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Randomized Controlled Trial
. 2023 Nov:265:114-120.
doi: 10.1016/j.ahj.2023.07.011. Epub 2023 Jul 28.

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

Niels M R van der Sangen  1 , I Tarik Küçük  1 , Shabiga Sivanesan  1 , Yolande Appelman  2 , Jurriën M Ten Berg  3 , Ashley Verburg  4 , Jaouad Azzahhafi  4 , E Karin Arkenbout  5 , Wouter J Kikkert  5 , Ron Pisters  6 , J Wouter Jukema  7 , Fatih Arslan  7 , Arnoud van 't Hof  8 , Mustafa Ilhan  8 , Loes P Hoebers  8 , René J van der Schaaf  9 , Peter Damman  10 , Pier Woudstra  11 , Tim P van de Hoef  12 , Matthijs Bax  13 , Rutger L Anthonio  14 , Jawed Polad  15 , Tom Adriaenssens  16 , Willem Dewilde  17 , Carlo Zivelonghi  18 , Peep Laanmets  19 , Risko Majas  19 , Marcel G W Dijkgraaf  20 , Bimmer E P M Claessen  1 , José P S Henriques  21
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Free article
Randomized Controlled Trial

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

Niels M R van der Sangen et al. Am Heart J. 2023 Nov.
Free article

Abstract

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.

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Conflict of interest statement

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.

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