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

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

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

5. How can we keep SFA open?

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

7. DEB Same Drug - Different Excipients and Coating Techs

8. 5 DEB Trials with 6-month LLL Primary Endpoint DEB vs Standard Balloon De novo lesions, 6-months LLL in SFA

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

10. DEB - Current issues 1.Intermittent claudicatio 2.Costs 3.Calcifications 4.Atherectomy 5.Long Lesions Fanelli et al

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

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

13. Duda et al. SIROCCO trial

14. 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

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

16. 3-Year Effectiveness Primary Patency DES (Zilver PTX) vs. PTA

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

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

19. DEB BTK Dior(Eurocor) IN.PACTAmphirion(Medtronic) DEB ATK IN-PACTAdmiral(Medtronic) FREEWAY (Eurocor) Cases (n) 2415105 Mean Lesion Length (mm) 281259272 Primary Patency at 1 year at 1 year 75707173 Secondary Patency at 1 year 80737880 Follow up (months) 45 141410 DEB : BTK and ATK From 2000 to 2012

20. DES BTK Dexamet™ (Biocompatible - Abbott Vascular) (Biocompatible - Abbott Vascular) DES BTK Amazonia Pax (Minvasys) DES ATK Zilver PTX (Cook) Cases (n) 251016 Primary Patency at 1 year at 1 year 68%70%63% Secondary Patency at 1 year 82%84%69% Follow up (months) 533018 DES : BTK and ATK From 2000 to 2012

21. For any questions… chirvascmo@gmail.com www.chirurgiavascolare.unimore.it

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