1 / 7

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

12-Month Analysis Barry T. Katzen MD, FACR, FACC Founder and Medical Director Baptist Cardiac & Vascular Institute. RESILIENT II: Trial Design. Lesions of SFA &/or Proximal Popliteal Artery Rutherford Category 1 - 3 Lesion Length: <150mm Edwards LifeStent + NT delivery system.

elon
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related