Restenosis After Tack Implantation is Associated with Less Complex Patterns of Restenosis Compared to Stent Implantation

Abstract

In-stent restenosis is complex, difficult to treat and has led to a ‘leave less metal behind’ approach to femoropopliteal intervention. Postangioplasty dissection often requires scaffolding to maintain patency. The Tack Endovascular System provides minimal-metal dissection repair that preserves future treatment options. Tack implants are designed to minimise the inflammation and neointimal hyperplasia that lead to in-stent restenosis. An independent angiographic core laboratory evaluated the restenosis patterns in clinically driven target lesion revascularisation (CD-TLR) during the 12 months following the index procedure in the Tack Optimized Balloon Angioplasty (TOBA) II study and compared these results to those published for nitinol stent implantation. Of the 213 patients in TOBA II, 31 (14.6%) required a CD-TLR. Of these, 28 had angiograms that were evaluated by the core laboratory, and 45.2%, 16.1%, and 29% were graded as Tosaka class I, II and III, respectively. There were no significant differences (p>0.05) in lesion length, degree of calcification or dissection class between the three groups. Tack restenotic lesion classification and analysis show a prevalence of both class I and shorter lesions relative to in-stent restenosis, which may be beneficial to long-term patient outcomes.