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

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

3. 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)

4. 137/78 HR 72 Lungs Clear Heart RRR, nl S1S2 no m/r/g CFA DP PT Right1+
Left

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

10. 5 x 4 80 cm shaft P3

12. 7 x 80 Zilver PTX

13. 6 x cm Diamond

15. 7 x 40 Zilver PTX

16. 6 x cm Diamond

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

19. Sep
6 month Arterial US with patent stent, no increase in velocity
Exercise ABI R > 0.72

20. 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

21. Nov

24. 7 x 40 Admiral

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

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

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

29. 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

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

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

32. 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.