Clinical outcome of low-dose and high-dose drug-coated balloon angioplasty with intraplaque wiring for femoropopliteal chronic total occlusion lesions.

Chronic total occlusion (CTO) lesions of the femoropopliteal artery have been shown to benefit from drug-coated balloon (DCB) angioplasty. However, because bailout stenting is often performed, the outcome of DCB angioplasty alone remains unknown, particularly the differences in outcomes between low-dose DCB (LD-DCB) and high-dose DCB (HD-DCB). To address these issues, we conducted a single-center, retrospective cohort study and enrolled 66 consecutive patients undergoing initial endovascular therapy with DCBs for femoropopliteal CTO lesions from June 2018 to February 2023. Of the 66 patients, 25 underwent LD-DCB angioplasty and 41 underwent HD-DCB angioplasty. In all lesions, no bailout stenting was performed and intraplaque wiring was confirmed by intravascular ultrasound. The primary outcome measure was 1-year primary patency and the secondary outcome measures were 1-year freedom from clinically driven target lesion revascularization (CD-TLR) and reocclusion. There were no significant differences between LD-DCB and HD-DCB angioplasty in patient and lesion characteristics, 1-year primary patency (76.4% vs. 85.9%, log-rank p = 0.51), CD-TLR (95.2% vs. 94.3%, log-rank p = 0.97), and reocclusion (95.0% vs. 94.3%, log-rank p = 0.99). Patients with two of the three risk factors for restenosis, i.e., minimum lumen area < 12.6 mm2, dissection angle > 63°, and calcification angle > 270°, had a significantly lower patency rate (no factor: 100% vs. 1 factor: 90.3% vs. 2 factors: 62.6%; log-rank p = 0.04). In patients undergoing DCB angioplasty for femoropopliteal CTO lesions, 1-year primary patency and freedom from CD-TLR were favorable, with no significant difference between LD-DCB and HD-DCB angioplasty.