Shorter Clot-Prevention Regimen After Stent Placement Shows Equal Effectiveness with Reduced Bleeding Risk for AFib Patients

A simplified medication approach for preventing blood clots after stent placement in adults with atrial fibrillation proved equally effective at preventing serious cardiovascular events while reducing bleeding complications compared to standard year-long treatment, according to research presented at the American Heart Association's Scientific Sessions 2025. The study, known as the OPTIMA-AF trial, represents the first investigation to suggest that shortening dual therapy duration to just one month provides comparable protection against stroke, heart attack and death while offering significant safety advantages.

The research involved 1,101 adults with an average age of 75.2 years who had atrial fibrillation and underwent drug-eluting stent implantation procedures at 75 hospitals in Japan between October 2019 and September 2024. Standard treatment following stent placement typically involves prescribing two clot-preventing medications for one year: a direct oral anticoagulant such as dabigatran, rivaroxaban, apixaban or edoxaban to prevent strokes, and a P2Y12 inhibitor like clopidogrel or prasugrel to prevent clots within the stent itself. However, this combination therapy carries an increased risk of serious bleeding complications that can significantly impact patient quality of life and healthcare costs.

In the randomized trial, half of the participants received both medications for one month followed by only the direct oral anticoagulant for the remaining eleven months, while the other half continued dual therapy for the full twelve-month period. The results showed that 5.4% of participants in the one-month group experienced heart attack, stroke or death compared to 4.5% in the twelve-month group, indicating comparable effectiveness between the two approaches. More significantly, the shorter regimen demonstrated substantial safety benefits, with only 4.8% of participants experiencing bleeding complications compared to 9.5% in the longer treatment group.

Study author Yohei Sotomi, M.D., Ph.D., director of the Osaka Cardiovascular Conference Multicenter Clinical Research Lab at University of Osaka Graduate School of Medicine, explained that previous research had confirmed that using two anti-clotting agents instead of three reduced bleeding, but no study had tested whether the duration of dual therapy could be safely shortened to just one month. The current findings suggest that reducing the length of time patients are exposed to combination therapy can lower bleeding risk without increasing cardiovascular event risk, addressing a serious concern particularly relevant for older adult populations.

The implications of this research are substantial given the prevalence of atrial fibrillation among stent recipients. Up to one in ten people who receive stents also have AFib, a heart rhythm disorder that increases stroke risk five-fold and can lead to blood clots, heart failure and death. According to American Heart Association 2025 Heart and Stroke statistics, approximately five million adults in the U.S. have atrial fibrillation, with projections indicating more than 12 million Americans will be affected by 2030. The study findings, available through the American Heart Association's professional resources, could influence clinical practice by providing evidence for shorter, safer medication regimens that maintain effectiveness while reducing complications.

While the study represents an important advancement, researchers noted several limitations. Conducted exclusively in Japan, the findings may not directly apply to populations in other countries. Additionally, most participants had stable heart disease, so results may not extend to patients with higher clotting risks. The study population also included only about 20% women, limiting generalizability to female patients. As with all research presented at scientific meetings, these findings are considered preliminary until published as a full manuscript in a peer-reviewed journal. The abstract is available in the American Heart Association Scientific Sessions 2025 Online Program Planner, where the complete study details and author disclosures can be reviewed.

This research addresses a critical balance in cardiovascular care between preventing dangerous blood clots and avoiding serious bleeding complications. For the millions of patients worldwide who require both anticoagulation for atrial fibrillation and antiplatelet therapy after stent placement, these findings could lead to treatment protocols that better optimize safety without compromising protection against life-threatening cardiovascular events.