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

BACKGROUND: Whether the anatomical complexity of percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS) influences the effects of antiplatelet therapy remains unknown. AIMS: 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: inhibitor monotherapy versus DAPT on the coprimary ischaemic or bleeding outcomes. CLINICALTRIALS: gov: NCT04360720.