The factors influencing the efficiency of drug-coated balloons

Abstract

The drug-coated balloon (DCB) is an emerging percutaneous coronary intervention (PCI) device that delivers drugs to diseased vessels to decrease the rate of vascular stenosis. Recent clinical studies have demonstrated that DCBs tend to have both good safety and efficacy profiles, leading to extended application indications in the clinic, including in-stent restenosis (ISR) for metal stents such as drug-eluting stents (DESs), small vascular disease, bifurcation disease, large vascular disease, acute coronary syndrome (ACS), and high bleeding risk. However, some previous clinical data have suggested that DCBs performed less effectively than DESs. No studies or reviews have systematically discussed the improvement strategies for better DCB performance until now. Drug loss during the process of delivery to the target lesion and inefficient delivery of the coating drug to the diseased vascular wall are two key mechanisms that weaken the efficiency of DCBs. This review is the first to summarize the key influencing factors of DCB efficiency in terms of balloon structure and principles, and then it analyzes how these factors cause outcomes in practice based on current clinical trial studies of DCBs in the treatment of different types of lesions. We also provide some recommendations for improving DCBs to contribute to better DCB performance by improving the design of DCBs and combining other factors in clinical practice.

Treatment of Peripheral Artery Disease Using Injectable Biomaterials and Drug-Coated Balloons: Safety and Efficacy Perspective

“…The main ways that drugs are released from DES are through diffusion-controlled release and erosion-controlled release. Adapted with permission from [ 30 , 31 , 32 ]. Copyright to the publisher Elsevier and Frontiers.…”

Small-vessel Coronary Angioplasty – Past, Present, and Future

“…About 1.27 µg/ mm 2 of sirolimus drug is delivered in 60 s, so ischemic time is also decreased from 3 min to 1 min with this DCB. [25] In the NANOLUTÈ registry, Sirolimus DEB was done in 156 SVD patients with favorable outcomes. In this registry, MACE was 3.8% and target lesion revascularization/target vessel revascularization was 2.8% at 12 months.…”

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

“…Comparative studies among current devices indicate that only a small fraction of coating material (<10%) is transferred to and resorbed by the arterial wall and most of the initial PTX dose (>90%) is lost to systemic circulation�this leads to ineffective and unpredictable patient outcomes and increases the risk of off-target drug effects. 6,17,18 Previous studies have aimed to enhance intraprocedural drug transfer via consideration of numerous balloon/coating designs, where typical device specification includes balloon size/compliance, drug type/dose, and excipient type/concentration. 19−22 A variety of excipients have been proposed in DCB design, including urea, polyethylene glycol, shellac/ shelloic acid, polysorbate, dextran, and other proprietary materials.…”

“…Previous studies have aimed to enhance intraprocedural drug transfer via consideration of numerous balloon/coating designs, where typical device specification includes balloon size/compliance, drug type/dose, and excipient type/concentration. − A variety of excipients have been proposed in DCB design, including urea, polyethylene glycol, shellac/shelloic acid, polysorbate, dextran, and other proprietary materials. , In all cases, excipients play the vital role of promoting adequate tissue uptake/retention of PTX and thus potentiate localized therapy. A meta-analysis of excipient performance in DCBs suggests a notable trade-off between hydrophilic and hydrophobic materials: hydrophilic materials lead to higher tissue levels of PTX, while hydrophobic materials better resist drug wash-off during procedures. − Thus, hydrophilic excipients enhance the local delivery of PTX, which is a poorly water-soluble drug, but also increase the risk of premature systemic release.…”

“…Despite large-scale clinical adoption of DCBs in PAD therapy, their comparatively sparse use in the coronary circulation suggests that clinical potential has not been fully realized. , Clinical hesitation for broader DCB use is in part due to our incomplete understanding of the key determinants of therapeutic efficacy − and the associated lack of generalizable strategies to promote efficient component transfer from the device to the arterial wall. Comparative studies among current devices indicate that only a small fraction of coating material (<10%) is transferred to and resorbed by the arterial wall and most of the initial PTX dose (>90%) is lost to systemic circulationthis leads to ineffective and unpredictable patient outcomes and increases the risk of off-target drug effects. ,, …”