Left Main PCI Integrated Use of IVUS and FFR Seung-Jung Park, MD, PhD Professor of Medicine, University of Ulsan College of Medicine, Heart Institute, Asan Medical Center, Seoul, Korea
Efficacy of Left Main PCI
Major Studies PCI vs CABG in Left Main Disease MAIN-COMPARE Registry, 3 year F/U SYNTAX RCT, subgroup LM, 4 year F/U MAIN-COMPARE Registry, 5 year F/U PRECOMBAT RCT, 2 year F/U META-ANAYLSIS of 4 RCTs Seung KB, Park DW, Park SJ, NEJM 2008;358:1781-92 Parick W.Serruys, et al. TCT 2011 presentation Park DW, et al. JACC 2010;56:117-2424 Park SJ et al, NEJM 2011; May 5;364(18):1718-27 Capodanno D etal, JACC 2011;58;1426-1432
PCI vs. CABG for Left Main Disease 1-Year Outcomes PCI (n = 809) CABG (n = 802) OR (95% CI) No Difference in Death or MI 14.5% 11.8% 1.28 ptvr is Higher in PCI group. (0.95-1.72) 3.0% 4.1% 0.74 Stoke is Higher in CABG group. Primary Endpoint Death (0.43-1.29) MI 28% 2.8% 29% 2.9% 098 0.98 (0.54-1.78) Stroke 0.1% 1.7% 0.15 (0.03-0.67) TVR 11.4% 5.4% 2.25 (1.54-3.29) P Value 0.11 0.29 095 0.95 0.013 < 0.001 Meta-Analysis; Capodanno D etal, JACC 2011;58;1426-1432
Joint 2010 ESC-EACTS Guidelines for unprotected LMCA PCI Subset of CAD by anatomy CABG PCI Left Main (Isolated or 1 VD, ostium/shaft) Left Main (Isolated or 1 VD, distal bifurcation) Left Main + 2VD or 3 VD, SYNTAX score <32 Left Main + 2VD or 3 VD, SYNTAX score >33 IA IA IA IA IIa, B IIb, B IIb, B III, B
Current Issue is, How To Do? Functional Angioplasty ; Integrated Use of IVUS and FFR
Is Angiography Enough for Diagnosis of Clinical i l Ischemia?
Visual Functional Mismatch Visual : 80% IVUS MLA : 62 6.2mm 2 FFR : 0.82 Treadmill test : Negative Thallium spect : Normal Stress Echo : Negative
Reverse Mismatch Visual Estimation : 30% FFR : 0.70 IVUS MLA: 4.5 mm2 Treadmill test: + stage 2 Thallium spect : + large LAD
Mismatches ; Significant Stenosis (>50%) with Negative FFR Reverse Mismatches ; Insignificant Stenosis (<50%) with Positive FFR
How Many Mismatches?
Mismatch in intermediate LM Disease 12% 6% 23% 59% Hamilos M, Circulation 2009; 120: 1505-1512
Mismatch in Isolated intermediate LM Disease (n=55) FFR 9% 26% DS % (QCA)
Why Relatively Higher Reverse Mismatches in LM disease?
LM supplied Large Myocardium DS=50% Large Myocardium FFR=0.70 DS=85% FFR=0.90 Acute Onic Injury Scar and/or Chronic Scar Small Myocardium
Univariable Analysis to Predict FFR <0.8 Variables C-OR 95%CI p-value MLA within LM 0.312 0.164-0.593 <0.001 Plaque burden 1.095 1.031-1.164 0.003 Lesion length 1.192 1.038-1.368 0.013 Rupture 3.273 0.953-11.243 0.060 Angiographic DS 1.049 0.993 1.108 0.088 Lesion location 2.081 1.070 4.046 0.031031 Male 0.511 0.127-2.057 0.345 Age 0.965 0.917-1.016 1 016 0.172 Diabetes melitus 1.062 0.304-3.710 0.924 Hypertension 1.3 0.412-4.101 4.101 0.654 Smoker 2.701 0.816-0.8945 0.104 Hyperlipidemia p 1.167 0.324-4.200 0.814 Stable presentation 0.476 0.078-2.894 0.42
Multivariable Analysis to Predict FFR Independent predictors for FFR as continuous variable MLA (β=0.58, 058 95%CI CI=0.02 002-0.04, 04 p<0.001) 001) Plaque rupture (β=-0.24, 95% CI= -0.09-0.01, p=0.036) Kang SJ et al, JACC. Cardiovascular Interventions. 2011 Nov;4(11):1168-74.
Presence of Plaque Rupture 70% FFR : 0.62 70% 0.68 70% 0.66 70% 0.58 Steady-state 3D Computed Simulation under Hyperemic Condition, AMC data
FFR theory FFR is more sensitive and integrated summation of physiological and anatomical aspects (total morphology) of a stenosis rather than 2-dimensional i angiographic g diameter stenosis.
Why FFR? 1. Angiography is not always enough! 2. FFR is the only matched index with objective ischemia even in the Left main disease.
IVUS MLA vs. FFR
IVUS MLA < 6.0 mm 2 is matched with FFR <0.75 2.8mm 5.9mm 2 67% 50% Jasti V et al. Circulation 2004;110:2831-6
New Comparison AMC prospective cohort registry (n=55 lesions), 2011 FFR vs. IVUS MLA JACC Cardiovasc Interv, 2011 (in press)
New IVUS MLA 4.1 mm 2 4.8 mm 2 Kang SJ, Park SJ et al, JACC. Cardiovascular Interventions. 2011 Nov;4(11):1168-74.
New IVUS MLA Matched with FFR <0.80 in LM Disease 4.8 mm 2 Kang SJ, Park SJ et al, JACC. Cardiovascular Interventions. 2011 Nov;4(11):1168-74.
Jasti s s dataa 1.0 0.9 FF FR 0.8 Large Vessels, 75% Negative FFR Not normal distribution 0.75 0.7 0.6 0.5 0 2 4 6 8 10 12 14 16 5.9 MLA (mm 2 )
Kang s data,amc Jasti s s dataa 1.0 0.9 0.8 FF FR 0.8 0.7 0.6 More Positive FFR Normal Distribution 0.5 Large Vessels, 75% Negative FFR Not normal distribution 0 2 4 6 8 10 12 14 16 4.8 MLA (mm 2 )
Ethnic Difference?
Reference Vessel Size of Left Main Coronary Artery by QCA 2309 USA/EU Patients in 17 Studies 3.5-4.0 mm m mm
FFR >0.8 1.0 Sensitivity 89% Specificity 83% NPV 89% PPV 82% 0.9 NPV 89% Accuracy 86% Don t Use Anymore the IVUS 0.8 MLA of 6 mm 2 for LM PCI. It s too Big! 0.7 FFR <0.8 PPV 82% PPV 53% 0.6 MLA mm 2 0 2.0 4.0 6.0 8.0 10.0 MLA 6.0 mm 2 MLA 4.8 mm 2
Why IVUS?
IVUS guidance saves lives in LM PCI ortali ity(%) ive M mulat Cum Angiography-guidance IVUS-guidance P=0.048 16.0% 44% 4.4% Park SJ et al, Circulation. Cardiovasc Interv. 2009 Jun;2(3):167-77.
Why IVUS guidance The IVUS-guidance will reduce 3-year mortality from MAIN COMPARE registry data. (Park SJ, et al. Circulation Cardiovasc Interv. 2009 Jun;2(3):167-77) Treat or not treat decision could be made by IVUS MLA 4.8 mm 2 (PPV:82%). IVUS guidance have more understanding about the inside of the vessel (negative remodeling, true reference vessel size and ostial lesion assessment). We can decide the treatment strategy based on IVUS guidance.
Ostial and Shaft LM PCI How to Do?
Ostial and Shaft LM PCI Functional Assessment (FFR) is Crucial. FFR works LAD LCX Courtesy of Akiko Maehara, MD
Ostial and Shaft LM PCI Functional Assessment (FFR) is Crucial. IVUS MLA (4.8 mm 2 ) can predict functional significance of stenosis of LM disease. Just Stent t it! It takes just 5 minutes! We have more than 5-10 year long-term data. No difference of death and MI compared with surgery (even better). Long-term clinical i l outcomes should be comparable to 100% of arterial grafts.
Distal Bifurcation LM PCI How to Do?
Problem of FFR for LMCA Lesions Possible False Negative Possible False Positive Conceptual Problem! LAD LCX Courtesy of Akiko Maehara, MD
In Reality,
Plaque Distribution by IVUS (n=140) 1/1,1,1 LMCA (1/1) 1/0,1,1 LMCA (1/0) 1/0,1,0 LMCA (1/0) LAD (1) LCX (1) LAD (1) LCX (1) LAD (1) LCX (0) 62% 14% 14% 0/111 0/1,1,1 0/010 0/0,1,0 0/011 0/0,1,1 0/101 0/1,0,1 LMCA (0/1) LMCA (0/0) LMCA (0/0) LMCA (0/1) LAD (1) LCX (1) LAD (1) LCX (0) LAD (1) LCX (1) LAD (0) LCX (1) 4% 3% 2% 1% In 90% plaque extends from LMCA-LAD Oviedo C et al. Circ Cardiovasc Interv 2010;3:105-12. 12.
Plaque Distribution by IVUS (n=82 82) In all cases, the LM disease extended into LAD and LCX continuously. Kang et al, Catheterization and Cardiovascular Interventions. 2011 Jul 29.
Placed Transducer Beyond Bifurcation inbothladandlcx LCX FFR still works. Single Unit of Disease LCX LAD
Distal LM Bifurcation PCI Single Stent Cross Over 2 Stents Procedures
When, 1 vs. 2 stents Single stent Normal ostial LCX with MEDINA 1.1.0. or 1.0.0. Small LCX with < 2.5 mm in diameter Diminutive LCX Normal or focal disease in distal LCX Two stent Diseased LCX with MEDINA 1.1.1., 1.0.1., or 0.1.1 stent Large LCX with 2.5 mm in diameter Diseased left dominant coronary system Concomitant diffuse disease in distal LCX Park SJ, Kim YH. Colombo A, Issam D. Moussa et al. Textbook of Bifurcation Stenting
Cu umulative in ncidence (% %) (%) incidence Cumulative 30 20 MI Nondistal vs Simple p=0.32 Nondistal vs Complex p<0.001 Simple vs Complex p=0.01 10 P<0.001 0 30 20 10 0 0 0 TVR Complex 2 stents Non-distal (Ostial and Shaft) Simple (single stent cross over) In LM bifurcation lesions Single Stent Cross Over 0.5 1.0 1.5 2.0 2.5 3.0 yrs MACE is Clearly l better! Nondistal vs Simple p=0.43 Nondistal vs Simple p=0.71 40 Nondistal vs Complex p<0.001 Nondistal vs Complex p<0.001 Simple vs Complex p=0.014 Simple vs Complex p<0.001 30 P<0.001 Cumulative incidence e (%) 0 0.5 1.0 1.5 2.0 2.5 3.0 yrs 0 50 20 10 P<0.001 0.5 1.0 1.5 2.0 2.5 3.0 yrs Kim WJ, et al. Catheter Cardiovasc Interv. 2011 May 1;77(6):775-82
Stent t Cross Over for LM Bifurcation Lesions
LM Bifurcation Lesion with minimal-disease of LCX 72/M, Unstable angina,
IVUS LAD Ostium LCX Ostium Minimal-disease MLA 5.4 mm 2
Single Stent Cross-Over with minimal-disease i at LCX OS LM-LAD cross over Cypher 3.5 23 mm Additional high pressure Inflation with 4.0 mm non-compliant balloon
Final Results after Single Stent t Cross-Over Immediate after the procedure, there was no significant p, g compromise of LCX ostium.
FFR of LCX is 0.94 Pre-adenosine Post-adenosine
Single Stent Cross-Over IVUS Guided Stent Cross over depending on LCX disease status t by IVUS, stent t size selection, stent optimization. FFR Guided decision making for further treatment about the compromised side branch (LCX).
2 stent techniques in LM true bifurcation lesions
2 stent Techniques T-stent, modified T-stent or TAP Mini-crush (or step crush) Culotte V-stent Y-stent (SKS-simultaneous kissing stents)
When to Choose Different 2 stent Techniques Technique T, modified d T, TAP: Culotte: Mini-crush (or step crush): V-stent: SKS: When to choose 75-90 angled LCX Y bif with matched LAD/LCX dia. Y bif with LAD/LCX dia mismatch. Medina 0,1,1 (true LMEQ ds) Short LM, unstable pt End with a FKB inflation with all 2-stent techniques Gregg W. Stone, Complex PCI: Left Main and CTO Summit, NY, 2012
Whatever you choose 2 stent techniques, You have to consider IVUS guided Stent Optimization!
IVUS Stent Area and its Impact for restenosis in 403 Patients with Unprotected Left Main Disease All patients treated with SES 100% Post-stent IVUS, 100% Angiography F/U at 9 months and 2 years clinical F/U Kang SJ, et al. Circulation. Cardiovascular Interventions. 2011 Dec 1;4(6):562-9.
Restenosis at 2 year % 30 Ostial and Shaft Bifurcation PCI 25.4 25 20 15 10 4.5 6.3 5 0 3/67 14/222 29/114 Single stent Any Two stent
IVUS Measurement for LM Bifurcation Stents LCX carina LCX Ostium LM Ostium *POC LAD Ostium 3 mm 3 mm *POC : Polygon Of Confluence LAD carina
100 80 Minimal Stent Area (mm 2 ) to predict ISR LCX 100 80 _ LAD Sens sitivity 60 40 20 0 5.01 mm 2 Sensitivity 78% specificity 78% AUC=0.852 95% CI=0.769-0.914 0 20 40 60 80 100 _ 100 100 80 POC 60 40 20 0 80 6.34 Sensitivity 73% specificity 85% AUC=0.847 95% CI=0.804-0.884 0 20 40 60 80 100 LM 60 40 20 0 723 7.23 Sensitivity 100% specificity 78% AUC=0.909 95% CI=0.874-0.938 0 0 20 40 60 80 100 Specificity 60 40 20 0 8.2 Sensitivity 80% specificity 81% AUC=0.868 95% CI=0.831-0.900 0 0 20 40 60 80 100
IVUS Stent Optimization (Stent Cross-sectionalsectional Area) 8 mm 2 LM 5678 5,6,7,8 mm 2 of fstent tcsac Can Make a Good 7 Clinical mm 2 Outcomes in 2 stents POC technique 6 mm 2 in LM bifurcation PCI. 5 mm (Restenosis Rate <5% dtlr<2%) 2 LAD and LCX Kang SJ et al. Circulation. Cardiovascular Interventions. 2011 Dec 1;4(6):562-9.
Whatever you choose 2 stent t techniques, IVUS Final stent CSA (5,6,7,8 mm 2 ) is the most important criteria for the good clinical i l outcomes!
Distal LM Bifurcation Treatment For the intermediate LM bifurcation disease, FFR still works. IVUS guidance give us more understanding about the inside of vessel. And also MLA of LM <4.8 mm 2 can predict functional significance of stenosis (PPV 83%). When we used single stent cross over, FFR guided side branch optimization is reasonable approach. When we used 2 stents technique, IVUS guided optimization of stent (IVUS stent CSA 5,6,7,8 mm 2 ) can make a good clinical outcomes.
Functional Angioplasty Integrated Use of FFR and IVUS Avoid unnecessary PCI Avoid unnecessary Surgery Minimize MACE Maximize clinical outcomes Save money Save lives