ReIntervention for Claudication: Is This Effective, or a Slippery - PDF document

4/17/2018 Re‐Intervention for Claudication: Is This Effective, or a Slippery Slope? Patrick Geraghty, MD, FACS, RPVI Professor of Surgery and Radiology Conflicts • Cook Medical trial PI • Bard/Lutonix trial PI, consulting • Boston Scientific trial PI, consulting • Intact Vascular trial PI • Pulse Therapeutics stock holder • Zimmer Biomet consulting 1

4/17/2018 PAD: Patterns of Presentation • Asymptomatic PAD • Claudication • Chronic Limb‐Threatening Ischemia (CLTI) Reintervention is Good for the Soul • Gives you a chance to appreciate how foolish you were for stenting the SFA in a ½ mile claudicant • After your bout of buyer’s remorse‐ because you bought this one‐ take stock of your options 2

4/17/2018 Options, options… • You’re now at Robert Frost’s fork in the woods; what factors dictate your choice? • Severity of secondary presentation • Stenosis versus occlusion • Smoking status • Artery diameter • ISR pattern • Runoff quality • Availability of good venous conduit • Surgical candidacy What Parameters Matter? • PSV? • PSV ratios? • Recurrent claudication? • “IDE study failures” with PSVRs of 2.0‐2.5 carry a very low risk of near term thrombosis 3

4/17/2018 Biology is the Culprit • Primary literature focus to date: diffuse in‐ stent restenosis secondary to intimal hyperplasia (IH) • Reintervention through stent can be technically difficult, particularly if one is employing debulking strategies Restoration + Prevention Extravascular LUMEN Infusion RESTORATION: Biologic Inhibition of Intimal ‐ PTA Hyperplasia Luminal Depot ‐Nitinol (DCB, DES) ‐DES ‐DCB Mechanical ‐Atherectomy Prevention of Covered Stent ‐Laser Luminal Ingrowth ‐Covered Stent 4

4/17/2018 SFA In‐Stent Restenosis • Seen in 20%‐ 40% of patients at one year post‐ intervention in recent trials • More common following treatment of long SFA occlusions, small diameter SFA, diffuse disease • Increases at sites of stent fracture or stent overlap; this has improved in the era of longer, more flexible constructs 5

4/17/2018 Current Options for SFA ISR • Plain Old Balloon Angioplasty (POBA) • Cutting/Scoring Balloon Angioplasty • Laser/Atherectomy • Covered Stent • Drug‐Eluting Stent • Drug‐Coated Balloon POBA for Prior SFA Intervention • 222 patients with prior SFA intervention • 58 asymptomatic and 164 symptomatic • Reintervention PTA: 59% and bypass 41% • Bypass was used for more complex failures (longer lesions, compromised runoff) but had better long term patency but higher initial morbidity - Davies et al, J Vasc Surg 2010 6

4/17/2018 Stent Failures • 239 PTA + stent in SFA & popliteal • 69 failures • Initial TASC C or D classification predicted higher risk of stent failure, failure with occlusion, need for surgical revascularization, and loss of outflow vessels -Gur et al, J Vasc Surg 2011 POBA for ISR • Tosaka et al, JACC 2012 • 133 SFA ISR treated with POBA from 2000‐2009 7

4/17/2018 POBA for ISR • Restenosis at 2 years after POBA for ISR: – Class I: 49.9% – Class II: 53.3% – Class III: 84.8% • Recurrent occlusion seen in 64.6% of Class III lesions treated with POBA • 11 Class III patients required bypass surgery • 1 required amputation POBA‐ Freedom from 2° Restenosis 8

4/17/2018 POBA for ISR‐ 2° Restenosis Armstrong et al. Cathet Cardiovasc Interv 2013;82:1168 POBA for ISR‐ Risk of Reocclusion T osaka et al. JACC 2012;59:16-23 Armstrong et al. Cathet Cardiovasc Interv 2013;82:1168 9

4/17/2018 POBA for ISR‐ Control Arm Data ‐ RELINE Trial, Bosiers et al, JEVT 2015 ‐ FAIR Trial, Krankenberg et al., Circulation 2015 Cutting Balloon Similar to POBA for ISR -Dick et al, Radiology 2008; 248:297-302 10

4/17/2018 Debulking Technology for ISR Atherectomy 11

4/17/2018 Standalone Excisional Atherectomy for ISR •- 43 limbs with femoropopliteal ISR •- Mean lesion length 131 ± 111 mm •- Additional low pressure PTA in 59% •- Primary patency at 12 months: 54% •- Primary patency at 18 months: 49% -Zeller et al, JACC 2006 Excisional Atherectomy for ISR -Zeller et al, JACC 2006 12

4/17/2018 Laser Atherectomy Laser Atherectomy for ISR‐ PATENT • Spectranetics Laser w/ Turbo Boost guide • 12.3 cm mean lesion length • 34% occlusions • Adjunctive PTA used in 88% • Distal embolization in 10% but no amputations • Primary Patency – 6 MONTHS 64% – 12 MONTHS 38% -Schmidt et al, J Endovasc Ther 2014;21:52-60 13

4/17/2018 Laser Atherectomy for ISR‐ PATENT Graph shows Freedom from TLR -Schmidt et al, J Endovasc Ther 2014;21:52-60 Covered Stent 14

4/17/2018 RELINE Trial – Viabahn vs PTA Freedom from Recurrent Restenosis (PSVR> 2.5) 75% Viabahn 28% PTA ‐ Bosiers et al, JEVT 2015 Covered Stent for ISR STUDY # of patients LESION LENGTH cm PRIMARY PATENCY at 12 MONTHS Kazemi et al 2006 17 15 65% Ansel et al 2007 27 26 52% (18 months) Monahan et al 24 n/a 62% J Vasc Surg 2011 Bosiers et al 39 17 75% JEVT 2015 15

4/17/2018 Drug‐Coated Balloon (PTX) Drug Coated Balloon for ISR Montevergine Registry IN.PACT DEB Mean stent length 150mm Mean lesion length 83mm Primary patency: One year 92% Two year 70% -Stabile, JACC 2012 16

4/17/2018 Femoral Artery In‐stent Restenosis Trial • POBA vs In.Pact DCB – Lesion length 82 mm – CTO in 24‐33% – Stenting in 2‐7% • Six month primary patency of 85% for DCB • Six month primary patency of 55% for POBA ‐ Krankenberg et al., Circulation 2015 IN.PACT Global‐ ISR Cohort • 149 lesions, length 17 +/‐ 10 cm, 34% CTO -Brodmann et al, JACC- Cardiovasc Intervent, 2017 17

4/17/2018 Drug‐Eluting Stent (PTX) ZILVER PTX Registry ISR Subset • 108 patients / 119 lesions with femoropopliteal ISR at entry to single‐arm global ZPTX registry • Lesion length 133 ± 91.7 mm • Occlusion present in 31% • Procedural success achieved in 98.2% -Zeller, J Am Coll Cardiol Intv 2013; 6:274-81 18

4/17/2018 ZPTX for ISR‐ Primary Patency 78.8% at 12 months ZPTX for ISR‐ Freedom from TLR 60.8% at 24 months 19

4/17/2018 Laser Atherectomy + DCB Laser + Paclitaxel DCB • 62 patients laser + DCB; 50 patients laser + PTA – Lesion length 247 mm – Occlusion present in 74% – Bailout stents in 32% of L‐DCBs, 58% of L‐PTAs • 12 month freedom from re‐occlusion – Laser + PTA 57% – Laser + POBA 87% -Kokkinidis, JEVT; 2018 20

4/17/2018 SUMMARY of ISR OPTIONS • Tosaka class predicts outcomes • Leave stable Tosaka class 3 alone (CTOs) • Poor results with POBA • Cutting=POBA • Consider use of distal embolic protection! • Improved results with covered stent • Promising results with local drug delivery using either DEB or DES, +/‐ atherectomy QUESTIONS? 21