IVUS-Guided LM Stenting

IVUS-Guided LM Stenting 

Technique and Outcomes 

Young-Hak Kim, MD, PhD, 

On behalf of CROSS and PERFECT investigators. 

Cardiac Center, University of Ulsan College of Medicine 

Asan Medical Center, Seoul, Korea 

Monday, December 7, 2009

Monday, December 7, 2009 

It took 1.5 days 

from Seoul, Korea to Curitiba, Brazil..


It took 1.5 days 

from Seoul, Korea to Curitiba, Brazil..





Upgrade of Recommendation 

for PCI at Unprotected Left Main Stenosis 


Circulation, 2009 NOV



Stenting is relatively more favorable for 

• Patients with isolated ULMCA lesions or 1-vessel disease, 

• Patients with ostial or mid ULMCA, 

• patients with factors for high-risk CABG. 

CABG may be relatively more favorable for 

• Patients with ULMCA plus multivessel disease, 

• Distal/bifurcation ULMCA lesions, or 

• Low surgical risk with a good chance of technical success. 





Stenting is relatively more favorable for 

• Patients with isolated ULMCA lesions or 1-vessel disease, 

• Patients with ostial or mid ULMCA, 

• patients with factors for high-risk CABG. 

CABG may be relatively more favorable for 

• Patients with ULMCA plus multivessel disease, 

• Distal/bifurcation ULMCA lesions, or 

• Low surgical risk with a good chance of technical success. 



An IVUS-guided stepwise approach 

make you feel comfortable.. 

• Lesion assessment 

• Selection of PCI technique 

• Selection of appropriate device 

• Procedural optimization 

• Assessment of DES failures 









Treat or not Treat 

Big discrepancy ! 

EEM : 14.04mm 2 

Lumen : 4.0mm 2 

Area stenosis : 71.5% 




Courtesy of Dr. Gary S. Mintz


0 1.0 4.0mm 



We can treat the LM disease 

in a case of MLA < 6.0 mm 2 … 

Prediction of FFR (0.75) with IVUS parameter 

2.8mm 5.9mm 2 

67% 50% 


Jasti V et al. Circulation 2004;110:2831

Plaque Characterization 

• Lesion preparation : need of rotablation, debulking 

• Drug : need of IIb/IIIa, aggressive antiplatelets 

Fibrous plaque 

Plaque rupture 

Thrombi 

Calcification 










Ostial and Shaft 

LM lesions 


IVUS Exam is very useful to assess… 

1. vessel size and lesion length 

2. presence of bifurcation stenosis 

3. optimal stent expansion with complete apposition 


Normal : LAD ostium, bifurcation and shaft 

Mild disease : LCX ostium 


Stenting with Xience V 4.0 x 15mm 


Stenting with Xience V 4.0 x 15mm 

It is very simple but please remember 

1. Ultras-short stent (< 10mm) is not good due to the likelihood of stent 

slippage. 

2. Big balloon dilatation (>4mm) is useful to avoid inapposition. 

3. Minimal protrusion of stent into aorta is fine. 

4. Final IVUS exam is mandatory. 


No inapposition 

No touch in LAD os or LCX os 

Worst area : 9.6 mm 2 


Os and Shaft LM stenting 

2-Year Outcomes 

International Multicenter Registry 

In Hospital 

Follow-Up 

(886±308 days) 

Cardiac death, n (%) 0 4(2.7) 

Cardiac death in 60 high-risk 

0 4(6.6) 

patients, n (%) 

Cardiac death in 87 low-risk 

patients, n (%) 

0 0 

Total death, n (%) 1 (0.7) 5(3.4) 

Q-wave MI, n (%) 0 1 (0.7) 

Non-Q-wave MI, n (%) 5 (3.4) 2 (1.4) 

TLR, n (%) 1 (0.7) 1 (0.7) 

TVR, n (%) 1 (0.7) 7 (4.7) 

MACE, n (%) 6 (4.0) 11 (7.4) 


Chieffo A, Kim YH, Park SJ et al. Circulation 2007;116:158

Left Main 

Bifurcation Approach 


Treatment for Bifurcation LM 

1-stent in LM 

& for LCX with .. 

2-stent in LM 

& LCX with .. 

1) No touch 

2) Provisional kissing 

3) Provisional T stenting 

4) Provisional Culotte 

5) Reverse crush 

6) Others 

1) Simultaneous kissing 

2) V-stenting 

3) Crush 

4) Culotte 

5) T-stenting 

6) Others 


IVUS-guided, 

Lesion-specific 

Single 

stent 

Two 

stent 

Normal ostial LCX with MEDINA 1.1.0. or 1.0.0. 

Small LCX with < 2.5 mm in diameter 

Ostial LCX area ≥ 4 mm 2 by IVUS 

Diminutive LCX 

Normal or focal disease in distal LCX 

Diseased LCX with MEDINA 1.1.1., 1.0.1., or 0.1.1 

Large LCX with ≥ 2.5 mm in diameter 

Ostial LCX area < 4 mm 2 by IVUS 

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 




Single 

stent 

Two 

stent 













Left Main Stenosis with Normal LCX 

• 60 Yr / Male 

• Stable angina 

• Scheduled to receive a surgery for ureter stone 

• Hypertension with normal EF (56%) 


Decision-Making of LM Lesion by IVUS 

Ostial LAD Distal LMCA Ostial LCX 

4.9 mm 2 (79%) 4.8 mm 2 (71%) 5.5 mm 2 (40%) 


Single 

stent 

Two 

stent 

Normal ostial LCX with MEDINA 1.1.0. or 

1.0.0. 












One-Stent Technique 

Predilation 



Predilation 

Xience V 2.75 * 28 mm 



Predilation 





Predilation 






Predilation 




Postdilation 



Final Angiogram

IVUS at Ostial LCX 

Carina Shift without Plaque 

LAD 

LCX os 3.3 mm 2 (46%) 

LCX to LM 

Longitudinal view 

IVUS from LCX 


Kissing balloon inflation 

Not mandatory 

FFR in LCX 

Indicated in 

Significant LCX jail 

TIMI flow < 3 

Dissection 

Low FFR < 0.80 


Unadjusted Outcomes of MAIN-COMPARE 

Study in Korea Between 1- vs. 2-Stent 

Cumulative incidence (%) 

15 

10 

5 

0 

0 

Death 

P=0.62 

1-stent 

2-stent 

0.5 1.0 1.5 2.0 2.5 3.0yrs 


20 

15 

10 

5 

0 

0 

MI 

P=0.009 

0.5 1.0 1.5 2.0 2.5 3.0yrs 


30 

20 

10 

0 

0 

TVR 

P



Single 

stent 

Two 

stent 













LM with 3 Vessel Disease 

• 76 Yr / Male 

• Diabetic on oral hypoglycemics 

• Unstable angina with EF of 63% 



Mild Ostial LCX Stenosis


Mild Ostial LCX Stenosis

Side branch assessment 

LM 

LAD 

LCX 




LAD 

LCX 

LCX os 

From LAD 



2.2 mm 2 


LCX os From 

LCX 

LAD 

LCX 

LCX os 

From LAD 


Single 

stent 

 

 

 



Normal ostial LCX with MEDINA 1.1.0. or 

1.0.0. 



Two 

stent 


Normal Diseased or LCX focal with disease MEDINA in distal 1.1.1., LCX1.0.1., or 0.1.1 



 


 




Stenting in LAD and LCX 

Followed by Crushing in Distal LM 

Several IVUS exams were done for optimal stenting 

Predilation 





Predilation 






Predilation 


Predilation 





Predilation 


Predilation 






Predilation 


Predilation 

Xience Kissing V 2.75 balloon * 18 mm 





Predilation 


Predilation 


After kissing balloon 





Predilation 


Predilation 








Predilation 


Predilation 



Xience Xience V 3.0 V 3.5 * 23 * mm 28 mm 





Predilation 


Predilation 



Xience Xience V 3.0 V 3.5 * 23 * mm 

Non-com. balloon 

28 mm 

3.0 to 25atm 





Predilation 


Predilation 





28 mm 

3.0 to 25atm 

Non-com. balloon 3.5 at 25atm 





Predilation 


Predilation 





28 mm 

3.0 to 25atm 

Non-com. Kissing balloon at 10 3.5 atm 25atm in both 





Predilation 


Predilation 





28 mm 

3.0 to 25atm 


Optimization with 3.0 ball. 





Predilation 


Predilation 





28 mm 

3.0 to 25atm 


Optimization with 3.0 ball. 

Optimization with 3.5mm ball. 



Final Results

MAIN-COMPARE in Korea 

70.0000 

52.5000 

50.0 

37.5 

43.6 

31.2 

35.0000 

17.5000 

61% 39% 

25.0 

12.5 

19.3 

0 

Simple 

cross-over 

1 

Complex 

Stenting 

0 

0.9 0.5 

1 

Complex Stenting Techniques 


MAIN-COMPARE in Korea 

Unadjusted Rate of 4-Yr LM-TLR 

% 

25.0 

18.8 

17.1 

19.4 

12.5 

12.5 

6.3 

0 

5.1 

14/267 14/82 6/31 7/56 

Cross Crush 

1 

T Kissing or V 









Goal of LM Stent Area 

> 9 mm 2 

% 

100 

75 

50 

25 

0 

“Optimal” SCA and Restenosis 

BMS 

8.5 9 9.5 1010.51111.51212.5 

Sensitivity 

Specificity 

 

100 

75 

50 

25 

0 

DES 

Sensitivity 

Specificity 

6.5 7 7.5 8 

 

8.5 9 9.5 1010.5 

10.1 

MSA (mm 2 ) 

8.8 


Park SJ et al, Circ Cardiovasc Intervent. 2009;2:167-177

Goal of LAD & LCX Stent Area 

> 6 mm 2 

“Optimal” SCA and Restenosis 

 

 

 

 

 

 

 

 

 

 

 

 

Specificity 

Sensitivity 

Stent CSA 

(mm 2 ) 

 

 

 

 

 

 

 

 

 

 


Hong MK, Eur Heart J, 2006:27:1305, AMC data

Practical Goal of Stent Area 

• ≥ 9 mm 2 for LM 


Final IVUS After Crush 

Ostial LAD Distal LMCA Ostial LCX 

7.0 mm 2 10.9 mm 2 6.2 mm 2 









Treatment for LM-DES ISR in AMC 

DES implantation for ULMCA disease 

(N = 509 ) between 2003.2 ~ 2007.12. 

Follow-up Angiography (n = 402, 79.0%) 

Angiographic Restenosis 

(N = 70, 17%) 

Optimal 

Medical 

Therapy 

(N = 21, 30%) 

Revascularization 

PCI 

(N = 40, 57%) 

CABG 

(N = 9, 13%) 

Another DES = 18 

Balloon angioplasty = 22 


DES-ISR at LMCA 

A patient was transferred after DES treatment. 


DES-ISR at LMCA 

A patient was transferred after DES treatment. 


LMCA-ISR due to.. 

• Under-expansion 

• Intimal hyperplasia 

• Restenosis in gap 

• Restenosis in edge 

Gap 


LMCA-ISR due to.. 

• Under-expansion 

• Intimal hyperplasia 

• Restenosis in gap 

• Restenosis in edge 

Gap 


ISR at LMCA 

Crush Technique with Xience V 

Conventional B. with 2.5 and 3.0 mm 

In LAD and LCX 






Crush with Xience 3.5 X 23mm 













Non-comp. B. 3.0 X 20mm 





















Kissing balloon inflation 


Final 

Ostial LCX 

(6.5mm 2 ) 

Ostial LAD 

(9.1mm 2 ) 

LMCA 

(14.3mm 2 ) 


Final 

Ostial LCX 

(6.5mm 2 ) 

Ostial LAD 

(9.1mm 2 ) 

LMCA 

(14.3mm 2 ) 


Is there clinical impact ? 

IVUS guided vs. Angio-guided 

In unselected “Real World” population 

From January 3,1998 to February 28, 2006 

AMC registry 2009 (N=8371) 


MAIN-COMPARE Registry 

IVUS guidance 

(N=756) 

Left Main PCI (N=975) 

Angiography guidance 

(N=219) 

Using Propensity Matching, 

The 3-year outcomes was compared 

Overall Population 

IVUS (N=201) 

Angio (N=201) 

BMS 


Angio (N=47) 

DES 


Angio (N=145) 

• Primary Endpoints : Mortality 

• Secondary Endpoints : MI, TVR, Composite of events 


Three-year Clinical Outcomes 

Overall population (N=8371), AMC registry 2009 

20.0 


Angio (N=3744) 

Event Rate, % 

15.0 

10.0 

5.0 

P

Death 


98.6 

97.3 96.5 

97.0 

95.3 

93.8 

Log-Rank test, p

Hazard Ratios of Clinical Outcomes 

IVUS guidance vs. Angiography guidance 


Multivariate Adjusted Adjusted for Propensity 

HR (95% CI) p HR (95% CI) p 

Death 0.49 (0.34-0.71)

DES Population 

N = 4581 Patients 


Death 


99.2 

97.8 97.4 

97.6 

95.9 

94.9 

Log-Rank test, p

Death 


IVUS guidance PCI 

Angiography guidance PCI 

p

Event Rate, % 

Three-year Clinical Outcomes in DES 

Propensity-Matched Patients 

40.0 

30.0 

20.0 

10.0 

p=0.048 

4.7 

16.0 


Angio (N=145) 

13.6 

26.8 

p=0.084 

7.1 

9.6 

18.6 

32.9 

p=0.074 

0 

p=0.618 

Death Death/MI TVR Death/MI/TVR 


Hazard Ratios of Clinical Outcomes 

IVUS guidance vs. Angiography guidance 


Multivariate Adjusted 

Adjusted for Propensity 

HR (95% CI) p HR (95% CI) p 

Death 0.52 (0.37-0.73)

IVUS Guided Procedures 

• IVUS evaluation in LM, LAD and LCX is mandatory. 

• Single-stent should be primarily attempted in nondiseased 

LCX. 

• However, two-stent should be considered in 

diseased LCX. 

• Stenting should be optimized by IVUS-guidance. 


IVUS Guided Procedures 

• IVUS evaluation in LM, LAD and LCX is mandatory. 

• Single-stent should be primarily attempted in nondiseased 

LCX. 

• However, two-stent should be considered in 

diseased LCX. 

• Stenting should be optimized by IVUS-guidance. 

Never try without IVUS assistance. 


To educate and understand LM PCI 

Organized by CRF, NY and CVRF, Seoul 

2007 


On-going RCT for LM disease 

PRE-COMBAT 

Left Main disease (1600) 

with or without MVD 

PCI with Cypher 

(N=300) 

Randomize 600 

(1:1) 

CABG 

(N=300) 

Registry 

group 1000 

 

CABG 

PCI 

Medication 

Primary Endpoint: 1-year MACCE including death, MI, stroke and ischemic TVR 

Secondary Endpoints: 9-mo angio, 2-yr and 5-yr MACCE and TVR 

PI: Seung-Jung Park 


PRECOMBAT-2 

PREmier COMparison of Bypass surgery and AngioplasTy-2 Using Everolimus Electing 

Stent in Patients with Left Main Coronary Disease 

PRE-COMBAT 

for unprotected left main disease 

Up to 13 cardiac centers in Korea 

Randomization of 600 (1:1) 

PCI with 

Cypher 

N=300 

Current Trial 

CABG 

N=300 

PRE-COMBAT-2 

for unprotected left main disease 

Up to 13 cardiac centers in Korea 

All patients receiving Xience V 

For 1 year upto 500 

PRECOMBAT- 

Eligible Cohort 

: Pts Meeting 

Randomization 

Criteria of 

‘PRECOMBAT’ 

N ~ 300 

PRECOMBAT-Not 

Eligible Cohort 

N ~ 200 

Primary Endpoint (MACCE): 

2-year death, MI, Stroke, and ischemic driven TVR 

PI: Seung-Jung Park 


EXCEL Trial 

(Evaluation of Xience prime versus Coronary artery bypass surgery 

for effectiveness of Left main revascularization) 

Left Main disease (2,500) 

with or without MVD 

Randomize 

(1:1) 

PCI with Xience V 

(N=1,250) 

CABG 

(N=1,250) 

Primary Endpoint: 3-year composite of death, MI, or stroke 

PI: Stone GW, Serruys PW 



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IVUS-Guided LM Stenting

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