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Welcome to the 5thEuropean Bifurcation Club
16-17 September 2009 - BERLIN
Stent Thrombosis in Coronary
Bifurcation After DES Implantation
Insight From J-Cypher Registry
and Asian Multicenter Registry
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Sunao Nakamura
Department of Cardiology : New Tokyo Hospital
FACC, FAHA, FESC, FSCAI
Department of Advanced Cardiovascular Medicine
On behalf of the j-Cypher Registry Investigators
Kazushige Kadota MD. Kurashiki Central Hospital
Toshihiro Tamura MD. Kyoto University HospitalTakeshi Kimura MD. Kyoto University Hospital
Kazuaki Mitsudo MD. Kurashiki Central HospitalTakeshi Morimoto MD. Kyoto University Hospital
: Kumamoto University
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Ehime Prefectural Central HospitalOgaki Municipal HospitalOsaka City General HospitalOsaka Red Cross HospitalSaiseikai Noe HospitalKanazawa Cardiovascular HospitalShonan Kamakura General HospitalKawasaki Social Insurance HospitalTokusyukai Kisiwada HospitalNational Hospital Organization
Kyusyu Cardiovascular CenterKyoto University HospitalKyoto second Red Cross HospitalKurashiki Central HospitalGunma Prefectural Cardiovascular CenterNoto General HospitalKokura Memorial HospitalNational Cardiovascular CenterSaiseikai Kumamoto HospitalSaitama Prefectural Cardiovascular Hospital
Sizuoka General HospitalShinkoga HospitalShinbeppu HospitalSendai Kousei HospitalTsuchiya General HospitalTeikyo University HospitalTokushima Red Cross HospitalTominaga HospitalToyohashi Higashi HospitalNanpuh HospitalFukuoka University HospitalFukuyama Cardiovascular HospitalBanbuntane Hotokukai HospitalHokuto Cardiovascular HospitalHokkou Memorial HospitalMaizuru Kyosai HospitalMatsue Red Cross HospitalMie Heart CenterMiyazaki Ishikai HospitalWakayama Red Cross Hospital
The j-Cypher Registry
J-Cypher Paticipating Centers
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ESC 2008
Her Majesty's Cardiac Center,Siriraj Hospital
-Multicenter Registry in Asia-
Tamil Selvan Muthusamy M.D. (Malaysia)
Jang-Ho Bae M.D. (Korea)
Sudaratana Tansuphaswadikul M.D. (Thailand)
Sunao Nakamura M.D, Ph.D. (Japan)
Yeo Hans Cahyadi M.D. (Indonesia)
Damras Tresukosol M.D. (Thailand)
Wasan Udayachalerm M.D. (Thailand)
New Tokyo Hospital
Chest Disease Institute
Konyang University Hospital
Husada Hospital
King ChulalongkornMemorial Hospital
Damansara Heart Center
PrésentateurCommentaires de présentationThese are the cardio vascular centers, which participated in our registry.
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The j-Cypher Registry
Stent Thrombosis in Japanese/Asian
1. Low Incidence of Stent Thrombosis J-Cypher and Asian Multicenter Registry
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0
0.01
0.02
0.03
0.04
0.05
0 365 730 1095Follow-up interval (Days)
30 Days 1 Yr. 2 Yrs. 3 Yrs. Cumulative incidences 0.36% 0.61% 0.84% 1.18%n of pts at risk 12,824 12,625 11,843 9,036 4,191
Between 30 Days and 3 YearsSlope 0.28% / Year
ARC Definite
# Events: Not yet fully adjudicated
Stent Thrombosis in J-Cypher Registry
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Daemen J., et al., Lancet 2007; 369: 667–78.
Incidence, PES (%) 1.2 1.3 2.0 2.7 3.2
Patients at risk (n) 3626 3493 2667 1131 68
Definite Stent ThrombosisBern/Rotterdam vs j-Cypher
Bern / Rotterdam
j-CypherCumulative Incidence (%) 0.3 0.4 0.6 0.8 1.2
Patients at Risk (n) 12682 12625 11843 9036 4191
Bern / Rotterdam
j-Cypher
Between 30 Days and 3 YearsSlope 0.5% / Year
SES
PES
Between 30 Days and 3 YearsSlope 0.28% / Year
Incidence, SES (%) 1.0 1.1 1.3 1.9 2.5Patients at Risk (n) 3535 3508 2671 1710 903
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2.0
1.5
1.0
0.5
00 6 12 18 24 30 36 42 48 54 60
Time (months) Time (months)
SESPES
BMSDES
BMS vs DES SES vs PES %%
0 6 12 18 24 30 36 42 48 54 60
2.0
1.5
1.0
0.5
0
SAT 0.5%, LAST 0.18%/year
ARC Definite / Probable
Stent Thrombosis to 5 Years-Asian Multicenter Registry-
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The j-Cypher Registry
Stent Thrombosis in Japanese
2. Predictor of Stent Thrombosis Multivariate Analysis of
Early ST and Late/Very Late ST
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Multivariable analysis
Factors R.R. 95%C.I. P Value
Emergency procedure (ACS) 1.88 (1.13 - 2.9) 0.02
Male gender 1.45 (0.95 - 2.49) 0.09
LVEF ≤ 40% 1.29 (0.84 - 1.87) 0.23
Predictors of Early ST
Early ST in 43 lesions among 17,050 lesionstreated exclusively by Cypher
Those variables with p value
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0
0.01
0.02
0 365 730 1095
Stent Thrombosis in STEMI
ARC Definite
Log rank p=0.0019 STEMI
Others
Follow-up interval (Days)
30 Days 1 Yr. 2 Yrs. 3 YrsSTEMI 0.76% 1.01% 1.21% 1.37%
1,321 1,269 1,149 831 342Others 0.2% 0.36% 0.51% 0.73%
18,354 18,108 17,013 13,013 6,001
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Multivariable analysis
Factors R.R. 95%C.I. P Value
Hemodialysis 1.91 (1.29 - 2.65) 0.002
ESRD (e-GFR < 30/Non-HD) 1.81 (1.2 - 2.65) 0.007
Two stents for bifurcation 1.81 (1.17 - 2.59) 0.01
Predictors of LST / VLST
LST / VLST in 67 lesions among 16,801 lesionstreated exclusively by Cypher
Those variables with p value < 0.1 in the univariable analysis were incorporated into the multivariable model.
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The j-Cypher Registry
3. Discontinuation of Anti-platelet Therapyand Timing of Stent Thrombosis
Stent Thrombosis in Japanese
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Surgery During Follow-up
Follow-up interval (Days)30 Days 6 Mos. 1 Yr. 2 Yrs. 3 Yrs
n of pts 0.3% 2.0% 4.2% 8.6% 12.8%at risk 12824 12,607 12,062 11,289 3,944 758
Excluding endovascular treatment and CABG
Cumulative Incidence
0
0.1
0.2
0.3
0.4
0.5
0 365 730 1095
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Days after discontinuation 30 90 365 730Cumulative incidence 23% 40% 67% 85% Number of events 11 18 31 40Number of patients at risk 48 37 30 17 8
Days after discontinuation 7 14 21 28Cumulative incidence 4% 15% 19% 21% Number of events 2 7 9 10Number of patients at risk 48 46 41 39 38
Discontinuation of Anti-platelet Therapyand Timing of Stent Thrombosis
Inci
denc
e of
ste
nt th
rom
bosi
s
Days after discontinuation of anti-platelet therapyIn
cide
nce
of s
tent
thro
mbo
sis
Days after discontinuation of anti-platelet therapy
All Stent ThrombosisST within 30 Days
after Discontinuation of APT
0 365 730 10950
0.2
0.4
0.6
0.8
1
0
0.1
0.2
0.3
0.4
0.5
0 7 14 21 28
From around 7 Days Later
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The j-Cypher Registry
4. Role of Thienopyridine 6 months afterImplantation of DES
Stent Thrombosis in Japanese
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Anti-platelet Therapy Discontinuation
Stent Thrombosis and Discontinuation of Aspirin and/or Thienopyridine
Incidence of Definite Stent Thrombosis
Discontinuation of both thienopyridine and aspirin, but not discontinuationof thienopyridine therapy alone, was associated with an increased risk of ST
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6-Month Landmark Analysis
Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after SES implantation
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The j-Cypher Registry
Comparing 1. Bifur. vs Non Bifur.2. One Stent vs Two Stent
Left Main Substudy From J-Cypher Registry
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582 patients underwent PCI for ULMCA
(4.5% of whole population)
476 patients treated exclusively with SES for ULMCA
Patients excluded:74 patients with non-SES treatment for ULMCA(non-stent, BMS or other type of DES)
Patients excluded:28 patients with hybrid treatment for ULMCA(SES and BMS or other type of DES)
Left Main Substudy from the j-Cypher Registry
12242 patients underwent
PCI for non-ULMCA
Sub-Analysis
Main-AnalysisVs.
Patients excluded:4 patients missing information on lesion location of ULMCA or bifurcation stent strategy
Toyofuku M, et al. Circulation 2009 in press.
j-Cypher registry (August 2004-November 2006)12824 patients with first registration
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Baseline and Procedural CharacteristicsULMCA(n=582)
Non-ULMCA (n=12242)
P
Bifurcation lesion 81% 24%
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0
0.2
0.4
0.6
0.8
1
0 365 730 10950
0.2
0.4
0.6
0.8
1
0 365 730 1095
Interval(Days) 0 365 730 1095
Non-ULMCA
Incidence (%) 3.8 6.6 9.2
No. at risk 12242 11394 8737 4055
ULMCA
Incidence (%) 8.7 9.2 14.8
No. at risk 582 517 396 188
P < 0.0001
Non-ULMCA
ULMCA
Non-ULMCA
ULMCA
90.8%85.4%
Interval(Days) 0 365 730 1095
Non-ULMCA
Incidence (%) 2.1 4.1 6.1
ULMCA
Incidence (%) 2.5 5.0 7.4
P =0.12
93.9%92.6%
Sur
viva
l
Sur
viva
lDays after stent implantation Days after stent implantation
Unadjusted Survival Adjusted Survival
Left Main Substudy from the j-Cypher Registry
PrésentateurCommentaires de présentationFigure 2
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0
0.2
0.4
0.6
0.8
1
0 365 730 10950
0.2
0.4
0.6
0.8
1
0 365 730 1095
Sur
viva
l
92.4%
Interval (Days) 0 365 730 1095
Ostial/Shaft
Incidence (%) 9.8 9.8 9.8
No. at risk 96 82 65 22
Distal Bifurcation
Incidence (%) 5.6 7.2 7.6
No. at risk 380 347 266 138
(A) Cardiac Mortality (B) Target Lesion Revascularization
Ostial/shaft Lesion
Distal Bifurcation Lesion
Interval (Days) 0 365 730 1095
Ostial/Shaft
Incidence (%) 1.1 3.6 3.6
No. at risk 96 80 62 22
Distal Bifurcation
Incidence (%) 11.4 14.8 17.1
No. at risk 380 309 222 113
Ostial/shaft Lesion
Distal Bifurcation Lesion
P=0.41
90.2%
P=0.0047
96.4%
82.9%
Free
dom
from
TLR
Days after stent implantation Days after stent implantation
Lesion Location and Clinical OutcomeOstial / Shaft versus Bifurcation
Bifurcation Lesion !!
PrésentateurCommentaires de présentationFigure 4
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0
0.2
0.4
0.6
0.8
1
0 365 730 10950
0.2
0.4
0.6
0.8
1
0 365 730 1095
Day 0 365 730 1095
Bifurcation One
Incidence (%) 5.6 7.6 11.1
No. at risk 261 229 161 76
Bifurcation Two
Incidence (%) 24.6 30.9 30.9
No. at risk 119 81 62 37
Day 0 365 730 1095
Bifurcation One
Incidence (%) 3.9 4.9 5.5
No. at risk 261 242 180 86
Bifurcation Two
Incidence (%) 9.4 12.2 12.2
No. at risk 119 105 86 52
Bifurcation One
Bifurcation Two
Bifurcation One
Bifurcation Two
(A) Cardiac Mortality (B) Target Lesion Revascularization94.5%
87.8%
P=0.018 P
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The j-Cypher Registry
Bifurcation Substudy From J-Cypher Registry
Predictor of Target Lesion Revascularization
in Elective Two-Stent Technique
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Bifurcation stenting strategy
2250 Bifurcation lesions
Provisional stentingN=1978 (87.8%)
Elective stentingN=272 (12.1%)
One stentingN=1889 (84.0%)
Two stentingN=361 (16.0%)
89( 4.5% )02721889
Crossover
The j-Cypher Registry
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Culotte technique 15.4%
Kissing 5.1%
Provisional : 1978
Elective : 272
Crush technique 26.8%
Strategy of Elective Two-stent approach
T-Stenting 52.6%The j-Cypher Registry
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0.0
á—
¦
0 100 200 300 400 500 600 700 800 900 1000
Cumulative incidence of Definite Stent Thrombosis
Days after stent implantation
(%)
Days after stent implantation
Number of events
365
3
730
4Cumulative incidence 1.2% 1.7%
Inci
denc
e of
ste
nt th
rom
bosi
s
The j-Cypher Registry
1095
4
1.7%
3.0
1.0
2.0
0
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Multivariate Analysis for the Predictors of TLR
TLROdds ratio (95% C.I.) P Value
Postprocedural main vesselreference diameter
Total stent length
Crush stenting
Two stent in Cx lesion
Postprocedural side branchreference diameter
0.08 (0.01-0.38)
1.03 (1.01-1.05)
3.10 (1.20-14.1)
1.69 (1.09-2.60)
6.18 (1.25-33.2)
0.0010
0.0014
0.0163
0.0198
0.0250
The j-Cypher Registry
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The j-Cypher Registry
Bifurcation Substudy From J-Cypher Registry
Role of Final Kissing Balloon Technique
in Single Main Branch Stenting
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Provisional stentingN=1978 (87.8%)
Elective stentingN=272 (12.1%)
One stentingN=1889 (84.0%)
Two stentingN=361 (16.0%)
89( 4.5% )02721889
Crossover
The j-Cypher Registry
Bifurcation stenting strategy
2250 Bifurcation lesions
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Multivariate Analysis for the Predictors of TLR
TLROdds ratio (95% C.I.) P Value
Postprocedural main vesselReference diameter
Severe calcification
Total stent length
Gender (Male)
Hemodialysis
DM
0.48 (0.30-0.76)
1.54 (1.17-1.97)
1.02 (1.01-1.03)
1.44 (1.11-1.94)
1.61 (1.15-2.17)
1.23 (1.03-1.48)
0.0018
0.0027
0.0033
0.0053
0.0077
0.025
The j-Cypher Registry
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SB %DS after MB stenting
Unknown:18
FKB (+)N=562 (53.4%)
FKB (-)N=491 (46.6%)
One stentingN=1889 (84.0%)
N=1053(56.3%)50%%DS
N=818(43.7%)
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Role of FKB in Lesions
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Cum
ulat
ive
surv
ival
-free
of S
T
0 .00 1 00 2 00 3 00 4 00 5 00 6 00 7 00 8 00 9 00 1 00 0
0 .0
0 .1
0 .2
0 .3
0 1 00 2 00 3 00 4 00 5 00 6 00 7 00 8 00 9 00 1 00 0Cum
ulat
ive
surv
ival
-free
of T
LR
Role of KBT in Lesions ≥50% Side-branch Stenosis After Main-branch Stenting
TLR Definite ST
FKB (-)
Days after stent implantation Days after stent implantation
P=n.s.P=n.s.
10
20
30
0 0
1.0
0
0.5
(%) (%)
FKB (-)
FKB (-)FKB (-)
Even if the side branch %diameter stenosis was more than 50% after main branch stenting , the FKB did not provide the benefit regarding TLR.
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Summary
3. Discontinuation of both thienopyridine and aspirin, but not discontinuationof thienopyridine therapy alone, was associated with an increased risk of Stent Thrombosis.
1. The incidence of stent thrombosis in Asian races is relatively low.
0.6% BMS0.14% BMS
0 BMS
: 0.5% DES : 0.2% DES : 0.4%/2y DES
SATLASTVLAST
at mean follow-up 5 years
4. Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after SES implantation
2. Emergent procedure for AMI was an only predictor of ST in early STand Hemodialysis, chronic renal failure(e-GFR < 30/Non-HD) and usageof two stent in bifurcation were predictor of late and very late ST.
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2. Patients with ostial /body LMCA lesion had extremely low rate of TLR.
Left Main Substudy from the j-Cypher Registry
1. The adjusted survival rate was comparable between the Non LMT stentinggroup and LMT stenting group of patients.
3. Among patients treated for ULMCA, bifurcation two stenting was associated with markedly higher rate of TLR and significantly higher rate of cardiac death.
Summary
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2. Patients with ostial /body LMCA lesion had extremely low rate of TLR.
Left Main Substudy from the j-Cypher Registry
1. The adjusted survival rate was comparable between the Non LMT stentinggroup and LMT stenting group of patients.
3. Among patients treated for ULMCA, bifurcation two stenting was associated with markedly higher rate of TLR and significantly higher rate of cardiac death.
Summary
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The j-Cypher Registry
Bifurcation Substudy from the j-Cypher Registry
1. True bifurcatiion lesion was seen in 64% of J-cypher: bifurcation. And among them, Elective two-stent strategy was used in 12.1% of all bifurcation lesions.
2. The incidence of death are 9.2% and TLR and definite stent thrombosis were 18.5 and 1.7%.
3. Total stent length, postprocedual main and side vessel diameter, two stent in circumflex and crush stenting were the predictor of TLR.
Predictor of Target Lesion Revascularization
in Elective Two-Stent Technique
Summary
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The j-Cypher Registry
Bifurcation Substudy from the j-Cypher Registry
Role of Final Kissing Balloon Technique
in Single Main Branch Stenting
1. The incidence of cardiac death, TLR and definite stent thrombosis were 3.5%, 9.5% and 0.72% at 3 year.
2. post main vessel diameter, severe calcification,total stent length, gender(Male), Hemodialysis and DM were the predictor of TLR.
3. There was no significant differences regarding TLR between FKB group and non-FKB group. (Even if the side branch %diameter stenosis was more than 50% after main branch stenting, the FKB did not provide the benefit regarding TLR.)
Summary
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Twenty years ago…
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Koki MizunoCeltic/Scotland Maritimo/Portugal
Takahito Soma
Junichi InamotStade Rennais/France
Takayuki MorimoCatania/ItalyGrenoble/France
Daisuke Matsui
Wolfsburg/GermanyMakoto Hasebe
Espanyol/SpainShunsuke Nakamura
Bochum/GermanyShinji Ono
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Let’s Join Bifurcation Club
EBC and JBC
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