Paclitaxel-Eluting Balloon Versus Standard Balloon Angioplasty in In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Artery: 1-Year Results of the PACUBA Trial.
JACC Cardiovasc Interv
; 9(13): 1386-92, 2016 07 11.
Article
en En
| MEDLINE
| ID: mdl-27388828
ABSTRACT
OBJECTIVES:
The hypothesis that paclitaxel-eluting balloon angioplasty provides higher 1-year patency rates in femoropopliteal artery in-stent restenosis compared with standard percutaneous transluminal angioplasty (PTA) was tested.BACKGROUND:
Several trials have demonstrated that paclitaxel-eluting balloon angioplasty reduces late luminal loss in comparison with PTA.METHOD:
In a prospective, randomized, single-blind, dual-center study, 74 patients with symptomatic peripheral artery disease due to in-stent restenosis were treated with either paclitaxel-based drug-eluting balloon (DEB) angioplasty (n = 35) or standard PTA (n = 39). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.RESULTS:
The mean lesion length was 17.3 ± 11.3 cm in the DEB group and 18.4 ± 8.8 cm in the PTA group. A single major complication (bleeding) was observed once (1.4%). The mean ankle-brachial index before endovascular treatment was 0.65 ± 0.16 in both groups and 0.79 ± 0.2 versus 0.84 ± 0.3 (p = 0.70, Student t test) in the DEB versus PTA group at 12 months. The 12-month primary patency rates were 40.7% (95% confidence interval [CI] 0.26 to 0.64) versus 13.4% (95% CI 0.05 to 0.36) (log-rank p = 0.02) in the DEB versus PTA group. The odds ratio for PTA over DEB angioplasty for experiencing an event was estimated at 2.8 (95% CI 1.2 to 6.6). Freedom from clinically driven target lesion revascularization was 49.0% (95% CI 0.32 to 0.75) versus 22.1% (95% CI 0.10 to 0.48) (log-rank p = 0.11) in the DEB versus PTA group. Clinical improvement by ≥1 Rutherford-Becker category was 68.8% versus 54.5% (p = 0.87) in the DEB versus PTA group at 12 months.CONCLUSIONS:
When treating peripheral artery disease in patients with in-stent restenosis in the femoropopliteal artery, paclitaxel-eluting balloon angioplasty provides significantly higher patency rates than standard PTA. (Paclitaxel Balloon Versus Standard Balloon in In-Stent Restenoses of the Superficial Femoral Artery [PACUBA I Trial] [PACUBA 1]; NCT01247402).Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Arteria Poplítea
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Fármacos Cardiovasculares
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Stents
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Paclitaxel
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Angioplastia de Balón
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Materiales Biocompatibles Revestidos
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Arteria Femoral
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Enfermedad Arterial Periférica
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Dispositivos de Acceso Vascular
Tipo de estudio:
Clinical_trials
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Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Aged
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Female
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Humans
/
Male
/
Middle aged
País/Región como asunto:
Europa
Idioma:
En
Revista:
JACC Cardiovasc Interv
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2016
Tipo del documento:
Article
País de afiliación:
Austria