A prior history of stroke independently increased the risk of stroke or systemic embolism (HR 3.4) in Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban.
Cohort (n=7,141)
Yes
In Japanese patients with non-valvular atrial fibrillation treated with rivaroxaban, history of stroke strongly predicts stroke/systemic embolism, while moderate renal impairment and other HAS-BLED components predict major bleeding.
Hazard Ratio: 3.4 (95% CI 2.5–4.7)
Absolute Event Rate: 2.3% vs 0.7%
p-value: p=<0.0001
For Japanese patients with non-valvular atrial fibrillation (NVAF), the risk of stroke and major bleeding events was assessed by using the CHADS2, CHA2DS2-VASc, and HAS-BLED scores. The risk factors for embolism and major bleeding under DOAC may be different from current reports. We analyzed the data set of the EXPAND Study to determine the risk factors for events among Japanese NVAF patients in the era of direct oral anticoagulant. Using the data of EXPAND Study, the validity for predictability of the CHADS2, CHA2DS2-VASc, and HAS-BLED scores was identified using the receiver operating characteristic curve analysis. Multivariate analysis was performed with the Cox proportional hazard model to determine the independent risk factors for stroke/systemic embolism and major bleeding among NVAF patients receiving rivaroxaban. Explanatory variables were selected based on the univariate analysis. A total of 7141 patients (mean age 71.6 ± 9.4 years, women 32.3%, and rivaroxaban 15 mg per day 56.5%) were included. Incidence rates of stroke/systemic embolism and major bleeding were 1.0%/year and 1.2%/year, respectively. The multivariate analysis revealed that only history of stroke was associated with stroke/systemic embolism (hazard ratio 3.4, 95% confidence interval 2.5-4.7, p < 0.0001). By contrast, age (1.7, 1.1–2.6, p = 0.0263), creatinine clearance (CrCl) 30–49 mL/min (1.6, 1.2-2.2, p = 0.0011), liver dysfunction (1.7, 1.1–2.8, p = 0.0320), history/disposition of bleeding (1.8, 1.0–3.0, p = 0.0348), and concomitant use of antiplatelet agents (1.6, 1.2–2.3, p = 0.0030) were associated with major bleeding. This sub-analysis showed that some components of the HAS-BLED score were independently associated with major bleeding in Japanese NVAF patients receiving anticoagulation therapy by rivaroxaban. Additionally, CrCl value of 30–49 mL/min was an independent predictor of major bleeding in patients receiving rivaroxaban.
Sakuma et al. (Fri,) conducted a cohort in Non-valvular atrial fibrillation (n=7,141). History of stroke vs. No history of stroke was evaluated on Stroke or systemic embolism (HR 3.4, 95% CI 2.5-4.7, p=<0.0001). A prior history of stroke independently increased the risk of stroke or systemic embolism (HR 3.4) in Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban.