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

Translated title of the contribution: 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

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

Research output: Contribution to journalArticle

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.

Original languagePortuguese
Pages (from-to)276-284
Number of pages9
JournalJornal Vascular Brasileiro
Volume16
Issue number4
DOIs
Publication statusPublished - Oct 1 2017
Externally publishedYes

Fingerprint

Paclitaxel
Registries
Arteries
Amputation
Equipment and Supplies
Extremities
Safety
Balloon Angioplasty
Peripheral Arterial Disease
Pharmaceutical Preparations
Lower Extremity
Therapeutics
Ischemia
Smoking
Mortality

Keywords

  • Endovascular therapy
  • Paclitaxel-Coated Balloon
  • Peripheral artery disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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

In: Jornal Vascular Brasileiro, Vol. 16, No. 4, 01.10.2017, p. 276-284.

Research output: Contribution to journalArticle

Brodmann, Marianne ; Zeller, Thomas ; Christensen, Johnny ; Binkert, Christoph ; Spak, Lubomir ; Schröder, Henrik ; Righini, Paolo ; Nano, Giovanni ; Tepe, Gunnar. / 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. In: Jornal Vascular Brasileiro. 2017 ; Vol. 16, No. 4. pp. 276-284.
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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.",
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T2 - Resultados após 12 meses do primeiro ano de seleção de pacientes para o registro BIOLUX P-III

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AU - Zeller, Thomas

AU - Christensen, Johnny

AU - Binkert, Christoph

AU - Spak, Lubomir

AU - Schröder, Henrik

AU - Righini, Paolo

AU - Nano, Giovanni

AU - Tepe, Gunnar

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