Efficacy and one-year outcomes of Luminor® paclitaxel-coated drug-eluting balloon in the treatment of popliteal artery atherosclerosis lesions.
Ann Vasc Surg
; 76: 370-377, 2021 Oct.
Article
em En
| MEDLINE
| ID: mdl-33951533
ABSTRACT
PURPOSE:
Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences.METHODS:
From January to June 2019, patients' data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean21.58; IQR20-24) months.RESULTS:
Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r0-10; SD3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR0.41-0.47 vs. 0.69; IQR0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively.CONCLUSIONS:
In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Artéria Poplítea
/
Fármacos Cardiovasculares
/
Paclitaxel
/
Angioplastia com Balão
/
Materiais Revestidos Biocompatíveis
/
Doença Arterial Periférica
/
Placa Aterosclerótica
/
Dispositivos de Acesso Vascular
/
Claudicação Intermitente
/
Isquemia
Tipo de estudo:
Observational_studies
/
Risk_factors_studies
Limite:
Aged80
Idioma:
En
Revista:
Ann Vasc Surg
Assunto da revista:
ANGIOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article