Clinical benefits of paclitaxel-coated balloons in the treatment of infrapopliteal limb-threatening peripheral artery disease

Summary: Background: Infrapopliteal lesions account for one-third of peripheral artery disease (PAD) cases; however, its endovascular treatment data are insufficient. Although paclitaxel-coated drug-coated-balloons (DCBs) reduce restenosis and the need for re-interventions in femoropopliteal arteries, their effectiveness in below-the-knee (BTK) vessels is uncertain. This study evaluated the real-world effectiveness and safety of paclitaxel-coated DCBs in BTK vessels. Patients and methods: This retrospective single-centre study included consecutive patients treated with paclitaxel-coated Luminor™ DCB in BTK arteries between August 2017 and March 2022. The follow-up extended to 60 months. Data were retrieved from archives, phone interviews and physician inquiries. Results: Seventy-nine patients (65.5% male; mean age 74.9±9.2 years) underwent 84 interventions with 114 DCBs. The overall and treated lesion lengths averaged 102.1±80.3 and 117.2±75.5 mm, respectively. The median preoperative Rutherford score was 5 [interquartile range (IQR), 5–5; n=80]. The ankle–brachial index (ABI, 0.8±0.4–1.0±0.2, P=.002) and toe–brachial index (TBI, 0.3±0.3–0.6±0.2, P=.039) significantly improved post-intervention. The wound, ischaemia and foot infection score components showed median value reductions from the pre- to the postinterventional assessment: wound, from 1 (IQR, 1–2) to 1 (0–1); ischaemia, from 1 (IQR, 0–2) to 0 (0–1); and foot infection, from 1 (IQR, 0–2) to 0 (0–1). Kaplan–Meier analysis revealed 25 major adverse limb events, 17 re-interventions, 15 major adverse cardiac events, and 8 major amputation events over 5 years. Re-intervention-free survival was lower in men than in women (P=.036). Diabetic status or renal function was not significantly different. The 3-year mortality was 46.4%. Conclusions: This study highlights the clinical benefit of infrapopliteal paclitaxel-coated DCBs in real-world patients. ABI and TBI improvements reflect ischaemia relief. Wound-healing trends suggest reduced ischaemia and infection within 3 days, but requires longer follow-up. High mortality rates emphasise the effect of comorbidities and multidisciplinary care requirements.