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Tratamientos endovasculares para la enfermedad arterial de los miembros inferiores / Endovascular therapies for lower limb arterial disease
Buenos Aires; IECS; oct. 2014.
Non-conventional in Spanish | BRISA/RedTESA, BRISA/RedTESA | ID: biblio-996758
Responsible library: BR1.1
RESUMEN

INTRODUCCIÓN:

La arteriopatía periférica (AP) dificulta el flujo sanguíneo arterial dirigido a las extremidades. La prevalencia oscila en un 4,6% entre los 49 a 59 años y un 14,7% en los mayores de 70 años y es más frecuente en varones. El objetivo del tratamiento es asegurar una óptima perfusión distal para calmar el dolor y ayudar a la curación de las lesiones tróficas. Éste se basa en la modificación de los factores de riesgo, asociado al uso de vasodilatores (pentoxifilina, cilostazol) para evitar o disminuir la claudicación intermitente, y de antiagregantes (aspirina, clopidogrel) para prevenir el riesgo de complicaciones trombóticas. La presencia de isquemia crítica implica la necesidad de tratamiento de revascularización por el elevado riesgo de pérdida de la extremidad. Su incidencia se calcula en 400 individuos por millón de habitantes al año. Las técnicas para revascularizar el miembro afectado son la cirugía de derivación femoro-distal -que es técnicamente compleja y se asocia con una mortalidad perioperatoria de entre el 1,8 y el 6%- y la angioplastia transluminal percutánea (ATP) con balón con altas tasas de re-estenosis arterial, entre un 40 a 70 % al año. Por estos motivos se han desarrollado la ATP con stent (con o sin drogas antiproliferativas) y la ATP con balón liberador de drogas, con el objeto de disminuir las tasas de re estenosis arterial y de re intervenciones. TECNOLOGÍA La ATP se realiza a través de una punción de la arteria femoral por donde se introduce un catéter que tiene en la punta un balón que se lleva hasta la arteria afectada para dilatar el segmento ocluido. Mediante este procedimiento se pueden utilizar otras estrategias como la utilización de un balón liberador de drogas (BLD) en lugar de uno convencional, o la colocación de un stent metálico, un stent liberador de drogas (SLD) o un stent autoexpandible. Tanto los BLD como los SLD suelen contener paclitaxel o sirolimus, drogas que al liberarse lentamente tienen el objetivo de inhibir la proliferación y migración de las células musculares lisas y la formación de matriz extracelular.

OBJETIVO:

Evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de tratamientos endovasculares (angioplastia transluminal percutánea con balón liberador de drogas, con stent metálico o con stent liberador de drogas) para el tratamiento de la enfermedad vascular periférica.

MÉTODOS:

Se realizó una búsqueda en las principales bases de datos bibliográficas (incluyendo Medline, Cochrane y CRD), en buscadores genéricos de Internet, agencias de evaluación de tecnologías sanitarias y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas, ensayos clínicos controlados aleatorizados (ECA), evaluaciones de tecnologías sanitarias y económicas, guías de práctica clínica y políticas de cobertura de otros sistemas de salud cuando estaban disponibles.

RESULTADOS:

No se encontraron estudios que comparen los tratamientos endovasculares evaluados con la cirugía de by-pass. Se incluyeron dos RS que comparaban los tratamientos endovasculares evaluados con ATP con balón, un ensayo clínico no incluido en las revisiones sistemáticas para BLD, nueve guías de práctica clínica, siete políticas de coberturas y tres estudios de costos.
ABSTRACT

INTRODUCTION:

Peripheral artery disease (PAD) makes arterial blood flow towards the extremities difficult. Its prevalence is approximately 4.6% at 49-59 years old and approximately 14.7% over 70 years old, being more common in males. The treatment is aimed at ensuring optimal distal perfusion in order to relieve pain and help cure trophic lesions. This is based on risk factor modification, associated to the use of vasodilators (pentoxiphilin, cilostazole) to prevent or decrease intermittent claudication and of anti-platelet agents (aspirin, clopidogrel) to prevent the risk of thrombotic complications. The presence of critical ischemia results in the need for revascularization therapy due to the high risk of losing the limb. It is calculated that its incidence is 400 individuals every million inhabitants per year. The techniques used to revascularize the extremity involved include femorodistal bypass surgery -which is technically complex and is associated to a 1.8-6% perioperative mortality- and balloon percutaneous transluminal angioplasty (PTA) with high rates of arterial restenosis, which is 40 to 70% per year. This is why, stent PTA (with or without anti-proliferative drugs) and PTA with drug-eluting balloon have been developed to decrease the rates of arterial restenosis and reinterventions. TECHNOLOGY PTA is carried out through a femoral artery puncture through which a catheter with a balloon in its end is introduced and advanced to the involved artery, to dilate the occluded segment. With this procedure, other strategies may be used such as using a drug-eluting balloon (DEB) rather than a conventional one or placing a metal stent, a drug-eluting stent (DES) or a self-expanding stent. Both DEB and DES usually contain paclitaxel or sirolimus; these are drugs which, when slowly released, are aimed at inhibiting smooth cell proliferation and migration and extracellular matrix buildup.

PURPOSE:

To assess the available evidence on the efficacy, safety and coverage policy related aspects on the use of endovascular therapies (percutaneous transluminal angioplasty) with drug-eluting balloon, with metal stent or drug-eluting stent) for the treatment of peripheral vascular disease.

Methods:

A bibliographic search was carried out on the main databases (such as MEDLINE, Cochrane and CRD), in general Internet engines, in health technology assessment agencies and health sponsors. Priority was given to including systematic reviews; controlled randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems, when available.

RESULTS:

No studies comparing the endovascular therapies assessed versus bypass surgery have been found. Two SRs comparing the assessed endovascular therapies with PTA with balloon, one clinical trial not included in the systematic reviews for DEB, nine clinical practice guidelines, six coverage policies and three cost studies have been included.

CONCLUSIONS:

No evidence allowing to determine if endovascular therapies (angioplasty with different types of stent and DEB angioplasty) are more effective than bypass surgery has been found. As regards comparing these therapies against conventional balloon percutaneous angioplasty, the quality of the evidence found is high. For the treatment of femoropopliteal artery disease, angioplasty with drug-eluting or conventional stent and drug-eluting balloons might reduce the rates of restenosis when compared with conventional percutaneous angioplasty with balloon. Additionally, angioplasty with DEB would decrease the need for new revascularization of the treated vessel. No benefits were shown in mortality in any of the therapies assessed. The CPGs recommend that choosing the right revascularization technique will depend on the patient's comorbidity and the risk-benefit ratio of bypass vs. endovascular therapies and the type of vascular lesion. They suggest the use of stent angioplasties in surface femoral artery lesions when balloon dilatation fails, not specifying the type of stent to be used. No recommendations on drug-eluting balloons have been found.
Subject(s)
Full text: Available Collection: Tematic databases Health context: 6_ODS3_enfermedades_notrasmisibles Health subject: 6_cardiovascular_diseases Database: BRISA/RedTESA Main topic: Peripheral Vascular Diseases / Angioplasty / Endovascular Procedures Type of study: Controlled clinical trial / Evaluation study / Practice guideline / Health technology assessment / Risk factors Demographic groups: Humans Language: Spanish Year: 2014 Document type: Non-conventional

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Full text: Available Collection: Tematic databases Health context: 6_ODS3_enfermedades_notrasmisibles Health subject: 6_cardiovascular_diseases Database: BRISA/RedTESA Main topic: Peripheral Vascular Diseases / Angioplasty / Endovascular Procedures Type of study: Controlled clinical trial / Evaluation study / Practice guideline / Health technology assessment / Risk factors Demographic groups: Humans Language: Spanish Year: 2014 Document type: Non-conventional