Iliac and Aortiliac Occlusions Stent Grafts or Bare

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

DISCLOSURES John R. Laird, Jr. , MD Consulting Fees – Abbott Vascular, Angio. Score, Inc. , Ardian, Inc. , Boston Scientific Corporation, Cordis, a Johnson & Johnson company, Lutonix, Medtronic Cardio. Vascular, Inc. Ownership Interest (Stocks, Stock Options or Other Ownership Interest) – Angioslide, Bio. Cardia, Inc. , Nex. Gen, Novo. Stent, Re. Vascular 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.

GORE VIABAHN Endoprosthesis

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

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 e. PTFE+corrugated ring (28 day) 18± 03* Uncoated slotted tube (28 day) 93± 16 e. PTFE+slotted tube (28 day) 17± 04*** e. PTFE+slotted tube (56 day) 13± 02 * P<0. 007 compared to uncoated corrugated ring **P<0. 0001 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)

Should Complex Aortoiliac PCI Always Be Treated With Balloon-Expandable Covered Stents? John Angle, MD, University of Virginia C 3 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. 5 months (92% primary patency versus 54% p=0. 002)

CTA followup Courtesy of Samir Saher Intimal hyperplasia

Courtesy of Samir Saher

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

C 0 BEST STUDY RESULTS TRIAL PROFILE 123 Patients (Limbs: 167) ICAST: V 12 Bare Metal Stent R v 12 (n = 83) 12 Months (n = 81) 12 18 Months (n = 69) Intention-to-Treat Analysis No Crossover BMS (n = 84) 12 Months (n = 79) On-Treatment Analysis 16 18 Months (n = 63)

COBEST: 18 -Month Results p <. 05 Comparing patency and clinical improvement between V 12 group and BMS group (Kruskal-Wallis test p <. 05)

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

™ i. CAST Atrium Registry Ultrasound Study

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

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

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

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)

Lesion Characteristics • Total Occlusions: 13 • Kissing Stents: 14 • Average Lesion Length: 30. 22

ABI ABI Before Procedure 0. 78 After Procedure 0. 96 1 Month 0. 97 9 Month 0. 97

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%)

30 -Day MAVE (Major Adverse Vascular Events) 30 Days Myocardial Infarction at 30 days 0 Stent thrombosis 1 Clinically apparent distal embolization – defined as causing end-organ damage (e. g. lower extremity ulceration, tissue necrosis, or gangrene) 0 Arterial rupture 0 Acute limb ischemia 0 Target limb amputation 0 Procedure related bleeding event requiring transfusion 0 Composite 1/86(1. 2%) Stent Thrombosis is same as TLR from primary endpoint (only TLR was Stent Thrombosis less than 24 hours)

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