TY - JOUR
T1 - Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease
T2 - consensus document of the Drug Coated Balloon Academic Research Consortium
AU - Fezzi, Simone
AU - Scheller, Bruno
AU - Cortese, Bernardo
AU - Alfonso, Fernando
AU - Jeger, Raban
AU - Colombo, Antonio
AU - Joner, Michael
AU - Shin, Eun Seok
AU - Kleber, Franz X.
AU - Latib, Azeem
AU - Rissanen, Tuomas T.
AU - Eccleshall, Simon
AU - Ribichini, Flavio
AU - Tao, Ling
AU - Koo, Bon Kwon
AU - Chieffo, Alaide
AU - Ge, Junbo
AU - Granada, Juan F.
AU - Stoll, Hans Peter
AU - Spaulding, Christian
AU - Cavalcante, Rafael
AU - Abizaid, Alexandre
AU - Muramatsu, Takashi
AU - Boudoulas, Konstantinos Dean
AU - Waksman, Ron
AU - Mehran, Roxana
AU - Cutlip, Donald E.
AU - Krucoff, Mitchell W.
AU - Stone, Gregg W.
AU - Garg, Scot
AU - Onuma, Yoshinobu
AU - Serruys, Patrick W.
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/7/7
Y1 - 2025/7/7
N2 - 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.
AB - 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.
KW - Academic Research Consortium
KW - Coronary artery disease
KW - Drug-coated balloon
KW - Randomized clinical trial
UR - https://www.scopus.com/pages/publications/105010740499
U2 - 10.1093/eurheartj/ehaf029
DO - 10.1093/eurheartj/ehaf029
M3 - Article
C2 - 40270117
AN - SCOPUS:105010740499
SN - 0195-668X
VL - 46
SP - 2498
EP - 2519
JO - European Heart Journal
JF - European Heart Journal
IS - 26
ER -