Copenhagen University Hospital Rigshospitalet Aarhus University Hospital Skejby Denmark

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1 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 trial 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 Copenhagen University Hospital Rigshospitalet Aarhus University Hospital Skejby Denmark

2 Disclosures 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.

3 Background 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

4 Drug-Eluting vs Bare-Metal Stent Implantation during Primary PCI Previous published studies with 150 patients Invasive RS,% MACE,% Study n FU DES/BMS DES/BMS Primary endpoint p STRATEGY TYPHOON PASSION SESAMI /28 7/20-9/21 18/32 7/14 9/13 7/17 MACCE TVF MACE RS

5 Purpose 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

6 Flow chart STEMI n=626 Randomization + Distal Protection - Distal Protection Bare Metal Stent Drug Eluting Stent Bare Metal Stent Drug Eluting Stent Post Procedure 1 month 8 months 15 months 3 years Angiography - QCA MACE Angiography - QCA / MACE MACE MACE

7 Flow chart STEMI n=626 Randomization + Distal Protection - Distal Protection Bare Metal Stent Drug Eluting Stent Bare Metal Stent Drug Eluting Stent Post Procedure 1 month 8 months 15 months 3 years Angiography - QCA MACE Angiography - QCA / MACE MACE MACE

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

9 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 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 Study Flow Screened patients 1687 Included patients 626 Excluded patients deaths 83 lost to re-angiography 543 patients for re-angiography 602 patients for 8-month FU 29 deaths 573 patients for 3-year FU 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

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

13 Baseline clinical characteristics DES n=313 BMS n=313 p 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 DES n=313 BMS n=313 p Infarct related coronary artery (%) LAD CX RCA Number of diseased vessel (%) 1 vessel disease vessel disease vessel disease Baseline TIMI flow TIMI 0-1 TIMI

15 Procedural results DES n=313 BMS n=313 p 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 MACE during 3 years DES BMS Events, % P= P= P= P= P< P< P= P= Death Cardiac death MI Reinfarction TLR TVR Stroke MACE

17 Freedom from MACE 100 Freedom from MACE DES BMS P= Days

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

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

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

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

22 Subgroup analysis Group n Rate of MACE (%) DES BMS Odds Ratio (95% CI) All Age < Age Male Female DM no DM Ref D > 3.1 mm Ref D 3.1 mm Visible thrombus No visible thrombus Stent length > 18 mm Stent length 18 mm LAD CX / RCA DES better BMS better

23 Subgroup analysis Group n Rate of MACE (%) DES BMS Odds Ratio (95% CI) All Age < Age Male Female DM no DM Ref D > 3.1 mm Ref D 3.1 mm Visible thrombus No visible thrombus Stent length > 18 mm Stent length 18 mm LAD CX / RCA DES better BMS better

24 Subgroup analysis Group n Rate of MACE (%) DES BMS Odds Ratio (95% CI) All Age < Age Male Female DM no DM Ref D > 3.1 mm Ref D 3.1 mm Visible thrombus No visible thrombus Stent length > 18 mm Stent length 18 mm LAD CX / RCA DES better BMS better

25 Subgroup analysis Group n Rate of MACE (%) DES BMS Odds Ratio (95% CI) All Age < Age Male Female DM no DM Ref D > 3.1 mm Ref D 3.1 mm Visible thrombus No visible thrombus Stent length > 18 mm Stent length 18 mm LAD CX / RCA DES better BMS better

26 Conclusions In the trial implantation of DES (compared with BMS) in STEMI patients reduced the rate of MACE and the need for repeat revascularization 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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