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

1. Case Presentation:
Polymer-Free DES
Fausto Feres
Alexandre Abizaid
J. Ribamar Costa Junior
Instituto Dante Pazzanese de Cardiologia
Sao Paulo- Brazil
SOLACI|
Santiago de Chile
August, 2011

2. VestaSync
(MIV technologies)

3. HAp Drug Delivery System
Stent Surface
HAp surface
modification
0.6um
HAp surface modification
loaded with encapsulated
drug formulation
0.6um
Stent Surface

4. VESTASYNC Sirolimus DES
MicroPorous
Hydroxyapatite
55ug Sirolimus
Formulation
0.7um
GenX Coronary Stent

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. Randomization (2:1)
Single de novo lesions in native vessels
RVD: 2.5 - 3.5 mm
Lesion length: ≤ 16mm
Stent diameter: 2.5. 3.0 e 3.5mm
Stent length: 19mm
Pre dilatation recommended
1 m 9 m 12 m
Clinical FU
Invasive FU (QCA & IVUS)
Primary endpoint In stent LLL & e % de NIH obstruction at 9 months
Secondary endpoints - MACE up to 5 years
- Acute success
-TLR, TVR & TLF up to 5 years
- Binary restenosis at 9 months
* DAPT for 6 months
Participating centers
• IDPC & Sta. Marcelina (Brazil)
24m
Study Design
QCA & IVUS corelabs
Cardiovascular Research Center (CRC) PI: Alexandre Abizaid
36m 48m 60m6 m

7. Variables N= 15 pts
Quantitative Coronary Angiography
Minimum lumen diameter. mm 2.29 ± 0.38
Diameter of stenosis. (%) 15.9 ± 8.20
In stent Lumen loss. mm 0.36 ± 0.23
Binary restenosis. n(%) 0
Intravascular Ultrasound
Volume of NIH. mm3 6.1 ± 4.9
% stent obstruction 3.8 ± 2.3
Nine-month QCA & IVUS data
VestaSync I trial
Costa Jr J. et al. J. Am. Coll. Cardiol. Intv.. 2009

8. 4 MONTH- FU 9 MONTH- FU
PRE POST
4 MONTH-FU 9 MONTH-FU
HigherLLL
(0.80mm)

9. PRE POST
4 MONTH- FU 9 MONTH- FU
LowerLLL
(-0.1mm)CRC

10. Case Presentation:
A journey to a simple LAD lesion

11. Pre Procedure

12. Pre Procedure

13. Pre Dilatation

14. 1st Stent Implantation

15. 2nd Stent Implantation

16. Angio post 2nd Stent

17. Angio post 2nd Stent

18. 3rd Stent Implantation

19. 4th Stent Implantation

20. Post Procedure

21. Post Procedure

22. Angio Follow-up at 9 months

23. Angio Follow-up at 9 months

24. IVUS Follow-up at 9 months

25. FOLLOW-UP 9 MONTHS