Polymer-Free DES

367 views

Published on

SOLACI Chile Congress 2011. Dr. Fausto Feres. Find more presentations on the web site: www.solaci.org/

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
367
On SlideShare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
5
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Polymer-Free DES

  1. 1. Case Presentation:Polymer-Free DESFausto FeresAlexandre AbizaidJ. Ribamar Costa JuniorInstituto Dante Pazzanese de CardiologiaSao Paulo- BrazilSOLACI|Santiago de ChileAugust, 2011
  2. 2. VestaSync(MIV technologies)
  3. 3. HAp Drug Delivery SystemStent SurfaceHAp surfacemodification0.6umHAp surface modificationloaded with encapsulateddrug formulation0.6umStent Surface
  4. 4. VESTASYNC Sirolimus DESMicroPorousHydroxyapatite55ug SirolimusFormulation0.7umGenX Coronary Stent
  5. 5. VESTASYNC Sirolimus DES• Stent platform: GenX• Surface modification: MicroPorous HAp• Drug: Sirolimus• Dose: 55 micrograms*• Formulation: Lipids• Encapsulation: Yes• Polymer free: Yes• Coating thickness: 0.6 microns* VESTASYNC: 55ug/19mm stent or 2.9ug/mm*Cypher: 140ug/18mm stent or 7.4 ug/mm
  6. 6. Randomization (2:1)Single de novo lesions in native vesselsRVD: 2.5 - 3.5 mmLesion length: ≤ 16mmStent diameter: 2.5. 3.0 e 3.5mmStent length: 19mmPre dilatation recommended1 m 9 m 12 mClinical FUInvasive FU (QCA & IVUS)Primary endpoint In stent LLL & e % de NIH obstruction at 9 monthsSecondary endpoints - MACE up to 5 years- Acute success-TLR, TVR & TLF up to 5 years- Binary restenosis at 9 months* DAPT for 6 monthsParticipating centers• IDPC & Sta. Marcelina (Brazil)24mStudy DesignQCA & IVUS corelabsCardiovascular Research Center (CRC) PI: Alexandre Abizaid36m 48m 60m6 m
  7. 7. Variables N= 15 ptsQuantitative Coronary AngiographyMinimum lumen diameter. mm 2.29 ± 0.38Diameter of stenosis. (%) 15.9 ± 8.20In stent Lumen loss. mm 0.36 ± 0.23Binary restenosis. n(%) 0Intravascular UltrasoundVolume of NIH. mm3 6.1 ± 4.9% stent obstruction 3.8 ± 2.3Nine-month QCA & IVUS dataVestaSync I trialCosta Jr J. et al. J. Am. Coll. Cardiol. Intv.. 2009
  8. 8. 4 MONTH- FU 9 MONTH- FUPRE POST4 MONTH-FU 9 MONTH-FUHigherLLL(0.80mm)
  9. 9. PRE POST4 MONTH- FU 9 MONTH- FULowerLLL(-0.1mm)CRC
  10. 10. Case Presentation:A journey to a simple LAD lesion
  11. 11. Pre Procedure
  12. 12. Pre Procedure
  13. 13. Pre Dilatation
  14. 14. 1st Stent Implantation
  15. 15. 2nd Stent Implantation
  16. 16. Angio post 2nd Stent
  17. 17. Angio post 2nd Stent
  18. 18. 3rd Stent Implantation
  19. 19. 4th Stent Implantation
  20. 20. Post Procedure
  21. 21. Post Procedure
  22. 22. Angio Follow-up at 9 months
  23. 23. Angio Follow-up at 9 months
  24. 24. IVUS Follow-up at 9 months
  25. 25. FOLLOW-UP 9 MONTHS

×