12-Month Results Published From LOCOMOTIVE EXTENDED Study of B. Braun Multi-Loc Stent System

November 26, 2020—B. Braun Melsungen AG advised that 12-month results from the prospective, single-arm, multicenter observational LOCOMOTIVE EXTENDED study of the company’s Multi-Loc multiple stent delivery system (MSDS) were published by Klaus Amendt, MD, et al online in Vasa: European Journal of Vascular Medicine.

The investigators concluded that LOCOMOTIVE EXTENDED demonstrated the safety and efficacy of the Multi-Loc MSDS for provisional focal stenting of the femoropopliteal artery.

As summarized in Vasa, the study enrolled 357 patients with 449 femoropopliteal lesions, all of which had flow-limiting dissections or recoil after angioplasty. Eligibility in the study included Rutherford classification 2 to 5 with a de novo or nonstented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon (DCB) angioplasty. The mean patient age was 71 ± 10 years. The mean lesion length was 16 ± 9.7 cm, with 44.5% TASC II C/D lesions and 31.4% chronic total occlusions.

By operator choice, 45% of the patients underwent DCB angioplasty. On average, four stents (each with 13-mm lengths) 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%.

The study’s 6- and 12-month efficacy endpoints included target lesion revascularization (TLR) and primary patency rates.

Findings in Vasa included the following:

• The freedom from clinically driven TLR was 95.5% at 6 months and 88.7% at 12 months.
• The primary patency rate was 88.7% at 6 months and 82.3% at 12 months.
• Significant improvements were noted in Rutherford categories and ankle-brachial indices at 12 months.

Additionally, diabetes mellitus and no distal run-off vessel both showed a trend toward worse TLR in multiple regression analyses. Other factors such as DCB predilation or lesion length were not predictive, reported the LOCOMOTIVE EXTENDED investigators in Vasa.