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口服抗凝药物在心血管疾病中的应用:利伐沙班目前和潜在适应证的观点。

Oral anticoagulant use in cardiovascular disorders: a perspective on present and potential indications for rivaroxaban.

机构信息

a Cardiovascular and Cell Sciences Research Institute , St George's, University of London and Imperial College , London , UK.

b Centre for Cardiovascular Science , University of Edinburgh and Royal Infirmary of Edinburgh , Edinburgh , UK.

出版信息

Curr Med Res Opin. 2018 Nov;34(11):1945-1957. doi: 10.1080/03007995.2018.1467885. Epub 2018 May 21.

Abstract

BACKGROUND

Four non-vitamin-K-antagonist oral anticoagulants (NOACs) have been approved for use in various cardiovascular indications. The direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors apixaban, edoxaban and rivaroxaban are now increasingly used in clinical practice. For some of these agents, available data from real-world studies support the efficacy and safety data in phase III clinical trials.

OBJECTIVES

This review aims to summarize the current status of trials and observational studies of oral anticoagulant use over the spectrum of cardiovascular disorders (excluding venous thrombosis), provide a reference source beyond stroke prevention for atrial fibrillation (AF) and examine the potential for novel applications in the cardiovascular field.

METHODS

We searched the recent literature for data on completed and upcoming trials of oral anticoagulants with a particular focus on rivaroxaban.

RESULTS

Recent data in specific patient subgroups, such as patients with AF undergoing catheter ablation or cardioversion, have led to an extended approval for rivaroxaban, whereas the other NOACs have ongoing or recently completed trials in this setting. However, there are unmet medical needs for several arterial thromboembolic-related conditions, including patients with: AF and acute coronary syndrome, AF and coronary artery disease undergoing elective percutaneous coronary intervention, coronary artery disease and peripheral artery disease, implanted cardiac devices, and embolic stroke of unknown source.

CONCLUSION

NOACs may provide alternative treatment options in areas of unmet need, and numerous studies are underway to assess their benefit-risk profiles in these settings.

摘要

背景

四种非维生素 K 拮抗剂口服抗凝剂(NOAC)已被批准用于各种心血管适应证。直接凝血酶抑制剂达比加群和直接因子 Xa 抑制剂阿哌沙班、依度沙班和利伐沙班现已在临床实践中得到越来越多的应用。对于其中一些药物,来自真实世界研究的可用数据支持 III 期临床试验中的疗效和安全性数据。

目的

本综述旨在总结口服抗凝剂在心血管疾病(不包括静脉血栓形成)谱中的试验和观察性研究的现状,为除房颤(AF)以外的卒中预防以外提供一个参考来源,并探讨在心血管领域的新应用的潜力。

方法

我们搜索了近期关于口服抗凝剂试验的文献数据,特别是利伐沙班的研究数据。

结果

特定患者亚组(如正在接受导管消融或电复律的 AF 患者)的近期数据导致了利伐沙班的扩展批准,而其他 NOAC 在此类患者中正在进行或最近完成了试验。然而,仍有几个与动脉血栓栓塞相关的疾病存在未满足的医疗需求,包括:AF 和急性冠状动脉综合征、AF 和择期经皮冠状动脉介入治疗的冠心病、冠心病和外周动脉疾病、植入式心脏设备和不明来源的栓塞性卒中。

结论

NOAC 可能在存在未满足需求的领域提供替代治疗选择,目前正在进行许多研究以评估它们在这些情况下的获益-风险特征。

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