Hendriks Stephan V, Klok Frederikus A, Stenger Wilhelmina J E, Mairuhu Albert T A, Eikenboom Jeroen, Fogteloo Jaap, Huisman Menno V
Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.
Department of Medicine, Haga Teaching Hospital, The Hague, The Netherlands.
TH Open. 2020 Jun 24;4(2):e119-e126. doi: 10.1055/s-0040-1713683. eCollection 2020 Apr.
Phase 3 trials have shown comparable efficacy of direct oral anticoagulants (DOACs) and vitamin K antagonists in patients with acute venous thromboembolism (VTE), with less major bleeding events in patients randomized to DOAC treatment. With DOACs being increasingly used in clinical practice, evaluation of the DOACs in daily practice-based conditions is needed to confirm their safety and effectiveness. The aim of this study is to evaluate the effectiveness and safety of apixaban in VTE patients in daily practice. In this retrospective cohort study, consecutive patients diagnosed with VTE in two Dutch hospitals (Leiden University Medical Center, Leiden and Haga Teaching Hospital, The Hague) were identified based on administrative codes. We assessed recurrent VTE, major bleeding and mortality during a 3-month follow-up period in those treated with apixaban. Of 671 consecutive VTE patients treated with apixaban, 371 presented with acute pulmonary embolism (PE) and 300 patients with deep-vein thrombosis. During 3 months treatment, 2 patients had a recurrent VTE (0.3%; 95% confidence interval [CI]: 0.08-1.1), 12 patients had major bleeding (1.8%; 95% CI: 1.0-3.2), and 11 patients died (1.6%; 95% CI: 0.9-2.9), of which one patient with recurrent PE and one because of a intracerebral bleeding. In this daily practice-based cohort, apixaban yielded a low incidence of recurrent VTE, comparable to the phase 3 AMPLIFY study patients. The incidence of major bleeding was higher than in the AMPLIFY-study patients, reflecting the importance of daily practice evaluation and the fact that results from phase III clinical studies cannot be directly extrapolated toward daily practice.
3期试验表明，直接口服抗凝剂（DOACs）与维生素K拮抗剂在急性静脉血栓栓塞（VTE）患者中疗效相当，随机接受DOAC治疗的患者发生的严重出血事件较少。随着DOACs在临床实践中的使用越来越多，需要在基于日常实践的条件下对DOACs进行评估，以确认其安全性和有效性。本研究的目的是评估阿哌沙班在日常实践中治疗VTE患者的有效性和安全性。
在这项回顾性队列研究中，根据管理代码确定了荷兰两家医院（莱顿大学医学中心、莱顿和海牙教学医院、海牙）连续诊断为VTE的患者。我们评估了接受阿哌沙班治疗的患者在3个月随访期内的复发性VTE、严重出血和死亡率。
在671例连续接受阿哌沙班治疗的VTE患者中，371例表现为急性肺栓塞（PE），300例为深静脉血栓形成。在3个月的治疗期间，2例患者发生复发性VTE（0.3%；95%置信区间[CI]：0.08-1.1），12例患者发生严重出血（1.8%；95%CI：1.0-3.2），11例患者死亡（1.6%；95%CI：0.9-2.9），其中1例为复发性PE患者，1例因脑出血死亡。
在这个基于日常实践的队列中，阿哌沙班导致复发性VTE的发生率较低，与3期AMPLIFY研究患者相当。严重出血的发生率高于AMPLIFY研究的患者，这反映了日常实践评估的重要性，以及III期临床研究的结果不能直接外推至日常实践这一事实。
