Xuanwu Hospital, Capital Medical University, Beijing, China.
Ann R Coll Surg Engl. 2022 Nov;104(9):667-672. doi: 10.1308/rcsann.2021.0335. Epub 2022 Apr 21.
It has been reported that excimer laser atherectomy combined with a drug-coated balloon (ELA+DCB) can achieve better results than simple balloon angioplasty, especially for the treatment of femoropopliteal in-stent restenosis. However, reports on the application of ELA+DCB in China for femoropopliteal arteriosclerosis obliterans are lacking. This study focuses on analysing the effectiveness and safety of ELA+DCB.
This was a single-centre retrospective study that enrolled patients from November 2016 to January 2019 who had femoropopliteal arteriosclerosis obliterans treated by ELA+DCB. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically.
There were 43 patients with an average patient age of 68.0±8.6 years; 79.1% were male. In 30 cases, the lesions were de novo and the others were in-stent restenosis (ISR). During the procedure, flow-limiting dissection (48.8%) was the main adverse event and there were 17 bailout stent implantations due to dissection. Mean (±sd) ankle-brachial index (ABI) in the patients was 0.42±0.31 before the operation and 0.83±0.13 before discharge. The mean (±sd) follow-up time was 29.35±9.71 months. The primary patency rate was 66.8%, 64.3% and 60.9% at 12, 24 and 36 months. Freedom from target lesion revascularisation (TLR) was 85.7%, 80.7% and 75.3% at 12, 24 and 36 months. Rutherford categories also greatly improved during follow-up. Overall mortality was 6.9% (3/48), and no deaths were related to the intervention.
The use of ELA+DCB had good clinical benefit for femoropopliteal arteriosclerosis obliterans, which had good primary patency and freedom from TLR, although intraoperative complications still required attention. Multicentre randomised controlled trials with long-term follow-up are needed.
据报道，准分子激光斑块切除术联合药物涂层球囊（ELA+DCB）的治疗效果优于单纯球囊血管成形术，尤其适用于股腘段支架内再狭窄病变的治疗。然而，在中国，关于 ELA+DCB 治疗股腘动脉硬化闭塞症的应用报道较少。本研究旨在分析 ELA+DCB 的有效性和安全性。
这是一项单中心回顾性研究，纳入了 2016 年 11 月至 2019 年 1 月期间接受 ELA+DCB 治疗的股腘动脉硬化闭塞症患者。对患者的术前人口统计学、手术细节和术后随访结果进行了统计学分析。
共纳入 43 例患者，平均年龄为 68.0±8.6 岁，79.1%为男性。30 例患者为初发病变，其余为支架内再狭窄（ISR）病变。术中主要不良事件为血流受限性夹层（48.8%），因夹层行 17 例补救性支架植入术。患者术前踝肱指数（ABI）平均为 0.42±0.31，出院前为 0.83±0.13。平均（±标准差）随访时间为 29.35±9.71 个月。12、24 和 36 个月时的一期通畅率分别为 66.8%、64.3%和 60.9%。12、24 和 36 个月时无靶病变血运重建（TLR）率分别为 85.7%、80.7%和 75.3%。随访期间，Rutherford 分级也显著改善。总死亡率为 6.9%（3/48），无死亡与介入治疗相关。
ELA+DCB 治疗股腘动脉硬化闭塞症具有良好的临床获益，其一期通畅率和无 TLR 率较高，但术中并发症仍需关注。需要开展多中心随机对照试验并进行长期随访。
