Imberti Davide, Barillari Giovanni
1 Division of Internal Medicine, Ospedale Civile di Piacenza, Piacenza, Italy.
2 Center for Hemorrhagic and Thrombotic Disorders, Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.
Clin Appl Thromb Hemost. 2018 Mar;24(2):241-247. doi: 10.1177/1076029617720067. Epub 2017 Jul 18.
Two large randomized controlled trials examined the efficacy and safety of rivaroxaban for the treatment of venous thromboembolism (VTE). The aim of this epidemiological study was to analyze a cohort of Italian patients affected by VTE who were treated with rivaroxaban in clinical practice. The data were collected by physicians using an online electronic questionnaire. The study was performed during a 6-month period from January to June 2014. We analyzed the clinical characteristics, risk factors for VTE, comorbidities, diagnostic techniques, and treatments in the whole population and in the subgroups with deep vein thrombosis (DVT) only, pulmonary embolism (PE) only, and DVT+PE. Overall, 75.9% of patients were affected by DVT; 20% of patients had DVT and PE; and 4.8% of patients had only PE. Approximately 90% of patients were symptomatic upon diagnosis, and 46.3% of patients required hospitalization. More than half of the patients switched to rivaroxaban after receiving another anticoagulant therapy. The main reasons for changing treatment included difficulties in managing vitamin K antagonists, patient choice, and prothrombin time-international normalized ratio (PT-INR) instability. The switch to rivaroxaban occurred after a mean of 1.8 PT-INR measurements. Clinical characteristic were overall similar to those of patients enrolled in prior clinical trials evaluating the safety and efficacy of rivaroxaban.
两项大型随机对照试验检验了利伐沙班治疗静脉血栓栓塞症(VTE)的疗效和安全性。这项流行病学研究的目的是分析一组在临床实践中接受利伐沙班治疗的意大利VTE患者。数据由医生通过在线电子问卷收集。该研究在2014年1月至6月的6个月期间进行。我们分析了全体患者以及仅患有深静脉血栓形成(DVT)、仅患有肺栓塞(PE)和患有DVT + PE的亚组患者的临床特征、VTE危险因素、合并症、诊断技术和治疗情况。总体而言,75.9%的患者患有DVT;20%的患者患有DVT和PE;4.8%的患者仅患有PE。约90%的患者在诊断时出现症状,46.3%的患者需要住院治疗。超过一半的患者在接受另一种抗凝治疗后改用利伐沙班。改变治疗的主要原因包括维生素K拮抗剂管理困难、患者选择以及凝血酶原时间 - 国际标准化比值(PT-INR)不稳定。改用利伐沙班发生在平均进行1.8次PT-INR测量之后。临床特征总体上与之前评估利伐沙班安全性和疗效的临床试验中纳入的患者相似。