Superficial Femoral Artery – Where Does the Data Stand? Director, Endovascular Services Mehdi H. Shishehbor, DO, MPH, PhD Cleveland Clinic

Disclosure Will be discussing off-label devices. Will be discussing off-label devices.

Current limitations Associated with SFA Stenting Patency Patency –Long lesions Stent Fracture Stent Fracture –Restenosis –Thrombosis –Pseudoaneurysm Technique Technique Cost Cost Scheinert D, et al. JACC 2005; 45 (2):

Length of the lesion (cm) Binary 12 months (%) PTA PLUS PROVISIONAL STENT PRIMARY STENT FAST RESILIENT ASTRON ABSOLUTE RESILIENT Lesion/stent Length and Patency Shillinger,M 2009

Length of the lesion (cm) Binary 12 months (%) PTA PLUS PROVISIONAL STENT PRIMARY STENT FAST RESILIENT ASTRON ABSOLUTE RESILIENT ZILVER Balloon optimal PTA plus stent ZILVER PTX ZILVER Balloon suboptimal RESILENT PTA ALONE DES Comparison of SFA Trials Shillinger & Baumgartner 2010

Length of the lesion (cm) Binary 12 months (%) PTA PLUS PROVISIONAL STENT PRIMARY STENT FAST RESILIENT ASTRON ABSOLUTE RESILIENT ZILVER Balloon optimal PTA plus stent ZILVER PTX Balloon suboptimal RESILENT PTA ALONE DES Comparison of SFA Trials Shillinger & Baumgartner 2010 VIABAHN FISCHER KEDORA & MCQUADE 25 CM VIPER & VIASTAR 19cm

Length of the lesion (cm) Binary 12 months (%) PTA PLUS PROVISIONAL STENT PRIMARY STENT FAST RESILIENT ASTRON ABSOLUTE RESILIENT ZILVER Balloon optimal PTA plus stent ZILVER PTX Balloon suboptimal RESILENT PTA ALONE DES Comparison of SFA Trials Shillinger & Baumgartner 2010 VIABAHN FISCHER KEDORA & MCQUADE 25 CM VIPER & VIASTAR 19cm SUPERA

Mean total lesion length of the treated arterial segment in the stent graft group was 25.6 cm (SD = 15 cm).

Primary PatencyViabahn Fem-Pop Bypass 1-year72%76% 2-year63% 3-year63% 4-year59%58%

Vienna FASTStudy Vienna FAST Study Resilient Mean lesion length45.2mm101mm61.8mm ISR 2 months32%36%20% Fracture rate12%2%2.9% In-stent Restenosis and Fracture

StentDesign Conformability Small crimped diameters Radial Strength Flexibility/Stiffness Fracture Resistance Surface Finish Axial Stiffness Torsional Stiffness Kink Radius

Standard Nitinol StentsWire InterwovenCovered/Stent (SNS)StentsGrafts Smart (Cordis)SUPERA (IDEV)Viabahn (Gore) Protégé Everflex (eV3)Fluency (Bard) LifeStent (Bard) Luminexx (Bard) Absolute (Abbott) Xpert (Abbott) Zilver / PTX (Cook) Complete SE (Medtronic) Misago (Terumo) FlexStent (Flexible Stent Tech)

Drug-Eluting Stents 81.2% 62.7% p<0.01

Drug Coated Balloons TM* Scheinert, D., et al., J Am Coll Cardiol Inv, 2014;7: p Micari, A., et al., J Am Coll Cardiol Inv, 2012;5: p Tepe G. Presentation, Charing Cross London 2. US Dept of HHS FDA Executive Summary: Circulatory System Devices Advisory Panel June 12,2014: Bard Lutonix® 035 Drug Coated Balloon PTA Catheter.

Paradigm Shift! Drug coated balloon Drug coated balloon Atherectomy + DCB Atherectomy + DCB DCB + Spot stenting DCB + Spot stenting DCB + TACK-IT technology DCB + TACK-IT technology

Current limitations of DEB Acute dissection Acute dissection Significant recoil Significant recoil Minimal acute luminal gain Minimal acute luminal gain Presence of Ca+ Presence of Ca+

Binary Restenosis 9 mo Binary Restenosis 9 mo Circulation 2007;116:2802-8

Biodegradable Stents CompanyMaterialStatus AmaranthPLLA, proprietary In development blends ARTPDLLA In development PV FIM in 2009 BTIPolyanhydrideIn development CV FIM in Brazil mNemoscienceProprietary shapeIn development memory polymers RevaPoly (DTE carbonate)FIM in June 2007 (tyrosine-derivedRedesign polycarbonate) Biodegradable Competitive Landscape