Sakaguchi Teruhiro, Osanai Hiroyuki, Murase Yosuke, Ishii Hideki, Nakashima Yoshihito, Asano Hiroshi, Suzuki Susumu, Takefuji Mikito, Inden Yasuya, Sakai Kazuyoshi, Murohara Toyoaki, Ajioka Masayoshi
Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan; Department of Cardiovascular Medicine, Tosei General Hospital, Seto, Japan.
Department of Cardiovascular Medicine, Tosei General Hospital, Seto, Japan.
J Cardiol. 2017 Sep;70(3):244-249. doi: 10.1016/j.jjcc.2016.11.013. Epub 2016 Dec 22.
Anti-Xa activity (AXA) in patients with nonvalvular atrial fibrillation (NVAF) and relationship to bleeding events remains unclear.
We evaluated AXA in 94 patients at both trough and peak rivaroxaban concentrations. Rivaroxaban dosage was determined according to creatinine clearance (CrCl): 10 and 15mg once daily for patients with CrCl 15-49 and CrCl ≥50mL/min, respectively. AXA value distribution and its association with bleeding events were examined in enrolled subjects.
The mean peak AXA level was significantly higher than the mean trough level (1.98±0.81 vs. 0.16±0.15IU/mL; p<0.001). The peak AXA level significantly differed among patients with CrCl 15-29, 30-49, 50-79, and ≥80mL/min (2.51±0.83, 1.72±0.76, 2.05±0.82, and 1.66±0.51IU/mL, respectively; p=0.004). Major and non-major clinically relevant bleeding events occurred in 22 patients (23.4% and 14.6% per year, respectively). The mean peak AXA level was significantly higher in patients who experienced bleeding events than in those who did not (2.40±0.70 vs. 1.84±0.80IU/mL; p=0.001). A Cox multivariate analysis showed that the peak AXA level was independently related to the incidence of major and non-major clinically relevant bleeding events (p=0.012). Cumulative bleeding rates were significantly higher in patients with high peak AXA levels (p<0.001).
Peak AXA level was an independent predictor for bleeding events in Japanese NVAF patients receiving rivaroxaban.
非瓣膜性心房颤动（NVAF）患者的抗Xa活性（AXA）及其与出血事件的关系尚不清楚。
我们评估了94例患者在利伐沙班谷浓度和峰浓度时的AXA。根据肌酐清除率（CrCl）确定利伐沙班剂量：CrCl为15 - 49和CrCl≥50mL/min的患者分别为每日1次，每次10和15mg。在纳入的受试者中检查AXA值分布及其与出血事件的关联。
平均峰AXA水平显著高于平均谷水平（1.98±0.81对0.16±0.15IU/mL；p<0.001）。CrCl为15 - 29、30 - 49、50 - 79和≥80mL/min的患者的峰AXA水平有显著差异（分别为2.51±0.83、1.72±0.76、2.05±0.82和1.66±0.51IU/mL；p = 0.004）。22例患者发生了主要和非主要临床相关出血事件（每年分别为23.4%和14.6%）。发生出血事件的患者的平均峰AXA水平显著高于未发生出血事件的患者（2.40±0.70对1.84±0.80IU/mL；p = 0.001）。Cox多变量分析显示，峰AXA水平与主要和非主要临床相关出血事件的发生率独立相关（p = 0.012）。峰AXA水平高的患者累积出血率显著更高（p<0.001）。
峰AXA水平是接受利伐沙班治疗的日本NVAF患者出血事件的独立预测因素。
