centro cuore columbus main session - drug eluting stents bifurcation lesions antonio colombo centro...

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Main SessionMain Session - - Drug Eluting Drug Eluting

StentsStents

Bifurcation lesionsBifurcation lesions

Antonio Antonio ColomboColomboCentro Cuore Columbus Milan, Centro Cuore Columbus Milan,

Italy S. Raffaele Italy S. Raffaele Hospital Milan, ItalyHospital Milan, Italy

Columbia University, NY, USAColumbia University, NY, USA

29th ANNUAL SCIENTIFIC SESSIONS – SCA&ICHICAGO, IL – MAY 10-14, 2006

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Conflicts: Conflicts:

Minor stock holder in Cappella Inc.Minor stock holder in Cappella Inc.

Manufacturing side branch stentManufacturing side branch stent

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COLUMBUSCOLUMBUS 1 or 2 stents?

A) If the side branch is significantly diseased at its ostium or nearby, it is sufficiently large to be stented, safety and duration of PCI are an issue: 2 stents

B) In all other conditions 1 stents and then evaluate

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11186/0211186/02

Treatment of Bifurcation Lesion with two stentsTreatment of Bifurcation Lesion with two stents

BaselineBaseline Final ResultFinal Result

Can you really use one stent ?

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11162/0211162/02


BaselineBaseline

TreatmentTreatment

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11162/0211162/02


Final ResultFinal Result

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COLUMBUSCOLUMBUS Crush

• Standard Crush: 7F, two stents in position together, side branch inflated first, main branch stent crushes side branch

• Reverse Crush, used when provisional stenting requires another stent in the side branch: 6F, main branch stent deployed first, side branch stent is crushed against the main vessel stent with a balloon

• Inverted Crush, makes recrossing easier and improves side branch coverage: 7F similar to Standard Crush but the side branch stent is positioned more proximally than the main branch stent, the side branch stent will crush the main branch stent.

• Step Crush, as standard Crush but can be done with 6F.Advance and deploy stent in side branch

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COLUMBUSCOLUMBUS About the side branch: wires for recrossingand Kissing Balloon dilatation

• Dilate the main vessel stent at high pressureDilate the main vessel stent at high pressure

• 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 in the side Always perform high pressure inflation in the side branch before doing kissingbranch before doing kissing

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COLUMBUSCOLUMBUS DES in Bifurcation Lesions (Milan experience April 2002 – March 2005)

Total number of patients: 368Total number bifurcations: 389

True bifurcational lesions: 60%

Bifurcations treated with Cypher stent: 54%Bifurcations treated with Taxus stent: 46%

Type D Type F Type G

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COLUMBUSCOLUMBUS DES in Bifurcation Lesions (389 de-novo bifurcations)

Lesion location

LMT (n=97)

LAD- diag(n=199)

LCX- OM(n=71)

RCA (n=22)

51%

25%

18%

6%

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COLUMBUSCOLUMBUS DES in Bifurcation Lesions

Stent technique

197 (50.4%)Stent on both branches

193 (49.6%)One stent on the MB

390 bifurcations

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Stent technique (one stent vs two stents)

Left main(n=98)

Other locations(n=292)

32%

68%

58%

42%

= One stent only = Stent on both branches

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Stent technique (one stent vs two stents)

True bifurcations(n=232)

Other bifurcations(n=158)

59%

41% 63%

37%

= One stent only = Stent on both branches

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COLUMBUSCOLUMBUS DES in Bifurcation Lesion in 292 lesions

Two-stent techniques NO LMT lesions

Crush

T- stent

V- stent

Culotte

83%3%

7%

7%

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COLUMBUSCOLUMBUS DES in Bifurcation Lesion in 292 lesions

Crush

T- stent

V- stent

Culotte

54%

10%27%

9%

Two-stent techniques Left main lesions

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COLUMBUSCOLUMBUSDDES in Bifurcation LesionES in Bifurcation Lesion

Milan ExperienceMilan Experience

Baseline Clinical Baseline Clinical Characteristics (II)Characteristics (II) Group 1S Group 1S

(n = 155 (n = 155 patients)patients)

Group 2S Group 2S (n = 119 (n = 119 patients)patients)

P P ValueValue

Diabetes mellitus, %Diabetes mellitus, % 37 (24%)37 (24%) 24 (21%)24 (21%) 0.50.5

SYNTAX scoreSYNTAX score 26.80±18.126.80±18.1 37.69±23.437.69±23.4 0.0010.001

LVEF, %LVEF, % 54±954±9 53±953±9 0.20.2

Prior CABG, %Prior CABG, % 10 (7%)10 (7%) 10 (9%)10 (9%) 0.50.5

Prior MI, %Prior MI, % 68 (54%)68 (54%) 41 (43%)41 (43%) 0.80.8

Unstable angina, %Unstable angina, % 49 (43%)49 (43%) 40 (35%)40 (35%) 0.70.7

GP 2b/3a inhibitors, GP 2b/3a inhibitors,

%%17 (11%)17 (11%) 27 (23%)27 (23%) 0.0090.009

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Milan ExperienceMilan ExperienceClinical Follow-Up at 12 Clinical Follow-Up at 12

months (n=367) months (n=367) All patientsAll patients



P P ValueValue

DeathDeath 3 (1.7%)3 (1.7%) 5 (2.7%)5 (2.7%) 0.50.5

MIMI

(after hospital (after hospital discharge)discharge)

1 (0.6%)1 (0.6%) 4 (2.2%)4 (2.2%) 0.20.2

TLRTLR 18 (5.0%)18 (5.0%) 40 (11.0%)40 (11.0%) 0.0020.002

TVRTVR 25 (6.9%)25 (6.9%) 52 (14.4%)52 (14.4%) 0.0010.001

Cumulative MACECumulative MACE 28 (7.6%)28 (7.6%) 55 (15.0%)55 (15.0%) 0.0010.001

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Milan ExperienceMilan ExperienceClinical Follow-Up at 12 Clinical Follow-Up at 12

months months NO left main NO left main (n=274)(n=274)

SES SES

(n = 156 (n = 156 patients)patients)

PES PES (n = 118 (n = 118 patients)patients)

P P ValueValue

DeathDeath 2 (1.3%)2 (1.3%) 1 (0.9%)1 (0.9%) 0.70.7

MIMI

(after hospital (after hospital discharge)discharge)

4 (2.6%)4 (2.6%) 00 0.080.08

TLRTLR 25 (16%)25 (16%) 14 (12%)14 (12%) 0.30.3

TVRTVR 33 (21%)33 (21%) 18 (16%)18 (16%) 0.20.2

Cumulative MACECumulative MACE 35 (22%)35 (22%) 19 (16%)19 (16%) 0.20.2

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Angiographic follow-upAngiographic follow-up(performed in 85% of lesions)(performed in 85% of lesions)

0

5

10

15

20

Main branch Side branch

Final kissing(76%)

No kissing(24%)

Restenosisrate (%)

10.0%

17.0%

6.6%

8.6%

P=0.07

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COLUMBUSCOLUMBUS Angiographic follow-upAngiographic follow-up

0

5

10

15

20


4.0%

12.0%

5.6%

4.6%

0

5

10

15

20


23% 28%

7.3%

11%

P=0.03 P=0.04

restenosis rate (%) One stent only Stents on both branches

= final kissing = No kissing

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Stent thrombosisStent thrombosis

0

1

2

3

acute sub- acute

and late

confirmed

one stent only both branches stent

0% 0.5%

1C

0.5% 2.5%

0.5% 1.5%

1 C

4T1C

2T1C

1C

(%)

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Provisional SB stenting

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Provisional Provisional BalloonBalloon –– TT stenting stenting of Bifurcation Lesionsof Bifurcation Lesions

11 22

BaselineBaseline Taxus 2.75/32: LADTaxus 2.75/32: LAD(wire protection of (wire protection of

Septal)Septal)

33

Balloon: D1Balloon: D1

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44 6655

• Taxus 2.5/24: Taxus 2.5/24: D1D1• Balloon: LADBalloon: LAD

Intermediate Intermediate resultresult

RESULTRESULT

3 STEPS:

-stent at 15-18atm. KISS-stent balloon down to 8 atm.-main branch balloon up to 20 atm.

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(8)(8)

Additional Taxus at proximal Additional Taxus at proximal LADLAD

(wire protection of RIM)(wire protection of RIM)

Final resultFinal result

(7)(7)

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Provisional Bifurcation Crush Provisional Bifurcation Crush StentingStenting with IVUS control

Baseline: LAD/ Diagonal

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Provisional Bifurcation Crush StentingProvisional Bifurcation Crush Stenting

Rotablation prox/mid LAD burr 1.5mm

After Rotablation

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Result after LAD stent

Stenting prox LAD, Cypher

3.5/33


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Result of SB Dilatation

Dilatation SBWiring SB

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Cypher stenting at side branch ostium:

2.5/18mm

MB: Quantum Maverick 3.5 mm

3 STEPS:

-stent at 15-18atm. KISS-stent balloon down to 8 atm.-main branch balloon up to 20 atm.

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FINAL RESULT

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Provisional Bifurcation Crush Provisional Bifurcation Crush StentingStenting IVUS controlled (Main

Branch)

Post bifurcation stentingAfter Rotabltor at MB,

before SB balloon dilatation

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Provisional Bifurcation Crush Provisional Bifurcation Crush StentingStenting Final IVUS: from MB to SB

diagonal

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Provisional Bifurcation Crush Provisional Bifurcation Crush StentingStenting Final IVUS: from SB to MB

Into the diagonal

LAD

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Provisional Bifurcation Crush Provisional Bifurcation Crush StentingStenting Final IVUS: from MB and

from SB

diaLAD

diaLAD

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Ostial disease: Type B, Type 4

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HSR 39456HSR 39456BaselineBaseline

V Stent-Balloon TechniqueV Stent-Balloon TechniqueFor bifurcational ostial lesions (IIIB and IV)For bifurcational ostial lesions (IIIB and IV)

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Step 1Step 1


HSR 39456HSR 39456

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Step 2Step 2


HSR 39456HSR 39456

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Final ResultFinal Result


HSR 39456HSR 39456

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COLUMBUSCOLUMBUS Randomized study MB vs MB and SB stentingSteigen et al ACC I2 Summit 2006

MB stenting 207 pts randomized vs MB+SB stenting 209

• Procedural and fluoro time, contrast use and biomarkers > when 2 stents where implanted

• 6 months MACE rates < 5% in 1 or 2 stents strategy with no difference

No report about angio FU, We do not know how many bifurcations where “True”

bifurcations: the lesion length in the SB was 6 mm vs 16 mm in the MB

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CACTUS: CACTUS:

A prospective randomized studyA prospective randomized study

n = 250 patients

6- 6- monthmonthAngio.Angio.

F/UF/U

6- 6- monthmonthAngio.Angio.

F/UF/URR Pre-dilatatioPre-dilatationn

de novo de novo TRUE TRUE bifurcation bifurcation lesions of the lesions of the native coronary native coronary arteriesarteries

de novo de novo TRUE TRUE bifurcation bifurcation lesions of the lesions of the native coronary native coronary arteriesarteries

“ “ Crushing” Crushing” CYPHER™ SELECT CYPHER™ SELECT

n = 125 n = 125

“ “ Crushing” Crushing” CYPHER™ SELECT CYPHER™ SELECT

n = 125 n = 125

Provisional TProvisional T CYPHER™ SELECT CYPHER™ SELECT

n = 125 n = 125

Provisional TProvisional T CYPHER™ SELECT CYPHER™ SELECT

n = 125 n = 125

12, 18, 24- month 12, 18, 24- month Clinical F/UClinical F/U

12, 18, 24- month 12, 18, 24- month Clinical F/UClinical F/U

1- 1- monthmonthClinic.Clinic.

F/UF/U

1- 1- monthmonthClinic.Clinic.

F/UF/U

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• Most bifurcations need the SB to stay Most bifurcations need the SB to stay

open at the end of the procedure, open at the end of the procedure,

residual stenosis appears less relevantresidual stenosis appears less relevant

• If optimal result on the side branch is If optimal result on the side branch is

important, in a true bifurcation 2 important, in a true bifurcation 2

stents may be needed at least 50% of the stents may be needed at least 50% of the

timetime

Conclusions for Conclusions for bifurcationsbifurcations

1 stent strategy 1 stent strategy

Angio F-U only if clinically Angio F-U only if clinically neededneeded

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