Helical stent for PAD safe, effective in complex real-world population
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A helical stent to treat peripheral artery disease without extensive lesion preparation was safe and effective at 2 years in a real-world population with long and complex lesions, a speaker reported.
The stent (BioMimics, Veryan Medical) “implants non-planar curvature to stented femoropopliteal segments, which generates swirling flow, providing an antiproliferative effect without a need for a drug,” Michael Lichtenberg, MD, chief physician at Arnsberg Vascular Center, Klinikum Hochsauerland, Arnsberg, Germany, said during a presentation at the International Symposium on Endovascular Therapy.
The stent has been successful in randomized trials, but the researchers launched the MIMICS-3D registry to evaluate it in a real-world population with longer and more complex lesions than those seen in the trials, he said.
Lichtenberg presented 2-year data from 507 patients in the registry (mean age, 70 years; 66% men; 37% with diabetes; 36% current smokers; 57% with chronic total occlusion; 24% with critical limb ischemia).
Mean percent diameter stenosis was 94.6%, mean lesion length was 127 mm and 38% of lesions had moderate to severe calcification, he said.
At 2 years, Kaplan-Meier freedom from loss of primary patency was 78% and Kaplan-Meier freedom from clinically driven target lesion revascularization was 83%, Lichtenberg said.
“The MIMICS-3D registry is studying a clinically relevant population and providing additional validation of the durable outcome benefit of swirling flow,” Lichtenberg said during the presentation.
“There was no statistical difference in freedom from clinically driven TLR between the drug-coated balloon and non-DCB cohorts,” he said. “The addition of paclitaxel adds no benefit of clinical outcome. We have comparable outcomes to drug-eluting stents and the Supera stent (Abbott Vascular) despite more challenging lesions, and without the need for extensive vessel preparation. The data support the therapeutic value of the swirling flow principle.”
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Lichtenberg M, et al. Poster 113. Presented at: the International Symposium on Endovascular Therapy (ISET); May 9-11, 2021; Miami Beach, Florida (hybrid meeting).
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