Alsubaie Norah S, Al Rammah Shahad M, Alshouimi Reema A, Alzahrani Mohammed Y, Al Yami Majed S, Almutairi Abdulaali R, Alfayez Osamah M, Korayem Ghazwa B, Almohammed Omar A
Department of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Thromb J. 2021 Oct 30;19(1):76. doi: 10.1186/s12959-021-00326-2.
Venous thromboembolism (VTE) is a common complication among patients with cancer and is one of the most common causes of increased morbidity and mortality. The use of direct oral anticoagulants (DOACs) for thromboprophylaxis and treatment of cancer-associated venous thromboembolism (CA-VTE) has been evaluated in several randomized clinical trials (RCTs). The aim of this meta-analysis was to assess efficacy and safety of using DOACs for thromboprophylaxis and treatment of CA-VTE and provide a summary for available guidelines' recommendations.
MEDLINE was searched to identify studies evaluating the use of DOACs for thromboprophylaxis or treatment in patients with cancer. Search was limited to peer-reviewed studies published in English. Studies were excluded if they were not RCTs or subgroup analyses of data derived from RCTs, if they did not report efficacy and safety data on patients with active cancer, or if they were published as an abstract. New VTE or VTE recurrence, and major or clinically relevant non-major bleeding (CRNMB) were used to assess the efficacy and safety, respectively. The Mantel-Haenszel random-effects model risk ratios (RRs) and the corresponding 95% confidence intervals (CIs) were calculated to estimate the pooled treatment effects of DOACs.
Four studies evaluating DOACs use for thromboprophylaxis and four - for treatment of CA-VTE were included. Thromboprophylaxis with DOACs was associated with a significant reduction in the risk of symptomatic VTE (RR = 0.58; 95%CI 0.37,0.91) but with an incremental risk of major bleeding or CRNMB (RR = 1.57; 95%CI 1.10,2.26). CA-VTE treatment with DOACs was linked with a significant reduction in VTE recurrence (RR = 0.62; 95%CI 0.44,0.87) but with an incremental risk of CRNMB (RR = 1.58; 95%CI 1.11,2.24).
The DOACs are associated with a lower risk of symptomatic VTE and VTE recurrence, but the risk of bleeding remains a considerable concern. Clinical decisions should be made by assessing individual patient's risk of VTE and bleeding.
静脉血栓栓塞症(VTE)是癌症患者常见的并发症,也是发病率和死亡率增加的最常见原因之一。在多项随机临床试验(RCT)中对直接口服抗凝剂(DOACs)用于癌症相关静脉血栓栓塞症(CA-VTE)的血栓预防和治疗进行了评估。本荟萃分析的目的是评估使用DOACs进行CA-VTE血栓预防和治疗的疗效和安全性,并为现有指南的建议提供总结。
检索MEDLINE以识别评估DOACs用于癌症患者血栓预防或治疗的研究。检索限于以英文发表的同行评审研究。如果研究不是RCT或来自RCT的数据的亚组分析,如果未报告活动性癌症患者的疗效和安全性数据,或者如果以摘要形式发表,则将其排除。新发VTE或VTE复发以及大出血或临床相关非大出血(CRNMB)分别用于评估疗效和安全性。计算Mantel-Haenszel随机效应模型风险比(RRs)和相应的95%置信区间(CIs)以估计DOACs的合并治疗效果。
纳入了四项评估DOACs用于血栓预防的研究和四项用于CA-VTE治疗的研究。使用DOACs进行血栓预防与有症状VTE风险的显著降低相关(RR = 0.58;95%CI 0.37,0.91),但大出血或CRNMB风险增加(RR = 1.57;95%CI 1.10,2.26)。使用DOACs治疗CA-VTE与VTE复发的显著降低相关(RR = 0.62;95%CI 0.44,0.87),但CRNMB风险增加(RR = 1.58;95%CI 1.11,2.24)。
DOACs与有症状VTE和VTE复发风险较低相关,但出血风险仍然是一个相当大的问题。临床决策应通过评估个体患者的VTE和出血风险来做出。