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

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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Publication Details

Journal
European Heart Journal
Published
2025-04-24
DOI
https://doi.org/10.1093/eurheartj/ehaf029
Citations
40
Primary Topic
Coronary Interventions and Diagnostics
Type
article
Field-Weighted Citation Impact
80.26

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article

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

Tuomas T. Rissanen, Ron Waksman, Ling Tao, Juan F. Granada et al.
40 citations
European Heart Journal
Coronary Interventions and Diagnostics
80.26
article

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

Tuomas T. Rissanen, Ron Waksman, Ling Tao, Juan F. Granada, Simon Eccleshall, Fernándo Alfonso, Roxana Mehran, Raban Jeger, Alaide Chieffo, Yoshinobu Onuma, F. X. Kleber, Antonio Colombo, Flavio Luciano Ribichini, Alexandre Abizaid, Gregg W. Stone, Azeem Latib, Donald E. Cutlip, Christian Spaulding, Scot Garg, Simone Fezzi, Patrick W. Serruys, Hans‐Peter Stoll, Bon‐Kwon Koo, Bruno Scheller, Takashi Muramatsu, Eun‐Seok Shin, Michael Joner, Konstantinos Dean Boudoulas, Bernardo Cortese, Junbo Ge, Rafael Cavalcante, Mitchell W. Krucoff
article en
40 citations

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.

European Heart JournalVol. 46(26)
Ulsan College (KR), University of Verona (IT), MedStar Washington Hospital Center (US), Beth Israel Deaconess Medical Center (US), Montefiore Medical Center (US), Harvard University (US), Vita-Salute San Raffaele University (IT), Inserm (FR), Sun Yat-sen University (CN), Duke University (US), University of Eastern Finland (FI), University of Basel (CH), University of Lancashire (GB), Wittenberg University (US), Ollscoil na Gaillimhe – University of Galway (IE), Fudan University (CN), Cardiovascular Institute of the South (US), University Hospitals of Cleveland (US), Norfolk and Norwich University Hospital (GB), Columbia University Irving Medical Center (US), Triemli Hospital (CH), Seoul National University Hospital (KR), Boston Scientific (United States) (US), University of Ulsan (KR), North Karelia Central Hospital (FI), Centro de Investigación en Red en Enfermedades Cardiovasculares (ES), Assistance Publique – Hôpitaux de Paris (FR), Fujita Health University Hospital (JP), Zhongshan Hospital (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Hospital Universitario de La Princesa (ES), Ulsan University Hospital (KR), Mylan (Switzerland) (CH), European Hospital (IT), Cardiovascular Research Foundation (US), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Deutsches Herzzentrum München (DE), Instituto do Coração (PT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Xijing Hospital (CN), Hope Foundation (US), Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele (IT), The Ohio State University (US), Technical University of Munich (DE), Universidad Autónoma de Madrid (ES), Saarland University (DE), Icahn School of Medicine at Mount Sinai (US), Air Force Medical University (CN)
B. Braun Melsungen
Good health and well-being
Openalex Percentile: Top 0%
Coronary Interventions and Diagnostics
80.26
DOIOpen Access PDFOpenAlex
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