Superiority of Anticoagulant Monotherapy Confirmed in Atrial Fibrillation Patients with Stent Implantation

Research Team from the Cardiology Department at Severance Hospital, Yonsei University

The research team from the Cardiology Department at Severance Hospital, Yonsei University-Professors Kim Jungseon, Park Heenam, Lee Seungjun, Yoo Heetae, Lee Yongjun, and Lee Sanghyup-announced on November 10 that, in patients with atrial fibrillation who have undergone stent implantation, anticoagulant monotherapy results in fewer side effects such as bleeding and demonstrates higher safety compared to dual therapy that adds a single antiplatelet agent.

The results of this study were simultaneously presented as a 'Late-breaking Clinical Trial' at the American Heart Association (AHA) and published in the international journal 'The New England Journal of Medicine (NEJM, IF 78.5)'.

Severance Hospital Cardiology Department research team: Professors Kim Jungseon, Park Heenam, Lee Seungjun, Yoo Heetae, Lee Yongjun, and Lee Sanghyup. Yonsei Medical Center

Atrial fibrillation is known as a major risk factor for stroke and systemic embolism. Therefore, anticoagulant therapy is recommended for patients with atrial fibrillation to prevent the formation of blood clots in the heart. Patients who have undergone percutaneous coronary intervention with stent implantation receive antiplatelet therapy to prevent myocardial infarction and stent thrombosis. Generally, for one year after stent implantation, patients take two types of antiplatelet agents, and after one year, it is recommended to maintain a single antiplatelet agent to reduce the risk of bleeding.

However, in cases where a patient with atrial fibrillation has received a stent, both anticoagulant therapy for atrial fibrillation and antiplatelet therapy for the stent are required even after one year of stent implantation. As with taking two antiplatelet agents, this increases the risk of bleeding, making it important to establish a treatment strategy that can appropriately manage this risk.

Currently, the clinical guidelines of the American and European cardiology societies recommend anticoagulant monotherapy for patients with atrial fibrillation who have received a stent, starting one year after the stent implantation. However, these recommendations are based on studies involving all patients with coronary artery disease, not just those with stent implantation, which limits their blanket application to stent recipients.

The research team conducted the ADAPT AF-DES study to establish the most appropriate antithrombotic treatment strategy specifically for patients with atrial fibrillation who have received a stent.

From April 2020 to May 2024, the team compared and analyzed the clinical outcomes of 'anticoagulant monotherapy' and 'dual therapy with anticoagulant and single antiplatelet agent' in 960 patients with atrial fibrillation who had received a stent, across 32 institutions in Korea. The enrolled patients were randomly assigned to either the anticoagulant monotherapy group using apixaban or rivaroxaban, or the dual therapy group, which added clopidogrel as a single antiplatelet agent to anticoagulant therapy, and were followed up for one year.

Analysis showed that, over the course of one year after enrollment, the incidence of death, myocardial infarction, stroke, systemic embolism, and major/minor bleeding events was 9.6% in the monotherapy group and 17.2% in the dual therapy group, confirming the higher safety of monotherapy.

Looking in more detail, there were no significant differences between the two groups in the rates of ischemic events such as mortality, myocardial infarction, stent thrombosis, stroke, and systemic embolism. However, the rates of major and minor bleeding events were 2.3% and 2.9% in the monotherapy group, compared to 6.1% and 7.1% in the dual therapy group, respectively, indicating that patients receiving dual therapy experienced more bleeding events.

Professor Kim Jungseon stated, "This study is particularly meaningful as it is a comparative study of treatment strategies conducted exclusively in patients with atrial fibrillation who have received a stent. We expect that, by confirming that anticoagulant monotherapy does not increase ischemic risk but reduces bleeding risk compared to dual therapy in these patients, we can provide a more strategic treatment approach for them."

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