Raghu Kolluri, William A Gray, Ehrin Armstrong, Brian C Fowler
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.
Disclosure: This study was funded by Intact Vascular. RK and BF are employees of Syntropic Core Laboratory. WG is the National Principal Investigator for TOBA II. EA is an investigator for TOBA II.
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Correspondence Details: Raghu Kolluri, 3535 Olentangy River Rd, Suite 514, Columbus, OH 43214, US. E: Raghu.Kolluri@ohiohealth.com
Open Access: This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.
The restenotic lesions were evaluated for per cent diameter occlusion and lesion length. They were classified using the methodology of Tosaka et al. as follows: class I – focal (<50 mm in length) lesions located within the stent body, at the stent edge, or a combination of both; class II – diffuse (>50 mm in length) including both stent body and stent edge lesions; and class III – total occlusion. As noted, the Tosaka classification system was developed to describe lesions in full-length stents. Unlike stents, Tacks, by design, do not cover the full length of treated lesions and multiple Tacks can be used to treat dissections. Due to this unique feature, the core lab also provided an analysis of the location of target lesion restenosis relative to Tack location(s) using the following qualitative analysis:
- proximal – lesion located proximal to an area that was Tacked;
- at – lesion located within a Tack;
- distal – lesion located distal to a Tacked area;
- between – lesion located between Tacks; and
- involving multiple – lesions located at multiple Tacks.
Characteristics of Restenotic Lesions in Patients Who Received Tacks
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