BACKGROUND: There remains uncertainty about the risk of cardiovascular events in stable outpatients with a history of myocardial infarction (MI), stroke, and atrial fibrillation in Japan. METHODS AND RESULTS: In the Japan Thrombosis Registry for Atrial Fibrillation, Coronary, or Cerebrovascular Events (J-TRACE), a nationwide prospective cohort of stable outpatients with a history of MI (n=2,291), stroke (n=3,554), and/or atrial fibrillation (n=2,242), 1-year follow-up data were available for 7,513 of 8,087 patients (follow-up rate: 92.9%). The primary endpoint (death/MI/stroke) was reported in 3.53 events per 100 person-years (95% confidence interval [CI]: 3.11-3.99) within 1 year. The rates of all-cause death, death from stroke, and death from MI within 1 year were 1.35 (95%CI: 1.10-1.65), 0.15 (95%CI: 0.08-0.27), and 0.06 (95%CI: 0.02-0.14) per 100 person-years, respectively. The rate of non-fatal stroke was 1.85 (95%CI: 1.55-2.19), while that of non-fatal MI was 0.33 (95%CI: 0.21-0.49). The rate of non-fatal stroke was highest among stroke patients (2.95; 95%CI: 2.39-3.60 per 100 person-years), while that of non-fatal MI was similar across all disease categories. Investigator-decided serious non-fatal bleeding events occurred in 0.21 events (95%CI: 0.12-0.34) per 100 person-years. CONCLUSIONS: In this large, nationwide Japanese registry, the highest stroke event rate was seen in patients with a history of stroke.
BACKGROUND: There remains uncertainty about the risk of cardiovascular events in stable outpatients with a history of myocardial infarction (MI), stroke, and atrial fibrillation in Japan. METHODS AND RESULTS: In the Japan Thrombosis Registry for Atrial Fibrillation, Coronary, or Cerebrovascular Events (J-TRACE), a nationwide prospective cohort of stable outpatients with a history of MI (n=2,291), stroke (n=3,554), and/or atrial fibrillation (n=2,242), 1-year follow-up data were available for 7,513 of 8,087 patients (follow-up rate: 92.9%). The primary endpoint (death/MI/stroke) was reported in 3.53 events per 100 person-years (95% confidence interval [CI]: 3.11-3.99) within 1 year. The rates of all-cause death, death from stroke, and death from MI within 1 year were 1.35 (95%CI: 1.10-1.65), 0.15 (95%CI: 0.08-0.27), and 0.06 (95%CI: 0.02-0.14) per 100 person-years, respectively. The rate of non-fatal stroke was 1.85 (95%CI: 1.55-2.19), while that of non-fatal MI was 0.33 (95%CI: 0.21-0.49). The rate of non-fatal stroke was highest among strokepatients (2.95; 95%CI: 2.39-3.60 per 100 person-years), while that of non-fatal MI was similar across all disease categories. Investigator-decided serious non-fatal bleeding events occurred in 0.21 events (95%CI: 0.12-0.34) per 100 person-years. CONCLUSIONS: In this large, nationwide Japanese registry, the highest stroke event rate was seen in patients with a history of stroke.