Twelve-Month Outcomes of the Prospective, Multicenter, Single-Arm Study of the 355-nm Laser for Treatment of Below-the-Knee Arteries: Final Results of the Auryon BTK.

In 30 seconds

This prospective, multicentre, single-arm study assessed 12-month outcomes after 355-nm laser atherectomy for infrapopliteal arterial disease in patients with chronic limb-threatening ischemia. Sixty patients with 61 lesions were enrolled at four US centres; 42 patients remained in the study at 12 months. Freedom from target lesion revascularization was 94.2% by proportional analysis and 94.0% by Kaplan-Meier analysis. Rutherford-Becker category improved by at least one category in 67.6% (23/34) of assessed patients. Quality-of-life scores improved, while walking impairment scores did not differ significantly from baseline at 12 months.

Key findings

• Freedom from target lesion revascularization at 12 months was 94.2% by proportional analysis and 94.0% by Kaplan-Meier analysis.
• Rutherford-Becker category improved by at least one category in 67.6% (23/34) of patients assessed at one year.
• EQ-5D total scores differed significantly from baseline at 30 days, 3, 6, and 12 months; WIQ scores did not differ significantly at 12 months (Δ-0.073, p = 0.678).
• Wounds healed in 33.3% (n = 4/12) of patients at 12 months.

Why it matters

Infrapopliteal disease in chronic limb-threatening ischemia is associated with substantial limb and functional burden. These prospective results describe one-year revascularization and patient-reported outcomes after laser atherectomy in a population with frequent severe calcification and chronic total occlusions. The findings add follow-up evidence, but the study design does not establish comparative benefit over other approaches.

What to keep in mind

The study was single-arm and included 60 patients; 42 remained in the study at 12 months, with 7 lost to follow-up, 5 withdrawals, and 7 deaths. Several outcomes were available for smaller subsets.