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. 2023 Dec 4;19(10):e807-e831.
doi: 10.4244/EIJ-E-22-00018.

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations

Mattia Lunardi  1   2 , Yves Louvard  3 , Thierry Lefèvre  3 , Goran Stankovic  4 , Francesco Burzotta  5 , Ghassan S Kassab  6 , Jens F Lassen  7 , Olivier Darremont  8 , Scot Garg  9 , Bon-Kwon Koo  10 , Niels R Holm  11 , Thomas W Johnson  12 , Manuel Pan  13 , Yiannis S Chatzizisis  14 , Adrian P Banning  15 , Alaide Chieffo  16 , Dariusz Dudek  17 , David Hildick-Smith  18 , Jérome Garot  3 , Timothy D Henry  19 , George Dangas  20 , Gregg Stone  20 , Mitchell W Krucoff  21 , Donald Cutlip  22 , Roxana Mehran  20 , William Wijns  1   23 , Faisal Sharif  1 , Patrick W Serruys  1   24 , Yoshinobu Onuma  1
Affiliations

Definitions and Standardized Endpoints for Treatment of Coronary Bifurcations

Mattia Lunardi et al. EuroIntervention. .

Abstract

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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1. Summary of Bif-ARC Recommendations. After identifying a bifurcation lesion, this should be classified according to MEDINA classification and the left main (LM) involvement.
Dedicated bifurcation quantitative coronary analysis (QCA) is strongly advised to be used by sites and core laboratories for quantitative assessment. To evaluate the eligibility of the lesion in a bifurcation trial, its side branch (SB) should be proven to be clinically relevant through different diagnostic techniques according to their availability in the center and the quality and type of the study. The Bifurcation Academic Research Consortium (Bif-ARC) recommends 6 classes of study type, based on the investigation. For every category of study, dedicated endpoints are provided and classified in 3 groups. The follow-up includes clinical, noninvasive, and invasive assessment.
Figure 2
Figure 2. General requirements for coronary bifurcation lesions studies.
The investigators should comply with minimal requirements before running a bifurcation study. Bif-ARC: Bifurcation Academic Research Consortium.
Figure 3
Figure 3. Coronary bifurcation composition.
(Top) Schematic representation of coronary bifurcation components. Angle A: access; Angle B: between; Angle C: PM-DM vessel angle. (A to F) Case example of coronary bifurcation on angiography analyzed with dedicated bifurcation quantitative coronary analysis. Arrows: identification of PMV, DMV, and SB by the analyst. DMV: distal main vessel; PMV: proximal main vessel; POB: point of bifurcation; POC: polygon of confluence; SB: side branch.
Figure 4
Figure 4. MEDINA classification.
Schematic representation of MEDINA classification for bifurcation lesions (A) showing the ranking of lesions severity (from highest to lowest severity), and adapted MEDINA classification for trifurcation lesions (B). Abbreviations as in Figure 3.
Figure 5
Figure 5. Pseudo-Fractal Geometry and Dedicated QCA.
Without implementation of dedicated bifurcation algorithms, taking into account the natural step-down phenomenon of the vessels in presence of bifurcations, the single-vessel QCA leads to erroneous estimation of the main vessel and side branch reference diameters, with over/underestimation of related stenosis. D: distal; DS: diameter stenosis; LM: left main coronary artery; M: main vessel; P: proximal; QCA: quantitative coronary analysis; S: side branch.
Figure 6
Figure 6. Algorithm to determine the lesion eligibility according to the sb relevance.
CMR: cardiac magnetic resonance; CT: computed tomography; FMM: fractional myocardial mass; IVUS: intravascular ultrasound; LCx: left circumflex coronary artery; MV: main vessel; OCT: optical coherence tomography; OM: obtuse marginal branch; RefD: reference diameter; SB: side branch; SPECT: single-photon emission computed tomography
Figure 7
Figure 7. MADS-2 classification of bifurcation stenting techniques.
The upper panel shows the standard techniques, whereas the lower panel shows the “inverted” techniques. Blue capital letters refer to the standard ballooning techniques, whereas the lower panel shows the “inverted” techniques. Common combinations of ballooning techniques are described as the sequential blue capital letters. Reproduced from Burzotta et al.55 DK: double kissing; MB: main branch; other abbreviations as in Figure 3
See this image and copyright information in PMC

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