TY - JOUR
T1 - Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients
T2 - Rationale and design of the LEGACY study
AU - van der Sangen, Niels M.R.
AU - Küçük, I. Tarik
AU - Sivanesan, Shabiga
AU - Appelman, Yolande
AU - ten Berg, Jurriën M.
AU - Verburg, Ashley
AU - Azzahhafi, Jaouad
AU - Arkenbout, E. Karin
AU - Kikkert, Wouter J.
AU - Pisters, Ron
AU - Jukema, J. Wouter
AU - Arslan, Fatih
AU - van ‘t Hof, Arnoud
AU - Ilhan, Mustafa
AU - Hoebers, Loes P.
AU - van der Schaaf, René J.
AU - Damman, Peter
AU - Woudstra, Pier
AU - van de Hoef, Tim P.
AU - Bax, Matthijs
AU - Anthonio, Rutger L.
AU - Polad, Jawed
AU - Adriaenssens, Tom
AU - Dewilde, Willem
AU - Zivelonghi, Carlo
AU - Laanmets, Peep
AU - Majas, Risko
AU - Dijkgraaf, Marcel G.W.
AU - Claessen, Bimmer E.P.M.
AU - Henriques, José P.S.
N1 - Funding Information:
The LEGACY study is funded through research grants from ZonMw (grant number: 10140022010007 ) and AstraZeneca . The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final content.
Funding Information:
The LEGACY study (ClinicalTrials.gov unique identifier NCT05125276) is an open-label, multicenter randomized controlled trial designed and sponsored by the Amsterdam University Medical Centers. The study is funded through a research grant from the Rational Pharmacotherapy Programme of ZonMw (grant number: 10140022010007) and a research grant from AstraZeneca. The steering committee is solely responsible for the study design, trial execution, data-analysis and reporting of results. The primary objective of our study is to determine 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 ( Figure 1 ). The study has been designed in accordance with the principles of the Declaration of Helsinki, including the requirement for each patient's written informed consent before initiation of any study-specific procedures.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/11/1
Y1 - 2023/11/1
N2 - 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.
AB - 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.
U2 - 10.1016/j.ahj.2023.07.011
DO - 10.1016/j.ahj.2023.07.011
M3 - Article
C2 - 37517430
SN - 0002-8703
VL - 265
SP - 114
EP - 120
JO - American Heart Journal
JF - American Heart Journal
IS - 1
ER -