DEDICATION DES in ACS - current state Leif Thuesen, D.M.Sc., FESC, Aarhus University Hospital,...
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Transcript of DEDICATION DES in ACS - current state Leif Thuesen, D.M.Sc., FESC, Aarhus University Hospital,...
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