A new animal study, presented at EuroPCR (17–20 May, Paris), indicates that a novel, fluoropolymer-coated, self-expanding, paclitaxel-eluting peripheral stent (Eluvia, Boston Scientific) is associated with significantly less neointima at 90 days than is a no polymer, paclitaxel-eluting peripheral stent (Zilver PTX, Cook Medical). Eluvia, which is CE marked but an investigational device in the USA, was also associated with more uniform neointimal coverage.
Speaking on behalf of Juan Granada (CRF Skirball Center for Inovation, New York, USA) at EuroPCR, Thomas Zeller (Department of Angiology, Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany) reported that preclinical data for Eluvia have already shown that due to its polymer coating it releases paclitaxel “steadily” and the amount of paclitaxel found in the heart, liver, and systemic blood “are below quantifiable” levels.
“Neointimal thickness is significantly inhibited by the fluoropolymer-coated, paclitaxel-eluting stent compared with a bare metal stent at 30 and 90 days, yielding reductions of in-stent stenosis by 48.1% and 51.9% for the fluoropolymer-coated paclitaxel-eluting stents vs. bare metal stents,” he added.
In this present study, 18 swine with familial hypercholesterolaemia received in an 1:1:1 ratio a bare metal stent, a Zilver PTX drug-eluting stent, or an Eluvia stent—with Zeller explaining that a familial hypercholesterolaemia swine model predicts “antirestenotic efficacy of peripheral drug-coated balloon in a dose-dependent manner”. The swine were then assessed at 30 and 90 days with optical coherence tomography (OCT) and quantitative vascular angiography (additional follow-up at 180 days is also planned). Zeller commented: “In the 30-day imaging data, both the Zilver PTX and Eluvia drug-eluting stent achieved profound antirestenotic effect in comparison to the bare metal stent”. According to the OCT findings, at 30 days, per cent diameter stenosis, late lumen loss, neointimal area, per cent area stenosis were all significantly lower with the paclitaxel-eluting stents compared with the bare metal stent.
However, at 90 days (when imaging data were available for half of the animals), Eluvia was associated with significantly lower area stenosis than both the Zilver PTX stent and the bare stent (30±9% vs. 53±12% vs.78±22%, respectively; p<0.01), and it was also associated with lower mean neointimal thickness than both devices (0.50±0.16mm vs. 0.89±0.24mm vs. 1.29±0.51mm, respectively; p<0.01). “The pattern of neointimal coverage appears more uniform longitudinally in Eluvia when compared to Zilver PTX,” Zeller noted.
He concluded: “The pending 180-day data will further inform the comparative differences in healing and neointimal suppression in this disease model.”
Zeller told Interventional News that the MAJESTIC study—a multicentre, single-arm study that included 57 patients—has also indicated that use of Eluvia (in humans) results in durable clinical improvement at one-year follow-up with a primary patency rate of 96.1% and a freedom from target lesion revascularisation rate of 96.2%. The two- and three-year follow-up is still pending. He added: “Another prospective trial (IMPERIAL), is still recruiting patients. The trial is randomly comparing Eluvia and Zilver PTX drug-eluting stents in patients with superficial femoral artery lesions.”