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CENTRO CENTRO
CUORE CUORE
COLUMBUSCOLUMBUS
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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COLUMBUSCOLUMBUS
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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COLUMBUSCOLUMBUS
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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COLUMBUSCOLUMBUS
11162/0211162/02
Treatment of Bifurcation Lesion with two stentsTreatment of Bifurcation Lesion with two stents
BaselineBaseline
TreatmentTreatment
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COLUMBUSCOLUMBUS
11162/0211162/02
Treatment of Bifurcation Lesion with two stentsTreatment of Bifurcation Lesion with two stents
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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COLUMBUSCOLUMBUS DES in Bifurcation Lesions
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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COLUMBUSCOLUMBUS DES in Bifurcation Lesions
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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COLUMBUSCOLUMBUSDDES in Bifurcation LesionES in Bifurcation Lesion
Milan ExperienceMilan ExperienceClinical Follow-Up at 12 Clinical Follow-Up at 12
months (n=367) months (n=367) All patientsAll patients
Group 1S Group 1S (n = 185 (n = 185 patients)patients)
Group 2S Group 2S (n = 183 (n = 183 patients)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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COLUMBUSCOLUMBUSDDES in Bifurcation LesionES in Bifurcation Lesion
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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COLUMBUSCOLUMBUSDDES in Bifurcation LesionES in Bifurcation Lesion
Milan ExperienceMilan Experience
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
Main branch Side branch
4.0%
12.0%
5.6%
4.6%
0
5
10
15
20
Main branch Side branch
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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COLUMBUSCOLUMBUSDDES in Bifurcation LesionES in Bifurcation Lesion
Milan ExperienceMilan Experience
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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Provisional Provisional BalloonBalloon –– TT stenting stenting of Bifurcation Lesionsof Bifurcation Lesions
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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Provisional Provisional BalloonBalloon –– TT stenting stenting of Bifurcation Lesionsof Bifurcation Lesions
(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
Provisional Bifurcation Crush StentingProvisional Bifurcation Crush Stenting
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Provisional Bifurcation Crush StentingProvisional Bifurcation Crush Stenting
Result of SB Dilatation
Dilatation SBWiring SB
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Provisional Bifurcation Crush StentingProvisional Bifurcation Crush Stenting
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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Provisional Bifurcation Crush StentingProvisional Bifurcation Crush Stenting
FINAL RESULT
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COLUMBUSCOLUMBUS
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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COLUMBUSCOLUMBUS
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
V Stent-Balloon TechniqueV Stent-Balloon TechniqueFor bifurcational ostial lesions (IIIB and IV)For bifurcational ostial lesions (IIIB and IV)
HSR 39456HSR 39456
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Step 2Step 2
V Stent-Balloon TechniqueV Stent-Balloon TechniqueFor bifurcational ostial lesions (IIIB and IV)For bifurcational ostial lesions (IIIB and IV)
HSR 39456HSR 39456
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Final ResultFinal Result
V Stent-Balloon TechniqueV Stent-Balloon TechniqueFor bifurcational ostial lesions (IIIB and IV)For bifurcational ostial lesions (IIIB and IV)
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