State of the Art: Bifurcation Treatment Strategies James B. - - PowerPoint PPT Presentation

State of the Art: Bifurcation Treatment Strategies

SCAI 2009 Fellows Course

James B. Hermiller, MD The Care Group, LLC The Heart Center of Indiana

• St. Vincent Hospital

Indianapolis, IN Mirage Hotel Las Vegas, NV Dec 8th, 2009

Disclosures

• Consultant:

–Abbott, BSC and St Jude

Bifurcations: Dangerous – High Stakes

Wrong Tool for the Job

Ingenuity

It can get you killed.

Outline

• Introduction
• DES vs BMS
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

Classification Schemes

Prebranch

Postbranch

Parent Vessel Only

Bifurcation

Ostial

Prebranch and Branch

French/Lefevre Duke Safien Chen-Gao Movahed Sanborn

Coronary Bifurcation Lesions

Medina Classification

Medina A, Rev Esp Cardiol.2006 Feb;59(2):183

The Key: The Branch

Main Consideration: The Branch

• Will the side branch close?

– Plaque at ostium and angulation (Aliabadi: Am J

Cardiol,1997;80:994-997)

• Is the side branch large enough to Stent? (>2.5 mm)

Dauerman HL, et al. JACC.1998;32:1845-52)

• Is the side branch plaque lengthy (not focal)?
• What’s the sidebranch angle? (<70o or > 70o)
• Can you rewire after main branch stent?

Eyeball – effect of angiography Oculostenotic Reflex

Result after Kissing

CSA : 3.4 mm2

IVUS

FFR : 0.80

Bifurcations

Oculostenosis and Branch Lesions

Koo BK. JACC. 2005;46:633-637

• 97 consecutive branch ostial lesions
• 2mm side branch with > 50% angiographic

stenosis

• FFR measured in 94 of the vessels
• No lesion less than 75% stenosis had

abnormal FFR < 0.75

• Of the 73 with >75% stenosis, only 20 had

were functionally significant. In those > 2.5 mm in diameter only 38% had abnormal FFR

Outline

• Introduction
• DES vs BMS
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

DES vs. BMS

Theusen L, et. Al. Am Heart J. 2006;152:1140-5. 126 with bifurcation lesions SES vs. BMS from overall SCANDSTENT trial

Sirolimus Eluting stent N=68 Bare Metal StentBare N=58

DES vs. BMS: Bifurcations

5.4 36 5.4 38 8.9 38 13.3 51

• 5

5 15 25 35 45 55

TLR MACE TLR MACE

DES - Ge et al. AJC 2005 BMS - Yamashita JACC 2000

% One Stent Two Stent

Outline

• Introduction
• DES vs BMS
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

Circulation 2006;114:1955-1961

NORDIC TRIAL

BBK (Bifurcations Bad Krozingen)

CACTUS

Circulation 2009;119:71-78.

BBC ONE

TCT 2008

Eur Heart J. 2008; 29(23): 2859–2867.

One stent vs. Two: TLR

1.9 1 10.9 8.9 5.6 5.8 4.8 3.8

2 4 6 8 10 12

Nordic I BBK CACTUS BBC One

One Stent Two-Stent

%TLR

4.3% Crossover; TIMI 0 post SB PTCA 18.8% Crossover; >60% and/

• r flow-limiting

dissection 31% Crossover; >50% and/

• r flow-limiting

dissection N= 413 202 350 500 3% Crossover; >70% and/

• r < TIMI 3

MV MV+SB P-value (n=201) (n=196) Total death (%) 2.9 5.8 0.15 Cardiac death (%) 1.4 1.5 1.00 Myocardial infarction (%)3.0 3.6 0.78 TLR (%) 8.0 9.7 0.60 TVR (%) 9.5 11.7 0.52

• Def. stent thromb. (%)

2.5 1.0 0.45

Nordic I

End points after 36 months

Sjögren EuroPCR 2009

Down Side of Two Stents

CKmb

Consensus: 1 Stent Preferred Over 2

Bestent1 Patients (n) 105 Reference (mm) 2.7±0.4 Lesion length (mm) 5.6±4.2 Stenosis SB (%) 49±37 TULIPE2 187 2.3±0.5 3.7±3.3 52±17

1 Gobeil et al, Am J Cardiol 2001, 2 Brunel et al Cathet Cardiovasc Intervent 68:67–73 (2006) 3 Colombo et al, Circulation 2004; 109: 1244-9, 4 Sengotuvel et al, JACC 2004 (abst.supp.)

Sirolimus3 85 2.1±0.3 5.3±4.2 52±19

What Patients in These Trials: Short Lesion in SB with Moderate Stenosis

Sirolimus4 47 2.1±0.5 4.5±3.0 42±23

Significant SB LL>3mm 10-24%

When PTCA or Stent Through MB: Absolutely End with a Kiss

Provisional T-stent

Single Stent Approaches

KIO

Provisional Stent Strategy

Keep It

Trapping the Wire

• Failure to use a “jailed wire in the SB

was an independent predictor

• f

reintervention at 7 months (OR 4.26; 95% CU 1.27 –14.2)

• Favorably modifies angulation
• Maintains patency of SB
• Identifies ostium when rewiring
• Non-hydrophilic/no-shaping ribbon
• Don’t trap large amount of wire
• If trouble removing – balloon backup

Brunel et al CCI 2006;68:67-73

TULIPE study (N=186):

Keep It Open (KIO)

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

• 1. Wire both branches
• 2. Dilate MB if needed
• 3. Stent MB and leave wire in the SB
• 4. Perform post-dilatation of the MB with jailed wire in

the SB

6 Fr guiding catheter

Do not re-wire SB or postdilate or predilate SB

NORDIC 3: KISS vs No KISS

• In a randomized clinical trial, to compare outcome of

two side-branch strategies in coronary bifurcation lesions treated with main vessel stenting using sirolimus eluting stents

No kissing balloon dilatation Kissing balloon dilatation

Bifurcation patients with successful MV stenting n: 477 No Kissing balloon n: 239

Randomization

Kissing balloon n: 238 Clinical follow‐up after 1 and 6 months n: 477 (100%)

Primary Endpoint

A 6-month composite end point of:

– Cardiac death – Index lesion myocardial infarction* – Target lesion revascularisation (TLR) – Stent thrombosis

• angiographic confirmation
• cardiac death

* Non-procedure related

Crush Culotte P-value (n=210)(n=215)

Aspirin Tx (%) 99.6 100.0 ns Clopidogrel Tx (%) 98.7 99.2 ns GPIIb/IIIa Tx (%) 28.9 29.1 ns Bivalirudin Tx (%) 20.9 26.2 ns Procedure time (min) 47 + 22 61 + 28 0.0001

• Fluorosc. time (min)

11 + 10 16 + 12 0.0001 Contrast (ml) 200 + 92 235 + 97 0.0001

Procedure data I

P value

n=210

Culotte

n=210

No kissing p-value

n=239

Kissing

n=238

1 2 3 4 5 6

NO KISSING KISSING %

2.9 2.9

Primary end point

MACE (cardiac death, index lesion MI, TLR, stent thrombosis) after 6 months ns

Conclusion

• In coronary bifurcation lesions, a strategy of

routine kissing balloon dilatation of side branch through the MV stent did not improve the 6-month clinical outcome as compared to a strategy of no kissing balloon dilatation

• In the kissing balloon dilatation group, the

procedure and fluoroscopy time and the use of contrast were significantly increased

Outline

• Introduction
• DES vs BMS
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

Two Stent Appoaches

T Kiss (SKS) Crush Culotte

Various Techniques for Stenting Bifurcation Lesions

Bifurcation Lesion

Main vessel Side- branch

Stent+PTCA Stent+stent (“T stenting”)

Blocking Balloon Technique:

Schwartz L, et al J Invasive Cardiol.2002;14:66-71 Dardas PS, et al, J Invasive Cardiol.2003;15:180-183

Ballon-Alignment Technique

Various Techniques for Stenting Bifurcation Lesions

Bifurcation Lesion

Main vessel Side- branch

Stent+PTCA Stent+stent (“T stenting”) Stent+stent (“reverse-T”)

TAP

Reverse T Stenting

• Stent main branch trapping wire
• Rewire sidebranch
• Dilate through struts of MB stent
• Deliver SB stent (proximal end of

SB stent 1 mm into MB)

• Deploy SB stent (balloon in MB)
• Pull back SB deployment balloon

slightly and kiss

• Exchange for non-compliant SB

balloon – 2 step SB dilatation (high pressure in SB then Kiss)

TAP: T-stenting and small protrusion

TAP Results

2 4 6 8 10

Death TLR TVR ST*

1 Stent TAP

%

N=207

Provisional TAP Technique 58% Remainder 1 MB Stent Gwon et al. ACC 2008

T Stent Summary

• Indications

– Bifurcation lesions with an angle between MB and SB of ~ 90 degrees. – TAP default strategy when single stent strategy fails

• Advantages

– The technique is easy, fast and not technically demanding.

• Drawbacks

– When trying to position the SB stent exactly at the ostium without minimal protrusion into the MB the stent often misses the ostium (gap) – particularly true as the side branch angle becomes less acute

Various Techniques for Stenting Bifurcation Lesions

Bifurcation Lesion

Main vessel Side- branch

Stent+PTCA Stent+stent (“T stenting”) Stent+stent (“reverse-T”) Stent+stent (“Kissing” “SKS”) Stent+stent (“V” - < 5mm)

“V”

1 1

V or Double D or SKS

• Simultaneous placement of 2 stents

at each ostium of the bifurcation; if more than 5 mm proximal overlap this is called a SKS (simultaneous kissing stent technique)

• Used in type 4 lesion (looks like

aorto-iliac stenosis)

Coronary Bifurcation Lesions

THERAPEUTIC APPROACH: 5 types

Iakovou et al. JACC 2005:46:1446-55.

Summary: SKS (V-stent)

• Indication

– Medina 0,1,1 bifurcations - proximal MB relatively free of disease - angle between both branches < 90 degree.

• Advantages

– Access preserved - no need for rewiring any of the

• branches. Its is relatively easy and fast.
• Disadvantages

– Creation of a metallic neo carina (particularly the SKS) - with stent mal-apposition - several concerns:

• The risk of proximal dissection
• Re-intervention - rewiring the stented vessels may be

complicated by wire passage behind stent struts.

• Restenosis in neo carina or proximal stent edge

Various Techniques for Stenting Bifurcation Lesions

Bifurcation Lesion

Main vessel Side- branch

Stent+PTCA Stent+stent (“T stenting”) Stent+stent (“reverse-T”) (“Crush”)

2 1

Stent+stent (“Kissing” “SKS”) Stent+stent (“V” - < 5mm)

“V”

1 1

Old Crush

d

1: Wire both branches and predilate if needed 2 : Long Overlap of SB by MB

Standard Crush Technique

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.

Mini-Crush Technique

Mini-Crush

• Standard

crush

Ormiston J, JACC Intervention 2008

• Mini crush

Mini-Crush

• 1-2 mm of SB stent positioned in MV (proximal SB stent marker on

MB wire or SB just covers proximal edge of ostium)

• The SB stent is deployed & stent balloon withdrawn slightly with high

RBP inflation (flares proximal stent) – then angiogram to make sure no distal dissection

• The SB is crushed by a MV balloon or a stent

Ormiston J, JACC Intervention 2008

Mini-Crush

• Rewire SB with two step dilatation
• SB – high pressure dilatation NC balloon and

then HP NC MB

• Final kissing balloon inflation 12 ATM

Ormiston J, JACC Intervention 2008

YES Final Kissing 163 pts. NO Final Kissing 14 pts. P

Myocardial infarction 7.5% 29% 0.001 TLR 6.3% 12.9% 0.25 MB restenosis 4.7% 16% 0.03 SB restenosis 11.9% 36% 0.001 Stent thrombosis 0.9% 6.5% 0.06

Influence of Final Kissing in the CACTUS trial

Colombo A, et al Circulation. 2009;119:71-78.

Two Step SB Inflation -- Crush

Ormiston J, JACC Intervention 2008

• High pressure dilatation of side-branch with a

non-compliant balloon

• Followed by final kissing inflation
• Two step Kiss

No Kiss Usual Kiss 2 Step Kiss

Two Step SB Inflation

Ormiston J, JACC Intervention 2008

CACTUS: Six Month Restenosis

6.7 4.6 14.7 13.2

5 10 15 20 Main Branch Side Branch

One Stent Two Stent

% Binary Restenosis

P=NS

Colombo A, et al Circulation. 2009;119:71-78.

CACTUS: Stent Thrombosis

Total Acute

(1st day)

Sub Acute Late

(30-81Days)

Crush

3 (1.7%) 1 (0.5%) 2* (1.1%)

Provisional

2 (1.1%) 0

1 (0.5%) 1 (0.5%)

P=0.66 crush vs provisional T * 1 patient took no clopidogrel post DC

Colombo A, et al Circulation. 2009;119:71-78.

CACTUS: Conclusions

P=0.66 crush vs provisional T * 1 patient took no clopidogrel post DC

• No advantage to double stents
• No penalty for implanting two stents
• When you need two stents, do it

(but achieve an optimal final result!)

Colombo A, et al Circulation. 2009;119:71-78.

Crush Stent: Problems

• Inability to rewire the side branch

– Use hydrophilic wires (careful manipulation). If they fail consider stiffer tapered tip wires (Miracle wire series).

• Inability to pass a balloon into the side

branch

– Use a 1.5 mm balloon – If it fails re wire the SB with a second wire at a different entry site – Buddy balloon in MB (may inflate at low pressure) – If it fails use a fixed wire balloon system (ACE)

Various Techniques for Stenting Bifurcation Lesions

Bifurcation Lesion

Main vessel Side- branch

Stent+PTCA Stent+stent (“T stenting”) Stent+stent (“reverse-T”) (“Crush”)

2 1

Stent+stent (“Kissing” “SKS”) Stent+stent (“V” - < 5mm)

“V”

1 1

(“Culotte”)

1 2

Iakovou et al. JACC 2005:46:1446-55.

Culotte

Outline

• Introduction
• DES vs BMS
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

Eight Months Angiographic Follow-up in Patients Randomized to Crush or Culotte Stenting of Coronary Artery Bifurcation Lesions The Nordic Bifurcation Stent Technique Study

Pål Gunnes, Matti Niemela, Kari Kervinen, Andrejs Erglis, Indulis Kumsars, Jens F Lassen, Michael Mæng, Jan Skov Jensen, Anders Galløe, Terje Steigen, Jan Ravkilde, Timo Makikallio, Kari Ylitalo, Inga Narbute, Evald Christiansen, Lars Krusell, Sindre Stavnes,, Rune Wiseth, Jens Aarøe, Leif Thuesen

For the Nordic-Baltic PCI Study Group

NORDIC II: Clinical Outcome

3.7 4.3

5 10 15 TVR

Culotte Crush

% TVR at 6 months Gunnes P et al. ACC 2008 P=0.19 P=0.8

NORDIC II

2 4.7 4.5 9.2

5 10 15 Main Branch Side Branch

Culotte Crush

% Binary Restenosis Gunnes P et al. ACC 2008 P=0.19 P=0.10

Influence of Bifurcation Angle on Outcome of Crush Technique

MACE-free survival

Kaplan-Meier plot comparing MACE-free Survival up to 648 days between the low-angle group (BA<50o and high-angle group BA>50o

Dzavik et al AHJ 2006;152:762-9

T-shape Y-shape

Bifurcation Bifurcation

T-stenting +++

• Crush
• +++

Culotte

• +++

Outline

• Introduction
• The Side Branch Issues
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

Provisional Stent Bailout

No Proposed Approach to Bifurcation True Bifurcation Lesion

(Significant Stenosis in MB and SB – Medina 1,1,1 – 1,0,1 – 0,1,1)

Stent MB & Wire/PTCA SB (KIO)

No Yes

Sidebranch Suitable for Stenting

Yes

Sidebranch Disease Focal < 3mm Elective MB and SB Stenting

No - Diffuse Yes

Provisional SB Stenting

Proposed Approach to Bifurcation Lesions with DES

Two Stents Necessary

(SB>2.5mm)

• Long Plaque in Sidebranch
• Severe Dissection pre-Dilatation
• Unfavorable Geometry for Rewiring

No

• Mini-Crush
• Culotte
• - MB = SB
• V-stent (0,1,1)
• TAP

Acute Side Branch Angle – Near 90o?

• Modified T
• TAP

Yes

• Introduction
• The Side Branch Issues
• One vs. Two Stents
• Two Stent Techniques
• If Two Stents, which Technique Best?
• Conclusions

Final Conclusions

Bifurcations

Bifurcations: 1 or 2 Stents

Bifurcations: Reframe Question

• - The Question is Not -- Which is Better – 1 or 2

Stents

• - Rather -- What is the Best Strategy for the

Bifurcation at Hand – Most often it’s Provisional but Sometimes it’s Two Stents (20%)

• r

The Main Branch is the Main Concern

End With a 2 Step Kiss!!!!!!!!

IVUS

Focus on One or Two Approaches

Best Two Stent Technique?

Thanks for your attention!!!!!