Marjolein P. A. Brekelmans and Suzanne M. Bleker, Department of Vascular Medicine, Academic Medical Centre, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands, Tel.: +31 20 5668791, Fax: +31 20 5669343, E-mail:
Thromb Haemost. 2017 Oct 5;117(10):1944-1951. doi: 10.1160/TH16-12-0946. Epub 2017 Aug 17.
Factor Xa (fXa)-inhibitors are as effective and safer than vitamin-K-antagonists (VKA) in the treatment of venous thromboembolism (VTE). We previously classified the severity of clinical presentation and course of all major bleeding events from the EINSTEIN, AMPLIFY and HOKUSAI-VTE trials separately. The current aim was to combine these findings in order to increase precision, assess a class effect and analyse presentation and course for different types of bleeding, i. e. intracranial, gastro-intestinal, and other. We classified the clinical presentation and course of all major bleeding events using pre-defined criteria. Both classifications comprised four categories; one being the mildest, and four the most severe. Odds ratios (OR) were calculated for all events classified as category three or four between fXa-inhibitors and VKA recipients. Also, ORs were computed for different types of bleeding. Major bleeding occurred in 111 fXa-inhibitor recipients and in 187 LMWH/VKA recipients. The clinical presentation was classified as category three or four in 35 % and 48 % of the major bleeds in fXa inhibitor and VKA recipients, respectively (OR 0.59, 95 % CI 0.36-0.97). For intracranial, gastro-intestinal and other bleeding a trend towards a less severe presentation was observed for patients treated with fXa inhibitors. Clinical course was classified as severe in 22 % of the fXa inhibitor and 25 % of the VKA associated bleeds (OR 0.83, 95 % CI 0.47-1.46). In conclusion, FXa inhibitor associated major bleeding events had a significantly less severe presentation and a similar course compared to VKA. This finding was consistent for different types of bleeding.
Xa 因子抑制剂（fXa-i）在治疗静脉血栓栓塞症（VTE）方面与维生素 K 拮抗剂（VKA）同样有效且更安全。我们之前分别对 EINSTEIN、AMPLIFY 和 HOKUSAI-VTE 试验中的所有大出血事件的临床表现和病程进行了严重程度分类。目前的目的是结合这些发现以提高精确度，评估类效应，并分析不同类型出血（即颅内、胃肠和其他类型）的表现和病程。我们使用预先定义的标准对所有主要大出血事件的临床表现和病程进行了分类。这两种分类均包括四个类别；一个是最轻微的，四个是最严重的。对于 fXa-i 和 VKA 接受者中所有分类为 3 或 4 类的事件，计算了优势比（OR）。此外，还计算了不同类型出血的 OR。在 111 名 fXa-i 接受者和 187 名低分子肝素/VKA 接受者中发生了主要出血。fXa-i 和 VKA 接受者的主要出血中，临床表现分别被分类为 3 或 4 类的占 35%和 48%（OR 0.59，95%CI 0.36-0.97）。对于颅内、胃肠和其他出血，接受 fXa-i 治疗的患者表现出较轻的趋势。在 fXa-i 和 VKA 相关出血中，分别有 22%和 25%的临床病程被分类为严重（OR 0.83，95%CI 0.47-1.46）。总之，与 VKA 相比，fXa-i 相关的主要出血事件具有明显较轻的表现和相似的病程。这一发现与不同类型的出血一致。
