As presented by

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EuroSTARThe European Cobalt Stent with
Antiproliferative for Restenosis Trial

• As presented by
• Keith D Dawkins MD FRCP FACC
• Southampton University Hospital
• United Kingdom

6-Month Results from Arm 1
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EuroSTAR TrialStudy 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
Investigator Hospital Center - Location Patients n 145
Stefan Verheye, M.D. AZ Middelheim Hospital Antwerpen, Belgium 32
Joseph Dens, M.D. Universitair Ziekenhuis - Leuven, Belgium 19
Professor, Dr. Harald Mudra Krankenhaus Munchen Neuperlach Munich, Germany 14
Professor, Dr. Helmut Schuhlen Medizinische Klinik Munchen, Germany 12
Dr. Keith Dawkins Southampton University Hospital - Southampton, England 11
Dr. Martyn Thomas Kings College Hospital London, England 11
Professor, Dr. Wolfgang Rutsch Universitatsklinikum Charite Mitte Humboldt Univ Berlin, Germany 10
Professor Patrick Serruys Thoraxcentrum Erasmus University - Rotterdam, Netherlands 7
Professor Pieter den Heijer Amphia Hospital / de Klokkenberg - Breda, Netherlands 7
Professor Victor Legrand C.H.U. Sart Tilman Liege, Belgium 7
Dr. M. J. Suttorp Sichting Sint Antonius Ziekenhuis Nieuwegein, Netherlands 7
Dr. Peter R. Stella Universitair Medisch Centrum Utrecht, Netherlands 5
Professor Francois Schiele Centre Hospitalier Universitaire Jean Minjoz Besancon, France 3
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EuroSTARThe 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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CoStar Stent Design
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EuroSTAR TrialStudy 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.

Arm 1 10 µg PTX / 24-30 days N 145 patients
IVUS Sub-Study N 50 patients Arm 1 vs. Arm 2
IVUS for Sub-Study patients only
Arm 2 30 µg PTX / 24-30 days N 125 patients
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EuroSTAR TrialStudy 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 TrialStudy 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 TrialStudy Exclusions
Major Exclusions Acute MI within 72
hours Ejection Fraction lt 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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EuroSTAR TrialBaseline Patient Demographics
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)
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EuroSTAR TrialVessel Disease
3 Vessel
1 Vessel
2 Vessel
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EuroSTAR TrialLesion Location
First Lesion (N 144)
LAD
RCA
Second Lesion (N 32)
LCX
LAD
RCA
LCX
194 CoStar Stents Implanted in 176 Lesions
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EuroSTAR TrialProcedural Outcomes
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
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EuroSTAR TrialClinical Outcomes In Hospital
Events Arm 1 N 145 patients, 176 lesions
Death 0 (0/145)
Myocardial Infarction Q-Wave Non Q-Wave 0 (0/145) 0 (0/145) 1.4 (2/145)
Emergent CABG 0 (0/145)
TLR 0 (0/176)
In-Hospital MACE 1.4 (2/145)
Cumulative MACE 1.4 (2/145)
Clinically Driven TLR based on number of lesions
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EuroSTAR TrialClinical Outcomes 30 Days
Events Arm 1 N 145 patients, 176 lesions
Death 0 (0/145)
Myocardial Infarction Q-Wave Non Q-Wave 0 (0/145) 0 (0/145) 1.4 (2/145)
Emergent CABG 0 (0/145)
TLR 0 (0/176)
Revascularization per Patient 0 (0/145)
Cumulative MACE 1.4 (2/145)
Clinically Driven TLR based on number of lesions
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EuroSTAR TrialClinical Outcomes 6 Months
Events Arm 1 N 144 patients, 176 lesions
Death 1.4
Myocardial Infarction Q-Wave Non Q-Wave 0 0 1.4
Emergent CABG 0
TLR 1.7
Revascularization per Patient 2.1
Cumulative MACE 4.8
Late Thrombosis 0.7
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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EuroSTAR TrialQCA analysis
Arm I (N 145 patients) Index Follow-up 8 Months
Reference Vessel Diameter (mean SD) 2.62 0.54 mm 2.64 0.46 mm
Lesion Length (mean SD) 10.97 5.28 mm -
Stent Length (mm) 17.08 7.46 mm 17.62 7.56 mm
In-Stent Diameter Stenosis () 61.89 10.32 23.42 13.39
In-Stent MLD (mean SD) 1.00 0.35 mm 2.12 0.54 mm
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Angiographic Follow-UpBinary Restenosis Rate (6
Months)
Binary Restenosis Rates per protocol/matched (n
149 lesions)
Restenosis Rate
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Subgroup Analysis by Vessel Diameter Binary
Restenosis Rate (6 Months)
Binary Restenosis Rates per protocol/matched (n
149 lesions)
Restenosis Rate
2.5mm (N61)
gt 2.5mm (N88)
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Subgroup Analysis by Stent LengthBinary
Restenosis Rate (6 Months)
Binary Restenosis Rates per protocol/matched (n
149 lesions)
Restenosis Rate
20mm (N95)
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Subgroup Analysis for Diabetes Binary Restenosis
Rate (6 Months)
Binary Restenosis Rates per protocol/matched (n
149 lesions)
Restenosis Rate
Non-Diabetics (N127)
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Subgroup Analysis Binary Restenosis Rate (6
Months)
Binary Restenosis Rates per protocol/matched (n
149 lesions)
In-Stent Restenosis ()
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Angiographic Follow-UpLate Loss (6 Months)
Late Loss per protocol/matched, n 149 lesions
Late Loss (mm)
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Subgroup Analysis Late Loss (6 Months)
Late Loss per protocol/matched, n 149 lesions
In-Stent Late Loss (mm)
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EuroSTAR TrialConclusions

• 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 lt2.5mm 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.