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
Year: 2025
Type: article
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.
Source: EuroIntervention
Authors: Simone Fezzi, Bruno Scheller, Bernardo Cortese, Fernando Alfonso, Raban Jeger, Antonio Colombo, Michael Joner, Eun-Seok Shin, Franz 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
Institutions: University of Verona, Ollscoil na Gaillimhe – University of Galway, Azienda Ospedaliera Universitaria Integrata Verona, Saarland University, University Hospitals of Cleveland, University Hospitals Cleveland Medical Center, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, University of Basel, Triemli Hospital, IRCCS Humanitas Research Hospital, Deutsches Herzzentrum München, Technical University of Munich, University of Ulsan, Ulsan University Hospital, Martin Luther University Halle-Wittenberg, Montefiore Medical Center, University of Eastern Finland, North Karelia Central Hospital, Norfolk and Norwich University Hospital, Xijing Hospital, Air Force Medical University, Seoul National University, Seoul National University Hospital, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, Fudan University, Zhongshan Hospital, Columbia University Irving Medical Center, Cardiovascular Research Foundation, Inserm, Assistance Publique – Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Boston Scientific (United States), Universidade de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Instituto do Coração - HCFMUSP, Fujita Health University, Fujita Health University Hospital, The Ohio State University, MedStar Washington Hospital Center, Icahn School of Medicine at Mount Sinai, Beth Israel Deaconess Medical Center, Harvard University, Duke University, Duke Medical Center, University of Lancashire, Royal Blackburn Teaching Hospital
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Ohio State University, B. Braun Melsungen, Boston Scientific Corporation, University of Central Lancashire, University of Galway, Institut National de la Santé et de la Recherche Médicale, Seoul National University, University of Ulsan, Assistance Publique - Hôpitaux de Paris, Fudan University, Seoul National University Hospital, Technische Universität München, Università degli Studi di Verona, Fourth Military Medical University, Fujita Health University, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, School of Medicine, Duke University, Ulsan University Hospital
OpenAlex ID: W4409781917