Pathak Ranjan, Pandit Anil, Karmacharya Paras, Aryal Madan Raj, Ghimire Sushil, Poudel Dilli Ram, Shamoun Fadi E
Department of Medicine, Reading Health System, Reading, Pennsylvania.
Division of Cardiovascular Diseases, Mayo Clinic, Arizona.
Am J Cardiol. 2015 Feb 1;115(3):323-7. doi: 10.1016/j.amjcard.2014.10.042. Epub 2014 Nov 13.
Apixaban is a novel oral anticoagulant which is approved for the management of atrial fibrillation and venous thromboembolism prophylaxis. There have been concerns regarding bleeding risks with apixaban in patients with renal impairment. We performed a systematic review and meta-analysis to evaluate the risk of bleeding with apixaban in these patients. Relevant studies were identified through electronic literature searches of MEDLINE, EMBASE, Cochrane library, and clinicaltrials.gov (from inception to February 24, 2014). Phase III randomized controlled trials that compared apixaban with conventional agents (vitamin K antagonist and/or warfarin, low molecular weight heparin, aspirin, and placebo) were included. We defined mild renal impairment as creatinine clearance of 50 to 80 ml/min and moderate to severe renal impairment as creatinine clearance <50 ml/min. Study-specific risk ratios were calculated, and between-study heterogeneity was assessed using the I(2) statistics. In 6 trials involving 40,145 patients, the risk of bleeding with apixaban in patients with mild renal impairment was significantly less (risk ratio 0.80, 95% confidence interval 0.66 to 0.96, I(2) = 13%) compared with conventional anticoagulants. In patients with moderate to severe renal impairment, the risk of bleeding with was found to be similar (risk ratio 1.01, 95% confidence interval 0.49 to 2.10, I(2) = 72%). In conclusion, compared with the conventional agents, bleeding risk with apixaban in patients with mild and moderate to severe renal insufficiency is lower and similar, respectively.
阿哌沙班是一种新型口服抗凝剂，已被批准用于治疗心房颤动和预防静脉血栓栓塞。肾功能不全患者使用阿哌沙班的出血风险一直受到关注。我们进行了一项系统评价和荟萃分析，以评估这些患者使用阿哌沙班的出血风险。通过对MEDLINE、EMBASE、Cochrane图书馆和clinicaltrials.gov（从创建到2014年2月24日）进行电子文献检索，确定了相关研究。纳入了比较阿哌沙班与传统药物（维生素K拮抗剂和/或华法林、低分子肝素、阿司匹林和安慰剂）的III期随机对照试验。我们将轻度肾功能不全定义为肌酐清除率为50至80 ml/分钟，中度至重度肾功能不全定义为肌酐清除率<50 ml/分钟。计算了各研究的风险比，并使用I(2)统计量评估了研究间的异质性。在涉及40145名患者的6项试验中，轻度肾功能不全患者使用阿哌沙班的出血风险明显低于传统抗凝剂（风险比0.80，95%置信区间0.66至0.96，I(2)=13%）。在中度至重度肾功能不全患者中，出血风险相似（风险比1.01，95%置信区间0.49至2.10，I(2)=72%）。总之，与传统药物相比，轻度和中度至重度肾功能不全患者使用阿哌沙班的出血风险分别较低和相似。
