MIMICS-3D 3-Year Outcomes in Complex Lesions

At Tuesday's ISET 2023 sessions, Dr. Robert Beasley presented 3-year results of MIMICS, a prospective, multicenter, observational study that evaluated BioMimics 3D in 507 patients with peripheral arterial disease at 23 investigational sites with a 3-year follow-up. 

Current drug-coated balloon (DCB) pivotal trials show improved outcomes compared to simple angioplasty in well-defined lesions. Global DCB registries contradict these exceptional outcomes because real-world patients and lesions are more complex than those recruited to the pivotal trials. The average provisional stent rate in those cases is 28% to 35.5%. In IN.PACT global, the rate was 53% for lesions >25cm. The strongest predictor of poor outcome is bilateral wall calcium.

The BioMimics 3D vascular stent system (Veryan) was designed specifically for the femoropopliteal segment. It has a unique 3D helical shape that mimics natural movement of the femoropopliteal segment, reduces vascular irritation and injury, and reduces risk of stent fracture. The elevated wall shear stress reduces restenosis by reducing thrombus formation and inflammation, reduces smooth muscle cell proliferation, and reduces neointimal hyperplasia.

MIMICS was a prospective, multicenter, observational study that evaluated BioMimics 3D in 507 patients with peripheral arterial disease at 23 investigational sites with a 3-year follow-up. Chronic limb-threatening ischemia (CLTI) was present in 24% of enrolled patients. The mean age was 70.1, 66% male, 37% had diabetes mellitus, 38% currently smoked, and the majority of patients were Rutherford Class 3-6. This study included longer, more complex lesions than previously studied and 53% of those lesions had moderate to severe calcification. More than 1 stent was used in 25% of lesions included in the study.

MIMICS-3D had a longer follow-up than other long lesion studies with a more challenging population. The 3-year results showed 78% Kaplan Meier freedom of clinically-driven target lesion revascularization, 71% freedom from loss of primary patency, and 0.4% stent fracture.

More complex lesions in this study included 9% long lesions (140mm to ≤190mm), 24% very long lesions (>190mm), 24% CLTI, 53% moderate to severe calcification, and 57% chronic total occlusion. The results of this study were comparable to outcomes with drug-eluting stents and Supera, despite the more complex nature of this population.