The BioMimics 3D Helical Centreline Nitinol Stent in Chronic Limb Threatening Ischaemia and Complex Lesions: Three Year Outcomes of the MIMICS-3D Registry.

OBJECTIVE: There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets.

METHODS: MIMICS-3D is a prospective, multicentre European real world registry. This is a post hoc analysis, comparing patients with CLTI vs. intermittent claudication, lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0-2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. 36 month endpoints were clinically driven target lesion revascularisation (TLR), death, major target limb amputation, and stent patency.

RESULTS: A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with intermittent claudication (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p = .003), but the difference diminished after propensity score matching (70.5% vs. 76.8%, p = .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from clinically driven TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for intermittent claudication (p = .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0-2 (p = .55), and 75.6% for CTO vs. 81.0% for no CTO (p = .11) CONCLUSIONS: The outcomes of the Mimics 3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives.