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. 2025 Apr 24;21(19):e1116-e1136.
doi: 10.4244/EIJ-E-25-00021. Online ahead of print.

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  1   2 , Bruno Scheller  3 , Bernardo Cortese  4   5   6 , Fernando Alfonso  7 , Raban Jeger  8   9 , Antonio Colombo  10 , Michael Joner  11 , Eun-Seok Shin  12 , Franz X Kleber  13 , Azeem Latib  14 , Tuomas T Rissanen  15   16 , Simon Eccleshall  17 , Flavio Ribichini  2 , Ling Tao  18 , Bon-Kwon Koo  19 , Alaide Chieffo  20   21 , Junbo Ge  22 , Juan F Granada  23 , Hans-Peter Stoll  24 , Christian Spaulding  25 , Rafael Cavalcante  26 , Alexandre Abizaid  27 , Takashi Muramatsu  28 , Konstantinos Dean Boudoulas  29 , Ron Waksman  30 , Roxana Mehran  31 , Donald E Cutlip  32 , Mitchell W Krucoff  33 , Gregg W Stone  31 , Scot Garg  34   35 , Yoshinobu Onuma  1 , Patrick W Serruys  1
Affiliations

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 et al. EuroIntervention. .

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.

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Conflict of interest statement

S.F.: grant from Science Foundation Ireland (15/RP/2765). B.S.: speaker honoraria from Medtronic and B. Braun, shareholder of InnoRa GmbH. R.J.: grants to the institution from Abbott, Amgen, AstraZeneca, Bayer, Biosense Webster, B. Braun Melsungen AG, Biotronik, Boston Scientific, Bristol Myers Squibb, Cardionovum, Cordis, Daiichi Sankyo, Edwards Lifesciences, GE Medical Systems, MCM Medsys, Medtronic, Novartis, Pfizer, Terumo, and Vascular Medical GmbH. B.-K.K.: institutional research grants from Abbott, Philips, and Boston Scientific. G.W.S.: speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Cardiomech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife, Elixir, Remote Cardiac Enablement, and Aria; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. G.W.S.’s employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc., Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. D.E.C.: grant support from Cordis; travel reimbursement from Abbott Vascular; and additional funding for the Clinical Events Committee from Boston Scientific. R.M.: institutional grant support from Abbott Laboratories, AstraZeneca, Bayer, CSL Behring, Daiichi Sankyo, Medtronic, Novartis, Bristol Myers Squibb, and OrbusNeich; consulting fees from Abbott Laboratories (paid to her institution), Spectranetics (Philips Volcano) (paid to her institution), Boston Scientific, Medscape (WebMD), Siemens Medical Solutions, Roivant Services, Sanofi, Regeneron, and Janssen Scientific Affairs; lecture fees from Abbott Laboratories (paid to her institution) and Medtelligence (Janssen Scientific Affairs); served on advisory boards for Bristol Myers Squibb (fees paid to her institution), PLx Opco, and Medtelligence (Janssen Scientific Affairs); data and safety monitoring board (fees paid to her institution) for Watermark Research Partners; nonfinancial support from Regeneron; and holds equity in Claret Medical and Elixir Medical. P.W.S. reports consultancy for Merillife, Novartis, SMT (Sahajanand Medical technological), Philips/Volcano, and Xeltis, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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