IVUS Use during Left Main PCI improve Immediate and Long Term Outcome Where is the Evidence? E Murat Tuzcu, MD, FACC Professor of Medicine Vice Chairman Department of Cardiovascular Medicine Cleveland Clinic Does IVUS improve PCI Outcomes 1990 -2000 Study Helpful SIPS X CRUISE X Choi et al X AVID X CENIC X Gaster et al X RESIST X TULIP X OPTICUS No X Role of IVUS in Stenting in the DES Era Intravascular IVUS-guided DES Placement Associated with Reduced Incidence of Recurrent Clinical Events 1504 pts, IVUS guidance in 632 (42%), F/U 2 yrs CRF and Amsterdam 15 Non IVUS Cohort IVUS Cohort 12 P=0.004 9 6 3 0 0 0.5 1.0 Time in Years B. Claessen et al., JACC 2010;56:41 1.5 2.0 Multivariate Analysis for Predicting Death/MI IVUS guidance Age CHF Renal impairment IVUS in LMCA Stenting Comparison of BMS (IVUS 75%) and DES (IVUS 86%) MACE Free Survival (%) 100 98.0 ± 1.4% 90 80 81.4 ± 3.7% 70 SES group BMS group 60 0 0 Park SJ et al., JACC 2005;45:351-356 2 4 6 8 Months 10 12 IVUS Guidance in DES for LMCA Stenosis Event Free Survival in 24 IVUS+ and 34 IVUS- Patients Event-free Survival (%) 1.0 IVUS (n=14) No IVUS (n=12) No IVUS (n=22) IVUS (n=10) .5 Distal LM Non-Distal LM 0.0 0 200 400 600 800 1000 Time (days) Agostoni et al AJC 2005;95:644-7 MAIN COMPARE REGISTRY • 975 elective BMS or DES for unprotected LMCA stenosis • IVUS (756), angiography (219) guidance by operator discretion • Angiography group was older and sicker • 201 propensity-score matching pairs (DES + BMS) • 145 propensity-score matching pairs of DES patients IVUS Guidance in Stenting for LMCA Stenosis 3 year death and MI (K-M) in 201 propensity matched pairs Death Death or MI Cumulative Incidence of Death or MI (%) Cumulative Mortality (%) 40 40 Angiography-guidance IVUS-guidance Angiography-guidance IVUS-guidance 30 30 P=0.078 P=0.063 22.7% (16.2-29.2%) 20 20 13.6% (8.0-19.24%) 13.9% (9.1-18.8%) 10 10 6.0% (2.6-9.4%) 0 0 180 360 540 720 900 1000 Days Patients at risk IVUS-guidance Angiography-guidance 0 0 201 201 194 191 180 360 540 720 900 1000 Days Patients at risk 143 138 88 64 IVUS-guidance Angiography-guidance 201 201 178 175 131 128 82 67 Park SJ Circ Cardiovasc Interv 2009;2:167-177 IVUS Guidance in DES for LMCA Stenosis 3 year TVR and MACE (K-M) in 201 propensity matched pairs TVR Death/MI/TVR Cumulative Incidence of Death, MI or TVR (%) Cumulative Incidence of TVR (%) 40 40 Angiography-guidance IVUS-guidance Angiography-guidance IVUS-guidance 30 30 28.0% P=0.274 P=0.056 22.2% 20 20 11.9% (7.3-16.5%) 10 10 8.8% (4.6-12.9%) 0 0 0 0 Patients at risk IVUS-guidance 201 Angiography-guidance 201 180 360 540 720 900 1080 Days 176 179 125 129 18 70 180 360 900 1000 Months Patients at risk IVUS-guidance Angiography-guidance 540 720 201 201 164 168 115 129 74 64 Park SJ Circ Cardiovasc Interv 2009;2:167-177 IVUS Guidance in DES for LMCA Stenosis 3 year mortality (K-M) in 145 propensity matched pairs Cumulative Mortality (%) 40 Angiography-guidance IVUS-guidance 30 P=0.048 20 16.0% 10 4.4% 0 0 180 360 540 720 900 1080 Months Patients at risk IVUS-guidance Angiography-guidance 145 145 140 137 98 88 37 29 Differences in Patient Outcomes for LMCA PCI Thoraxcenter vs. Asan Medical Center: Impact of Baseline Characteristics on Outcomes of DES Age 65, LVEF 45% Euroscore 4.3, IVUS 32%, SYNTAX score 39 STEMI 23%, Shock 9% Age 61, LVEF 59% Euroscore 3.3, IVUS 89% 32%, SYNTAX score 39 STEMI 0%, Shock 0% All Cause Mortality 35% versus, 6% Onuma et al. JACC Int, 2010 Park DW et al., JACC, 2010 Left Main Coronary Artery (LMCA) Disease To treat or not to treat? That is the question. IVUS and Left Main Disease 7 6 5 4 3 2 1 0 r=0.364 0 1 IVUS ref (mm) IVUS MLD (mm) 122 patients with moderate LMCA disease, f/u 1 year 2 3 4 5 6 7 QCA MLD (mm) 8 7 6 5 4 3 2 1 0 MACE 1.0 0.9 DM and 1 untreated vessel with DS 50% 0.8 0.7 r=0.495 0 1 2 3 4 5 6 7 8 QCA Ref. (mm) DM and no untreated vessels 0.6 0.5 No DM and 1 untreated vessel with DS 50% 0.4 100 Independent predictors of MACE Any untreated lesion >50% (p=0.04) IVUS MLD (P=0.005) p=0.106 80 IVUS DS DM (P=0.004) 0.3 60 0.1 40 0.0 20 0 0 AS Abizaid et al JACC 1999;34:707-15 0.2 20 40 60 80 100 QCA DS No DM and no untreated vessels 1.4 2.2 3.0 3.8 4.6 5.4 1.8 2.6 3.4 4.2 5.0 5.8 IVUS MLD (mm) Assessment of Intermediate LMCA Lesions by IVUS LITRO Study – 22 Spanish Centers 354 Patients MLA ≥6.0 mm2 (N=186) MLA <6.0 mm2 (N=168) 7 revascularized 16 not revascularized No LMCA revascularization (n=179, 96%) 56% PCI of other vessels LMCA revascularization (n=152, 90%) 55% CABG 45% PCI (+ other vessels in 62%) De La Torre Hernandez et al. ACCi2 2010 Assessment of Intermediate LMCA Lesions by IVUS Survival in Revascularized and Deferred Patients Defer Defer (n=179) Revascularization Revascularization (n=152) Survival free of cardiac death, MI and any revascularization P=0.22 Survival free of cardiac death P=0.20 De La Torre Hernandez et al. ACCi2 2010 Assessment of Intermediate LMCA Lesions by IVUS LITRO Study – Survival in Medically Treated Patients 100 80 60 40 Defer (medical therapy) with MLA ≥6mm2 (n=179) Defer (medical therapy) with MLA <6mm2 (n=160) 20 Survival free of Cardiac Death P=0.02 0 0 100 200 300 400 500 600 700 Time De La Torre Hernandez et al. ACCi2 2010 The Assessment of LMCA Shortfalls of Luminology for Even Experienced Clinicians Agreement or Disagreement on Stenosis Severity 51 intermediate LMT assessed by angiography and FFR Reviewer Assessment Results Visual Assessment Reviewer A Reviewer B Reviewer C Reviewer C ns s u ns s u ns s u ns s u correct incorrect unsure correct incorrect unsure correct incorrect unsure correct incorrect unsure % (absolute #) 53% 22% 25% 49% 39% 12% 51% 49% 45% 33% 22% 27/51 11/51 13/51 25/51 20/51 6/51 26/51 25/51 0/51 23/51 17/51 11/51 •4 experienced interventional cardiologist correctly classified lesion severity in 50% of patients. •Interobserver variability was large resulting in unanimous correct classification in only 29% Lindstaedt M et al. Int J Cardiol. 2007;120(2):254-261 The Grey Zone of FFR 100 Specificity 80 FFR Caveats • Other coronary stenosis • Distal LMCA stenosis 60 40 Sensitivity 20 0 0.2 0.3 0.4 0.5 0.6 0.7 0.8 FFR Sensitivity • Variability of hyperemic response Specificity De Bruyne B et al. Circulation 2001;104:157-162 FFR = 0.75 0.80 0.9 1.0 IVUS shows us so much more! • Vessel size • Remodeling • Length • Calcification • Ostium • Bifurcation Courtesy of G Mintz (modified) Morphological Assessment of LMCA by IVUS Distribution of atherosclerosis in LMCA: Ostium vs Bifurcation Ostium n=32 Bifurcation n=55 p value Plaque burden (%) 62 ± 15 80 ± 9 <0.0001 Max Calcium Arc (°) 78 ± 65 195 ± 101 <0.0001 Eccentric plaque (%) 97 76 0.01 2.3 ± 2.4 4.5 ± 2.7 0.001 Lesion length (mm) Remodeling index 0.87 ± 0.19 1.01 ± 0.21 0.005 Bifurcation vs Ostium: more calcium and plaque, longer, and more positive remodeling Maehara A et al., AJC 2001;88:1-4 Others All lesions (n=80) Medina 1,1,1 (n=21) Medina 1,1,0 (n=9) Medina 1,0,1 (n=6) Medina 0,1,1 (n=11) Medina 1,0,0 (n=7) Medina 0,1,0 (n=14) Medina 0,0,1 (n=12) Medina 0,0,0 (n=60) 0% Oviedo et al. Circ Cardiovasc Interv. 2010;3:105-12 100% Impact of IVUS on TVR after LMCA Stenting 168 patients with distal LMCA stenosis w/ 42 mo F/U POC: Polygon of confluance • Pre-PCI MLA at POC was predictor of MACE. • MLA at POC determined final stent size Kang SJ et al., 2011;107:367-373 Ostial Left Main Stenosis Ostial Left Main Stenosis B A A B Why IVUS is Important in LMCA Intervention • IVUS improves our understanding of the pathology better and helps to plan the strategy of PCI • Determination of the extent and distribution of atheroma in distal LMT, ostial LAD and Cx • Location and involvement of the ostium of LMCA • True vessel size of LMCA • True vessel size of LAD and Cx • Optimize stent expansion particularly at the ostea • Ensure coverage of the LMCA-ostium when necessary • Identify and treat complications