Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

Abstract

Sirolimus-coated balloons (SCB) have demonstrated much promise as an alternative drug eluting device to the existing paclitaxel coated balloon platforms for the treatment of peripheral arterial disease (PAD). They have been well tested pre-clinically and have demonstrated anti-restenotic effects as well as clinical safety in its use for treatment of coronary artery disease. The existing approved SCBs have thus far demonstrated good short-term patency (12-months) and did not exhibit any major adverse events or device related shortcomings in its use for treatment of PAD. There are several studies ongoing which aim to further investigate the efficacy of existing SCBs and establish a direct comparison of its outcomes compared with plain balloon angioplasty. Also, SCB utility to salvage failing arteriovenous fistulas for haemodialysis patients has also been explored. We review the current progress made in the establishment of SCB in the treatment of PAD as well as highlight ongoing studies investigating the role of SCB in various settings.

Vascular Inflammatory Markers as Predictors of Peripheral Arterial Disease Patients’ Quality-of-Life Changes after Endovascular Treatment

“…In this study, we tried to limit factors influencing inflammation and eicosanoid concentrations and bias the results. Sirolimus, which is one of the substances used in drug-eluting stents (DES) and drug-coated balloons (DCB), has strong anti-inflammatory properties [45]. The use of drug-coated devices also requires prolonged dual antiplatelet therapy influencing the endovascular treatment outcomes significantly but also reducing vascular inflammation [46,47].…”

Tratamiento de las lesiones oclusivas tibiales complejas mediante balón liberador de sirólimus

“…Esta intervención ha sido tradicionalmente llevada a cabo mediante cirugía abierta a través de bypass. Sin embargo, el desarrollo de novedosas técnicas de PTA ha representado un avance importante en considerar el tratamiento endovascular como primera línea de abordaje terapéutico en la revascularización de miembros inferiores 22 .…”

“…El concepto de balón cubierto de fármaco (DCB -"drug coated balloons" por sus siglas en inglés) fue introducido para mitigar los efectos de NIH a través del uso de agentes antiproliferativos como el paclitaxel. Los balones recubiertos de paclitaxel (PCB -"paclitaxel coated balloons", por sus siglas en inglés), tratan de evitar la aparición de hiperplasia de la íntima gracias al efecto citotóxico que produce el fármaco, retrasando la reestenosis e incrementando la permeabilidad luminal 22 . Los PCBs han mostrado mejores resultados clínicos, en términos de tasa de permeabilidad y pérdida del lumen del vaso al compararlos con los balones convencionales.…”

“…Sin embargo, la mayoría de estudios clínicos realizados con el sirolimus, tanto en stents como en balones, han sido realizados a nivel coronario mostrando su potencial anti-reestenótico 22 . El uso de este medicamento en regiones periféricas se enfrenta con una de sus principales desventajas y es su problema de biodisponibilidad.…”

Photochemically Aided Arteriovenous Fistula Creation to Accelerate Fistula Maturation

“…Specifically, expansive remodeling requires reorganization of the matrix accompanied by SMC detachment, migration, and proliferation, while the mitigation of occlusive hyperplasia requires inhibition of the SMC migration and proliferative response as well as control of ECM synthesis and deposition [6,7]. Although paclitaxel-or sirolimus-coated balloons have demonstrated efficacy in salvaging failed AVFs, conventional anti-proliferative therapies currently in clinical use for other vascular pathologies are not suitable to meet these unique demands [8].…”