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. 2025 Feb 14:24:e20240103.
doi: 10.1590/1677-5449.202401032. eCollection 2025.

Efficacy and safety of paclitaxel drug-coated balloon angioplasty for stenosis of hemodialysis vascular access: 6-month results from a brazilian multicenter prospective study

Leonardo de Oliveira Harduin  1   2   3 , Thiago Almeida Barroso  4 , Julia Bandeira Guerra  2   3 , Márcio Gomes Filippo  5 , Leonardo Cortizo de Almeida  6 , Carlos Alexandre Rosa Gama  7 , Brunno Ribeiro Vieira  8 , Renata Silveira Mello  2 , Adriano Martins Galhardo  4 , Jorge Paulo Strogoff-de-Matos  9
Affiliations

Efficacy and safety of paclitaxel drug-coated balloon angioplasty for stenosis of hemodialysis vascular access: 6-month results from a brazilian multicenter prospective study

Leonardo de Oliveira Harduin et al. J Vasc Bras. .

Abstract
in English, Portuguese

Background: Stenosis resulting from neointimal hyperplasia remains a significant concern associated with dysfunction of arteriovenous fistulas (AVF).

Objectives: To investigate the safety and efficacy of paclitaxel drug-coated balloon (DCB) angioplasty for treating failing AVFs.

Methods: Investigators analyzed 58 hemodialysis patients treated with RangerTM DCBs from December 2022 to December 2023 across four centers. Lesions treated were de novo or restenotic and located in the juxta-anastomosis, cannulation zone, and outflow segment. Patients were evaluated through physical examinations and Duplex ultrasound at 1, 3, and 6 months. The primary efficacy endpoint was target lesion primary patency at 1, 3, and 6 months, and the primary safety endpoint was freedom from serious adverse events through 30 days post-procedure. Secondary endpoints were access circuit primary patency and technical and procedural success.

Results: Nine patients (16%) had thrombosed access at the initial presentation, and 31 (53%) presented with recurrent stenosis. The target lesion primary patency rate at 6 months was 85.7%, and the access circuit primary patency rate at 6 months was 67.5%. No serious adverse events, either local or systemic, were reported. Sex, age, stenosis location, type of lesion, presence of thrombosis, lesion recurrence, diabetes status, or whether post-ballooning dilation was performed did not significantly affect the 6-month target lesion primary patency.

Conclusions: DCB angioplasty was shown to be safe and effective for treating peripheral stenosis in vascular access.

Contexto: A estenose resultante da hiperplasia neointimal continua sendo uma preocupação significativa associada à disfunção das fístulas arteriovenosas (FAVs).

Objetivos: Investigar a segurança e eficácia da angioplastia com balão revestido com paclitaxel (DCB) para o tratamento de FAVs em falência.

Métodos: Os investigadores analisaram 58 pacientes em hemodiálise tratados com o DCB Ranger™ de dezembro de 2022 a dezembro de 2023, em quatro centros. As lesões tratadas eram de novo ou restenóticas, localizadas próximas à anastomose, na zona de canulação ou no segmento de saída. Os pacientes foram avaliados por meio de exames físicos e ultrassom Duplex aos 1, 3 e 6 meses. O desfecho primário de eficácia foi a perviedade primária da lesão-alvo aos 1, 3 e 6 meses, e o desfecho primário de segurança foi a ausência de eventos adversos graves até 30 dias após o procedimento. Os desfechos secundários foram a perviedade primária do circuito de acesso e o sucesso técnico e procedimental.

Resultados: Nove pacientes (16%) apresentaram trombose das FAVs na apresentação inicial e 31 (53%) apresentaram estenose recorrente. A taxa de perviedade primária da lesão-alvo aos 6 meses foi de 85,7%, e a taxa de perviedade primária do circuito de acesso aos 6 meses foi de 67,5%. Nenhum evento adverso grave, local ou sistêmico, foi relatado. Sexo, idade, localização da estenose, tipo de lesão, presença de trombose, recorrência da lesão, status diabético e realização de dilatação pós-balão não afetaram significativamente a perviedade primária da lesão-alvo aos 6 meses.

Conclusões: A angioplastia com DCB demonstrou ser segura e eficaz para o tratamento da estenose periférica em acessos vasculares.

Keywords: RangerTM; hemodialysis; paclitaxel-coated balloon; stenosis; vascular access.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest: No conflicts of interest declared concerning the publication of this article.

Figures

Figure 1
Figure 1. Example of procedural outcomes in a patient with radiocephalic AVF with stenosis at juxta-anastomosis. a) Angiography of a radiocephalic AVF with stenosis at juxta-anastomosis. b) Pre-dilation with 6x60mm high-pressure balloon; c) Preoperative angiography demonstrating adequate vessel preparation; d) Angioplasty with RangerTM DCB (8x80mm); e) Control angiography; f, g, and h) Control Doppler 6 months after the initial procedure without signs of restenosis and with a flow volume of 933ml/min.
Figure 2
Figure 2. Target lesion primary patency rates were 100% at 1 month, 96.5% at 3 months, and 85.7% at 6 months.
Figure 3
Figure 3. Access circuit primary patency rates were 100% at 1 month, 91.3% at 3 months, and 67.5% at 6 months.
See this image and copyright information in PMC

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