Stent Graft for the Treatment of ISR: Lessons from the RELINE Clinical Trial Robert M. Bersin, MD, MPH CRT Luncheon Symposium February 20, 2017

Robert M. Bersin, MD   I disclose the following relevant financial relationship: WL Gore Medical: Consulting Relationship

The Viabahn Endoprosthesis Contoured proximal edge Heparin Bioactive Surface Ultra-thin wall ePTFE tube Unique, durable bonding film Polished nitinol support Lengths: 2.5, 5, 10, 15, 25 cm Diameters: 5 – 13 mm

More than 1,100 Limbs in 17 Independent Studies* VIABAHN® Device 1-Year Primary Patency in the SFA Based on Lesion Length More than 1,100 Limbs in 17 Independent Studies* 100% 80% 60% One Year Primary Patency 40% 20% 0% 5 10 15 20 25 30 35 Average Stented Length (cm)

VIASTAR Randomized Trial All lesions Lesions ≥ 20 cm Lammer J et al J Am Coll Cardiol 2013; 62(15): 1320-1327

Endografts vs. Prosthetic Fem-Pop Bypass Graft Surgery McQuade K et al J Vasc Surg 2009; 49: 109-116 McQuade K et J Vasc Surg 2010; 52: 584-591

25cm Viabahn Study 12-month Patency and fTLR

Primary Patency of Interventional Therapies in TASC C/D Lesions Deloose K MEET 2014

TASC II SFA-Politeal ISR Lesions PTA Results by Tosaka Classification Recurrent Restenosis Rates With PTA for ISR Tosaka A et al J Am Coll Cardiol 2102; 59(1): 16-23

RELINE Clinical Trial Randomization

Lesion Characteristics Lesion characteristics similar across treatment groups M Bosiers et al J Endovasc Ther 2015: 22(1): 1–10

Primary Patency Primary patency with GORE® VIABAHN® Endoprosthesis in the per-protocol analysis (shown below), intent-to-treat analysis, and in comparison to optimal PTA cohort M Bosiers et al J Endovasc Ther 2015: 22(1): 1–10

Target-Lesion Revascularization (TLR) Per-Protocol Analysis Patients in the GORE® VIABAHN® Endoprosthesis arm were three times less likely to require a TLR at 1 year M Bosiers et al J Endovasc Ther 2015: 22(1): 1–10

TASC II C ISR Lesions Randomized Trials Laser DCB Viabahn EXCITE ISR Trial 1-yr PP 40.0% Ave LL 19.6 cm FAIR Trial 1-yr PP 70.5% Ave LL 8.2 cm RELINE Trial 1-yr PP 74.8% Ave LL 17.3 cm

Target-Lesion Revascularization (TLR) Per-Protocol Analysis Patients in the GORE® VIABAHN® Endoprosthesis arm were three times less likely to require a TLR at 2 years 66.3% P<0.001 23.0% K Deloose, MD LINC 2015

ISR Case Study 64 yo male HTN DM on oral meds Hypercholesterolemia September 5, 2012 64 yo male HTN DM on oral meds Hypercholesterolemia Carotid artery disease Peripheral arterial disease Bilateral Rutherford III calf claudication Bilateral internal iliac occlusions Bilateral SFA occlusions with 3-vessel runoff

Bilateral SFA CTO Interventions ISR Case Study Bilateral SFA CTO Interventions OCT 2012: R SFA CTO recanalization using the Crosser Catheter and Pioneer re-entry, placement of three GORE VIABAHN® Endografts (two 6-mm and one 7-mm), and placement of 7 x 60 mm Everflex into R Ext Iliac artery. NOV 2012: L SFA and above-knee popliteal CTO recanalization using Pioneer re-entry, Turbohawk atherectomy, and placement of three 6 mm EverFlex self-expanding stents. Presents 20 months later in June 2014 with recurrent LLE symptoms

ISR Case Study Studies: June, 2014 ABI Right = 0.91, Left = 0.48 Vascular Ultrasound shows re-occlusion of L SFA

L SFA: BMS Tosaka III ISR Occlusion August 13, 2014

L SFA: BMS Tosaka III ISR Occlusion August 13, 2014

Preserved 3-Vessel Run-off August 13, 2014

Day 1: Laser, Angiojet and EKOS Lysis 2.3 mm Laser Laser and Angiojet August 13, 2014

Day 2: Angiojet and Laser Post 7F Turbo Tandem Laser Post EKOS Post Angiojet August 14, 2014

VIABAHN® Endoprostheses August 14, 2014

1-Year Primary Patency of Viabahn Endografts for BMS Tosaka 3 ISR ABIs 0.90 Rt, 0.94 Lt Patient asymptomatic July 17, 2015

2-Year Primary Patency of Viabahn Endografts for BMS Tosaka 3 ISR ABIs 0.90 Rt, 0.93 Lt Patient asymptomatic Proximal Edge August 22, 2016 Distal Edge

Conclusions Patency is excellent with the Viabahn in long (>20 cm) TASC C/D SFA lesions, and is equivalent to bypass grafting with synthetic conduit RELINE Trial results indicate superior performance of the VIABAHN endoprosthesis in long ISR lesions Mean lesion lengths 17.3 cm and 19.0 cm 12-month primary patency of 75% vs 28% 12-month fTLR 80% vs 42% The VIABAHN endoprosthesis is a good choice for treating long-segment de novo as well as in-stent restenosis lesions