Endovascular Options in Critical Limb Ischemia: Below The Knee Therapies

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1 Endovascular Options in Critical Limb Ischemia: Below The Knee Therapies Bret N. Wiechmann, MD FSIR FAHA FSVM Vascular & Interventional Physicians Gainesville, Florida

2 Disclosures Consultant: Medcomp Bard Peripheral Vascular Endoshape, Inc. Stockholder: PQ Bypass BrightWater Medical Grant/Research Support: Cardinal Health/Cordis Intact Vascular Boston Scientific Corporation Medical/Scientific Boards: Boston Scientific Corporation BrightWater Medical

3 Mainstay BTK therapy: PTA Simple, straight-forward, inexpensive Device improvement Long balloons specific for BTK applications Technique variable Inflation time Inflation pressure Balloon overlap Restenosis remains a problem 12m TLR 12m

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5

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7 Early Randomized trials for DES-BTK Achilles Sirolimus eluting (Cypher) stent vs. POBA Yukon Sirolimus eluting (Yukon/no polymer) stent vs. BMS Destiny Everolimus eluting stent (Xience) vs. BMS (Multilink Vision)

8 Summary of DES-BTK randomized trials 12 month Patency Trial DES PTA/BMS Mean Lesion length Achilles 80.6% 58.1% 26.9mm Yukon 80.6% 55.6% 30mm Destiny 85.2% 54.4% 15.9mm

9 JACC Cardiovasc Interv 2013 (6)12:

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11 Is there any new data for DES-BTK?

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13 Long lesions??? The average lesion length for diabetics with critical limb ischemia can be up to 15-20cm Not practical to use DES in current design to treat these long lesions Can drug coated balloons be used for these challenging lesions?? A few early, single-center studies looked favorable

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15 Prospective, Randomized, Independently adjudicated and monitored trial of infrapopliteal antiproliferative therapy for critical limb ischemia

16 Real World Enrollment with Real World lesions being treated

17 FAILED TO MEET PRIMARY EFFICACY ENDPOINT OF SUPERIORITY OVER PTA SECONDARY SAFETY ENDPOINTS MAJOR AMP, AMP-FREE SURVIVAL, DEATH TRENDED AGAINST DCB

18

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20 SO Why have the DCB-BTK trials failed so far? Is it the drug? Is it the patients? Is it the excipient? Or.is POBA not as bad as we orginally thought? Exactly how effective is POBA for BTK? Refine, standardize technique?

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26 Katsanos K, Kitrou P, Spiliopoulos S, Diamantopoulos A, Karnabatidis D Comparative Effectiveness of Plain Balloon Angioplasty, Bare Metal Stents, Drug-Coated Balloons, and Drug-Eluting Stents for the Treatment of Infrapopliteal Artery Disease: Systematic Review and Bayesian Network Meta-analysis of Randomized Controlled Trials. J Endovasc Ther Dec;23(6):

27 Tibial occlusive disease High Frequency occlusions Success of PTA in complex dz dissection Frequent Heavy Ca++ Elastic recoil Diffuse, longsegment dz Early failure

28

29 Reduce limitations of PTA Better acute/long term results Improve LS rates Excise plaque Ablate plaque Reduce Ca++ Remove any/all material

30 BTK Atherectomy data The issue at hand: Little data on purely BTK applications in CLI Most data for atherectomy is published as infrainguinal and includes claudicants & CLI Frequently multisegment disease Rarely atherectomy stand-alone therapy Adjunctive PTA and/or stent (confounders) Lack of consistent endpoints Data therefore difficult to interpret

31 50 PTS 1 endpoint <30% residual stenosis No dissection > C 25 OA + PTA 25 PTA ALONE

32 CALCIUM 360 <30% stenosis/ no dissection Stent 93% OA+PTA 82%PTA 6.9% OA + PTA 14.3% PTA Freedom from TLR *Death, major amp, TLR Freedom From MAE* 93% OA+PTA 80% PTA 93% OA+PTA 58% PTA

33 J Vasc Surg 2013;58: CLI INTERVENTIONS LOSS OF PATENCY COMPLICATIONS MAJOR AMPUTATION PTA +/- STENT N = 339 (6 STENT) ATHERECTOMY ASSISTED N = 79 (68 ATH + PTA) 11% 8% 17% 13% 13% 13% POST PROCEDURAL OUTCOMES (30 DAYS) NO STATISTICALLY SIGNIFICANT DIFFERENCE

34 418 CLI INTERVENTIONS J Vasc Surg 2013;58: PATENCY 1 ASSISTED PATENCY 2 PATENCY LIMB SALVAGE OVERALL SURVIVAL PTA 12M 36M ATHERECTOMY- ASSISTED 12M 36M Adjunctive use of atherectomy offers 69% no improvement 83% 94% in primary 79% 55% 71% 89% 70% outcomes over PTA alone in early/late outcomes in endovascular CLI interventions. 61% 46% 85% 67% 95% 89% 81% 77% 77% 56% 80% 50%

35 Whats on the Horizon??

36

37

38 Summary No magic bullet restenosis, reintervention in infrapopliteal vessels common PTA mainstay of therapy BTK Randomized trials demonstrate the superior primary patency of DES over POBA and BMS for short below knee lesions (3-4cm) The patency benefit does not translate into limb salvage or survival benefit at 12m Longer follow up is eagerly awaited Single center studies of DCB encouraging for long lesions with respect to patency but randomized data demonstrates concerns over safety of this technology for CLI. BTK results in the US are years away. Conflicting data regarding the use of atherectomy with or without drug eluting technology

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