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

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

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

How can we keep SFA open?

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

DEB Same Drug - Different Excipients and Coating Techs

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

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

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

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

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

Duda et al. SIROCCO trial

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

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%

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

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

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

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

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

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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