status of the leopard trial: comparing the afx endologix ......status of the leopard trial:...

Status Of The LEOPARD Trial: Comparing the AFX Endologix Graft To Other Standard EVAR EndograftsChris Kwolek, MD, FACSPrincipal Investigator, LEOPARD Trial

Director of Vascular and Endovascular Training ProgramMassachusetts General HospitalChief of Vascular Surgery, Newton Wellesley Hospital

The AFX® System is approved to treat infrarenal abdominal aortic aneurysms. The AFX® Endovascular AAA System and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specific indications, contraindications, all warnings and precautions. Rx only

Faculty DisclosuresI disclose the following financial relationships:

• Endologix


What have we learned about EVAR after two decades with more than 20 different devices?


What Have We Learned About EVAR?• Low perioperative mortality• No sustained long-term mortality benefit • No consensus on cost-effectiveness

• Historic Evidence (EVAR1, DREAM, OVER) does not reflect current practice • No head-to-head studies• Mostly on-IFU patients


Economic Pressures Are Rising


Looking at EVAR Outcomes by Primary Analysis of Randomized Data

Prospective, randomized, multicenter study

Real-world patient population

Head-to-head comparison of EVAR endograft systems

At least 400 patients

Up to 80 US Centers

Follow-Up: 5 Years

RANDOMIZATION SCHEME

ANATOMIC FIXATIONAFX/AFX2

With DURAPLY

PROXIMAL FIXATIONZENITH, EXCLUDER,

OR ENDURANT*

One Device Selected Prospectively by

Each Investigator*


Basis for Randomization AFX/AFX2 with Duraply vs. Traditional EVAR Devices

Sealing zones defined by high strength, highly

conformable DURAPLY ePTFE graft material

Anatomic fixation suppresses graft migration

independent of neck anatomy of the neck

Preservation of native bifurcation


Primary Endpoint: One-Year Survival from Aneurysm Related Complications (ARC)

Peri-procedural death (<30d)

Rupture

Conversion to Open Surgical Repair

Endoleak

Occlusion

Migration >10 mm

Aneurysm Enlargement >5 mm

Device or AAA-Related Reintervention

Composite of Most Relevant EVAR-Related Outcomes


Randomization StatusComposite of Most Relevant EVAR-Related Outcomes

ANATOMIC FIXATION PROXIMAL FIXATION

234 224

ENDURANT EXCLUDER ZENITH

92 75 57

*Data cut August 2, 2017; Total number accounts for subjects exited and those currently in randomization phase of study


LEOPARD RCT – 1 Year Results*Freedom from AAA Related Complications

PROXIMAL FIXATIONZENITH, EXCLUDER, OR ENDURANT*

ANATOMIC FIXATIONAFX/AFX2 with DURAPLY

85%

80%

84.7%

82.0%

N=234 N=224


*Data cut August 2, 2017; Results are preliminary and not statistically significant.

• Anatomic Fixation reflects lower rates of endoleak, limb occlusions and secondary interventions.

• No Type 3 endoleak in either arm

Preliminary 1-Year Results*Freedom from AAA Related Complications

AFX with DURAPLY REFERENCE GROUPRupture - -Conversion - 2Post-op Endoleaks 12 14Type 3a or 3b Endoleak 0 0Migration >=10mm 2 -Sac enlargement >=5mm - 1Limb occlusions - 5Reinterventions for device/AAA-related 6 10Peri-Operative Death 3 -TOTAL SUBJECTS with ARC 19 22Evaluable, per having 1 year visit 124 122FREEDOM from ARC 84.7% 82%RELATIVE DIFFERENCE ~3% (in AFX favor)

*Data cut August 2, 2017; Results are preliminary and not statistically significant.AFX/AFX2 reflecting lower rates of endoleak, limb occlusions and secondary interventions. Zero Type III endoleaks.


STATISTICAL CONSIDERATIONS for Patient EnrollmentNon-Inferiority Demonstrated at Current Enrollment; Superiority is Futile

-.08 0

Superior

Non-Inferior

No difference between groupsNon-inferiority Margin

Direction study is currently trending n~250

If trend holds, where study would end with n=800Non-Inferior

If the trend holds, study requires n ~2,200 for Superiority

Confidence Intervals for difference in freedom-from-ARC


Conclusions• Critical need for Level 1 evidence in contemporary, real-world patient

population using commercially available EVAR devices• Non-inferiority at current enrollment

• 3% relative difference in favor of AFX/AFX2 with Duraply• No Type 3 endoleak in either arm

• Full 1 Year Aneurysm-Related Complications to be reported end of 2018• Follow-up to continue to 5 years


status of the leopard trial: comparing the afx endologix ......status of the leopard trial:...

Documents