DEDICATION

DES in ACS - current state

Leif Thuesen, D.M.Sc., FESC,Aarhus University Hospital, Skejby, Denmark

DEDICATION

Peter Clemmensen, Henning Kelbæk, Anne Kaltoft, Steffen Helqvist, Jens Flensted Lassen, Lene Kløvgaard, Christian J Terkelsen, Hans

Henrik Tilsted, Thomas Engstrøm, Lars R Krusell, Evald H. Christiansen, Kari Saunamäki, Erik Jørgensen, Hans E. Bøtker, Jan

Ravkilde, Klaus F Kofoed, Lars Køber, Leif Thuesen

Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with

ST-elevation myocardial infarction

3-year follow-up of the randomized DEDICATION trial

Copenhagen University HospitalRigshospitalet

Aarhus University HospitalSkejby

Denmark

DEDICATION

The study has received unrestricted grants from:

Johnson & Johnson; Medtronic; Abbott; and Boston Scientific

The presenter has previously or currently been involved in research contracts, consulting, speakers bureau or received research and educational grants from:Medtronic, Cordis, Boston Scientific, Abbot, Terumo.

Otherwise the authors have no disclosures withregard to the conduction of this study

Disclosures

DEDICATION

Implantation of drug eluting stents (DES) has proven to be both safe and efficient in most patients with coronary artery disease. However, long-term data are scarce with regard to their use in STEMI patients treated with PCI

Background

DEDICATIONDrug-Eluting vs Bare-Metal Stent Implantation during Primary PCI

Previous published studies with ≥ 150 patients

Study

STRATEGY

TYPHOON

PASSION

SESAMI

n

175

712

619

320

FU

133

170

-

166

DES/BMS

18/32

7/14

9/13

7/17

DES/BMS

8/28

7/20

-

9/21

endpoint

MACCE

TVF

MACE

RS

p

0.001

0.004

0.09

0.03

Invasive PrimaryRS,% MACE,%

DEDICATION

The purpose of this study was to evaluate the clinical results 3 years after implantation of DES vs BMS in STEMI patients treated with primary PCI

Purpose

DEDICATION

STEMI n=626

Randomization

+ Distal Protection - Distal Protection

Bare Metal Stent

MACE

Angiography - QCA / MACE

1 month

15 months

Bare Metal StentDrug Eluting Stent Drug Eluting Stent

Flow chart

Post Procedure Angiography - QCA

MACE

MACE

8 months

3 years

DEDICATION

STEMI n=626

Randomization

+ Distal Protection - Distal Protection

Bare Metal Stent

MACE

Angiography - QCA / MACE

1 month

15 months

Bare Metal StentDrug Eluting Stent Drug Eluting Stent

Flow chart

Post Procedure Angiography - QCA

MACE

MACE

8 months

3 years

DEDICATION

• MACE (cardiac death, re-infarction, TLR) at 3 years

• Cardiac death at 3 years• Total mortality• MI• TLR• TVR• Stroke

Endpoints

DEDICATION

Major inclusion criteria

• Patients who presented with the symptoms and signs of a first time large STEMI

• Chest pain ≤ 12 hours duration

• ST-elevation > 4 mm in contiguous leads

• High grade stenosis/occlusion of a native coronary artery that could be crossed with a guidewire

DEDICATION

Major exclusion criteria

• History of a previous myocardial infarction

• Left main stem stenosis

• Gastrointestinal bleeding within 1 month

• Expected survival < 1 year

• Linguistic difficulties needing an interpretor

DEDICATION

Screened patients1687

Included patients626

Excluded patients1061

- 216 Clinically or psychologically instability / unconsciousness- 162 ST-elevation < 4 mm- 141 Participation in another study- 140 Vessel unsuitable for filterwire- 78 Onset symptoms >12 hours- 72 Linguistic problems - 68 Screening log not filled in - 58 Previous infarction- 43 Severe other disease- 35 Refused to participate - 26 Significant left main stenosis- 22 Other

24 deaths

83 lost to re-angiography

Study Flow

543 patients for re-angiography

602 patients for 8-month FU

573 patients for 3-year FU

29 deaths

DEDICATION

STEMI - PPCI n: 626

Randomization

Drug Eluting Stentn: 313

Bare Metal Stentn: 313

Number of Patients

DEDICATION

Age (years)

Male gender (%)

Diabetes Mellitus (%)

Hypertension (%)

Hyperlipidemia (%)

Current smoker (%)

Family history of CAD (%)

Left ventricular ejection fraction

Previous myocardial infarction (%)

Previous PCI / CABG (%)

Symptom onset to arrival, min

Door-to-balloon, min

62

72.8

9.3

32.3

18.7

52.7

37.3

0.48

6.1

4.5

197

25

63

73.5

11.5

34.0

21.4

54.7

38.2

0.47

7.1

5.4

200

25

0.41

0.93

0.30

0.67

0.54

0.88

0.87

0.45

0.20

0.56

0.69

0.63

Baseline clinical characteristics

DESn=313

BMSn=313

p

DEDICATION

Infarct related coronary artery (%)

LAD

CX

RCA

Number of diseased vessel (%)

1 vessel disease

2 vessel disease

3 vessel disease

Baseline TIMI flow

TIMI 0-1

TIMI 2-3

44

11

45

65

25

10

65

35

38

14

48

61

29

10

70

30

0.57

0.47

Baseline lesion characteristics

0.27

DESn=313

BMSn=313

p

DEDICATION

Use of GP IIb/IIIa inhibitor, %

Visible thrombus,%

Filterwire used, %

Stent implanted, %

Number of stents per lesion

Stented length, mm

Stent diameter, mm

Max deployment pressure, mm Hg

TIMI III post procedure

Procedural success, %

97

74

40

99

1.3

22.2

3.54

16.7

90

98

95

72

42

98

1.3

21.0

3.53

16.3

90

99

0.21

0.33

0.38

0.29

0.52

0.13

0.86

0.20

1.00

0.73

Procedural results

DESn=313

BMSn=313

p

DEDICATION

11.5

18.2

0

5

10

15

20

25

30

Death Cardiacdeath

MI Re-infarction

TLR TVR Stroke MACE

Eve

nts

%

DES

BMS

P=0.024

MACE during 3 years

DEDICATION

0 200 400 600 800 1000 1200

P=0.028

DESBMS

100

80

60

40

Fre

edom

from

MA

CE

Freedom from MACE

Days

DEDICATION

11.5

3.2

8.9

6.1

1.94.2

6.1

10.5

18.2

2.6

19.8

16.3

3.25.4

1.9

6.4

0

5

10

15

20

25

30

Death Cardiacdeath

MI Re-infarction

TLR TVR Stroke MACE

Eve

nts

%

DES

BMS

P=0.084

P=0.013 P=0.58

P=0.45

P<0.001

P<0.001

P=0.64

P=0.024

MACE during 3 years

DEDICATION

0 200 400 600 800 1000 1200

P=0.059

DESBMS

100

80

60

40Fre

edom

from

all-

caus

e m

orta

lity

(%)

Freedom from all-cause mortality

Days

DEDICATION

0 200 400 600 800 1000 1200

P=0.008

DESBMS

100

80

60

40Fre

edom

from

car

diac

mor

talit

y (%

)

Freedom from cardiac mortality

Days

DEDICATION

10

8

6

4

2

0

P=0.511

DESBMS

Cum

ulat

ive

inci

denc

e (%

)

0 200 400 600 800 1000 1200

Any stent thrombosis

Days

DEDICATION

10

8

6

4

2

0

P=0.296

DESBMS

Cum

ulat

ive

inci

denc

e (%

)

0 200 400 600 800 1000 1200

Definite stent thrombosis

Days

DEDICATION

• reduced the rate of MACE and the need for repeatrevascularization

Conclusions

In the DEDICATION trial implantation of DES

(compared with BMS) in STEMI patients

• was not associated with an increased rate of myocardial

infarction or stent thrombosis

• was associated with an increased risk of cardiac death

Vink M. American College of Cardiology 2010 Scientific Sessions; March 16, 2010; Atlanta, GA.

PASSIONCardiac death, TLR and MACE

620 patients

Taxus BMS p

Cardiac death 9.5 % 11.5 % ns

TLR 7.3 % 10.5 % ns

MACE 18.3 % 22.0 % ns

Vink M. American College of Cardiology 2010 Scientific Sessions; March 16, 2010; Atlanta, GA.

PASSIONStent thrombosis

620 patients

Stent thrombosis

Taxus BMS p

Definite 3.6 % 1.7 % 0.20

Definite or probable

3.9 % 3.4 % 0.85

Possible 6.8 % 6.7 % 0.93

SESAMIThree-year event rates

320 patients

End pointSirolimus-eluting stent (%)

Bare-metal stent (%)

p

MACE 12.7 21.0 0.034

TLR 7.0 13.5 0.048

TVR 8.0 16.0 0.027

TVF 11.5 20.5 0.028

Violini R, et al. J Am Coll Cardiol 2010; 55:810-814.

End point Taxus n=2257

(%)

BMS n=749

(%)

Hazard ratio (95% CI)

TLR 4.5 7.5 0.59 (0.43–0.83)•Safety MACE 8.1 8.0 1.02 (0.76–1.36)•All-cause mortality 3.5 3.5 0.99 (0.64–1.55)•MI 3.7 4.5 0.81 (0.54–3.22)•Stroke 1.0 0.7 1.52 (0.58–4.00)•Stent thrombosis 3.1 3.4 0.92 (0.58–1.45)Lesion restenosis 10.0 22.9 0.44 (0.33–0.57)Patient restenosis 10.9 24.9 0.4 (0.33–0.57)

Stone G. TCT 2008; October 15, 2008; Washington, DC.

HORIZONS-AMI: Primary efficacy and safety end points

End point Taxus n=2257

(%)

BMS n=749

(%)

Hazard ratio (95% CI)

TLR 4.5 7.5 0.59 (0.43–0.83)•Safety MACE 8.1 8.0 1.02 (0.76–1.36)•All-cause mortality 3.5 3.5 0.99 (0.64–1.55)•MI 3.7 4.5 0.81 (0.54–3.22)•Stroke 1.0 0.7 1.52 (0.58–4.00)•Stent thrombosis 3.1 3.4 0.92 (0.58–1.45)Lesion restenosis 10.0 22.9 0.44 (0.33–0.57)Patient restenosis 10.9 24.9 0.4 (0.33–0.57)

Stone G. TCT 2008; October 15, 2008; Washington, DC.

HORIZONS-AMI: Primary efficacy and safety end points

End point Taxus n=2257

(%)

BMS n=749

(%)

Hazard ratio (95% CI)

TLR 4.5 7.5 0.59 (0.43–0.83)•Safety MACE 8.1 8.0 1.02 (0.76–1.36)•All-cause mortality 3.5 3.5 0.99 (0.64–1.55)•MI 3.7 4.5 0.81 (0.54–3.22)•Stroke 1.0 0.7 1.52 (0.58–4.00)•Stent thrombosis 3.1 3.4 0.92 (0.58–1.45)Lesion restenosis 10.0 22.9 0.44 (0.33–0.57)Patient restenosis 10.9 24.9 0.4 (0.33–0.57)

Stone G. TCT 2008; October 15, 2008; Washington, DC.

HORIZONS-AMI: Primary efficacy and safety end points

End point Taxus n=2257

(%)

BMS n=749

(%)

Hazard ratio (95% CI)

TLR 4.5 7.5 0.59 (0.43–0.83)•Safety MACE 8.1 8.0 1.02 (0.76–1.36)•All-cause mortality 3.5 3.5 0.99 (0.64–1.55)•MI 3.7 4.5 0.81 (0.54–3.22)•Stroke 1.0 0.7 1.52 (0.58–4.00)•Stent thrombosis 3.1 3.4 0.92 (0.58–1.45)Lesion restenosis 10.0 22.9 0.44 (0.33–0.57)Patient restenosis 10.9 24.9 0.4 (0.33–0.57)

Stone G. TCT 2008; October 15, 2008; Washington, DC.

HORIZONS-AMI: Primary efficacy and safety end points

DEDICATION

DES in ACS - current stateDES vs. BMS

• Increased efficacy

• Similar safety