Angelo Cioppa, MD  I have the following potential conflicts of interest to report:  Research contracts  Consulting  Employment in industry  Stockholder of a healthcare company  Owner of a healthcare company  Other(s) X I do not have any potential conflict of interest Potential conflicts of interest

Angelo Cioppa, MD Montevergine Clinic, Mercogliano, Italy Superficial Femoral Artery Angioplasty The Cardiologist’s Approach HOW DID I TREAT ?

Treatment Choice Endovascular

Approach/Materials JR4 5F +0,035” Floppy Wire JR4 5F +0,035” Stiff Wire JR4 5F Pull Back6F cross-over Sheath

JR4 5F to manage the lesion 0,035” wire passed throught the lesion

Debulking or ELCA. Balloon PTA (standard or DCB). Stenting (BMS or DES or Covered). Treatment Strategy

Mean Lesion Length (cm) One-Year Primary Patency Bare Nitinol Stent vs POBA12-month Patency Rates RCS and Multicenter Registries More reports exist for using Bare Nitinol Stents in longer lesions compared to POBA Throughout the treatment range, Bare Nitinol Stents exhibit patency rates higher than POBA

Superficial Femoral Artery (SFA) is the “nightmare “ for the Interventionalists. Restenosis rate after SFA treatment was reported between 35-75%. No data suggest use of primary stent in short SFA lesions

 Zilver PTX Clinical Trial  Cook Zilver stent coated with Paclitaxel  Randomized arm (480 pts.) and Registry arm (790 pts.)  Mean lesion length 9.7 cm  Freedom from TLR (6 months 96%; 24 months ≈ 85 %)  STRIDES Study: A safety and efficacy study  DYNALINK-E Everolimus Eluting Peripheral Stent System  Prospective, single-arm, non-randomized, multi-center 100 pts.  Average lesion length 9 cm  12 month primary patency 69% (freedom from TLR 80%)  SIROCCO  SMART Stent versus Sirolimus-eluting SMART Stent  Prospective, randomized, multi-center 93 CLI pts.  Average lesion length 8.3 cm  Patency failure defined as PSV > 100% or no Doppler signal  Comparable 24 month primary patency of Sirolimus stent vs bare (77.1% vs 78.9%) Drug Eluting Stents in the SFA

Limitations Stent Fractures/compression Discordant results Costs Drug Eluting Stent in the SFA

DEB in the SFA THUNDER PACCOCATH™ vs. PTA vs. PTX in contrast medium SFA de-novo 6m LLL G.Tepe et al. N Engl J Med 2008;358: FEMPAC PACCOCATH™ vs.PTASFA de-novo6m LLL M.Werk et al. Circulation. 2008;118: LEVANT I MOXY™ vs. PTASFA de-novo6m LLLD.Scheinert TCT 2010 PACIFIRE In.Pact Pacific vsPTASFA De novo/ISR6m LLLM. Werk Cirse 2011 DEB better than PTA in TLR reduction. Mean Lesion Length 7,2 cm. At least 15% of procedure finished with stent implantation PaccocathMoxyIn.Pact

In.Pact™ DEB with FreePac™ Coating Technology Urea ‘Spacer’ Molecule Paclitaxel Molecule biocompatible | hydrophilic naturally-occurring high degree of transfer efficiency In.Pact  Medtronic-Invatec DEB balloon line Freepac  proprietary hydrophilic drug coating formulation – separates Paclitaxel molecules – balances hydrophilic and lipophilic properties – facilitates Paclitaxel elution into the vessel wall

Acute Results Device success100% Technical success89.6% PTA alone100(87.6 %) PTA + stenting14 (12.3 %) Reason for stenting Flow limiting dissection12 (11.7 %) Final Result (resid.Sten.)12.2 ±9.5 % Survival from TLR, Occlusion, >50% Restenosis 6m Primary Patency = 87.8% 1y Primary Patency = 83.7% PSVR < m0-6 m0-12 m Death Amputation TLR 1 (1.1%) 0% 1 (1.1%) 0% 4 (4.5%) 2 (2.2%) 0% 8 (8.7%) Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease. 12-Month Results From a Multicenter Italian Registry Antonio Micari, MD, PHD et Al., Palermo, Mercogliano, Cotignola, Lecce, Bari, and Rapallo, Italy J Am Coll Cardiol Intv 2012;5:331– 8

Our Strategy Balloon PTA - DEB – Provisional Stenting Pre-dilatation (120”) 5,0-150mm Balloon Basal Angio

After Pre-Dilatation Spiral Dissection

Drug Eluting Balloon Dilatation (180”) 6,0 - 40mm 5,0 -120mm Urea ‘spacer’ Molecule Paclitaxel Molecule In.Pact  Medtronic-Invatec DEB balloon line Freepac  proprietary hydrophilic drug coating formulation –separates Paclitaxel molecules –balances hydrophilic and lipophilic properties –facilitates Paclitaxel elution into the vessel wall

After DEB - Dilatation Persistent (after 2 more dilatations)Spiral Dissection What should I do? Leave it? Stenting? Other?

Our Choice: to Stent. Which Stent? -The Heliflex Ti design can be bent up to 180° and can be twisted into a double knot without kinking HIGHER: FLEXIBILITY CONFORMABILITY FRACTURE RESISTANCEHIGHER: FLEXIBILITY CONFORMABILITY FRACTURE RESISTANCE HELIFLEX Bio Active Coating (Titanium Nitride Oxide) HELIFLEX HELIFLEX HELICOÏDAL STRUCTURE HELIFLEX HELICOÏDAL STRUCTURE SUPERIOR CORROSION RESISTANCE SUPERIOR CORROSION RESISTANCE FEATURES & BENEFITS The HELIFLEX Ti self-expanding stent is the only peripheral stent to benefit from the patented Titanium-Nitride-Oxide Bio Active Coating to reduce RESTENOSIS, THROMBOSIS, CORROSION and FRACTURE.

Self-Expandable HeliFlex Ti 6,0-80 mm

Post-Stent Implantation Stent Post Dilatation Balloon 6,0-120 nc

Final Angiography

Closing Remarks SFA Angioplasty is still a challenge procedure. There is no role for primary stenting in the SFA setting. Drug Coated Balloon have shown improved long term patency after SFA angioplasty. Neverthenless, somethimes, bailout stenting is necessary to achieve a good acute result. New generation stent, as Heliflex Ti, seems to have a better perfomance, lower rate of fractures and might improve SFA-PTA long term results.