Twelve-Month LOCOMOTIVE Data Presented for B. Braun's Multi-Loc System
March 6, 2018—Klaus Amendt, MD, presented the 12-month follow-up results from the LOCOMOTIVE all-comers registry at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
The prospective, multicenter, LOCOMOTIVE registry is evaluating the VascuFlex Multi-Loc multiple stent delivery system (MSDS; B. Braun Melsungen AG), which is indicated for flow-limiting dissections and recoil after plain old balloon angioplasty and drug-coated balloon dilatation to treat peripheral artery disease.
According to Dr. Amendt's presentation, the registry is collecting all-comers data on procedures as well as preliminary safety and efficacy data on the MSDS to treat de novo and restenotic lesions of common femoral to distal popliteal arteries in patients with Rutherford class 2 to 5 or Fontaine stage 2-4 disease.
To be included in the registry, patients have to have stenosis and occlusions of the superficial femoral artery, popliteal artery (P1-3), and redo lesion length suitable for release of at least two stents with a distance of at least 5 mm between two stents; a reference diameter of 4 to 7 mm; distal runoff in at least one vessel in the foot and collaterals supplying sufficient flow to the foot; and severe calcification after subintimal percutaneous transluminal angioplasty.
Investigators prepared femoropopliteal lesions with uncoated and/or paclitaxel-coated peripheral balloon catheters. When flow-limiting dissections, elastic recoil, or recoil caused by calcification required stenting, investigators then spot stented using the VascuFlex Multi-Loc.
LOCOMOTIVE's primary endpoint of all-cause target lesion revascularization (TLR) rate at 6 months was 5.3% (four of 75 patients) in the overall cohort with a primary patency rate of 90.7% (68 of 75 patients). This was reported at LINC 2017 and subsequently published by Dr.Amendt et al in Vasa: European Journal of Vascular Medicine (2017;46:452–461).
As presented by Dr. Amendt at LINC 2018, at 12-month follow-up, all-cause TLR rate was 9.3% (seven of 75 patients) in the overall cohort with a primary patency rate of 86.7% (54 of 63 patients). The findings included TLR rates in critical limb ischemia (CLI) and non-CLI patients of < 10% and an assisted primary patency rate of 96.8%, including 100% in CLI cases and 95.8% in intermittent claudication cases.
The study investigators concluded that these 12-month data show that the MSDS strategy is safe and effective in patients with PAD (Rutherford class 2–5) with femoropopliteal lesions. There was a high procedural success rate (100%) to release the individual stent segments and in morphologically challenging lesions. There was no stent loss and no conversion to standard stenting. Additionally, almost half of the lesion length could be saved from stenting as compared to the "long stent" strategy.
The LOCOMOTIVE registry has been extended to include patients until December 2018, advised Dr. Amendt at LINC 2018.