LEOPARD Study - Looking at EVAR Outcomes by Primary Analysis of Randomized Data

1. LEOPARD Study
Looking at EVAR Outcomes by Primary
Analysis of Randomized Data
• Prospective, randomized, multicenter study
• Real-world patient population
• Head-to-head comparison on commercially
available endograft systems
– Outcomes
– Costs

2. Basis for Randomization
• AFX® versus alternative EVAR devices
• Unique design of AFX
– Anatomic fixation suppresses graft migration
independent of anatomy of the neck
– Sealing zones defined by highly conformable
ePTFE graft material
– Preservation of native bifurcation

3. Emerging New Data on AFX
Performance
• Retrospective, observational,
multi-center cohort
– 181 patients
– 11 month FUP
• Findings
– Extension of the seal zone beyond
anatomic neck in 70% of the patients
– Significant correlation of the “effective
seal length” to early sac regression
– Low reported rates of endoleaks
• Type I: 0% in friendly and 4% in hostile necks
• Type II: 5.5% overall
1 Welborn et al. Clinical outcome of an extended proximal seal zone with the AFX endovascular aortic aneurysm system. JVS ePublished 5/2014.
2 Arthurs, et al. Endograft Apposition at the Proximal Aortic Neck Predicts Aneurysm Sac Regression . Western Vascular Society, 9/2014.
3 Motaganahalli, et al: Clinical Characteristics and Mid-Term Outcome of Abdominal Aortic Aneurysm Repair with the AFX Device in Patients with Hostile Neck
Anatomy. Midwestern Vascular Society, 9/2014.

4. Primary Endpoint
Survival in the absence of Aneurysm Related Complications
(ARC) at 12 months. ARC is a composite of most relevant
EVAR related outcomes:
• Peri-procedural death (<30d)
• Rupture
• Conversion to Open Surgical Repair
• Endoleak
• Migration >10 mm
• Aneurysm Enlargement >5 mm
• Occlusions
• Secondary Endovascular Procedure for Device or Aneurysm
Related Indication

5. Study Design
• Prospective, randomized, multi-
center, “all-comers” design
• Sample size: 800
• Sites: 80 Sites maximum
• Enrollment: 18 months
• Follow-up: 5 years
• Independent core lab analysis
and event adjudication
• Powered for two-staged
hypothesis testing
• Non-inferiority followed by superiority
Randomization
Scheme
Patient Population per
Investigator
AFX®
Reference Group
(One Device Selected
Prospectively by Each
Investigator*)
* Selection of Zenith®, Excluder®, or Endurant® devices

6. Study is Powered To Show
Superiority of AFX
• Details of study design to be published in peer-reviewed publication
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100 300 500 700 900 1100 1300 1500
DeltainCompositeendpoint(AFX-control)
Required Sample size (Overall Study, includes both arms)
Non-inferiority and Superiority tests
Superiority, 80% Power Non-Inferiority, 99% power
Proposed # of patients

7. Planned Secondary Analyses
• MAEs at 30 days, 12 months and annually
• Aneurysm-related complications (ARC) post 12 months,
up to 5 years
• Aneurysm-related mortality (ARM)
• Endoleaks classified by type
• Loss of neck apposition
• AAA-related secondary procedures up to 5 years
• Device integrity throughout study
• Component utilization
• Total radiation exposure
• % bilateral PEVAR
• Access-related complications

8. Planned Economic Sub-Studies
• Economic Sub-study
• Subset of the study population will be part of an economics
outcomes assessed by site specific billing information
• Patient Related Outcomes
• Subset of the study population will be assessed for certain
patient-related outcomes indicative of patient satisfaction and
QoL.
Modern Cost and Comparative Effectiveness*
* Independent analysis

9. LEOPARD STEERING COMMITTEE
Benjamin Starnes, MD
University of Washington
Christopher Kwolek, MD
Massachusetts General Hospital
Newton Wellesley Hospital
Daniel Clair, MD
Cleveland Clinic
Thomas Maldonado, MD
Manhattan VA Hospital
Timothy Sullivan, MD
Minneapolis Heart Institute at
Abbott Northwestern Hospital
COMMITTEE CHAIR
NATIONAL PRINCIPAL
INVESTIGATOR MEMBER
Jason T. Lee, MD
Stanford University Medical
Center
MEMBER
MEMBER MEMBER

10. SUMMARY
• Critical need for Level 1 evidence in contemporary,
real-world patient population using commercially
available EVAR devices
– Understanding the outcomes
– Guiding treatment strategies
– Therapy cost analysis
– Solid reference for future therapy developments
• LEOPARD
– Robust, statistically powered study design
– Landmark data set for future EVAR-EVAS
comparison