Polymer-Free DES

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