Jornal Vascular Brasileiro
https://app.periodikos.com.br/journal/jvb/article/doi/10.1590/1677-5449.202401032
Jornal Vascular Brasileiro
Original Article

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

Eficácia e segurança da angioplastia com balão revestido com paclitaxel para estenose em acessos vasculares de hemodiálise: resultados de 6 meses de um estudo prospectivo multicêntrico brasileiro

Leonardo de Oliveira Harduin; Thiago Almeida Barroso; Julia Bandeira Guerra; Márcio Gomes Filippo; Leonardo Cortizo de Almeida; Carlos Alexandre Rosa Gama; Brunno Ribeiro Vieira; Renata Silveira Mello; Adriano Martins Galhardo; Jorge Paulo Strogoff-de-Matos

http://dx.doi.org/10.1590/1677-5449.202401032 J Vasc Bras, vol.24, e20240103, 2024
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Abstract

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.

 

Keywords

hemodialysis; paclitaxel-coated balloon; RangerTM; vascular access; stenosis

Resumo

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.

Palavras-chave

hemodiálise; balão revestido com paclitaxel; Ranger™; acesso vascular; estenose

References

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Submitted date:
07/02/2024

Accepted date:
08/22/2024

Sociedade Brasileira de Angiologia e Cirurgia Vascular (SBACV)"> Sociedade Brasileira de Angiologia e Cirurgia Vascular (SBACV)">
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