Safety and Effectiveness of Excimer Laser Ablation Combined With Drug-Coated Balloon for Atherosclerotic Obliterans in the Lower Extremity

Abstract

Purpose: To evaluate the safety and effectiveness of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for atherosclerotic obliterans (ASO) of the lower extremities. Materials and Methods: From June 2019 to December 2020, all eligible patients were enrolled. Demographics, characteristics of lesions, complications, and follow-up information were collected and analyzed. The primary endpoint was major amputation-free survival (MAFS). Secondary endpoints included technical success, primary patency, bailout stent, distal embolization, target lesion reintervention (TLR), and ulcer healing rate. Major amputation-free survival and primary patency were calculated by Kaplan-Meier analysis. Results: A total of 71 patients were enrolled. Forty-eight (81.7%) patients presented critical limb ischemia (CLI) and 48.6% of them was calcification class 4 according to Peripheral Arterial Calcium Scoring System (PACSS). Chronic totally occluded (CTO) disease was the most common lesion in 66.0% of them and superficial femoral artery (SFA) was the most common segment in 59.6%. Technical success rate was 93.0%. One-year follow-up was finished in 25 (35.2%) patients. The primary patency and MAFS were 92.0%±27.6% and 96.0%±20.0% at 12 months, respectively. During the mean follow-up of 9.4±4.3 months, clinically-driven TLR occurred in 2 (2.8%) patients, and major and minor amputation occurred in 2 (2.8%) and 1 (1.4%) patient, respectively. Conclusion: The early results demonstrated that ELA was an effective treatment in de novo, in-stent restenosis (ISR) and CTO lesions. Meanwhile, ELA could prepare the lumen for the use of DCB and reduce the implantation of stents, especially in segments unsuitable for stenting. Mid-term and long-term results need to be awaited.

Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial

“… ABI ankle-brachial index, QoL quality of life, PACSS peripheral arterial calcium scoring system [ 25 ], DSA digital substract angiography, IVUS intravascular ultrasound, NRS numerical rating scale, DUS Doppler ultrasound (a) (b): evaluated by DSA in both groups before and after intervention; (c) (d): evaluated by IVUS in study group before and after laser …”

“…ABI ankle-brachial index, QoL quality of life, PACSS peripheral arterial calcium scoring system [ 25 ], DSA digital substract angiography, IVUS intravascular ultrasound, NRS numerical rating scale, DUS Doppler ultrasound…”

“…The establishment of access was as our previous study [ 25 ]. And the extend of the calcification of the targeted lesions will be assessed according to Peripheral Arterial Calcium Scoring System (PACSS) [ 26 ].…”