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.
Authors
- Tuomas T. Rissanen (ORCID: https://orcid.org/0000-0002-1914-2282)
- Ling Tao (ORCID: https://orcid.org/0000-0003-2919-5641)
- Juan F. Granada (ORCID: https://orcid.org/0000-0003-2399-8320)
- Simon Eccleshall (ORCID: https://orcid.org/0000-0002-6395-2389)
- Fernándo Alfonso (ORCID: https://orcid.org/0000-0002-7480-2511)
- Roxana Mehran (ORCID: https://orcid.org/0000-0002-5546-262X)
- Raban Jeger (ORCID: https://orcid.org/0000-0003-1290-5491)
- Alaide Chieffo (ORCID: https://orcid.org/0000-0002-3505-9112)
- Yoshinobu Onuma (ORCID: https://orcid.org/0000-0001-7702-0649)
- F. X. Kleber (ORCID: https://orcid.org/0000-0002-3847-2033)
- Antonio Colombo (ORCID: https://orcid.org/0000-0002-2940-2455)
- Flavio Luciano Ribichini (ORCID: https://orcid.org/0000-0002-6662-0304)
- Alexandre Abizaid (ORCID: https://orcid.org/0000-0001-8689-9990)
- Gregg W. Stone (ORCID: https://orcid.org/0000-0002-3416-8210)
- Azeem Latib (ORCID: https://orcid.org/0000-0001-9035-343X)
- Donald E. Cutlip (ORCID: https://orcid.org/0000-0002-7583-9893)
- Christian Spaulding (ORCID: https://orcid.org/0000-0002-1644-2079)
- Scot Garg (ORCID: https://orcid.org/0000-0002-8911-0278)
- Simone Fezzi (ORCID: https://orcid.org/0000-0003-2755-2094)
- Patrick W. Serruys (ORCID: https://orcid.org/0000-0002-9636-1104)
- Hans‐Peter Stoll (ORCID: https://orcid.org/0000-0003-2784-3326)
- Bon‐Kwon Koo (ORCID: https://orcid.org/0000-0002-8188-3348)
- Bruno Scheller (ORCID: https://orcid.org/0000-0001-7139-5298)
- Takashi Muramatsu (ORCID: https://orcid.org/0000-0001-5925-2489)
- Eun‐Seok Shin (ORCID: https://orcid.org/0000-0002-9169-6968)
- Konstantinos Dean Boudoulas (ORCID: https://orcid.org/0000-0003-0625-8750)
- Bernardo Cortese (ORCID: https://orcid.org/0000-0002-5808-7810)
- Junbo Ge (ORCID: https://orcid.org/0000-0002-9360-7332)
- Rafael Cavalcante (ORCID: https://orcid.org/0000-0003-0158-811X)
- Mitchell W. Krucoff
- Michael Joner
- Ron Waksman
Institutions
- 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)
- 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)
- University Hospital Galway (IE)
- Seoul National University Hospital (KR)
- San Raffaele University of Rome (IT)
- University of Ulsan (KR)
- North Karelia Central Hospital (FI)
- Hôpital Européen Georges-Pompidou (FR)
- Biomed Research Institute (US)
- 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)
- Cardiovascular Research Foundation (US)
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR)
- Deutsches Herzzentrum München (DE)
- Royal Blackburn Teaching Hospital (GB)
- IRCCS Humanitas Research Hospital (IT)
- Innova (Italy) (IT)
- The Ohio State University (US)
- Technical University of Munich (DE)
- Universidad Autónoma de Madrid (ES)
- Martin Luther University Halle-Wittenberg (DE)
- Saarland University (DE)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- EuroIntervention
- Published
- 2025-09-29
- DOI
- https://doi.org/10.4244/eij-e-25-00021
- Citations
- 8
- Primary Topic
- Coronary Interventions and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 16.05