Coronary interventions

P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial

EuroIntervention 2023;19:e323-e329. DOI: 10.4244/EIJ-D-23-00125

Patricia  O Guimarães
Patricia O Guimarães1, MD, PhD; Marcelo Franken1, MD, PhD; Caio A. M. Tavares1,2, MD, PhD; Fabio S Silveira3, MD; Murillo O Antunes4, MD, PhD; Ricardo R Bergo5, MD; Rodrigo M Joaquim6, MD; Jessica C.S. Hirai1, PharmD; Pedro B Andrade7, MD, PhD; Fabio G Pitta1,2, MD; José Mariani Jr.1, MD, PhD; Bruno R Nascimento8, MD, PhD; João E.T. de Paula9, MD; Marcos S. Silveira3, MD; Tiberio A.O. Costa4, MD; Frederico T.C. Dall’Orto5, MD; Renato G. Serpa10, MD; Fernanda B.A. Sampaio11, MD; Louis N Ohe12, MD; Fernanda M Mangione13, MD; Remo H.M. Furtado2, MD, PhD; Rogerio Sarmento-Leite14, MD, PhD; Frederico Monfardini1, MSc; Silvia R.L. Assis1, MS; José C. Nicolau2, MD, PhD; Andrei C. Sposito15, MD, PhD; Renato D. Lopes16, MD, PhD; Yoshinobu Onuma17, MD, PhD; Marco Valgimigli18,19, MD, PhD; Dominick J. Angiolillo20, MD, PhD; Patrick W. Serruys17, MD, PhD; Otavio Berwanger1, MD, PhD; Fernando Bacal1,2, MD, PhD; Pedro A Lemos1,2, MD, PhD
1. Hospital Israelita Albert Einstein, São Paulo, Brazil; 2. Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, São Paulo, Brazil and Universidade de São Paulo, São Paulo, Brazil; 3. Research Center, Clínica do Coração, Aracaju, Brazil; 4. Hospital Universitário São Francisco de Assis na Providência de Deus, Bragança Paulista, Brazil; 5. Hospital Santa Lucia, Poços de Caldas, Brazil; 6. Instituto de Cardiologia de Santa Catarina, São José, Brazil; 7. Irmandade da Santa Casa de Misericórdia de Marilia, Marilia, Brazil; 8. Hospital Universitário Ciências Médicas, Belo Horizonte, Brazil; 9. Instituto Cardiovascular de Linhares, Linhares, Brazil; 10. Hospital Santa Casa de Misericórdia de Vitória, Vitória, Brazil; 11. Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil; 12. Dante Pazzanese Institute of Cardiology, São Paulo, Brazil; 13. Beneficência Portuguesa de São Paulo, São Paulo, Brazil; 14. Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil; 15. Department of Internal Medicine, School of Medical Sciences, State University of Campinas, Campinas, Brazil; 16. Duke Clinical Research Institute, Duke University, Durham, NC, USA; 17. Department of Cardiology, University of Galway, Galway, Ireland; 18. Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland; 19. Università della Svizzera Italiana, Lugano, Switzerland; 20. Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator’s discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. ( NCT04360720)

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