Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study - 11/10/23
Doi : 10.1016/j.ahj.2023.07.011
Niels M.R. van der Sangen, MD a, ⁎, I. Tarik Küçük, MD a, ⁎, Shabiga Sivanesan, MD a, Yolande Appelman, MD, PhD b, Jurriën M. ten Berg, MD, PhD c, d, Ashley Verburg, MD c, Jaouad Azzahhafi, MD c, E. Karin Arkenbout, MD, PhD e, Wouter J. Kikkert, MD, PhD e, Ron Pisters, MD, PhD f, J. Wouter Jukema, MD, PhD g, Fatih Arslan, MD, PhD g, Arnoud van ‘t Hof, MD, PhD d, h, Mustafa Ilhan, MD d, h, Loes P. Hoebers, MDPhD d, h, René J. van der Schaaf, MD, PhD i, Peter Damman, MD, PhD j, Pier Woudstra, MD, PhD k, Tim P. van de Hoef, MD, PhD l, Matthijs Bax, MD, PhD m, Rutger L. Anthonio, MD, PhD n, Jawed Polad, MD, MRCP o, Tom Adriaenssens, MD, PhD p, Willem Dewilde, MD, PhD q, Carlo Zivelonghi, MD, PhD r, Peep Laanmets, MD, PhD s, Risko Majas, MD s, Marcel G.W. Dijkgraaf, PhD t, Bimmer E.P.M. Claessen, MD, PhD a, José P.S. Henriques, MD, PhD a, ⁎ 
a Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands
b Department of Cardiology, Amsterdam UMC, VU University, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands
c Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands
d Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), University Medical Center Maastricht, Maastricht, The Netherlands
e Department of Cardiology, Tergooi Hospital, Hilversum, The Netherlands
f Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands
g Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
h Department of Cardiology, Zuyderland Medical Center, Heerlen, The Netherlands
i Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands
j Department of Cardiology, Radboud University Medical Centre, Nijmegen, The Netherlands
k Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands
l Department of Cardiology, University Medical Center Maastricht, Maastricht, The Netherlands
m Department of Cardiology, Haga Teaching Hospital, The Hague, The Netherlands
n Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, The Netherlands
o Department of Cardiology, Jeroen Bosch Ziekenhuis, Hertogenbosch, The Netherlands
p Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium
q Department of Cardiology, Imelda Hospital Bonheiden, Bonheiden, Belgium
r Department of Cardiology, HartCentrum, Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium
s Department of Cardiology, North Estonia Medical Center Foundation, Tallinn, Estonia
t Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
#Reprint requests: José P.S. Henriques, MD, PhD, Department of Cardiology, Amsterdam UMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.Department of CardiologyAmsterdam UMCMeibergdreef 9Amsterdam1105 AZThe Netherlands
Résumé |
Background |
Early aspirin withdrawal, also known as P2Y12-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 P2Y12-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 P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.
Le texte complet de cet article est disponible en PDF.Abbreviations : ACS, BARC, CCS, DAPT, LEGACY, MI, NSTE-ACS, NSTEMI, PCI
Plan
© 2023
The Author(s). Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 265
P. 114-120 - novembre 2023 Retour au numéro
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