Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes

Guimarães, Patricia O. M.D., Ph.D.
Franken, Marcelo M.D., Ph.D.
Tavares, Caio A.M. M.D., Ph.D.
Antunes, Murillo O. M.D., Ph.D.
Silveira, Fabio S. M.D.
Andrade, Pedro B. M.D., Ph.D.
Bergo, Ricardo R. M.D.
Joaquim, Rodrigo M. M.D.
Tinoco de Paula, João E. M.D.
Nascimento, Bruno R. M.D., Ph.D.
Pitta, Fabio G. M.D., Ph.D.
Arruda, José A. M.D., Ph.D.
Serpa, Renato G. M.D.
Ohe, Louis N. M.D.
Mangione, Fernanda M. M.D.
Furtado, Remo H.M. M.D., Ph.D.
Ferreira, Esmeralci M.D., Ph.D.
Sampaio, Fernanda B.A. M.D.
T. Nascimento, Charlene do M.D.
Genelhu, Luiz O.O. M.D.
Bezerra, Cristiano G. M.D., Ph.D.
Sarmento-Leite, Rogério M.D., Ph.D.
Maia, Lilia N. M.D., Ph.D.
Oliveira, Flavio R.A. M.D.
Wainstein, Marco V. M.D., Ph.D.
Dall’Orto, Frederico T.C. M.D.
Monfardini, Frederico M.Sc.
Assis, Silvia R.L. M.S.
Nicolau, José C. M.D., Ph.D.
Sposito, Andrei C. M.D., Ph.D.
Lopes, Renato D. M.D., Ph.D.
Onuma, Yoshinobu M.D., Ph.D.
Valgimigli, Marco M.D., Ph.D.
Angiolillo, Dominick J. M.D., Ph.D.
Serruys, Patrick W.J.C. M.D., Ph.D.
Berwanger, Otavio M.D., Ph.D.
Bacal, Fernando M.D., Ph.D.
Lemos, Pedro A. M.D., Ph.D.

¹Hospital Israelita Albert Einstein, São Paulo
²Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo
³Hospital Universitário São Francisco de Assis na Providência de Deus da Universidade São Francisco, Bragança Paulista, Brazil
⁴Centro de Pesquisa Clínica do Coração, Aracaju, Brazil
⁵Irmandade da Santa Casa de Misericórdia de Marilia, Marilia, Brazil
⁶Hospital Santa Lucia, Poços de Caldas, Brazil
⁷Instituto de Cardiologia de Santa Catarina, São José, Brazil
⁸Instituto Cardiovascular de Linhares, Linhares, Brazil
⁹Hospital Universitário Ciências Médicas, Belo Horizonte, Brazil
¹⁰Hospital Evangélico de Vila Velha, Vila Velha, Brazil
¹¹Hospital Santa Casa de Misericórdia de Vitória, Vitória, Brazil
¹²Dante Pazzanese Institute of Cardiology, São Paulo
¹³A Beneficiência Portuguesa de São Paulo, São Paulo
¹⁴Brazilian Clinical Research Institute, São Paulo
¹⁵Universidade do Estado do Rio de Janeiro, Rio de Janeiro
¹⁶Instituto Nacional de Cardiologia, Rio de Janeiro
¹⁷Hospital Regional de Presidente Prudente, Presidente Prudente, Brazil
¹⁸Hospital Municipal Antonio Giglio, Osasco, Brazil
¹⁹Hospital Ana Nery, Salvador, Brazil
²⁰Instituto de Cardiologia do Rio Grande do Sul–Fundação Universitária de Cardiologia, Porto Alegre, Brazil
²¹Centro Integrado de Pesquisa, Hospital de Base, São José do Rio Preto, Brazil
²²Instituto de Medicina Integral Prof Fernando Filgueira, Recife, Brazil
²³Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
²⁴Department of Internal Medicine, School of Medical Sciences, State University of Campinas, Campinas, Brazil
²⁵Duke Clinical Research Institute, Duke University, Durham, NC
²⁶Department of Cardiology, University of Galway, Galway, Ireland
²⁷Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano, Switzerland
²⁸Division of Cardiology, University of Florida College of Medicine, Jacksonville
²⁹George Institute for Global Health UK, London
³⁰Imperial College London, London

Dr. Lemos can be contacted at [email protected] or at Hospital Israelita Albert Einstein, Avenue Albert Einstein 627, São Paulo-SP, Brazil 05620-900.

* A full list of NEO-MINDSET Trial Investigators is provided in the Supplementary Appendix, available at NEJM.org.

New England Journal of Medicine Publish Ahead of Print, August 31, 2025. | DOI: 10.1056/NEJMoa2507980

Abstract

Background

Whether potent P2Y12 inhibitor monotherapy without aspirin initiated shortly after successful percutaneous coronary intervention (PCI) is effective and safe for patients with acute coronary syndromes is unclear.

Methods

We conducted a multicenter, open-label, randomized trial in Brazil involving patients with acute coronary syndromes who had undergone successful PCI. Patients were assigned in a 1:1 ratio within the first 4 days of hospitalization to stop treatment with aspirin and receive potent P2Y12 inhibitor monotherapy (ticagrelor or prasugrel) or to receive dual antiplatelet therapy (aspirin and a potent P2Y12 inhibitor) for 12 months. The two ranked primary outcomes, assessed through 12 months, were a composite of death from any cause, myocardial infarction, stroke, or urgent target-vessel revascularization (tested for noninferiority, with a noninferiority margin of 2.5 percentage points) and major or clinically relevant nonmajor bleeding (tested for superiority).

Results

A total of 3410 patients were included in the intention-to-treat population (1712 in the monotherapy group and 1698 in the dual antiplatelet therapy group). At 12 months, death from any cause, myocardial infarction, stroke, or urgent revascularization had occurred in 119 patients (Kaplan–Meier estimate, 7.0%) in the monotherapy group and in 93 patients (Kaplan–Meier estimate, 5.5%) in the dual antiplatelet therapy group (absolute risk difference, 1.47 percentage points; 95% confidence interval [CI], −0.16 to 3.10; P=0.11 for noninferiority). Major or clinically relevant nonmajor bleeding had occurred in 33 patients (Kaplan–Meier estimate, 2.0%) in the monotherapy group and in 82 patients (Kaplan–Meier estimate, 4.9%) in the dual antiplatelet therapy group (absolute risk difference, −2.97 percentage points; 95% CI, −4.20 to −1.73). Stent thrombosis occurred in 12 patients in the monotherapy group and in 4 in the dual antiplatelet therapy group.

Conclusions

Among patients who had undergone successful PCI for acute coronary syndromes, potent P2Y12 inhibitor monotherapy was not found to be noninferior to dual antiplatelet therapy with respect to a composite of death or ischemic events at 12 months. (Funded by the Brazilian Ministry of Health; NEO-MINDSET ClinicalTrials.gov number, NCT04360720.)

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