Results of Excimer Laser Ablation Combined with Drug-Coated Balloon for Atherosclerotic Obliterans of Lower Extremity and Risk Factors for Loss of Primary Patency.

ABSTRACT

BACKGROUND: The results of excimer laser ablation (ELA) combining with drug-coated balloon (DCB) in the treatment for atherosclerotic obliterans (ASO) remains unclear. METHODS: Retrospectively enrolled patients who underwent ELA combined with DCB in 2 centers. The primary endpoint was primary patency, and secondary endpoints included technical success, procedure-related complications, major amputation, clinically driven target lesions reintervention (CD-TLR), measurements of ankle-brachial index (ABI), and quality of life (QoL). RESULTS: 102 patients were enrolled. The primary patency was 86.7% (95% confidence interval [CI] 72.9%-89.0%) at 12 months and 82.6% (95% CI 78.2%-92.1%) at 24 months. The freedom from reintervention was 87.8% (95% CI 79.5%-92.9%) at 12 months and 86.6% (95% CI 78.1%-92.0%) at 24 months. The ABI measurement and QoL were significantly improved at each follow-up point. Sixteen (15.7%) patients lost the primary patency. Patients losing the primary patency demonstrated higher Rutherford class (P = 0.004), worse runoff (P < 0.001), higher Peripheral Arterial Calcium Scoring System (PACSS) (P < 0.001), and smaller ratio of tube diameter to reference vessel diameter (TD/RVD) (P < 0.001) compared with patients without losing it. The run-off ≥7 (adjusted odds ratio [aOR] 34.3; 95% CI 2.9-398.3; P = 0.005) and TD/RVD <4.9 (aOR 24.7; 95% CI 1.7-359.5; P = 0.019) were independent risk factors for loss of primary patency. CONCLUSIONS: ELA combined with DCB seemed an effective and safe treatment for ASO of lower extremity, and it could not only reduce the implantation of stent but significantly improve QoL. The run-off ≥7 and TD/RVD <4.9 were independent risk factors for loss of primary patency.