Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system - 12-month results from the LOCOMOTIVE EXTENDED study.

Abstract

Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71±10years. The mean lesion length was 16.0±9.7cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.