Technical and Clinical Barriers to Adoption of Drug-Coated Balloons in Cardiac Interventions

Abstract

Drug-coated balloons (DCBs) represent an important advancement in percutaneous coronary intervention, offering a therapeutic strategy that combines mechanical vessel dilation with localized drug delivery while avoiding permanent intravascular implants. The clinical rationale for DCB use is grounded in the concept of transient drug exposure to inhibit neointimal hyperplasia, thereby reducing restenosis without the long-term risks associated with metallic stents or polymer coatings. Over the past decade, drug-coated balloons have demonstrated encouraging outcomes in selected clinical scenarios, particularly in the treatment of in-stent restenosis and small vessel coronary disease. Despite this promise, their adoption in routine cardiac interventions remains limited and inconsistent across regions and clinical settings.

From a technical perspective, challenges related to drug delivery efficiency, coating durability, balloon design, and procedural complexity continue to influence operator confidence and clinical reliability. Variability in drug pharmacokinetics, dependence on optimal lesion preparation, and sensitivity to procedural technique distinguish DCBs from more forgiving implant-based devices. These technical dependencies contribute to heterogeneous clinical outcomes and raise concerns regarding reproducibility outside controlled trial environments.

Clinically, uncertainties persist regarding long-term safety, durability of treatment effect, and appropriate patient selection. Conflicting evidence from clinical studies, particularly in complex coronary lesions, has contributed to cautious guideline recommendations and limited clinician acceptance. Additionally, the absence of standardized procedural protocols and uneven training opportunities further hinder integration into routine practice. By synthesizing existing clinical trials, technical studies, and expert consensus documents, this paper aims to provide a comprehensive analysis of the non-economic, non-regulatory barriers affecting DCB adoption. Understanding these challenges is essential for optimizing clinical use, guiding future device development, and informing evidence-based integration of drug-coated balloons into contemporary cardiac care.