阿哌沙班用于房颤患者。

Apixaban in patients with atrial fibrillation.

机构信息

Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.

出版信息

N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.

DOI:10.1056/NEJMoa1007432

PMID:21309657

Abstract

BACKGROUND

Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients.

METHODS

In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism.

RESULTS

Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups.

CONCLUSIONS

In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).

摘要

背景

维生素 K 拮抗剂已被证明可预防房颤患者的中风。然而，许多患者不适合或不愿意接受维生素 K 拮抗剂治疗，这些患者中风风险较高。新型 Xa 因子抑制剂阿哌沙班可能是这些患者的另一种治疗选择。

方法

在一项双盲研究中，我们将 5599 名有中风风险且不适合维生素 K 拮抗剂治疗的房颤患者随机分为阿哌沙班组（每日两次，每次 5 毫克）或阿司匹林组（每天 81 至 324 毫克），以确定阿哌沙班是否更优。平均随访时间为 1.1 年。主要终点为中风或全身性栓塞的发生。

结果

入组前，40%的患者曾使用过维生素 K 拮抗剂。数据和安全监测委员会建议提前终止研究，因为阿哌沙班有明显的优势。阿哌沙班组中有 51 例主要结局事件（每年 1.6%），阿司匹林组中有 113 例（每年 3.7%）（阿哌沙班的风险比为 0.45；95%置信区间[CI]为 0.32 至 0.62；P<0.001）。阿哌沙班组的死亡率为每年 3.5%，阿司匹林组为每年 4.4%（风险比为 0.79；95%CI 为 0.62 至 1.02；P=0.07）。阿哌沙班组有 44 例大出血（每年 1.4%），阿司匹林组有 39 例（每年 1.2%）（阿哌沙班的风险比为 1.13；95%CI 为 0.74 至 1.75；P=0.57）；阿哌沙班组有 11 例颅内出血，阿司匹林组有 13 例。与阿司匹林相比，阿哌沙班可降低因心血管原因首次住院的风险（每年 12.6%比 15.9%，P<0.001）。治疗效果在重要亚组中一致。