Beyer-Westendorf Jan, Marten Sandra, Tittl Luise, Naue Christiane, Bornhäuser Martin
Thrombosis Research Unit, Division Hematology, Department of Medicine I, University Hospital "Carl Gustav Carus" Dresden, Dresden, Germany.
Kings Thrombosis Service, Department of Hematology, Kings College, London, United Kingdom.
TH Open. 2021 May 4;5(2):e143-e151. doi: 10.1055/s-0041-1728675. eCollection 2021 Apr.
The effectiveness and safety of venous thromboembolism (VTE) treatment with apixaban, demonstrated in phase III trials, need to be confirmed in daily care. Using data from the prospective, noninterventional cross-indication we evaluated rates of VTE recurrence and bleeding complications during apixaban treatment of VTE patients. For this analysis, we only included patients with acute VTE who started apixaban within 14 days after diagnosis and who were enrolled within these 14 days. Patient characteristics, treatment persistence, and clinical outcomes were assessed. Between August 1st, 2014 and October 31, 2018, 352 patients with apixaban treatment for acute VTE were enrolled. During treatment (median exposure 13.7 ± 9.8 months; median follow-up 21.7 ± 6.1 months) rates of recurrent VTE and International Society on Thrombosis and Haemostasis major bleeding were 1.3/100 pt.years (95% confidence interval or CI 0.4-3.0) and 1.5/100 pt.years (0.6-3.3), respectively. At 6 months. 68.6% of patients were still taking apixaban, 23.9% had a scheduled end of treatment, 6.3% were switched to other anticoagulants, and the remaining 2.3% had unplanned complete discontinuation of anticoagulation. Of the 188 patients stopping apixaban, 12 (6.4%) experienced a recurrent VTE (six pulmonary embolisms ± deep vein thrombosis, six deep vein thrombosis; mean time between stopping anticoagulation and VTE recurrence 5.2 ± 4.1 months [range 14-417 days]). Our findings suggest that, in daily care, apixaban demonstrated high effectiveness, safety, and persistence in the treatment of acute VTE with low rates of unplanned discontinuation.
在III期试验中已证实阿哌沙班治疗静脉血栓栓塞（VTE）的有效性和安全性，但其在日常护理中的效果仍需确认。我们利用前瞻性、非干预性交叉适应症研究的数据，评估了阿哌沙班治疗VTE患者期间VTE复发率和出血并发症。在本次分析中，我们仅纳入了急性VTE患者，这些患者在诊断后14天内开始服用阿哌沙班，并在这14天内入组。我们评估了患者特征、治疗持续性和临床结局。2014年8月1日至2018年10月31日期间，共有352例急性VTE患者接受了阿哌沙班治疗。在治疗期间（中位暴露时间为13.7±9.8个月；中位随访时间为21.7±6.1个月），VTE复发率和国际血栓与止血学会（ISTH）定义的大出血发生率分别为1.3/100患者年（95%置信区间或CI 0.4-3.0）和1.5/100患者年（0.6-3.3）。在6个月时，68.6%的患者仍在服用阿哌沙班，23.9%的患者按计划结束治疗，6.3%的患者改用其他抗凝药物，其余2.3%的患者意外完全停用抗凝药物。在188例停用阿哌沙班的患者中，12例（6.4%）发生了VTE复发（6例肺栓塞合并深静脉血栓形成，6例深静脉血栓形成；停用抗凝药物至VTE复发的平均时间为5.2±4.1个月[范围14-417天]）。我们的研究结果表明，在日常护理中，阿哌沙班在治疗急性VTE方面显示出高有效性、安全性和持续性，意外停药率较低。
