Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial.
EuroIntervention
; 15(18): e1633-e1640, 2020 04 03.
Article
em En
| MEDLINE
| ID: mdl-31687933
ABSTRACT
AIMS:
Although paclitaxel drug-coated balloon (DCB) angioplasty is an established endovascular treatment for peripheral artery disease, restenosis remains a major concern. Thus, we compared a novel paclitaxel-coated DCB with nano-coating technology with uncoated plain old balloon angioplasty (POBA). METHODS ANDRESULTS:
This multicentre trial randomly assigned 171 patients with stenotic and occlusive lesions of the femoropopliteal artery to angioplasty with a novel DCB or uncoated POBA. The primary endpoint, late lumen loss at six months, was 0.92 mm lower in the DCB group (95% CI -1.36 to -0.49 mm, p<0.001). Patients showed improved walking after DCB treatment at six months (p=0.021). In the DCB group, 44.6% and 50% of the patients improved by three Rutherford-Becker classification stages after six to 12 months, respectively (POBA 27.8% and 36.8%, respectively). Only one patient needed TLR (1.3%) in the DCB group, compared to 14 patients (18.7%) in the POBA group after 12 months (relative risk [RR]=0.08, 95% CI 0.01-0.53, p<0.001). Primary patency was 90.3% (DCB group) versus 65.3% (POBA group) after 12 months (RR=1.38, 95% CI 1.14-1.67, p<0.001).CONCLUSIONS:
The novel DCB was effective and safe for inhibiting restenosis. Moreover, it demonstrated a better improvement in walking than POBA and showed no mortality concerns due to paclitaxel application after 12 months. Clinical Trials Identifier NCT02540018
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Artéria Poplítea
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Paclitaxel
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Angioplastia com Balão
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Materiais Revestidos Biocompatíveis
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Artéria Femoral
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Doença Arterial Periférica
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
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Etiology_studies
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
EuroIntervention
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPEUTICA
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Alemanha