1 2008PCI 新进展. 2 ﻤ Dﻤ DES 的安全性得到进一步确认 ﻤ 复ﻤ 复杂血管病变的选择 : CABG 还是 PCI ？ ﻤ 冠ﻤ 冠状动脉分叉病变：处理越简单越好？

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2008PCI 新进展2008PCI 新进展

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DES م 的安全性得到进一步确认复杂血管病变的选择 م : CABG 还是 PCI ？？冠状动脉分叉病变：处理越简单越好 م血流储备分数指导的 م PCI 治疗新一代可吸收或可降解药物洗脱支架 م？比伐卢定能否替代普通肝素 م

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Kirtane AJ, Stone GW. Comprehensive meta-analysis of DES vs BMS randomized trials and registries; March 28, 2008; Chicago, IL.

MEGA meta-analysis MEGA meta-analysis

Study type Patients,

n

Trials,

n

Relative

risk

p

RCT: all 8867 21 0.97 0.72a

RCT: on-label 4818 10 1.05 0.69a

RCT: off-label 4049 12 0.84 0.24a

Registries 161 232 28 0.80 <0.001b

a. Fixed-effects modelb. Random-effects model

All-cause mortality

5


MIMI


n

Trials,

n

Relative

risk

p

RCT: all 8850 20 0.94 0.54a

RCT: on-label 4318 9 1.03 0.82a

RCT: off-label 4532 12 0.77 0.19b

Registries 129 955 24 0.89 0.023b

a. Fixed-effects modelb. Random-effects model


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Target-vessel revascularizationTarget-vessel revascularization


n

Trials,

n

Relative

risk

P*

RCT: all 7291 16 0.45 <0.001

RCT: on-label 4618 9 0.53 <0.001

RCT: off-label 2673 8 0.38 <0.001

Registries 73 819 17 0.53 <0.001

*Random-effects model


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The safety and effectiveness of the *TAXUS® Express2® Stent System have not been established in the following patient populations: patients with vessel thrombus at the lesion site;

patients with coronary artery lesions longer than 28 mm or requiring more than one TAXUS Stent; lesions located in the unprotected left main coronary artery, or lesions located at a

bifurcation/trifurcation; patients with moderate or severe calcification in the lesion or a chronic total occlusion; or patients with multi-vessel disease. The TAXUS Express Stent System has not

been specifically indicated for patients with diabetes.

SYNTAX (SYNergy between PCI with

TAXUS* and cardiac surgery)

9

Patient ProfilingPatient Profiling

Local Heart team (surgeon & interventional cardiologist) assessed each patient in regards to:

Patient’s operative risk (EuroSCORE & Parsonnet score)

Coronary lesion complexity (newly developed SYNTAX score)

• The goal of the SYNTAX score is to

provide a tool to assist physicians in their revascularization strategies for patients with high risk lesions

Sianos et al, EuroIntervention 2005;1:219-227Valgimigli et al, Am J Cardiol 2007;99:1072-1081Serruys et al, EuroIntervention 2007;3:450-459Coronary tree segments based on the classification proposed by the AHA and modified for the ARTS study Circulation 1975; 51:31-3 & Semin Interv Cardiol 1999; 4:209-19

Leaman score, Circ 1981;63:285-299Lesions classification ACC/AHA , Circ 2001;103:3019-3041Bifurcation classification, CCI 2000;49:274-283CTO classification, J Am Coll Cardiol 1997;30:649-656

Tortuosity

Thrombus

Bifurcation

Total Occlusion

3 Vessel

Left Main

Dominance

Calcification

Number & location

of lesions

SYNTAXscore

10

71% enrolled (N=3,075)

All Pts with de novo 3VD and/or LM disease (N=4,337)

Treatment preference (9.4%) Referring MD or pts. refused

informed consent (7.0%) Inclusion/exclusion (4.7%) Withdrew before consent (4.3%) Other (1.8%) Medical treatment (1.2%)TAXUS

n=903PCI

n=198CABG

n=1077CABGn=897

no f/un=428

5yr f/un=649

PCIall captured w/

follow up

CABG2500

750 w/ f/uvsvs

Total enrollment N=3075

Stratification: LM and Diabetes

Two Registry ArmsRandomized Armsn=1800

Two Registry ArmsN=1275

Randomized ArmsN=1800

Heart Team (surgeon & interventionalist)

PCIN=198

CABGN=1077

Amenable for only one treatment approach

TAXUS*

N=903 CABG

N=897vsvs

Amenable for bothtreatment options

Stratification: LM and Diabetes

LM33.7%

3VD66.3%

LM34.6%

3VD65.4%

DM 28.5%

Non DM71.5%

NonDM71.8%

DM28.2%

23 US Sites62 EU Sites +

SYNTAX Trial DesignSYNTAX Trial Design

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Adverse Events to 12 Months

ITT populationEvent Rate ± 1.5 SE, *Fisher exact test

All Death

Revascularization

CVA (Stroke)

Myocardial Infarction

TAXUS* (N=903)CABG (N=897)

12

MACCE to 12 MonthsMACCE to 12 Months

P=0.0015*

0 6 12

10

20

0

Months Since Allocation

Cu

mu

lati

ve E

ven

t R

ate

(%

)

ITT population

12.1%

17.8%

Event Rate ± 1.5 SE. *Fisher’s Exact Test


13

Symptomatic Graft Occlusion & Symptomatic Graft Occlusion & Stent Thrombosis to 12 MonthsStent Thrombosis to 12 MonthsSymptomatic Graft Occlusion & Symptomatic Graft Occlusion & Stent Thrombosis to 12 MonthsStent Thrombosis to 12 Months

3.33.33.43.4

CABGCABG TAXUSTAXUS

P=0.89Pati

en

ts (

%)

n=27n=27 n=28n=28

ITT population


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Overall MACCE at 12 MonthsOverall MACCE at 12 MonthsLeft Main Subset

Overall MACCE at 12 MonthsOverall MACCE at 12 MonthsLeft Main Subset

ITT population

8.5

13.2

15.8

19.8 19.3

13.715.4

14.4

7.57.1

0

5

10

15

20

25

LM all LM only LM+1VD LM+2VD LM+3VD

TAXUS*CABG

(n=705) (n=91) (n=138) (n=218) (n=258)

P=0.44 P=1.0 P=0.27 P=0.29 P=0.42

Pati

en

ts

(%)

15

2.1

7.47

9.9

8.19.2

14.5

7.7

4.5

00

2

4

6

8

10

12

14

16

LM all LM only LM+1VD LM+2VD LM+3VD

TAXUS*CABG

(n=705) (n=91) (n=138) (n=218) (n=258)

Pati

en

ts

(%)

Safety at 12 MonthsSafety at 12 MonthsDeath/CVA/MI Death/CVA/MI in the in the Left Main Subset

P=0.29 P=1.0 P=0.72 P=0.57 P=0.11

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MACCE to 12 Months 3VD Subset

MACCE to 12 Months 3VD Subset

0 6 12

20

40

0

Months Since Allocation

Cu

mu

lati

ve E

ven

t R

ate

(%

) P<0.001*

19.1%

11.2%

ITT populationEvent Rate ± 1.5 SE, *Fisher exact test

TAXUS (n=546)CABG (n=549)

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1.2 1.0

2.41.7

5.2

2.2

0.2

2.4

3.5

6.0

0

5

10

Death CVA MI Revasc. MACCE

MACCE Components 3VD to 30 Days

P=0.08*

30

Day E

ven

t R

ate

, %

P=0.03* P=0.02*P=0.20†

TAXUS* (n=546)CABG (n=549)

P=0.45*

*chi-square test; †Fisher exact test

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6.68.0

CABG TAXUS*

P=0.39

3 Vessel Disease*

n=34 n=43

*per protocol and ITT populations had same outcome

Combined Safety (Death/CVA/MI) 3VD

Pati

en

ts (

%)

19

14.413.5

11.7

16.6

10.7

23.3

0

5

10

15

20

25

30

MACCE to 12 Months vs SYNTAX Score

SYNTAX Score

≤22

PP=0.10=0.10 PP<0.001<0.001PP=0.71=0.71

12-m

on

th M

AC

CE,

%

SYNTAX ScoreKM Estimates, Event Rate ± 1.5 SE; *chi square test; raw SYNTAX score for illustrative purposes only

RCT ITT pts; site-reported data

SYNTAX Score

23-32

SYNTAX Score

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BBC ONEBBC ONE

The British Bifurcation Coronary study: Old, New and Evolving strategies

a randomized comparison of simple versus complex drug-eluting stenting for bifurcation lesions

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PRIMARY ENDPOINTComposite (9months) Death, MI, TVF

PRIMARY ENDPOINTComposite (9months) Death, MI, TVF

Complex Simple P value Death 2 (0.8%) 1 (0.4%) - Myocardial infarction

28 (11.2%) 9 (3.6%) 0.001

Target vessel failure

18 (7.2%) 14 (5.6%) -

Primary endpoint 38 (15.2%) 20 (8.0%)

0.009HR 2.0 (1.2 to

3.5)

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In-hospital MACCEIn-hospital MACCE

Complex

Simple P value

No. patients 20 (8.0%) 5 (2.0%) 0.002RR 4.0 (1.5 to

10.5)

Death 1 0

Myocardial infarction

18 5

CABG 3 0

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CONCLUSIONSCONCLUSIONS

For unselected bifurcation lesions, a stepwise provisional T stent trategy is superior to a systematic dual tenting strategy in all domains:

procedural success procedural complications in-hospital and 9-month MACE

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FRACTIONAL FLOW RESERVE FRACTIONAL FLOW RESERVE versusversus ANGIOGRAPHY FOR GUIDING PCI IN ANGIOGRAPHY FOR GUIDING PCI IN PATIENTS WITH MULTIVESSEL CORONARY PATIENTS WITH MULTIVESSEL CORONARY ARTERY DISEASEARTERY DISEASE

FAMEFAME

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ANGIO-group

N=496

FFR-group

N=509P-valueP-value

Events at 1 year, No (%)Events at 1 year, No (%)

Death, MI, CABG, or repeat-PCIDeath, MI, CABG, or repeat-PCI 91 (18.4) 67 (13.2) 0.020.02

DeathDeath 15 (3.0) 9 (1.8) 0.190.19

Death or myocardial infarctionDeath or myocardial infarction 55 (11.1) 37 (7.3) 0.040.04

CABG or repeat PCICABG or repeat PCI 47 (9.5) 33 (6.5) 0.080.08

Total no. of MACETotal no. of MACE 113 76 0.020.02

Adverse Events at 1 yearAdverse Events at 1 year

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FAME study: Procedural ResultsFAME study: Procedural Results

ANGIO-group

N=496

FFR-group

N=509P-valueP-value

Procedure time (min)Procedure time (min) 70 ± 44 71 ± 43 0.510.51

Contrast agent used (ml)Contrast agent used (ml) 302 ± 127 272 ± 133 <0.001<0.001

Materials used at procedure Materials used at procedure

(US $)(US $)

6007 5332 <0.001<0.001

Length of hospital stay (days)Length of hospital stay (days) 3.7 ± 3.5 3.4 ± 3.3 0.050.05

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Routine measurement of FFR during DES-Routine measurement of FFR during DES-stenting in patients with multivessel disease is stenting in patients with multivessel disease is superior to current angiography guided superior to current angiography guided treatment.treatment.

It improves outcome of PCI significantlyIt improves outcome of PCI significantly

It supports the evolving paradigm of It supports the evolving paradigm of “Functionally Complete Revascularization”, i.e. “Functionally Complete Revascularization”, i.e. stenting of ischemic lesions and medical stenting of ischemic lesions and medical treatment of non-ischemic ones.treatment of non-ischemic ones.

FAME study: CONCLUSIONS FAME study: CONCLUSIONS

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ABSORBABSORB

The goal of this trial was to evaluate the use of The goal of this trial was to evaluate the use of a bioabsorbable drug-eluting stent (DES) platfa bioabsorbable drug-eluting stent (DES) platform among patients undergoing elective percuorm among patients undergoing elective percutaneous coronary intervention (PCI) for a de ntaneous coronary intervention (PCI) for a de n

ovo coronary lesion.ovo coronary lesion.

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CharacteristicEverolimus eluting

stent platform(n=30)

Mean minimum lumen diameter (MLD) (mm) 1.10

Percent stenosis (%) 59

Lesion length (mm) 8.66

LAD Lesion location (%) 50

Type B1 lesions (%) 65

ABSORB Trial: Baseline Characteristics

ABSORB Trial: Baseline Characteristics

ACC 2007ACC 2007

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stent platform(n=26)

Mean MLD (mm) 2.33

Stenosis (%) 16

ABSORB Trial: Post-procedure Data

ABSORB Trial: Post-procedure Data

ACC 2007ACC 2007

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stent platform (n=26)

In-stent late loss (mm) 0.44

Mean MLD (mm) 1.88

Stenosis (%) 27

Volume Obstruction (%) 5.54

Neointimal volume (mm3) 4.26

Incomplete apposition at 6 mos. (% of patients) 23.1

Late incomplete apposition (% of patients) 26.9

ABSORB Trial: Six Month Follow-up Characteristics

ABSORB Trial: Six Month Follow-up Characteristics

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Biolimus-Eluting Stent With Biodegradable Polymer Versus Sirolimus-Eluting Stent With Durable

Polymer:

A Randomised, Non-Inferiority Trial

Biolimus-Eluting Stent With Biodegradable Polymer Versus Sirolimus-Eluting Stent With Durable

Polymer:

A Randomised, Non-Inferiority Trial

LEADERS

36

0

5

10

15

850 791 786 784 781 777 771 758 751 746857 806 798 796 792 784 779 777 771 761

No. at risk

0 1 2 3 4 5 6 7 8 9Months of Follow-up

SESBES

Cumulative Incidence (%)

Primary EndpointCardiac Death, MI, or TVR @ 9 months

Sirolimus Stent 10.5%

Biolimus Stent 9.2%

Risk Difference -1.3%, Upper Limit 95% CI 1.1%

Pnon-inferiority = 0.003

Rate Ratio = 0.88, 95% CI 0.64 - 1.19

37

2.6

1.6

5.75.3

0.5

6.7

2.8 2.5

4.63.9

0.8

6.6

0

2

4

6

8

10

Death CardiacDeath

MyocardialInfarction

NQWMI QWMI CardiacDeath or MI

Biolimus Stent (N=857) Sirolimus Stent (N=850)

Safety Endpoints @ 9 MonthsRR=0.91

(0.51-1.62)P=0.74*

%

RR=1.36(0.87-2.15)

P=0.18*

RR=0.56(0.16-1.93)

P=0.35*

RR=1.01(0.70-1.47)

P=0.95*

RR=1.25(0.82-1.92)

P=0.30*

RR=0.66(0.34-1.30)

P=0.22*

* P values for superiority

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Angiographic Follow-up @ 9 MonthsEndpoint: Percent Diameter Stenosis

Angiographic Follow-up @ 9 MonthsEndpoint: Percent Diameter Stenosis

0

10

20

30

40

Biolimus Stent Sirolimus Stent

In-Stent In-Segment

% D

iam

ete

r S

teno

sis

N=253 N=231 N=253 N=231

20.9 ± 17.523.3 ± 19.6

0

10

20

30

40

Biolimus Stent Sirolimus Stent

27.1 ± 16.429.9 ± 18.5

2.2% (95% CI -6.0 to 1.6)Pnon-inferiority=0.001

% D

iam

ete

r S

teno

sis

39

SummarySummary

ABSORB: Among patients undergoing elective PCI for a single de novo lesion, short term follow-up data in a very small number of patients have shown feasibility of use of bioabsorbable everolimus-eluting stents

LEADERS :Since non-inferiority was achieved for the clinical and angiographic outcome measures in a non-restricted patient population with predominant off-label characteristics, the findings of the present study provide a high level of generalisability to routine clinical practice.

ABSORB: Among patients undergoing elective PCI for a single de novo lesion, short term follow-up data in a very small number of patients have shown feasibility of use of bioabsorbable everolimus-eluting stents

LEADERS :Since non-inferiority was achieved for the clinical and angiographic outcome measures in a non-restricted patient population with predominant off-label characteristics, the findings of the present study provide a high level of generalisability to routine clinical practice.

ACC 2007ACC 2007

40


41

ISAR-REACT 3 ISAR-REACT 3

Is bivalirudin superior to UFH in patients with stable or unstable angina undergoing PCI after

pre-treatment with 600 mg of clopidogrel?

42

ISAR-REACT 3 ResultsISAR-REACT 3 Results Primary composite endpoint : bivalirudin 8.3% vs UFH 8.7%

RR = 0.94 (95% CI, 0.77-1.15) p=0.57

Ischemic composite: bivalirudin 5.9% vs UFH 5.0%

RR= 1.16 (95% CI, 0.91 – 1.49) p=0.23

Major bleeding reduced by 33% with bivalirudin

4.6% vs 3.1% UFH

RR= 0.67 (95% CI, 0.50 - 091) p=0.0001

TIMI major bleeding reduced by 50% with bivalirudin

1.0% vs 0.5% UFH

RR= 0.50 (95% CI, 0.23 – 0.98) p=0.04

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PROlonged Bivalirudin Infusion Versus PROlonged Bivalirudin Infusion Versus Intraprocedural only RandomIzed study. Intraprocedural only RandomIzed study. PROlonged Bivalirudin Infusion Versus PROlonged Bivalirudin Infusion Versus

Intraprocedural only RandomIzed study. Intraprocedural only RandomIzed study.

PROBI VIRIPROBI VIRI

44

Results- P.E.Results- P.E.Results- P.E.Results- P.E.

0

5

10

15

20

25

30

Short Bivalirudin Long Bivalirudin

16,7%16,7%

6,8%6,8%p=0.041

45

CONTROL

GROUP

(n=90)

PROL BIV

(n=88)

p value

30-days MACE, %30-days MACE, % 3,33,3 1,11,1 0.430.43

Death, % 1,1 0 0.37

Q-wave MI, % 2,2 1,1 0.7

TVR, % 1,1 0 0.37

6-months MACE, %6-months MACE, % 16,716,7 10,210,2 0.180.18

Death, % 2,2 1,1 0.7

Q-wave MI, % 4,4 3,4 0.76

TVR, % 12,2 8,0 0.33

Stent thrombosis, % 0 0 1

ResultsResults

46

In-hospital Major Bleedings, %In-hospital Major Bleedings, % 1,11,1 1,11,1 0.870.87

In-hospital Minor Bleedings, %In-hospital Minor Bleedings, % 3,33,3 3,43,4 0.960.96

86,6% radial

access!

ResultsResults

CONTROL

GROUP (n=90)

PROL BIV

(n=88)

p value

47

ConclusionsConclusionsConclusionsConclusions

Urgent or Emergent PCI

In a complex PCI setting, bivalirudin prolonged infusion after PCI seems a promising choice to reduce myocardial injury

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Documents

1 2008PCI 新进展. 2 ﻤ Dﻤ DES 的安全性得到进一步确认 ﻤ 复ﻤ 复杂血管病变的选择 : CABG 还是 PCI ？ ﻤ 冠ﻤ 冠状动脉分叉病变：处理越简单越好？