Paclitaxel-Coated Balloons for Femoropopliteal Artery Disease Treatment in French Patients: A Longitudinal Observational Study.

Abstract

Background: Clinical studies have demonstrated the safety and effectiveness of drug-coated balloon (DCB) angioplasty for femoropopliteal revascularization. Long-term studies in routine practice are limited.

Aims: The aim of this study was to assess long-term outcomes after DCB angioplasty for femoropopliteal peripheral artery disease in a real-word-French population.

Methods: Patients with lower-limb PAD treated with at least one IN.PACT Admiral DCB in the year 2018 were identified from the French National Health Data System, representing > 99% of the French population. Primary outcomes were all-cause mortality, major amputation (including target and nontarget limbs and vessels), and reintervention (any infrainguinal reintervention or new intervention of the target lesions, nontarget lesions, target limbs, or contralateral limbs) within 1 year from the date of angioplasty. Patients were followed for 3 years from the date of angioplasty.

Results: A total of 3595 patients (average age 71.2 years) were enrolled, including 35.7% females, 35.3% with chronic limb-threatening ischemia (CLTI), 38.2% with diabetes, and 35.9% with a history of revascularization. All-cause mortality was 7.5% at 1 year and 19.7% at 3 years. The major amputation rate was 2.7% at 1 year and 4.6% at 3 years. The total reintervention rate was 25.9% at 1 year and 43.4% at 3 years. Three-year rates were significantly higher in patients with CLTI (vs. patients with intermittent claudication), diabetes (vs. no diabetes), and prior revascularization (vs. no prior revascularization).

Conclusions: This real-world analysis with long-term follow-up showed satisfactory limb salvage and low mortality following angioplasty with DCBs for the treatment of femoropopliteal artery disease.