目的:缺乏比较个别非维生素K拮抗剂(NOAC)安全性和有效性的前瞻性收集数据。我们的目的是直接比较新诊断的房颤(AF)患者NOAC的有效性和安全性。
方法:在GLORIA-AF中,一个大的,prospective,全局注册程序,连续新诊断房颤患者随访3年.对倾向评分(PS)匹配的患者组进行(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。比例风险回归用于估计目标结果的风险比(HR)。
结果:在2014年1月至2016年12月期间,GLORIA-AFIII期注册登记了21,300名患者。其中,3839人被处方达比加群,4015利伐沙班和4505阿哌沙班,平均年龄为71.0、71.0和73.0岁,分别。在PS匹配的集合中,达比加群和利伐沙班的校正HR和95%置信区间(CI)为,行程:1.27(0.79-2.03),大出血0.59(0.40-0.88),心肌梗死0.68(0.40-1.16),全因死亡0.86(0.67-1.10)。为了比较达比加群和阿哌沙班,在PS匹配的集合中,调整后的HR是,对于行程1.16(0.76-1.78),心肌梗死0.84(0.48-1.46),大出血0.98(0.63-1.52)和全因死亡1.01(0.79-1.29)。对于利伐沙班与阿哌沙班的比较,在PS匹配的集合中,调整后的HR是,对于行程0.78(0.52-1.19),心肌梗死0.96(0.63-1.45),大出血1.54(1.14-2.08),全因死亡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41%,但是中风的风险相似,MI,和死亡。相对于阿哌沙班,接受达比加群治疗的患者有类似的卒中风险,大出血,MI,和死亡。利伐沙班相对于阿哌沙班增加了大出血的风险,但是中风的风险相似,MI,和死亡。
背景:URL:https://www。
结果:政府。唯一标识符:NCT01468701、NCT01671007。注册日期:2013年9月。
OBJECTIVE: 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.
BACKGROUND: URL: https://www.
RESULTS: gov . Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013.