Cold Laser vs Excimer Laser in Lower Limb Atherosclerosis: A Prospective Multicenter Randomized Trial.

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Vascular Surgery

Background:

• Peripheral artery disease (PAD) poses a significant global health challenge, with complex lesions like calcified segments and chronic total occlusions remaining difficult to treat with current endovascular therapies.
• The 355-nm cold laser atherectomy (CLA) system presents a novel photochemical, low-thermal approach for plaque ablation, potentially improving safety and efficacy in PAD treatment.

Purpose of the Study:

• To evaluate the safety and efficacy of the 355-nm CLA system compared to excimer laser atherectomy (ELA) for treating lower limb atherosclerotic stenosis and occlusion.
• To assess primary patency, target lesion revascularization (TLR), Rutherford classification, and ankle-brachial index at 30 days and 6 months post-procedure.

Main Methods:

• A prospective, multicenter, randomized controlled trial involving 110 patients with symptomatic lower extremity PAD (Rutherford classes 2-5) and significant stenosis or occlusion.
• Patients were randomized to either the 355-nm CLA or ELA group, with the primary endpoint being the improvement in vessel diameter stenosis (DS%) before adjunctive therapy.

Main Results:

• Both CLA and ELA significantly improved postprocedural DS% without significant intergroup differences, meeting the noninferiority threshold.
• At 6 months, patency rates were 71.7% for CLA and 61.5% for ELA, with TLR rates of 6.5% and 10.2%, respectively.
• Subgroup analyses indicated that CLA demonstrated lower TLR rates in complex lesions, including TASC C/D and long lesions (≥10 cm).

Conclusions:

• The 355-nm CLA system demonstrated comparable safety and efficacy to ELA for treating lower limb PAD.
• CLA showed a trend towards reduced TLR in complex PAD lesions, suggesting its potential as an advanced endovascular tool to enhance revascularization strategies and patient outcomes.