1. Modern treatment of SFA
Valeri Gelev
University Emergency Hospital “N.I. Pirogov”

2. Femoro-Popliteal Artery: Biomechanics

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

4. 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

5. 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

6. 1-Year Restenosis Rates in the SFA POBA vs. BMS
The Tigris stent comparing 2 types of nitinol stents

7. 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)

8. Absolute Trial Results

9. Absolute Trial Results

10. 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
Lesion length
Bosiers M

11. 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
Lesion length cm
Bosiers M

12. 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

13. 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)

14. 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.
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, 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.

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

16. DES – Zilver PTX

17. DES – Zilver PTX

18. 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
Lesion length cm
Bosiers M

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

20. 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

21. 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
Lesion length
Bosiers M

22. 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

23. 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

24. 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

27. 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
Lesion length
Bosiers M

28. 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
Lesion length cm
Bosiers M

29. 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
Lesion length cm
Adapted from Bosiers M

30. 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
Lesion length
Bosiers M

31. 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

33. 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

34. 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.