New research presented at the American Heart Association’s Scientific Sessions 2025 suggests that a simplified one-month regimen of dual anti-clotting medication after stent placement is as effective as the standard year-long course for adults with atrial fibrillation (AFib), while substantially lowering bleeding risks. The findings, released on November 8, 2025, in New Orleans, could prompt a shift in clinical practice for managing these high-risk patients.
The OPTIMA-AF trial, led by Dr. Yohei Sotomi of Osaka University Graduate School of Medicine, enrolled 1,101 adults in Japan with AFib who underwent drug-eluting stent implantation. Participants were randomly assigned to receive either one month of dual therapy (a direct oral anticoagulant plus a P2Y12 inhibitor) followed by 11 months of anticoagulant alone, or the standard 12-month dual therapy. At one year, the composite endpoint of stroke, heart attack, or death occurred in 5.4% of the one-month group versus 4.5% in the 12-month group, indicating non-inferiority. Crucially, bleeding complications were nearly halved in the short-duration arm: 4.8% versus 9.5%.
“These results may help doctors feel more confident in prescribing shorter durations of dual antithrombotic therapy after stenting among some patients with AFib,” Sotomi said. “By reducing the length of time individuals are exposed to combination therapy, we can lower the risk of bleeding—a serious concern for many older adults—without increasing their risk of stroke or heart attack.” The study, which was not peer-reviewed and is considered preliminary, is the first to test a one-month dual therapy strategy in this population.
AFib affects an estimated 5 million U.S. adults, with projections exceeding 12 million by 2030, according to the American Heart Association 2025 Heart and Stroke Statistics. Up to 10% of stent recipients also have AFib, which increases stroke risk fivefold. Standard post-stent care includes dual antiplatelet therapy for one year to prevent stent thrombosis and stroke, but the combination of anticoagulants and antiplatelets raises bleeding risk. Previous studies confirmed that using two instead of three agents reduces bleeding, but the optimal duration remained unclear.
The trial enrolled participants from 75 Japanese hospitals between October 2019 and September 2024. Most had stable heart disease, and only 20% were women, limiting generalizability. Researchers noted that the findings may not directly apply to patients in other countries or those with higher thrombotic risk. Nonetheless, the results offer a potential strategy to balance ischemic and bleeding risks. “These results may help doctors feel more confident in prescribing shorter durations of dual antithrombotic therapy after stenting among some patients with AFib,” Sotomi reiterated.
Bleeding events, while often non-fatal, increase healthcare utilization and affect quality of life. The one-month regimen’s 50% reduction in bleeding could translate to fewer emergency visits, hospitalizations, and diagnostic tests. The study’s full details are available in the American Heart Association Scientific Sessions 2025 Online Program Planner.
