Jornal Vascular Brasileiro
https://www.jvascbras.org/article/doi/10.1590/1677-5449.007317
Jornal Vascular Brasileiro
Original Article

Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment

Experiência real com balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas: resultados após 12 meses do primeiro ano de seleção de pacientes para o registro BIOLUX P-III

Marianne Brodmann, Thomas Zeller, Johnny Christensen, Christoph Binkert, Lubomir Spak, Henrik Schröder, Paolo Righini, Giovanni Nano, Gunnar Tepe

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Abstract

Background: Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective: The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods: 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results: Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion: In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.

Keywords

Peripheral artery disease; Paclitaxel-Coated Balloon; endovascular therapy.

Resumo

Contexto: O manejo endovascular de artérias infrainguinais ateroscleróticas recentemente tem mudado para dispositivos farmacológicos, desenhados para impedir localmente o processo de reestenose. Numerosos estudos clínicos descrevem uma vantagem da angioplastia com uso de balões farmacológicos sobre os balões convencionais no tratamento de doença arterial periférica dos membros inferiores. No entanto, considerando que as plataformas do revestimento farmacológico e dos balões são diferentes, cada dispositivo requer avaliações clínicas específicas. Objetivo: Fazer investigação adicional sobre a segurança e eficácia de um balão revestido com paclitaxel para o tratamento de artérias infrainguinais ateroscleróticas em um cenário de mundo real. Métodos: 203 pacientes de uma amostra final de 882 pacientes foram incluídos neste registro prospectivo observacional multicêntrico de inclusão sequencial, durante os primeiros 12 meses. Os desfechos primários foram eventos adversos maiores (definidos como morte relacionada ao procedimento ou ao dispositivo em até 30 dias após o procedimento-índice, necessidade de revascularização da lesão-alvo ou amputação significativa do membro-alvo) em 6 meses e ausência de de revascularização da lesão-alvo em 12 meses. Ambos os desfechos foram adjudicados por um comitê de eventos clínicos. Resultados: A idade média foi 70,2±10,4 anos (60,1% sexo masculino). 47,3% dos pacientes eram diabéticos, e 67,5% tinham história de tabagismo. Claudicação severa foi relatada em 37,4%, e 40% apresentava isquemia crítica de membro. 257 lesões, incluindo 13,2% em território infrapoplíteo, foram tratadas com o balão Passeo-18 Lux (comprimento médio das lesões 75,1 mm±69,4, 20% oclusões, 76,3% calcificadas). Aos 6 meses, a taxa de eventos adversos maiores foi de 5,5% (95%CI 3,1-9,7). A ausência de revascularização da lesão-alvo aos 12 meses foi de 93,2% (95%CI 89,1-95,8). Mortalidade por todas as causas foi de 6,5% (95%CI 3,8-11,0) e a taxa geral de amputação foi de 4,2% (95%CI 2,1-8,3) aos 12 meses. Conclusão: Em um cenário de mundo real, os resultados preliminares do registro BIOLUX P-III confirmam a segurança e eficácia do balão revestido com paclitaxel Passeo-18 Lux como opção de tratamento único para artérias infrainguinais ateroscleróticas. Palavras-chave: doença arterial periférica; balão revestido com paclitaxel; terapia endovascular

Palavras-chave

doença arterial periférica; balão revestido com paclitaxel; terapia endovascular.

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