非维生素 K 拮抗剂在临床实践中治疗心房颤动的疗效和安全性比较：GLORIA-AF 登记研究。
Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry.
机构信息
Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.
Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Medical University of Silesia, Silesian Centre for Heart Diseases, Zabrze, Poland.
出版信息
Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16.
BACKGROUND AND PURPOSE
Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF).
METHODS
In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest.
RESULTS
The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79-2.03), major bleeding 0.59 (0.40-0.88), myocardial infarction 0.68 (0.40-1.16), and all-cause death 0.86 (0.67-1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76-1.78), myocardial infarction 0.84 (0.48-1.46), major bleeding 0.98 (0.63-1.52) and all-cause death 1.01 (0.79-1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52-1.19), myocardial infarction 0.96 (0.63-1.45), major bleeding 1.54 (1.14-2.08), and all-cause death 0.97 (0.80-1.19).
CONCLUSIONS
Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov . Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013.
背景与目的
缺乏个体非维生素 K 拮抗剂（NOACs）安全性和有效性的前瞻性数据比较。我们的目的是直接比较新诊断心房颤动（AF）患者中 NOACs 的有效性和安全性。
方法
在 GLORIA-AF 大型前瞻性全球注册项目中，连续随访了 3 年新诊断为 AF 的患者。对（1）达比加群与利伐沙班或阿哌沙班和（2）利伐沙班与阿哌沙班的比较分析，是在倾向评分（PS）匹配的患者组中进行的。使用比例风险回归来估计感兴趣结局的风险比（HR）。
结果
GLORIA-AF III 期注册研究于 2014 年 1 月至 2016 年 12 月期间共纳入了 21300 名患者。其中，3839 名患者接受达比加群治疗，4015 名患者接受利伐沙班治疗，4505 名患者接受阿哌沙班治疗，中位年龄分别为 71.0、71.0 和 73.0 岁。在 PS 匹配组中，达比加群与利伐沙班相比，卒中的调整 HR 和 95%置信区间（CI）为 1.27（0.79-2.03），大出血为 0.59（0.40-0.88），心肌梗死为 0.68（0.40-1.16），全因死亡为 0.86（0.67-1.10）。对于达比加群与阿哌沙班的比较，在 PS 匹配组中，卒中的调整 HR 为 1.16（0.76-1.78），心肌梗死为 0.84（0.48-1.46），大出血为 0.98（0.63-1.52），全因死亡为 1.01（0.79-1.29）。对于利伐沙班与阿哌沙班的比较，在 PS 匹配组中，卒中的调整 HR 为 0.78（0.52-1.19），心肌梗死为 0.96（0.63-1.45），大出血为 1.54（1.14-2.08），全因死亡为 0.97（0.80-1.19）。
结论
与利伐沙班相比，接受达比加群治疗的患者大出血风险降低了 41%，但卒中、心肌梗死和死亡风险相似。与阿哌沙班相比，接受达比加群治疗的患者卒中、大出血、心肌梗死和死亡风险相似。与阿哌沙班相比，利伐沙班大出血风险增加，但卒中、心肌梗死和死亡风险相似。
登记
URL：https://www.。
临床试验
gov。独特标识符：NCT01468701，NCT01671007。登记日期：2013 年 9 月。
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