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Title: | 3-or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation | Authors: | Mehran, 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 |
Issue Date: | 2021 | Publisher: | ELSEVIER SCIENCE INC | Source: | JACC: cardiovascular interventions (Print) , 14 (17), p. 1870–1883 | Abstract: | OBJECTIVES 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. | Notes: | Mehran, 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. roxana.mehran@mountsinai.org |
Keywords: | bleeding;everolimus-eluting stent;high bleeding risk;percutaneous coronary intervention;short DAPT;thrombosis | Document URI: | http://hdl.handle.net/1942/35759 | ISSN: | 1936-8798 | e-ISSN: | 1876-7605 | DOI: | 10.1016/j.jcin.2021.07.016 | ISI #: | WOS:000696806200009 | Rights: | 2021 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/ ) . | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2022 |
Appears in Collections: | Research publications |
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1-s2.0-S193687982101339X-main.pdf | Published version | 2.59 MB | Adobe PDF | View/Open |
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