polymer-free des
DESCRIPTION
SOLACI Chile Congress 2011. Dr. Fausto Feres. Find more presentations on the web site: www.solaci.org/TRANSCRIPT
![Page 1: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/1.jpg)
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
![Page 2: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/2.jpg)
VestaSync(MIV technologies)
![Page 3: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/3.jpg)
HAp Drug Delivery System
Stent Surface
HAp surface
modification
0.6um
HAp surface modification
loaded with encapsulated
drug formulation
0.6um
Stent Surface
![Page 4: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/4.jpg)
VESTASYNC Sirolimus DES
MicroPorous
Hydroxyapatite55ug Sirolimus
Formulation
0.7um
GenX Coronary Stent
![Page 5: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/5.jpg)
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
![Page 6: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/6.jpg)
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
![Page 7: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/7.jpg)
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
![Page 8: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/8.jpg)
4 MONTH- FU 9 MONTH- FU
PRE POST
4 MONTH-FU 9 MONTH-FU
Hig
her
LL
L
(0.8
0 m
m)
![Page 9: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/9.jpg)
PRE POST
4 MONTH- FU 9 MONTH- FU
Lo
wer
LL
L
(-0
.1 m
m)
CRC
![Page 10: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/10.jpg)
Case Presentation:
A journey to a simple LAD lesion
![Page 11: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/11.jpg)
Pre Procedure
![Page 12: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/12.jpg)
Pre Procedure
![Page 13: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/13.jpg)
Pre Dilatation
![Page 14: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/14.jpg)
1st Stent Implantation
![Page 15: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/15.jpg)
2nd Stent Implantation
![Page 16: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/16.jpg)
Angio post 2nd Stent
![Page 17: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/17.jpg)
Angio post 2nd Stent
![Page 18: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/18.jpg)
3rd Stent Implantation
![Page 19: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/19.jpg)
4th Stent Implantation
![Page 20: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/20.jpg)
Post Procedure
![Page 21: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/21.jpg)
Post Procedure
![Page 22: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/22.jpg)
Angio Follow-up at 9 months
![Page 23: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/23.jpg)
Angio Follow-up at 9 months
![Page 24: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/24.jpg)
IVUS Follow-up at 9 months
![Page 25: Polymer-Free DES](https://reader034.vdocuments.us/reader034/viewer/2022051610/549c441eb47959bd318b46c8/html5/thumbnails/25.jpg)
FOLLOW-UP 9 MONTHS