BALONES

FÁRMACOACTIVOS

Mecanismo de acción

Evidencia científica

Dra. Lucía Martínez Carnovale

Unidad Funcional del Acceso Vascular (FUVA)

Hospital de Terrassa, CST. Barcelona

INTRODUCCIÓN

Las fístulas arteriovenosas son los accesos vasculares de

elección

Una de la principal causa de disfunción son las estenosis

NUEVA GUÍA ESPAÑOLA

ANGIOPLASTIA SIMPLE

Menos invasiva

Menor morbilidad

No requiere colocación de un CVC

PRINCIPAL DESVENTAJA

Alta tasa de re-estenosis lo que condiciona la necesidad de realizar de

forma periódica procedimientos intervencionistas adicionales para

mantener la permeabilidad del acceso

SE PUEDEN MEJORAR LOS

RESULTADOS DE LA PTA SIMPLE?

BALONES

FÁRMACO-ACTIVOS

Son balones de angioplastia recubiertos de paclitaxel

Sus resultados han demostrado ser superiors en lesiones arteriales

coronarias y fémoro-popliteas

Diferencias histológicas entre

venas y arterias

Diferencias en el patrón de flujo sanguineo

Incremento en el índice de proliferación

en las re-estenosis

CONSIDERACIONES EN FAV

PACLITAXEL

Agente citotóxico y antiproliferativo que estabiliza los microtúbulos

durante la metafase de la mitosis celular

Presenta liberación rápida y retención prolongada

Muy hidrofílico por lo que penetra rapidamente por las membranas

celulares

BALONES EN EL MERCADO

Existe una variedad de balones DEB de 0.035-, 0.018-, y 0,014 pulgadas

para el tratamiento de la enfermedad arterial periférica y la angioplastia

coronaria

MECANISMO DE ACCIÓN

Después de la pre-dilatación de la estenosis el balón farmacoactivo se centra a través

de toda la zona tratada

Se recomienda inflado durante 2,2-minutos transfiere una dosis terapéutica óptima de

la droga a la superficie endoluminal

El Paclitaxel difunde en la pared del vaso

Se mantiene 30 días después del tratamiento para inhibir la re-estenosis en la pared

del vaso al tiempo que permite que el lumen se restaurare y re-endotelice

Evidencia de picos de efectos farmacológicos a los 90 días

EVIDENCIA CIENTÍFICA

At 6 months, cumulative target lesion primary

patency 70% in PCB group vs. 25% in BA group,

p,0.001; HR 0.30, 95% CI 0.12 to 0.71, p,0.006.

ENSAYOS CLÍNICOS EN

CURSO CLINICALTRIALS.GOV

Trial

Name

DCB n= Primary Outcome

Proportion of patients with primary patency of AVF at 6

months

Double-blind comparison of the proportion of primary

patency at 6 months after treatment of stenosis of AVF by

conventional angioplasty + additional angioplasty. Primary

patency is defined as absence of reintervention for stenosis

at initial angioplasty site.

Adequate functioning of the hemodialysis access at 6

months.

Period of adequate functioning of the hemodialysis access

after treatment, defined according to the NKF-DOQI

protocol criteria

DEB after

CB

ELUTAX®

DCB

40 Time to worsening of dialysis fistula function at one year 

Late luminal loss at 6 months 

Late luminal loss is defined as the difference between the

minimum lumen diameters after angioplasty and at the end

of the 6-month follow-up angiogram.

DEBAPTA IN.PACT®

DCB

125

ABISS* LUTONIX®

DCB

Catheter

150

APERTO APERTO®

DCB

150

DEBAVAS ADVANCE

® 18 PTX

120 Primary patency of the vascular access after endovascular

angioplasty of a stenosis with drug-eluting balloon

compared with treatment with plain-balloon

[ Time Frame: at 12 months ]

DEBEFF* LUTONIX®

DCB

Catheter

70 Primary patency at 6 months  Patency of AVF without any

additional procedures. Patency is defined as supporting HD

with a pump speed of at least 300ml/min.

Restenosis rate at 6 months

Incidence of >50% stenosis at the treatment site

Freedom from target lesion revascularizationat 12 months.

Percentage of patients that do not need any

revascularization proceeding during the following twelve

months after catheter insertion.

Primary Patency: 6 months.  Patency is defined as the

interval following index procedure intervention until

clinically driven reintervention of the target lesion or access

thrombosis.

Safety: Freedom from any serious adverse event(s)

involving the AV access circuit

•    Proportion of subjects with freedom from any

serious adverse event(s) involving the AV access

circuit Time Frame: 30 days. 

Proportion of subjects with target lesion primary patency

at 6 Months. Defined as the interval following index

procedure until clinically-driven reintervention of the target

lesion or access thrombosis, through 6 months. Clinically-

driven reintervention is defined as a lesion that has ≥50%

stenosis and at least one clinical, physiological or

hemodynamic abnormality attributable to the stenosis

defined in the K/DOQI guidelines.

Time to end of target lesion primary patency* is

determined through AVF imaging when patient is referred

for a re-intervention, at any point during follow-up (1-3

years).

*Primary patency fails when any of the following occur:

1. Clinically driven re-intervention to the treatment

segment

2. Thrombotic occlusion that includes the treatment

segment

3. Surgical intervention that excludes the treatment

segment from the access circuit

4. Abandonment of the AVF due to an inability to retreat

the treatment segment

DEB

Cephalic

LEGFLOW

® DCB

50

FISBAL Unknown

Brand

134

PAVE* LUTONIX®

DCB

Catheter

211

LUTONIX

AV IDE

LUTONIX®

DCB

Catheter

285

LUTONIX

AV

Registry

LUTONIX®

DCB

Catheter

300

•    Proportion of subjects with freedom from any

serious adverse event(s) involving the AV access

circuit Time Frame: 30 days. 

Proportion of subjects with target lesion primary patency

at 6 Months. Defined as the interval following index

procedure until clinically-driven reintervention of the target

lesion or access thrombosis, through 6 months. Clinically-

driven reintervention is defined as a lesion that has ≥50%

stenosis and at least one clinical, physiological or

hemodynamic abnormality attributable to the stenosis

defined in the K/DOQI guidelines.

Time to end of target lesion primary patency* is

determined through AVF imaging when patient is referred

for a re-intervention, at any point during follow-up (1-3

years).

*Primary patency fails when any of the following occur:

1. Clinically driven re-intervention to the treatment

segment

2. Thrombotic occlusion that includes the treatment

segment

3. Surgical intervention that excludes the treatment

segment from the access circuit

4. Abandonment of the AVF due to an inability to retreat

the treatment segment

PAVE* LUTONIX®

DCB

Catheter

211

LUTONIX

AV

Registry

LUTONIX®

DCB

Catheter

300

CONSIDERACIONES FINALES

El uso de DEB en la angioplastia de estenosis de AV es segura y

efectiva

Ofrece intervalos superiores libres de intervención comparados

con los balones tradicionales

Reduce las restenosis sin complicaciones derivadas de los

dispositivos

Es necesario determinar las lesiones candidatas a este tratamiento

La evidencia científica en este campo es limitada

GRACIAS POR VUESTRA ATENCIÓN!!!