Paclitaxel coated balloons, the time for awareness has come

Cortese, Bernardo; Sgueglia, Gregory A.; Granada, Juan F.

doi:10.1016/j.ijcard.2012.05.037

Cited by 9 publications

(3 citation statements)

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“…Since the publication of the first trial in man, we observed a progressive rush of either companies or investigators to reach fast diffusion of this technology. Actually, this interest brought to considerable confusion and technological and strategic mistakes by the different actors . However, interventional cardiologists involved in this field have learned a lot from some of these errors.…”

Section: Introductionmentioning

confidence: 99%

Drug‐coated balloon treatment of coronary artery disease: A position paper of the Italian Society of Interventional Cardiology

Cortese¹,

Berti

Biondi‐Zoccai

et al. 2013

Cathet Cardio Intervent

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Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

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Section: Introductionmentioning

confidence: 99%

Drug‐coated balloon treatment of coronary artery disease: A position paper of the Italian Society of Interventional Cardiology

Cortese¹,

Berti

Biondi‐Zoccai

et al. 2013

Cathet Cardio Intervent

Self Cite

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“…Even though a number of different devices are available in different countries, with at least ten CE-marked DCB in Europe, the clinical applicability of the technology is not yet fully understood [6]. While a fairly large number of reported clinical studies including different types of lesions, patients, and locations has not been able to resolve the existing uncertainties [6], hardly any literature on in vitro characterization of these devices has been published.…”

Section: Introductionmentioning

confidence: 99%

“…While a fairly large number of reported clinical studies including different types of lesions, patients, and locations has not been able to resolve the existing uncertainties [6], hardly any literature on in vitro characterization of these devices has been published. In comparison to some traditional dosage forms, the examination of drug release into stirred media will not answer the questions associated with this type of delivery, since only drug transferred to the vessel wall will be able to impart the desired effect, while drug released into the blood will be cleared from the site.…”

Section: Introductionmentioning

confidence: 99%

In Vitro Determination of Drug Transfer from Drug-Coated Balloons

et al. 2013

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Drug-coated balloons are medical devices designed to locally deliver drug to diseased segments of the vessel wall. For these dosage forms, drug transfer to the vessel wall needs to be examined in detail, since drug released into the blood is cleared from the site. In order to examine drug transfer, a new in vitro setup was developed combining the estimation of drug loss during advancement to the site of application in a model coronary artery pathway with a hydrogel compartment representing, as a very simplified model, the vessel wall. The transfer of fluorescent model substances as well as the drug paclitaxel from coated balloons to the simulated vessel wall was evaluated using this method. The model was suitable to quantify the fractions transferred to the hydrogel and also to qualitatively assess distribution patterns in the hydrogel film. In the case of fluorescein sodium, rhodamin b and paclitaxel, vast amounts of the coated substance were lost during the simulated passage and only very small fractions of about 1% of the total load were transferred to the gel. This must be attributed to good water solubility of the fluorescent substances and the mechanical instability of the paclitaxel coating. Transfer of the hydrophobic model substance triamterene was however nearly unaffected by the preliminary tracking procedure with transferred fractions ranging from 8% to 14%. Analysis of model substance distribution yielded inhomogeneous distributions indicating that the coating was not evenly distributed on the balloon surface and that a great fraction of the coating liquid did not penetrate the folds of the balloon. This finding is contradictory to the generally accepted assumption of a drug depot inside the folds and emphasizes the necessity to thoroughly characterize in vitro performance of drug-coated balloons to support the very promising clinical data.

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