OPTIMA-AF: One-Month Dual Therapy After PCI in Atrial Fibrillation Matches One-Year Regimen, With Less Bleeding

Results from the OPTIMA-AF trial, presented by Yohei Sotomi, MD, PhD of the Osaka University Graduate School of Medicine, Japan, at the American Heart Association (AHA) 2025 Scientific Sessions and simultaneously published in the New England Journal of Medicine, suggest that one month of dual antithrombotic therapy after PCI may be all that’s needed for many patients with atrial fibrillation (AF) and coronary artery disease (CAD).

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Shorter Therapy, Same Efficacy, Less Bleeding

The study enrolled 1,088 patients (mean age 75; 79% men) with AF and stable or unstable angina or silent myocardial ischemia, but excluded those with acute myocardial infarction (STEMI or NSTEMI). All participants underwent imaging-guided PCI with everolimus-eluting stents (Xience, Abbott).

Patients were randomized to either:

• Short-duration therapy: 1 month of a direct oral anticoagulant (DOAC) plus a P2Y12 inhibitor (clopidogrel or prasugrel), followed by DOAC monotherapy for the remaining 11 months.

• Long-duration therapy: The same DOAC plus P2Y12 inhibitor continued for the entire 12 months.

• Aspirin use was optional but limited to the first month post-PCI.

At 1 year, death or thromboembolic events occurred in 5.4% of the short-duration group versus 4.5% of the long-duration group (P = 0.002 for noninferiority). Major or clinically relevant nonmajor bleeding was cut nearly in halfwith shorter therapy (4.8% vs 9.5%; P = 0.004).

“Patients with AF who receive a stent may only need one month of dual antithrombotic therapy instead of one year,” Sotomi said, highlighting the potential to reduce bleeding complications without compromising protection against ischemic events.

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Implications for Clinical Practice

The results support a de-escalation strategy that balances ischemic protection with bleeding risk, aligning with evolving guidelines that favor early discontinuation of antiplatelet therapy in select patients after PCI.

However, experts urged caution before adopting this approach universally. The study population consisted solely of East Asian patients, who may have different bleeding and thrombotic risk profiles than Western populations. Larger, diverse global studies are needed to confirm safety and efficacy across broader patient groups.

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Key Takeaway

In patients with atrial fibrillation undergoing PCI for stable or unstable CAD, one month of DOAC plus P2Y12 inhibitor, followed by DOAC alone, provides similar ischemic protection and significantly less bleeding than continuing dual therapy for a full year. If validated in more diverse populations, this strategy could redefine post-PCI antithrombotic management—offering simpler, safer, and more individualized care.

(Source: AHA 2025 Scientific Sessions; NEJM 2025)