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在结构完善的心房颤动诊所接受治疗的心房颤动患者中,非维生素K拮抗剂口服抗凝剂的安全性和持久性。

The safety and persistence of non-vitamin-K-antagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic.

作者信息

Al-Khalili Faris, Lindström Catrine, Benson Lina

机构信息

a Stockholm Heart Center , Stockholm , Sweden ;

b Department of Clinical Sciences, Karolinska Institutet , Danderyd Hospital , Stockholm , Sweden ;

出版信息

Curr Med Res Opin. 2016;32(4):779-85. doi: 10.1185/03007995.2016.1142432. Epub 2016 Feb 10.

Abstract

AIMS

To examine the long-term persistence and safety of the non-vitamin-K-antagonist oral anticoagulants (NOACs) dabigatran (D), rivaroxaban (R) and apixaban (A) in patients with non-valvular atrial fibrillation (AF) treated in the framework of a well structured, nurse-based AF unit for initiation and follow-up of NOAC.

METHODS

Retrospective clinical data were collected for 766 consequent patients from a single cardiology outpatient clinic incorporating the AF unit.

RESULTS

The follow-up time, median (q1-q3), was 367 days (183-493) for D patients (n = 233), 432 days (255-546) for R patients (n = 282) and 348 days (267-419) for A patients (n = 251). No significant differences were found between the three groups with regard to age, sex, renal function, or CHA2DS2-VASc score. For all bleeding events the incidence rates per 100 patient-years of follow-up (95% confidence interval [CI], p-value) were reported more often for treatment with R (17.2, 12.7-22.8) than for D (7.0, 4.0-11.3, p = 0.001) and A (8.7, 5.2-13.6, p = 0.013). The differences remained significant after adjustment for clinically relevant variables. Discontinuation rates (n = 167) were lower for A (11.5, 7.5-16.8) than for D (30, 23.4-37.9, p < 0.001) and R (23.9, 18.6-30.1, p = 0.001), and were mainly attributed to drug-specific side effects and bleedings. The majority of discontinued patients (n = 142, 85%) proceeded with other types of oral anticoagulants.

LIMITATION

The main limitation of the study is the small patient population with a short follow-up time.

CONCLUSION

In a retrospective study at a single AF clinic, NOACs showed significantly different bleeding rates and varied discontinuation rates when compared to each other, related mainly to agent-specific side effects and bleedings. The majority of patients that discontinued proceeded with other types of oral anticoagulant.

摘要

目的

在一个结构完善、由护士主导的房颤单元中,对非瓣膜性房颤(AF)患者启动和随访非维生素K拮抗剂口服抗凝药(NOACs)达比加群(D)、利伐沙班(R)和阿哌沙班(A),以研究其长期持续性和安全性。

方法

从一个纳入了房颤单元的单一心脏病门诊收集了766例连续患者的回顾性临床数据。

结果

D组患者(n = 233)的随访时间中位数(四分位间距)为367天(183 - 493天),R组患者(n = 282)为432天(255 - 546天),A组患者(n = 251)为348天(267 - 419天)。三组在年龄、性别、肾功能或CHA2DS2 - VASc评分方面未发现显著差异。对于所有出血事件,每100患者年随访的发生率(95%置信区间[CI],p值),R治疗组(17.2,12.7 - 22.8)比D治疗组(7.0,4.0 - 11.3,p = 0.001)和A治疗组(8.7,5.2 - 13.6,p = 0.013)报告得更频繁。在对临床相关变量进行调整后,差异仍然显著。A组(11.5,7.5 - 16.8)的停药率(n = 167)低于D组((30,23.4 - 37.9,p < 0.001)和R组(23.9,18.6 - 30.1,p = 0.001),且主要归因于药物特异性副作用和出血。大多数停药患者(n = 142,85%)改用其他类型的口服抗凝药。

局限性

本研究的主要局限性是患者数量少且随访时间短。

结论

在一个单一房颤门诊的回顾性研究中,与彼此相比,NOACs显示出显著不同的出血率和不同的停药率,主要与药物特异性副作用和出血有关。大多数停药患者改用其他类型的口服抗凝药。

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