Patricia  O Guimarães; Marcelo Franken; Caio  A. M. Tavares; Fabio  S Silveira; Murillo  O Antunes; Ricardo  R Bergo; Rodrigo  M Joaquim; Jessica  C.S. Hirai; Pedro  B Andrade; Fabio  G Pitta; José Mariani Jr.; Bruno  R Nascimento; João  E.T. de Paula; Marcos  S. Silveira; Tiberio  A.O. Costa; Frederico  T.C. Dall’Orto; Renato  G. Serpa; Fernanda  B.A. Sampaio; Louis  N Ohe; Fernanda  M Mangione; Remo  H.M. Furtado; Rogerio Sarmento-Leite; Frederico Monfardini; Silvia  R.L. Assis; José  C. Nicolau; Andrei  C. Sposito; Renato  D. Lopes; Yoshinobu Onuma; Marco Valgimigli; Dominick Angiolillo; Patrick  W. Serruys; Otavio Berwanger; Fernando Bacal; Pedro  A Lemos

doi:10.4244/EIJ-D-23-00125

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

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

Abstract

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...

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