Al Yami Majed S, Kurdi Sawsan, Abraham Ivo
Department of Pharmacy Practice, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.
J Blood Med. 2018 Feb 21;9:25-34. doi: 10.2147/JBM.S149202. eCollection 2018.
Standard-duration (7-10 days) thromboprophylaxis with low molecular weight heparin, low dose unfractionated heparin, or fondaparinux in hospitalized medically ill patients is associated with ~50% reduction in venous thromboembolism (VTE) risk. However, these patients remain at high risk for VTE post-discharge. The direct oral anticoagulants (DOACs) apixaban, rivaroxaban and betrixaban have been evaluated for extended-duration (30-42 days) thromboprophylaxis in this population.
We review the efficacy and safety results from the 3 pivotal trials of extended-duration DOAC thromboprophylaxis in medically ill patients. We performed a meta-analysis of these pivotal trials focusing on 6 VTE (efficacy) and three bleeding outcomes (safety). These results were integrated into a quantitative risk/benefit assessment.
The trials evaluating extended-duration DOAC thromboprophylaxis in medically ill patients failed to establish clear efficacy and/or safety signals for each agent. Our meta-analysis shows that, as a class, DOACs have selective and partial extended-duration prophylactic activity in preventing VTE events. However, this is associated with a marked increase in the risk of various bleeding events. The risk/benefit analyses fail to show a consistent net clinical benefit of extended-duration DOAC prophylaxis in medically ill patients.
At this time, the evidence of safe and effective extended-duration thromboprophylaxis with DOACs in this population is inconclusive.
在住院的内科疾病患者中，使用低分子量肝素、低剂量普通肝素或磺达肝癸钠进行标准疗程（7 - 10天）的血栓预防可使静脉血栓栓塞（VTE）风险降低约50%。然而，这些患者出院后VTE风险仍很高。已对阿哌沙班、利伐沙班和贝曲沙班等直接口服抗凝剂（DOACs）在该人群中进行延长疗程（30 - 42天）的血栓预防评估。
我们回顾了在内科疾病患者中进行的延长疗程DOAC血栓预防的3项关键试验的疗效和安全性结果。我们对这些关键试验进行了荟萃分析，重点关注6项VTE（疗效）和3项出血结局（安全性）。这些结果被纳入定量风险/效益评估。
评估在内科疾病患者中延长疗程DOAC血栓预防的试验未能为每种药物确立明确的疗效和/或安全性信号。我们的荟萃分析表明，作为一个类别，DOACs在预防VTE事件方面具有选择性和部分延长疗程的预防活性。然而，这与各种出血事件风险的显著增加相关。风险/效益分析未能显示延长疗程DOAC预防在内科疾病患者中具有一致的净临床效益。
目前，在该人群中使用DOACs进行安全有效的延长疗程血栓预防的证据尚无定论。
