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EuroSTAR II The European Randomized CoStar ™ Trial: Cobalt-Chromium Paclitaxel-eluting Stent vs. identical BMS. Sigmund Silber, MD, FACC, FESC Cardiology Practice and Hospital Munich, Germany sigmund@silber.com. EuroSTAR II. Disclosure.

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slide1

EuroSTAR II The European Randomized CoStar™ Trial:Cobalt-Chromium Paclitaxel-eluting Stent vs. identical BMS

Sigmund Silber, MD, FACC, FESC

Cardiology Practice and Hospital

Munich, Germany

sigmund@silber.com

disclosure

EuroSTAR II

Disclosure

Consulting fees and honoraria from various companies,

No stocks or patents, no conflict of interest related to this presentation

costar stent platform

EuroSTAR II

CoStar™ Stent Platform

UniStar™ Cobalt Chromium

stent platform

Paclitaxel

PLGA

Bioresorbable polymer

costar resorbable polymer animal data

EuroSTAR II

CoStar™ Resorbable Polymer- Animal Data

Explant In-vivo porcine model

No residual polymer following tissue removal at 180 days

slide5

EuroSTAR II

CoStar™ Stent Design

Alternating hexagonal pattern

Reservoirs

Bridge Elements

Ductile Hinges

slide6

EuroSTAR II

CoStar™ Stent Design

Alternating hexagonal pattern

Reservoirs

Bridge Elements

Ductile Hinges

highly deliverable

slide7

EuroSTAR II

CoStar™ Stent Design

Avoid possible cracking of polymer

Reservoirs

Bridge Elements

Ductile Hinges

the power of reservoir technology

EuroSTAR II

The Power of Reservoir Technology

Bi-Directional

Uni-Directional

Single Drug

Structure

Drug Delivery Reservoirs

Single

Adjacent

Multiple Drug

Structures

slide9

EuroSTAR II

EuroSTAR II TrialProspective, Multi-Center, Randomized, Study of the CoStar™ Paclitaxel-eluting Coronary Stent System in Patients with De Novo Lesions of Native Coronary Arteries

Objective:

  • To compare the the CoStar™ Paclitaxel-Eluting Coronary Stent System to the same stent without a drug or polymer.
  • Dose: 10 µg / 30 days (in-vitro)
study administration

EuroSTAR II

Study Administration

Principal Investigator:

Prof. Dr. S. Silber, Munich, Germany

Data Coordinating Center:

DATATRAK Deutschland GmbH

Bonn, Germany

Steering Committee:

Prof. Dr. S. Silber, Munich, Germany

Dr. Suryapranata, Zwolle, Netherlands

Dr. B. Chevalier, Saint-Denis, France

QCA Core Lab:

Bio-Imaging Technologies

Leiden, The Netherlands

Data Safety Monitoring Committee /

Clinical Events Committee

Dr. Marcus Lins, Kiel, Germany

Prof. Dr. Blanchard, France

Jan Bart Hak, Netherlands (Chairman)

Sponsor:

BIOTRONIK GmbH & Co. KG

slide11

EuroSTAR II

Study Design

Prospective, Randomized, Multi-Center European Study Lesions  25 mm in length, 2.5 – 3.5 mm diameter303 Patients at 18 Centers

Randomized 1:1

UniStar™ Coronary Stent(Control Group) N = 151

CoStar ™Paclitaxel-eluting Stent N = 152

Antiplatelet Therapy: Clopidogrel 300 mg loading dose, 75 mg QD for  6 monthsAspirin 100 mg QD for 6 months, and daily ASA indefinitely

study endpoints

EuroSTAR II

Study Endpoints

Primary

  • In-segment binary angiographic restenosis at 8 months

Secondary

  • Angiographic Endpoints
    • In-stent late lumen loss at 8 months
    • In-stent and in-lesion minimum lumen diameter (MLD)
  • Clinical Endpoints
    • MACE at 30 days and 8 months
    • Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 8 months
statistical assumptions

EuroSTAR II

Statistical Assumptions
  • Assumptions:
    • 5% in treatment group
    • 15% in control group
    •  = 0.05 and  = 0.2
  • 110 patients needed to provide 80% power to detect a difference in the primary endpoint of in-segment binary restenosis
  • A total of 150 patients will be needed in each group due to an assumed 25% lost to follow-up
key inclusion criteria

EuroSTAR II

Key Inclusion Criteria
  • Up to two discrete de-novo lesions in two native coronary arteries
  • Stenosis between 50-99% (visual estimate)
  • Reference vessel diameter (RVD) 2.5 – 3.5 mm
  • Lesion length  25 mm
  • TIMI flow 1 or higher
slide15

EuroSTAR II

Study Investigators

slide16

EuroSTAR II

Study Investigators

18 Sites in 3 European States

slide18

EuroSTAR II

QCA Analysis

8 month binary angiographic restenosis

41.9% Reduction

EuroSTAR II

8-Month Binary Angiographic Restenosis

p=0.0002

p=0.0327

29/103

12/132

27/89

22/125

Primary Endpoint

late loss at 8 months

EuroSTAR II

Late Lossat 8 Months

p<0.0001

p<0.0001

0.81 ± 0.49

0.64 ± 0.49

0.41 ± 0.48

0.29 ± 0.50

mace at 30 days

EuroSTAR II

MACE at 30-Days

p=NS for all comparisons

MACE defined as composite of TVR, new Q- or non-Q-wave MI attributed to target vessel, or cardiac death attributed to target vessel

mace at 8 months

EuroSTAR II

MACE at 8 Months

p=0.0214

p=0.0079

p=0.0465

p=NS

p=NS

p=NS

stent thrombosis definitions per protocol

EuroSTAR II

Stent Thrombosis: Definitions per Protocol
  • Subacute:
    • Abrupt vessel closure of the treatment site that results in clinical manifestations of ischemia and occlusion occurring after the patient left the cath lab but with 30 days of index procedure
      • MI attributed to target vessel
      • ACS with angiographic evidence of thrombus
      • Death within 30 days that cannot be attributed to other obvious cause
  • Late:
    • MI attributable to the target vessel, with angiographic documentation or thrombus or total occlusion at the target lesion 31-120 days post-procedure
stent thrombosis

EuroSTAR II

Stent Thrombosis

p=NS for all comparisons

slide25

The four Studies with the Cobalt-Chromium CoStar™ Stentreleasing Paclitaxel 10µg/30 days (in-vitro)

slide26

The four Studies with the Cobalt-Chromium CoStar™ Stentreleasing Paclitaxel 10µg/30 days (in-vitro)

different release kinetics ?

slide27

Angiography 1 month after

the primary clinical endpoint at 8 months

Angiography routinely performed at primary angiographic endpoint of 8 months

The four Studies with the Cobalt-Chromium CoStar™ Stentreleasing Paclitaxel 10µg/30 days (in-vitro)

conclusions

EuroSTAR II

Conclusions
  • EuroSTAR II is a positive trial, having reached its primary endpoint.
  • The CoStar™ Paclitaxel-eluting stent had a significantly lower angiographic restenosis rate and a significantly lower late loss than the identically designed bare UniStar™.
  • With comparable vessel size and comparable lesion length in the TAXUS-IV trial, in-stent late loss of the CoStar™ Paclitaxel-eluting stent in the EuroSTAR II trial was in the range of the Taxus stent.
  • TLR, TVR and MACE were also significantly reduced.
  • No early or late stent thromboses were seen with the CoStar™ stent.
  • The reservoir technology combined with a completely absorbable polymer offers a great potential for further development using different drugs with modifiable optimization of release kinetics, specifically taylored to the patients’ needs.