P2Y12 inhibitor monotherapy versus dual antiplatelet therapy after complex percutaneous coronary intervention in patients with acute coronary syndromes: a NEO-MINDSET trial substudy.
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Prado Guy F A, Beraldo de Andrade Pedro, Garzon Dias Lemos Stefano, Franken Marcelo, Oliveira Guimaraes Patricia, de Assis Moura Tavares Caio, Grunspun Pitta Fabio, Mateus Teixeira Bezerra Felipe, Carlos Bandeira Willterson, Sanali Maria, Regina Lamas Assis Silvia, Monfardini Frederico, de Carvalho Abrão Lailah Cristina, Coura Rocha Rosana, Mangione Fernanda, Arantes Pazolini Vitor, Justi Bertolin Adriadne, Antunes Murillo, Serra Silveira Fabio, Nascimento Bruno Ramos, Ohe Louis N, Ferreira Esmeralci, Sampaio Fernanda B A, Sarmento-Leite Rogerio, Wainstein Marco V, Guedes Bezerra Cristiano, Airton Arruda Jose, Oliveira Almeida Breno, Paradies Valeria, Mariani Junior Jose, Alves Lemos Neto Pedro
Аннотация
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 co-primary 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 co-primary endpoint (p-interaction=0.68). Likewise, PCI complexity did not have an effect on the comparative risk of BARC Type 2, 3, or 5 bleeding 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 co-primary ischaemic or bleeding outcomes.
CLINICALTRIALS: gov: NCT04360720.