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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
[object Object],[object Object],[object Object],Disclosures
[object Object],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,%
[object Object],[object Object],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
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Endpoints
Major inclusion criteria ,[object Object],[object Object],[object Object],[object Object],[object Object]
Major exclusion criteria ,[object Object],[object Object],[object Object],[object Object],[object Object]
Screened patients 1687 Included patients 626 Excluded patients 1061 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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
[object Object],Conclusions In the DEDICATION trial implantation of DES (compared with BMS) in STEMI patients ,[object Object],[object Object],[object Object]

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Dedication-Clemmensen

  • 1. 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
  • 2.
  • 3.
  • 4. 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.
  • 6. 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
  • 7. 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
  • 8.
  • 9.
  • 10.
  • 11.
  • 12. STEMI - PPCI n: 626 Randomization Drug Eluting Stent n: 313 Bare Metal Stent n: 313 Number of Patients
  • 13. 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
  • 14. 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
  • 15. 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, %
  • 16. 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
  • 17. 0 200 400 600 800 1000 1200 P=0.028 DES BMS 100 80 60 40 Freedom from MACE Freedom from MACE Days
  • 18. 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. 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. 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. 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. 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
  • 23. 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
  • 24. 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
  • 25. 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
  • 26.