One-year results of the MIMICS-3D study were announced today at the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA). Freedom from clinically-driven target lesion revascularisation (CD-TLR) was 89%, which aligns with results from the MIMICS RCT and MIMICS-2 studies, despite treatment of more complex disease.
In addition, the percentage of patients with improvement of ≥1 Rutherford category at one year compared to baseline was 87% (322/370), and for patients treated with or without a drug-coated balloon and BioMimics 3D, there was no difference in CD-TLR (89.5% and 88.5%, respectively; P>0.88).
BioMimics 3D (Veryan Medical) is a nitinol stent designed to provide optimal radial support, flexibility, durability, visualisation, and delivery accuracy for femoropopliteal intervention. The addition of a unique three-dimensional (3D) helical centreline provides the advantages of biomechanical stability and swirling blood flow.
BioMimics 3D was evaluated in the MIMICS randomised controlled trial (RCT) in which patients received either a BioMimics 3D helical stent or a straight stent control. The Kaplan-Meier estimate of freedom from clinically driven target lesion revascularisation (CD-TLR) at 1 year for those treated with BioMimics 3D was 91%. A second study, MIMICS-2, conducted in the USA, Japan, and Europe, met 30-day safety and 12-month primary patency endpoints, and the 1-year Kaplan-Meier estimate of freedom from CD-TLR was 88%.
The MIMICS-3D European registry is now investigating outcomes in patients with longer, more complex lesions; complementary use with drug-coated balloons occurred in 50% of procedures. MIMICS-3D enrolled 507 patients at 23 sites. The primary safety endpoint is a composite of major adverse events (MAEs) or CD-TLR through 30 days. The primary outcome measure for effectiveness is freedom from CD-TLR through 12 months. An independent clinical events committee adjudicated MAEs.