EuroSTAR II EuroSTAR II The European The European Randomized Randomized CoStar CoStar ™ Trial: Trial: Cobalt-Chromium Paclitaxel- Cobalt-Chromium Paclitaxel- eluting Stent vs. identical BMS eluting Stent vs. identical BMS Sigmund Silber, MD, FACC, FESC Cardiology Practice and Hospital Munich, Germany [email protected]
30
Embed
Cobalt-Chromium Paclitaxel-eluting Stent vs. identical BMS
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
EuroSTAR II EuroSTAR II The European Randomized The European Randomized
Consulting fees and honoraria from various companies,Consulting fees and honoraria from various companies,No stocks or patents, no conflict of interest related to this presentationNo stocks or patents, no conflict of interest related to this presentation
CoStar™ Stent Platform
UniStar™ Cobalt
Chromium stent
platform
PLGA
Bioresorbable
polymer
Paclit
axel
EuroSTAR IIEuroSTAR II
No residual polymer following tissue removal at 180 days
CoStar™ Resorbable Polymer- Animal Data
Explant In-vivo porcine model
EuroSTAR IIEuroSTAR II
CoStar™ Stent Design
Bridge Elements ReservoirsDuctile Hinges
Alternating hexagonal pattern
EuroSTAR IIEuroSTAR II
CoStar™ Stent Design
Bridge Elements ReservoirsDuctile Hinges
Alternating hexagonal pattern
EuroSTAR IIEuroSTAR II
highly deliverable
CoStar™ Stent Design
Bridge Elements Reservoirs
Avoid possible cracking of polymer
EuroSTAR IIEuroSTAR II
Ductile Hinges
The Power of Reservoir Technology
Single DrugStructure
Multiple DrugStructures
Drug Delivery ReservoirsDrug Delivery Reservoirs
Bi-Directional Uni-Directional
Single Adjacent
EuroSTAR IIEuroSTAR II
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)
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
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
EuroSTAR IIEuroSTAR II
Study AdministrationEuroSTAR IIEuroSTAR II
Principal Investigator:Principal Investigator:Prof. Dr. S. Silber, MunichProf. Dr. S. Silber, Munich, Germany, Germany
Data Coordinating Center:Data Coordinating Center:DATATRAK Deutschland GmbHDATATRAK Deutschland GmbHBonn, GermanyBonn, Germany
Steering Committee:Steering Committee:Prof. Dr. S. Silber, MunichProf. Dr. S. Silber, Munich, Germany, GermanyDr. Suryapranata, Zwolle, NetherlandsDr. Suryapranata, Zwolle, NetherlandsDr. B. Chevalier, Saint-Denis, FranceDr. B. Chevalier, Saint-Denis, France
QCA Core Lab:QCA Core Lab:
Bio-Imaging TechnologiesBio-Imaging Technologies
Leiden, The NetherlandsLeiden, The Netherlands
Data Safety Monitoring Committee /Data Safety Monitoring Committee /
Dr. Marcus Lins, Kiel, GermanyDr. Marcus Lins, Kiel, Germany
Prof. Dr. Blanchard, FranceProf. Dr. Blanchard, France
Jan Bart Hak, Netherlands (Chairman)Jan Bart Hak, Netherlands (Chairman)
Sponsor:Sponsor:BIOTRONIK GmbH & Co. KGBIOTRONIK GmbH & Co. KG
Study DesignStudy Design
Prospective, Randomized, Multi-Center European Study Prospective, Randomized, Multi-Center European Study Lesions Lesions 25 mm in length, 2.5 – 3.5 mm diameter 25 mm in length, 2.5 – 3.5 mm diameter
303 Patients at 18 Centers303 Patients at 18 Centers
Antiplatelet Therapy: Antiplatelet Therapy: Clopidogrel 300 mg loading dose, 75 mg QD for Clopidogrel 300 mg loading dose, 75 mg QD for 6 months 6 monthsAspirin 100 mg QD for 6 months, and daily ASA indefinitelyAspirin 100 mg QD for 6 months, and daily ASA indefinitely
EuroSTAR IIEuroSTAR 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
EuroSTAR IIEuroSTAR 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
EuroSTAR IIEuroSTAR 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
EuroSTAR IIEuroSTAR II
Study InvestigatorsStudy Investigators
Investigator Investigator Site Name and LocationSite Name and Location
Prof. Dr. D. AndresenProf. Dr. D. Andresen Vivantes Klinikum Am Urban, Berlin, DVivantes Klinikum Am Urban, Berlin, D Prof. Dr. S. BehrensProf. Dr. S. Behrens Vivantes GmbH Reinickendorf, Berlin, DVivantes GmbH Reinickendorf, Berlin, D Prof. Dr. H. DariusProf. Dr. H. Darius Vivantes Klinikum NeukVivantes Klinikum Neukölln, ölln, Berlin, D Berlin, D Prof. Dr. H. D. GlogarProf. Dr. H. D. Glogar AHK, Wien, AAHK, Wien, A Dr. S. HoffmannDr. S. Hoffmann Vivantes Friedrichshain, Berlin, DVivantes Friedrichshain, Berlin, D Dr. M. JereczekDr. M. Jereczek Vivantes Klinikum Spandau, Berlin, DVivantes Klinikum Spandau, Berlin, D Prof. Dr. A. JeronProf. Dr. A. Jeron PD Dr. B. Lauer, PD Dr. B. Lauer,
UniversitUniversitätsklinik, Regensburg, Dätsklinik, Regensburg, D Zentralklinik, Bad Berka, DZentralklinik, Bad Berka, D
Dr. K. M. J. MarquesDr. K. M. J. Marques Vu Medisch Centrum, Amsterdam, NLVu Medisch Centrum, Amsterdam, NL Prof. Dr. C. NienaberProf. Dr. C. Nienaber UniversitUniversitätsklinik, Rostock, Dätsklinik, Rostock, D Prof. Dr. G. RichardtProf. Dr. G. Richardt Kliniken GmbH, Bad Segeberg, DKliniken GmbH, Bad Segeberg, D Prof. Dr. S. SilberProf. Dr. S. Silber Cardiology Practice and Hospital, Munich, DCardiology Practice and Hospital, Munich, D Dr. T. SlagboomDr. T. Slagboom OLVG Amsterdam, NLOLVG Amsterdam, NL Dr. H. SuryapranataDr. H. Suryapranata Isala Klinicken Zwolle, NLIsala Klinicken Zwolle, NL Dr. M. J. SuttorpDr. M. J. Suttorp Antonius Zh Nieuwegein, NLAntonius Zh Nieuwegein, NL Prof. Dr. W. VoelkerProf. Dr. W. Voelker UniversitUniversitätsklinik, Würzburg, Dätsklinik, Würzburg, D Dr. M. WiemerDr. M. Wiemer Herzzentrum NRW, Bad Oeynhausen, DHerzzentrum NRW, Bad Oeynhausen, D Dr. B. WitzenbichlerDr. B. Witzenbichler Campus Benjamin Franklin, Berlin , DCampus Benjamin Franklin, Berlin , D
EuroSTAR IIEuroSTAR II
Study InvestigatorsStudy Investigators
Investigator Investigator Site Name and LocationSite Name and Location
Prof. Dr. D. AndresenProf. Dr. D. Andresen Vivantes Klinikum Am Urban, Berlin, DVivantes Klinikum Am Urban, Berlin, D Prof. Dr. S. BehrensProf. Dr. S. Behrens Vivantes GmbH Reinickendorf, Berlin, DVivantes GmbH Reinickendorf, Berlin, D Prof. Dr. H. DariusProf. Dr. H. Darius Vivantes Klinikum NeukVivantes Klinikum Neukölln, ölln, Berlin, D Berlin, D Prof. Dr. H. D. GlogarProf. Dr. H. D. Glogar AHK, Wien, AAHK, Wien, A Dr. S. HoffmannDr. S. Hoffmann Vivantes Friedrichshain, Berlin, DVivantes Friedrichshain, Berlin, D Dr. M. JereczekDr. M. Jereczek Vivantes Klinikum Spandau, Berlin, DVivantes Klinikum Spandau, Berlin, D Prof. Dr. A. JeronProf. Dr. A. Jeron PD Dr. B. Lauer, PD Dr. B. Lauer,
UniversitUniversitätsklinik, Regensburg, Dätsklinik, Regensburg, D Zentralklinik, Bad Berka, DZentralklinik, Bad Berka, D
Dr. K. M. J. MarquesDr. K. M. J. Marques Vu Medisch Centrum, Amsterdam, NLVu Medisch Centrum, Amsterdam, NL Prof. Dr. C. NienaberProf. Dr. C. Nienaber UniversitUniversitätsklinik, Rostock, Dätsklinik, Rostock, D Prof. Dr. G. RichardtProf. Dr. G. Richardt Kliniken GmbH, Bad Segeberg, DKliniken GmbH, Bad Segeberg, D Prof. Dr. S. SilberProf. Dr. S. Silber Cardiology Practice and Hospital, Munich, DCardiology Practice and Hospital, Munich, D Dr. T. SlagboomDr. T. Slagboom OLVG Amsterdam, NLOLVG Amsterdam, NL Dr. H. SuryapranataDr. H. Suryapranata Isala Klinicken Zwolle, NLIsala Klinicken Zwolle, NL Dr. M. J. SuttorpDr. M. J. Suttorp Antonius Zh Nieuwegein, NLAntonius Zh Nieuwegein, NL Prof. Dr. W. VoelkerProf. Dr. W. Voelker UniversitUniversitätsklinik, Würzburg, Dätsklinik, Würzburg, D Dr. M. WiemerDr. M. Wiemer Herzzentrum NRW, Bad Oeynhausen, DHerzzentrum NRW, Bad Oeynhausen, D Dr. B. WitzenbichlerDr. B. Witzenbichler Campus Benjamin Franklin, Berlin , DCampus Benjamin Franklin, Berlin , D
EuroSTAR IIEuroSTAR II
18 Sites in 3 European States
UniStarUniStarn = 151n = 151
CoStarCoStarn = 152n = 152
Age, yearsAge, years 65.7 65.7 ± 9.4± 9.4 64.4 64.4 ± 9.2± 9.2 Male, %Male, % 68.968.9 74.374.3 Angina, %Angina, % 87.487.4 84.284.2 Stable Angina, % Stable Angina, % 74.274.2 77.377.3 Prior MI, %Prior MI, % 27.227.2 27.027.0 Prior CABG, %Prior CABG, % 8.68.6 2.02.0 Prior PCI, %Prior PCI, % 31.131.1 36.836.8 History of Stroke or TIA, %History of Stroke or TIA, % 2.72.7 4.614.61 Diabetes Melitus, %Diabetes Melitus, % 22.522.5 26.326.3 Insulin Dependent, %Insulin Dependent, % 41.241.2 37.537.5 History of Smoking, %History of Smoking, % 42.442.4 46.746.7 History of Hyperlipidemia, %History of Hyperlipidemia, % 61.661.6 61.261.2 History of Hypertension, %History of Hypertension, % 72.272.2 65.865.8 LVEF, %LVEF, % 61.1 61.1 ± 12.9± 12.9 62.2 62.2 ± 13.0± 13.0
EuroSTAR IIEuroSTAR IIDemographics and Clinical Characteristics
Angiography routinely performed at primary angiographic endpoint of 8 months
Angiography 1 month after the primary clinical endpoint at 8 months
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.