Optimal blood pressure levels for patients with atrial fibrillation who are on undergoing anticoagulant therapy: a large-scale real-world data (F-CREATE project).

This study aimed to use real-world data obtained from a claim database based on the general population to indicate the optimal blood pressure (BP) level for preventing cardiovascular disease and bleeding in patients with atrial fibrillation (AF) undergoing anticoagulant therapy. We conducted a retrospective cohort study using claims data and health checkup data collected from multiple health insurance companies in Japan. A total of 4039 AF patients with health examination data who were receiving anticoagulant therapy were analyzed. BP is classified the Japanese Society of Hypertension Guidelines for the management of elevated blood pressure and hypertension 2025 (JSH 2025). Primary outcome was cardiovascular disease, Safety outcomes were intracranial bleeding and extracranial bleeding. During a mean follow-up period of 2.80 years, 133 cardiovascular disease events, 33 intracranial and 152 extracranial bleeding were observed. The incidence rates of cardiovascular disease and intracranial bleeding patients increased with the elevation of BP levels. The incidence of cardiovascular disease was lowest in those with BP levels <120/80 mmHg. The incidence of intracranial bleeding was lowest in those with BP < 130/80 mmHg. Extracranial bleeding found no clear association with BP. This real-world data of AF patients undergoing anticoagulant therapy, optimal systolic BP levels was <120-130 mmHg for prevention of cardiovascular disease and of intracranial bleeding.