Impact of Fluoropolymer-Based Paclitaxel Delivery on Neointimal Proliferation and Vascular Healing

Abstract

Background-A polymer-free peripheral paclitaxel-eluting stent (PES, Zilver PTX, Cook, IN) has shown to improve vessel patency after superficial femoral angioplasty. A new-generation fluoropolymer-based PES (FP-PES; Eluvia, Boston Scientific, MA) displaying more controlled and sustained paclitaxel delivery promise to improve the clinical outcomes of first-generation PES. We sought to compare the biological effect of paclitaxel delivered by 2 different stent-coating technologies (fluoropolymer-based versus polymer-free) on neointimal proliferation and healing response in the familial hypercholesterolemic swine model of femoral restenosis. Methods and Results-The biological efficacy of clinically available FP-PES (n=12) and PES (n=12) Histological evaluation showed larger lumen areas and evidence of higher biological activity (smooth muscle cell loss and fibrin deposition) in the FP-PES compared with PES and bare metal stent. Conclusions-In the familial hypercholesterolemic swine model of femoral restenosis, the implantation of an FP-PES resulted in lower levels of neointimal proliferation and sustained biological effect ≤90 days compared with a polymerfree stent-based approach. (Circ Cardiovasc Interv. 2017;10:e004450.

Drug-Eluting Stents

“…45 Fluoropolymer-bound paclitaxel-eluting stents had lower levels of neointimal hyperplasia when compared with free paclitaxel-eluting stents and BMS. 45…”

“…The Eluvia self-expanding DES from Boston Scientific has recently been developed with a prolonged paclitaxel elution profile through its binding to the stent using a fluoropolymer coating, and contains a lower paclitaxel dose (0.167 μg/mm 2 ) compared with the Zilver PTX stent (3.0 μg/mm 2 ). 44 45 The Eluvia stent delivers approximately 40% of the available drug in the first 30 days with continued release of drug over time with an estimated 90% eluted at 12 months in swine models. 45 Polymer-free DESs such as Zilver PTX on the other hand release 95% of the drug within the first day of deployment with sustained paclitaxel levels in the artery wall up to 56 days in swine models.…”

“…44 45 The Eluvia stent delivers approximately 40% of the available drug in the first 30 days with continued release of drug over time with an estimated 90% eluted at 12 months in swine models. 45 Polymer-free DESs such as Zilver PTX on the other hand release 95% of the drug within the first day of deployment with sustained paclitaxel levels in the artery wall up to 56 days in swine models. 45 Fluoropolymer-bound paclitaxel-eluting stents had lower levels of neointimal hyperplasia when compared with free paclitaxel-eluting stents and BMS.…”

“…45 Polymer-free DESs such as Zilver PTX on the other hand release 95% of the drug within the first day of deployment with sustained paclitaxel levels in the artery wall up to 56 days in swine models. 45 Fluoropolymer-bound paclitaxel-eluting stents had lower levels of neointimal hyperplasia when compared with free paclitaxel-eluting stents and BMS. 45…”

Atherosclearosis plaque formation is related to EndMT in diabetic minipigs with coronary heart disease and the effect of Traditional Chinese medicine FTZ Prescription

“…Cross-section lumen, device areas, and percent area stenosis were measured as previously described [28,29]. Percentage area of stenosis was calculated as [1-(lumen area/inner area)] × 100 [30,31].…”