, PhD; Sorin J. Brener, MD. Angiographic Core Lab Philippe Généreux, MD; Maria Corral, MD; Champika Djurkovic, MD; Mitchel Lustre, MD; Douey Wright, MD. Cardiovascular Research Foundation NIRS/IVUS Core Lab Akiko 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 Biostatistics Aaron Crowley, MA; OvidiuDressler, MD, Thomas McAndrew, PhD. Cardiovascular Research Foundation Sponsor James E. Muller, MD; Priti Shah; Michael Hendricks, BS; Sean Madden, PhD; InfraReDx Study Organization

  14. COLOR Registry Patients with Clinical Indication for Coronary Angiography and Possible Revascularization N=1899 Excluded: No NIRS or poor quality n=185 Planned CABG n=7 NIRS only n=705 NIRS/IVUS n=1194 Pre-PCI Culprit NIRS (1265 lesions in 1168 pts) Non-culprit NIRS (1072 lesions in 927 pts) Median Follow-up 731d (IQR 711, 746) Primary Endpoint MACE (cardiac death, myocardial infarction, stent thrombosis, revascularization, hospitalization) ClinicalTrials.govNCT00831116

  15. Patient Characteristics N=1899

  16. 2-year Outcomes KM estimates

  17. 2-Year Outcomes 15 14.1% All patients 12.0% 12 9.7% 8.3% 9 6.5% Non-culprit lesion 6.7% MACE (%) Culprit lesion 5.2% 6 6.0% 5.4% 3.1% 4.2% 3 Indeterminate 2.9% 2.4% 2.0% 1.6% 1.1% 0 0 180 365 550 730 Time in Days Number at risk: All 1,899 1,716 1,578 1,488 911 CL related 1,899 1,766 1,651 1,571 977 NCL related 1,899 1,759 1,630 1,542 943 Indeterminate 1,899 1,810 1,714 1,645 1,019

  18. COLOR Registry Patients with Clinical Indication for Coronary Angiogram and Possible Revascularization N=1899 Pre-PCI Culprit NIRS (1265 lesions in 1168 pts) Median Follow-up 731d (IQR 711, 746) Primary Endpoint MACE (cardiac death, myocardial infarction, stent thrombosis, revascularization, hospitalization) ClinicalTrials.govNCT00831116

  19. 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%)

  20. PCI Patient Characteristics

  21. Culprit lesion related MACE by maxLCBI4mm 10 8 6.3% 6 5.4% MACE (%) 4 Hazard Ratio = 0.83 [0.52, 1.30] 2 P-Value = 0.41 maxLCBI4mm < 304 [median] maxLCBI4mm≥ 304 [median] 0 0 180 365 550 730 Time in Days Number at risk: < 304 632 605 584 571 544 524 521 514 313 ≥ 304 633 606 600 584 571 538 532 531 356

  22. Relationship Between NIRS and Culprit-lesion related MACE maxLCBI4mm Total lesion LCBI 1.00 1.00 0.75 0.75 Sensitivity Sensitivity 0.50 0.50 AUC [95% CI] = 0.53 [0.46,0.60] AUC [95% CI] = 0.53 [0.46,0.60] 0.25 0.25 P value = 0.42 P value = 0.41 0.00 0.00 0.00 0.25 0.50 0.75 1.00 0.00 0.25 0.50 0.75 1.00 1-Specificity 1-Specificity

  23. Lesion Level Multivariable Model Culprit-lesion related MACE

  24. Lesion Level Multivariable Model Culprit-lesion related MACE

  25. Limitations • Voluntary registry, not consecutive patients. Selection bias cannot be excluded • Operators not blinded to NIRS/IVUS imaging which may have affected treatment strategy • Imaging was not done routinely post-PCI • Angiographic follow-up was not performed • Only few lesions responsible for non-culprit lesion-related events were imaged at baseline, precluding in-depth analysis

  26. 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-up • PCI of NIRS-defined LRPs was safe, and was not associated with increased peri-procedural or late adverse outcomes compared to PCI of non-LRPs • The Clinical significance of NIRS-defined non-culprit LRPs will be determined by two ongoing prospective outcome studies (LRP study and PROSPECT-II)

  27. COLOR 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, MD On behalf of the COLOR Investigators

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