As presented by Keith D Dawkins MD FRCP FACC Southampton University Hospital United Kingdom EuroSTAR The European Cobalt Stent with Antiproliferative for.

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Presentation transcript:

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

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

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

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.

Bridge Elements Reservoirs Reservoirs Ductile Hinges CoStar™ Stent Design

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 / days N = 145 patients Arm 2 30 µg PTX / days N = 125 patients

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

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

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

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

EuroSTAR Trial Vessel Disease 1 Vessel 2 Vessel 3 Vessel

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

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

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

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

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

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) ± 5.28 mm- Stent Length (mm) ± 7.46 mm17.62 ± 7.56 mm In-Stent Diameter Stenosis (%) ± 10.32%23.42 ± 13.39% In-Stent MLD (mean ± SD) 1.00 ± 0.35 mm2.12 ± 0.54 mm EuroSTAR Trial QCA analysis

Angiographic Follow-Up Binary Restenosis Rate (6 Months) * Restenosis Rate % * Binary Restenosis Rates per protocol/matched (n = 149 lesions)

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 %

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 %

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 %

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)

Angiographic Follow-Up Late Loss (6 Months) * * * Late Loss per protocol/matched, n = 149 lesions Late Loss (mm)

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

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.