Case Presentation: SFA or BTK DES J.P. Reilly, MD, FSCAI, FACC Ochsner Medical Center New Orleans, LA 70115

Disclosure Slide Speaker’s Bureau: Daiichi Sankyo/Eli Lilly Consultant Cordis DES and DEB are not currently approved in US

Patient CT 6-8-2008 60 yo male DM, hyperlipidemia, CAD s/p CABG 1997 EF 40% Complaints of bilateral claudication at one block, frequently having to stop at work (chef)

137/78 HR 72 Lungs Clear Heart RRR, nl S1S2 no m/r/g CFA DP PT Right 1+ Left

ABI at rest R - 1.08 L- 1.09 with exercise R-0.64 L-0.57 CTA revealed severe disease of bilateral SFA

5 x 4 80 cm shaft P3

7 x 80 Zilver PTX

6 x 40 75cm Diamond

7 x 40 Zilver PTX

6 x 40 75 cm Diamond

April 14 2008 Rest ABI R- 1.37 L-1.05 Exercise R-1.07 L- 0.49 Arterial US demonstrates patent stent

Sep 23 2008 6 month Arterial US with patent stent, no increase in velocity Exercise ABI R 1.11 -> 0.72

Arterial US R SFA 11/25/2008 Stent origin Stent proximal Stent mid Stent distal 55 cm/sec 346 cm/sec 75 cm/sec 49 cm/sec

Nov 26 2008

7 x 40 Admiral

Zilver Stent Self-expanding stent Gold markers at ends Paclitaxel coating without polymer or binder <5 mm thickness 3mcg/mm2

Zilver PTX Trial Prospective, multi-center randomized trial PTA vs Zilver paclitaxel coated stent For PTA failure, second randomization between Zilver stent vs BMS

De novo or restenotic lesions without previous stent > 50% stenosis of SFA or proximal popliteal Rutherford II or greater

Zilver PTX trial Primary Endpoint: 12 month patency by Duplex USG 12 month event free survival Follow-up USG 6, and 12 months, then annually X-ray of stent 1, 3 and 5 years

Zilver PTX PTA Alone Primary Patency 74.8% (2 years) 32.8% (One year) Event Free Survival 86.6%

PTA Failure Group Zilver PTX BMS Primary Patency 81.2% 62.7%

Summary Drug eluting stents for intervention of the lower extremities significantly reduced the need for repeat intervention and icreased primary patency out to two years.