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糖尿病合并非瓣膜性心房颤动患者的卒中预防策略是否存在偏好?华法林、达比加群和利伐沙班的比较。

Is There a Preferred Stroke Prevention Strategy for Diabetic Patients with Non-Valvular Atrial Fibrillation? Comparing Warfarin, Dabigatran and Rivaroxaban.

机构信息

Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Miaoli County, Taiwan.

Department of Health Services Administration, China Medical University, Taichung City, Taiwan.

出版信息

Thromb Haemost. 2018 Jan;118(1):72-81. doi: 10.1160/TH17-02-0095. Epub 2018 Jan 5.

Abstract

BACKGROUND

The prevalence of diabetes is growing, and diabetes is an independent risk factor for both atrial fibrillation (AF) and stroke. However, the relative effectiveness and safety of different oral anticoagulants for diabetic patients with non-valvular AF remain unclear. We aimed to compare thromboembolic events, bleeding and mortality in diabetic AF patients treated with rivaroxaban, dabigatran and warfarin.

METHODS AND RESULTS

Diabetic AF patients taking dabigatran ( = 322), rivaroxaban ( = 320) or warfarin ( = 1,899) were identified from the nationwide diabetes pay-for-performance program ( = 814,465) in Taiwan. Outcomes and comorbidities were evaluated by linking with Taiwan National Health Insurance Research Database. Propensity score weighting method was used to balance covariates across study groups. Patients were followed up until the first occurrence of any study outcome or the study end date. Compared with warfarin, dabigatran significantly decreased the risk of all-cause mortality (hazard ratio [HR] = 0.348, 95% confidence interval [CI] = 0.157-0.771) and gastrointestinal bleeding (HR = 0.558, 95% CI = 0.327-0.955). Relative effectiveness and safety outcomes between rivaroxaban and warfarin were comparable. Compared with rivaroxaban, dabigatran significantly decreased the risk of all-cause mortality (HR = 0.310, 95% CI = 0.121-0.798) and was associated with a borderline reduced risk for composite safety end points (HR = 0.670, 95% CI = 0.421-1.067).

CONCLUSION

In diabetic AF patients, dabigatran and rivaroxaban showed a superior or non-inferior effectiveness and safety profile compared with warfarin. Dabigatran was associated with a significantly lower risk of mortality than rivaroxaban.

摘要

背景

糖尿病的患病率正在上升,糖尿病是心房颤动(AF)和中风的独立危险因素。然而,对于非瓣膜性 AF 的糖尿病患者,不同口服抗凝药物的相对有效性和安全性仍不清楚。我们旨在比较服用利伐沙班、达比加群和华法林的糖尿病 AF 患者的血栓栓塞事件、出血和死亡率。

方法和结果

从台湾全国糖尿病按绩效付费计划(共 814465 例)中确定了服用达比加群( = 322)、利伐沙班( = 320)或华法林( = 1899)的糖尿病 AF 患者。通过与台湾全民健康保险研究数据库链接来评估结局和合并症。使用倾向评分加权法在研究组之间平衡协变量。患者随访至任何研究结局首次发生或研究结束日期。与华法林相比,达比加群显著降低全因死亡率(风险比 [HR] = 0.348,95%置信区间 [CI] = 0.157-0.771)和胃肠道出血(HR = 0.558,95% CI = 0.327-0.955)的风险。利伐沙班和华法林之间的相对有效性和安全性结局相当。与利伐沙班相比,达比加群显著降低全因死亡率(HR = 0.310,95% CI = 0.121-0.798),且复合安全性结局的风险有降低的趋势(HR = 0.670,95% CI = 0.421-1.067)。

结论

在糖尿病 AF 患者中,与华法林相比,达比加群和利伐沙班显示出更好或非劣效的有效性和安全性。与利伐沙班相比,达比加群的死亡率风险显著降低。

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