Role of Covered Stents and Drug Eluting Balloons In Dialysis Access

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1 Role of Covered Stents and Drug Eluting Balloons In Dialysis Access Joseph Habib, MD, FACS Assistant Professor Department of Surgery Division of Vascular and Endovascular Surgery University of Florida Jacksonville, FL Caution: Investigational Device. Not for sale in the US. Limited by Federal (or US) law to Investigational Use

2 None Disclosures

3 Hemodialysis Treatment for ESRD End-stage renal disease (ESRD) is treated in >600k patients in the US 1 >120k new ESRD patients annually 1 >$50B cost to Medicare 1 Hemodialysis represents a significant burden to healthcare system Over past 20 years, significant shift from AVG to AVF (Fistula First) 1-2 Both AVF and AVG failures necessitate access revisions Path from ESRD to AV Access Failures (US-2014) 1 ESRD End Stage Renal Disease RRT Renal Replacement Therapies HD Vascular Access Types 678k prevalent population 7% Peritoneal dialysis 30% Renal Transplant 63% Hemodialysis (HD) 19% Catheters 63% AVF - 18% AVG AVF and AVG Primary Patency mo: 48-80% 24-mo: 50-70% 1. Saran R, et al. US Renal Data System 2016 Annual Data Report: epidemiology of kidney disease in the United States. 11Am J Kidney Dis 2017;69:S1-S Tokars JI, et al. Semin Dial 2000;13: Al-Jaishi AA, et al. Am J Kidney Dis 2014;63: Palder SB, et al. Ann Surg 1985;202: Lumsden AB, et al. J Vasc Surg 1997;26: Munda R, et al. J Am Med Assoc 1983;249:

4 Stenosis in the Access Circuit National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) PTA first line treatment for stenosis Stent placement recommended: acute recoil after PTA stenosis recurring within 3 months patients at increased risk for surgery following vessel rupture KDOQI clinical practice guidelines (2006)

5 Stenosis in the Access Circuit 73% of cases of restenosis in the HD access circuit are secondary to in-stent restenosis No guidelines for treatment of in-stent restenosis Theoretically stent grafts provide a combination of endoluminal support to maintain vessel patency and biocompatible barrier to prevent cellular ingrowth Stent grafts provide a barrier to intimal hyperplasia, reduce in-stent restenosis Falk et al. 2016

6 Covered Stents in Dialysis Access Fluency Plus Vascular Stent Graft (Bard) FLAIR Endovascular Stent Graft (Bard) Viabahn Endoprosthesis (W.L. GORE)

7 Covered Stents Fluency Plus Vascular Stent Graft (BARD) Self expanding nitinol scaffolding with 2 layers of PTFE, carbon impregnated 5 mm to 13.5 mm diameters 20 mm to 120 mm lengths 8-10F compatible

8 Covered Stents FLAIR endovascular stent graft (BARD) Flared configuration, PTFE, carbon impregnated 6-9 mm diameters mm lengths 9F compatible

9 Covered Stents Gore Viabahn Endoprosthesis self expanding Nitinol skeleton covered with PTFE Propaten bioactive surface 5 mm-13 mm diameter mm lengths 6F-12F compatible

10 REVISE TRIAL RCT 293 patients (145 SG, 148 PTA) Viabahn Endoprothesis (GORE) vs. PTA to revise AV grafts TAPP (treatment area primary patency) 6 months: 51.6% SG vs 34.2 % PTA (p=0.006) Vesely et al. Journal of Vascular Surgery 2016

11 RENOVA Study Prospective, controlled trial 28 US sites, 270 patients enrolled, 191 completed (97 SG, 94 PTA) FLAIR Endovascular Stent Graft (BARD) vs PTA on revision of AV graft anastomotic stenosis through 2 years TAPP: 12 months: 47.6% SG vs. 24.8% PTA (p<0.001) 24 months: 26.9% SG vs 13.5% PTA (p<0.001) Haskal et al. J Vasc Interv Radiology 2016

12 RESCUE Study RCT 275 patients randomized (23 US sites) Fluency stent graft (BARD) compared with PTA for treatment of in-stent restenosis in AV grafts and fistulas TAPP: 6 months: 66.4% SG vs % PTA (p < 0.001) 12 months: 32.7% SG vs. 5.6% PTA 24 months: 15.6% SG vs. 2.2% PTA Falk et al. J Vasc Interv Radiology 2016

13 Stenosis in the dialysis circuit Uremia, oxidative stress, and inflammation When you arterialize a vein you create significant changes in flow dynamics which result in neo-intimal hyperplasia causing stenosis. Endovascular treatment of stenoses produce mechanical forces that induce more neointimal hyperplasia and fibrotic scar formation

14 Paclitaxel Cytotoxic drug Inhibits disassembly of microtubules during the M phase of the cell cycle, driving cells to apoptosis Theoretically this could lead to deceleration of neo-intimal hyperplasia and improve circuit patency Karnabatidis et al. 2017

15 Drug Eluting Balloons Paclitaxel-coated balloons Tested in the arterial bed with encouraging results in the SFA/popliteal location Nothing left behind principle no foreign material left behind to irritate the vascular wall. Karnabatidis et al. 2017

16 US DCB Device Overview Configurations Lutonix 035 (Bard) 4-7mm diameter mm length 1 IN.PACT Admiral (MDT) 4-7mm diameter mm length 2 Platform Lutonix PTA Admiral PTA Drug and Dosage Paclitaxel 2.0µg/mm 2 Paclitaxel 3.5µg/mm 2 Excipient / Coating Sorbitol / Polysorbate Urea Commercial Availability Worldwide Worldwide US Indication SFA & PA + ISR SFA & PA + ISR 1. IN.PACT Admiral introduced 150mm lengths July 2016.

17 Limited Available Literature for DEB in the Dialysis circuit Most reports employ the US-available DCBs (Bard Lutonix 035 and Medtronic IN.PACT DCB) One core lab-adjudicated multicenter randomized controlled trial (RCT) [Bard Lutonix AV Clinical Trial] Handful of single-center randomized and single-arm studies One planned core lab-adjudicated RCT [Medtronic IN.PACT AV Access Trial]

18 DEB in the Dialysis Circuit RCT 40 patients (20 DEB, 20 BA) Venous stenosis lesions both AVF/AVGs IN.PACT DEB TAPP (treatment area primary patency) 6 months (p<0.001) 70% DEB 25% BA Katsanos et al. J. Endvasc. Ther 2012

19 DEB in the Dialysis Circuit RCT 40 patients (DEB 20, BA 20) IN.PACT DEB vs PTA both AVF and AVGs TAPP at 12 months (p<0.001) 35% DEB vs. 5% BA Kitrou et al. European Journal of Radiology 2014

20 DEB in the dialysis circuit RCT comparing IN.PACT vs. standard PTA in failing AVFs 40 patients (20 DEB, 20 BA) TLR-free survival (308 d DEB vs. 161 d BA)(p=0.03) ACPP (access circuit primary patency) (DEB 270 d vs. BA 161 d) (p=0.04) Kitrou et al. J Vasc. Interv Radiology 2015

21 DEB in the dialysis circuit Single Center, retrospective analysis 39 patients, 61 interventions 20 AVFs, 19 AVGs Bard Lutonix PCB used TAPP at 6 months was 72.2% Kitrou et al. Cardiovas Interv. Rad. 2017

22 AV Access RCT: Lutonix AV Clinical Trial Design 1 Prospective, multicenter, randomized trial 23 global sites 285 subjects randomized 1:1 to PTA Primary Endpoints Efficacy: 6-month target lesion primary patency Safety: 30-day freedom from serious adverse events involving the access circuit Follow-up Fully-enrolled 1, 3, 6, 9, 12, 18, and 24 months 1. Presented by Treretola SO, LINC Leipzig, Germany 2017.

23 AV Access RCT: Lutonix AV Clinical Trial Key Inclusion and Exclusion Criteria 1 Inclusion Male and non-pregnant female Upper extremity AVF w/ clinical, physiological, or hemodynamic abnormality Fistula created 30 days 1 hemodialysis session 2 needles Catheter removed 30 days Lesion length 10cm 50% stenosis Successful predilation 4-12mm diameter vessel Exclusion Low extremity access Central veins Thrombosed access >2 lesions in circuit Secondary non-target lesion that cannot be successfully treated Central veins as a secondary lesion that is clinically significant Bare or covered stent in target or secondary non-target lesions 1. Presented by Treretola SO, LINC Leipzig, Germany 2017.

24 AV Access RCT: Lutonix AV Clinical Trial Key Patient and Lesions Characteristics 1 Patient Variable Lutonix 035 DCB (n=141) PTA (n=144) Mean Age 63.6y 61.0y Male 61.7% 59.0% Hypertension 94.3% 98.6% Diabetes Mellitus 58.2% 65.3% Dyslipidemia 60.3% 58.3% Current Smoking 13.5% 14.6% Peripheral Arterial Disease 9.9% 18.1% Coronary Artery Disease 30.5% 27.8% Lesion Variable Lutonix 035 DCB (n=141) 1. Presented by Treretola SO, LINC Leipzig, Germany 2017; p-values not presented. PTA (n=144) De Novo 30.5% 27.1% Tandem 2.8% 7.0% Target Lesion Length (mean ± SD) 28.4mm ± mm ± 18.69

25 AV Access RCT: Lutonix AV Clinical Trial Summary 1 First prospective, multicenter, randomized DCB AV access study First in fistula trial designed to incorporate a wide variety of lesions/fistula types 240-day Safety and Efficacy outcomes demonstrated: Safety outcomes non-inferior to PTA Target lesion primary patency 61.6% DCB vs. 49.4% PTA ( 12.2% p=0.02) 29.8% fewer interventions required to maintain target lesion patency in DCB arm Through 240 days, interventions required to maintain target lesion patency for DCB and PTA were 66 and 94, respectively 1. Presented by Treretola SO, LINC Leipzig, Germany Data shown are interim, site-reported and subject to change.

26 Overview Purpose Future IN.PACT AV Access IDE Trial To evaluate the safety and efficacy of the IN.PACT AV Access DCB compared to PTA for treatment of subjects presenting with de-novo or non-stented restenotic obstructive lesions of native AVF in the upper extremity. Design Prospective, global, multicenter, randomized, single-blinded study ~30 Global Sites (US, Japan & New Zealand) 330 patients 24 month follow-up 1:1 randomization Lesions up to 10 cm in length in the AVF Principal Investigators Robert Lookstein, MD (New York, USA) Andrew Holden (Auckland, New Zealand) Hiroaki Haruguchi, MD (Tokyo, Japan) 1.Katsanos K, et al. J Endovasc Ther 2012;19:

27 Endpoints Future IN.PACT AV Access IDE Trial Primary Safety Endpoint Serious Adverse Event Rate through 30 days: Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post-procedure Primary Efficacy Endpoint Primary Patency Rate through 6 months: Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured at 6 months postprocedure Estimated Start Second Half of Katsanos K, et al. J Endovasc Ther 2012;19:

28 Conclusions Hemodialysis represents a significant burden to healthcare system High rates of AVF and AVG failures necessitate frequent revascularization procedures When compared with standard PTA, stent grafts show superior TAPP for treatment of stenoses in AVGs/Fistulas DCB clinical data for AVF/G revision mostly limited to single-center studies One prospective, multicenter, RCT Lutonix AV Clinical Trial (Bard-sponsored) 1 Two single-center RCTs 2-4 One single-center prospective single-arm study 5 One single-center retrospective study 6 One single-center retrospective study on AVF ISR 7 DCB demonstrates improved outcomes over PTA in randomized studies While limited results show promise, larger RCTs needed 1. Presented by Treretola SO, LINC Leipzig, Germany Katsanos K, et al. J Endovasc Ther 2012;19: Kitrou PM, et al. Eur J Radiol 2015;84: Kitrou PM, et al. J Vasc Interv Radiol 2015;26: Patanè D, et al. J Vasc Access 2014;15: Kitrou PM, et al. Cardiovasc Interv Radiol 2017;40: Swinnen J, et al. J Vasc Access 2015;16:

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