October 30, 2018
Twelve-Month LOCOMOTIVE Results Published for B. Braun's VascuFlex Multi-Loc System
October 31, 2018—Online in CardioVascular and Interventional Radiology, Martin Sigl, MD, et al reported 12-month clinical outcomes from the observational all-comers LOCOMOTIVE study of the VascuFlex Multi-Loc multiple stent delivery system (MSDS; B. Braun Melsungen AG) to treat complex femoropopliteal lesions.
Earlier this year, Lead Investigator Klaus Amendt, MD, presented the 12-month results at LINC 2018, the Leipzig Interventional Course held January 30–February 2 in Leipzig, Germany.
Previously, the investigators reported the 6-month clinical outcomes of the LOCOMOTIVE study, which demonstrated the safety and efficacy of the MSDS with a favorable target lesion revascularization (TLR) rate of 5.3% and a 90.7% patency rate at 6 months in claudicants and critical limb ischemia patients.
LOCOMOTIVE studied the Multi-Loc system 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. Investigators evaluated the efficacy and safety of the MSDS approach in an all-comers population. Clinical follow-up at 6 and 12 months was scheduled to assess TLR, ankle-brachial index (ABI), and vessel patency based on sonographic imaging.
At 12 months, the primary unassisted patency rate was 85.7% and the all-cause TLR rate was 9.3% in the overall cohort. Between baseline and 12 months, the target leg ABI increased from 0.62 ± 0.24 to 0.91 ± 0.38 (P < .001) and the mean Rutherford class improved from 3.5 to 1.9 (P < .001).
Over a 12-month postprocedural period, MSDS for focal provisional stenting of complex femoropopliteal lesions demonstrated promising primary patency and freedom from TLR after 12 months. Additionally, significant improvements were observed in symptom classification and hemodynamics, concluded the investigators in CardioVascular and Interventional Radiology.