One- versus three-month DAPT after everolimus-eluting stent implantation in diabetic patients at high bleeding risk: results from the XIENCE Short DAPT programme
- PMID: 40522307
- PMCID: PMC12151164
- DOI: 10.4244/EIJ-D-24-00897
One- versus three-month DAPT after everolimus-eluting stent implantation in diabetic patients at high bleeding risk: results from the XIENCE Short DAPT programme
Abstract
Background: In patients with diabetes mellitus (DM) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI), the optimal duration of dual antiplatelet therapy (DAPT) remains uncertain.
Aims: We sought to compare early DAPT discontinuation in DM and non-DM patients enrolled in the prospective XIENCE Short DAPT programme.
Methods: The effects of 1- versus 3-month DAPT on ischaemic and bleeding outcomes were compared using propensity score stratification. The primary endpoint was a composite of all-cause death or myocardial infarction (MI) at 1 year. The incidence of Bleeding Academic Research Consortium (BARC) Type 2 to 5 bleeding was the key secondary endpoint.
Results: Out of 3,352 included patients, 1,299 (38.8%) had DM; diabetic patients had a higher 1-year incidence of death or MI (DM vs non-DM: 10.1% vs 6.6%) and similar BARC 2-5 bleeding (DM vs non-DM: 9.5% vs 9.2%). With 1- versus 3-month DAPT, the incidence of death or MI did not statistically differ in DM patients (adjusted hazard ratio [adjHR] 0.70, 95% confidence interval [CI]: 0.47-1.05) and non-DM patients (adjHR 1.26, 95% CI: 0.87-1.81), although heterogeneity by DM status was evident (p for interaction=0.015). BARC 2-5 bleeding was numerically lower with 1-month DAPT in both groups (DM: adjHR 0.67, 95% CI: 0.45-1.01; non-DM: adjHR 0.78, 95% CI: 0.56-1.07; p for interaction=0.973).
Conclusions: Among HBR patients with DM undergoing PCI, 1-month DAPT, as compared to 3-month DAPT, was not associated with an excess of fatal or non-fatal MI and even reduced the occurrence of bleeding. These findings should be interpreted in the context of a predominantly stable patient population with low procedural complexity and may not be generalisable to higher-risk cases.
Conflict of interest statement
D.J. Angiolillo declares that he has received consulting fees or honoraria from Abbott, Amgen, Anthos, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Daiichi Sankyo, Eli Lilly, Faraday, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma, Pfizer, and Sanofi; and institution research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Faraday, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, and the Scott R. MacKenzie Foundation. M. Valgimigli reports grants and personal fees from Terumo, AstraZeneca, Alvimedica/CID, Abbott, Daiichi Sankyo, Bayer, CoreFlow, Idorsia Pharmaceuticals Ltd, Universität Basel - Departement Klinische Forschung, Vifor, Bristol-Myers Squibb, Biotronik, Boston Scientific, Medtronic, Vesalio, Novartis, Chiesi, and PhaseBio. D. Cao reports consulting fees from Terumo. D.L. Bhatt discloses the following relationships - advisory board: 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; board of directors: American Heart Association New York City; Angiowave (stock options), Bristol-Myers Squibb (stock), DRS.LINQ (stock options), and High Enroll (stock); consultant: Broadview Ventures, GlaxoSmithKline, Hims, SFJ, and Youngene; data monitoring committees: Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic, Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical; for ALLAY-HF, funded by Alleviant Medical), Novartis, Population Health Research Institute, and Rutgers University (for the NIH-funded MINT Trial); honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), 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), CSL Behring (AHA lecture), Cowen and Company, 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, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), WebMD (CME steering committees), and Wiley (steering committee); other: Clinical Cardiology (Deputy Editor); patent: sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women’s Hospital who assigned to Lexicon; neither he nor Brigham and Women’s Hospital receive any income from this patent); research funding: 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, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89Bio; royalties: Elsevier (Editor, Braunwald’s Heart Disease); site co-investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, and Vascular Solutions; trustee: American College of Cardiology; and unfunded research: FlowCo. J. Hermiller has been part of the Abbott advisory board for the last two years. F.-J. Neumann received consultancy honoraria from Novartis and Meril Life Sciences; speaker honoraria from Boston Scientific, Amgen, Daiichi Sankyo, and Meril Life Sciences; reports speaker honoraria paid to his institution from BMS/Pfizer, Daiichi Sankyo, Boston Scientific, Siemens Healthineers, and Amgen; as well as research grants paid to his institution from Boston Scientific and Abbott. R. Mehran reports institutional research payments from Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, AtriCure Inc., Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, Cardiawave, CeloNova, CERC, Chiesi, Concept Medical, Cytosorbents, Daiichi Sankyo, Duke, Element Science, Essential Medical, Faraday, Idorsia Pharmaceuticals, Janssen, MedAlliance, Mediasphere, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Population Health Research Institute, Protembis, Recor Medical, RenalPro, RM Global, Sanofi, Shockwave Medical, Vivasure, and Zoll; personal fees from Affluent Medical, Cardiovascular Research Foundation (CRF), Cordis, Daiichi Sankyo Brasil, E.R. Squibb & Sons, Esperion Science/Innovative Biopharma, Europa Group/Boston Scientific, Gaffney Events, Educational Trust, Henry Ford Health Cardiology, Ionis Pharmaceuticals, Medcon International, Novartis, Novo Nordisk, PeerView Institute for Medical Education, Terumo Europe N.V., Vectura, Vox Media, WebMD, IQVIA, Radcliffe, and Tarsus Cardiology; no fees from AMA (Scientific Advisory Board), SCAI (Women in Innovations Committee Member); faculty: CRF; honorarium: JAMA Cardiology (Associate Editor), ACC (BOT Member, SC Member CTR Program); and equity <1% in Applied Therapeutics, Elixir Medical, Stel, and ControlRad (spouse). The other authors have no relevant conflicts of interest to declare regarding the present manuscript.
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