The Final Triumph Of Endovascular Therapy In SFA Treatment

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1 The Final Triumph Of Endovascular Therapy In SFA Treatment MEET 07 Mark W. Mewissen, M.D. Director, St Lukes Vascular Center Milwaukee, WI

2 Endovascular Therapy In SFA Treatment: Works In Progress! Mark W. Mewissen, M.D. Director, St Lukes Vascular Center MEET 07 Milwaukee, WI

3 Treatment of Choice for A and D Lesions TASC Recommendation Endovascular procedure is the treatment of choice for type A lesions, and JVS 2000 surgery for D lesions TASC A Treatment of Choice for B and C Lesions More evidence is needed to make any firm recommendations about the best treatment for type B and C lesions P A T E N C Y TASC A TASC B, C TASC B, C Management of PAD-TransAtlantic Inter-Society Consensus (TASC) JVS (1;2)

4 Short Focal Stenosis POBA (Plain Old Balloon Angioplasty) Post PTA

5 Results of SFA PTA Approximately 1,500 limbs with 5 cm lesions (J Cardiovasc Surg 2004;45:193)

6 Complex SFA Lesion POBA (Plain Old Balloon Angioplasty) >7cm: 3-6 Months STENT? Post PTA

7 Self-Expanding Nitinol Stents: Which stent to use? Protégé (15 cm) Smart Stent Absolute Everflex Luminexx Edwards Lifestent AND THE LIST KEEPS GROWING Viabahn Endoprosthesis (15 cm)

8 Case Presentation (TH) 01/04 76 YO IDDM Non-healing Rt foot ulcer S/P Rt Infra-inguinal Bypass x 2 CABG X 2

9 Case Presentation 01/04 Outback Smart Stents

10 Case Presentation 07/05 Duplex surveillance In-stent stenosis 08/05 (20 months) Atherectomy Duplex at 3 months (Post atherectomy) patent stents Asymptomatic Patient died 1/06/06: CHF (2 years)

11 Primary Stenting Technique: C Lesion-occlusion Mewissen MW. Self-Expanding nitinol stents in the FP segment: technique and mid-term results Techniques in Vascular and Interventional Radiology. 7(1): 2-5, 2004 Mar

12 Self-Expanding Nitinol Stents in the FP Segment: Technique and Mid-term Results 137 FP Lesions (122 pts) L: 12.2cm (4-28cm) High Technical success (98%) Irrespective of TASC Grades Safe Acute stent occlusion is rare (<1%) Endpoint: >50% stenosis DUPLEX % Stenosis Free Survival 92 DUPLEX SS STENT months 12 months 24 months Mewissen MW. Self-Expanding nitinol stents in the FP segment: technique and mid-term results Techniques in Vascular and Interventional Radiology. 7(1): 2-5, 2004

13 SIROCCO uncoated Stent 6 months post PTA SIROLIMUS-Stent 6 months post PTA Source: Prof Duda, ISET-2004, Long-term Follow-up of the SIROCCO Trial

14 Sirocco 2: 9 months duplex In Stent Binary restenosis Occlusion Sirolimus N=26 7.7% N=1 0% Control N=23 8.7% N=2 4.3% N=1 Total 7.7% N=1 13% N=3 Not significant

15 Self-Expanding Nitinol Stents: Natural history in FP segment STENT FRACTURE

16 Self-Expanding Nitinol Stents: Natural history in FP segment N=121 Primary Pat. 12 Months Stent FX X-Ray FX/Stenosis SMART Cordis SelfX Abbott Luminexx Bard 82% 15% No 44% 31% Yes 27% 52% Yes Scheinert at al. TCT 04

17 Balloon Angioplasty versus Implantation of Nitinol Stents in the Superficial Femoral Artery. ABSOLUTE Trial 104 patients PTA 53 ( mm) Random Pr. Stenting 51 ( mm) Sec. Stenting 17(32%) P=0.05 P=0.01 PTA Stent Schillinger et al. N Eng J Med 2006;354: PP angio 6 mo. PP duplex 12 mos

18 RESILIENT 2 Edwards Lifestent 6 months Data: TCT patients Multicenter, prospective randomized trial 206 Pts. randomized 2:1 LifeStent NT (n=134) to PTA (n=72) Primary endpoint: TLR at 6 months 90 PTA N= months LifeStent NT N= 134 Secondary endpoint: Primary and secondary patency at 6 and 12 months; stent integrity at 18 months Average vessel diameter: 5.2 mm (stent & PTA) Average of 1.6 stents/pt.;192 stents implanted 4 fractures seen to date (2.2%) PP TLR PTA Stent Presented by J Laird, MD; TCT 06

19 FAST Trial 12 months Data: TCT patients 244 Pts. randomized between LUMINEXX (n=123) and PTA (n=121) Single lesion, 1-10 cm long 12-month restenosis rates Stent: 31.7% (Note: authors expected 25%) PTA: 38.6% (Note: authors expected 45%) Intent To Treat: P=0.377 (NS) 83/101 pts. were assessed for restenosis (x-ray) 10 stent fractures observed (12%) Fracture did not appear to have an impact on restenosis PTA N= months 68.3 LUMINEXX N= 123 PTA Stent PP Presented by: Hans Krankenberg, MD, TCT 06

20 FP Primary Stenting Patency SE STENTS TASC B, C = Patency PTA TASC A P A T E N C Y PTA A PTA B, C SE Stent B, C, (D?)

21 FDA indicated for SFA use in June , 5, 10, 15 cm Diameter Profile Vessel Size 5 mm 8 Fr mm 6 mm 8 Fr mm 7 mm 9 Fr mm 8 mm 9 Fr mm

22 CLAUDICATION CRITICAL LIMB ISCHEMIA 4.8 mm 3.2 mm

23 58 YO man with right LE calf claudication ABI: 0.5 at rest; 0.2 post exercise

24 58 YO man with right LE calf claudication > 4.8 cm

25 58 YO man with right LE calf claudication (15 cm x 6mm) x2

26 GORE VIABAHN Endoprosthesis Primary Patency 100% 80% 60% 40% 20% 0% Good Good Technique Technique Avoid Avoid spot spot stenting stenting Avoid Avoid stent stent edge edge dilatation dilatation Objective Objective hemodynamic hemodynamic follow-up follow-up Primary Primary patency patency = = 79% 79% at at 2 2 years years (10 studies, average lesion length (10 studies, average lesion 15 cm) length 15 cm) Panetta Hartung Saxon Bleyn Jahnke, Brossman Fischer Saxon Bauermeister Lammer Bajwa Chopra Schroe Turicchia Railo Average Years

27 COMPARISON TO AK BYPASS COMPARISON TO AK BYPASS 100% 80% Primary Patency 60% 40% 20% 0% Vein Bypass 50 Viabahn vs 50 Prosthetic BGP Bypass Viabahn (all data) No difference Kedora et al JVS 2007; 45, Years Modality # papers # limbs length Primary Patency (years) (cm) Vein Bypass % 81% 77% 71% 70% Prosthetic Bypass % 77% 66% 59% 51% Viabahn (all data) % 79% 76% 67% 60%

28 VIBRANT Study VIaBahn versus bare Nitinol stent in the Treatment of Long Lesion ( 8cm) Superficial Femoral Artery Occlusive Disease Principle Investigators Gary Ansel, MD; Columbus, OH Pat Geraghty, MD; Wash U, St. Louis, MO Mark Mewissen, MD; St. Luke s Milwaukee, WI

29 Infrainguinal Disease (TASC D): Treatment Algorithm Chronic Limb Ischemia Claudication Critical Limb ischemia Failed Medical Tx Straight line flow AK Popliteal BK Popliteal Yes No >4.8 MM <4.8 MM Percutaneous Bypass/Combined Percutaneous VIABAHN?Percutaneous? SE Stent Bypass