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, I. Tarik Küçük, S. Sivanesan, Yolande Appelman, Jurriën M. ten Berg, Ashley Verburg, Jaouad Azzahhafi, E. Karin Arkenbout, Wouter J. Kikkert, Ron Pisters, J. Wouter Jukema, Fatih Arslan, Arnoud W.J. van ‘t Hof, Mustafa İlhan, Loes P. Hoebers, René J. van der Schaaf, Peter Damman, Pier Woudstra, Tim P. van de Hoef, Matthijs Bax, Rutger L. Anthonio, Jawed Polad, Tom Adriaenssens, Willem Dewilde, Carlo Zivelonghi, Peep Laanmets, Risko Majas, Marcel G. W. Dijkgraaf, Bimmer E. Claessen, José P.S. Henriques
Abstract
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. 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 3090 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 non-inferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT. 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.