1 / 25

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

EuroSTAR The Euro pean Cobalt St ent with A ntiproliferative for R estenosis Trial. As presented by Keith D Dawkins MD FRCP FACC Southampton University Hospital United Kingdom. 6-Month Results from Arm 1. EuroSTAR Trial Study Administration. Principal Investigators:

manton
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. 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

  3. EuroSTAR Arm 1 Enrolling Investigators

  4. 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.

  5. Reservoirs Ductile Hinges Bridge Elements CoStar™ Stent Design

  6. Baseline Angiography & IVUS* 1 Month Clinical 6 Month Clinical 6 Month Angiographic with QCA & IVUS* 1 Year Clinical EuroSTAR TrialStudy Design & Patient Follow-Up • Prospective, multi-center study, scheduled to sequentially enroll patients from 21 European & New Zealandcenters 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

  7. 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

  8. 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

  9. EuroSTAR TrialStudy 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

  10. EuroSTAR TrialBaseline Patient Demographics

  11. EuroSTAR TrialVessel Disease 3 Vessel 1 Vessel 2 Vessel

  12. EuroSTAR TrialLesion Location First Lesion (N = 144) RCA LAD Second Lesion (N = 32) LCX LAD RCA LCX 194 CoStar™ Stents Implanted in 176 Lesions

  13. EuroSTAR TrialProcedural Outcomes

  14. EuroSTAR TrialClinical Outcomes – In Hospital *Clinically Driven TLR based on number of lesions

  15. EuroSTAR TrialClinical Outcomes – 30 Days *Clinically Driven TLR based on number of lesions

  16. EuroSTAR TrialClinical Outcomes – 6 Months *Clinically Driven TLR based on number of lesions #One patient was a failure to cross and followed only to 30 days

  17. EuroSTAR TrialQCA analysis

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

  19. Subgroup Analysis by Vessel Diameter BinaryRestenosis Rate (6 Months)* *Binary Restenosis Rates per protocol/matched (n = 149 lesions) Restenosis Rate % ≤ 2.5mm (N=61) > 2.5mm (N=88)

  20. > 20mm (N=54) Subgroup Analysis by Stent LengthBinaryRestenosis Rate(6 Months)* *Binary Restenosis Rates per protocol/matched (n = 149 lesions) Restenosis Rate % ≤ 20mm (N=95)

  21. Diabetics (N=22) Subgroup Analysis for DiabetesBinaryRestenosis Rate (6 Months)* *Binary Restenosis Rates per protocol/matched (n = 149 lesions) Restenosis Rate % Non-Diabetics (N=127)

  22. Non-Diabetics >20mm All Patients ≤2.5mm >2.5mm ≤20mm Diabetics Stent Length RVD Subgroup AnalysisBinary Restenosis Rate (6 Months)* *Binary Restenosis Rates per protocol/matched (n = 149 lesions) In-Stent Restenosis (%)

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

  24. Non-Diabetics >20mm All Patients ≤2.5mm >2.5mm ≤20mm Diabetics Stent Length RVD Subgroup AnalysisLate Loss (6 Months)* *Late Loss per protocol/matched, n = 149 lesions In-Stent Late Loss (mm)

  25. 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 <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.

More Related