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

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

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    Polymer-Free DES Polymer-Free DES Presentation Transcript

    • Case Presentation:Polymer-Free DESFausto FeresAlexandre AbizaidJ. Ribamar Costa JuniorInstituto Dante Pazzanese de CardiologiaSao Paulo- BrazilSOLACI|Santiago de ChileAugust, 2011
    • VestaSync(MIV technologies)
    • HAp Drug Delivery SystemStent SurfaceHAp surfacemodification0.6umHAp surface modificationloaded with encapsulateddrug formulation0.6umStent Surface
    • VESTASYNC Sirolimus DESMicroPorousHydroxyapatite55ug SirolimusFormulation0.7umGenX 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 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
    • 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
    • 4 MONTH- FU 9 MONTH- FUPRE POST4 MONTH-FU 9 MONTH-FUHigherLLL(0.80mm)
    • PRE POST4 MONTH- FU 9 MONTH- FULowerLLL(-0.1mm)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