1. TRI : An Emerging Mini-invasive PCI New Model from Treating LM Bifurcation Lesion
Yuejin Yang MD, PhD, FACC
Cardiovascular Institute and Fu-Wai
Hopital, CAMS & PUMC
2011 Dun Huang International CV Forum,
Lan Zhou, 2011/07/22

2. Cardiovascular Institute and Fu-Wai
TRI : An Emerging Mini-invasive PCI New Model from Treating LM Bifurcation Lesion
Yuejin Yang MD, PhD, FACC
Cardiovascular Institute and Fu-Wai
Hopital, CAMS & PUMC
The 5th QianJiang International CV Congress in Conjunction with ZheJiang Annual CV Meeting

3. Honorable Guest Lecture at C3 2011 Cardiovascular Institute and Fu-Wai
TRI : An Emerging Mini-invasive PCI New Model from Treating Bifurcated LM Lesion----- Fu Wai Experience
Yuejin Yang MD, PhD, FACC
Cardiovascular Institute and Fu-Wai
Hopital, CAMS & PUMC
The 7th Annual Complex CV Catheter Therapeutics (C3), June 27, 2011, Orlando, Florida, USA

4. TRI : Strategy and Tactics in Treating Bifurcated LM Lesion
From Asia to the World at C3 2011
TRI : Strategy and Tactics in Treating Bifurcated LM Lesion
Yuejin Yang MD, PhD, FACC
Cardiovascular Institute and Fu-Wai
Hopital, CAMS & PUMC
The 7th Annual Complex CV Catheter Therapeutics (C3), June 27, 2011, Orlando, Florida, USA

5. Contents Why TRI ? TRI for complex lesions (feasible) ?
TRI for LM bifurcation (feasible) ?
Evolution of LM PCI
Strategic determinations
Technical considerations
Fu-Wai Experience and data
Warning for LM PCI
Conclusions

6. The Shortcomings of TFI
Forceful lying on bed：
undurable for patients
high risk of death for induced DVT+PE！
Complications at puncture site：
bleeding and hemotoma
also high risk of death due to
post peritoneal bleeding！
Occlude device：
cost more

7. The Advantages of TRI Free mobile post procedure ：
unpainful and acceptable for patients
no risk of death induced by DVT+PE！
Less puncture site complications
no big hamotoma and
less risk of hemorhegic death！
Much less care work needed
Save human resources
No occlude device and short hos. stay:
cost less

8. The Differences Between TRI vs TFI
Access site: radial vs femoral A
Artery size : smaller vs bigger
Guiding size: 6Fr and under vs
6Fr and beyond
Major differences before guiding engagement,
Almost the same after guiding in place

9. Feasible Technically The majority of TFI is routinely performed
with 6Fr guiding.
The size of radial artery in the majority of Chinese adults also fits with 6Fr guiding.
TRI is actually as same as TFI with 6Fr guiding.
Routine TRI is as possible as TFI in daily
practice with 6Fr guiding.

10. Numbers of PCI @ Fu Wai Each Year
80.22% in 2007

11. Numbers and Rates of TRI at Fu-Wai Hosptal in 2008
TRI account for 84％(4326/5148)
3283
3884
4778
5148
4326
3840
2823
2034
1000
2000
3000
4000
5000
6000
2005
2006
2007
2008
PCI
TRI

12. 2010 PCI at FuWai CV Hosptal PCI number: 8050 cases
Mortality rate: Only 0.05% ( 10 times lower than the 0.5% upper limit determined by the Public Health Ministry of China)
TRI：89.8%（90%）
In March: >1000 cases performed
Q1+Q2: 5300 cases performed
2011: expected to reach cases!

13. Key Skills for Successful TRI
Accurate radial A puncturing for successful cannulation
Gentle catheter forwarding and manipulating to avoid initiating radial A spasm
Unique guiding catheter manipulating for coronary ostium engaging.
Special guiding catheter choosing to get enough backup support

14. Selection in TRI Principles For Guiding Catheter
RCA :6F-JR4(80%). Amplatz L1 or XB-RCA (20%)
LAD :6F-JFL. EBU-3.5、XB-3.5、Amplatz L1 (>80%) and JL3.5 (20%)
LCX and CTO, long diffuse ,bifurcation, tortuous and angutating lesions (100%) :6F -JFL. EBU-3.5 、XB-3.5、Amplatz L1
Kissing and crushing technique :6F-Luncher (larger lumen, ID0.071”)guiding catheter

15. The Dominances in TRI Techniques
Not only simple lesions
But also complex lesions & cases

16. New Techniques Currently Used for Complex Lesions
For CTO: final stronghold
antigrade approach
retrograde approach
For LM: high risk
one-stent techniques
two-stent
For bifurcation: complicated
One stent technique
Two stent technique
DK crush
Cullotte
SKS
Provisional T
TAP

17. New Techniques for Complex Lesions in TRI Practice
For CTO:
anti-grade approach
retro-grade approach？
For LM:
one-stent technique
two-stent techniques
For bifurcation:
step DK crush
step DK inverse crush
step cullotte
step kissing stent
Provisional T
TAP

18. PCI for LM Bifurcation
High risk
Complicated

19. Evolution of LM PCI PTCA：No, because of deadly acute closure ！
BMS: OK, no acute closure, acute/ subacute stent thrombosis also resolved, but high rate of restenosis.
DES: Yes, due to remarkable reduction in restenosis rate.

20. Dominances of LM PCI in DES Era
Remarkable reduction in restenosis
rate (about 5-10%)
Remarkable reduction in revascularization
rate (< 10%)
Much improved in stenting techniques
one-stent
two-stent
IVUS check
Dual antiplatelet therapy regimen

21. Clinical Evidence: Support of LM PCI
Clinical trial
indicative of safty and efficacy
DES vs BMS
DES vs CABG
Randomized clinical tial
PES （Taxus） : SYNTAX
SES（ Sirolimus） : COMBAT
Guidelines: IIb indication

23. SYNTAX Trial Design + TAXUS n=903 PCI n=198 CABG n=1077 n=897 N=198
62 EU Sites +
23 US Sites
TAXUS
n=903
PCI
n=198
CABG
n=1077
n=897
no f/u
n=428
5yr f/u
n=649
all captured w/
follow up
2500
750 w/ f/u vs
Total enrollment N=3075
Stratification: LM and Diabetes
Two Registry Arms
Randomized Arms
n=1800
N=1275
N=1800
Heart Team (surgeon & interventionalist)
N=198
N=1077
Amenable for only one treatment approach
TAXUS*
N=903
N=897
Amenable for both
treatment options LM
33.7%
3VD
66.3%
34.6%
65.4%
71% enrolled (N=3,075)
All Pts with de novo 3VD and/or LM disease (N=4,337)
Treatment preference (9.4%)
Referring MD or pts. refused informed consent (7.0%)
Inclusion/exclusion (4.7%)
Withdrew before consent (4.3%)
Other (1.8%)
Medical treatment (1.2%)
该研究所有入选患者的临床评估由包括心脏介入学者和心外科专家在内的多学科综合小组完成。对于专家们认为两种血运重建方式均适合的患者，按照1:1的方式分别使用紫杉醇洗脱支架(TAXUS)及CABG处理病变。研究共纳入了62 个欧洲地区和23个美国地区的1800例患者。 DM
28.5%
Non DM
71.5%
NonDM
71.8%
28.2% 23

24. Adverse Events to 12 Months
All Death
CVA (Stroke)
Myocardial Infarction
Revascularization
PCI组较CABG组有更高的再次血运重建率（13.7% vs. 5.9%），CABG组的卒中率显著增高（2.2% vs. 0.6%）；
P-value and n’s from Exhibit 1; event rates from exhibit 28 (subtract from 100%)
SYNTAX 3VD Only(Site BL) Subset 02OCT08.doc
CABG (N=897)
TAXUS* (N=903)
Event Rate ± 1.5 SE, *Fisher exact test
ITT population 24

25. Symptomatic Graft Occlusion & Stent Thrombosis to 12 Months
TAXUS (N=903)
CABG (N=897)
P=0.89
Patients (%)
Exhibit 2 SYNTAX_CSR_Randomized_Unblinded_2008Aug07.doc
\\natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\RCT data
3.4
3.3
n=27
n=28
CABG
TAXUS
ITT population 25

26. Death/CVA/MI to 12 Months
TAXUS (N=903)
CABG (N=897) 6 12 10 20
Months Since Allocation
Cumulative Event Rate (%)
P=0.98*
7.7%
SYNTAX ESC2008 Rand Proc Characteristics Supplement 18AUG08.rtf
\\natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\RCT data
7.6%
Event rate ± 1.5 SE. *Fisher exact test
ITT population 26

27. MACCE† to 12 Months TAXUS (N=903) CABG (N=897) 6 12 10 206 12 10 20
Months Since Allocation
Cumulative Event Rate (%)
P=0.002*
17.8%
12.1%
exhibit 2, 32
SYNTAX_CSR_Randomized_Unblinded_2008Aug07.doc
\\natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\RCT data
Event rate ± 1.5 SE. *Fisher exact test
†MACCE: Death, CVA, MI and Repeat Revascularization; ITT population 27

28. Number & location of lesions
Patient Profiling
Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to:
Patient’s operative risk (EuroSCORE & Parsonnet score)
Coronary lesion complexity (newly developed SYNTAX score)
Goal: SYNTAX score to provide guidance on optimal revascularization strategies for patients with high-risk lesions
Number & location of lesions
Dominance
SYNTAX
score
Left Main
Calcification
3 Vessel
Thrombus
Total Occlusion
Bifurcation
Tortuosity
EuroInterv 2005;1:
BARI classification of coronary segments
Leaman score, Circ 1981;63:
Lesions classification ACC/AHA , Circ 2001;103:
Bifurcation classification, CCI 2000;49:
CTO classification, J Am Coll Cardiol 1997;30:
Sianos et al, EuroIntervention 2005;1:
Valgimigli et al, Am J Cardiol 2007;99:
Serruys et al, EuroIntervention 2007;3: 28

29. MACCE to 12 months vs SYNTAX Score: Low scores (0-22)
TAXUS (N=299)
CABG (N=274) 6 12 20 30
Months Since Allocation
Cumulative Event Rate (%) 10
P=0.71*
14.4%
13.5%
Exhibit 1 for n’s and p-value and Exhibit 22 for event rates
SYNTAX Registry SX 0-22(Corelab) Subset 23SEP08doc.doc
Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only
RCT ITT pts; site-reported data 29 29

30. MACCE to 12 months vs SYNTAX Score: Intermediate scores (23-32)
TAXUS (N=310)
CABG (N=300) 6 12 20 30
Months Since Allocation
Cumulative Event Rate (%) 10
P=0.10*
16.6%
11.7%
Exhibit 1 for n’s and p-value and Exhibit 22 for event rates
SYNTAX Registry SX 23-32(Corelab) Subset 23SEP08doc.doc
Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only
RCT ITT pts; site-reported data 30 30

31. MACCE to 12 months vs SYNTAX Score: High scores (≥33)
TAXUS (N=290)
CABG (N=316) 6 12 20 30
Months Since Allocation
Cumulative Event Rate (%) 10
P<0.001*
23.3%
10.7%
Exhibit 1 for n’s and p-value and Exhibit 22 for event rates
SYNTAX Registry SX 33+(Corelab) Subset 23SEP08doc.doc
Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only
RCT ITT pts; site-reported data 31 31

32. LM PCI Strategic Determinations
PCI vs CABG selection
PCI itself strategies
One-stent
Two-stent
Crush or step crush
Cullotte
T or provisional T
Kissing or step kissing
Principal: safety first !!!

33. PCI vs CABG selection Both technical mature and safety considered
Both technical mature and both safe:
CABG of choice, PCI second choice
PCI mature and safe : PCI
CABG mature and safe : CABG
PCI mature but high risk : No PCI
CABG mature but high risk : No CABG
Both technical premature : Neither CABG
nor PCI
Both high risk : neither CABG nor PCI

34. LM PCI Itself Strategy Procedural unrisk----safety first !!!
Procedural strategies---- feasibility
Acute outcome----in-hosp death & ST
Long-term outcome----MACE
Low risk (pure LM disease ) : PCI
High risk (LM+TVD) : No PCI
CABG recommended
Cardiac surgeon consulted

36. LM PCI: Technical Considerations
Experienced operators
Pre-determined strategy
Cardiac surgery stand-by and support
Emergency measures during procedure
: device and drug
Pre-IABP (not stand-by): routine use for high risk patients
Routine IVUS check after procedure
Post-procedural monitoring (CCU)

37. LM PCI：Key Determinant Factors
Operators’ experience
Risk evaluation and comparison (PCI vs CABG)
LM function
LM lesion location and anatomy
Simple or complex LM with TVD
Durable dual antiplatelet therapy for at least one year
IVUS available
CCU available
Clinical and CAG follow-up

38. Shi JF F yrs
病案号：
CABG for 3 months
LIMA 100%,
SVG-LCX 100%
LM bifurcation: 90%
LM step crush technique used
IVUS checked
Follow-up CAA(io-1-20)
SVG-RCA: patent

39. Baseline CAA+PCI(crush)(09-8-24)

44. Follow-up CAA( )

45. LM Step Crush Technique
Yang Peng M 79 Yrs
No :709952,
LM bifurcation both 90%
LAD: CTO
LCX: 90%
RCA: unremarkable
CABG indicated and suggested but declined by surgeon due to chronic lymphatic leukemia
IABP used
TRI+Step crush done
IAPB rupture while withrawal and withdrawaled successfully

46. Baseline CAA+ Step Crush

47. LAD Predilatation+Stenting

48. LM Step Crush Procedure

49. LM Step Crush & Final Results

50. Final Results & IABP Rupture Withdrawal

51. LM Body+Bfurcation: Reverse Crush
李金平 M 82 Yrs
Unique No：714400
LM body+bifurcation lesion:90%
LAD: 80-90%
CABG recommended but refused by Pts
IABP
TRI + reverse crush procedure
Optimal results

52. IABP+Baseline CAA+ Ballooning

53. Reverse Crush Procedure

54. LAD Stenting

55. Final Results

56. Step Kissing for LM Bifurcation Lasion with Big LM Stem
苏润平 M yrs

60. IVUS RAMUS-LM

61. IVUS LAD-LM

62. 刘忠 M yrs
647737
STEMI×3weeks
Primary PCI failure
TRI（ ）
IABP support
LM bifurcation with step kissing
due to very big LM stem
IVUS check
Follow up CAA ( )

63. LM OK, LAD ostium 90% LCX ostium 90%
Baseline CAA
LM OK, LAD ostium 90% LCX ostium 90%
RCA Normal

64. Pro-dilatation & step kissing
two wires pretection, Pro-dilatation of LAD（16atm）
Pro-LCX Pro-dilatation LCX: liberte 3.5×16mm（16atm）LAD: 30mm balloon
LAD ballooning first proximal kissing

65. Pro-dilatation & step kissing
LAD stenting（liberte 3.5×20mm, 16atm） LCX balloon（quantum 3.5×15mm）
Kissing proximal stents rekissing post kiss stents

66. LAD post dilatation（quantum 4.5×15mm） LCX （quantum 4.0×15mm）
big balloon kissing
LAD post dilatation（quantum 4.5×15mm） LCX （quantum 4.0×15mm）
LCX pos dilatation（20atm） final kissing（20atm）proximal stent kissing（20atm）

67. Final results

68. Distal LCX, LCX stent, Ostum LCX LM with in stent, LM out of stent

69. LAD distal LAD, distal stent, proximal stent, Ostum LAD stent
LM with in stent, LM out of stent

70. LM Bifurcation Step Kissing: 1 yrs Follow-up CAA（09-2-12）

71. Very High Rsik Case Mr. Wang Wei M 46y File NO. 756170, 2011-4-20
NSTE-ACS 2MS ago
CAA 3wks ago showed
LM-Bifurcation 90%
LAD Ostium 90%
LCX Ostium 90-95%
LVDF LVEF 45%
CABG was suggested but refused by Cardiac Surgeon because of both LAD & LCX diffuse disease without landing zone
PCI with IABP Support
TRI: Reverse Crush
Successful

72. Baseline CAA Guiding: 6Fr AL2; Wires: pilot 50×2 LM Bifurcation 90%
LAD & LCX diffuse disease without langding zone for CABG

73. Very Challenging in Wiring

74. Ballooning(2.5×20mm)
Still tight lesion at ostium of LCX

75. Stenting (1)
Liberty 3.5×12mm in LAD, with 2.5mm balloon crushing

76. Stenting(2)
Liberty 4.5×16mm in LM-LCX Post stenting deployment

77. Rewiring & Ballooning
Rewiring Reballooning with 1.25mm balloon

78. Sequencial HP Post-dilatation

79. Final Kisssing

80. LM Stem Injury ?

81. LM Stem Stenting
Liberty 5.0 by 12 mm
Stent deployment

82. Post Stenting IVUS Check

83. Another Round of Final Kissing

84. Another IVUS Exam

85. Final Results

86. Final Results

87. Safety and Efficacy ?
What’s the data?

95. Always High Risk & Complicated！
Warnings : LM PCI
Always High Risk & Complicated！

96. LM PCI: Conclusions Safety first !!! Experienced operator: necessary
Risk and feasibility evaluation:
very important vs CABG
Pre-determined strategy: needed
Pre-IABP: routine used for high risk Pts.
Avoidance of LM injury: key for the safety
Contrast media injection: gentle, shorter
(<2cycles) and small amount(<2cc)
IVUS check: key for the complete apposition

97. TRI for LM: Conclusions
Both strong TRI & LM PCI experience
Strategic and technical considerations
as TFI (safety first !)
Safety not only during hospital stay
But Good long-term outcomes also
CAG and clinical follow-up needed
Non-inferiority to TFI in both efficacy
and safety

98. Conclusion(3)
TRI: An new mini-invasive PCI model is emerging in stead of a simple approach !
In both simple and complex lesios
In both low and high risk patients
In daily practice with routine precedures
Available academic data convincing

99. Thank You for Your Attention !

100. Welcome Chaired by Yue-Jin Yang MD. PhD. FACC Co-Chaired by Dr. Saito
Attend China Heart Conference (IHF2011)：
3rd international TR Coronary Therapeutics (TRCT)
Chaired by
Yue-Jin Yang MD. PhD. FACC
Co-Chaired by
Dr. Saito
Dr. kiemeneiji
NCC, 2011/08/12-15, Beijing, China