1. One-Year Interim Results
Gore VIBRANT Clinical Study
[GORE] VIaBahn® [Endoprosthesis] veRsus bAre Nitinol stenT in the Treatment of Long Lesion (≥ 8 cm) Superficial Femoral Artery Occlusive Disease
Dr. Gary Ansel, MD, FACC
For the VIBRANT Study Investigators

2. Gary M. Ansel, MD DISCLOSURES Royalty Cook Medical Consulting Fees
AccessClosure, Inc., AngioSlide, Ltd., AtheroMed,Inc., Bacchus Vascular, Bard Peripheral Vascular, Inc., BioCardia, Inc., Boston Scientific Corporation, Cordis, a Johnson & Johnson company, ev3, Inc.
Honoraria
Abbott Vascular
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
ICON Interventional Systems, Inc.

3. Goals Leading to VIBRANT
Real world fempop lesions
Real world device use
Stent overlaps allowed
Core lab controlled, longer term results
Clinical application of various duplex velocities
Evaluate potential predictors of patency

4. Gore VIBRANT Clinical Study Investigators
Co-PIs: Gary Ansel, MD; Columbus, Ohio
Patrick Geraghty, MD; Washington University, St. Louis, Missouri
Mark Mewissen, MD; St. Luke’s Hospital, Milwaukee, Wisconsin
Core Lab: The Vascular Ultrasound Core Laboratory, Boston, MA
Dr. Michael R. Jaff, DO, RPVI, FACP, FACC
Site Investigators:
David Lasorda, DO, Allegheny General Hospital, Pittsburgh, Pennsylvania
Michael Rush, MD, Holy Cross Hospital, Ft Lauderdale, Florida
Jeffrey Goldstein, MD, St. Johns, Springfield, Illinois
Bob Smouse, MD, St. Francis, Peoria, Illinois
Manju Kalra, MD, Mayo Clinic, Rochester, Minnesota
Sean Lyden, MD, Cleveland Clinic, Cleveland, Ohio
Rauh, MD, Midwest Heart Foundation, Lombard, Illinois
Arun Chervu, MD, Vascular Surgical Associates, Austell, Georgia
William Gray, MD, Columbia University Medical Center, New York, New York
Romi Chopra, MD, Midwest Institute, Melrose Park, Illinois
Sam Money, MD, Mayo Clinic, Scottsdale, Arizona
David Mego, MD, Arkansas Heart, Little Rock, Arkansas
Mark Bates, MD, Charleston Medical Center, West Virginia
Richard Begg, MD, Heritage Valley Health System, Beaver Falls, Pennsylvania
W. Charles Sternbergh, MD, Ochsner Clinic, New Orleans, Louisiana

5. Take Home Points
VIBRANT: Multicenter; core lab controlled; real world trial of the highest femoropopliteal disease burden ever performed
Treating claudicants with long diffuse disease is clinically safe and clinically effective at one year
Stent grafts restenosed at edge; bare metal stents restenosed diffusely
Primary patencies suboptimal; primary-assisted and secondary patencies are good even in diffuse lesions but strategies need to be refined
Even helical stents appear to have high fracture rates in long lesions and these are associated with vessel restenosis
Viabahn fracture is a rare event
Surveillance appears to be important at achieving high assisted and secondary patency to over 80% at 1-year
Longer term follow-up continues; primary end point will be
completed 2011

6. Study Hypothesis: (3-year study)
The use of GORE VIABAHN® Endoprosthesis will result in greater mid- and long-term patency (≥ 2-yr) of the treated arterial lesion compared to the use of bare nitinol stents in treating chronic SFA long lesion (≥ 8 cm) stenoses and occlusions

7. Study Design 148 randomized patients enrolled
TEST GROUP: GORE VIABAHN® Endoprosthesis
FDA approved for SFA indication, June 14, 2005
Does not include Bioactive Heparin Surface or contoured edge device
n = 72
CONTROL GROUP: Bare Nitinol Stent
Commercially available bare nitinol stent as determined by institutional standard of care when treating SFA occlusive disease and were not devices approved for SFA use
n = 76

8. Study Endpoints Primary Endpoints Secondary Endpoints
Three-year primary patency (duplex PSV ratio < 2.0 / core lab determination)
Safety (30 day composite of major complications)
Secondary Endpoints
Primary assisted patency
Secondary patency
Technical success
Target vessel revascularization, target lesion revascularization
Clinical success
Change in ABI from baseline
Alternate peak systolic velocity ratios of and 3.0 (core lab adjudicated)
Stent fracture on plain X-ray (core lab adjudicated)

9. GORE VIABAHN® Endoprosthesis
Patient Demographics
GORE VIABAHN® Endoprosthesis
Bare
Nitinol Stent
p-value
NUMBER OF RANDOMIZED SUBJECTS 72 76
Gender (% male)
62.5%
64.5%
0.87
Average Age (years) 69 64
0.01
SMOKING STATUS
0.36
Current / Previous Smoker
81.9%
88.2%
Never Smoked
18.1%
11.8%
GENERAL MEDICAL HISTORY
Diabetes
43.1%
44.7%
Myocardial Infarction
22.2%
25.0%
0.70
Hypertension
87.5%
76.3%
0.09
Dyslipidemia
70.8%
77.6%
Family History of CAD
60.0%
0.05
COPD
12.5%
7.9%
0.42
Previous PTA on Study Limb
6.9%
5.3%
0.74
Follow-up available for 120 patients (81%)

10. Lesion Characteristics: Diffuse and complex
GORE VIABAHN® Endoprosthesis
Bare
Nitinol Stent
p-value
TREATED OCCLUSIONS
59.7%
56.6%
0.74
TARGET LESION LENGTH (cm)
0.87
Mean (Std Dev)
19 (8)
18 (7)
Median (Range)
20 (8 – 40)
16 (8 – 36)
LESION CALCIFICATION
0.01
None – Mild
37.5%
57.9%
Moderate – Severe
62.5%
42.1%
TIBIAL RUNOFF
0.10
1 Vessel
15.3%
22.4%
2 Vessel
50.0%
32.9%
3 Vessel
34.7%
44.7%

11. GORE VIABAHN® Endoprosthesis
SAFETY Study Endpoint
30-DAY SAFETY OUTCOMES
GORE VIABAHN® Endoprosthesis
Bare
Nitinol Stent
NUMBER OF ENROLLED SUBJECTS 72 76
PROCEDURE-RELATED SAFETY ISSUES
Access / Treatment Site Complications 1*
OTHER SAFETY EVENTS
Death
Myocardial Infarction
Acute Renal Insufficiency
Study Limb Amputation
* The single access site complication was thrombosis in the non-treatment leg, that was resolved with subsequent treatment.

12. GORE VIABAHN® Endoprosthesis
One-Year Interim Data
INTERIM ONE-YEAR EFFICACY OUTCOMES
GORE VIABAHN® Endoprosthesis
Bare
Nitinol Stent
p-value
Technical Success
97%
1.00
Primary Patency (PSVR 2.5)
53%
58%
0.58
Freedom from TLR
73%
69%
0.69
Assisted Primary Patency
84%
91%
0.41
Secondary Patency
93%
98%
0.19

13. GORE VIABAHN® Endoprosthesis
Acute Limb Ischemia
Acute Limb Ischemia
GORE VIABAHN® Endoprosthesis
Bare
Nitinol Stent
p-value
DEVICE OCCLUSION 9 6
0.18 2 4
0.14
Chronic Limb Ischemia 7
Intervention < 24 hours 1
0.09
Intervention > 24 hours
0.04
Investigator defined

14. Clinical Success Quality of Life Questionnaires
Significant improvement in IC and SF-36 physical summary scores at one year
No significant difference between treatment groups

15. Patterns of Restenosis
GORE VIABAHN® Endoprosthesis
Focal edge stenosis comprised 87% GORE VIABAHN® Endoprosthesis failures
50% isolated proximal edge
30% both proximal and distal edges
6% isolated distal edge
14% undetermined
Bare Nitinol Stent
In-stent stenosis comprised 93% bare nitinol stent failures

16. Representative Images of Restenosis

21. Observations of Restenosis Patterns

22. Observations of Restenosis Patterns

23. Clinical Implications of Restenosis Patterns
Flow Dynamics Calculations
Assuming 80% focal (5 mm) versus diffuse (10 cm) restenosis pattern
Pressure Drop in diffuse, in-stent stenosis is an order of magnitude higher than a focal edge stenosis
Flow Rate through diffuse, in-stent stenosis is reduced by 50% as compared to flow through an edge stenosis

24. GORE VIABAHN® Endoprosthesis
Stent Fracture
GORE VIABAHN® Endoprosthesis
Bare
Nitinol Stent
p-value
STENT FRACTURE
1/47 (2%)
16/52 ( 30.8%)
< 0.01
FRACTURE SEVERITY*
Grade 1 1 7
Grade 2
Grade 3 3
Grade 4 2
* Not mutually exclusive

25. Stent Fracture
Bare nitinol stents experienced significantly higher fracture rate
Bare stent fractures independent of stent type
11/37 Tubular Stent fractures (30%)
6/17 Helical Stent fractures (35%)
Fracture occurred predominantly in lesions longer than 15 cm
In long lesions (> 15 cm), fractured stents were associated with a 17% lower patency rate and 25% higher TLR rate compared to unfractured stents (p = 0.40 and 0.17, respectively)

26. Representative Stent Fracture Images

30. Addressing the future VIPER (New Viabahn generation trial) Bare Stents
Heparin Bioactive Surface
“Contoured” end—potentially improved flow dynamics on the proximal end
Bare Stents
Is it back to the drawing board for stent designs for the treatment of longer lesions?
We really do not have a bare metal solution for long SFA disease
DOES A FRACTURE RATE OF > 30% MAKE BARE METAL STENTING A NON-STARTER, AT LEAST FOR LESIONS > 15 CM IN LENGTH?

31. Take Home Points
VIBRANT: Multicenter; core lab controlled; real world trial of the highest femoropopliteal disease burden ever performed
Treating claudicants with long diffuse disease is clinically safe and clinically effective at one year
Stent grafts restenosed at edge; bare metal stents restenosed diffusely
Primary patencies suboptimal; primary-assisted and secondary patencies are good even in diffuse lesions but strategies need to be refined
Even helical stents appear to have high fracture rates in long lesions and these are associated with vessel restenosis
Viabahn fracture is a rare event
Surveillance appears to be important at achieving high assisted and secondary patency to over 80% at 1-year
Longer term follow-up continues; primary end point will be completed 2011