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University of Modena and Reggio Emilia Vascular Surgery – Director: prof. Coppi

Silingardi R. Veronesi J. Gennai S. . University of Modena and Reggio Emilia Vascular Surgery – Director: prof. Coppi. Where are we with drug eluting balloons and stents for SFA?. Veronesi J. . chirvascmo@gmail.com . University of Modena and Reggio Emilia.

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University of Modena and Reggio Emilia Vascular Surgery – Director: prof. Coppi

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  1. Silingardi R. Veronesi J. Gennai S. University of Modena and Reggio Emilia Vascular Surgery – Director: prof. Coppi

  2. Where are we with drug eluting balloons and stents for SFA? Veronesi J. chirvascmo@gmail.com University of Modena and Reggio Emilia

  3. PTA and BMS in SFA 12 Months Primary Patency BMS provides improved patency, but data are limited for medium and long lesions

  4. How can we keep SFA open?

  5. DEB Drug eluting balloon Local release of medication into the vessel wall during dilatation

  6. DEB Same Drug - Different Excipients and Coating Techs

  7. DEB vs Standard Balloon De novo lesions, 6-months LLL in SFA 5 DEB Trials with 6-month LLL Primary Endpoint

  8. DEBvs PTA Meta-analysis Cassese et al. 2012 • 4 Fem--‐pop trials: Thunder, FemPac, Levant I, Pacifier • 433 patients • DEB at 10.3 months --‐> reduced TLR, LLL, Restenosis • All cause mortality unchanged

  9. DEB - Current issues • Intermittent claudicatio • Costs • Calcifications • Atherectomy • Long Lesions Fanelli et al

  10. DEB - Our indications • In-stent restenosis • Femoro-popliteal segment disease • Lesions < 10 cm • No calcified lesions • Young patients University of Modena and Reggio Emilia

  11. Drug Eluting Stents (DES)Trials • SIROCCO I e II (Cordis) • STRIDES (Abbott) • Zilver PTX (Cook) University of Modena and Reggio Emilia

  12. SIROCCO trial Duda et al.

  13. Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial • Trend for greater efficacy in the sirolimus-eluting stent group • No statistically significant differences in any of the variables

  14. STRIDES trial • TLR after 6 and 12 months was 95% and 80% • Primary patency after 6 and 12 months • was 94% and 68% Everolimus-eluting self-expanding nitinol stent can be successfully implanted in pts with severe PAD

  15. 3-Year EffectivenessPrimary Patency DES (Zilver PTX) vs. PTA

  16. DES – Current issues • Stent fracture • Mid- and long-term results? • Are costs justified?

  17. DES - Our indications • Bailout after PTA • Stent fracture • Rutherford scale  categories IV°, V°, VI° corresponded to resting pain, minor ulcerations and gangrenes • Young patients University of Modena and Reggio Emilia

  18. DEB : BTK and ATK From 2000 to 2012

  19. DES : BTK and ATK From 2000 to 2012

  20. For anyquestions… chirvascmo@gmail.com www.chirurgiavascolare.unimore.it

  21. CONCLUSIONS DEB & DES in SFA • DEB in SFA has demonstrated (in RCTs) clinical and morphologic benefits in the mid-term compared with uncoated balloon • DES promises improved patency compared with BMS • Results from different DES trials are controversial • “Drug-eluting technology” seems to reduce the need for reinterventions and compensation with costs • Promising technology with long DEB and drug bioabsorbable stents is desirable

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