NOAC monotherapy beyond 12 months after PCI reduced bleeding regardless of PCI complexity compared to NOAC plus clopidogrel (P=0.02), with no significant difference in ischemic outcomes.
RCT
Does NOAC monotherapy improve clinical outcomes compared to NOAC plus clopidogrel in patients with atrial fibrillation and prior complex PCI?
NOAC monotherapy beyond 12 months after PCI reduces bleeding without significantly increasing ischemic risk, even in patients with prior complex PCI.
p-value: p==0.02
BACKGROUND: In patients with atrial fibrillation and chronic coronary syndrome beyond 12 months after percutaneous coronary intervention (PCI), oral anticoagulant monotherapy is recommended by the guideline; however, its efficacy and safety in patients with complex PCI remain uncertain. METHODS: We conducted a post hoc analysis of the randomized ADAPT AF-DES trial (Appropriate Duration of Antiplatelet and Thrombotic Strategy After 12 Months in Patients With Atrial Fibrillation Treated With Drug-Eluting Stents), which compared non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy with NOAC plus clopidogrel in patients with atrial fibrillation ≥12 months after second- or third-generation drug-eluting stent implantation. Complex PCI was defined by one of the following characteristics: ≥3 stents, ≥3 lesions, bifurcation with 2 stents, total stent length ≥60 mm, left main PCI, or chronic total occlusion PCI. Net adverse clinical events, ischemic composite outcomes, and bleeding composite outcomes were evaluated according to PCI complexity. RESULTS: =0.02), with no significant interaction. Ischemic outcomes were infrequent and did not differ significantly between treatment strategies regardless of PCI complexity, whereas bleeding outcomes were consistently lower with NOAC monotherapy in both complex and noncomplex PCI groups. CONCLUSIONS: In this post hoc analysis of the randomized ADAPT AF-DES trial, NOAC monotherapy beyond 12 months after PCI was associated with a substantial reduction in bleeding regardless of PCI complexity. Although limited by low absolute event rates, ischemic outcomes did not differ significantly between treatment strategies. These findings suggest that a bleeding-focused long-term antithrombotic strategy may be reasonable in patients with atrial fibrillation and chronic coronary syndrome, including those with prior complex PCI, although prospective validation remains warranted. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04250116.
Jeon et al. (Fri,) conducted a rct in Atrial fibrillation and chronic coronary syndrome. NOAC monotherapy vs. NOAC plus clopidogrel was evaluated on Net adverse clinical events, ischemic composite outcomes, and bleeding composite outcomes (p==0.02). NOAC monotherapy beyond 12 months after PCI reduced bleeding regardless of PCI complexity compared to NOAC plus clopidogrel (P=0.02), with no significant difference in ischemic outcomes.