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The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients., Competing Interests: Funding Support and Author Disclosures This work is supported by a Science Foundation Ireland Research Professorship Award (RSF 1413) including grants to Drs Lunardi and Wijns. Dr Lefèvre has received speaker fees from Abbott, Medtronic and Terumo. Dr Burzotta has received speaker fees from Medtronic, Abiomed, and Abbott. Dr Lassen has received speaker fees from Medtronic, Boston Scientific, Biotronik, Abbott and Biosensors. Dr Darremont has received speaker fees from Edwards. Dr Holm has received institutional research grants and speaker fees from St. Jude Medical and Terumo. Dr Johnson has received speaker fees from Abbott, Boston Scientific, Medtronic, and Terumo; and has received institutional funding for fellowships from Boston Scientific and Terumo. Dr Pan has received speaker fees from Abbott, Terumo, and Volcano. Dr Chatzizisis has received speaker fees and consultation fees from Boston Scientific; and has received research support from Boston Scientific and Medtronic. Dr Banning has received institutional funding of a fellowship from Boston Scientific; and has received speaker fees from Boston, Abbott, Medtronic, Philips/Volcano, and Miracor. Dr Chieffo has received speaker fees from Abiomed and GADA. Dr Dudek has received grants and personal fees from Boston Scientific, Philips, Abbott, Medtronic, and Biotronik. Dr Hildick-Smith has received advisory board, consultancy, and research funding from Terumo, Medtronic, Abbott, and Boston Scientific. Dr Dangas has received lecture fees from Bayer and Daiichi-Sankyo; has received institutional and grant support from Daiichi-Sankyo; and has held equity in Medtronic. Dr Stone has received lecture fees from Terumo and Amaranth; has received consulting fees from Shockwave Medical, TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Matrizyme, Miracor Medical, Neovasc, V-Wave, Abiomed, Claret Medical, Sirtex Medical, MAIA Pharmaceuticals, VALFIX Medical, SpectraWAVE, Ancora, and Vectorious Medical Technologies; holds equity in VALFIX Medical, Ancora, Qool Therapeutics, Orchestra BioMed, Cagent Vascular, Applied Therapeutics, Biostar, MedFocus, Aria CV, Cardiac Success, and SpectraWAVE; holds stock options in Ancora, Qool Therapeutics, Orchestra BioMed, Cagent Vascular, Applied Therapeutics, Biostar, MedFocus, Aria CV, and Cardiac Success; and has received personal fees from Qool Therapeutics and Orchestra BioMed. Dr Cutlip has received grant support from Cordis; has received travel reimbursement from Abbott Vascular; and has received additional funding for the Clinical Events Committee from Boston Scientific. Dr Mehran has received institutional grant support from Abbott Laboratories, AstraZeneca, Bayer, CSL Behring, Daiichi-Sankyo, Medtronic, Novartis, Bristol Myers Squibb, and OrbusNeich; has received 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; has received lecture fees from Abbott Laboratories (paid to her institution), and Medtelligence (Janssen Scientific Affairs); has served on advisory boards for Bristol Myers Squibb (fees paid to her institution), PLx Opco, and Medtelligence (Janssen Scientific Affairs); has served on a data and safety monitoring board (fees paid to her institution) for Watermark Research Partners; has received nonfinancial support from Regeneron; and holds equity in Claret Medical and Elixir Medical. Dr Wijns has received institutional research grants from Terumo, MiCell, and MicroPort; has received honoraria from MicroPort; has been a medical advisor of Rede Optimus Research; and is cofounder of Argonauts, an innovation accelerator. Dr Serruys has received personal fees from Philips/Volcano, SMT, Novartis, Xeltis, and Merillife. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background/purpose: A coronary stent with thromboresistant and pro-healing properties such as the polymer polyzene F-coated (COBRA PzF) stent might safely allow for a very short duration of triple therapy in patients taking oral anticoagulation (OAC) who undergo coronary stenting., Methods: The COBRA-REDUCE trial is a prospective, multinational, randomized, open-label, assessor-blinded trial. A total of 996 patients at high bleeding risk because of requirement for OAC (with a vitamin K antagonist or non-vitamin K antagonist for any indication) will be randomized at sites in the United States and Europe to treatment with the COBRA-PzF stent followed by very short duration (14 days) DAPT or a Food and Drug Administration (FDA)-approved new generation drug-eluting stent followed by guideline-recommended DAPT duration (3 or 6 months). Two co-primary endpoints will be tested at 6 months: a bleeding co-primary endpoint (bleeding academic research consortium [BARC] ≥2 bleeding beyond 14 days or after hospital discharge, whichever is later [superiority hypothesis]) and a thrombo-embolic co-primary endpoint (the composite of all-cause death, myocardial infarction, definite/probable stent thrombosis or ischaemic stroke [non-inferiority hypothesis]). The trial is registered at clinicaltrials.gov (NCT02594501)., Conclusion: The COBRA-REDUCE trial will determine whether coronary stenting with the COBRA PzF stent followed by 14 days of clopidogrel will reduce bleeding without increasing thrombo-embolic events compared with FDA-approved DES followed by 3-6 months clopidogrel in patients taking OAC and aspirin., Competing Interests: Declaration of competing interest Dr Colleran reports speakers fees from Medtronic. Dr Joner reports personal fees from Biotronik, personal fees from Orbus Neich, grants and personal fees from Boston Scientific, grants and personal fees from Edwards, personal fees from Astra Zeneca, personal fees from Recor, grants from Amgen outside the submitted work. Dr Urban reports honoraria for CEC and DSMB activities from Edwards Lifesciences and Cardialysis, is a consultant for Biosensors and is a shareholder of CERC (Massy, France) and of MedAlliance (Morges, Switzerland). Dr Maeng has received lecture or advisory board fees from Astra-Zeneca, Bayer, Boehringer-Ingelheim, Boston Scientific, Bristol-Myers Squibb, and Novo Nordisk; and has received a research grant from Bayer. Dr Barakat is an employee of Celonova Biosciences Inc. Dr Mehran reports consultant fees to the institution from Abbott Laboratories and Spectranetics/Philips/Valcano Corp; consulting fees from Boston Scientific, Cardiovascular Systems Inc., Medscape, Siemens Medical Solutions, Regeneron Pharmaceuticals Inc., Roivant Sciences Inc., and Sanofi; being the spouse of a consultant for Abiomed and The Medicines Company; research funding to the institution from AstraZeneca, Bayer, Beth Israel Deaconess Hospital, BMS, CSL Behring, Eli Lilly and DSI, Medtronic, Novartis Pharmaceuticals, and Orbus Neich; scientific advisory board fees from PLx Opco Inc., dba PLx Pharma Inc.; scientific advisory board fees to the institution from Bristol-Myers Squibb; executive committee fees from Janssen Pharmaceuticals and Osprey Medical; speaker engagements for Abbott Laboratories; equity from Claret Medical and Elixir Medical; and Data Safety Monitoring Board fees to the institution from Atermark Research Partners. Dr. Kirtane reports institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; no speaking/consulting fees were personally received; personal fees received consist of travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Byrne reports research funding to the institution of prior employment from Celonova Biosciences and research or educational funding to the institution of current employment from Abbott Vascular, Biosensors, Biotronik and Boston Scientific. The other authors report no conflicts of interest., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)