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RESILIENT II Trial: LifeStenting for Femoral Artery Lesions under 150mm

Read about the 12-month analysis of the RESILIENT II Trial evaluating Edwards LifeStent for SFA and popliteal artery lesions. Results show superior outcomes with stenting compared to PTA alone, evidenced by improved patency and reduced TLR rates.

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RESILIENT II Trial: LifeStenting for Femoral Artery Lesions under 150mm

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  1. 12-Month Analysis Barry T. Katzen MD, FACR, FACC Founder and Medical Director Baptist Cardiac & Vascular Institute

  2. RESILIENT II: Trial Design • Lesions of SFA &/or Proximal Popliteal Artery • Rutherford Category 1 - 3 • Lesion Length: <150mm • Edwards LifeStent + NT delivery system 1:2 Randomization PTA Only Control Arm n=69 PTA + LifeStent Test Arm n=137 n=206 24 sites Clinical/MACE* 3yr 2yr 18mo 12mo 6mo 30d Duplex US Primary Endpoint: TLR and/or TVR at 6 months Secondary Endpoints: Patency; Lesion-, Procedure- & Clinical-Success; QOL measurements *MACE = Major Adverse Clinical Events

  3. Study Device LifeStent • Edwards LifeStent • Self-expanding Nitinol stent • Helically-designed • Stent Diameters: 6, 7mm • Stent Lengths: 40, 60, 80mm • Edwards LifeStent NT Delivery System LifeStent NT Delivery System

  4. 12-Month Results 100% PTA 87% 86% 86% PTA+LifeStent 80% 80% 72% 60% 46% p=.91 38% 40% 34% p<.0001 p<.0001 20% p<.0001 0% Freedom from Prim. Patency Freedom from TLR* Clinical success MACE* (duplex)* *Data from Kaplan-Meier Survival Analysis

  5. 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. 70 60 50 40 30 20 10 0 WIQ - Pain WIQ - Stair WIQ - Distance WIQ - Speed Baseline 6 Months 12 Months

  6. Conclusions RESILIENT’s Level 1 evidence illustrates: • In claudicants with lesions shorter than 150 mm,a primarystenting 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

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