Effect of Bare-Metal Nitinol Stent Implantation and Paclitaxel-Eluting Nitinol Stent Implantation on Vascular Response in the Superficial Femoral Artery Lesion Assessed on Intravascular Ultrasound

Background: Although previous intravascular ultrasound (IVUS) studies reported that the drug-eluting stent (DES) has successfully decreased in-stent restenosis (ISR) by inhibiting neointimal hyperplasia (NIH) in the coronary artery lesion, no IVUS data for vascular response after DES implantation in the superficial femoral artery (SFA) have been published. Methods and Results: We retrospectively analyzed 38 de novo SFA lesions from 32 patients who underwent endovascular therapy (EVT) with self-expanding bare-metal nitinol stent (25 lesions; BMS group) or self-expanding paclitaxel-eluting nitinol stents (13 lesions; PES group). At 6 months after EVT, follow-up IVUS was done to evaluate NIH. Serial IVUS volumetric analysis was done after stent deployment and at follow-up. Mean stent, lumen and neointimal areas were calculated as the volume divided by the stent length. The primary endpoint of this study was mean late lumen loss at 6-month follow-up. The mean follow-up period was 189±39 days. Mean neointimal area was smaller in the PES group compared to the BMS group (3.3±1.0mm2 vs. 10.2±4.1mm2, P