Stent Thrombosis in Coronary Bifurcation After DES ...€¦ · Stent Thrombosis in Coronary...

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

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

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

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.


Stent Thrombosis in Japanese/Asian

1. Low Incidence of Stent Thrombosis J-Cypher and Asian Multicenter Registry

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

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


SES

PES


Incidence, SES (%) 1.0 1.1 1.3 1.9 2.5Patients at Risk (n) 3535 3508 2671 1710 903

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-


Stent Thrombosis in Japanese

2. Predictor of Stent Thrombosis Multivariate Analysis of

Early ST and Late/Very Late ST

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

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

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.


3. Discontinuation of Anti-platelet Therapyand Timing of Stent Thrombosis


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

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


4. Role of Thienopyridine 6 months afterImplantation of DES


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

6-Month Landmark Analysis

Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after SES implantation


Comparing 1. Bifur. vs Non Bifur.2. One Stent vs Two Stent

Left Main Substudy From J-Cypher Registry

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

Baseline and Procedural CharacteristicsULMCA(n=582)

Non-ULMCA (n=12242)

P

Bifurcation lesion 81% 24%

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


PrésentateurCommentaires de présentationFigure 2

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

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


Bifurcation Substudy From J-Cypher Registry

Predictor of Target Lesion Revascularization

in Elective Two-Stent Technique

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


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

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


1095

4

1.7%

3.0

1.0

2.0

0

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



Bifurcation Substudy From J-Cypher Registry

Role of Final Kissing Balloon Technique

in Single Main Branch Stenting

Provisional stentingN=1978 (87.8%)

Elective stentingN=272 (12.1%)


Two stentingN=361 (16.0%)

89( 4.5% )02721889

Crossover


Bifurcation stenting strategy

2250 Bifurcation lesions

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


SB %DS after MB stenting

Unknown:18

FKB (+)N=562 (53.4%)

FKB (-)N=491 (46.6%)


N=1053(56.3%)50%%DS

N=818(43.7%)

Role of FKB in Lesions

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.

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.

2. Patients with ostial /body LMCA lesion had extremely low rate of TLR.


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


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


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

Twenty years ago…

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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Stent Thrombosis in Coronary Bifurcation After DES ...€¦ · Stent Thrombosis in Coronary...

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