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

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

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

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

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

Edge Restenosis in Stent-Graft Patient

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

Current Use of Covered Stents: Diffuse ISR

Current Use of Covered Stents: Long Occlusions

Predilatation

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

PTX® Coated

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

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

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

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

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

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

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.

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

DEB Catheter Treatement (LEVANT-Study)

DEB Catheter Treatement for Long Lesions

Focal stenting of prox. + dist. entry Final result

Are calcified lesions suitable for DEB?

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

How WILL Drug Eluting Devices Effect Practice? 31

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