Three-Year Results of Combining Debulking Devices with Drug-coated Balloons for the Treatment of De Novo Femoropopliteal Arteriosclerosis Obliterans.

Abstract

Objectives: To compare the safety and efficacy of debulking devices, including directional atherectomy (DA) and excimer laser atherectomy (ELA), when combined with drug-coated balloons (DCB) for treating de novo femoropopliteal atherosclerotic obliterans (ASO). Additionally, to evaluate the long-term outcomes and application status of these different debulking devices.

Methods: Clinical data were collected from patients with femoropopliteal ASO who underwent combined debulking and DCBs at the Vascular Surgery Department of Xuanwu Hospital, Capital Medical University, China, between January 2018 and January 2023. In accordance with the different atherectomy devices used during the surgery, patients were divided into the directional atherectomy group and the excimer laser group. Patient baseline characteristics, Rutherford classification, lesion length, stenosis degree, TASC II classification, calcification degree, and surgical-related data were recorded. Follow-up data over 36 months were collected to obtain efficacy indicators such as primary patency rate and freedom from clinically-driven target lesion revascularizition rate (fCD-TLR), etc. RESULTS: A total of 167 primary femoropopliteal lesions were treated with debulking combined with DCB intervention, with a technical success rate of 100%. The DA combined with DCB group included 90 cases, while the ELA combined with DCB group included 77 cases. Both groups showed significant improvement in postoperative Rutherford classification compared to preoperative. The primary patency rates at 12, 24, and 36 months for the DA and ELA groups were 88.89% vs. 81.74% (P=0.15), 74.66% vs. 74.01% (P=0.99), and 63.37% vs. 67.24% (P=0.84), respectively. The fCD-TLR rates were 94.44% vs. 92.15% (P=0.53); 83.82% vs. 80.87% (P=0.42); and 68.47% vs. 72.87% (P=0.22), with no significant statistical differences. Notably, there were certain intergroup differences. Patients in the DA group had more comorbidities but lighter Rutherford classification compared to the ELA group. In the ELA group, the average lesion length was significantly longer than that in the DA group (140 mm vs. 108 mm, P= 0.007), and 75.3% of the lesions were occlusive. In contrast, only 24.4% of the lesions in the DA group were occlusive (P<0.001). Additionally, the use of embolic protection devices was more common in the DA group (78.9% vs. 49.4%, P<0.001), while the ELA group had a higher incidence of dissection and a higher rate of bailout stent implantation. Subgroup analysis showed that for severe stenotic lesions, the primary patency rate in the DA group was higher than that in the ELA group (P=0.04), whereas for occlusive lesions, the ELA group had a better primary patency rate (P=0.002). Independent risk factors for restenosis included smoking history, hypertension, coronary artery disease, and severe calcified lesions.

Conclusion: Both DA and ELA can treat femoropopliteal ASO effectively and improved clinical symptoms with few perioperative complications. However, the specific applications and long-term outcomes of the two debulking devices are influenced by the characteristics of the lesions. Additionally, there are certain differences in the use of bailout stenting and distal protection devices. Severe calcified lesions were an independent risk factor for reduced primary patency rate, warranting further in-depth research on the treatment of highly calcified lesions.