Comparative Long-Term Outcomes of Drug-Coated Balloons Alone Versus Combined Treatment with Rotational Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis

Abstract

Objective:

To evaluate and compare the efficacy and safety of drug-coated balloon angioplasty (DEB) versus rotational atherectomy combined with DEB (RA + DEB) in patients with in-stent restenosis (ISR) in the femoropopliteal territory.

Methods:

Retrospective multicenter observational study based on data from a prospective registry of patients with femoropopliteal stents treated between January 2017 and March 2022.

Results:

One hundred and six patients were included (53 in each group) with 3 years median follow-up. At 2 years, freedom from clinically driven target lesion revascularization (CD-TLR) was 87.1 ± 3.9% in the RA + DEB group compared to 75.5 ± 8.7% in the DEB group. At 5 years, the CD-TLR rates were 64.0 ± 9.4% in RA + DEB and 30.5 ± 10.6% in DEB (P = .036). Additionally, 5-year thrombosis-free survival was significantly higher in RA + DEB (74.6 ± 7.6%) compared to DEB (37.2 ± 10.5%, P = .026). There were no statistically significant differences in MALE between the treatment groups. In multivariable analysis, RA + DEB reduced TLR risk and improved assisted primary patency, while Tosaka 3 and lesion length predicted worse outcomes.

Conclusions:

RA combined with DEB offers advantages over DEB alone in femoropopliteal ISR, reducing reinterventions, enhancing assisted primary patency, and lowering thrombosis rates without increasing MALE.

Clinical Impact

This study addresses the current lack of long-term evidence on the treatment of femoropopliteal in-stent restenosis (ISR) using drug-coated balloons (DEB) alone versus DEB combined with rotational atherectomy (RA). Clinically, RA+DEB significantly reduces reinterventions and thrombosis, and improves assisted primary patency without increasing complications. For clinicians, this supports a more effective and durable option for complex ISR, particularly in occlusive or long lesions. The innovation lies in demonstrating the added value of vessel preparation with RA, offering a lesion-specific strategy in the absence of clear guideline recommendations.