TRI : An Emerging Mini-invasive PCI New Model from for the LM Bifurcation Lesion

1. TRI : An Emerging Mini-invasive PCI New Model from for the LM Bifurcation Lesion Yuejin Yang MD, PhD, FACC Cardiovascular Institute and Fu-Wai Hopital, CAMS & PUMC • The 25th Tian Jin Cardiovascular Circulation (TJCC ) 2011-5-22, T J, China

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

3. 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

4. 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

5. 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

6. 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.

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

8. 6000 5148 4778 5000 4326 3884 3840 PCI 4000 3283 2823 3000 TRI 2034 2000 1000 0 2005 2006 2007 2008 Numbers and Rates of TRI at Fu-Wai Hosptal in 2008 TRI account for 84％(4326/5148)

9. 2011 PCI at FuWai CV Hosptal • PCI number: 8050 cases • Mortality rate: 0.05% ( 万分之五) • TRI：89.8%（90%） • 2011？Should be more! • In Mar：>1000 cases performed • Expected to reach 10000 cases in 2001 !

10. 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

11. Principles For Guiding Catheter Selection in TRI • 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

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

13. New Technology 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

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

15. PCI for LM Bifurcation • High risk • Complicated

16. 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.

17. 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

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

20. SYNTAX Trial Design 62 EU Sites 23 US Sites 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%) 71% enrolled (N=3,075) + Heart Team (surgeon & interventionalist) Total enrollment N=3075 Amenable for both treatment options Amenable for only one treatment approach Stratification: LM and Diabetes DM 28.2% NonDM 71.8% Stratification: LM and Diabetes DM 28.5% Non DM 71.5% Randomized Arms N=1800 Two Registry Arms N=1275 Randomized Arms n=1800 Two Registry Arms PCI N=198 PCI all captured w/ follow up CABG N=1077 CABG n=1077 CABG 2500 750 w/ f/u CABG n=897 TAXUS n=903 PCI n=198 TAXUS* N=903 vs CABG N=897 no f/u n=428 5yr f/u n=649 vs LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4%

21. Adverse Events to 12 Months CVA (Stroke) All Death Myocardial Infarction Revascularization TAXUS* (N=903) CABG (N=897) ITT population Event Rate ± 1.5 SE, *Fisher exact test

22. Symptomatic Graft Occlusion & Stent Thrombosis to 12 Months TAXUS(N=903) CABG(N=897) P=0.89 Patients (%) 3.4 3.3 n=27 n=28 CABG TAXUS ITT population

23. Death/CVA/MI to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.98* 7.7% 7.6% Event rate ± 1.5 SE. *Fisher exact test ITT population

24. MACCE† to 12 Months TAXUS(N=903) CABG(N=897) 20 10 Cumulative Event Rate (%) 0 0 6 12 Months Since Allocation P=0.002* 17.8% 12.1% Event rate ± 1.5 SE. *Fisher exact test †MACCE: Death, CVA, MI and Repeat Revascularization; ITT population

25. 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 SYNTAX score Number & location of lesions Dominance Left Main Calcification 3 Vessel Thrombus Total Occlusion Bifurcation Tortuosity EuroInterv 2005;1:219-227 • BARI classification of coronary segments • Leaman score, Circ 1981;63:285-299 • Lesions classification ACC/AHA , Circ 2001;103:3019-3041 • Bifurcation classification, CCI 2000;49:274-283 • CTO classification, J Am Coll Cardiol 1997;30:649-656 Sianos et al, EuroIntervention 2005;1:219-227 Valgimigli et al, Am J Cardiol 2007;99:1072-1081 Serruys et al, EuroIntervention 2007;3:450-459

26. MACCE to 12 months vs SYNTAX Score: Low scores (0-22) CABG(N=274) TAXUS(N=299) 30 20 Cumulative Event Rate (%) 10 0 0 6 12 Months Since Allocation P=0.71* 14.4% 13.5% RCT ITT pts; site-reported data Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

27. MACCE to 12 months vs SYNTAX Score: Intermediate scores (23-32) CABG(N=300) TAXUS(N=310) 30 20 Cumulative Event Rate (%) 10 0 0 6 12 Months Since Allocation P=0.10* 16.6% 11.7% RCT ITT pts; site-reported data Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

28. MACCE to 12 months vs SYNTAX Score: High scores (≥33) CABG(N=316) TAXUS(N=290) 30 20 Cumulative Event Rate (%) 10 0 0 6 12 Months Since Allocation P<0.001* 23.3% 10.7% RCT ITT pts; site-reported data Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

29. 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 !!!

30. 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

31. 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

33. 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)

34. 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

35. Shi JF F 64yrs 病案号：692169 09-8-24 • CABG for 3 months • LIMA 100%, • SVG-LCX 100% • LM bifurcation: 90% • Crush technique used • IVUS checked • Follow-up CAA(io-1-20) • SVG-RCA: patent

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

41. Follow-up CAA(2010-1-20)

42. LM Reverse Crush Yang Peng M 79 Yrs No :709952, 2010-03-01 LM bifurcation both 90% LAD: CTO LCX: 90% RCA: unremarkable CABG indicated and suggested but declined by surgeon due to 慢淋 IABP used TRI+Reverse crush done IAPB rupture while withrawal and withdrawaled successfully

43. Baseline CAA+Reverse Crush

44. LAD Predilatation+Stenting

45. LM Reverse Crush Procedure

46. LM Reverse Crush & Final Results

47. Final Results & IABP Rupture Withdrawal

48. LM Body+Bfurcation Reverse Crush 李金平 M 82 Yrs 2010-03-03 Unique No：714400 LM body+bifurcation lesion:90% LAD: 80-90% CABG recommended but refused by Pts IABP TRI + reverse crush procedure Optimal results

49. IABP+Baseline CAA+ Ballooning

50. Reverse Crush Procedure