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; Shabiga 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 van 't Hof; Mustafa Ilhan; 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 P M Claessen; José P S Henriques

doi:10.1016/j.ahj.2023.07.011

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, Shabiga 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 van 't Hof, Mustafa Ilhan, Loes P Hoebers, René J van der Schaaf, Peter Damman, Pier Woudstra, Tim P van de Hoef, Matthijs BaxRutger L Anthonio, Jawed Polad, Tom Adriaenssens, Willem Dewilde, Carlo Zivelonghi, Peep Laanmets, Risko Majas, Marcel G W Dijkgraaf, Bimmer E P M Claessen, José P S Henriques^*

^*Corresponding author for this work

Division of Heart & Lungs

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Pages (from-to)	114-120
Number of pages	7
Journal	American Heart Journal
Volume	265
DOIs	https://doi.org/10.1016/j.ahj.2023.07.011
Publication status	Published - Nov 2023

Keywords

Acute Coronary Syndrome/drug therapy
Aspirin
Drug Therapy, Combination
Hemorrhage/chemically induced
Humans
Percutaneous Coronary Intervention/methods
Platelet Aggregation Inhibitors/adverse effects
Treatment Outcome

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van der Sangen, N. M. R., Küçük, I. T., Sivanesan, S., Appelman, Y., Ten Berg, J. M., Verburg, A., Azzahhafi, J., Arkenbout, E. K., Kikkert, W. J., Pisters, R., Jukema, J. W., Arslan, F., van 't Hof, A., Ilhan, M., Hoebers, L. P., van der Schaaf, R. J., Damman, P., Woudstra, P., van de Hoef, T. P., ... Henriques, J. P. S. (2023). Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study. American Heart Journal, 265, 114-120. https://doi.org/10.1016/j.ahj.2023.07.011

@article{58fe8eedb5de4a8f8bc021773bf34230,

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

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.",

keywords = "Acute Coronary Syndrome/drug therapy, Aspirin, Drug Therapy, Combination, Hemorrhage/chemically induced, Humans, Percutaneous Coronary Intervention/methods, Platelet Aggregation Inhibitors/adverse effects, Treatment Outcome",

author = "{van der Sangen}, {Niels M R} and K{\"u}{\c c}{\"u}k, {I Tarik} and Shabiga Sivanesan and Yolande Appelman and {Ten Berg}, {Jurri{\"e}n M} and Ashley Verburg and Jaouad Azzahhafi and Arkenbout, {E Karin} and Kikkert, {Wouter J} and Ron Pisters and Jukema, {J Wouter} and Fatih Arslan and {van 't Hof}, Arnoud and Mustafa Ilhan and Hoebers, {Loes P} and {van der Schaaf}, {Ren{\'e} J} and Peter Damman and Pier Woudstra and {van de Hoef}, {Tim P} and Matthijs Bax and Anthonio, {Rutger L} and Jawed Polad and Tom Adriaenssens and Willem Dewilde and Carlo Zivelonghi and Peep Laanmets and Risko Majas and Dijkgraaf, {Marcel G W} and Claessen, {Bimmer E P M} and Henriques, {Jos{\'e} P S}",

note = "Publisher Copyright: {\textcopyright} 2023 The Author(s)",

year = "2023",

month = nov,

doi = "10.1016/j.ahj.2023.07.011",

language = "English",

volume = "265",

pages = "114--120",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby Inc.",

}

van der Sangen, NMR, Küçük, IT, Sivanesan, S, Appelman, Y, Ten Berg, JM, Verburg, A, Azzahhafi, J, Arkenbout, EK, Kikkert, WJ, Pisters, R, Jukema, JW, Arslan, F, van 't Hof, A, Ilhan, M, Hoebers, LP, van der Schaaf, RJ, Damman, P, Woudstra, P, van de Hoef, TP, Bax, M, Anthonio, RL, Polad, J, Adriaenssens, T, Dewilde, W, Zivelonghi, C, Laanmets, P, Majas, R, Dijkgraaf, MGW, Claessen, BEPM & Henriques, JPS 2023, 'Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study', American Heart Journal, vol. 265, pp. 114-120. https://doi.org/10.1016/j.ahj.2023.07.011

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

PY - 2023/11

Y1 - 2023/11

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.

KW - Acute Coronary Syndrome/drug therapy

KW - Aspirin

KW - Drug Therapy, Combination

KW - Hemorrhage/chemically induced

KW - Humans

KW - Percutaneous Coronary Intervention/methods

KW - Platelet Aggregation Inhibitors/adverse effects

KW - Treatment Outcome

UR - http://www.scopus.com/inward/record.url?scp=85166750415&partnerID=8YFLogxK

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

ER -

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

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