1. Are we using fewer Covered Stents for SFA Occlusive Disease?
During teh next 15 min I will try to explain my personal point of view, my vision in relation to the role of the cardiologist in the peripheral field.
Since I started to work within the EuroPCR, i am trying to bring the cardiologist into ,better back to teh peripheral field.
D. Scheinert, MD
Center for Vascular Medicine –
Angiology and Vascular Surgery
Park Hospital Leipzig Germany

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Minnow Medical Consultant
Lutonix Consultant
Atheromed Consultant
Angioscore Consultant
Cook Medical Consultant
Invatec Medtronic Consultant
Ev3 Consultant
IDEV Techn. Stockholder
Abbott Advisory Board
Boston Scientific Advisory Board
Cordis Advisory Board
Novostent Advisory Board
Angioslide Advisory Board
Gardia Medical Advisory Board
Revascular Therapeutics Advisory Board
I took this from a presentation at LINC – needs review

3. Covered Stents in the Femoral Arteries
USA:
Covered stents are approved
Covered stents are reimbursed
Europe:
Many devices are approved
Covered stents are expensive, reimbursement is difficult 5 3

4. Covered Stents Additional Questions:
How effective are covered stents (Restenosis)?
Graft thrombosis in case of incomplete stent expansion?
Worsening of symptoms in case of stent thrombosis due to coverage of collaterals? 5 4

5. Vibrant-Study VIaBahn veRsus bAre Nitinol stenT
Covered Stents
Vibrant-Study VIaBahn veRsus bAre Nitinol stenT
Viabahn vs. bare nitinol-stent
Randomized, multi-center
SFA-lesions with length > 8 cm
148 patients planed
3-year surveillance via ultrasound

8. Edge Restenosis in Stent-Graft Patient

9. Covered Stents for SFA: What`s the evidence?
No general advantage of covered stents over non-covered stents
Fracture rate is very low
Restenosis tends to be focal and more easily treatable
Who should be treated with
Covered stents ? 5 9

10. Current Use of Covered Stents:
Diffuse ISR

11. Current Use of Covered Stents:
Long Occlusions

12. Predilatation

14. Competetive Devices in the Femoral Arteries
Main Competitors:
Bare stents
DES (Zilver PTX)
DEB 5 14

15. PTX® Coated

18. DES for SFA: What`s the evidence?
Primary patency rates for Zilver PTX is significantly better than for bare Zilver
83% Patency for Zilver PTX at 1 year is quite competetive
Who should be treated with
Zilver PTX ? 5 18

19. Zilver PTX Worldwide Registry
- Long Lesions Subset -
Consider expanding table with more Primary EP information and statistically powered secondary endpoints (if known). Depending on final number of studies listed, consider larger summary tables by indication. 19

20. Zilver PTX Worldwide Registry Limitation: Max. Stent Length so far 8cm
- Long Lesions Subset -
Consider expanding table with more Primary EP information and statistically powered secondary endpoints (if known). Depending on final number of studies listed, consider larger summary tables by indication.
Limitation: Max. Stent Length so far 8cm 20

21. Zilver PTX Worldwide Registry - In-Stent-Restenosis Subset -
Consider expanding table with more Primary EP information and statistically powered secondary endpoints (if known). Depending on final number of studies listed, consider larger summary tables by indication. 21

22. Zilver PTX Worldwide Registry - In-Stent-Restenosis Subset -
Consider expanding table with more Primary EP information and statistically powered secondary endpoints (if known). Depending on final number of studies listed, consider larger summary tables by indication. 22

23. THUNDER Trial Tepe et al., NEJM 2008; 358:689-99
Consider expanding table with more Primary EP information and statistically powered secondary endpoints (if known). Depending on final number of studies listed, consider larger summary tables by indication.
Tepe et al., NEJM 2008; 358:689-99 23

24. 6 Month Mean Late Lumen Loss Comparison
(median 1.1)
(median 0.8)
(median 0.3)
(median 0.2)
N=39
N=35
N=41
N=48
N=31
N=34
LEVANT I
THUNDER1
FemPac2
1 Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of
paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–699.
2 Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropoplitealarteries: paclitaxel-coated versus uncoated balloon: femoralpaclitaxel randomized pilot trial. Circulation. 2008;118:1358 –13565.

25. DEB for SFA: What`s the evidence?
Primary patency rates for DEB is significantly better than for plain balloon PTA (confirmed in 3 RCT)
Patency of DEB compareable to stents?
Who should be treated with
Drug-eluting Balloons? 5 25

26. DEB Catheter Treatement (LEVANT-Study)

27. DEB Catheter Treatement for Long Lesions

28. Focal stenting of
prox. + dist. entry
Final result

29. Are calcified lesions suitable for DEB?

30. How HAVE Drug Eluting Devices Effected Practice in Europe?
Almost not at all, yet !! 5
Data from Millennium Research Group Market Survey 2010 30

31. How WILL Drug Eluting Devices Effect Practice?31

32. Conclusion There is increasing evidence that Drug-eluting
stents and balloons have the potential to improve
the patency rates compared to uncoated devices
Adoption of these technologies will largely depend
on the price – clinical benefit ratio
Utilization of stent-based vs. balloon based
approaches will be patient or lesion specific