Division of Clinical Electrophysiology, Johann Wolfgang Goethe-University, Theodor-Stern-Kai 7, D 60590 Frankfurt, Germany.
Eur Heart J. 2013 Sep;34(35):2752-9. doi: 10.1093/eurheartj/eht292. Epub 2013 Jul 25.
The aim of this study was to evaluate the effects of apixaban, a novel oral factor Xa inhibitor, on the need for cardiovascular hospitalization.
Our analysis is based on data from AVERROES, a randomized double-blind trial testing the efficacy and safety of apixaban against aspirin for the prevention of thrombo-embolism in 5599 atrial fibrillation (AF) patients unsuitable for vitamin K antagonist therapy. Hospitalizations were captured by dedicated case report forms and the outcome variable was time from randomization to the first hospitalization. Effects of treatment with apixaban on the rates of cardiovascular and non-cardiovascular hospitalizations were assessed using Cox proportional hazards regression models. During a mean follow-up of 1.1 years, 800 patients were hospitalized at least once for cardiovascular reasons, 442 (15.4%/year) in the aspirin group, 358 (12.3%) in the apixaban group [hazard ratio (HR) 0.80, 95% confidence interval (CI) 0.69-0.92; P = 0.002]. The reduction in cardiovascular hospitalization in the apixaban arm was predominantly due to a reduction in hospitalization for strokes, but there were also fewer hospitalizations for other cardiovascular causes. Patients with paroxysmal AF were significantly more likely to be hospitalized for AF treatment, whereas more heart failure admissions occurred in patients with permanent AF. Assignment to apixaban was the only independent predictor for a reduction in hospitalization. Cardiovascular hospitalization was the strongest independent predictor of subsequent mortality (HR: 3.95, 95% CI: 3.06-5.09; P < 0.001).
In AVERROES, patients on apixaban therapy were less likely to be hospitalized. This may have important consequences for patients' well-being and for healthcare resources. This trial is registered underClinicalTrials.gov number, NCT00496769.
本研究旨在评估新型口服因子 Xa 抑制剂阿哌沙班对心血管住院需求的影响。
我们的分析基于 AVERROES 研究的数据，该研究是一项随机、双盲试验，旨在测试阿哌沙班预防不适合维生素 K 拮抗剂治疗的 5599 例心房颤动（AF）患者血栓栓塞的疗效和安全性。住院情况通过专用病例报告表进行记录，结局变量为从随机分组到首次住院的时间。使用 Cox 比例风险回归模型评估阿哌沙班治疗对心血管和非心血管住院率的影响。在平均 1.1 年的随访期间，800 例患者因心血管原因至少住院一次，阿司匹林组 442 例（15.4%/年），阿哌沙班组 358 例（12.3%）[风险比（HR）0.80，95%置信区间（CI）0.69-0.92；P=0.002]。阿哌沙班组心血管住院减少主要归因于中风住院减少，但其他心血管原因住院也有所减少。阵发性 AF 患者因 AF 治疗而住院的可能性显著更高，而永久性 AF 患者心力衰竭入院的可能性更高。阿哌沙班的使用是住院减少的唯一独立预测因素。心血管住院是随后死亡的最强独立预测因素（HR：3.95，95%CI：3.06-5.09；P<0.001）。
在 AVERROES 中，接受阿哌沙班治疗的患者住院的可能性较低。这可能对患者的健康和医疗资源产生重要影响。本试验在 ClinicalTrials.gov 注册号为 NCT00496769 下注册。
