1. Iliac and Aortiliac Occlusions: Stent Grafts or Bare Metal Stents…
Iliac and Aortiliac Occlusions: Stent Grafts or Bare Metal Stents…. Does it Matter?
John R. Laird, MD
Professor of Medicine
Medical Director of the Vascular Center
UC Davis Medical Center

2. John R. Laird, Jr., MD DISCLOSURES Consulting Fees
Abbott Vascular, AngioScore, Inc., Ardian, Inc., Boston Scientific Corporation, Cordis, a Johnson & Johnson company, Lutonix, Medtronic CardioVascular, Inc.
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
Angioslide, BioCardia, Inc., NexGen, NovoStent, ReVascular Therapeutics, Inc.
I intend to reference unlabeled/unapproved uses of drugs or devices in my presentation.
I intend to reference off-label use of stents.

3. GORE VIABAHN Endoprosthesis

4. Atrium iCAST Covered Stent
iCAST is:
Balloon expandable
Stainless steel
PTFE encapsulated stent
PTFE covers inside and outside of the stent so no metal is exposed
Low profile 6Fr and 7Fr compatible
Able to be post dilated and flared
Currently approved for treatment of tracheobronchial strictures, not approved for vascular applications

5. Rationale: For Covering
Encapsulation platform has been shown to help reduce restenosis and limit neointimal thickness, regardless of stent strut design.
Stent type
Neointimal (µm)
Uncoated corrugated ring (28 day)
72±23
ePTFE+corrugated ring (28 day)
18±03*
Uncoated slotted tube (28 day)
93±16
ePTFE+slotted tube (28 day)
17±04***
ePTFE+slotted tube (56 day)
13±02
* P<0.007 compared to uncoated corrugated ring
**P< compared to uncoated slotted tube
Rogers, C & E. Edelman. A Non-GLP Study of Biologic Responses to Uncoated and PTFE Coated Steel Stents in Rabbit Iliac Arteries. (1997)

6. Should Complex Aortoiliac PCI Always Be Treated With Balloon-Expandable Covered Stents? John Angle, MD, University of Virginia C3 Conference 2009
S.S. Sabri, JF. Angle, A.F. Choudhri, MD., M. Dake, MD studied patients with aortic bifurcation disease with bilateral common iliac kissing balloon expandable stents
54 consecutive patients, retrospectively reviewed (26 covered vs 28 BMS)
Covered stents were superior to BMS with mean follow-up of 29.5months (92% primary patency versus 54% p=0.002)

7. CTA followup
Intimal hyperplasia
Courtesy of Samir Saher

8. Courtesy of Samir Saher

9. COBEST “Covered Versus Balloon Expandable Stent Trial” P
COBEST “Covered Versus Balloon Expandable Stent Trial” P. Mwipatayi MD, Royal Perth Hospital VIVA 2009
Prospective multi-center randomized trial (Australia)
Atrium covered stent to BX BMS in Tasc B,C,and D lesions

10. C0BEST TRIAL PROFILE R STUDY RESULTS Bare Metal Stent v12 BMS (n = 83)
123 Patients (Limbs:167)
ICAST:V12
Bare Metal Stent R
v12
(n = 83)
Intention-to-Treat Analysis
BMS
(n = 84)
12 Months
(n = 81)
(n = 79)
No Crossover 12 16
On-Treatment Analysis
18 Months
(n = 69)
18 Months
(n = 63)

11. COBEST: 18-Month Results
p < .05
Comparing patency and clinical improvement between V12 group and BMS group
(Kruskal-Wallis test p < .05)

12. Binary Restenosis Binary Restenosis
Cox adjusted plots stratified for the type of stent used according to the TASC C/D group
Binary Restenosis
Cox adjusted plots stratified for the type of stent used according to the TASC B group
Binary Restenosis

13. iCAST™ Atrium Registry Ultrasound Study

14. Study Design
Prospective, multicenter, non-randomized single arm registry to assess the safety and effectiveness of the Atrium iCAST PTFE covered iliac stent as compared to a performance metric
(derived from data from previous FDA
Iliac stent trials – Wallstent, SMART, Intrastent)

15. Study Design Up to 25 sites 225 Subjects
Up to 35 subjects with total occlusions (approximately 15%)
Clinical Follow up at 30 days, 6, 9 and 12 months
Long term annual follow up through 36 months

16. Primary Endpoint Composite primary endpoint of:
Occurrence of death within 30 days
Target site revascularization (need to intervene at the target site) within 9 months
Restenosis by ultrasound within 9 months post procedure

17. Enrollment To Date 98 Patients/146 Limbs (Lesions: 164) 184 Devices
1 Month
86 Patients (Lesions: 153)
6 Months
67 Patients (Lesions: 112)
9 Months
42 Patients (Lesions = 90)

18. Lesion Characteristics
Total Occlusions: 13
Kissing Stents: 14
Average Lesion Length: 30.22

19. ABI ABI Before Procedure 0.78 After Procedure 0.96 1 Month 0.97

20. Primary Endpoint Primary Endpoint Occurrence of Death within 30 days
0/86
Target Site Revascularization within 9 months
1/42
Restenosis by Ultrasound within 9 months
0/42
Composite (patients reaching 9 months)
1/42 (2.4%)

21. 30-Day MAVE (Major Adverse Vascular Events)
30 Days
Myocardial Infarction at 30 days
Stent thrombosis 1
Clinically apparent distal embolization – defined as causing end-organ damage (e.g. lower extremity ulceration, tissue necrosis, or gangrene)
Arterial rupture
Acute limb ischemia
Target limb amputation
Procedure related bleeding event requiring transfusion
Composite
1/86(1.2%)
Stent Thrombosis is same as TLR from primary endpoint (only TLR was Stent Thrombosis less than 24 hours)

22. Summary
Preliminary results from the ICARUS trial show low restenosis and TVR rates at 9 months
Evolving data to suggest that ePTFE covered stents may offer benefits over bare metal stents in the iliac arteries – particularly for more complex lesion subsets