SFA In-stent Restenosis

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1 Disclosure In-Stent Restenosis: Endo-Salvage Works for Most Patients Peter A. Schneider, MD Hawaii Permanente Medical Group and Kaiser Foundation Hospital Honolulu, Hawaii Peter A. Schneider Potential conflicts of interest to report: Enter patients in studies sponsored by: Gore, Cordis Modest royalty from Cook UCSF Vascular Symposium, 2014 The Risk of Restenosis SFA In-stent Restenosis 5% 10-20% ~5-10% ~25-50%? Common: 18%- 40% at 12 months in recent trials More common in the setting of long SFA occlusions, small diameter SFA, diffuse disease May be associated with stent fracture or stent overlap Everyone knows that in-stent restenosis stinks! 1

2 Steven Van Zandt Richard Gere In-Stent Restenosis Treatment Options Young Al Pacino Plain Old Balloon Angioplasty Cutting/scoring balloon Debulking/Atherectomy Re-stent (Bare metal) Stent-graft Drug-eluting balloon Drug-eluting stent 2

3 SFA In-Stent Restenosis Treated with Balloon Angioplasty Study Patients Primary Patency at 12 months RELINE % FAIR % 133 SFA ISR lesions treated from at centers in Japan POBA only for all cases Deloose et al. LINC 2014 Krankenberg et al. LINC 2014 Tosaka et al. JACC 2012;59:16-23 Freedom from Recurrent Restenosis Class III= occluded stent Recurrent restenosis at 2 Years: Class I: 49.9% Class II: 53.3% Class III: 84.8% Recurrent occlusion in 64.6% of Class III Bypass surgery performed in 11 limbs Major amputation in 1 limb Tosaka et al. JACC 2012;59:16-23 Tosaka et al.jacc 2012;59:

4 Freedom from Recurrent Restenosis Freedom from Re-occlusion due to ISR Restenosis by ISR Class Armstrong et al. Cathet Cardiovasc Interv 2013;82:1168 Tosaka et al. JACC 2012;59:16-23 Armstrong et al. Cathet Cardiovasc Interv 2013;82:1168 ISR-Cutting Balloon Same as POBA Debulking for ISR Potential advantages: Better angiographic and hemodynamic result Remove thrombus within stent to reduce distal embolization (Laser, Pathway) Dick et al. Radiology

5 Excisional Atherectomy for ISR Excisional Atherectomy for ISR Silverhawk Post Zeller et al. JACC 2006 Excisional Atherectomy for ISR Result after 2.0mm Turbo Booster-Laser 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 before after treatment 5

6 Laser Atherectomy for ISR PATENT Study Turbo Elite Laser with Booster 89 patients Lesion length 123mm Occlusion 34% Distal embolization 10% Freedom from TLR Reline Trial Endoprosthesis vs PTA 74.8 % 28.0 % p<0.001 xxxxxxxxxxxxxxxxxxxx 12 month primary patency Duplex ratio <2.5 Zeller 2014 Number at risk baseline 1MFU 6MFU 12MFU PTA Viabahn Deloose et al. LINC 2014 FMRP Stent-graft for ISR Study No. Lesion Length Kazemi et al. TCT 2006 Ansel et al. CC&I 2007 Monahan et al. JVS 2011 Deloose et al. Reline Trial % Primary Patency 12 month % (18 mos) 24 N/A 62% % IN.PACT DEB Mean stent length 150mm Mean lesion length 83mm Primary patency One year 92% Two year 70% DEB for ISR Montevergine Registry Stabile et al. JACC 2012;60:1739 6

7 DEB for ISR-Results by Lesion Type Montevergine Registry FAIR Trial: Prospective RCT POBA vs IN.PACT DEB % p = % (25/40) DEB PTA p N Dist SFA / P1 50% (31/62) 38.5% (22/57) %DS (% ± SD) 89.0 ± 8.9% 89.9 ± 9.6% RVD (mm, mean±sd) 5.1 ± ± Lesion Length (mm, mean±sd) 82.3 ± ± Tot Occlusive ISR 24.2% (15/62) 33.3% (19/57) ISR pattern: focal 25.9% (15/58) diffuse 51.7% (30/58) multifocal 22.4% (13/58) 27.8% (15/54) 53.7% (29/54) 18.5% (10/54) Heavy Calcium 9.7% (6/62) 8.8% (5/57) % (13/44) Stabile et al. JACC 2012;60:1739 Krankenberg LINC 2014 Zilver PTX Registry Zilver PTX Global Registry ISR Subanalysis Dake LINC 2014 Dake LINC

8 Treatment for In-stent Restenosis Treatment Patency 12m Comment PTA 28-38% Depends upon number of Class III patients Cutting Same as PTA Atherectomy 43-54% Lack data on othr types of modified balloon designs Plays a role in debulking Stent-graft 62-75% Collaterals, all available data with Viabahn DEB 71-92% Small series, recently published, one RCT not yet published. DES 80% Registry data SFA ISR: Conclusions Poor results with POBA ( particularly for instent occlusion) Cutting and debulking may be adjunctive but results not adequate as stand alone therapy Improved results with endoprosthesis Promising results with local drug delivery using either DEB or DES. Class I ISR has substantially better results and Class III has worse results. Mr. Biceps circa 1992 In-stent restenosis a) Is best treated with balloon angioplasty. b) Can be treated with any modality and achieve approximately the same results. c) Has worse results of treatment when the stent is occluded. d) Occurs with about the same frequency in the SFA as it does after carotid or iliac stenting. 97% 0% 3% 0% I s b e s t t r e a t e... C a n b e t r e a t e d... H a s w o r s e r e s u... O c c u r s w i t h a b... 8