1 / 16

Why I like the DEVAX AXXESS stent …

Why I like the DEVAX AXXESS stent …. Dr. Christophe Dubois University Hospital Leuven Belgium. The holy grail of dedicated bifurcation stent technology ?. Flexible sizing Ease of use / predictable acute outcome

tchilders
Download Presentation

Why I like the DEVAX AXXESS stent …

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. Why I like theDEVAX AXXESS stent … Dr. Christophe Dubois University Hospital Leuven Belgium

  2. The holygrail of dedicatedbifurcationstenttechnology ? • Flexible sizing • Ease of use / predictable acute outcome • Conformance to vessel contour without disruption of the stent or coating • Preservation of the side branch • Single metal layer • Better long term outcomes /Enhanced safety • Cost/Benefit balance

  3. AXXESS Stent • Nitinol material conforms to the anatomy of the vessel/lesion • BA9 drug reduces restenosis in side branch • Allows optimal size selection and placement of additional stents • Easy delivery with fully compatible Rx catheter system

  4. Delivery System Safety lock Sheath actuator Stent deployed by sheath retraction Sheath markers Flush port AXXESS stent The DIVERGE Trial

  5. A self expanding stent can span both sides of the carina at once The flared distal end enhances this ability The nitinol material will conform to the shape of the bifurcation Two Vessel Coverage

  6. Stent Boost Imaging shows SB ostial coverage Example of Stent Conformity Final Angiogram PV: Axxess + Cypher SB: PTCA

  7. Bare metal version of Axxess Stent • Safety and effectiveness study • Six-month follow-up completed AXXESSn = 43 • Evaluated drug-eluting Axxess stent to bare metal stent • Safety and effectiveness study • Follow up through 3 years complete AXXESS PLUSn = 139 • International safety and effectiveness study • Evaluated best practices from AXXESS PLUS • Follow up through 12 months complete DIVERGEn = 302 • Multi-center pilot study for Axxess Left Main stent • 12 months follow-up complete • Study showed potential for effective LMCA intervention AXXENTn = 33 AXXESS Clinical Experience Over 500 Patients Studied

  8. AXXESS PLUS: Key Findings Lesion Success and Restenosis were improved by presence of SB stent: * Attainment of < 50% residual stenosis of the target lesion using any combination of percutaneous devices; † P = 0.003 vs. stent (DES) Grube E. et al, Am J Cardiol 2007;99:1671-97

  9. Based on AXXESS PLUS findings, the Axxess procedure was modified to obtain an optimal outcome in the SB (<30% residual stenosis post procedure) Optimal Technique Pre Final

  10. DIVERGE Results Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9

  11. AXXESS+ PV: 17.7% AXXESS+ PV + SB: 64.7% AXXESS+ SB: 4.0% SB Stent: 68.7% Stent Distribution Patterns AXXESS only: 12.3% Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9 The DIVERGE Trial

  12. Location Analysis: Proximal edge: 2.8% SB stent: 4.8% (105 SB stents) AXXESS: 0.7% Distal PV Cypher: 2.1% Angiographic Outcomes Any in-bifurcation restenosis: 6.4% (9/140 at 9 months) Parent Vessel RS Side Branch RS 2 pts 3 pts 4 pts Both Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9

  13. DIVERGE at 9 months Verheye S., Agostoni P., Dubois C. et al, J Am Coll Cardiol 2009;53:1031-9

  14. Impact of Optimizing Therapy Kaplan Meier 1 Year Event Free Survival * *25% Δ; p = 0.09 Unpublished data

  15. Durable Outcomes 4 year Kaplan Meier Curve AXXESS PLUS Trial 4 Events Years 1-4 83% MACE Free

  16. The holygrail of dedicatedbifurcationstenttechnology ? • Flexible sizing • Ease of use / predictable acute outcome • Conformance to vessel contour without disruption of the stent or coating • Preservation of the side branch • Single metal layer • Better long term outcomes /Enhanced safety • Cost/Benefit balance 95% - 97% - 99% AXXESS PLUS DIVERGE ?

More Related