Jensen, Ivar S. http://orcid.org/0000-0002-0524-2709
Wu, Elizabeth
Cyr, Philip L.
Claussen, Marc
Winkler, Thomas
Salahuddin, Khalid
Prats, Jayne
Mahaffey, Kenneth W.
Gibson, Charles Michael
Steg, Philippe Gabriel
Stone, Gregg W.
Bhatt, Deepak L.
Funding for this research was provided by:
The manuscript was funded by Chiesi, Inc
Article History
Accepted: 7 July 2021
First Online: 31 July 2021
Declarations
:
: The assumptions used for the model are all from published sources and referenced throughout the manuscript. The results from the model are reported in the tables. No other data or materials are available from this analysis.
: This manuscript was funded by Chiesi, Inc. The authors approved all content and results reported in this manuscript.
: Ivar S. Jensen, Elizabeth Wu, and Philip L. Cyr are employees of PrecisionHEOR, which provides consulting services to the pharmaceutical industry, including Chiesi, Inc. Marc Claussen and Khalid Salahuddin are employees of Chiesi, Inc.; Thomas Winkler was an employee of Chiesi at the time of developing this analysis; and Jayne Prats is a consultant to Chiesi, Inc. Kenneth W. Mahaffey’s financial disclosures can be viewed at ExternalRef removed. C. Michael Gibson receives research support and consulting fees from Janssen and Johnson & Johnson, and also receives consulting fees from Bayer. Gabriel Steg discloses the following relationships: research grant from Amarin, Bayer, Sanofi, and Servier, and speaking or consulting fees from Amarin, Amgen, AstraZeneca, Bayer/Janssen, Boehringer-Ingelheim, Bristol-Myers-Squibb, Chiesi, Idorsia, Myokardia, Novartis, Novo-Nordisk, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company. Gregg W. Stone has received speaker or other honoraria from Cook, Terumo, QOOL Therapeutics, and Orchestra Biomed, and has served as a consultant to Valfix, TherOx, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, V-Wave, Abiomed, Ancora, and MAIA. Deepak L. Bhatt discloses the following relationships: Advisory Board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Janssen, Level Ex, Medscape Cardiology, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, and Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), and Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI Clinical Trial Steering Committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (Clinical Trial Steering Committees), Duke Clinical Research Institute (Clinical Trial Steering Committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor, Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS Operations Committee, Publications Committee, Steering Committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME Steering Committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Lexicon, Lilly, Medtronic, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, The Medicines Company, and 89Bio; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; and Unfunded Research: FlowCo, Merck, Takeda.
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: ISJ, EW: Conceptualization, methodology, model programming, writing, review, and editing. PLC, MC, TW, KS, JP: Conceptualization, methodology, validation, writing, review and editing. KWM, CMG, GS, GWS, and DLB: Validation, writing, review, and editing.