Meta-Analysis on Risk of Bleeding With Apixaban in Patients With Renal Impairment

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...

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Veröffentlicht in:The American journal of cardiology 2015-02, Vol.115 (3), p.323-327
Hauptverfasser: Pathak, Ranjan, MD, Pandit, Anil, MD, Karmacharya, Paras, MD, Aryal, Madan Raj, MD, Ghimire, Sushil, MD, Poudel, Dilli Ram, MD, Shamoun, Fadi E., MD
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container_title The American journal of cardiology
container_volume 115
creator Pathak, Ranjan, MD
Pandit, Anil, MD
Karmacharya, Paras, MD
Aryal, Madan Raj, MD
Ghimire, Sushil, MD
Poudel, Dilli Ram, MD
Shamoun, Fadi E., MD
description 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
doi_str_mv 10.1016/j.amjcard.2014.10.042
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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 &lt;50 ml/min. Study-specific risk ratios were calculated, and between-study heterogeneity was assessed using the I2 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, I2  = 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, I2  = 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.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2014.10.042</identifier><identifier>PMID: 25527282</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Atrial Fibrillation - complications ; Atrial Fibrillation - drug therapy ; Cardiovascular ; Factor Xa Inhibitors - adverse effects ; Hemorrhage - chemically induced ; Hemorrhage - complications ; Humans ; Pyrazoles - adverse effects ; Pyridones - adverse effects ; Renal Insufficiency - complications ; Risk ; Severity of Illness Index ; Stroke - etiology ; Stroke - prevention &amp; control ; Venous Thromboembolism - prevention &amp; control</subject><ispartof>The American journal of cardiology, 2015-02, Vol.115 (3), p.323-327</ispartof><rights>Elsevier Inc.</rights><rights>2015 Elsevier Inc.</rights><rights>Copyright © 2015 Elsevier Inc. 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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 &lt;50 ml/min. Study-specific risk ratios were calculated, and between-study heterogeneity was assessed using the I2 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, I2  = 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, I2  = 72%). 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subjects Atrial Fibrillation - complications
Atrial Fibrillation - drug therapy
Cardiovascular
Factor Xa Inhibitors - adverse effects
Hemorrhage - chemically induced
Hemorrhage - complications
Humans
Pyrazoles - adverse effects
Pyridones - adverse effects
Renal Insufficiency - complications
Risk
Severity of Illness Index
Stroke - etiology
Stroke - prevention & control
Venous Thromboembolism - prevention & control
title Meta-Analysis on Risk of Bleeding With Apixaban in Patients With Renal Impairment
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