Abstract
Drug-coated balloons (DCB) represent a novel clinical treatment modality for coronary and peripheral artery disease. Advantages over standard angioplasty and stent technologies including homogeneous drug delivery to the vessel wall, immediate drug release without the use of a polymer, the option of using balloon catheters alone or in combination with a bare metal stent, no foreign object that remains in the body, the potential of reducing antiplatelet therapy, and lower restenosis rates in some indications. As with drug-eluting stents (DES), one cannot assume a class effect for DCB. So far, data from randomized clinical trials identify the treatment of coronary in-stent restenosis (ISR) and of de novo and restenotic lesions in peripheral artery disease as viable options. Furthermore, treatment of de novo lesions in small coronary vessels, bifurcation lesions, long lesions, pediatric interventions, and cerebrovascular applications are potential beneficial indications. In the coronary application, a strategy of DCB angioplasty with provisional spot-stenting in the case of severe dissections may become a better alternative in long and complex lesions, bifurcations, or in patients with contraindications for DES.
Zusammenfassung
Mit Medikamenten beschichtete Ballonkatheter („drug-coated balloons“, DCB) sind eine neue Behandlungsmöglichkeit in der interventionellen Kardiologie und Angiologie. Dabei wird die Ballonoberfläche mit einem wachstumshemmenden Medikament beschichtet, das am Ort der Gefäßverengung anders als bei Medikamente freisetzenden Stents („drug-eluting stents“, DES) sofort freigesetzt wird. Ein Polymer ist für die Freisetzungsmodulation nicht nötig, allerdings spielen Zusatzstoffe eine wesentliche Rolle. Im Gegensatz zur Stent-Therapie bleibt nach dem Eingriff kein Fremdkörper zurück. In Deutschland sind derzeit 5 DCB für die koronare Indikation sowie 3 DCB für periphere Gefäße zugelassen und verfügbar. Alle DCB sind mit Paclitaxel beschichtet. Unterschiede bestehen bei den Zusatzstoffen und dem Beschichtungsverfahren. Analog zu den DES besteht auch für DCB kein Klasseneffekt. DCB erscheinen in Koronararterien v. a. für Situationen geeignet, in denen eine Stent-Einlage ungünstig erscheint. Publiziert sind bislang 3 randomisierte klinische Studien zur Therapie der In-Stent-Stenose nach BMS-Implantation, die zu einer Klasse-IIa-Empfehlung in den aktuellen ESC-Leitlinien zur Revaskularisation für die in den Studien geprüften DCB geführt haben. Weitere mögliche Indikationen sind die Therapie der DES-Restenose, De-novo Läsionen in kleinen Koronargefäßen und Bifurkationsläsionen; hier stehen die Wirknachweise in randomisierten klinischen Studien allerdings noch aus. Der Einsatz kurzer Stents für Dissektionen und DCB für das gesamte erkrankte Areal könnte möglicherweise Vorteile gegenüber einer vollständigen Stent-Versorgung („full metal jacket“) sehr langer Koronarläsionen haben. Weiterhin fand sich für DCB in randomisierten klinischen Studien ein Wirknachweis für Stenosen und Verschlüsse im Oberschenkelbereich. Darüber hinaus gibt es erste positive Erfahrungen mit DCB bei langen Läsionen und Verschlüssen im Unterschenkel, in der Neuroradiologie und in der Kinderkardiologie. Die Möglichkeiten und Grenzen von DCB müssen zukünftig in randomisierten klinischen Studien zu unterschiedlichen Indikationen, aber auch für die unterschiedlichen DCB-Konzepte weiter untersucht werden.
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Conflict of interest
The corresponding author reports receiving speaker honoraria from B. Braun and Invatec Medtronic; in addition, he is a shareholder in InnoRa GmbH, Berlin, and is named as a co-inventor on a patent application submitted by Charité University Hospital (Berlin, Germany).
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Scheller, B. Opportunities and limitations of drug-coated balloons in interventional therapies. Herz 36, 232–240 (2011). https://doi.org/10.1007/s00059-011-3462-3
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DOI: https://doi.org/10.1007/s00059-011-3462-3