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 randomised DEDICATION trial Copenhagen University Hospital Rigshospitalet Aarhus University Hospital Skejby Denmark
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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 randomised DEDICATION trial
Copenhagen University HospitalRigshospitalet
Aarhus University HospitalSkejby
Denmark
DEDICATION
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.
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