Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium
Simone Fezzi, Bruno Scheller, Bernardo Cortese, Fernándo Alfonso, Raban Jeger, Antonio Colombo, Michael Joner, Eun‐Seok Shin, F. X. Kleber, Azeem Latib, Tuomas T. Rissanen, Simon Eccleshall, Flavio Ribichini, Ling Tao, Bon‐Kwon Koo, Alaide Chieffo, Junbo Ge, Juan F. Granada, Hans‐Peter Stoll, Christian Spaulding, Rafael Cavalcante, Alexandre Abizaid, Takashi Muramatsu, Konstantinos Dean Boudoulas, Ron Waksman, Roxana Mehran, Donald E. Cutlip, Mitchell W. Krucoff, Gregg W. Stone, Scot Garg, Yoshinobu Onuma, Patrick W. Serruys
Abstract
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.