Guy Prado; Pedro de; Stefano Dias; Marcelo Franken; Patricia Guimaraes; Caio Assis; Fabio Pitta; Felipe Teixeira; Willterson Bandeira; Maria Sanali; Silvia Lamas; Frederico Monfardini; Lailah de; Rosana Rocha; Fernanda Mangione; Vitor Pazolini; Adriadne Bertolin; Murillo Antunes; Fabio Silveira; Bruno Nascimento; Louis Ohe; Esmeralci Ferreira; Fernanda Sampaio; Rogerio Sarmento-Leite; Marco Wainstein; Cristiano Bezerra; Jose Arruda; Breno Almeida; Valeria Paradies; Jose Junior; Pedro Lemos

doi:10.4244/EIJ-D-26-00409

P2Y12 inhibitor monotherapy versus dual antiplatelet therapy after complex percutaneous coronary intervention in patients with acute coronary syndromes: a NEO-MINDSET trial substudy

Guy F.A. Prado¹^,², MD; Pedro Beraldo de³, MD, PhD; Stefano Garzon Dias¹^,², MD; Marcelo Franken¹, MD, PhD; Patricia Oliveira Guimaraes¹, MD; Caio de Assis¹^,⁴, MD, PhD; Fabio Grunspun Pitta¹^,⁴, MD, PhD; Felipe Mateus Teixeira¹, MD; Willterson Carlos Bandeira¹, MD; Maria Sanali⁵, MD, PhD; Silvia Regina Lamas¹, MSc; Frederico Monfardini¹, MSc; Lailah Cristina de¹, MSc, PhD; Rosana Coura Rocha¹, BSN; Fernanda Mangione⁶, MD; Vitor Arantes Pazolini⁷, MD; Adriadne Justi Bertolin⁴, MD, PhD; Murillo Antunes⁴^,⁸, MD, PhD; Fabio Serra Silveira⁹, MD; Bruno Ramos Nascimento¹⁰, MD, PhD; Louis N. Ohe¹¹, MD; Esmeralci Ferreira¹², MD, PhD; Fernanda B.A. Sampaio¹³, MD; Rogerio Sarmento-Leite¹⁴, MD, PhD; Marco V. Wainstein¹⁵, MD, PhD; Cristiano Guedes Bezerra¹⁶, MD, PhD; Jose Airton Arruda⁷, MD, PhD; Breno Oliveira Almeida¹, MD, PhD; Valeria Paradies¹⁷, MD, MSc; Jose Mariani Junior¹, MD, PhD; Pedro Alves Lemos¹^,¹⁸, MD, PhD

Abstract

Background: Whether the anatomical complexity of percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS) influences the effects of antiplatelet therapy remains unknown.

Aims: We aimed to evaluate the impact of coronary anatomical complexity on clinical outcomes in patients receiving potent P2Y₁₂ inhibitor monotherapy or dual antiplatelet therapy (DAPT).

Methods: In the NEO-MINDSET trial, patients with ACS were randomised after successful PCI to 12-month ticagrelor- or prasugrel-based monotherapy or DAPT initiated within the first 4 days of hospitalisation. The coprimary endpoints were (i) a composite of death, myocardial infarction, urgent target vessel revascularisation, or stroke; and (ii) Bleeding Academic Research Consortium (BARC) Type 2, 3, or 5 bleeding. Complex PCI was defined by one or more of the following criteria: three-vessel PCI, ≥3 treated lesions, ≥3 stents implanted, total stent length >60 mm, two-stent bifurcation, or stenting in the left main coronary artery, in a bypass graft, or in a chronic total occlusion lesion.

Results: Of the 3,408 randomised patients with available procedural data, 791 (23.2%) underwent complex PCI. Compared with the non-complex PCI group, patients in the complex PCI group were older (mean age 60.63±10.52 years vs 59.33±10.83 years; p=0.005) and had a higher prevalence of hypertension (67.9% vs 62.9%; p=0.010). Among patients undergoing complex PCI, 1, 2, or ≥3 complexity criteria were present in 45.5% (n=360), 22.5% (n=178), and 32.0% (n=253), respectively. PCI complexity did not significantly modify the treatment effects of monotherapy versus DAPT on the ischaemic coprimary endpoint (p-interaction=0.68). Likewise, PCI complexity did not have an effect on the comparative risk of BARC Type 2, 3, or 5 bleedings between monotherapy versus DAPT.

Conclusions: In this post hoc analysis of the NEO-MINDSET trial, PCI complexity did not significantly modify the treatment effects of potent P2Y₁₂ inhibitor monotherapy versus DAPT on the coprimary ischaemic or bleeding outcomes. ClinicalTrials.gov: NCT04360720

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