Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy.
Department of Medicine and Surgery, University of Insubria, Varese, Italy.
Intern Emerg Med. 2017 Oct;12(7):923-934. doi: 10.1007/s11739-017-1724-7. Epub 2017 Aug 7.
Direct-acting oral anticoagulants (DOACs), by virtue of pharmacological properties perceived as innovative, are changing the therapeutic scenario of patients requiring short- and long-term anticoagulation. The evidence gathered so far (from pre-approval pivotal trials to real-world post-marketing observational data) consistently confirms that DOACs are overall comparable to vitamin-K antagonists (VKAs) in terms of safety, efficacy, effectiveness and unequivocally documents a clinically relevant reduced risk of intracranial bleeding in the settings of non-valvular atrial fibrillation (AF) and venous thromboembolism. The following issues are attracting considerable clinical interest: (a) identifying specific subpopulations of patients with AF most likely to benefit from one of these agents (the so-called tailored therapy), and (b) expanding therapeutic indications in emerging diseases characterized by arterial and venous thromboembolic risk. In these scenarios, the risk-benefit profile of DOACs, as compared to VKAs or heparins, is still incompletely characterized. In cardiology, the challenging task of selecting a suitable or even the most appropriate DOAC for patients with AF and a particular phenotype prompted experts to provide suggestions based on careful review of subgroups of patients from pivotal RCTs. However, in the past few months, variegated multicenter trials have been published (RE-CIRCUIT, PIONEER-AF-PCI, GEMINI-ACS-1), with potential influence on clinical practice. Therefore, this review aims to update the latest evidence on the evolving therapeutic uses of DOACs in the cardiovascular area, addressing potential impact for clinicians.
直接口服抗凝剂（DOACs）以其被认为具有创新性的药理学特性，正在改变需要短期和长期抗凝治疗的患者的治疗方案。迄今为止收集的证据（从批准前的关键试验到真实世界的上市后观察性数据）一致证实，DOACs 在安全性、疗效、有效性方面与维生素 K 拮抗剂（VKA）总体相当，并明确证明在非瓣膜性心房颤动（AF）和静脉血栓栓塞症（VTE）中颅内出血风险降低具有临床意义。以下问题引起了相当大的临床关注：（a）确定最有可能从这些药物中的一种中获益的特定 AF 患者亚群（所谓的量身定制治疗），以及（b）在具有动脉和静脉血栓栓塞风险的新兴疾病中扩大治疗适应症。在这些情况下，与 VKA 或肝素相比，DOAC 的风险效益比仍然不完全明确。在心脏病学中，为 AF 患者和特定表型选择合适甚至最合适的 DOAC 的艰巨任务促使专家根据关键 RCT 中患者亚组的仔细审查提供建议。然而，在过去的几个月里，已经发表了各种多中心试验（RE-CIRCUIT、PIONEER-AF-PCI、GEMINI-ACS-1），这可能对临床实践产生影响。因此，本综述旨在更新 DOAC 在心血管领域不断发展的治疗用途的最新证据，为临床医生提供潜在影响。
