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 Hospital Rigshospitalet Aarhus University Hospital Skejby 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 with regard 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

DEDICATION Drug-Eluting vs Bare-Metal Stent Implantation during Primary PCI Previous published studies with 150 patients Study STRATEGY TYPHOON PASSION SESAMI n FU DES/BMS 18/32 7/14 9/13 7/17 DES/BMS 8/28 7/20 - 9/21 endpoint MACCE TVF MACE RS p Invasive Primary RS,% 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 Flow chart Post Procedure Angiography - QCA 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 Flow chart Post Procedure Angiography - QCA 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 patients 1687 Included patients 626 Excluded patients Clinically or psychologically instability / unconsciousness ST-elevation < 4 mm Participation in another study 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 Stent n: 313 Bare Metal Stent n: 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 Baseline clinical characteristics DES n=313 BMS n=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 Baseline lesion characteristics 0.27 DES n=313 BMS n=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, % Procedural results DES n=313 BMS n=313 p

DEDICATION P=0.024 MACE during 3 years

DEDICATION P=0.028 DES BMS Freedom from MACE Days

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

DEDICATION P=0.059 DES BMS Freedom from all-cause mortality (%) Freedom from all-cause mortality Days

DEDICATION P=0.008 DES BMS Freedom from cardiac mortality (%) Freedom from cardiac mortality Days

DEDICATION P=0.511 DES BMS Cumulative incidence (%) Any stent thrombosis Days

DEDICATION P=0.296 DES BMS Cumulative incidence (%) Definite stent thrombosis Days

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

Vink M. American College of Cardiology 2010 Scientific Sessions; March 16, 2010; Atlanta, GA. PASSION Cardiac death, TLR and MACE 620 patients TaxusBMSp Cardiac death9.5 %11.5 %ns TLR7.3 %10.5 %ns MACE18.3 %22.0 %ns

Vink M. American College of Cardiology 2010 Scientific Sessions; March 16, 2010; Atlanta, GA. PASSION Stent thrombosis 620 patients Stent thrombosis TaxusBMSp Definite3.6 %1.7 %0.20 Definite or probable 3.9 %3.4 %0.85 Possible6.8 %6.7 %0.93

SESAMI Three-year event rates 320 patients End point Sirolimus-eluting stent (%) Bare-metal stent (%) p MACE TLR TVR TVF Violini R, et al. J Am Coll Cardiol 2010; 55:

End pointTaxus n=2257 (%) BMS n=749 (%) Hazard ratio (95% CI) TLR (0.43–0.83) Safety MACE (0.76–1.36) All-cause mortality (0.64–1.55) MI (0.54–3.22) Stroke (0.58–4.00) Stent thrombosis (0.58–1.45) Lesion restenosis (0.33–0.57) Patient restenosis (0.33–0.57) Stone G. TCT 2008; October 15, 2008; Washington, DC. HORIZONS-AMI: Primary efficacy and safety end points

End pointTaxus n=2257 (%) BMS n=749 (%) Hazard ratio (95% CI) TLR (0.43–0.83) Safety MACE (0.76–1.36) All-cause mortality (0.64–1.55) MI (0.54–3.22) Stroke (0.58–4.00) Stent thrombosis (0.58–1.45) Lesion restenosis (0.33–0.57) Patient restenosis (0.33–0.57) Stone G. TCT 2008; October 15, 2008; Washington, DC. HORIZONS-AMI: Primary efficacy and safety end points

End pointTaxus n=2257 (%) BMS n=749 (%) Hazard ratio (95% CI) TLR (0.43–0.83) Safety MACE (0.76–1.36) All-cause mortality (0.64–1.55) MI (0.54–3.22) Stroke (0.58–4.00) Stent thrombosis (0.58–1.45) Lesion restenosis (0.33–0.57) Patient restenosis (0.33–0.57) Stone G. TCT 2008; October 15, 2008; Washington, DC. HORIZONS-AMI: Primary efficacy and safety end points

End pointTaxus n=2257 (%) BMS n=749 (%) Hazard ratio (95% CI) TLR (0.43–0.83) Safety MACE (0.76–1.36) All-cause mortality (0.64–1.55) MI (0.54–3.22) Stroke (0.58–4.00) Stent thrombosis (0.58–1.45) Lesion restenosis (0.33–0.57) Patient restenosis (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 state DES vs. BMS Increased efficacy Similar safety