OPTIMA AF: Short-duration dual antithrombotic therapy after PCI in patients with atrial fibrillation

The OPTIMA AF study evaluates the safety and efficacy of an abbreviated antithrombotic strategy in patients with atrial fibrillation undergoing PCI. 

Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) represent a clinical challenge, as they require oral anticoagulation to prevent stroke and antiplatelet therapy to avoid stent thrombosis. The combination of these therapies increases bleeding risk, making it crucial to define the optimal duration of dual antithrombotic therapy. 

The OPTIMA AF trial, a prospective, open-label, randomized study conducted at 75 centers in Japan, evaluated whether a 1-month dual therapy regimen, followed by direct oral anticoagulant (DOAC) monotherapy, would be non-inferior to a standard 12-month dual therapy regimen in terms of thromboembolic events, with a potential reduction in bleeding. A total of 1,101 patients with AF and stable coronary artery disease were treated with everolimus-eluting stents and randomized 1:1 between the two regimens. The use of intracoronary imaging (OCT/IVUS) was nearly universal, exceeding 99%. 

The primary efficacy endpoint, a composite of death or thromboembolic events (myocardial infarction, stent thrombosis, stroke, or systemic embolism), occurred in 5.4% of patients receiving 1-month dual therapy and 4.5% of those receiving 12-month therapy, an absolute difference of +0.9% (95% CI, −1.7 to +3.5), meeting the non-inferiority criterion (p=0.002). The primary safety endpoint, major or clinically relevant non-major bleeding (ISTH criteria), was significantly lower with the shorter strategy (4.8% vs. 9.5%; HR 0.50; 95% CI, 0.31–0.80; p=0.004). Therefore, the study met its first two prespecified hypotheses — non-inferiority for efficacy and superiority for safety — but did not show superiority for ischemic outcomes alone. 

Among the study limitations, the authors noted the open-label design, the exclusive enrollment of a Japanese population — known to have a lower ischemic event rate and higher bleeding susceptibility — and the near-universal use of intracoronary imaging, which may limit generalizability. Additionally, the lower-than-expected event rate resulted in a relatively wide non-inferiority margin. 

In summary, among patients with AF undergoing PCI primarily for chronic coronary syndrome, a 1-month dual antithrombotic regimen followed by DOAC monotherapy proved non-inferior to the standard 12-month strategy for thromboembolic outcomes and superior in reducing bleeding, yielding an overall favorable clinical profile. These findings support the growing concept that less may be more in post-PCI antithrombotic management for AF, though extrapolation to other populations and acute settings should be made cautiously. 

Editorial note: This content was developed with the support of artificial intelligence technologies to optimize writing and structure. All material has been carefully reviewed, validated, and supplemented by human experts prior to publication to ensure scientific accuracy and compliance with editorial best practices. 

Referências:  

1. Sotomi Y, Kozuma K, Higuchi Y, et al. Short Dual Antithrombotic Therapy After PCI in Patients With Atrial Fibrillation: The OPTIMA AF Trial. Presented at the American Heart Association Scientific Sessions (AHA®) 2025.