title: Carotid artery stenting using a novel self-expanding braided nickel-titanium stent: feasibility and safety porcine trial.
abstract: We studied the deliverability and safety of a braided, self-expanding, closed-cell nickel-titanium (NiTi) stent (E-volution, Jotec GmbH, Hechingen, Germany) especially designed for the endovascular treatment of carotid artery bifurcation stenosis with special regard to in-stent stenosis and thrombosis compared with a laser-cut reference nitinol stent in a porcine model of percutaneous vascular interventions. We aimed to assess histopathologic response in minipig carotid and subclavian arteries. Eight minipigs received a total of 42 stents: 14 reference stents and 28 E-volution stents. Eleven of the E-volution stents were additionally coated with heparin. Control angiography was obtained immediately before and after vascular intervention as well as 4 weeks after the procedure. Primary endpoints were 28 days of angiographic analyses as well as histomorphometric analysis, including injury score, inflammation score, luminal diameter, vessel diameter, maximal neointimal thickness, and area of in-stent stenosis. Secondary end points were procedural success, 28-day mortality, and stent thrombosis. All stents could be delivered successfully without procedural complications, morbidity, or mortality during our observation time. As confirmed by histology, no in-stent thrombosis was observed. Compared with common carotid arteries, subclavian arteries are significantly more vulnerable to developing in-stent stenosis caused by neointima proliferation (p < 0.05). Compared with the use of 1 single stent/artery, serial application of two stents leads to a more excessive but not significantly different neointimal proliferation (p > 0.05). The E-volution stent, especially when heparin coated, is in line with the comparison to the laser-cut reference stent displaying similar results of angiographic, histologic, and histomorphometric analyses (p > 0.05). Compared with the reference laser-cut stent, the self-expanding nitinol stent (E-volution) with its advanced braiding technology is feasible and safe. In our opinion, the high radial resistive force and the advanced braided design with tight stent-strut interstices may be beneficial in terms of plaque stabilization. Further studies are necessary and warranted.
authors.affiliation: Clinic for Diagnostic and Interventional Neuroradiology, School of Medicine, Saarland-University, Homburg, Germany. frah1@gmx.de
authors.forename: Frank
authors.initials: F
authors.lastname: Ahlhelm
authors.forename: Ralf
authors.initials: R
authors.lastname: Kaufmann
authors.forename: Dirk
authors.initials: D
authors.lastname: Ahlhelm
authors.forename: Mai Fang
authors.initials: MF
authors.lastname: Ong
authors.forename: Christian
authors.initials: C
authors.lastname: Roth
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Reith
mesh_terms: D000704:Analysis of Variance; D000792:Angiography; D000818:Animals; D016893:Carotid Stenosis / Q000601:surgery*; D020099:Coated Materials, Biocompatible; D004195:Disease Models, Animal; D005240:Feasibility Studies; D009532:Nickel; D011183:Postoperative Complications; D011474:Prosthesis Design; D015641:Radiography, Interventional; D018709:Statistics, Nonparametric; D015607:Stents; D013348:Subclavian Artery; D013552:Swine; D013556:Swine, Miniature; D014025:Titanium; D014654:Vascular Patency
chemical_list: D020099:Coated Materials, Biocompatible; D009532:Nickel; D014025:Titanium