SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Biomedical Engineering

Background:

• Lower limb arterial obstructive disease poses significant challenges in patient treatment.
• Nitinol stent technology has advanced, offering potential improvements in long-term outcomes.
• Evaluating novel stent designs is crucial for optimizing treatment strategies.

Purpose of the Study:

• To assess the long-term outcomes of an interwoven nitinol stent design in treating lower limb arterial obstructive disease.
• To compare the stent's performance against a Food and Drug Administration (FDA) mandated objective performance goal (OPG).

Main Methods:

• An open-label, single-arm study was conducted.
• 325 patients (264 intention-to-treat) were enrolled with a mean follow-up of 887 days.
• Lesion characteristics included treated lengths of 7.8 cm and 24.6% chronic total occlusions.

Main Results:

• Freedom from clinically driven target lesion revascularization (CD-TLR) was 89% at 12 months, 84% at 24 months, and 82% at 36 months.
• Stent deployment variations (compression/elongation) impacted CD-TLR rates, with moderate compression showing 90% freedom from CD-TLR.
• Stent fractures were rare, with only one event reported over 36 months.

Conclusions:

• The interwoven nitinol stent demonstrates excellent primary patency and durability up to 36 months.
• Optimal vessel preparation and stent deployment are critical for achieving the best performance.
• This stent design represents a best-in-class option for lower limb arterial obstructive disease.