Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial
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Otros documentos de la autoría: Moreno-Sánchez, T.; Moreno-Ramírez, M.; Machancoses, Francisco H.; Pardo-Moreno, P.; Navarro-Vergara, P. F.; García-Revillo, J.
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https://doi.org/10.1007/s00270-019-02372-w |
Metadatos
Título
Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized TrialAutoría
Fecha de publicación
2020Editor
Springer VerlagISSN
0174-1551; 1432-086XCita bibliográfica
Moreno-Sánchez, T., Moreno-Ramírez, M., Machancoses, F.H. et al. Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial. Cardiovasc Intervent Radiol 43, 382–390 (2020). https://doi.org/10.1007/s00270-019-02372-wTipo de documento
info:eu-repo/semantics/articleVersión de la editorial
https://link.springer.com/article/10.1007/s00270-019-02372-wVersión
info:eu-repo/semantics/publishedVersionPalabras clave / Materias
Resumen
Purpose:
A controlled, prospective, multicenter, randomized trial to compare primary patency after angioplasty with a drug-coated balloon versus plain angioplasty balloon in stenosis of dysfunctional fistulae and ... [+]
Purpose:
A controlled, prospective, multicenter, randomized trial to compare primary patency after angioplasty with a drug-coated balloon versus plain angioplasty balloon in stenosis of dysfunctional fistulae and grafts for hemodialysis.
Materials and Methods:
A total of 136 patients (148 angioplasties) at four centers were randomized to receive a drug-coated balloon or plain angioplasty balloon after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival.
Results:
Primary patency after angioplasty was higher in the group treated with the drug-coated balloon than the plain angioplasty balloon (153.01 to 141.69 days at 6 months; 265.78 to 237.83 days at 12 months). Drug-coated balloon angioplasty resulted in superior patency after 6 and 12 months, but this result was not statically significant (P = 0.068 at 6 months; P = 0.369 at 12 months). There was no relation between target lesion patency and the other variables studied. Overall mortality in the plain angioplasty balloon group was higher (9% vs. 5.7%) but not statistically significant.
Conclusions:
Drug-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 6 and 12 months, but this result was not statistically significant. Both arms show equivalent complications and similar mortality. [-]
Publicado en
CardioVascular and Interventional Radiology, 2020, vol. 43, no 3Proyecto de investigación
Biotronik SE & Co. KG, Berlin, Germany: Grant Number “Ref.2015 CEM BIOTRONIK S.A./FABIS 01Derechos de acceso
© Springer Nature
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