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

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Presentation on theme: "DEDICATION Peter Clemmensen, Henning Kelbæk, Anne Kaltoft, Steffen Helqvist, Jens Flensted Lassen, Lene Kløvgaard, Christian J Terkelsen, Hans Henrik Tilsted,"— Presentation transcript:

1 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 Hospital Rigshospitalet Aarhus University Hospital Skejby Denmark

2 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 with regard to the conduction of this study Disclosures

3 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

4 DEDICATION Drug-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 Primary RS,% MACE,%

5 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

6 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 Flow chart Post Procedure Angiography - QCA MACE 8 months 3 years

7 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 Flow chart Post Procedure Angiography - QCA MACE 8 months 3 years

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

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 Screened patients 1687 Included patients 626 Excluded patients 1061 - 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

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

13 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 DES n=313 BMS n=313 p

14 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 DES n=313 BMS n=313 p

15 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 DES n=313 BMS n=313 p

16 DEDICATION P=0.084 P=0.013 P=0.58 P=0.45 P<0.001 P=0.64 P=0.024 MACE during 3 years

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

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

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

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

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

22 DEDICATION 00.51.00.52.0 no DM56111.317.7 DM 6513.822.2 Female16810.624.1 Male45811.816.1 Age  6331113.7 17.1 Age < 63315 9.419.4 All62611.5 18.2 Group n DESBMS DES betterBMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA368 9.416.4 LAD25814.820.6 Stent length  18 mm310 9.517.9 Stent length > 18 mm30912.917.8 No visible thrombus16811.124.1 Visible thrombus45811.615.9 Ref D  3.1 mm29912.020.8 Ref D > 3.1 mm317 9.615.6

23 DEDICATION 00.51.00.52.0 no DM56111.317.7 DM 6513.822.2 Female16810.624.1 Male45811.816.1 Age  6331113.7 17.1 Age < 63315 9.419.4 All62611.5 18.2 Group n DESBMS DES betterBMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA368 9.416.4 LAD25814.820.6 Stent length  18 mm310 9.517.9 Stent length > 18 mm30912.917.8 No visible thrombus16811.124.1 Visible thrombus45811.615.9 Ref D  3.1 mm29912.020.8 Ref D > 3.1 mm317 9.615.6

24 DEDICATION 00.51.00.52.0 no DM56111.317.7 DM 6513.822.2 Female16810.624.1 Male45811.816.1 Age  6331113.7 17.1 Age < 63315 9.419.4 All62611.5 18.2 Group n DESBMS DES betterBMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA368 9.416.4 LAD25814.820.6 Stent length  18 mm310 9.517.9 Stent length > 18 mm30912.917.8 No visible thrombus16811.124.1 Visible thrombus45811.615.9 Ref D  3.1 mm29912.020.8 Ref D > 3.1 mm317 9.615.6

25 DEDICATION 00.51.00.52.0 no DM56111.317.7 DM 6513.822.2 Female16810.624.1 Male45811.816.1 Age  6331113.7 17.1 Age < 63315 9.419.4 All62611.5 18.2 Group n DESBMS DES betterBMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA368 9.416.4 LAD25814.820.6 Stent length  18 mm310 9.517.9 Stent length > 18 mm30912.917.8 No visible thrombus16811.124.1 Visible thrombus45811.615.9 Ref D  3.1 mm29912.020.8 Ref D > 3.1 mm317 9.615.6

26 DEDICATION reduced the rate of MACE and the need for repeat revascularization 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

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