Istituto di Ricovero e Cura a Carttere Scientifico San Raffaele Pisana, Rome, Italy.
Dipartimento Scienze Cliniche e Medicina traslazionale, Università Tor Vergata, Rome, Italy.
Intern Emerg Med. 2018 Oct;13(7):1069-1075. doi: 10.1007/s11739-018-1896-9. Epub 2018 Jun 28.
In the past few years, new oral anticoagulants (NOACs) targeting directly a single activated clotting factor, have been developed for the treatment of non-valvular atrial fibrillation (AF), which are currently recommended as first-line therapy in AF. The aim of this study is to provide an overall picture on the extent to which oral anticoagulation (OAC) with NOACs correspond to actually prescribed OAC therapy in an unselected, real world, population of consecutive patients with AF in Italy. Compliance with the therapy and quality of life were also assessed. A 50 cardiology unit network located in different geographic areas of Italy enrolled a total of 1742 consecutive outpatients with AF (54.6% males, 45.4% females, mean age 72.5 years). NOACs were prescribed in 56.1% patients and VKA in 43.9% (P < 0.0001). NOACs were significantly more prescribed than VKA in patients with high thrombo-embolic risk score (i.e., CHADS-VASc > 2) (78.2 vs 67.3%, P < 0.0001), but also patients at low risk (i.e., CHADS-VASc < 1 and HAS-BLED < 3) were still under OAC therapy with either NOACs (27%) or VKA (73%). Adherence to therapy (Morisky test) was greater in patients taking NOACs as was the quality of life. The ISPAF-2 study shows that in an Italian population of real-world patients with AF the prescription of OAC according to current guidelines and stroke-risk scoring system is rather high although it still needs to be improved. Contrary to recommendations, in a high proportion of low-risk patients, anticoagulation therapy, with either NOACs and VKA is still prescribed, and this exposes patients to unjustified risks.
在过去的几年中，已经开发出了针对单一激活凝血因子的新型口服抗凝剂（NOAC），用于治疗非瓣膜性心房颤动（AF），目前被推荐为 AF 的一线治疗方法。本研究的目的是全面了解意大利未经选择的真实世界人群中，NOAC 口服抗凝剂（OAC）与实际处方 OAC 治疗的符合程度。还评估了治疗的依从性和生活质量。意大利 50 个心脏病学单位网络位于不同的地理区域，共招募了 1742 名连续的 AF 门诊患者（54.6%为男性，45.4%为女性，平均年龄 72.5 岁）。56.1%的患者处方了 NOAC，43.9%的患者处方了 VKA（P < 0.0001）。在高血栓栓塞风险评分（即 CHADS-VASc > 2）的患者中，NOAC 的处方明显多于 VKA（78.2%比 67.3%，P < 0.0001），但在低风险患者（即 CHADS-VASc < 1 和 HAS-BLED < 3）中，仍有部分患者接受 OAC 治疗，NOAC（27%）或 VKA（73%）。服用 NOAC 的患者对治疗的依从性（Morisky 测试）更高，生活质量也更好。ISPAF-2 研究表明，在意大利真实世界的 AF 患者人群中，根据当前指南和中风风险评分系统开具 OAC 的处方率相当高，尽管仍需要改进。与建议相反，在很大一部分低风险患者中，仍开具了抗凝治疗，包括 NOAC 和 VKA，这使患者面临不合理的风险。
