1. 1-Month or 3-Month DAPT in Women and Men at High Bleeding Risk Undergoing PCI.
- Author
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Kunadian V, Gitto M, Vogel B, Sartori S, Angiolillo DJ, Bhatt DL, Chehab BM, Feng Y, de la Torre Hernandez JM, Krucoff MW, Maksoud A, Mankerious N, Oliva A, Picon H, Richardt G, Sardella G, Thiele H, Toelg R, Varenne O, Vranckx P, Windecker S, Valgimigli M, and Mehran R
- Abstract
Background: In patients at high bleeding risk (HBR), short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is associated with reduced bleeding and preserved ischemic protection., Objectives: The aim of this study was to compare 2 short DAPT regimens, followed by aspirin monotherapy, in women and men at HBR undergoing PCI., Methods: Data from 3 prospective, international studies (XIENCE Short DAPT Program) including patients at HBR undergoing PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (XIENCE) were analyzed. The primary endpoint was the composite of death or myocardial infarction (MI) at 1 year. The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding., Results: Among 3,364 patients, 1,154 (34.3%) were women. At 1 year, the rates of death or MI (7.6% vs 8.1%) and BARC types 2 to 5 bleeding (9.5% vs 9.2%) were similar in women and men. One-month and 3-month DAPT conferred a similar risk for death or MI in women (adjusted HR: 0.86; 95% CI: 0.54-1.36) and men (adjusted HR: 1.04; 95% CI: 0.75-1.44) (P for interaction = 0.783). In both sexes, BARC types 2 to 5 bleeding was numerically lower with 1-month DAPT, although not significant after propensity score stratification (women: 7.1% vs 11.2%; adjusted HR: 0.66; 95% CI: 0.43-1.02; men: 8.5% vs 9.7%; adjusted HR: 0.78; 95% CI: 0.57-1.06) (P for interaction = 0.378)., Conclusions: Among patients at HBR undergoing PCI with everolimus-eluting stents, 1- and 3-month DAPT was associated with similar risk for ischemic events irrespective of sex. In both women and men, 1-month DAPT resulted in less clinically relevant bleeding, although the bleeding risk difference was not significant after propensity score stratification., Competing Interests: Funding Support and Author Disclosures This study was sponsored by Abbott. Dr Richardt has received an institutional research grant from Boston Scientific. Dr Vranckx has received grants and/or personal fees from AstraZeneca, Terumo, Abbott Vascular, Daiichi-Sankyo, Bayer, and CSL Behring. Dr Valgimigli has received grants and personal fees from Terumo; and has received personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Bayer, CoreFLOW, Idorsia Pharmaceuticals, Universität Basel/Department Klinische Forschung, Vifor, Bristol Myers Squibb, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio, outside the submitted work. Dr Angiolillo has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, CSL Behring, Daiichi-Sankyo, Eli Lilly, Faraday, Haemonetics, Janssen, Merck, Novartis, Novo Nordisk, PhaseBio, PLx Pharma, Pfizer, Sanofi, and Vectura, outside the submitted work; and has received research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Faraday, Gilead, Idorsia, Janssen, Matsutani Chemical Industry, Merck, Novartis, and the Scott R. MacKenzie Foundation. Dr Bhatt is an advisory board member for Angiowave, Bayer, Boehringer Ingelheim, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, and Stasys; is on the boards of directors of the American Heart Association New York City, Angiowave (stock options), Bristol Myers Squibb (stock), DRS.LINQ (stock options), and High Enroll (stock); is a consultant for Broadview Ventures, Hims, SFJ, and Youngene Therapeutics; is a data and safety monitoring committee member for Acesion Pharma, Assistance Publique–Hôpitaux de Paris, the Baim Institute for Clinical Research (formerly the Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (chair, PEITHO trial), the Cleveland Clinic, Contego Medical (chair, PERFORMANCE 2), the Duke Clinical Research Institute, the Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo; for the ABILITY-DM trial, funded by Concept Medical; and for ALLAY-HF, funded by Alleviant Medical), Novartis, the Population Health Research Institute, and Rutgers University (for the National Institutes of Health–funded MINT trial); has received honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org; chair, American College of Cardiology Accreditation Oversight Committee), the Arnold & Porter law firm (work related to Sanofi/Bristol Myers Squibb clopidogrel litigation), the Baim Institute for Clinical Research (formerly the 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), the Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (American Heart Association lecture), Cowen & Company, the 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), the Journal of the American College of Cardiology (guest editor, associate editor), K2P (cochair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (continuing medical education steering committees), MJH Life Sciences, Oakstone CME (course director, Comprehensive Review of Interventional Cardiology), Piper Sandler, the Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and U.S. national coleader, funded by Bayer), WebMD (continuing medical education steering committees), and John Wiley (steering committee); is deputy editor of Clinical Cardiology; is named on a patent for sotagliflozin assigned to Brigham and Women’s Hospital, which assigned to Lexicon; neither Dr Bhatt nor Brigham and Women’s Hospital receives any income from this patent); has received research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Eli Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, the Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89Bio; has received royalties from Elsevier (editor, Braunwald’s Heart Disease); is a site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; is a trustee of the American College of Cardiology; and has conducted unfunded research for FlowCo. Dr Toelg has received speaker honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr Maksoud is member of Speakers Bureaus for Abbott Vascular, Pfizer, and Bristol Myer Squib. Dr Chehab has received research grants from Edwards Lifesciences and Abbott; and has received speaker honoraria and/or personal fees from Edwards Lifesciences and Abbott and Biotronik. Dr de la Torre Hernandez has received grants and research support from Abbott, Amgen, and Biotronik; and has received honoraria or consultation fees from Boston Scientific, Medtronic, Biotronik, Abbott, Philips, IHT, and iVascular. Dr Krucoff has received grants and/or personal fees from Abbott Vascular, Biosensors, Boston Scientific, Nipro, Medtronic, OrbusNeich, and Terumo. Dr Kunadian has received personal fees and honoraria from Bayer, AstraZeneca, Abbott, Amgen, and Daiichi Sankyo. Dr Varenne has received personal fees and honoraria from Abbott Vascular, Boston Scientific, Biosensors, and AstraZeneca. Dr Windecker has received research, travel, or educational grants to his institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse, Fumedica, Guerbet, Idorsia, Inari Medical, Infraredx, Janssen-Cilag, Johnson & Johnson, MedAlliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave, with payments to the institution but no personal payments; and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from the American College of Cardiology, Boston Scientific, the California Institute for Regenerative Medicine, Cine-Med Research, Janssen, WebMD, and the Society for Cardiovascular Angiography and Interventions; has received consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; holds equity (<1%) in Applied Therapeutics, Elixir Medical, STEL, and ControlRad (spouse); and is a scientific advisory board member for the American Medical Association and Biosensors (spouse). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2025
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