TRI : An Emerging Mini-invasive PCI New Model from Treating LM Bifurcation LesionYuejin Yang MD, PhD, FACCCardiovascular Institute and Fu-Wai Hopital, CAMS & PUMC2011 Dun Huang International CV Forum, Lan Zhou, 2011/07/22

TRI : An Emerging Mini-invasive PCI New Model from Treating LM Bifurcation LesionYuejin Yang MD, PhD, FACCCardiovascular Institute and Fu-Wai Hopital, CAMS & PUMCThe 5th QianJiang International CV Congress in Conjunction with ZheJiang Annual CV Meeting

TRI : An Emerging Mini-invasive PCI New Model from Treating Bifurcated LM Lesion----- Fu Wai ExperienceYuejin Yang MD, PhD, FACCCardiovascular Institute and Fu-Wai Hopital, CAMS & PUMC

The 7th Annual Complex CV Catheter Therapeutics (C3), June 27, 2011, Orlando, Florida, USA

Honorable Guest Lecture at C3 2011

TRI : Strategy and Tactics in Treating Bifurcated LM LesionYuejin Yang MD, PhD, FACCCardiovascular Institute and Fu-Wai Hopital, CAMS & PUMC

The 7th Annual Complex CV Catheter Therapeutics (C3), June 27, 2011, Orlando, Florida, USA

From Asia to the World at C3 2011

Contents Why TRI ?TRI for complex lesions (feasible) ?TRI for LM bifurcation (feasible) ?Evolution of LM PCIStrategic determinationsTechnical considerationsFu-Wai Experience and data Warning for LM PCIConclusions

The Shortcomings of TFIForceful lying on bedundurable for patientshigh risk of death for induced DVT+PEComplications at puncture sitebleeding and hemotomaalso high risk of death due to post peritoneal bleedingOcclude devicecost more

The Advantages of TRIFree mobile post procedure unpainful and acceptable for patientsno risk of death induced by DVT+PELess puncture site complicationsno big hamotoma and less risk of hemorhegic deathMuch less care work neededSave human resourcesNo occlude device and short hos. stay:cost less

The Differences Between TRI vs TFIAccess site: radial vs femoral AArtery size : smaller vs biggerGuiding size: 6Fr and under vs 6Fr and beyond Major differences before guiding engagement, Almost the same after guiding in place

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.

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

Numbers and Rates of TRI at Fu-Wai Hosptal in 2008TRI account for 84(4326/5148)

2010 PCI at FuWai CV HosptalPCI number: 8050 casesMortality rate: Only 0.05% ( 10 times lower than the 0.5% upper limit determined by the Public Health Ministry of China)TRI89.8%90%In March: >1000 cases performed Q1+Q2: 5300 cases performed2011: expected to reach 10000 cases!

Key Skills for Successful TRIAccurate radial A puncturing for successful cannulationGentle catheter forwarding and manipulating to avoid initiating radial A spasmUnique guiding catheter manipulating for coronary ostium engaging.Special guiding catheter choosing to get enough backup support

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

The Dominances in TRI TechniquesNot only simple lesionsBut also complex lesions & cases

New Techniques Currently Used for Complex LesionsFor CTO: final stronghold antigrade approach retrograde approachFor LM: high risk one-stent techniques two-stentFor bifurcation: complicated One stent techniqueTwo stent techniqueDK crushCullotte SKSProvisional TTAP

New Techniques for Complex Lesions in TRI PracticeFor CTO: anti-grade approachretro-grade approachFor LM:one-stent techniquetwo-stent techniquesFor bifurcation:one-stent techniquetwo-stent techniquesstep DK crushstep DK inverse crushstep cullottestep kissing stentProvisional TTAP

PCI for LM Bifurcation High riskComplicated

Evolution of LM PCIPTCANo, 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.

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

Clinical Evidence: Support of LM PCIClinical trial indicative of safty and efficacy DES vs BMS DES vs CABGRandomized clinical tial DES vs CABG PES Taxus : SYNTAX SES Sirolimus : COMBATGuidelines: IIb indication

+SYNTAX Trial Design

Adverse Events to 12 Months ITT populationEvent Rate 1.5 SE, *Fisher exact testAll DeathRevascularizationCVA (Stroke)Myocardial InfarctionTAXUS* (N=903)CABG (N=897)

Event Rate 1.5 SE. *Fishers Exact Test

ITT population

P=0.37*

All-Cause Death to 12 Months

4.3%

3.5%

*

Exhibit 33

CVA to 12 Months

0.6%

2.2%

ITT population

P=0.003*

Event Rate 1.5 SE. *Fishers Exact Test

*

Exhibit 36

Myocardial Infarction to 12 Months

3.2%

4.8%

ITT population

P=0.11*

Event Rate 1.5 SE. *Fishers Exact Test

*

Exhibit 37

Repeat Revascularization to 12 Months

5.9%

13.7%

ITT population

P

Symptomatic Graft Occlusion & Stent Thrombosis to 12 Months3.33.4CABGTAXUSP=0.89Patients (%)n=27n=28ITT population

Death/CVA/MI to 12 MonthsP=0.98*ITT population7.7% 7.6% Event rate 1.5 SE. *Fisher exact test

MACCE to 12 MonthsP=0.002*MACCE: Death, CVA, MI and Repeat Revascularization; ITT population12.1% 17.8% Event rate 1.5 SE. *Fisher exact test

Patient Profiling Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to:Patients 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 lesionsSianos et al, EuroIntervention 2005;1:219-227Valgimigli et al, Am J Cardiol 2007;99:1072-1081Serruys et al, EuroIntervention 2007;3:450-459BARI classification of coronary segmentsLeaman score, Circ 1981;63:285-299Lesions classification ACC/AHA , Circ 2001;103:3019-3041Bifurcation classification, CCI 2000;49:274-283CTO classification, J Am Coll Cardiol 1997;30:649-656TortuosityThrombusBifurcationTotal Occlusion3 VesselLeft MainEuroInterv 2005;1:219-227DominanceCalcificationNumber & location of lesions

13.5%14.4%P=0.71*MACCE to 12 months vs SYNTAX Score: Low scores (0-22)Event Rate 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes onlyRCT ITT pts; site-reported data

MACCE to 12 months vs SYNTAX Score: Intermediate scores (23-32)16.6%11.7%P=0.10*RCT ITT pts; site-reported dataEvent Rate 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

MACCE to 12 months vs SYNTAX Score: High scores (33)23.3%10.7%P

LM PCI Strategic DeterminationsPCI vs CABG selectionPCI itself strategiesOne-stentTwo-stentCrush or step crushCullotteT or provisional TKissing or step kissingPrincipal: safety first !!!

PCI vs CABG selectionBoth technical mature and safety considered Both technical mature and both safe:CABG of choice, PCI second choicePCI mature and safe : PCICABG mature and safe : CABGPCI mature but high risk : No PCICABG mature but high risk : No CABGBoth technical premature : Neither CABG nor PCIBoth high risk : neither CABG nor PCI

LM PCI Itself StrategyProcedural unrisk----safety first !!!Procedural strategies---- feasibilityAcute outcome----in-hosp death & STLong-term outcome----MACELow risk (pure LM disease ) : PCIHigh risk (LM+TVD) : No PCICABG recommended Cardiac surgeon consulted

LM PCI: Technical ConsiderationsExperienced operators Pre-determined strategy Cardiac surgery stand-by and supportEmergency measures during procedure : device and drug Pre-IABP (not stand-by): routine use for high risk patientsRoutine IVUS check after procedurePost-procedural monitoring (CCU)

LM PCIKey Determinant FactorsOperators experience Risk evaluation and comparison (PCI vs CABG)LM functionLM lesion location and anatomy Simple or complex LM with TVDDurable dual antiplatelet therapy for at least one year IVUS availableCCU availableClinical and CAG follow-up

Shi JF F 64yrs692169 09-8-24CABG for 3 months LIMA 100%, SVG-LCX 100%LM bifurcation: 90%LM step crush technique usedIVUS checkedFollow-up CAA(io-1-20)SVG-RCA: patent

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

Follow-up CAA(2010-1-20)

LM Step Crush TechniqueYang Peng M 79 Yrs No :709952, 2010-03-01LM bifurcation both 90%LAD: CTOLCX: 90%RCA: unremarkableCABG indicated and suggested but declined by surgeon due to chronic lymphatic leukemiaIABP usedTRI+Step crush doneIAPB rupture while withrawal and withdrawaled successfully

Baseline CAA+ Step Crush

LAD Predilatation+Stenting

LM Step Crush Procedure

LM Step Crush & Final Results

Final Results & IABP Rupture Withdrawal

LM Body+Bfurcation: Reverse Crush M 82 Yrs 2010-03-03Unique No714400LM body+bifurcation lesion:90%LAD: 80-90%CABG recommended but refused by PtsIABP TRI + reverse crush procedureOptimal results

IABP+Baseline CAA+ Ballooning

Reverse Crush Procedure

LAD Stenting

Final Results

Step Kissing for LM Bifurcation Lasionwith Big LM Stem M 41yrs 678194

IVUS RAMUS-LM

IVUS LAD-LM

M 40yrs647737STEMI3weeksPrimary PCI failureTRI08-1-28IABP support LM bifurcation with step kissing due to very big LM stemIVUS check Follow up CAA (09-2-12)

Baseline CAALM OK, LAD ostium 90% LCX ostium 90%RCA Normal

Pro-dilatation & step kissingtwo wires pretection, Pro-dilatation of LAD16atmPro-LCX Pro-dilatation LCX: liberte 3.516mm16atmLAD: 30mm balloonLAD ballooning first proximal kissing

Pro-dilatation & step kissingLAD stentingliberte 3.520mm, 16atm LCX balloonquantum 3.515mmKissing proximal stents rekissing post kiss stents

big balloon kissingLAD post dilatationquantum 4.515mm LCX quantum 4.015mmLCX pos dilatation20atm final kissing20atmproximal stent kissing20atm

Final results

LCXDistal LCX, LCX stent, Ostum LCXLM with in stent, LM out of stent

LADdistal LAD, distal stent, proximal stent, Ostum LAD stentLM with in stent, LM out of stent

LM Bifurcation Step Kissing: 1 yrs Follow-up CAA09-2-12

Very High Rsik Case Mr. Wang Wei M 46yFile NO. 756170, 2011-4-20NSTE-ACS 2MS agoCAA 3wks ago showedLM-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 zonePCI with IABP SupportTRI: Reverse Crush Successful

Baseline CAAGuiding: 6Fr AL2; Wires: pilot 502LM Bifurcation 90%LAD & LCX diffuse disease without langding zone for CABG

Very Challenging in Wiring

Ballooning(2.520mm)Still tight lesion at ostium of LCX

Stenting (1)Liberty 3.512mm in LAD, with 2.5mm balloon crushing

Stenting(2)Liberty 4.516mm in LM-LCX Post stenting deployment

Rewiring & Ballooning Rewiring Reballooning with 1.25mm balloon

Sequencial HP Post-dilatation

Final Kisssing

LM Stem Injury ?

LM Stem StentingLiberty 5.0 by 12 mmStent deployment

Post Stenting IVUS Check

Another Round of Final Kissing

Another IVUS Exam

Final Results

Final Results

Safety and Efficacy ?

Whats the data?

Warnings : LM PCIAlways High Risk & Complicated

LM PCI: Conclusions Safety first !!!Experienced operator: necessary Risk and feasibility evaluation: very important vs CABG Pre-determined strategy: neededPre-IABP: routine used for high risk Pts.Avoidance of LM injury: key for the safetyContrast media injection: gentle, shorter (

TRI for LM: ConclusionsBoth strong TRI & LM PCI experienceStrategic and technical considerations as TFI (safety first !)Safety not only during hospital stay But Good long-term outcomes alsoCAG and clinical follow-up neededNon-inferiority to TFI in both efficacy and safety

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

Thank You for Your Attention !

Welcome Attend China Heart Conference (IHF2011) 3rd international TR Coronary Therapeutics (TRCT)Chaired byYue-Jin Yang MD. PhD. FACCCo-Chaired byDr. SaitoDr. kiemeneijiNCC, 2011/08/12-15, Beijing, China

*1:1(TAXUS)CABG62 231800 ***PCICABG13.7% vs. 5.9%CABG2.2% vs. 0.6% P-value and ns from Exhibit 1; event rates from exhibit 28 (subtract from 100%)SYNTAX 3VD Only(Site BL) Subset 02OCT08.doc**Exhibit 2 SYNTAX_CSR_Randomized_Unblinded_2008Aug07.doc\\natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\RCT data*SYNTAX ESC2008 Rand Proc Characteristics Supplement 18AUG08.rtf\\natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\RCT data**exhibit 2, 32SYNTAX_CSR_Randomized_Unblinded_2008Aug07.doc\\natfile06\depts\Clinical\Clinical Communications\Projects\IC\TAXUS\SYNTAX\Data Tables\RCT data*****Exhibit 1 for ns and p-value and Exhibit 22 for event ratesSYNTAX Registry SX 0-22(Corelab) Subset 23SEP08doc.doc***Exhibit 1 for ns and p-value and Exhibit 22 for event ratesSYNTAX Registry SX 23-32(Corelab) Subset 23SEP08doc.doc***Exhibit 1 for ns and p-value and Exhibit 22 for event ratesSYNTAX Registry SX 33+(Corelab) Subset 23SEP08doc.doc*