Prospective, Multi-center, Single-Arm Study of the Auryon Laser System for Treatment of Below-the-Knee Arteries in Patients With Chronic Limb-Threatening Ischemia: 30-Day Results of the Auryon BTK

Abstract

The 355 nm Auryon laser has been shown to be effective and safe in treating various morphology lesions in the femoropopliteal arteries. There are limited data on the Auryon laser in treating below the knee (BTK) arteries in patients with chronic limb threatening ischemia (CLTI). We present the 30-day efficacy and safety findings from the ongoing Auryon BTK study.Patients with CLTI were prospectively enrolled in the Auryon BTK study between March 2022 and February 2023 in 4 US centers after obtaining informed consent. The primary safety endpoint included Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days defined as a composite of all-cause death, major amputation and target vessel revascularization. Demographic, procedural, angiographic and outcome data were collected.A total of 60 patients (61 lesions) were treated. The mean age was 74.6 ± 10.3 years with 65.0 % males, 58.3% diabetics, 43.3% Rutherford Becker (RB) IV and 56.7% RB V. Of the 61 lesions, 59% had severe calcification, 31.1 % were chronic total occlusions and 90.2% were denovo disease. Baseline diameter stenosis was 80.2 ± 16.4%, post laser 57.4 ± 21.7% and post final treatment 24.0 ± 23.1% (p value < 0.0050). The primary performance endpoint showed a procedure success rate of 37/68 (63.8%). Bailout stenting occurred in 1/61 lesions (1.6%). Rutherford Becker category was 100% RB IV or higher at baseline versus 35.3% at 30-day. At 30 days, there was no target vessel revascularization and patency was 88.9% (PSVR ≤ 2.4). In conclusion, the Auryon laser is safe and relatively effective in treating BTK lesions with minimal complications.