Key result
Three major risk factors linked to ~149% higher major bleeding risk in rivaroxaban-treated AF patients.
Why the study?
To evaluate the impact of three risk factors (age >=75 years, renal impairment, and low body weight) on clinical outcomes in patients with nonvalvular atrial fibrillation treated with rivaroxaban in a real-world setting.
Does the accrual of risk factors (age ≥75, CrCl <50, weight ≤50 kg) increase the risk of bleeding and thromboembolic events in Japanese patients with NVAF receiving rivaroxaban?
Observational (n=9,823)
Yes
Does the accrual of risk factors (age ≥75, CrCl <50, weight ≤50 kg) increase the risk of bleeding and thromboembolic events in Japanese patients with NVAF receiving rivaroxaban?
In Japanese patients with NVAF taking rivaroxaban, the accumulation of risk factors (age ≥75, renal impairment, low body weight) is associated with increased risks of major bleeding and thromboembolic events.
May warrant closer monitoring for high-risk patients on rivaroxaban; leaves open optimal dosing strategies pending prospective trials.
Background To evaluate the impact of three risk factors (age [≥75 years], renal impairment [creatinine clearance <50 ml/min], and low body weight [≤50 kg]) on the risk of any bleeding events, all‐cause mortality, and stroke, non‐central nervous system (non‐CNS) systemic embolism (SE), and myocardial infarction (MI) in patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban in a real‐world clinical setting. Methods The Xarelto Post‐Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a prospective, single‐arm, observational study. Enrolled patients were divided into four subgroups by the number of risk factors. Results Overall, 9823 patients were included: 4299 with low risk, 2816 with moderate risk, 1574 with high risk, and 1134 with very high risk. The hazard ratios (95% confidence interval) (reference: low risk) for the moderate‐, high‐, and very‐high‐risk groups were 1.62 (1.19, 2.21) ( p = 0.002), 2.15 (1.47, 3.15) ( p < 0.001), and 2.49 (1.60, 3.87) ( p <0.001) for major bleeding, and 1.98 (1.47, 2.66), 2.29 (1.59, 3.29), and 2.74 (1.81, 4.16) ( p <0.001 for all) for stroke/non‐CNS SE/MI, respectively. Conclusions Age ≥75 years and renal impairment, but not low body weight, were determinants for major bleeding. The accrual of three risk factors was associated with increased risk for major bleeding and stroke/non‐CNS SE/MI in patients with NVAF receiving rivaroxaban; there was no increase in the cumulative risk for these with an increasing number of risk factors.
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Ikeda et al. (2022) conducted an observational in Nonvalvular atrial fibrillation (n=9,823). Rivaroxaban (Very high risk group: 3 risk factors) vs. Rivaroxaban (Low risk group: 0 risk factors) was evaluated on Major bleeding (HR 2.49, 95% CI 1.60, 3.87, p=<0.001). In patients with nonvalvular atrial fibrillation receiving rivaroxaban, having three major risk factors increased major bleeding risk (HR 2.49) compared to patients with no risk factors.
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