Drug-Coated Balloons for the Dysfunctional Vascular Access: An Evidence-Based Road Map to Treatment and the Existing Obstacles

Kitrou, Panagiotis; Κατσάνος, Κωνσταντίνος; Georgopoulou, Georgia; Karnabatidis, Dimitrios

doi:10.1055/s-0042-1742483

Cited by 11 publications

(2 citation statements)

References 58 publications

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“…As mentioned earlier, DCBs should be considered an adjunct to successful POBA with the goal of preventing restenosis, not treating the lesion or replacing POBA. Until a lesion has successfully undergone high-quality plain balloon angioplasty, as discussed in part 1 of this review, a DCB should not be considered ( 72 ).…”

Section: Dcb Procedural Considerationsmentioning

confidence: 99%

Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance

DePietro¹,

Trerotola²

2023

Cardiovasc Diagn Ther

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Background and Objective: Drug-coated balloons (DCBs) seek to inhibit restenosis in treated hemodialysis access lesions by delivering an anti-proliferative agent (paclitaxel) into the vessel wall. While DCBs have proven effective in the coronary and peripheral arterial vasculature, the evidence for their use in arteriovenous (AV) access has been less robust. In part two of this review, a comprehensive overview of DCB mechanisms, implementation, and design is provided, followed by an examination of the evidence basis for their use in AV access stenosis.Methods: An electronic search was performed on PubMed and EMBASE to identify relevant randomized controlled trials (RCTs) comparing DCBs and plain balloon angioplasty from January 1, 2010 to June 30, 2022 published in English. As part of this narrative review, a review of DCB mechanisms of action, implementation, and design is provided, followed by a review of available RCTs and other studies.Key Content and Findings: Numerous DCBs have been developed, each with unique properties, although the degree to which these differences impact clinical outcomes is unclear. Target lesion preparation, achieved by pre-dilation, and balloon inflation time have proven important factors in achieving optimal DCB treatment. Numerous RCTs have been performed, but have suffered from significant heterogeneity, and have often reported contrasting clinical results, making it difficult to draw conclusions on how to implement DCBs in daily practice. On the whole, it is likely there is a population of patients who benefit from DCB use, but it is unclear which patients benefit most and what device, technical, and procedural factors lead to optimal outcomes. Importantly, DCBs use appears safe in the end-stage renal disease (ESRD) population.Conclusions: DCB implementation has been tempered by the lack of clear signal regarding the benefits of DCB use. As further evidence is obtained, it is possible that a precision-based approach to DCBs may shed light onto which patients will truly benefit from DCBs. Until that time, the evidence reviewed herein may serve to guide interventionalists in their decision making, knowing that DCBs appear safe when used in AV access and may provide some benefit in certain patients.

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Section: Dcb Procedural Considerationsmentioning

confidence: 99%

Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance

DePietro¹,

Trerotola²

2023

Cardiovasc Diagn Ther

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“…Given that PTX delivery is a primary function of DCBs, hydrophilic excipients have gained favor among device manufacturers despite the wash-off potential, with the remaining design imperative to increase drug delivery efficiency within this device subclass. ,− In the present study, we seek to elucidate if the PTX delivery efficiency from DCBs formed with two leading hydrophilic excipients can be quantitatively related to the coating microstructure. Our focus on PTX transfer efficiency, as opposed to the total amount delivered, is in line with the notion that a higher fractional payload delivery will enable effective devices with a lower initial dosing, thus mitigating the risk of local tissue toxicity and off-target drug effects.…”

Section: Introductionmentioning

confidence: 99%

Hydrophilic Coating Microstructure Mediates Acute Drug Transfer in Drug-Coated Balloon Therapy

Shazly,

Eberth,

Kostelnik

et al. 2024

ACS Appl. Bio Mater.

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Drug-coated balloon (DCB) therapy is a promising endovascular treatment for obstructive arterial disease. The goal of DCB therapy is restoration of lumen patency in a stenotic vessel, whereby balloon deployment both mechanically compresses the offending lesion and locally delivers an antiproliferative drug, most commonly paclitaxel (PTX) or derivative compounds, to the arterial wall. Favorable long-term outcomes of DCB therapy thus require predictable and adequate PTX delivery, a process facilitated by coating excipients that promotes rapid drug transfer during the inflation period. While a variety of excipients have been considered in DCB design, there is a lack of understanding about the coating-specific biophysical determinants of essential device function, namely, acute drug transfer. We consider two hydrophilic excipients for PTX delivery, urea (UR) and poly(ethylene glycol) (PEG), and examine how compositional and preparational variables in the balloon surface spray-coating process impact resultant coating microstructure and in turn acute PTX transfer to the arterial wall. Specifically, we use scanning electron image analyses to quantify how coating microstructure is altered by excipient solid content and balloon-to-nozzle spray distance during the coating procedure and correlate obtained microstructural descriptors of coating aggregation to the efficiency of acute PTX transfer in a one-dimensional ex vivo model of DCB deployment. Experimental results suggest that despite the qualitatively different coating surface microstructures and apparent PTX transfer mechanisms exhibited with these excipients, the drug delivery efficiency is generally enhanced by coating aggregation on the balloon surface. We illustrate this microstructure−function relation with a finite element-based computational model of DCB deployment, which along with our experimental findings suggests a general design principle to increase drug delivery efficiency across a broad range of DCB designs.

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The Clotted Access

Almehmi,

Al-Balas

2024

Principles of Dialysis Access

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Drug-Coated Balloons for the Dysfunctional Vascular Access: An Evidence-Based Road Map to Treatment and the Existing Obstacles

Cited by 11 publications

References 58 publications

Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance

Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance

Hydrophilic Coating Microstructure Mediates Acute Drug Transfer in Drug-Coated Balloon Therapy

The Clotted Access

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