New research has found that a simplified regimen of clot-preventing medication following stent placement in adults with atrial fibrillation (AF) was just as safe and effective in preventing strokes, heart attack and death when compared to a standard yearlong treatment regimen. This preliminary late-breaking science was presented at the 2025 American Heart Association (AHA) Scientific Sessions (7–10 November, New Orleans, USA).
The study—the OPTIMA-AF trial—included adults with AF who received a stent in a heart artery to improve blood flow. According to study author Yohei Sotomi (University of Osaka Graduate School of Medicine, Osaka, Japan), while standard treatment after a stent implantation is a prescription for two clot-preventing medications for one year, these medications can also increase the risk of serious bleeding. These two medications include a direct oral anticoagulant, such as dabigatran, rivaroxaban, apixaban and edoxaban, to help prevent strokes; and a P2Y12 inhibitor, such as clopidogrel or prasugrel, to prevent clots in the stent.
In OPTIMA-AF, researchers explored if using both medication types for one month among people with AF who received a stent would be equally safe and effective as 12 months of treatment, while helping to reduce bleeding risk associated with the medications.
“Previous studies confirmed that using two anti-clotting agents instead of three reduced bleeding; however, no study has tested whether the duration of dual therapy could be safely shortened to just one month,” Sotomi said. “Our study is the first to show that a one-month strategy is both safe and effective, offering real-world benefits for patients and doctors.”
Researchers studied more than 1,000 adult AF patients in Japan who received a stent in a heart artery. After the stent placement procedure, half of the study participants were prescribed both types of medications for one month, then only the direct oral anticoagulant for the remaining 11 months. The other half of the participants continued dual therapy for 12 months. Participants were followed for one year to monitor if they had a stroke or heart attack, or died, and the researchers also analysed how many participants had complications like gastrointestinal bleeding.
The analysis ultimately found that 5.4% of participants in the one-month group and 4.5% in the 12-month group had a heart attack, stroke or died, which the researchers feel suggests that the shorter approach was equally effective. In addition, participants in the one-month dual-treatment group had notably fewer bleeding complications (4.8%) versus the 12-month group (9.5%). According to the researchers, most of this bleeding reduction came from less serious bleeds that required medical attention, which affects quality of life and can increase healthcare costs for emergency or clinic visits, and lab and imaging tests.
“These results may help doctors feel more confident in prescribing shorter durations of dual antithrombotic therapy after stenting among some patients with AF,” Sotomi commented. “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.”
Among the limitations of the OPTIMA-AF study is the fact that it was conducted in Japan, meaning its findings may not directly apply to people in other countries. Additionally, study participants mostly had stable heart disease, so the results may not apply to patients who are higher risk for blood clots, and only about 20% of the study population were women, further limiting its generalisability.
