Brekelmans Marjolein P A, Bleker Suzanne M, Bauersachs Rupert, Boda Zoltan, Büller Harry R, Choi Youngsook, Gallus Alex, Grosso Michael A, Middeldorp Saskia, Oh Doyeun, Raskob Gary, Schwocho Lee, Cohen Alexander T
Marjolein P. A. Brekelmans, Department of Vascular Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands, Tel.: +31 20 5668791, Fax: +31 20 5669343, E-mail:
Thromb Haemost. 2016 Jul 4;116(1):155-61. doi: 10.1160/TH15-11-0892. Epub 2016 Mar 24.
Edoxaban is a once-daily direct oral anticoagulant (DOAC). The Hokusai-VTE study revealed that, after initial treatment with heparin, edoxaban was non-inferior to and safer than vitamin K antagonists (VKA) in the prevention of recurrent deep-vein thrombosis and pulmonary embolism. This is the first report on the clinical relevance and management of bleeding events with edoxaban. All major bleeding events were classified blindly by three study-independent adjudicators. Pre-defined criteria were used to classify severity of clinical presentation and, separately, the clinical course and outcome into four categories. Major bleeding occurred in 56 patients treated with edoxaban and 65 patients treated with VKA. The severest categories (3 or 4) of the clinical presentation were assigned to 46 % of the major bleeding episodes in edoxaban recipients versus 58 % of the major bleeds in VKA recipients (odds ratio [OR] 0.62, 95 % confidence interval [CI] 0.30-1.27, p = 0.19). Clinical course was classified as severe (category 3 or 4) in 23 % of the edoxaban and 29 % of the VKA associated bleeds (OR 0.73, 95 % CI 0.32-1.66, p = 0.46). In conclusion, edoxaban associated major bleeding events have a comparable clinical presentation and course to major bleeds with VKA in patients treated for venous thromboembolism in the Hokusai-VTE study. These results may assure physicians that it is safe to prescribe this medication. If a major bleeding during edoxaban treatment occurs, its clinical presentation and clinical course are not worse than in VKA-treated patients.
依度沙班是一种每日服用一次的直接口服抗凝剂（DOAC）。北陆-VTE研究表明，在肝素初始治疗后，依度沙班在预防复发性深静脉血栓形成和肺栓塞方面不劣于维生素K拮抗剂（VKA），且更安全。这是关于依度沙班出血事件的临床相关性和管理的首份报告。所有主要出血事件均由三名独立于研究的评判员进行盲法分类。使用预先定义的标准对临床表现的严重程度进行分类，并分别将临床病程和结局分为四类。接受依度沙班治疗的56例患者和接受VKA治疗的65例患者发生了主要出血。依度沙班治疗患者中46%的主要出血事件属于最严重类别（3或4级），而VKA治疗患者中这一比例为58%（优势比[OR]0.62，95%置信区间[CI]0.30 - 1.27，p = 0.19）。依度沙班相关出血事件中23%的临床病程被分类为严重（3或4级），VKA相关出血事件中这一比例为29%（OR 0.73，95% CI 0.32 - 1.66，p = 0.46）。总之，在北陆-VTE研究中，依度沙班相关的主要出血事件在接受静脉血栓栓塞治疗的患者中，其临床表现和病程与VKA引起的主要出血相当。这些结果可能会让医生放心，开具这种药物是安全的。如果在依度沙班治疗期间发生主要出血，其临床表现和临床病程并不比接受VKA治疗的患者更差。
