Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions

Abstract

Objectives: This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length.

Methods: Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging.

Results: Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year.

Conclusions: The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions.

Trial registration: ClinicalTrials.gov NCT00637741.

Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.