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

ABSTRACT

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 was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), 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. The 36 month endpoints were clinically driven target lesion revascularisation (CD-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 IC (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 reduced 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 CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (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 outcome 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.