دورية أكاديمية
أعرض في EDS

Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study.

التفاصيل البيبلوغرافية
العنوان: Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study.
المؤلفون: van der Sangen NMR; Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands., Küçük IT; Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands., Sivanesan S; Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands., Appelman Y; Department of Cardiology, Amsterdam UMC, VU University, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands., Ten Berg JM; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), University Medical Center Maastricht, Maastricht, The Netherlands., Verburg A; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands., Azzahhafi J; Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands., Arkenbout EK; Department of Cardiology, Tergooi Hospital, Hilversum, The Netherlands., Kikkert WJ; Department of Cardiology, Tergooi Hospital, Hilversum, The Netherlands., Pisters R; Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands., Jukema JW; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands., Arslan F; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands., van 't Hof A; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), University Medical Center Maastricht, Maastricht, The Netherlands; Department of Cardiology, Zuyderland Medical Center, Heerlen, The Netherlands., Ilhan M; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), University Medical Center Maastricht, Maastricht, The Netherlands; Department of Cardiology, Zuyderland Medical Center, Heerlen, The Netherlands., Hoebers LP; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), University Medical Center Maastricht, Maastricht, The Netherlands; Department of Cardiology, Zuyderland Medical Center, Heerlen, The Netherlands., van der Schaaf RJ; Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands., Damman P; Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands., Woudstra P; Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands., van de Hoef TP; Department of Cardiology, University Medical Center Maastricht, Maastricht, The Netherlands., Bax M; Department of Cardiology, Haga Teaching Hospital, The Hague, The Netherlands., Anthonio RL; Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, The Netherlands., Polad J; Department of Cardiology, Jeroen Bosch Ziekenhuis, Hertogenbosch, The Netherlands., Adriaenssens T; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium., Dewilde W; Department of Cardiology, Imelda Hospital Bonheiden, Bonheiden, Belgium., Zivelonghi C; Department of Cardiology, HartCentrum, Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium., Laanmets P; Department of Cardiology, North Estonia Medical Center Foundation, Tallinn, Estonia., Majas R; Department of Cardiology, North Estonia Medical Center Foundation, Tallinn, Estonia., Dijkgraaf MGW; Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands., Claessen BEPM; Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands., Henriques JPS; Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. Electronic address: j.p.henriques@amsterdamumc.nl.
المصدر: American heart journal [Am Heart J] 2023 Nov; Vol. 265, pp. 114-120. Date of Electronic Publication: 2023 Jul 28.
نوع المنشور: Randomized Controlled Trial; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
أسماء مطبوعة: Original Publication: St. Louis, MO : Mosby
مواضيع طبية MeSH: Acute Coronary Syndrome*/drug therapy , Acute Coronary Syndrome*/surgery , Percutaneous Coronary Intervention*/methods, Humans ; Aspirin ; Platelet Aggregation Inhibitors/adverse effects ; Drug Therapy, Combination ; Hemorrhage/chemically induced ; Treatment Outcome
مستخلص: Background: Early aspirin withdrawal, also known as P2Y 12 -inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI.
Methods: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y 12 -inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT.
Conclusions: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y 12 -inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.
Competing Interests: Disclosures Dr. Yolande Appelman has received a research grant from the Dutch Heart Foundation. Prof. dr. Jurriën M. ten Berg has received research grants from the ZonMw and speaker fees from Accumetrics, AstraZeneca, Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo, Eli Lilly, Ferrer, the Medicines Company and Pfizer. Dr. Peter Damman has received a research grant from AstraZeneca. Dr. Tim P. van de Hoef has received research grants and speaker fees and from Abbott and Philips. Dr. Bimmer E.P.M. Claessen has received speaker fees from Abiomed and consultancy fees from Amgen, Sanofi, Boston Scientific and Philips. Prof. dr. José P.S. Henriques has received research grants from Abbott Vascular, AstraZeneca, B. Braun, Getinge, Ferrer, Infraredx and ZonMw. All other authors have no relationships with industry to disclose.
(Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
المشرفين على المادة: R16CO5Y76E (Aspirin)
0 (Platelet Aggregation Inhibitors)
تواريخ الأحداث: Date Created: 20230730 Date Completed: 20231023 Latest Revision: 20231120
رمز التحديث: 20240628
DOI: 10.1016/j.ahj.2023.07.011
PMID: 37517430
قاعدة البيانات: MEDLINE
الوصف
تدمد:1097-6744
DOI:10.1016/j.ahj.2023.07.011