Why the study?
There was a lack of standardization and comparability between studies evaluating drug-coated balloons for the treatment of obstructive coronary artery disease.
This consensus document standardizes study designs and endpoints for clinical trials evaluating drug-coated balloons in coronary artery disease to improve comparability across studies.
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Enhances cross-trial comparability for drug-coated balloons; extends consensus standardization to designs, endpoints, and analyses.
The Drug Coated Balloon Academic Research Consortium project originated from the lack of standardization and comparability between studies using drug-coated balloons in the treatment of obstructive coronary artery disease. This document is a collaborative effort between academic research organizations and percutaneous coronary intervention societies in Europe, the USA, and Asia. This consensus sought to standardize study designs and endpoints for clinical trials involving drug-coated balloons, including defining angiographic, intravascular, and non-invasive imaging methods for lesion assessment, alongside considerations for post-revascularization pharmaco-therapy. The concept of 'blended therapy', which advocates for combining device strategies, is also discussed. This paper delineates study types, endpoint definitions, follow-up protocols, and analytical approaches, aiming to provide consistency and guidance for interventional cardiologists and trialists.
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Fezzi et al. (2025) studied this question.
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