Key Points:
• In patients with atrial fibrillation (AF) undergoing PCI, prolonged dual antithrombotic therapy increases bleeding risk.
• OPTIMA-AF tested whether one-month of dual therapy (DOAC + P2Y12i) followed by DOAC alone was as effective as 12 months of dual therapy.
• The shorter strategy was noninferior for thromboembolic events and significantly reduced clinically relevant bleeding.
• These results support a shorter dual antithrombotic strategy in selected AF patients undergoing PCI.
Antithrombotic management in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) remains a clinical challenge due to competing risks of thromboembolism and bleeding. While prolonged dual therapy with a direct oral anticoagulant (DOAC) and antiplatelet agent has been standard, recent strategies have moved toward shortening the duration to minimize bleeding.
The OPTIMA-AF trial (jRCTs051190053) was a multicenter, open-label, blinded-endpoint randomized study conducted across 75 sites in Japan. The trial protocol was previously published.1 A total of 1,088 patients with AF (CHA₂DS₂-VASc ≥1) undergoing PCI with imaging-guided implantation of everolimus-eluting stents were randomized 1:1 to receive either one month or 12 months of dual therapy (DOAC + P2Y12 inhibitor), followed by DOAC monotherapy.
During a Late-Breaking Clinical Trials session at the American Heart Association (AHA) 2025 Scientific Sessions on November 8, 2025, Dr. Yohei Sotomi from Osaka University presented the findings. The primary efficacy endpoint was a composite of all-cause death, myocardial infarction, definite stent thrombosis, stroke, or systemic embolism at 12 months. The primary safety endpoint was major or clinically relevant non-major bleeding per ISTH definition.
At 12 months, the efficacy endpoint occurred in 5.4% of patients in the one-month group and 4.5% in the 12-month group (risk difference 0.9%, 95% CI –1.7 to +3.5), meeting the criterion for noninferiority (P for noninferiority = 0.002). Notably, bleeding rates were significantly lower in the one-month group: 4.8% vs. 9.5% (hazard ratio [HR] 0.50, 95% CI 0.31–0.80; P = 0.004 for superiority).
Secondary endpoints, including rates of myocardial infarction, stroke, and cardiovascular death, were similar between groups. Most patients were on apixaban (57.2%) or rivaroxaban (35.9%), and results were consistent across key subgroups.
In his presentation, Dr. Sotomi remarked, “OPTIMA-AF is the first randomized trial to demonstrate that one month of dual antithrombotic therapy is sufficient after PCI in AF patients. With no compromise in ischemic protection and a 50% reduction in clinically relevant bleeding, this approach could shift our current practice.”
Study limitations include its open-label design, exclusion of high-risk ACS patients, almost universal use of intracoronary imaging, and limited generalizability beyond the East Asian population. Nonetheless, OPTIMA-AF provides strong evidence in favor of a shorter dual therapy strategy in stable AF patients undergoing modern PCI. The study was funded by Abbott Medical Japan.
