Modern treatment of SFA Valeri Gelev University Emergency Hospital “N.I. Pirogov” e-mail: vlgelev@abv.bg

Femoro-Popliteal Artery: Biomechanics

Arterial Tortuosity: Knee Flexion Vessels loose elasticity and flexibility over time – leads to increased compression and kinking 45 y

Superficial Femoral Artery The most common site of peripheral arterial involvement and the leading cause of claudication >50% of peripheral lesions are located in the femoropoliteal segment most commonly - adductor canal Long lesions- plaque can involve the entire 30cm artery Occlusions -3 times more common than stenoses Significant calcification Very often both legs are afected Profunda femoral artery collaterals usually sustain limb and progression to limb threat is unusual: 2%- 3%/year

SFA Treatment Options Vein bypass • Prosthetic bypass • Plain Old Balloon Angioplasty (POBA) • Cutting Balloon Angioplasty • Cryo-balloon Angioplasty • Drug-eluting Balloon Angioplasty • Atherectomy • Bare Nitinol Stenting • Drug-eluting Stenting • Covered Stenting

1-Year Restenosis Rates in the SFA POBA vs. BMS The Tigris stent comparing 2 types of nitinol stents

Absolute Trial n=104 • PTA plus optional stenting (n=53) vs. primary stenting (n=51) • Rutherford stages 2 to 5 • de‐novo and restenotic lesions • mean treated length 12.0 cm (range 3 to 33cm) • 1/3 chronic total occlusions • Devices: Dynlink / Absolute Stents (Abbott Vascular)

Absolute Trial Results

Absolute Trial Results

Results with PTA in SFA PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 100 90 80 70 60 50 40 30 20 10 PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 4. Saxon 5. ASTRON 6. VIENNA 7. VIENNA-3 8. Kougias 2 1 12-month Primary Patency (%) 7 4,5 6 3 8 0 5 10 15 20 30 Lesion length Bosiers M

Results with Stents in SFA 100 90 80 70 60 50 40 30 20 10 Stent Fractures ranges from 0 – 3,1% Stent 1. FAST 2. FACT 3. RESILIENT 4. DURABILITY 5. ASTRON 6.VIENNA 7. Supera 8. VIBRANT 9. DURABILITY-200 7 3 2 4 1 5 9 Stents 6 8 12-month Primary Patency (%) PTA Supera 0% Relistent 3,1 0 5 10 15 20 30 Lesion length cm Bosiers M

Stent Fracture Grading RESILIENT study Type I Type II Type III Type IV Type V None associated with restenosis at 12 months. 45% 55% 50% Jaff, et al. 2007

Durability 200 study Inclusion criteria 100 patients Rutherford category 2-5 SFA stenosis >50% or occlusion Lesion length >150mm At least one-vessel run-off to the foot Primary endpoint Primary patency at 12 months, defined as: No binary re-stenosis (>50%) on duplex ultrasound No TLR performed within 12 months (TASC C&D)

Durability-200 : 12-month primarypatency 64,8% Mean Lesion Length 242 cm Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions. Bosiers M, Deloose K, Callaert J, Moreels N, Keirse K, Verbist J, Peeters P. Source Department of Vascular Surgery, Algemeen Ziekenhuis Sint-Blasius, Dendermonde, Belgium. marc.bosiers@telenet.be Abstract OBJECTIVES: This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length. METHODS: Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging. RESULTS: Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year. CONCLUSIONS: The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions.

Polymer free paclitaxel eluting stent DES – Zilver PTX Cook Medical Polymer free paclitaxel eluting stent SIROCCO II trial

DES – Zilver PTX

DES – Zilver PTX

Results with Stents in the SFA 100 90 80 70 60 50 40 30 20 10 Stent 1. DURABILITY-200 DES Stent Drug Eluting Stent 2. Zilver PTX 12-month Primary Patency (%) Primary Patency Rates PT A + Stent = 68% PTA + DES = 77% Supera 0% Relistent 3,1 0 5 10 15 20 30 Lesion length cm Bosiers M

Contoured proximal edge CARMEDA® Bioactive Surface Covered Stents Contoured proximal edge CARMEDA® Bioactive Surface (CBAS® Surface) Viabahn Covered Stent (Gore and Asociates)

Covered Stents First results comparable to bypass surgery VIBRANT study – Covered stent / Nitinol stent in lesions >80mm length Primary Patency and TVR - no diference Less Stent Fracures with covered stents VIPER registry – 1 y 74% PP VIASTAR study – covered stent / nitinol stent Preliminary 12-month results from this study suggest restenosis rates of 27% with Viabahn stent grafting compared to 59% for bare-nitinol stents

Drug Coated Balloons No data in TASC C and D lesions PTA 1. FAST 100 90 80 70 60 50 40 30 20 10 PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 4. Saxon 5. ASTRON 6. VIENNA 7. VIENNA-3 8. Kougias DES A B 2 Stent 1 12-month Primary Patency (%) No data in TASC C and D lesions 7 4,5 6 3 8 DCB A. FemPac B. THUNDER 0 5 10 15 20 30 Lesion length Bosiers M

SFA Treatment Options Vein bypass • Prosthetic bypass • Plain Old Balloon Angioplasty (POBA) • Cutting Balloon Angioplasty • Cryo-balloon Angioplasty • Drug-eluting Balloon Angioplasty • Atherectomy • Bare Nitinol Stenting • Drug-eluting Stenting • Covered Stenting No enough data

Conclusions New generation stents increase primary patency over PTA alone, especially in long lesions DES are slightly better than non-eluting stents No data on DCB for long lesions

Future Directions New generation and longer stents, plus next generation DES Waiting for results with longer DCB and debulking devices The Future of Bioabsorbable DES in periferal interventions

Results with PTA in SFA PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 100 90 80 70 60 50 40 30 20 10 PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 4. Saxon 5. ASTRON 6. VIENNA 7. VIENNA-3 8. Kougias A B 2 1 12-month Primary Patency (%) 7 4,5 6 3 8 DCB A. FemPac B. THUNDER 0 5 10 15 20 30 Lesion length Bosiers M

Drug Eluting Balloons Stent 1. DURABILITY-200 DES 100 90 80 70 60 50 40 30 20 10 Stent 1. DURABILITY-200 DES Drug Eluting Stent 2. Zilver PTX Stent 12-month Primary Patency (%) Drug Eluting Balloons Supera 0% Relistent 3,1 0 5 10 15 20 30 Lesion length cm Bosiers M

Results with Stents the SFA 100 90 80 70 60 50 40 30 20 10 Stent 1. FAST 2. FACT 3. RESILIENT 4. DURABILITY 5. ASTRON 6.VIENNA 7. Supera 8. VIBRANT 9. DURABILITY-200 7 3 2 4 1 5 9 Stents 6 8 12-month Primary Patency (%) PTA 0 5 10 15 20 30 Lesion length cm Adapted from Bosiers M

PTA in the SFA PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 4. Saxon 100 90 80 70 60 50 40 30 20 10 PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 4. Saxon 5. ASTRON 6. VIENNA 7. VIENNA-3 8. Kougias A B 2 1 12-month Primary Patency (%) 7 4,5 6 3 8 0 5 10 15 20 30 Lesion length Bosiers M

PTA in the SFA PTA 1. FAST 2. ZILVER PTX 3. RESILIENT 4. Saxon 5. ASTRON 6. VIENNA 7. VIENNA-3 8. Kougias A B 2 1 7 4,5 6 3 8 Bosiers M

SFA Treatment Options Vein bypass • Prosthetic bypass • Plain Old Balloon Angioplasty (POBA) • Cutting Balloon Angioplasty • Cryo-balloon Angioplasty • Drug-eluting Balloon Angioplasty • Atherectomy • Bare Nitinol Stenting • Drug-eluting Stenting • Covered Stenting

4.5.3.2.2 Femoropopliteal segment One of the main problems with endovascular therapy in this segment is the high prevalence of diffuse disease. Furthermore, different mechanical forces act on the superficial femoral artery. This artery is deformed repetitively in multiple directions by leg movements. A high technical success rate, due to technical developments and increasing operator experience, in combination with low risk, make endovascular therapy the preferred choice also in patients with long and complex femoropopliteal lesions. The landscape of endovascular treatment of femoropopliteal disease has changed decisively with the development of selfexpandable nitinol stents. The previous strategy was to use stents as the treatment option only in the case of initial PTA failure or late recurrence. However, according to an increasing number of randomized studies, primary nitinol stenting can now be recommended as the first-line treatment for intermediate length superficial femoral artery lesions due to improvement of at least mid-term patency.285,286 The restenosis rate after 1–2 years is 20–30% lower after primary stenting compared with angioplasty. The decision to stent the superficial femoral artery is based mainly on the clinical indication for revascularization and on the lesion length and complexity. In the case of CLI, stenting can be applied more liberally for limb salvage and ulcer healing. In the past, there was much concern about stent fractures. Several risk factors have been identified for stent fractures: number and length of implanted stents, overlapping stents, amount of calcification, and deployment technique.287 The higher fracture resistance of the latest generation of stents in combination with the production of long nitinol stents (up to 20 cm in length) broadens the possibilities of endovascular therapies in the case of more difficult and complex lesions. In-stent restenosis is the major drawback of stent implantation. To date there is no proof of any impact of stent design on restenosis rates. Isolated balloon angioplasty of restenosis lesions has a very high failure rate. Other treatment modalities have been investigated, but there is no single randomized trial in patients with in-stent restenosis demonstrating the superiority of one technique over the other. Drug-eluting stents have been investigated in a few studies in the superficial femoral artery, and until now no advantage has been shown compared with bare-metal nitinol stents.288 Early studies with drug-eluting balloons in the femoropopliteal arteries showed improved short-term patency rates compared with plain balloon angioplasty.289 Covered stents (stent grafts) appear to be a viable option for the treatment of complex superficial femoral artery lesions, with outcomes comparable with prosthetic above-knee femoropopliteal bypass surgery.290 Despite its widespread use, research data regarding subintimal angioplasty are sparse. There are no data comparing patency rates between intraluminal and subintimal angioplasty. However, in many interventions an unintentional subintimal passage is unavoidable. Regarding atherectomy, different devices are used with unclear long-term benefits. Currently there are niche indications in severely calcified lesions and non-stent areas (e.g. the common femoral and popliteal artery). However, there are some concerns regarding the risk of distal embolization with these devices.