12-Month Analysis

Barry T. Katzen MD, FACR, FACCFounder and Medical Director

Baptist Cardiac & Vascular Institute

RESILIENT II: Trial Design

n=20624 sites

1:2 Randomization

Clinical/MACE*

Duplex US30d30d 6mo6mo 12mo12mo 18mo18mo 2yr2yr 3yr3yr

*MACE = Major Adverse Clinical Events

Primary Endpoint: TLR and/or TVR at 6 monthsSecondary Endpoints: Patency; Lesion-, Procedure- & Clinical-Success;

QOL measurements

PTA OnlyControl Arm

n=69

• Lesions of SFA &/or Proximal Popliteal Artery• Rutherford Category 1 - 3• Lesion Length: <150mm• Edwards LifeStent + NT delivery system

• Lesions of SFA &/or Proximal Popliteal Artery• Rutherford Category 1 - 3• Lesion Length: <150mm• Edwards LifeStent + NT delivery system

PTA + LifeStentTest Arm

n=137

PTA + LifeStentTest Arm

n=137

Study Device

• Edwards LifeStent

• Self-expanding Nitinol stent

• Helically-designed

• Stent Diameters: 6, 7mm

• Stent Lengths: 40, 60, 80mm

• Edwards LifeStent NT

Delivery System

LifeStent

LifeStent NT Delivery System

12-Month Results

p=.91

p<.0001p<.0001

p<.0001

*Data from Kaplan-Meier Survival Analysis

86%

38%

46%

34%

86%80%

87%

72%

0%

20%

40%

60%

80%

100%

Freedom fromMACE*

Prim. Patency(duplex)*

Freedom from TLR* Clinical success

PTA

PTA+LifeStent

Quality of Life Assessment (LifeStent Arm)

• Walking Impairment Questionnaire (WIQ) utilized for Disease-Specific Quality of Life assessment. • LifeStent arm demonstrated dramatic improvement over baseline

at 6-months with sustained/improved benefit at 12-months.

0

10

20

30

40

50

60

70

WIQ - Pain WIQ - Stair WIQ - Distance WIQ - Speed

Baseline 6 Months 12 Months

Conclusions

RESILIENT’s Level 1 evidence illustrates:

• In claudicants with lesions shorter than 150 mm,a primary stenting strategy with the LifeStentis superior to a PTA alone strategy …– Peri-procedurally –

as evidenced by a larger luminal diameter,lesion success and procedure success, and

– at one year –as evidenced by primary patency and freedom from TLR

• PTA + LifeStent did not lead to a higher rate of“Major Clinical Adverse Events” than PTA alone