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台湾高龄心房颤动患者中达比加群、利伐沙班和华法林的应用

Dabigatran, Rivaroxaban, and Warfarin in the Oldest Adults with Atrial Fibrillation in Taiwan.

机构信息

Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan.

Center for Critical Care Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan.

出版信息

J Am Geriatr Soc. 2018 Aug;66(8):1567-1574. doi: 10.1111/jgs.15430. Epub 2018 Jul 4.

Abstract

OBJECTIVES

To compare the effectiveness and safety of reduced-dose dabigatran, reduced-dose rivaroxaban, and warfarin in individuals aged 85 and older with atrial fibrillation (AF).

DESIGN

Retrospective cohort study.

SETTING

Taiwan National Health Insurance claims database, 2011∼2015.

PARTICIPANTS

Individuals with AF aged 85 and older (mean 88.6) with incident use of oral anticoagulants between June 1, 2012 and May 31, 2015 (N=4,722; dabigatran 110 mg, n=1,489; rivaroxaban 15 mg/10 mg, n=1,736; warfarin, n=1,497).

MEASUREMENTS

Clinical outcomes included all-cause death, cardiovascular death, ischemic stroke, acute myocardial infarction, arterial embolism or thrombosis, intracranial hemorrhage, and gastrointestinal hemorrhage needing transfusion. Propensity score-matched analysis was performed, and the marginal proportional hazards model was used to estimate the relative risk of various clinical outcomes in a matched dabigatran-warfarin cohort (n=1,180 in each group) and a rivaroxaban-warfarin cohort (n=1,207 in each group) RESULTS: Mean follow-up was 6.6 months for the overall population. Dabigatran group participants had lower risks of all-cause death (hazard ratio (HR)=0.59, 95% confidence interval (CI)=0.45-0.77) and cardiovascular death (HR=0.45, 95% CI=0.30-0.68) than warfarin group participants. Rivaroxaban users also had lower risks of all-cause death (HR=0.61, 95% CI=0.47-0.79) and cardiovascular death (HR=0.52, 95% CI=0.35-0.75) than warfarin users. Dabigatran users also had a lower risk of intracranial hemorrhage than warfarin users (HR=0.31, 95% CI=0.10-0.97).

CONCLUSION

Individuals with AF aged 85 and older who used reduced-dose dabigatran or reduced-dose rivaroxaban had statistically significantly lower all-cause mortality and cardiovascular mortality than those who used warfarin. Reduced-dose dabigatran was also associated with lower risk of intracranial hemorrhage than warfarin.

摘要

目的

比较 85 岁及以上人群中使用低剂量达比加群、低剂量利伐沙班和华法林的疗效和安全性。

设计

回顾性队列研究。

地点

2011 年至 2015 年台湾全民健康保险理赔数据库。

参与者

2012 年 6 月 1 日至 2015 年 5 月 31 日期间使用口服抗凝剂的年龄在 85 岁及以上的房颤(AF)患者(n=4722;达比加群 110mg,n=1489;利伐沙班 15mg/10mg,n=1736;华法林,n=1497)。

测量方法

临床结局包括全因死亡、心血管死亡、缺血性卒、急性心肌梗死、动脉栓塞或血栓形成、颅内出血和需要输血的胃肠道出血。采用倾向评分匹配分析,边缘比例风险模型估计匹配的达比加群-华法林队列(每组 1180 例)和利伐沙班-华法林队列(每组 1207 例)中各种临床结局的相对风险。结果:总体人群的中位随访时间为 6.6 个月。与华法林组相比,达比加群组参与者的全因死亡(风险比(HR)=0.59,95%置信区间(CI)=0.45-0.77)和心血管死亡(HR=0.45,95%CI=0.30-0.68)风险较低。利伐沙班组参与者的全因死亡(HR=0.61,95%CI=0.47-0.79)和心血管死亡(HR=0.52,95%CI=0.35-0.75)风险也较低。与华法林组相比,达比加群组参与者的颅内出血风险也较低(HR=0.31,95%CI=0.10-0.97)。

结论

85 岁及以上的房颤患者使用低剂量达比加群或低剂量利伐沙班与使用华法林相比,全因死亡率和心血管死亡率有统计学意义降低。与华法林相比,低剂量达比加群还与较低的颅内出血风险相关。

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