1. DEDICATION
Long-term outcome after drug-eluting versus
bare-metal stent implantation in patients with
ST-elevation myocardial infarction
3 year follow-up of the randomised DEDICATION trial
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
Copenhagen University Hospital
Rigshospitalet
Aarhus University Hospital
Skejby
Denmark

2. DEDICATION
Disclosures
The study has received unrestricted grants from the
Johnson & Johnson, Medtronic, Abbott, and Boston
Scientific companies
The presenter has previously or currently been involved in
research contracts, consulting or received research and
educational grants from:
Abbott, AstraZeneca, Aventis, Bayer, Bristol Myers Squibb,
Eli-Lilly, Merck, Myogen, Medtronic, Mitsubishi Pharma,
Nycomed, Organon, Pfizer, Pharmacia, Sanofi-Synthelabo,
Searle, The Medicines Company.

3. DEDICATION
Background
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

4. DEDICATION
Drug-Eluting vs Bare-Metal Stent
Implantation during Primary PCI
Previous published studies with ≥ 150 patients
Invasive RS,% MACE,% Primary
Study n FU DES/BMS DES/BMS endpoint p
STRATEGY 175 133 8/28 18/32 MACCE 0.001
TYPHOON 712 170 7/20 7/14 TVF 0.004
PASSION 619 - - 9/13 MACE 0.09
SESAMI 320 166 9/21 7/17 RS 0.03

5. DEDICATION
Purpose
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

6. DEDICATION
Flow chart
STEMI n=626
Randomization
+ Distal Protection - Distal Protection
Bare Metal Stent Drug Eluting Stent Bare Metal Stent Drug Eluting Stent
Post Procedure Angiography - QCA
1 month MACE
8 months Angiography - QCA / MACE
15 months MACE
3 years MACE

7. DEDICATION
Flow chart
STEMI n=626
Randomization
+ Distal Protection - Distal Protection
Bare Metal Stent Drug Eluting Stent Bare Metal Stent Drug Eluting Stent
Post Procedure Angiography - QCA
1 month MACE
8 months Angiography - QCA / MACE
15 months MACE
3 years MACE

8. DEDICATION
Endpoints
• MACE (cardiac death, re-infarction, TLR) at 3 years
• Cardiac death at 3 years
• Total mortality
• MI
• TLR
• TVR
• Stroke

9. 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

10. 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

11. DEDICATION
Study Flow
Screened patients
1687
Included patients Excluded patients
626 1061
24 deaths - 216 Clinically or psychologically
instability / unconsciousness
- 162 ST-elevation < 4 mm
83 lost to re-angiography - 141 Participation in another study
- 140 Vessel unsuitable for filterwire
- 78 Onset symptoms >12 hours
543 patients for re-angiography - 72 Linguistic problems
- 68 Screening log not filled in
602 patients for 8-month FU - 58 Previous infarction
- 43 Severe other disease
- 35 Refused to participate
29 deaths - 26 Significant left main stenosis
- 22 Other
573 patients for 3-year FU

12. DEDICATION
Number of Patients
STEMI - PPCI
n: 626
Randomization
Drug Eluting Stent Bare Metal Stent
n: 313 n: 313

13. DEDICATION
Baseline clinical characteristics
DES BMS p
n=313 n=313
Age (years) 62 63 0.41
Male gender (%) 72.8 73.5 0.93
Diabetes Mellitus (%) 9.3 11.5 0.30
Hypertension (%) 32.3 34.0 0.67
Hyperlipidemia (%) 18.7 21.4 0.54
Current smoker (%) 52.7 54.7 0.88
Family history of CAD (%) 37.3 38.2 0.87
Left ventricular ejection fraction 0.48 0.47 0.45
Previous myocardial infarction (%) 6.1 7.1 0.20
Previous PCI / CABG (%) 4.5 5.4 0.56
Symptom onset to arrival, min 197 200 0.69
Door-to-balloon, min 25 25 0.63

14. DEDICATION
Baseline lesion characteristics
DES BMS p
n=313 n=313
Infarct related coronary artery (%)
LAD 44 38
CX 11 14 0.57
RCA 45 48
Number of diseased vessel (%)
1 vessel disease 65 61
2 vessel disease 25 29 0.47
3 vessel disease 10 10
Baseline TIMI flow
TIMI 0-1 65 70
TIMI 2-3 35 30 0.27

15. DEDICATION
Procedural results
DES BMS p
n=313 n=313
Use of GP IIb/IIIa inhibitor, % 97 95 0.21
Visible thrombus,% 74 72 0.33
Filterwire used, % 40 42 0.38
Stent implanted, % 99 98 0.29
Number of stents per lesion 1.3 1.3 0.52
Stented length, mm 22.2 21.0 0.13
Stent diameter, mm 3.54 3.53 0.86
Max deployment pressure, mm Hg 16.7 16.3 0.20
TIMI III post procedure 90 90 1.00
Procedural success, % 98 99 0.73

16. DEDICATION
MACE during 3 years
30
DES
25
BMS
P<0.001
20 P=0.024
19.8
P<0.001
Events, %
18.2
15 16.3
P=0.084
10 11.5
10.5
P=0.013 P=0.58 8.9
5 6.4 6.1 P=0.45 6.1 P=0.64
5.4
4.2
3.2 3.2 2.6
1.9 1.9
0
Death Cardiac MI Re- TLR TVR Stroke MACE
death infarction

17. DEDICATION
Freedom from MACE
100
Freedom from MACE
80
60 DES
BMS
P=0.028
40
0 200 400 600 800 1000 1200
Days

18. DEDICATION
Freedom from all-cause mortality
100
Freedom from all-cause mortality (%)
80
60 DES
BMS
P=0.059
40
0 200 400 600 800 1000 1200
Days

19. DEDICATION
Freedom from cardiac mortality
100
Freedom from cardiac mortality (%)
80
60 DES
BMS
P=0.008
40
0 200 400 600 800 1000 1200
Days

20. DEDICATION
Any stent thrombosis
10
DES
Cumulative incidence (%)
8 BMS
P=0.511
6
4
2
0
0 200 400 600 800 1000 1200
Days

21. DEDICATION
Definite stent thrombosis
10
DES
Cumulative incidence (%)
8 BMS
P=0.296
6
4
2
0
0 200 400 600 800 1000 1200
Days

22. DEDICATION
Subgroup analysis
Group n Rate of MACE (%)
DES BMS Odds Ratio (95% CI)
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age ≥ 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
DM 65 13.8 22.2
no DM 561 11.3 17.7
Ref D > 3.1 mm 317 9.6 15.6
Ref D ≤ 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length ≤ 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX / RCA 368 9.4 16.4
0 0.5 1.0 0.5 2.0
DES better BMS better

23. DEDICATION
Subgroup analysis
Group n Rate of MACE (%)
DES BMS Odds Ratio (95% CI)
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age ≥ 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
DM 65 13.8 22.2
no DM 561 11.3 17.7
Ref D > 3.1 mm 317 9.6 15.6
Ref D ≤ 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length ≤ 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX / RCA 368 9.4 16.4
0 0.5 1.0 0.5 2.0
DES better BMS better

24. DEDICATION
Subgroup analysis
Group n Rate of MACE (%)
DES BMS Odds Ratio (95% CI)
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age ≥ 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
DM 65 13.8 22.2
no DM 561 11.3 17.7
Ref D > 3.1 mm 317 9.6 15.6
Ref D ≤ 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length ≤ 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX / RCA 368 9.4 16.4
0 0.5 1.0 0.5 2.0
DES better BMS better

25. DEDICATION
Subgroup analysis
Group n Rate of MACE (%)
DES BMS Odds Ratio (95% CI)
All 626 11.5 18.2
Age < 63 315 9.4 19.4
Age ≥ 63 311 13.7 17.1
Male 458 11.8 16.1
Female 168 10.6 24.1
DM 65 13.8 22.2
no DM 561 11.3 17.7
Ref D > 3.1 mm 317 9.6 15.6
Ref D ≤ 3.1 mm 299 12.0 20.8
Visible thrombus 458 11.6 15.9
No visible thrombus 168 11.1 24.1
Stent length > 18 mm 309 12.9 17.8
Stent length ≤ 18 mm 310 9.5 17.9
LAD 258 14.8 20.6
CX / RCA 368 9.4 16.4
0 0.5 1.0 0.5 2.0
DES better BMS better

26. DEDICATION
Conclusions
In the DEDICATION trial implantation of DES
(compared with BMS) in STEMI patients
• reduced the rate of MACE and the need for repeat
revascularization
• was not associated with an increased rate of myocardial
infarction or stent thrombosis
• was associated with an increased risk of cardiac death