背景:非维生素K拮抗剂口服抗凝药(NOACs),包括阿哌沙班,建议用于预防非瓣膜性心房颤动(NVAF)的中风和全身性栓塞。
目的:描述开始抗凝治疗的患者的特征,确定与阿哌沙班处方相关的特征,并描述了阿哌沙班在法国的使用。
方法:这是一项非干预的多中心法国研究。在前3个月开始抗凝治疗的NVAF患者(年龄≥18岁)在四组中进行了评估(NOAC[阿哌沙班,达比加群或利伐沙班]或维生素K拮抗剂[VKA])。
结果:2027例患者的数据符合分析条件。平均年龄为73.0±11.2岁,56.6%为男性,80.2%为初治抗凝剂。≥4期慢性肾脏病在服用阿哌沙班的患者中存在2.2%,没有那些处方达比加群或利伐沙班,以及16.8%的规定VKAs。所有三种NOAC的CHA2DS2-VASc评分中位数为3,VKAs为4;在2.5-5.9%的患者和12.0%的患者中,HAS-BLED评分中位数≥3。在出血风险较高和肾功能下降的老年患者中,阿哌沙班比其他NOAC更有可能被处方,和VKAs患者出血风险较低,肾功能较好。患者接受减少剂量(5mg/天;30.4%的患者)或全剂量(10mg/天;69.6%的患者)的阿哌沙班。只有79.3%的患者处方阿哌沙班的剂量与产品特征总结一致;给药不足比给药过量更频繁。观察到阿哌沙班的标签外使用,主要是老年患者,尽管肾功能和体重正常。
结论:在年龄增加的患者中,开始使用阿哌沙班与NOAC更为常见,更高的出血风险和肾功能下降,而在出血风险较低、肾功能较好的患者中,开始使用阿哌沙班和VKAs更为常见.
BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs), including apixaban, are recommended for prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF).
OBJECTIVE: To describe the characteristics of patients starting anticoagulant treatment, identify the characteristics associated with apixaban prescription, and describe apixaban use in France.
METHODS: This was a non-interventional multicentre French study. Patients with NVAF (aged≥18 years) with anticoagulant treatment started in the preceding 3 months were evaluated in four groups (NOAC [apixaban, dabigatran or rivaroxaban] or vitamin K antagonist [VKA]).
RESULTS: Data from 2027 patients were eligible for analysis. Mean age was 73.0±11.2 years, 56.6% were men and 80.2% were anticoagulant naïve. Stage≥4 chronic kidney disease was present in 2.2% of patients prescribed apixaban, none of those prescribed dabigatran or rivaroxaban, and 16.8% of those prescribed VKAs. The median CHA2DS2-VASc score was 3 for all three NOACs and 4 for VKAs; the median HAS-BLED score was≥3 for 2.5-5.9% of patients prescribed NOACs and 12.0% of those prescribed VKAs. Apixaban was more likely to be prescribed than other NOACs in older patients with higher bleeding risk and decreased renal function, and VKAs in patients with lower bleeding risk and better renal function. Patients received a reduced dose (5mg/day; 30.4% patients) or a full dose (10mg/day; 69.6% patients) of apixaban. Only 79.3% of patients prescribed apixaban had doses consistent with the summary of product characteristics; underdosing was more frequent than overdosing. Off-label use of apixaban was observed, mainly in elderly patients, despite normal renal function and weight.
CONCLUSIONS: Initiation of apixaban versus NOACs was more common among patients with increased age, higher bleeding risk and decreased renal function, whereas initiation of apixaban versus VKAs was more common among patients with lower bleeding risk and better renal function.