Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Vascular and Wound Treatment Center, Jinshan Hospital, Fudan University, Shanghai, China.
J Endovasc Ther. 2023 Oct;30(5):721-729. doi: 10.1177/15266028221092979. Epub 2022 May 6.
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.
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.
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.
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.
评估准分子激光消融（ELA）联合药物涂层球囊（DCB）治疗下肢粥样硬化闭塞症（ASO）的安全性和有效性。
本研究纳入了 2019 年 6 月至 2020 年 12 月期间所有符合条件的患者。收集并分析了患者的人口统计学、病变特征、并发症和随访信息。主要终点为免于重大截肢的生存（MAFS）。次要终点包括技术成功率、一期通畅率、挽救性支架植入、远端栓塞、靶病变再介入（TLR）和溃疡愈合率。MAFS 和一期通畅率采用 Kaplan-Meier 分析法进行计算。
共纳入 71 例患者。48 例（81.7%）患者表现为严重肢体缺血（CLI），其中 48.6%的患者根据外周动脉钙化评分系统（PACSS）为 4 级钙化。66.0%的患者为慢性完全闭塞（CTO）病变，最常见的病变部位是股浅动脉（SFA），占 59.6%。技术成功率为 93.0%。25 例（35.2%）患者完成了 1 年随访。12 个月时，一期通畅率和 MAFS 分别为 92.0%±27.6%和 96.0%±20.0%。在 9.4±4.3 个月的平均随访期间，2 例（2.8%）患者因临床需要进行 TLR，2 例（2.8%）和 1 例（1.4%）患者分别发生了大截肢和小截肢。
早期结果表明，ELA 是治疗新发、支架内再狭窄（ISR）和 CTO 病变的有效方法。同时，ELA 可以为 DCB 的使用准备管腔，减少支架植入，特别是在不适合支架植入的部位。需要等待中期和长期结果。
