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As presented by Keith D Dawkins MD FRCP FACC Southampton University Hospital United Kingdom EuroSTAR The European Cobalt Stent with Antiproliferative for Restenosis Trial 6-Month Results from Arm 1
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EuroSTAR Trial Study Administration Principal Investigators: Keith D. Dawkins M.D. – Southampton University Hospital Antonio Colombo M.D. – HSR San Raffaele Hospital Angiographic Core Lab: Cardialysis BV, The Netherlands
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EuroSTAR Arm 1 Enrolling Investigators InvestigatorHospital Center - Location Patients n = 145 Stefan Verheye, M.D.AZ Middelheim Hospital – Antwerpen, Belgium32 Joseph Dens, M.D.Universitair Ziekenhuis - Leuven, Belgium19 Professor, Dr. Harald MudraKrankenhaus Munchen Neuperlach – Munich, Germany14 Professor, Dr. Helmut SchuhlenMedizinische Klinik – Munchen, Germany12 Dr. Keith DawkinsSouthampton University Hospital - Southampton, England11 Dr. Martyn ThomasKing’s College Hospital – London, England11 Professor, Dr. Wolfgang RutschUniversitatsklinikum Charite Mitte Humboldt Univ – Berlin, Germany 10 Professor Patrick SerruysThoraxcentrum Erasmus University - Rotterdam, Netherlands 7 Professor Pieter den HeijerAmphia Hospital / de Klokkenberg - Breda, Netherlands7 Professor Victor LegrandC.H.U. Sart Tilman – Liege, Belgium7 Dr. M. J. SuttorpSichting Sint Antonius Ziekenhuis – Nieuwegein, Netherlands 7 Dr. Peter R. StellaUniversitair Medisch Centrum – Utrecht, Netherlands5 Professor Francois SchieleCentre Hospitalier Universitaire Jean Minjoz – Besancon, France 3
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EuroSTAR The European Cobalt Stent with Antiproliferative for Restenosis Trial Study Purpose: To demonstrate the safety and performance of the Conor CoStar™ Paclitaxel-Eluting Stent System for the treatment of ischemic heart disease attributable to stenotic de novo lesions in native coronary arteries.
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Bridge Elements Reservoirs Reservoirs Ductile Hinges CoStar™ Stent Design
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EuroSTAR Trial Study Design & Patient Follow-Up Prospective, multi-center study, scheduled to sequentially enroll patients from 21 European & New Zealand centers into one of two registry arms with two different dose formulations of paclitaxel. An IVUS sub-study of patients from both arms is also planned. 1 Month Clinical 6 Month Clinical 6 Month Angiographic with QCA & IVUS * 1 Year Clinical Baseline Angiography Baseline Angiography & IVUS * * IVUS for Sub-Study patients only IVUS Sub-Study N = 50 patients Arm 1 vs. Arm 2 Arm 1 10 µg PTX / 24-30 days N = 145 patients Arm 2 30 µg PTX / 24-30 days N = 125 patients
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EuroSTAR Trial Study Endpoints Primary Endpoint: Angiographic (by QCA) Late Loss at 6 Months Secondary Endpoints: MACE at 30 days, 6 months & 1 year Binary Restenosis at 6 months Late Loss at 6 months TLR and TVR at 6 months Procedural Success Primary Device Success Lesion Success
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EuroSTAR Trial Study Inclusions Major Inclusions: Up to two native coronary lesions in multiple vessels that have not undergone previous PCI RVD between 2.5mm – 3.5mm Lesion length ≤ 25 mm in length TIMI flow of Grade I or higher
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EuroSTAR Trial Study Exclusions Major Exclusions: Acute MI within 72 hours Ejection Fraction < 30% Patients with known drug hypersensitivities or contraindications Angiographic evidence of thrombus in the target vessel Target lesions involving a bifurcation that require treatment
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Arm 1 N = 145 patients, 176 lesions Age in Years (mean ± SD) 63.5 ± 10.5 Gender (% Male) 70.3% (102/145) History of Smoking 67.6% (98/145) Diabetes Mellitus 15.9% (23/145) Hypertension 69.0% (100/145) Dyslipidemia 77.9% (113/145) Prior MI 31.7% (46/145) Prior CABG 3.4% (5/145) Prior Angioplasty 19.3% (28/145) Prior Stent Implant 13.1% (19/145) EuroSTAR Trial Baseline Patient Demographics
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EuroSTAR Trial Vessel Disease 1 Vessel 2 Vessel 3 Vessel
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EuroSTAR Trial Lesion Location First Lesion (N = 144) Second Lesion (N = 32) 194 CoStar™ Stents Implanted in 176 Lesions LCX LCX LAD LAD RCA RCA
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Arm 1 N = 145 patients Total Lesions Treated 176 lesions Total Number of CoStar ™ Stent Implanted 194 Stents Average Number of Stents per Patient 1.3 Average Number of Stents per Lesion 1.1 Direct Stenting per Lesion 51.7% Procedural Success 97.2% Lesion Success 99.0% Device Success 99.0% EuroSTAR Trial Procedural Outcomes
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Events Arm 1 N = 145 patients, 176 lesions Death0% (0/145) Myocardial Infarction: Q-Wave Non Q-Wave 0% (0/145) 1.4% (2/145) Emergent CABG0% (0/145) TLR * 0% (0/176) In-Hospital MACE1.4% (2/145) Cumulative MACE1.4% (2/145) EuroSTAR Trial Clinical Outcomes – In Hospital * Clinically Driven TLR based on number of lesions
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Events Arm 1 N = 145 patients, 176 lesions Death0% (0/145) Myocardial Infarction: Q-Wave Non Q-Wave 0% (0/145) 1.4% (2/145) Emergent CABG0% (0/145) TLR * 0% (0/176) Revascularization per Patient0% (0/145) Cumulative MACE1.4% (2/145) EuroSTAR Trial Clinical Outcomes – 30 Days * Clinically Driven TLR based on number of lesions
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Events Arm 1 N = 144 # patients, 176 lesions Death1.4% Myocardial Infarction: Q-Wave Non Q-Wave 0% 1.4% Emergent CABG0% TLR * 1.7% Revascularization per Patient2.1% Cumulative MACE4.8% Late Thrombosis0.7% EuroSTAR Trial Clinical Outcomes – 6 Months * Clinically Driven TLR based on number of lesions # One patient was a failure to cross and followed only to 30 days
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Arm I (N = 145 patients) Index Follow-up 8 Months Reference Vessel Diameter (mean ± SD) 2.62 ± 0.54 mm2.64 ± 0.46 mm Lesion Length (mean ± SD) 10.97 ± 5.28 mm- Stent Length (mm) 17.08 ± 7.46 mm17.62 ± 7.56 mm In-Stent Diameter Stenosis (%) 61.89 ± 10.32%23.42 ± 13.39% In-Stent MLD (mean ± SD) 1.00 ± 0.35 mm2.12 ± 0.54 mm EuroSTAR Trial QCA analysis
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Angiographic Follow-Up Binary Restenosis Rate (6 Months) * Restenosis Rate % * Binary Restenosis Rates per protocol/matched (n = 149 lesions)
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Subgroup Analysis by Vessel Diameter Binary Restenosis Rate (6 Months) * ≤ 2.5mm (N=61)> 2.5mm (N=88) * Binary Restenosis Rates per protocol/matched (n = 149 lesions) Restenosis Rate %
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Subgroup Analysis by Stent Length Binary Restenosis Rate (6 Months) * * Binary Restenosis Rates per protocol/matched (n = 149 lesions) ≤ 20mm (N=95)> 20mm (N=54) Restenosis Rate %
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Subgroup Analysis for Diabetes Binary Restenosis Rate (6 Months) * * Binary Restenosis Rates per protocol/matched (n = 149 lesions) Non-Diabetics (N=127)Diabetics (N=22) Restenosis Rate %
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Subgroup Analysis Binary Restenosis Rate (6 Months) * In-Stent Restenosis (%) RVD Stent Length All Patients≤2.5mm>2.5mm≤20mmDiabetics Non-Diabetics >20mm * Binary Restenosis Rates per protocol/matched (n = 149 lesions)
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Angiographic Follow-Up Late Loss (6 Months) * * * Late Loss per protocol/matched, n = 149 lesions Late Loss (mm)
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Subgroup Analysis Late Loss (6 Months) * In-Stent Late Loss (mm) RVD Stent Length All Patients≤2.5mm>2.5mm≤20mmDiabetics Non-Diabetics >20mm * * Late Loss per protocol/matched, n = 149 lesions
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EuroSTAR Trial Conclusions The CoStar™ Cobalt Chromium stent system is highly deliverable, radiopaque and permits high rates of acute success and direct stenting. The Costar stent is safe with acceptably low rates of complications in both single and multi-vessel patient populations. The CoStar Stent is effective with low rates of clinical recurrence (1.7% TLR), MACE (4.8%), in-stent late loss (0.26mm) and in-stent restenosis (3.4%) at 8 months. Low in-stent restenosis rates for <2.5mm vessels demonstrates effectiveness of CoStar in small vessels. Extremely low rates of in-segment late loss (0.07mm) and no demonstrable edge effects are probably reflective of unique stent design and absence of a surface coating.
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