Observational studyCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025
Paclitaxel-Coated Balloons for Femoropopliteal Artery Disease Treatment in French Patients: A Longitudinal Observational Study.
Observational study in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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5 authors.
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Abstract
backgroundClinical studies have demonstrated the safety and effectiveness of drug-coated balloon (DCB) angioplasty for femoropopliteal revascularization. Long-term studies in routine practice are limited.
aimsThe aim of this study was to assess long-term outcomes after DCB angioplasty for femoropopliteal peripheral artery disease in a real-word-French population.
methodsPatients 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.
resultsA 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).
conclusionsThis 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.
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