1-month versus 12-month dual antithrombotic therapy after percutaneous coronary intervention in patients with atrial fibrillation (OPTIMA-AF): a multicentre, open-label, hybrid non-inferiority and superiority, randomised, controlled trial

BACKGROUND: The optimal duration of dual antithrombotic therapy after percutaneous coronary intervention (PCI) in patients with atrial fibrillation remains uncertain. We aimed to compare the efficacy and safety of 1-month versus 12-month dual antithrombotic therapy in this population. METHODS: OPTIMA-AF was an active-control, randomised, hybrid non-inferiority and superiority trial in which patients with atrial fibrillation undergoing PCI with intravascular imaging guidance were randomly assigned (1:1) to receive 1-month dual antithrombotic therapy (direct oral anticoagulant DOAC plus P2Y12 inhibitor) followed by DOAC monotherapy or 12-month dual therapy followed by DOAC monotherapy, across 75 sites in Japan. Eligible patients were aged 20 years or older with non-valvular atrial fibrillation, a CHADS FINDINGS: From Oct 7, 2019, to Sept 3, 2024, 1101 patients were assessed for eligibility; 1088 were randomly assigned to treatment and 1079 were included in the full analysis set (1-month dual therapy n=542; 12-month dual therapy n=537). Median age was 76 years (IQR 70-81). 225 (21%) of 1079 patients were female and 854 (79%) were male. Median CHADS INTERPRETATION: Among patients with atrial fibrillation and predominantly chronic coronary syndrome undergoing PCI with intravascular imaging guidance, 1-month dual antithrombotic therapy followed by DOAC monotherapy was non-inferior to 12-month therapy for death or thromboembolic events and reduced major or clinically relevant non-major bleeding at 12 months, suggesting an overall favourable net clinical profile. Efficacy findings should be interpreted with appropriate caution in light of the lower-than-anticipated event rates and fixed absolute non-inferiority margin. FUNDING: Abbott Medical Japan. TRANSLATIONS: For the Japanese translation of the abstract see Supplementary Materials section.