Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/35759
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dc.contributor.authorMehran, Roxana-
dc.contributor.authorCao, Davide-
dc.contributor.authorAngiolillo, Dominick J.-
dc.contributor.authorBangalore, Sripal-
dc.contributor.authorBhatt, Deepak L.-
dc.contributor.authorGe, Junbo-
dc.contributor.authorHermiller, James-
dc.contributor.authorMakkar, Raj R.-
dc.contributor.authorNeumann, Franz-Josef-
dc.contributor.authorSaito, Shigeru-
dc.contributor.authorPicon, Hector-
dc.contributor.authorToelg, Ralph-
dc.contributor.authorMaksoud, Aziz-
dc.contributor.authorChehab, Bassem M.-
dc.contributor.authorDe la Torre Hernandez, Jose M.-
dc.contributor.authorKunadian, Vijay-
dc.contributor.authorSardella, Gennaro-
dc.contributor.authorThiele, Holger-
dc.contributor.authorVarenne, Olivier-
dc.contributor.authorVRANCKX, Pascal-
dc.contributor.authorWindecker, Stephan-
dc.contributor.authorZhou, Yujie-
dc.contributor.authorKrucoff, Mitchell W.-
dc.contributor.authorRuster, Karine-
dc.contributor.authorWang, Jin-
dc.contributor.authorValgimigli, Marco-
dc.date.accessioned2021-11-04T10:42:48Z-
dc.date.available2021-11-04T10:42:48Z-
dc.date.issued2021-
dc.date.submitted2021-10-28T14:09:37Z-
dc.identifier.citationJACC: cardiovascular interventions (Print) , 14 (17), p. 1870–1883-
dc.identifier.issn1936-8798-
dc.identifier.urihttp://hdl.handle.net/1942/35759-
dc.description.abstractOBJECTIVES The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). BACKGROUND Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown. METHODS The XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y(12) inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score-stratified analysis. RESULTS A total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (P-noninferiority = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (P-noninferiority = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3-or 1-month DAPT, while BARC types 3 to 5 bleeding was reduced in both experimental groups. The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28. CONCLUSIONS Among HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis. (C) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.-
dc.description.sponsorshipThis study was sponsored by Abbott. 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). Dr Angiolillo has received consulting fees or honoraria from Abbott, Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, DaiichiSankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St. Jude Medical, outside the present work; and has received research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry, Merck, Novartis, Osprey Medical, Renal Guard Solutions, and the Scott R. MacKenzie Foundation. Dr Bangalore has received grants from Abbott Vascular; and has received personal fees from Abbott Vascular, Biotronik, Amgen, and Pfizer. Dr Bhatt is an advisory board member for Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Janssen, Level Ex, Medscape Cardiology, MyoKardia, Novo Nordisk, PhaseBio, PLx Pharma, and Regado Biosciences; is a board of directors member for the Boston VA Research Institute, the Society of Cardiovascular Patient Care, and TobeSoft; is chair of the American Heart Association Quality Oversight Committee; is a member of data monitoring committees for the Baim Institute for Clinical Research (formerly the Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), the Cleveland Clinic (including for the ExCEED trial, funded by Edwards Lifesciences), 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), and the Population Health Research Institute; has received honoraria from the American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org; vice chair, ACC Accreditation Committee), 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), the Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (editor-inchief, Journal of Invasive Cardiology), the Journal of the American College of Cardiology (guest editor, associate editor), K2P (co-chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (continuing medical education steering committees), MJH Life Sciences, the Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national coleader, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), the Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (continuing medical education steering committees); is deputy editor of Clinical Cardiology; is chair of the NCDR-ACTION Registry Steering Committee and the VA CART Research and Publications Committee; has received research funding from 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, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, The Medicines Company, and 89Bio; has received royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); is a site coinvestigator for Abbott, Biotronik, Boston Scientific, CSI, St Jude Medical (now Abbott), and Svelte; is a trustee of the American College of Cardiology; and has conducted unfunded research for FlowCo, Merck, and Takeda. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as a national principal investigator for Portico (Abbott) and Acurate (Boston Scientific) U.S. investigational device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller has received consulting and proctoring fees from Abbott and Edwards Lifesciences; and has received consulting fees from Medtronic. Dr Toelg has received speaker honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr Neumann has received grants and/or personal fees from Amgen, Boehringer Ingelheim, Daiichi-Sankyo, Novartis, Pfizer, Biotronik, Edwards Lifesciences, Medtronic, Bayer Healthcare, GlaxoSmithKline, Boston Scientific, and Ferrer. Dr Maksoud is a member of the Speakers Bureaus of Abbott Vascular, Pfizer, and Bristol Myers Squibb. Dr Chehab has received research grants from Edwards Lifesciences and Abbott; and has received speaker honoraria and/or personal fees from Edwards Lifesciences, Abbott, and Biotronik. Dr de la Torre Hernandez has received grants and research support from Abbott Medical, Biosensors, Bristol Myers Squibb, and Amgen; and has received honoraria or consulting fees from Boston Scientific, Medtronic, Biotronik, AstraZeneca, Daiichi-Sankyo. Dr Kunadian has received personal fees and honoraria from Bayer, AstraZeneca, Abbott, Amgen, and DaiichiSankyo. Dr Varenne has received personal fees and honoraria from Abbott Vascular, Boston Scientific, Biosensors, and AstraZeneca. Dr Vranckx has received grants and/or personal fees from AstraZeneca, Terumo, Abbott Vascular, Daiichi-Sankyo, Bayer, and CLS Behring. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, Cardiovalve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; serves as unpaid advisory board member and/or unpaid member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bristol Myers Squibb, Boston Scientific,-
dc.language.isoen-
dc.publisherELSEVIER SCIENCE INC-
dc.rights2021 THE AUTHORS. PUBLISHED BY ELSEVIER ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE ( http://creativecommons.org/licenses/by/4.0/ ) .-
dc.subject.otherbleeding-
dc.subject.othereverolimus-eluting stent-
dc.subject.otherhigh bleeding risk-
dc.subject.otherpercutaneous coronary intervention-
dc.subject.othershort DAPT-
dc.subject.otherthrombosis-
dc.title3-or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation-
dc.typeJournal Contribution-
dc.identifier.epage1883-
dc.identifier.issue17-
dc.identifier.spage1870-
dc.identifier.volume14-
local.format.pages14-
local.bibliographicCitation.jcatA1-
dc.description.notesMehran, R (corresponding author), Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, One Gustave L Levy Pl,Box 1030, New York, NY 10029 USA.-
dc.description.notesroxana.mehran@mountsinai.org-
local.publisher.placeSTE 800, 230 PARK AVE, NEW YORK, NY 10169 USA-
local.type.refereedRefereed-
local.type.specifiedArticle-
dc.identifier.doi10.1016/j.jcin.2021.07.016-
dc.identifier.pmid34503737-
dc.identifier.isiWOS:000696806200009-
dc.identifier.eissn1876-7605-
local.provider.typewosris-
local.description.affiliation[Mehran, Roxana; Cao, Davide] Icahn Sch Med Mt Sinai, New York, NY 10029 USA.-
local.description.affiliation[Angiolillo, Dominick J.] Univ Florida, Coll Med, Jacksonville, FL USA.-
local.description.affiliation[Bangalore, Sripal] NYU, Langone Med Ctr, New York, NY USA.-
local.description.affiliation[Bhatt, Deepak L.] Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA 02115 USA.-
local.description.affiliation[Ge, Junbo] Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China.-
local.description.affiliation[Hermiller, James] St Vincents Med Ctr Indiana, Indianapolis, IN USA.-
local.description.affiliation[Makkar, Raj R.] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA.-
local.description.affiliation[Neumann, Franz-Josef] Univ Heart Ctr Freiburg, Bad Krozingen, Germany.-
local.description.affiliation[Saito, Shigeru] Shonan Kamakura Gen Hosp, Kamakura, Kanagawa, Japan.-
local.description.affiliation[Picon, Hector] Redmond Reg Med Ctr, Rome, GA USA.-
local.description.affiliation[Toelg, Ralph] Segeberger Kliniken, Herzzentrum, Bad Segeberg, Germany.-
local.description.affiliation[Maksoud, Aziz] Kansas Heart Hosp, Wichita, KS USA.-
local.description.affiliation[Maksoud, Aziz] Univ Kansas, Sch Med, Wichita, KS 67214 USA.-
local.description.affiliation[Chehab, Bassem M.] Ascension Via Christi Hosp, Wichita, KS USA.-
local.description.affiliation[De la Torre Hernandez, Jose M.] Hosp Univ Marques de Valdecilla, IDIVAL, Santander, Spain.-
local.description.affiliation[Kunadian, Vijay] Newcastle Univ, Translat & Clin Res Inst, Newcastle Upon Tyne, Tyne & Wear, England.-
local.description.affiliation[Kunadian, Vijay] Newcastle Upon Tyne Hosp NHS Fdn Trust, Cardiothorac Ctr, Freeman Hosp, Newcastle Upon Tyne, Tyne & Wear, England.-
local.description.affiliation[Sardella, Gennaro] Policlin Umberto I Roma, Rome, Italy.-
local.description.affiliation[Thiele, Holger] Univ Leipzig, Heart Ctr Leipzig, Leipzig, Germany.-
local.description.affiliation[Thiele, Holger] Leipzig Heart Inst, Leipzig, Germany.-
local.description.affiliation[Varenne, Olivier] Hosp Cochin, Paris, France.-
local.description.affiliation[Vranckx, Pascal] Heart Ctr Hasselt, Hasselt, Belgium.-
local.description.affiliation[Vranckx, Pascal] Univ Hasselt, Hasselt, Belgium.-
local.description.affiliation[Windecker, Stephan] Bern Univ Hosp, Bern, Switzerland.-
local.description.affiliation[Zhou, Yujie] Beijing AnZhen Hosp, Beijing, Peoples R China.-
local.description.affiliation[Krucoff, Mitchell W.] Duke Univ, Med Ctr, Durham, NC USA.-
local.description.affiliation[Krucoff, Mitchell W.] Duke Clin Res Inst, Durham, NC USA.-
local.description.affiliation[Ruster, Karine; Wang, Jin] Abbott, Santa Clara, CA USA.-
local.description.affiliation[Valgimigli, Marco] Lugano & Bern Univ Hosp, Cardioctr Ticino, Bern, Switzerland.-
local.uhasselt.internationalyes-
item.fullcitationMehran, Roxana; Cao, Davide; Angiolillo, Dominick J.; Bangalore, Sripal; Bhatt, Deepak L.; Ge, Junbo; Hermiller, James; Makkar, Raj R.; Neumann, Franz-Josef; Saito, Shigeru; Picon, Hector; Toelg, Ralph; Maksoud, Aziz; Chehab, Bassem M.; De la Torre Hernandez, Jose M.; Kunadian, Vijay; Sardella, Gennaro; Thiele, Holger; Varenne, Olivier; VRANCKX, Pascal; Windecker, Stephan; Zhou, Yujie; Krucoff, Mitchell W.; Ruster, Karine; Wang, Jin & Valgimigli, Marco (2021) 3-or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation. In: JACC: cardiovascular interventions (Print) , 14 (17), p. 1870–1883.-
item.accessRightsOpen Access-
item.fulltextWith Fulltext-
item.contributorMehran, Roxana-
item.contributorCao, Davide-
item.contributorAngiolillo, Dominick J.-
item.contributorBangalore, Sripal-
item.contributorBhatt, Deepak L.-
item.contributorGe, Junbo-
item.contributorHermiller, James-
item.contributorMakkar, Raj R.-
item.contributorNeumann, Franz-Josef-
item.contributorSaito, Shigeru-
item.contributorPicon, Hector-
item.contributorToelg, Ralph-
item.contributorMaksoud, Aziz-
item.contributorChehab, Bassem M.-
item.contributorDe la Torre Hernandez, Jose M.-
item.contributorKunadian, Vijay-
item.contributorSardella, Gennaro-
item.contributorThiele, Holger-
item.contributorVarenne, Olivier-
item.contributorVRANCKX, Pascal-
item.contributorWindecker, Stephan-
item.contributorZhou, Yujie-
item.contributorKrucoff, Mitchell W.-
item.contributorRuster, Karine-
item.contributorWang, Jin-
item.contributorValgimigli, Marco-
item.validationecoom 2022-
crisitem.journal.issn1936-8798-
crisitem.journal.eissn1876-7605-
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