Bifurcation and Left Main Bifurcation and Left Main StentingStenting

Jeffrey W Moses MDJeffrey W Moses MDProfessor of MedicineProfessor of Medicine

Director , CIVTDirector , CIVTColumbia University Medical CenterColumbia University Medical Center

Disclosures :Jeffrey MosesDisclosures :Jeffrey Moses

• Speaker: Cordis,AbbottSpeaker: Cordis,Abbott

• Account for 15-20% of PCIAccount for 15-20% of PCI• Why an indivdualized approach?Why an indivdualized approach?

Variations in AnatomyVariations in Anatomy• Left main bifurcation diseaseLeft main bifurcation disease• Plaque burden & location of plaquePlaque burden & location of plaque• Angle between MB and SBAngle between MB and SB

Dynamic changes in anatomy during treatmentDynamic changes in anatomy during treatment• Plaque shiftPlaque shift• DissectionDissection

No two bifurcations are identicalNo two bifurcations are identical• An appropriate strategy from the outset saves time An appropriate strategy from the outset saves time

and minimizes complicationand minimizes complication

Bifurcation PCIBifurcation PCI

Colombo et al(n=85)

Pan et al(n=91)

Steigen et al(n=413)

Ferenc et al(n=202)

Tsuchida et al(n=324)

Colombo et al(n=350)

Clinical outcomesClinical outcomes in Randomized Trials in Randomized Trials comparing 1DES vs. 2DES Strategycomparing 1DES vs. 2DES Strategy

Restenosis ratesRestenosis rates in Randomized Trials in Randomized Trials comparing 1DES vs. 2DES Strategycomparing 1DES vs. 2DES Strategy

•Colombo A, et al. Circulation 2004;109:1244-9•Pan M, et al. Am Heart J 2004;148:857-64.•Steigen TK, et al. Circulation 2006;114:1955-61.

p = NSp = NS

p = NSp = NS

p = NSp = NS

Colombo et alColombo et al Pan et alPan et al Steigen et alSteigen et al

What type of bifurcations are What type of bifurcations are commonly treated?commonly treated?

• Majority (65%) are “True” Majority (65%) are “True” bifurcations bifurcations

• Extent of SB disease may Extent of SB disease may determine strategydetermine strategy

• Non-LM Bifs treated in Non-LM Bifs treated in Milan (n=320). Extent of SB Milan (n=320). Extent of SB

disease:disease:• 00 18%18%• <5mm<5mm 27%27%• 5-10mm5-10mm 19%19%• >10mm>10mm 36%36%

How often do we need a second stent How often do we need a second stent when using the Provisional approach?when using the Provisional approach?

•Colombo A, et al. Circulation 2004;109:1244-9•Pan M, et al. Am Heart J 2004;148:857-64.

•Steigen TK, et al. Circulation 2006;114:1955-61.

>50% DS >50% DSAnd

TIMI<3

TIMI=0 after balloon dilatation

Stent Thrombosis Stent Thrombosis rates in Trials rates in Trials comparing 1 DES vs. 2 DES Strategycomparing 1 DES vs. 2 DES Strategy

•Colombo A, et al. Circulation 2004;109:1244-9•Pan M, et al. Am Heart J 2004;148:857-64.•Steigen TK, et al. Circulation 2006;114:1955-61.•Tsuchida K, et al. Eur Heart J 2007.

• Which stent to implant?Which stent to implant? BMS vs. DESBMS vs. DES

• How to approach a bifurcation?How to approach a bifurcation? How many wires?How many wires? Predilate SB or not?Predilate SB or not? How many stentsHow many stents

Questions most operators askQuestions most operators ask

• The provisional approach of implanting one The provisional approach of implanting one stent technique on the MB should be the stent technique on the MB should be the default approach in most bifurcations lesionsdefault approach in most bifurcations lesions

• The approach is dictated by the SB:The approach is dictated by the SB: True vs. Non-trueTrue vs. Non-true Size of SBSize of SB Extent and distribution of disease in SBExtent and distribution of disease in SB How important the side branch is for that patient How important the side branch is for that patient

and for that specific anatomyand for that specific anatomy

The approach to Bifurcation PCIThe approach to Bifurcation PCI

True Bifurcation (significant stenosis on the main and side branches)

No Yes

Stent on MB “Keep It Open” for SB

Is SB suitable for stenting?

SB disease is diffuse &/or not localized to within 3 mm from the ostium?

Provisional SB stenting

Elective implantation of two stents (MB and SB)

Provisional SB stenting

Yes

Yes

No

No

• Keep it OpenKeep it Open

• ProvisionalProvisional

• Two stentsTwo stents

Our proposed strategy to Our proposed strategy to Bifurcation PCI Bifurcation PCI

• Protects SB from closure due to plaque shift and/or Protects SB from closure due to plaque shift and/or stent struts during MB stenting stent struts during MB stenting

• Jailed SB wire facilitates re-wiring of the SB:Jailed SB wire facilitates re-wiring of the SB: widening the angle between the MB and SBwidening the angle between the MB and SB by acting as a marker for the SB ostium if SB by acting as a marker for the SB ostium if SB

occludesoccludes changing the angle of SB take-offchanging the angle of SB take-off

• In the Tulipe multicenter study, absence of this In the Tulipe multicenter study, absence of this jailed jailed wire was associated with a higher rate of re-wire was associated with a higher rate of re-interventions (OR:4.26; 1.27–14.35) during follow-upinterventions (OR:4.26; 1.27–14.35) during follow-up

• CAUTION WHEN REMOVING JAILED WIRES!CAUTION WHEN REMOVING JAILED WIRES!

Why wire both branches?Why wire both branches?

•cclusion of SB’s >1mm associated with cclusion of SB’s >1mm associated with 14% incidence of Myocardial Infarction14% incidence of Myocardial Infarction

• Arora RR et al. Cathet Cardiovasc Diagn 1989;18:210-2.Arora RR et al. Cathet Cardiovasc Diagn 1989;18:210-2.

•B closure associated with large B closure associated with large periprocedural MIperiprocedural MI

• Chaudhry EC et al. J Thromb Thrombolysis 2007.Chaudhry EC et al. J Thromb Thrombolysis 2007.

Why Protect SB’s from Closure?Why Protect SB’s from Closure?

Optimal performance of 2 stent techniques Optimal performance of 2 stent techniques important in reducing event ratesimportant in reducing event rates

Impact of learning curve in Technique; TCT 2006

• High pressure side branch inflationHigh pressure side branch inflation• 2-step Kiss: Pre-FKI side branch 2-step Kiss: Pre-FKI side branch

dilatationdilatation• Use of low-compliant balloonsUse of low-compliant balloons• Less protrusion of SB stent into MB Less protrusion of SB stent into MB

(mini-crush)(mini-crush)• IVUS-guided stenting (INSIDE Trial)IVUS-guided stenting (INSIDE Trial)

Technical factors that may be important in Technical factors that may be important in reducing restenosis & TLR when 2 stents reducing restenosis & TLR when 2 stents

implanted in bifurcationsimplanted in bifurcations

When the SB has ostial or diffuse disease AND When the SB has ostial or diffuse disease AND when the SB when the SB is not suitableis not suitable (too small) for (too small) for stenting or clinically not relevant stenting or clinically not relevant

• 6 Fr guiding catheter6 Fr guiding catheter1.1. Wire both branchesWire both branches

2.2. Dilate MB if neededDilate MB if needed

3.3. Stent MB and leave wire in the SBStent MB and leave wire in the SB

4.4. Post-dilatation of MB with jailed wire in SBPost-dilatation of MB with jailed wire in SB

Keep It Open (KIO)Keep It Open (KIO)

Do not re-wire SB or postdilate or predilate SBDo not re-wire SB or postdilate or predilate SB

When SB has minimal disease or only at the When SB has minimal disease or only at the ostium AND when ostium AND when SB is suitable for stentingSB is suitable for stenting

• 6 Fr guiding catheter (7F if using Xience-Promus)6 Fr guiding catheter (7F if using Xience-Promus)1.1. Wire both branchesWire both branches

2.2. Dilate MB and SB if neededDilate MB and SB if needed

3.3. Stent MB leaving a wire in the SBStent MB leaving a wire in the SB

4.4. Re-wire SB and then remove jailed wireRe-wire SB and then remove jailed wire

5.5. Kissing balloon inflationKissing balloon inflation

6.6. Stent SB Stent SB onlyonly if suboptimal result (TAP, reverse crush, if suboptimal result (TAP, reverse crush, culotte)culotte)

ProvisionalProvisional

About the Side Branch: Wires for RecrossingAbout the Side Branch: Wires for Recrossingand Kissing Balloon Dilatationand Kissing Balloon Dilatation

• Dilate the main vessel stent at high Dilate the main vessel stent at high pressurepressure

• The original Universal Balance wireThe original Universal Balance wire• Prowater/ Rinato (Asahi Intech wire)Prowater/ Rinato (Asahi Intech wire)• Intermediate wireIntermediate wire• Pilot 50 or 150 wirePilot 50 or 150 wire• Always perform high pressure inflation Always perform high pressure inflation

in the side branch before doing kissingin the side branch before doing kissing

When SB has disease extending beyond its When SB has disease extending beyond its ostium AND when SB is suitable for stentingostium AND when SB is suitable for stenting

• 8 Fr guiding catheter8 Fr guiding catheter1.1. Wire both branchesWire both branches

2.2. Dilate MB and SB if neededDilate MB and SB if needed

3.3. Perform crush, culotte or V-stentPerform crush, culotte or V-stent

4.4. If crush: rewire SB and perform high pressure SB If crush: rewire SB and perform high pressure SB dilatation (2-step kiss)dilatation (2-step kiss)

5.5. Final kissing balloon inflation Final kissing balloon inflation always!always!

Two StentsTwo Stents

0%

20%

40%

60%

80%

100%

One-step kissing post-

dilatation No kissing

Two-step kissing post-

dilatation

We observed that two-step kissing was more effective than one-step kissing for improving metallic side-branch ostial area

Ormiston

58 crush deployments

SB ostial stenosis (%) with one step vs. two step kissing

Two steps:1) Inflate at high pressure only the SB balloon1) Perform kissing inflation

p = <0.0001p = <0.0001

One-step Two-step

33%(CI 28,37)

53%(CI 46, 59)

Side

-bra

nch

Ost

ial S

teno

sis

Stent thrombosisStent thrombosisTotalTotal Acute Acute

(first day)(first day)SubacuteSubacute

(days 2-30)(days 2-30)LateLate

(days 31-180)(days 31-180)

CrushCrush(n=177)(n=177)

3 (1.7%)3 (1.7%) 1 (0.5%)1 (0.5%) 22** (1.1%) (1.1%) 00

Prov.TProv.T(n=173)(n=173)

2 (1.1%)2 (1.1%) 00 1 (0.5%)1 (0.5%) 1 (0.5%)1 (0.5%)(definitive)(definitive)

p = 0.62 for comparisons between crush and prov.-T* One patient did not take thienopyridine therapy after discharge

CACTUS TrialCACTUS TrialCCoronary Bifurcation oronary Bifurcation AApplication of the pplication of the

CCrush rush TTechnique echnique UUsing sing SSirolimus-Eluting irolimus-Eluting stentsstents

YES Final YES Final Kissing Kissing

163 pts.163 pts.

NO Final NO Final KissingKissing

14 pts. 14 pts.

PP

Myocardial infarctionMyocardial infarction 7.5%7.5% 29%29% 0.0010.001

TLRTLR 6.3%6.3% 12.9%12.9% 0.250.25

MB restenosisMB restenosis 4.7%4.7% 16%16% 0.030.03

SB restenosisSB restenosis 11.9%11.9% 36%36% 0.0010.001

Stent thrombosisStent thrombosis 0.9%0.9% 6.5%6.5% 0.060.06

Influence of Final Kissing in the CACTUS Influence of Final Kissing in the CACTUS TrialTrial

An approach for bifurcational lesions when An approach for bifurcational lesions when using 2 stents as intention to treatusing 2 stents as intention to treat

Bifurcational lesion with no Bifurcational lesion with no disease proximal to the disease proximal to the bifurcation or very short bifurcation or very short

left mainleft main

Bifurcational lesion with Bifurcational lesion with main branch disease main branch disease

extending proximal to the extending proximal to the bifurcation and side branch bifurcation and side branch which has origin with about which has origin with about

90° angle90° angle

Bifurcational lesion with Bifurcational lesion with main branch disease main branch disease

extending proximal to the extending proximal to the bifurcation and side branch bifurcation and side branch which ha origin with about which ha origin with about

60° angle60° angleV-StentV-Stent T-StentT-Stent Short-Mini Short-Mini

Crush/colotteCrush/colotte

Cross Section

Pre Post

Pre Post

Pre Post

Nordic II: Rate of Restenosis Nordic II: Rate of Restenosis ((≥50% Diameter Stenosis ≥50% Diameter Stenosis by QCA) at 8Mby QCA) at 8M

In-segment

0

2

4

6

8

10

12

1412.1

6.6

4.7

2.0

4.5

9.2

Crush Culotte

P=0.10P=0.10P=0.19P=0.19

P=0.10P=0.10

MV+SBMV+SB MVMV SBSB

Res

teno

sis

(%)

Erglis et al. Circ Cardiov Interv 2009

The T-stenting with protrusion technique (TAP) as a cross-over from the provisional approach

Wire both branches and pre-dilate the main and the side

branch as required.

Step 1: Stent the MB jailing the SB wire

If the result in SB unsatisfactory due to plaque shift or dissection

and SB has to be stented, then re-cross into the SB through the MB

stent struts

Step 2:

The T-stenting with protrusion technique (TAP) as a cross-over from the provisional approach

Position stent in SB ensuring coverage of ostium with minimal

protrusion into MB and place non-compliant balloon in MB stent

Final Result:

Inflate the delivery balloon in the SB and the MB balloon

simultaneously

Step 3:

Step 4:

3: Rewire side branch and advance a balloon

and dilate toward SB

4: Position a stent in the SB with minimal protrusion in the MB. Leave a balloon

in the MB

EVALUATE RESULT: if the result is not acceptable then

Reverse crush stenting

B

5: Deploy the stent in the SB and remove the wire and

the balloon

6: Crush the short protruding part of SB

stent over the stent in MB by inflating the MB

balloon

Reverse crush stenting

C

7: Rewire the SB and perform high

pressure dilatation

8: Perform final kissing balloon inflation

Reverse crush stenting

D

1: Wire both branches and predilate if

needed

2: Position two parallel stents covering both branches

and extending into the main branch

V: minimal protrusion into MB

SKS: double barrel into the MB

V stenting

A

3: Deploy one stent

4: Deploy the second stent

Some operators deploy the two stents simultaneously

V stenting

B

5: Perform high pressure single stent postdilatation and

medium pressure kissing inflation with short and non-

compliant balloons

V stenting

C

1: Wire both branches and predilate if

needed

2: Position two parallel stents covering both branches

and extending into the main branch

V: minimal protrusion into MB

SKS: double barrel into the MB

SKS: simultaneous kissing stents

SKS stenting

A

3: Deploy one stent

4: Deploy the second stent

Some operators deploy the two stents simultaneously

SKS stenting

B

5: Perform kissing inflation

SKS stenting

C

1: Wire both branches and predilate if needed

2 : Advance the 2 stents.MB stent positioned

proximally. The SB stent will protrude

only minimally into MB

Crush stenting

A

3: Deploy the SB stent

4: Check for optimal result in the SB and then remove

balloon and wire from SB.

Deploy the MB stent

Crush stenting

B

5: Rewire the SB and perform high pressure dilatation

6: Perform kissing balloon inflation

Crush stenting

C

1: Wire both branches and predilate if

needed

2: Remove from or leave the wire in the more straight

branch (MB) and deploy a stent in the more

angulated branch (SB)

Culotte stenting

A

3: Remove the wire from the stented branch and cross

with a wire and balloon into the of the unstented branch

and dilate (MB).

4: Place a second stent into the unstented branch

(MB) and expand the stent leaving some proximal

overlap

BCulotte stenting

5: Cross with a wire the first stent (SB) and

perform kissing balloon inflation.

C

Culotte stenting

ConclusionsConclusions

A.A. Bifurcations without SB ostial disease are Bifurcations without SB ostial disease are usually successfully treated with 1 stent on the usually successfully treated with 1 stent on the MB and kissing balloon inflation toward the side MB and kissing balloon inflation toward the side branch, cross over to 2 stents very rarebranch, cross over to 2 stents very rare

B.B. Bifurcation with significant narrowing at the Bifurcation with significant narrowing at the ostium of the SB are treated with 1 stent, in ostium of the SB are treated with 1 stent, in 20-30% of cases need to cross over to 2 stents20-30% of cases need to cross over to 2 stents

C.C. Bifurcation with a large SB and with disease Bifurcation with a large SB and with disease extending more than 3-4 mm from the ostium are extending more than 3-4 mm from the ostium are treated with 2 stentstreated with 2 stents

If you need 2 stents implant 2 stentsIf the result is optimal the FU will be favorable

Left Main: Key Issues in Play• Acute Procedural/in-hospital Complications

Operator expertise/Technique In-hospital mortality from 2% in low risk, to 21% in high risk

(ULTIMA registry) • Stent Thrombosis

May be fatal, as high as 2.5% in bifurcation disease Rate is unknown, not examined in DES era systematically

• Restenosis (up to one year) Pre-DES: 7.3% (Black), 34% (Ultima registry) DES: 3% (Lefevre, et al.), 19% (Chieffo et al.), 30%

(Teirstein et al.) Long-term Safety and efficacy compared to CABG

What is the Reality of What is the Reality of Surgical Outcomes? Surgical Outcomes?

NYS Database NYS Database CABG for Left Main Disease 1997–2000CABG for Left Main Disease 1997–2000

CP1131285-5CP1131285-5

Ed Hannon, David Faxon: Personal communication to Roxana MehranEd Hannon, David Faxon: Personal communication to Roxana Mehran

No exclusions!No exclusions!

6.8

9.6

12.8

02468

101214

1 yr 2 yr 3 yrDeath

Mor

talit

y ra

te (%

)

N = 16,365N = 16,365

Factors to be Considered in Factors to be Considered in LM InterventionLM Intervention

Prognostic FactorsPrognostic Factors

Emergency versus Emergency versus Elective InterventionElective Intervention

High-risk versus High-risk versus Low-risk PatientLow-risk Patient

Technique for Technique for bifurcation treatmentbifurcation treatment CrushCrush CulotteCulotte V stentingV stenting T stentingT stenting Final kissing Final kissing

balloon inflationballoon inflation

Technical ConsiderationsTechnical Considerations

Isolated LM versus LM + other Isolated LM versus LM + other major epicardial vesselsmajor epicardial vessels

Use of support devicesUse of support devices

Use of debulking devicesUse of debulking devices

Use of IVUSUse of IVUS

Aorto-ostial/Shaft location Aorto-ostial/Shaft location versus Bifurcation/Trifurcationversus Bifurcation/Trifurcation

What are the Current What are the Current DES Data? DES Data?

823 citations 823 citations retrieved from retrieved from

database searchesdatabase searches

46 complete articles 46 complete articles assessed according to assessed according to the selection criteriathe selection criteria

17 studies (16 cohorts) 17 studies (16 cohorts) finally included in the finally included in the

systematic reviewsystematic review

777 titles/abstracts excluded777 titles/abstracts excludedbecause non-relevantbecause non-relevant

29 articles excluded according to 29 articles excluded according to explicit inclusion/exclusion criteriaexplicit inclusion/exclusion criteria 7 duplicate publications7 duplicate publications 4 enrolling <20 patients4 enrolling <20 patients 8 ongoing 8 ongoing 5 unpublished5 unpublished 5 using BMS only5 using BMS only

A Meta-analysis of ULM Stenting with DESA Meta-analysis of ULM Stenting with DES

Biondi AHJ 2008:155 ;274

Rate of Mid-term MACE (%)Rate of Mid-term MACE (%)

19,019,09,19,1

54,054,08,88,8

25,525,523,723,7

26,226,210,610,6

4,64,610,910,9

14,314,35,85,8

7,17,132,732,7

8,28,215,515,5

00 1515 3030 4545 6060

Wood et al (2006, 100 pts)Wood et al (2006, 100 pts)Sheiban et al (2006, 72 pts)Sheiban et al (2006, 72 pts)

Price et al (2006, 50 pts)Price et al (2006, 50 pts)Park et al (2005, 102 pts)Park et al (2005, 102 pts)

Palmerini et al (2006, 94 pts)Palmerini et al (2006, 94 pts)Migliorini et al (2006, 156 pts)Migliorini et al (2006, 156 pts)

Lozano et al (2005, 42 pts)Lozano et al (2005, 42 pts)Lee et al (2006, 50 pts)Lee et al (2006, 50 pts)

KOMATE (2005, 54 pts)KOMATE (2005, 54 pts)Han et al (2006, 138 pts)Han et al (2006, 138 pts)

Dudek et al (2006, 28 pts)Dudek et al (2006, 28 pts)de Lezo et al (2004, 52 pts)de Lezo et al (2004, 52 pts)

Christiansen et al (2006, 42 pts)Christiansen et al (2006, 42 pts)Chieffo et al (2005, 85 pts)Chieffo et al (2005, 85 pts)

Carriè et al (2006, 49 pts)Carriè et al (2006, 49 pts)Agostoni et al (2005, 58 pts)Agostoni et al (2005, 58 pts)

16,3 (11,4-21,2)16,3 (11,4-21,2)Overall estimate (95%CI)Overall estimate (95%CI)

Stud

ySt

udy

Biondi AHJ 2008:155 ;274

8,08,0

2,62,6

10,010,0

0,00,013,813,8

10,910,9

19,119,1

4,04,0

1,91,9

5,15,1

0,00,0

4,84,8

2,82,8

0,00,0

5,25,2

00 1515 3030 4545

Wood et al (2006, 100 pts)Wood et al (2006, 100 pts)Sheiban et al (2006, 72 pts)Sheiban et al (2006, 72 pts)

Price et al (2006, 50 pts)Price et al (2006, 50 pts)Park et al (2005, 102 pts)Park et al (2005, 102 pts)

Palmerini et al (2006, 94 pts)Palmerini et al (2006, 94 pts)Migliorini et al (2006, 156 pts)Migliorini et al (2006, 156 pts)

Lozano et al (2005, 42 pts)Lozano et al (2005, 42 pts)Lee et al (2006, 50 pts)Lee et al (2006, 50 pts)

KOMATE (2005, 54 pts)KOMATE (2005, 54 pts)Han et al (2006, 138 pts)Han et al (2006, 138 pts)

de Lezo et al (2004, 52 pts)de Lezo et al (2004, 52 pts)Christiansen et al (2006, 42 pts)Christiansen et al (2006, 42 pts)

Chieffo et al (2005, 85 pts)Chieffo et al (2005, 85 pts)Carriè et al (2006, 49 pts)Carriè et al (2006, 49 pts)

Agostoni et al (2005, 58 pts)Agostoni et al (2005, 58 pts)

Stud

ySt

udy

4,9 (2,8-7,0)4,9 (2,8-7,0)Overall estimate (95%CI)Overall estimate (95%CI)

6060

Rate of Mid-term Death (%)Rate of Mid-term Death (%)

Biondi AHJ 2008:155 ;274

8,08,0

3,93,944,044,0

2,02,0

12,112,1

2,42,4

6,36,3

2,32,3

7,37,3

0,00,0

1,91,9

4,84,8

18,818,8

2,02,0

6,96,9

00 1515 3030 4545 6060

Wood et al (2006, 100 pts)Wood et al (2006, 100 pts)Sheiban et al (2006, 72 pts)Sheiban et al (2006, 72 pts)

Price et al (2006, 50 pts)Price et al (2006, 50 pts)Park et al (2005, 102 pts)Park et al (2005, 102 pts)

Migliorini et al (2006, 156 pts)Migliorini et al (2006, 156 pts)Lozano et al (2005, 42 pts)Lozano et al (2005, 42 pts)

Lee et al (2006, 50 pts)Lee et al (2006, 50 pts)KOMATE (2005, 54 pts)KOMATE (2005, 54 pts)Han et al (2006, 138 pts)Han et al (2006, 138 pts)

Dudek et al (2006, 28 pts)Dudek et al (2006, 28 pts)de Lezo et al (2004, 52 pts)de Lezo et al (2004, 52 pts)

Christiansen et al (2006, 42 pts)Christiansen et al (2006, 42 pts)Chieffo et al (2005, 85 pts)Chieffo et al (2005, 85 pts)

Carriè et al (2006, 49 pts)Carriè et al (2006, 49 pts)Agostoni et al (2005, 58 pts)Agostoni et al (2005, 58 pts)

6,6 (3,7-9,4)6,6 (3,7-9,4)Overall estimate (95%CI)Overall estimate (95%CI)

Stud

ySt

udy

Rate of Mid-term TVR (%)Rate of Mid-term TVR (%)

Biondi AHJ 2008:155 ;274

Body or Ostial ULMBody or Ostial ULMNo Involvement of BifurcationNo Involvement of Bifurcation

144 pts in 5 centers144 pts in 5 centers• 39 PES39 PES• 105 SES105 SES• 19.4%19.4%

diabeticsdiabetics• 50% IVUS guidance50% IVUS guidance• 99% procedural 99% procedural

successsuccess

75 pts75 pts 41 pts41 pts

28 pts28 pts

2 Milan, 1 Turin, 1 Rotterdam, 1 Korea2 Milan, 1 Turin, 1 Rotterdam, 1 Korea

Chieffo et al. submitted 2007Chieffo et al. submitted 2007

Chieffo Circ 2007:116;158

Body or Ostial ULMBody or Ostial ULMNo No InvolvementInvolvement of Bifurcation of Bifurcation

1 year Follow-Up1 year Follow-Up• Angio F-UAngio F-U

100 pts (70%)100 pts (70%) Death: 1 ptDeath: 1 pt PCI: 1 ptPCI: 1 pt CABG: 1 ptCABG: 1 pt

75 pts75 pts 41 pts41 pts

28 pts28 pts

Chieffo Circ 2007:116;158

What are the Longer Term What are the Longer Term DES DES

Data? Data?

Korean Experience on LMCAKorean Experience on LMCA

• Patients treated with DES were older, more often diabetics, with lower Patients treated with DES were older, more often diabetics, with lower ejection fraction and more frequently had multivessel diseaseejection fraction and more frequently had multivessel disease

• Distal location was more frequent in DES (72.4%) as compared with Distal location was more frequent in DES (72.4%) as compared with BMS (37.8%)BMS (37.8%)

• Provisional T stenting was used in 54.8% of DES, “crush” technique Provisional T stenting was used in 54.8% of DES, “crush” technique was used in 19.2%, other two stenting techniques (culotte, Y, etc.) was used in 19.2%, other two stenting techniques (culotte, Y, etc.) were used in 6.9% of the caseswere used in 6.9% of the cases

255 pts BMS255 pts BMS 315 pts DES315 pts DES

Total 570 pts with Total 570 pts with LMCA diseaseLMCA disease

301 pts SES301 pts SES 14 pts PES14 pts PES

Data presented ACC 2007Data presented ACC 2007

570 Patients with 570 Patients with Unprotected LM StentingUnprotected LM Stenting

Primary End point: Death from any cause at 3 years F/UPrimary End point: Death from any cause at 3 years F/UOther outcomes: Stent thrombosis, Composite of Death, Other outcomes: Stent thrombosis, Composite of Death, MI and reinterventionMI and reintervention

Nov, 1995Nov, 1995 Mar, 2003Mar, 2003 Feb, 2006Feb, 2006

BMSBMS DESDES255 315

Different Treatment StrategyDifferent Treatment StrategySingle Stent Cross-overSingle Stent Cross-over CrushCrush KissingKissing Big LMBig LM

LCX disease +LCX disease +

Big LMBig LMLCX disease -LCX disease -

Small LMSmall LMLCX disease +LCX disease +

Small LMSmall LMLCX disease -LCX disease -

19% 21%

55%0

20

40

60

80

100

1 2 3 4 5 6Reference diameter of LMCA (mm)

Dia

met

er s

teno

sis

of L

CX

(%)

Survival-free from Survival-free from All Death or MIAll Death or MIat 3 Year Follow-upat 3 Year Follow-up

80

82

84

86

88

90

92

94

96

98

100

0 90 180 270 360 450 540 630 720 810 900 990 1080

Time after index procedure (days)

Free

dom

from

Dea

th/M

I (%

)

p (log-rank) = 0.605p (log-rank) = 0.605DESDES

BMSBMS

98.7%98.7%

98.3%98.3% 96.7%96.7% 95.7%95.7%

96.2%96.2%97.4%97.4%

Survival-free from Survival-free from TLRTLRat 3 Year Follow-upat 3 Year Follow-up

50

60

70

80

90

100

0 90 180 270 360 450 540 630 720 810 900 990 1080

Time after index procedure (days)

Free

dom

from

TLR

(%)

p (log-rank) < 0.0001p (log-rank) < 0.0001DESDES

BMSBMS

95.4%95.4%

82.9%82.9% 81.1%81.1% 81.1%81.1%

91.9%91.9%92.6%92.6%

Korean Experience on LMCAKorean Experience on LMCA

3.2%

0.6% 0.6%

7.0%

3.9%

0.4% 1.2%

17.6%

0

5

10

15

20

Death MI StentThrombosis

TVR

%

DESBMS

3 Years Clinical Follow-Up3 Years Clinical Follow-Up

nsns

nsns nsns

P=0.001P=0.001

Data presented ACC 2007Data presented ACC 2007

No Definite Stent Thrombosis,No Definite Stent Thrombosis,Probable 1 Patient (0.2%)Probable 1 Patient (0.2%)Possible 4 Patients (0.7%)Possible 4 Patients (0.7%)

BMS 3/255 (1.2%)BMS 3/255 (1.2%) DES 2/315 (0.6%)DES 2/315 (0.6%)

EarlyEarly(<1M)(<1M)

LateLate(1~12M)(1~12M)

Very LateVery Late(>12M)(>12M)

00 66 1818 2424 3030 3636MonthsMonths1212

January, 2000

March, 2003

June, 2006

Phase I (Era of Bare-Metal Stents)

LMCA disease (N=775)

BMS (N=336) CABG (N=439)

Phase II (Era of Drug-Eluting Stents)

LMCA disease (N=1536)

DES (N=805) CABG (N=731)

MAIN-COMPARE RegistryMAIN-COMPARE Registry Stenting (BMS vs. DES) vs. CABG

PCI (N=1141) CABG(N=1170)Total (N=2311)

CABG

1.0Years after treatment

0.0 2.0 3.00

5

Cum

ulat

ive

Inci

denc

e (%

) 15

10 BMSCABG

1.0Years after treatment

0.0 2.0 3.00

5

15

10

DES

Phase I Phase IIHR 2.58 (1.35-4.94) P=0.004P=0.004

HR 0.90 (0.56-1.45) P=0.664P=0.664

Korean Main COMPARE LM Registry Korean Main COMPARE LM Registry

Death or Q-wave MIDeath or Q-wave MI

DES TVR=6%

1.0Years after treatment

0.0 2.0 3.00

10

Cum

ulat

ive

Inci

denc

e ( %

) 30

20

1.0Years after treatment

0.0 2.0 3.00

10

Cum

ulat

ive

Inci

denc

e ( %

) 30

20

Main COMPARE :New RevascularizationMain COMPARE :New Revascularization

CABG

BMS

CABG

DES

Phase I Phase II

HR 5.57 (3.13-9.88) P<0.001 HR 5.05 (2.87-8.67)

P<0.001

What are the What are the Randomized Data?Randomized Data?

LEMANS: 1 Year Survival LEMANS: 1 Year Survival 

Buszman et al, JACC 2008;51:538-45

F-Cox test: p=0.081F-Cox test: p=0.081

Cum

ulat

ive

Surv

ival

Time (months)

CABG=53PCI=52

Completed Truncated

0 10 20 30 40 500.5

1.0

0.9

0.8

0.7

0.6

0

10

20

30

40

50

60

70

0 12

LEMANS: LVEF at 1 Year LEMANS: LVEF at 1 Year

Buszman et al, JACC 2008;51:538-45

LVEF

(%)

Time (months)

p=0.04p=0.04p=0.85p=0.85

p=0.22p=0.22 p=0.01p=0.01

PCI CABG Mean + SD

53.5+10.795%CI:50.5-56.5

53.5+6.795%CI:51.8-55.5

54.1+8.995%CI:51.6-56.7

58.0+6.895%CI:56.0-60.0

PRE-COMBATPRE-COMBATPREPREmiere of Randomized miere of Randomized COMCOMparison of parison of BBypass ypass

Surgery versus Surgery versus AAngioplasngioplasTTy Using Sirolimus-Eluting y Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery DiseaseStent in Patients with Left Main Coronary Artery Disease

Primary Endpoint: 1-year major cardiac and cerebrovascular event (MACCE) – Primary Endpoint: 1-year major cardiac and cerebrovascular event (MACCE) – death, MI, stroke and TVRdeath, MI, stroke and TVR

PI: Seung-Jung ParkPI: Seung-Jung Park8 major centers in Korea8 major centers in Korea

Left main disease with or without multivessel disease (n=1,600)

PCI with Cypher(n=300)

CABG(n=300)

RegistryScreening log failure

Randomization 600 (1:1)Randomization 600 (1:1) Non-randomizationNon-randomization

Pre-COMBAT: Random Group (ITT)Pre-COMBAT: Random Group (ITT)1-Year Outcomes (Preliminary Analysis)1-Year Outcomes (Preliminary Analysis)

PCIPCI(n=196)(n=196)

CABGCABG(n=184)(n=184)

pp

DeathDeath 2 (1.0%)2 (1.0%) 5 (2.7%)5 (2.7%) 0.3470.347

Cardiac deathCardiac death 1 (0.5%)1 (0.5%) 3 (1.6%)3 (1.6%) 0.4560.456

Non-cardiac deathNon-cardiac death 1 (0.5%)1 (0.5%) 2 (1.1%)2 (1.1%) 0.6120.612

Myocardial infarctionMyocardial infarction 9 (4.6%)9 (4.6%) 15 (8.2%)15 (8.2%) 0.1540.154

Non-Q MINon-Q MI 9 (4.6%)9 (4.6%) 9 (4.9%)9 (4.9%) 0.8910.891

Q MI Q MI 00 6 (3.3%)6 (3.3%) 0.0120.012

Repeat revascularizationRepeat revascularization 10 (5.1%)10 (5.1%) 6 (3.3%)6 (3.3%) 0.3720.372

PCIPCI 9 (4.6%)9 (4.6%) 6 (3.3%)6 (3.3%) 0.8640.864

CABGCABG 1 (0.5%)1 (0.5%) 00 1.0001.000

StrokeStroke 1 (0.5%)1 (0.5%) 00 1.0001.000

Total MACCETotal MACCE 19 (9.7%)19 (9.7%) 23 (12.5%)23 (12.5%) 0.4160.416

SYNTAX Randomized TrialSYNTAX Randomized Trial

Left main diseaseLeft main disease(minimum 710)(minimum 710) 3-vessel disease3-vessel disease

De novo disease acceptable for revascularization :85 SitesDe novo disease acceptable for revascularization :85 Sites

PIs: Patrick Serruys PIs: Patrick Serruys and Frederick Mohrand Frederick Mohr

andand/or/or

TAXUS PCITAXUS PCI CABGCABG

Randomize 1800

Primary NI endpoint – 1 year MACCEPrimary NI endpoint – 1 year MACCE All cause death, MI, cerebrovascular All cause death, MI, cerebrovascular

events, repeat revascularization events, repeat revascularization

PCIPCIRegistryRegistry

198198

CABGCABGRegistryRegistry

10781078

SYNTAXSYNTAXSCORESCORE

LesionLesionLocationLocation

LeftLeftMainMain

TortuosityTortuosity

3 Vessel3 VesselThrombusThrombus

BifurcationBifurcation CTOCTO

CalcificationCalcification

SYNTAX score to provide guidance on optimal revascularization strategies for patients with high risk lesions

Lesion and Patient ComplexityLesion and Patient ComplexityRandomized vs. Registry CohortsRandomized vs. Registry Cohorts

Data are site reported * Based on baseline SYNTAX score

PatientPC

IC

AB

G

Randomized Randomized N=1800N=1800

CABG RegistryCABG RegistryN=649N=649

PCI RegistryPCI RegistryN=198N=198

3 Vessel Disease (%)3 Vessel Disease (%) 60.6% 60.6% 54.5% 54.5% 65.2% 65.2% LM (%)LM (%) 39.4% 39.4% 45.5% 45.5% 34.8% 34.8% Diabetics (%)Diabetics (%) 24.6% 24.6% 29.4% 29.4% 35.5% 35.5% Bifurcation (% pts)Bifurcation (% pts)** 62.7% 62.7% -- 58.6% 58.6% Total Occlusion (% pts)Total Occlusion (% pts) 27.2% 27.2% -- 39.6% 39.6% Total stent length >100mm Total stent length >100mm

(% pts)(% pts)34.2% 34.2% -- 11.2% 11.2%

Number of stents (per pt)Number of stents (per pt) 4.74.7 -- 3.13.1Arterial grafts (%)Arterial grafts (%) 94.9% 94.9% 91.5% 91.5% --Complete arterial Complete arterial

revascularization (%)revascularization (%)18.6% 18.6% 12.5% 12.5% --

Double IMA grafts (%)Double IMA grafts (%) 26.9% 26.9% 16.0%16.0% --Conduits used to LAD (%)Conduits used to LAD (%) 95.2% 95.2% 92.5% 92.5% --

Overall MACCE at 12 MonthsOverall MACCE at 12 MonthsLeft Main SubsetLeft Main Subset

ITT population

8.5

13.215.8

19.8 19.3

13.715.414.4

7.57.1

0

5

10

15

20

25

LM all LM only LM+1VD LM+2VD LM+3VD

TAXUSCABG

(n=705) (n=91) (n=138) (n=218) (n=258)

P=0.44 P=1.0 P=0.27 P=0.29 P=0.42

Patie

nts

(%)

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

) P=0.88*

Death (All-cause) to 12 MonthsDeath (All-cause) to 12 MonthsLeft Main SubsetLeft Main Subset

4.2%4.4%

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test ITT population

CVA (Stroke) to 12 MonthsCVA (Stroke) to 12 Months Left Main SubsetLeft Main Subset

2.7%0.3%

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

) P=0.009*

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test ITT population

Myocardial Infarction to 12 MonthsMyocardial Infarction to 12 MonthsLeft Main SubsetLeft Main Subset

4.1%4.3%

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

) P=0.97*

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test ITT population

Death/CVA/MI to 12 MonthsDeath/CVA/MI to 12 MonthsLeft Main SubsetLeft Main Subset

P=0.29*

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

)

9.1% 7.0%

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test ITT population

RevascularizationRevascularization** to 12 Months to 12 MonthsLeft Main SubsetLeft Main Subset

6.7%

12.0%

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

) P=0.02*

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test *Any revascularization (PCI or CABG); ITT population

MACCE to 12 MonthsMACCE to 12 MonthsLeft Main SubsetLeft Main Subset

P=0.44*

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

)

13.6% 15.8%

TAXUS (N=357)CABG (N=348)

Event rate ± 1.5 SE, *Fisher exact test ITT population

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

)

TAXUS (N=118)CABG (N=103)

P=0.19*

7.7%13.0%

Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population

MACCE to 12 Months by SYNTAX MACCE to 12 Months by SYNTAX Score TertileScore Tertile

Low Scores (0-22) LM SubsetLow Scores (0-22) LM Subset

Mean baselineSYNTAX Score

CABG 15.5 ± 4.3TAXUS 15.7 ± 4.4

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

)

TAXUS (N=195)CABG (N=92)

Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population

P=0.54*

15.5%12.6%

MACCE to 12 Months by SYNTAX Score TertileIntermediate Scores (23-32) LM Subset

Mean baselineSYNTAX Score

CABG 27.2 ± 3.0TAXUS 27.0 ± 2.7

0 6 12

20

40

0

Months Since Allocation

Cum

ulat

ive

Even

t Rat

e (%

)

TAXUS (N=135)CABG (N=150)

P=0.008*

25.3%

12.9%

Event rate ± 1.5 SE, *Fisher exact test Calculated by core laboratory; ITT population

MACCE to 12 Months by SYNTAX Score TertileHigh Scores (≥33) Left Main Subset

Mean baselineSYNTAX Score

CABG 42.1 ± 7.6TAXUS 43.8 ± 9.1

Should I Do It?Should I Do It?

• What is the likelihood I can achieve optimal What is the likelihood I can achieve optimal short and long term results?short and long term results?

Entry angle for wiringEntry angle for wiring Ability to maintain flow in both branchesAbility to maintain flow in both branches Consequences of closureConsequences of closure

• Size of CircumflexSize of Circumflex• RCA CTORCA CTO• LV functionLV function

ObjectivesObjectives

• Initial procedural success (safety)Initial procedural success (safety)• Long-term success (limit MACE) Long-term success (limit MACE) ConsiderationsConsiderations• Can it be doneCan it be done• 1 stent or 2 1 stent or 2 • Hemodynamic support vs. no supportHemodynamic support vs. no support

ConsiderationsConsiderations

If two stents which technique? If two stents which technique? • TT• KissingKissing• CrushCrush• CulotteCulotte• VVDebulkingDebulking• Roto- with Ca++Roto- with Ca++• Cutting/scoring –to avoid plaque shiftCutting/scoring –to avoid plaque shift• DCA-doubtfulDCA-doubtful

Support – usually not neededSupport – usually not needed

• IABP –usually sufficientIABP –usually sufficient• Impella-under investigationImpella-under investigation• Tandem Heart-for ultra high riskTandem Heart-for ultra high risk Think of “Bang-bang”Think of “Bang-bang”

What is ‘Bang-bang”What is ‘Bang-bang”

• 7-8F Guide7-8F Guide• Two wires down LADTwo wires down LAD• Balloon on oneBalloon on one• Stent on secondStent on second• Both placed at distal guide with 2 Both placed at distal guide with 2

inflation devicesinflation devices• Dilate balloon for 5 seconds at high Dilate balloon for 5 seconds at high

pressurepressure• Pull balloon and wire backPull balloon and wire back• Place and deploy stentPlace and deploy stent• DONE!!!!!DONE!!!!!

One Stent vs. TwoOne Stent vs. Two

• What is the likelihood of acute What is the likelihood of acute closure and long-term closure and long-term patency patency

• Safety firstSafety first

One or Two Stents: CMSE-SICI One or Two Stents: CMSE-SICI Unprotected Distal LMUnprotected Distal LM

• 773 patients773 patients• 60% one stent60% one stent• Two stents: 40% “T” 40% “Crush” 20% “V”Two stents: 40% “T” 40% “Crush” 20% “V”• No difference death, MINo difference death, MI• TLR 13% vs. 27%TLR 13% vs. 27%• No differences among two stent techniquesNo differences among two stent techniques• Kissing – 50% decrease in MACEKissing – 50% decrease in MACE

But no QCA data But no QCA data (or even bifurcation class) (or even bifurcation class)

Palminteri et al, Arch Card Int 2008;1:188

ISAR LM: Excellent Results with Liberal ISAR LM: Excellent Results with Liberal Use of Two Stent StrategyUse of Two Stent Strategy

• 60% LM patients60% LM patients• 2 year follow-up2 year follow-up• 30% DM30% DM• 71% 3VD71% 3VD• 63% Distal63% Distal• 80% two stent (Cullotte)80% two stent (Cullotte)• 90% kissing 90% kissing • 87% angio follow-up87% angio follow-up

• Death 9.5%• MI 5.0%• CAGB 1%• TLR 9.9%• 2 stent restenosis 16%• ST 0.5%• LST 0%

Mehilli et al, JAMA 2009

ConclusionsConclusions• Left main and bifurcation stenting with DES is a Left main and bifurcation stenting with DES is a

feasible and safe procedure with low rates of ST feasible and safe procedure with low rates of ST (2-3 yr FU, with most of pts on double antiplatelet (2-3 yr FU, with most of pts on double antiplatelet therapy)therapy)

• The main limitations are the relatively high The main limitations are the relatively high revascularization rates in bifurcations with revascularization rates in bifurcations with double stents and the uncertainty regarding the double stents and the uncertainty regarding the duration of double antiplatelet therapyduration of double antiplatelet therapy

• For lesions located in the body and ostium of LM For lesions located in the body and ostium of LM no disadvantage seems to be present, compared no disadvantage seems to be present, compared to CABG, in terms of need for repeat to CABG, in terms of need for repeat revascularization or safetyrevascularization or safety

• Technical progress and a growing evidence base Technical progress and a growing evidence base will make this a promising treatment in certain will make this a promising treatment in certain patients in the next few yearspatients in the next few years