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Mauro Gargiulo

Il Drug Eluting Balloon nella pratica clinica. Prospettive diverse per un risultato comune Il Chirurgo Vascolare: “leave nothing behind” o “full metal jacket”. Mauro Gargiulo. Chirurgia Vascolare, Università di Bologna Policlinico S.Orsola-Malpighi Bologna (Dir. Prof. Andrea Stella).

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Mauro Gargiulo

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  1. Il Drug Eluting Balloon nella pratica clinica. Prospettive diverse per un risultato comuneIl Chirurgo Vascolare: “leave nothing behind” o “full metal jacket” Mauro Gargiulo Chirurgia Vascolare, Università di Bologna Policlinico S.Orsola-Malpighi Bologna (Dir. Prof. Andrea Stella)

  2. Vascular Surgery – University of Bologna

  3. Tibial arteries disease B C D A Occlusion > 4 cm ATA + PTA + obstructiondistal peronealartery Occlusion > 4 cm 3 tibial arteries Occlusion ≤ 4 cm Stenosis TWC run off autologous vein III D ≠ III D NO YES good poor Cryopreserved vessels High risk patient Infection + Ischemic foot Ischemic foot BYPASS TWC III TWC < III PTA+/-stent AMPUTATION Stella A, Gargiulo M eds, Arteriopatia Diabetica Periferica, Minerva Medica Torino, pag 123-128, 2009

  4. How to perform Endovascular Revascularization • PTA • PTA-stent • Drug-eluting devices • Endoprosthesis • Debulking Techniques

  5. How to perform Endovascular Revascularization • PTA • PTA-stent • Drug-eluting devices • Endoprosthesis • Debulking Techniques

  6. Balloon dilatation and stent implantation for treatment of femoro-popliteal arterial disease: Meta-Analysis Muradin GSR et al. Radiology 2001; 221: 137-145 Patients with CLI Restenosis rate 2 year 51% 64%

  7. Vascular Surgery – University of Bologna SFA – Endovascular treatment 136 limbs Restenosis 24 months: 64.8% 24 months 35.2% PrimaryPatency % months Mean follow-up 28.34 ± 22.4 months (range 6-81.8)

  8. What’s next after optimal infrapopliteal angioplasty ? Clinical and ultrasonografic results of a prospective single-center study. Gargiulo M e t al. J Endovasc Ther 2008; 15: 363-369 Tibial arteries PTA 87 limbs 86.4% Restenosis: 62.1% 65.4% Primary Patency (%) 37.9% Months

  9. Angiographic patency and clinical outcome after Balloon-Angioplasty for extensive infrapopliteal arterial disease Schmidt A et al . Catheterization and Cardiovascular Interventions 2010; 76:1047-54 • Inclusion Criteria • - CLI • - Tibial arteries disease lenght ≥ 80 mm • 3 month angiographical follow up: 58pts / 62 legs • - average lesion lenght: 18.3 ± 7.5 cm • - tibial arteries disease: stenosis 35.1%, occlusion 64.9% • - clinical improvement : 75.8% limbs • - angiography: < 50% restenosis 31.2% • > 50% restenosis 31.2% • occlusion 37.6% • focal restenosis 19% • entire segment 81% • - reinterventions 31/62 (50%) Restenosis rate 68.8%

  10. How to perform Endovascular Revascularization • PTA • PTA-stent • Drug-eluting devices • Endoprosthesis • Debulking Techniques

  11. Combined Nitinol Randomized Data 1 yr SFA In-stent restenosis = 30%

  12. Angioplasty versus stenting for superficial femoral artery lesions (Review) Twine CP, Coulston J, Shandall A, McLain AD The Cochrane Library 2009, Issue 2 • Selection criteria • Randomised trials of PTA alone vs PTA-stenting for the treatment of SFA lesions • Results • Trials: 8 • Patients 968 • Average age 67 • Follow up 2 years • Main Results • 6 months patency PTA-stenting > PTA • 12, 24 months patency PTA-stenting = PTA • 6, 12, 24 months quality of life PTA-stenting = PTA Conclusion: There is limited benefit to stenting lesions of the SFA in addition to PTA; this cannot be recommended routinely based on the results of this analysis

  13. Stent Placement Versus Balloon Angioplasty for the Treatment of Obstructive Lesions of the Popliteal Artery: A Prospective, Multicenter, Randomized Trial Rastan A et al Circulation 2013;127:2535-2541 Conclusion: a provisional stenting strategy should be considered over primary stenting for the treatment of PA lesions

  14. Infragenicular stent implantation for below-the-knee atherosclerosis disease: Clinical evidence from an international collaborative Meta-Analysis on 640 patients Biondi-Zoccai GGL et al J Endovasc Ther 2009; 16: 251-260

  15. Incidence,anatomical location and clinical significance of Compression and Fractures in Infrapopliteal Balloon-Expandable Metal Stents Karnabatidis D et al. J Endovasc Ther 2009; 16: 15-22 Results • follow up (mean) 15±11 months • stent fracture or compression 12 (3.2%) • compression 11 • fracture type grade IV 1 • no difference in the rate stainless-steel vs cobalt-chromium • no difference in the rate BMS vs DE stents • restenosis/reocclusion • compression/fracture 100% • no compression/restenosis 47.3%

  16. Il Drug Eluting Balloon nella pratica clinica. Prospettive diverse per un risultato comuneIl Chirurgo Vascolare: “leave nothing behind” o “full metal jacket” Mauro Gargiulo Chirurgia Vascolare, Università di Bologna Policlinico S.Orsola-Malpighi Bologna (Dir. Prof. Andrea Stella)

  17. How to perform PTA – Stent Implantation Inclusion criteria • Persistent residual stenosis • Flow limiting dissection • Intraluminal thrombosis

  18. Infrainguinal arteries PTA – Achilles’ heel • Technical failure • calcified lesions • long obstructions • Restenosis

  19. Restenosis - Pathophysiology Restenosis arises from neointimal formation and arterial remodelling PTA Arterial remodelling Neointimal formation Endothelial denudation SMC proliferation and migration to the intima and extracellular matrix synthesis Exposure of subendothelial matrix Platelets adhesion and activation Platelets release mitogens (thromboxane A2, serotonin, PDGFs)

  20. Restenosis - Pathophysiology PTA Arterial remodelling R Zargham Clinical Science 2008; 114:257-264 Expansive remodeling Constrictive remodeling Intimal hyperplasia RESTENOSIS

  21. Restenosis – Pathophysiology and drugs prevention Restenosis arises from neointimal formation and arterial remodelling PTA Statins Arterial remodelling Neointimal formation Endothelial denudation SMC proliferation and migration to the intima and extracellular matrix synthesis Exposure of subendothelial matrix Antiplatelets LMWH AT1 receptor blokers Cilostazol LMWH Platelets adhesion and activation Platelets release mitogens (thromboxane A2, serotonin, PDGFs)

  22. Restenosis – Prevention: Devices • Drug-eluting stent • Drug-eluting balloon • Cryoplasty (?) • Cutting balloon • Irradiation (endovascular brachytherapy or external beam irradiation) • Mechanical barrier (stent-graft)

  23. Restenosis – Prevention with Devices: Drug eluting balloon Inhibit proliferation and migration of vascular smooth muscle cells

  24. Vascular Surgery – University of Bologna CLI - Infrainguinal PAD SFA - PA • Thunder Trial • FemPac Trial • Pacifier RCT • Debellum • DEB SFA Italian Registry 1-year Primary Patency[1] = 83.7% 2-year[2] Primary Patency[1] = 72.4% Tibial arteries Survival from TLR, Occlusion, >50% Restenosis

  25. DEB for Long SFA-Lesions - Limbs treated: 183 - Lesion-length: 23.7 ± 8.6 cm - Balloon-number (median) 3 - Stenosis / occlusion: 39.9 % / 60.1 % - De-novo: 56.3 % - Restenosis: 10.4 % - In-stent restenosis: 33.3 % 82.4 % primary patency at 1 year A. Schmidt , LINC 2013

  26. Vascular Surgery – University of Bologna CLI - Infrainguinal PAD Tibial arteries

  27. Leipzig DEB-BTK RegistryA.Schmidt JACC 2011 • Key Baseline characteristics • CLI = 82.6%; Diabetics = 73% • Avg Lesion length = 173 ± 87 mm • Tot Occlusions = 61.9% 104 patients (angio subgroup = 84 arteries) RC 3-4-5-6 IN.PACT Amphirion Low restenosis rates at 3 months in long BTK lesions and occlusions Primary EP: 3m (angio) Rest. Rate * PTA historical cohort (A.Schmidt et al. CCI 2010)

  28. DEBATE BTK RCTF.Liistro EuroPCR 2012 Significant reduction in 12-m Rest. Rate vs. PTA in BTK / CLI / Diabetics 150 lesions RC 4-5-6 CLI and Diabetes 12-month FU Angio: 81% (DEB) / 89% (PTA) Duplex: 18% (DEB) / 11% (PTA) random 1:1 IN.PACT PTA P=0.0004 P=0.0006 Primary EP: 12m (angio) Rest. Rate • Key Baseline characteristics (DEB vs. PTA): • CLI = 100% • Diabetics = 100% • Mean lesion length = 121 ± 83 vs. 123 ± 68 (p=ns) • Tot Occlusions = 80% vs. 82% (p=ns) • Pre-dilat. = 100% PTA DEB 2013

  29. Restenosis after PTA – Prevention with DEB Inclusion Criteria • Post-revascularizationlong-timewoundheeling • IschemicRestpain • Ischemiculcers or gangrene

  30. Vascular Surgery – University of Bologna “Left open”

  31. Vascular Surgery – University of Bologna Pre-op Pre-op Periop. 15 days 4 months 24 days 10 months 9 months 10 months

  32. Vascular Surgery – University of Bologna Pre-op Pre-op What’s next after optimal infrapopliteal angioplasty ? Clinical and ultrasonografic results of a prospective single-center study. Periop. Gargiulo M e t al. J Endovasc Ther 2008; 15: 363-369 15 days 4 months 24 days 9 months 10 months

  33. Restenosis after PTA – Prevention with DEB Inclusion Criteria • Post-revascularization long-time wound heeling • Ischemic Rest pain • Ischemic ulcers or gangrene

  34. Restenosis after PTA – Prevention with DEB 3/2010 Rutherford 4

  35. Restenosis after PTA – Prevention with DEB 3/2010 9/2010 Rutherford 4 PTA result

  36. Restenosis after PTA – Prevention with DEB Inclusion Criteria • Post-revascularization long-time wound heeling • Ischemic Rest pain • Ischemic ulcers or gangrene

  37. Restenosis after PTA – Prevention with DEB Ischemic gangrene 21 days follow up Inpact Amphirion 3 x 80, 2.5 x120mm 9-18 months follow up

  38. Restenosis after PTA – Prevention with DEB Inpact Amphirion 2.5x120mm 9 months follow up after PTA and minor amputation

  39. Restenosis after PTA – Prevention with DEB Neuro-Ischemic ulcers

  40. Restenosis after PTA – Prevention with DEB Neuro-Ischemic ulcers + 21 days follow up

  41. Conclusions • PTA: high Restenosis-rate • Restenosis decrease the % of limb salvage and wound healing • DEBs, in preclinical and clinical studies, have been demostrated • to be effective in lowering the restenosis rate • DEB is a promising new tool in the treatment of infrainguinal PAOD The Role of DEB for distal PTA

  42. SFA – Endovascular Treatment 41% reduction in TLR ratecompared to percutaneous transluminal angioplasty (PTA)[1-9] 12 months post-procedure 24 months post-procedure Device % patients without TLR[1–8] DEB 93% 86% Drug eluting stent 91% 84% Bare metal stent 87% 78% PTA 71% 51% By Chris Bingham 2013

  43. Sustained Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Lesions : 2-Year Follow-Up From the Zilver PTX Randomized and Single-Arm Clinical Studies M.D. Dake et al J Am Coll Cardiol 2013;61:2417 - 2427 83.4% P < 0.01 64.1%

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