1. Can Drug-Coated Balloons Work in Synergy with Stent Grafts?
BAD KROZINGEN
T. Zeller, MD
University Heart Center Freiburg-Bad Krozingen
Bad Krozingen, Germany
Can Drug-Coated Balloons Work in Synergy with Stent Grafts?

2. Faculty Disclosure Thomas Zeller, MD
For the 12 months preceding this presentation, I disclose the following types of financial relationships:
Honoraria received from: Abbott Vascular, Angioslide, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Cordis Corp., Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, VIVA Physicians
Consulted for: Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics
Research, clinical trial, or drug study funds received from: 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Cordis Corp., Gore & Associates, Abbott Vascular, Medtronic, Spectranetics, Terumo, TriReme, Volcano

3. DCB in SFA Evidence: Proof-of-Concept
7 Trials / 6 DEB Technologies; 6-month LLL (Primary Endpoint)
PACCOCATH
PTX 3µgr/mm2 + Ultravist
ADVANCE PTX
PTX 3µgr/mm2
NO Excipient
PASSEO 18 LUX
PTX 3µgr/mm2
+ BTHC
LUTONIX
PTX 2µgr/mm2
+ Polysorbate
& Sorbitol
IN.PACT
PTX 3µgr/mm2
+ Urea
CVI
PTX / Excipient (?)
single-arm
p=NS
[1] G.Tepe et al. - NEJM 2008; [2] M.Werk et al. - Circulation 2008; [3] D.Scheinert - TCT 2012 oral presentation; [4] M.Werk et al. - Circulation CI ; [5] D.Scheinert – EuroPCR 2012 oral presentation; [6] D.Scheinert – LINC 2013 oral presentation; [7] S.Duda – EuroPCR 2013 oral presentation

4. 2-Year Primary Patency INPACT SFA vs. Levant 2
∆ 20.8%
Levant 2

5. DCB Performs Good in the SFA but is not yet Perfect
After stenting
Bailout-stenting rate up to 40 % (Resilient)

6. Procedural Characteristics
IN.PACT GLOBAL LONG LESIONS IMAGING COHORT: Lesion/procedural characteristics
Lesions (N)
164
Lesion Type:
de novo
restenotic (no ISR)
ISR
83.2% (134/161)
16.8% (27/161)
0.0% (0/161)
Lesion Length
26.40 ± 8.61 cm
Total Occlusions
60.4% (99/164)
Calcification
Severe
71.8% (117/163)
19.6% (32/163)
RVD (mm)
4.594 ± 0.819
Diameter Stenosis (pre-treatment)
90.9% ± 14.2
Dissections: 0
37.9% (61/161)
A-C
47.2% (76/161)
D-F
14.9% (24/161)
Procedural Characteristics
Device Success
99.5% (442/444)
Procedure Success
99.4% (155/156)
Clinical Success
Pre-dilatation
89.8% (141/157)
Post-dilatation
39.1% (61/156)
Provisional Stent
LL cm:
LL > 25 cm:
40.4% (63/156)
33.3% (33/99)
52.6% (30/57)
Device success: successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst below the RBP
Procedure success: residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab (if core lab was not available then the site reported estimate was used)
Clinical success: procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge 6

7. Primary Patency at 360 days Primary Patency at 390 days
IN.PACT GLOBAL LONG LESIONS IMAGING COHORT: Lesion/procedural characteristics
Primary Patency at 360 days
91.1%
Primary Patency at 390 days
80.7%
 10.4% 7

8. Neointimal Hyperplasia
Stent Graft (VIABAHN)
Mechanical Barrier
Achilles' heel of SFA stenting
Original stimulus for stenosis removed from the equation
Pore size provides a barrier to tissue ingrowth

10. 4.4.11

11. 4.4.11

12. VIASTAR 2-Year Freedom from TLR
79.4%
80%
73%
61.9%
log rank p=0.37
log rank p=0.13
Lammer et al . CVIR 2014

13. 25cm Viabahn 12M Data Mean Lesion Length 26.5cm Primary patency: 67%
freedom from TLR: 78.2%
Primary patency: 67%
secondary patency: 96.9%
Zeller et al. JEVT 2014

14. 25cm Viabahn 12M Data – Primary Patency
Current data is in line with the previously published data of the current generation of the GORE® VIABAHN® Endoprosthesis
% Occlusions at baseline
Avg lesion length
Primary patency at 1Y
25cm Study
92.9%
26.5cm
67%
VIPER
56%
>20cm subset
70%
VIASTAR
79%
71%

15. Edge Stenosis - Neointimal Hyperplasia Achilles’ Heel of Viabahn
Stent Graft (VIABAHN)
Mechanical Barrier
Potential
Solution:
Preparing
the landing
zone
with DCB
Pore size provides a barrier to tissue ingrowth through the fabrique but not from the edges

16. Femoro-popliteal Artery - Biomechanics
Zone A
Zone B
Zone C
Zone D
Bend / Kink
Fixed
Compress /
Slight curve
Lansky, A; Angiographic Analysis of Strut Fractures in the SIROCCO Trial. TCT 2004

17. Straight Stents Inhibit Shortening
Dominant force in vessel is axial compression
Up to 23% shortening in native vessel during flexion*
Straight stent may limit shortening to around 10%*
Risk of kinking at stent end or slack vessel
straight stent
vessel kink
* Smouse BH, Nikanorov A, LaFlash D. Biomechanical forces in the femoropopliteal arterial segment. Endovasc Today. 2005;4:60-66

18. 3D Stent Design vs. Straight Nitinol Stents
Test setup replicates adductor canal / proximal popliteal fossa
Helical Nitinol stent
150mm stents undergoing 10% compression
Straight Nitinol stent
Straight stent is Everflex
Potential chronic micro injuries
at the Viabahn edges

19. BioMimics 3D vs. Straight Nitinol Stents
Test setup replicates adductor canal / proximal popliteal fossa
150mm stents undergoing 10% compression
Straight Nitinol stent
Proximal Popliteal Fossa
Adductor Canal
40mm
Straight stent is Everflex
13mm 
From VIBRANT 12-month data presentation (G. Ansel);
example of bare Nitinol stent fracture
PAM 098 Issue 00

20. DCB & Stentgrafts in Femoro-Popliteal Lesions Conclusions
DCB perform well in femoro-popliteal disease
Limitations of POBA
Dissection
Recoil
Thrombus
Viabahn endoprosthesis provides a mechanical barrier against tissue ingrowth
Limitation: Edge stenosis
Preparation of the landing zones of the Viabahn stentgraft might solve the limitations of both individual devices
Costs?
Pathophysiology?