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

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

3. 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

4. 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)

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

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

7. 25cm Viabahn Study 12-month Patency and fTLR

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

9. 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

10. RELINE Clinical Trial Randomization

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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

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

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

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

21. Preserved 3-Vessel Run-off
August 13, 2014

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

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

24. VIABAHN® Endoprostheses
August 14, 2014

25. 1-Year Primary Patency of Viabahn Endografts for BMS Tosaka 3 ISR
ABIs 0.90 Rt, 0.94 Lt
Patient asymptomatic
July 17, 2015

26. 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

27. 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