Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease (Registro nro. 22814)

000 -Cabecera
Campo de control interno 03247nam a2200277 4500
001 - Número de control
control field ESSALUD
007 - Tipo material - Descripcion fisica - info general
Tipo material - Descripcion fisica - info general ta
008 - Elementos de Longitud Fija - Información General
Elementos de Longitud Fija - Información t pe ||||| |||| 00| 0 spa d
040 ## - Origen de la Catalogación
Origen de la Catalogación BMG
041 ## - Idioma
Idioma eng
100 ## - Autor
Autor Barco, Stefano
Rol del Autor Autor
9 (RLIN) 54060
245 ## - Titulo
Titulo Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease
300 ## - Páginas
Paginación páginas: 561-570
520 ## - Resumen
Resumen Background: Whether sirolimus-coated balloon angioplasty for infrainguinal artery disease reduces the incidence of major adverse limb events remains unknown. Methods: In this prospective, open-label, noninferiority trial with a prespecified sequential testing strategy for superiority and blinded outcome adjudication, we randomly assigned patients with infrainguinal artery disease in a 1:1 ratio to undergo angioplasty with a sirolimus-coated balloon or with an uncoated balloon. The primary outcome was a composite of unplanned major amputation affecting the target limb or endovascular or surgical revascularization of the target lesion for critical limb ischemia within 1 year after randomization. The key secondary outcome was a composite of any unplanned amputation affecting the target limb or revascularization of the target lesion for critical or noncritical limb ischemia within 1 year after randomization. The noninferiority margin was 5 percentage points. The primary safety outcome was death from any cause within 1 year after randomization. Results: A total of 1252 patients were enrolled in the trial: 626 patients were assigned to the sirolimus-coated–balloon group and 626 to the uncoated-balloon group. The median age of the patients was 75 years, and 35.1% were women. A primary-outcome event occurred in 55 patients (8.8%) in the sirolimus-coated–balloon group and in 94 patients (15.0%) in the uncoated-balloon group (median unbiased estimate of risk difference, −4.9 percentage points; 95% confidence interval [CI], −8.5 to −1.3; P<0.001 for noninferiority; P=0.009 for superiority); a key secondary-outcome event occurred in 144 patients (23.0%) and 193 patients (30.8%), respectively (risk difference, −7.8 percentage points; 95% CI, −12.7 to −2.9; P=0.002). Death occurred in 74 patients (11.8%) in the sirolimus-coated–balloon group and in 80 patients (12.8%) in the uncoated-balloon group (risk difference, −1.0 percentage points; 95% CI, −4.6 to 2.7; P=0.67). The incidence of adverse events appeared to be similar in the two groups. Conclusions: Among patients with infrainguinal artery disease undergoing endovascular treatment, angioplasty with sirolimus-coated balloons led to a lower incidence of major adverse limb events at 1 year than angioplasty with uncoated balloons.
650 ## - Temas - Descriptores
Temas - Descriptores CARDIOLOGÍA
9 (RLIN) 11301
650 ## - Temas - Descriptores
Temas - Descriptores ENFERMEDAD ARTERIAL PERIFÉRICA AORTICA
9 (RLIN) 54061
650 ## - Temas - Descriptores
Temas - Descriptores ANGIOPLASTIA
9 (RLIN) 37212
700 ## - Autor Personal
Autor Personal Engelberger, Rolf P.
9 (RLIN) 54062
700 ## - Autor Personal
Autor Personal Held, Ulrike
9 (RLIN) 54063
700 ## - Autor Personal
Autor Personal Fumagalli, Riccardo M.
9 (RLIN) 54064
700 ## - Autor Personal
Autor Personal Grigorean, Alexandru
9 (RLIN) 54065
700 ## - Autor Personal
Autor Personal Hayoz, Daniel
9 (RLIN) 54066
700 ## - Autor Personal
Autor Personal Münger, Mario
9 (RLIN) 54067
773 0# - Revista (Relacion con el numero)
Host Biblionumber 22717
Host Itemnumber 22644
Ciudad, Editorial Massachusetts NEJM Group
Codigo barras item/ejemplar NEJM009
Titulo de la Revista The New England Journal of Medicine
Número de control de registro ESSALUD
ISSN 0028-4793
942 ## - Elementos de Koha
Tipo de Documento Artículos
Fecha procesamiento 2026-08-14
Catalogador SQB

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