• J Vasc Access · Nov 2019

    Multicenter Study

    Drug-coated balloon angioplasty in failing haemodialysis arteriovenous shunts: 12-month outcomes in 200 patients from the Aperto Italian registry.

    • Matteo Tozzi, Marco Franchin, Daniele Savio, Simone Comelli, Luca Di Maggio, Luciano Carbonari, Reza Ebrahimi, Federico Fontana, Filippo Piacentino, Maria Cristina Cervarolo, Vincenzo Palermo, and Gabriele Piffaretti.
    • Vascular Surgery Unit, Department of Medicine and Surgery, Circolo University Teaching Hospital, University of Insubria, Varese, Italy.
    • J Vasc Access. 2019 Nov 1; 20 (6): 733-739.

    BackgroundWe evaluated the safety and technical and clinical outcomes of angioplasty with a drug-coated balloon for the management of venous stenosis in arteriovenous grafts and arteriovenous fistulas in patients undergoing haemodialysis.MethodsData were obtained from an ongoing prospective, non-randomised registry conducted at three Italian centres. Patients were treated with a drug-coated balloon according to standard procedures in each participating centre. Evaluation was by colour Doppler imaging every 3 months. The primary end-point was primary assisted patency. The secondary end-point was the rate of assisted patency of the vascular access.ResultsA total of 311 angioplasty procedures in 200 patients, (60.4% male), were analysed. The procedural success rate was 100%. A total of 192 treatments of restenosis were necessary in 81 patients during average 21 ± 8 months follow-up. Kaplan-Meier estimates indicated that 88.0%, 64.2% and 40.6% of treated lesions were free from restenosis at 6, 12 and 24 months, respectively. Including multiple angioplasty, circuit patency rates were 99.2%, 92.5% and 84.8% at 6, 12 and 24 months, respectively. Primary patency rates were highest in shunts treated de novo with drug-coated balloons. Risk of restenosis was associated with circuit age (p = 0.017), history of treatment with conventional angioplasty (p < 0.001) and the kind of balloon used during pre-dilation (p = 0.001).ConclusionThe results suggest that favourable long-term patency rates can be achieved with the drug-coated balloon in a varied population of patients with failing haemodialysis arteriovenous shunts treated under conditions of actual care.

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