TCT-43 Definitions and Standardized Endpoints for the Use of Drug Coated Balloon in Coronary Artery Disease: Consensus Document of Drug Coated Balloon Academic Research Consortium

Abstract

Background
Drug-coated balloons (DCBs) are an intriguing addition to the therapeutic arsenal for treating obstructive coronary artery disease (CAD). This technology facilitates rapid and uniform delivery of antiproliferative drugs into the vessel wall during balloon inflation, eliminating the need for permanent vessel scaffolding and caging. DCBs possess inherently distinct characteristics compared to drug-eluting stents (DES) and offer several advantages in treating obstructive CAD. They allow for lesion regression with antiatherogenic drugs and are particularly beneficial in diffuse, small vessel, and distal lesions where percutaneous coronary intervention (PCI) with stents is less effective. However, the lack of metallic caging or radio-opaque markers to identify the treated segment poses challenges. These include difficulties in recognizing the treated lesion during follow-up, analyzing and colocalizing the treated lesion at different time points, and during final clinical event adjudication, such as restenosis and occlusion.

Methods
As part of the Academic Research Consortium (ARC), this document aims to establish dedicated study designs and define the recommended parameters of assessment and endpoints for clinical trials. The goal is to provide consistent, practical, and reproducible terminology for interventional cardiologists and trialists. These comprehensive definitions will incorporate methods of angiographic assessment, the role of intravascular imaging, noninvasive coronary imaging, new image-based methods of functional lesion evaluation, and dedicated postrevascularization antiplatelet therapy, including type, duration, and intensity.

Results
This position paper aims to describe types of clinical studies; endpoint definitions, including composite clinical endpoints, procedural, mechanistic (anatomical and functional), and cost-effectiveness endpoints, as well as patient-, site-, and central adjudication-reported endpoints; follow-up methods; analytical plans; and lesion and clinical settings for the use of DCBs.

Conclusion
This document intends to enhance the design and conduct of clinical trials, ensuring optimal use of DCB technology in treating obstructive CAD.