Dedication-Clemmensen
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Dedication-Clemmensen Dedication-Clemmensen Presentation Transcript

  • 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
    • 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
    • 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
  • 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,%
    • 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
  • STEMI n=626 Randomization + Distal Protection - Distal Protection Bare Metal Stent MACE Angiography - QCA / MACE 1 month 15 months Bare Metal Stent Drug Eluting Stent Drug Eluting Stent Flow chart Post Procedure Angiography - QCA MACE MACE 8 months 3 years
  • STEMI n=626 Randomization + Distal Protection - Distal Protection Bare Metal Stent MACE Angiography - QCA / MACE 1 month 15 months Bare Metal Stent Drug Eluting Stent Drug Eluting Stent Flow chart Post Procedure Angiography - QCA MACE MACE 8 months 3 years
    • MACE (cardiac death, re-infarction, TLR) at 3 years
    • Cardiac death at 3 years
    • Total mortality
    • MI
    • TLR
    • TVR
    • Stroke
    Endpoints
  • 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
  • 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
  • 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
  • STEMI - PPCI n: 626 Randomization Drug Eluting Stent n: 313 Bare Metal Stent n: 313 Number of Patients
  • Baseline clinical characteristics DES n=313 BMS n=313 p 0.41 0.93 0.30 0.67 0.54 0.88 0.87 0.45 0.20 0.56 0.69 0.63 63 73.5 11.5 34.0 21.4 54.7 38.2 0.47 7.1 5.4 200 25 62 72.8 9.3 32.3 18.7 52.7 37.3 0.48 6.1 4.5 197 25 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
  • Baseline lesion characteristics 0.27 DES n=313 BMS n=313 p 0.57 0.47 38 14 48 61 29 10 70 30 44 11 45 65 25 10 65 35 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
  • Procedural results DES n=313 BMS n=313 p 0.21 0.33 0.38 0.29 0.52 0.13 0.86 0.20 1.00 0.73 95 72 42 98 1.3 21.0 3.53 16.3 90 99 97 74 40 99 1.3 22.2 3.54 16.7 90 98 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, %
  • 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
  • 0 200 400 600 800 1000 1200 P=0.028 DES BMS 100 80 60 40 Freedom from MACE Freedom from MACE Days
  • 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
  • 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
  • 10 8 6 4 2 0 P=0.511 DES BMS Cumulative incidence (%) 0 200 400 600 800 1000 1200 Any stent thrombosis Days
  • 10 8 6 4 2 0 P=0.296 DES BMS Cumulative incidence (%) 0 200 400 600 800 1000 1200 Definite stent thrombosis Days
  • 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 n DES BMS DES better BMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA 368 9.4 16.4 LAD 258 14.8 20.6 Stent length  18 mm 310 9.5 17.9 Stent length > 18 mm 309 12.9 17.8 No visible thrombus 168 11.1 24.1 Visible thrombus 458 11.6 15.9 Ref D  3.1 mm 299 12.0 20.8 Ref D > 3.1 mm 317 9.6 15.6
  • 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 n DES BMS DES better BMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA 368 9.4 16.4 LAD 258 14.8 20.6 Stent length  18 mm 310 9.5 17.9 Stent length > 18 mm 309 12.9 17.8 No visible thrombus 168 11.1 24.1 Visible thrombus 458 11.6 15.9 Ref D  3.1 mm 299 12.0 20.8 Ref D > 3.1 mm 317 9.6 15.6
  • 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 n DES BMS DES better BMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA 368 9.4 16.4 LAD 258 14.8 20.6 Stent length  18 mm 310 9.5 17.9 Stent length > 18 mm 309 12.9 17.8 No visible thrombus 168 11.1 24.1 Visible thrombus 458 11.6 15.9 Ref D  3.1 mm 299 12.0 20.8 Ref D > 3.1 mm 317 9.6 15.6
  • 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 n DES BMS DES better BMS better Odds Ratio (95% CI) Rate of MACE (%) Subgroup analysis CX / RCA 368 9.4 16.4 LAD 258 14.8 20.6 Stent length  18 mm 310 9.5 17.9 Stent length > 18 mm 309 12.9 17.8 No visible thrombus 168 11.1 24.1 Visible thrombus 458 11.6 15.9 Ref D  3.1 mm 299 12.0 20.8 Ref D > 3.1 mm 317 9.6 15.6
    • 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