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:Abbott, AstraZeneca, Aventis, Bayer, Bristol Myers Squibb, Eli-Lilly, Fibrex, Merck, Myogen, Medtronic, Mitsubishi Pharma, The Medicines Company, Nycomed, Organon, Pfizer, Pharmacia, Sanofi-Synthelabo, Searle, Servier.

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

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=0.028

DESBMS

100

80

60

40

Fre

edom

from

MA

CE

Freedom from MACE

Days

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

0 0.5 1.0 0.5 2.0

no DM 561 11.3 17.7

DM 65 13.8 22.2

Female 168 10.6 24.1

Male 458 11.8 16.1

Age 63 311 13.7 17.1

Age < 63 315 9.4 19.4

All 626 11.5 18.2

Group nDES BMS

DES better BMS better

Odds Ratio (95% CI)

Rate of MACE (%)

Subgroup analysis

CX / RCA 368 9.4 16.4LAD 258 14.8 20.6Stent length 18 mm 310 9.5 17.9Stent length > 18 mm 309 12.9 17.8No visible thrombus 168 11.1 24.1

Visible thrombus 458 11.6 15.9

Ref D 3.1 mm 299 12.0 20.8Ref D > 3.1 mm317 9.6 15.6

DEDICATION

0 0.5 1.0 0.5 2.0

no DM 561 11.3 17.7

DM 65 13.8 22.2

Female 168 10.6 24.1

Male 458 11.8 16.1

Age 63 311 13.7 17.1

Age < 63 315 9.4 19.4

All 626 11.5 18.2

Group nDES BMS

DES better BMS better

Odds Ratio (95% CI)

Rate of MACE (%)

Subgroup analysis

CX / RCA 368 9.4 16.4LAD 258 14.8 20.6Stent length 18 mm 310 9.5 17.9Stent length > 18 mm 309 12.9 17.8No visible thrombus 168 11.1 24.1

Visible thrombus 458 11.6 15.9

Ref D 3.1 mm 299 12.0 20.8Ref D > 3.1 mm317 9.6 15.6

DEDICATION

0 0.5 1.0 0.5 2.0

no DM 561 11.3 17.7

DM 65 13.8 22.2

Female 168 10.6 24.1

Male 458 11.8 16.1

Age 63 311 13.7 17.1

Age < 63 315 9.4 19.4

All 626 11.5 18.2

Group nDES BMS

DES better BMS better

Odds Ratio (95% CI)

Rate of MACE (%)

Subgroup analysis

CX / RCA 368 9.4 16.4LAD 258 14.8 20.6Stent length 18 mm 310 9.5 17.9Stent length > 18 mm 309 12.9 17.8No visible thrombus 168 11.1 24.1

Visible thrombus 458 11.6 15.9

Ref D 3.1 mm 299 12.0 20.8Ref D > 3.1 mm317 9.6 15.6

DEDICATION

0 0.5 1.0 0.5 2.0

no DM 561 11.3 17.7

DM 65 13.8 22.2

Female 168 10.6 24.1

Male 458 11.8 16.1

Age 63 311 13.7 17.1

Age < 63 315 9.4 19.4

All 626 11.5 18.2

Group nDES BMS

DES better BMS better

Odds Ratio (95% CI)

Rate of MACE (%)

Subgroup analysis

CX / RCA 368 9.4 16.4LAD 258 14.8 20.6Stent length 18 mm 310 9.5 17.9Stent length > 18 mm 309 12.9 17.8No visible thrombus 168 11.1 24.1

Visible thrombus 458 11.6 15.9

Ref D 3.1 mm 299 12.0 20.8Ref D > 3.1 mm317 9.6 15.6

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