Decision-making about the use of non-vitamin K oral anticoagulant therapies for patients with atrial fibrillation
Decision-making about the use of non-vitamin K oral anticoagulant therapies for patients with atrial fibrillation
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DOI：
10.1007/s11239-015-1276-5
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发表时间：
2016-02-01
影响因子：
4
通讯作者：
Eckman, Mark H.
中科院分区：
文献类型：
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作者：
Eckman, Mark H.
直到最近，维生素K拮抗剂华法林是美国最常用的药物，一直是预防房颤患者中风的唯一口服抗凝疗法。在过去的5年里，四种新的非维生素K口腔抗凝剂，即所谓的NOAC或新型口腔抗凝剂，已经上市并获得联邦药物管理局的批准。尽管在预防房颤相关卒中方面即使不是更好，也可以与之相媲美，而且大出血的风险普遍较低，尤其是颅内出血，但这些药物的吸收一直很缓慢。许多障碍阻碍了这些新型制剂的更广泛使用。其中最主要的是对缺乏解毒剂或逆转药物的担忧。其他担忧包括需要严格遵守药物治疗，因为即使错过一剂也可能导致非抗凝状态；患者的自付费用；在使用这些药物时缺乏容易获得的实验室测试来定量评估这些药物的抗凝活性水平；严重的慢性肾脏疾病患者使用的禁忌症；以及关于过早停止使用这些药物会增加血栓栓子事件风险的黑箱警告。幸运的是，一些逆转因素正在酝酿之中。三种逆转剂，idarucizumab，anddexanet alfa和aripazine，已经在人体研究中取得进展，并显示出作为特定药物的解毒剂或作为通用逆转剂的巨大前景。这些逆转药物的上市可能会增加非维生素K口服抗凝剂的临床应用。考虑到围绕着为任何房颤患者选择最佳抗凝剂的许多复杂和微妙的问题，以患者为中心/共享决策方法将是有用的。
Until recently, vitamin K antagonists, warfarin being the most commonly used agent in the United States, have been the only oral anticoagulant therapies available to prevent stroke in patients with atrial fibrillation (AF). In the last 5 years four new, non-vitamin K oral anticoagulants, the so-called NOACs or novel oral anticoagulants, have come to market and been approved by the Federal Drug Administration. Despite comparable if not superior efficacy in preventing AF-related stroke, and generally lower risks of major hemorrhage, particularly intracranial bleeding, the uptake of these agents has been slow. A number of barriers stand in the way of the more widespread use of these novel agents. Chief among them is concern about the lack of antidotes or reversal agents. Other concerns include the need for strict medication adherence, since missing even a single dose can lead to a non-anticoagulated state; out-of-pocket costs for patients; the lack of easily available laboratory tests to quantitatively assess the level of anticoagulant activity when these agents are being used; contraindications to use in patients with severe chronic kidney disease; and black-box warnings about the increased risk of thromboembolic events if these agents are discontinued prematurely. Fortunately, a number of reversal agents are in the pipeline. Three reversal agents, idarucizumab, andexanet alfa, and aripazine, have already progressed to human studies and show great promise as either antidotes for specific drugs or as universal reversal agents. The availability of these reversal agents will likely increase the clinical use of the non-vitamin K oral anticoagulants. In light of the many complex and nuanced issues surrounding the choice of an optimal anticoagulant for any AF patient, a patient-centered/shared decision-making approach will be useful.