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SOLACI Chile Congress 2011. Dr. Fausto Feres. Find more presentations on the web site: www.solaci.org/
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Case Presentation:
Polymer-Free DESFausto Feres
Alexandre Abizaid
J. Ribamar Costa Junior
Instituto Dante Pazzanese de Cardiologia
Sao Paulo- Brazil
SOLACI|
Santiago de Chile
August, 2011
VestaSync(MIV technologies)
HAp Drug Delivery System
Stent Surface
HAp surface
modification
0.6um
HAp surface modification
loaded with encapsulated
drug formulation
0.6um
Stent Surface
VESTASYNC Sirolimus DES
MicroPorous
Hydroxyapatite55ug Sirolimus
Formulation
0.7um
GenX Coronary Stent
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
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
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
4 MONTH- FU 9 MONTH- FU
PRE POST
4 MONTH-FU 9 MONTH-FU
Hig
her
LL
L
(0.8
0 m
m)
PRE POST
4 MONTH- FU 9 MONTH- FU
Lo
wer
LL
L
(-0
.1 m
m)
CRC
Case Presentation:
A journey to a simple LAD lesion
Pre Procedure
Pre Procedure
Pre Dilatation
1st Stent Implantation
2nd Stent Implantation
Angio post 2nd Stent
Angio post 2nd Stent
3rd Stent Implantation
4th Stent Implantation
Post Procedure
Post Procedure
Angio Follow-up at 9 months
Angio Follow-up at 9 months
IVUS Follow-up at 9 months
FOLLOW-UP 9 MONTHS