Different doses of rivaroxaban versus enoxaparin for prevention of venous thromboembolism after total hip arthroplasty: a meta-analysis of safety and efficacy

doi:10.3969/j.issn.2095-4344.2016.53.017

Abstract

Abstract:

BACKGROUND: Rivaroxaban and enoxaparin are commonly used drugs to prevent venous thromboembolism after total hip arthroplasty. There is still some controversy on the safety and efficacy. At present, there is no research on the optimal dose of rivaroxaban in domestic and foreign countries.

OBJECTIVE: To systematically review the protective effect and safety for prevention of venous thromboembolism after total hip arthroplasty between rivaroxaban and enoxaparin.

METHODS: Databases were retrieved including The Cochrane Library (Issue 9, 2014), Medline, EMbase, PubMed, VIP, WanFang and CNKI (from database foundation to September 2015) for randomized controlled trials about rivaroxaban compared with enoxaparin to prevent venous thromboembolism after total hip arthroplasty. Meta-analysis was conducted in two kinds of treatment of deep vein thrombosis, major venous thromboembolism, major bleeding events, non-major bleeding and minor bleeding events.

RESULTS AND CONCLUSION: (1) Overall results showed that: efficacy of rivaroxaban was better than enoxaparin in the prevention of venous thromboembolism after total hip arthroplasty, but rivaroxaban has greater risk for hemorrhage. (2) Subgroup analysis results demonstrated that the efficacy of rivaroxaban at 10 and 30 mg/d was better than that of enoxaparin in the prevention of venous thromboembolism (P < 0.05). The efficacy of rivaroxaban at 10 mg/d was better than that of enoxaparin in the prevention of venous thromboembolism (P < 0.05). The risk of hemorrhage when using rivaroxaban at 30, 40 and 60 mg/d was higher than that of enoxaparin (P < 0.05). (3) Comprehensive subgroup analysis results showed that the efficacy and safety of rivaroxaban at 10 mg/d were better than enoxaparin. (4) Due to the limited quantity and quality of included studies, these conclusions need more high-quality and large multicenter randomized controlled trials to verify.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Arthroplasty, Replacement, Prostheses and Implants, Venous Thrombosis, Tissue Engineering

Wei Zhi-hui, Zhang Ming-hua, Zhao Bo, Min Jing, Qiu Hao, Lu Min-peng. Different doses of rivaroxaban versus enoxaparin for prevention of venous thromboembolism after total hip arthroplasty: a meta-analysis of safety and efficacy[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(53): 8022-8031.

Figures/Tables 6

References

[1] Falck-Ytter Y,Francis CW,Johanson NA,et al.Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e278S-325S.

[2] Geerts WH,Bergqvist D,Pineo GF,et al.Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest.2008;133(6 Suppl): 381S-453S.

[3] 吕厚山.人工关节置换术后下肢深静脉血栓形成和肺栓塞的防治[J].中华创伤骨科杂志, 2007,9(3):201-204.

[4] 李佩佳,高玉镭,王东辰,等.利伐沙班与低分子肝素在预防人工全髋关节置换术后深静脉血栓形成的分析[J],中国矫形外科杂志,2012,20(11):998-1000.

[5] 邱贵兴,戴尅戎,杨庆铭,等.预防骨科大手术后深静脉血栓形成的专家建议[J].中国临床医生,2006,34(1):27-28.

[6] Eriksson BI,Rosencher N,Friedman RJ,et al.Concomitant use of medication with antiplatelet effects in patients receiving either rivaroxaban or enoxaparin after total hip or knee arthroplasty.Thromb Res,2012;130(2):147-151.

[7] 邱贵兴.中国骨科大手术静脉血栓栓塞症预防指南[J].中华关节外科杂志(电子版),2009,3(3):380-383.

[8] Eriksson BI,Borris LC,Friedman RJ,et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty.N Engl J Med.2008;358(26):2765-2775.

[9] Gomez-Outes A,Terleira-Fernandez AI,Suarez-Gea ML,et al.Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons.BMJ.2012; 14(344): e3675.

[10] 钟文昭,吴一龙,谷力加. Review Manager (RevMan)-临床医生通向Meta分析的桥梁[J].循证医学,2013,3(4): 234-246.

[11] Harris RP,Helfand M,Woolf SH,et al.Methods Work Group,Third U.S. Preventive Services Task Force. Current methods of the U.S. Preventive Services Task Force.A review of the process.Am J Prev Med.2001; 20(Suppl 3):21-35.

[12] Eriksson BI,Borris LC,Dahl OE,et al.Dose-escalation study of rivaroxaban (BAY 59-7939)--an oral, direct Factor Xa inhibitor--for the prevention of venous thromboembolism in patients undergoing total hip replacement.Thromb Res. 2007;120(5): 685-693.

[13] Eriksson BI,Borris L,Dahl OE,et al.Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement. J Thromb Haemost.2006;4(1): 121-128.

[14] Kakkar AK,Brenner B,Dahl OE,et al.Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial.Lancet.2008;372(9632): 31-39.

[15] Eriksson BI,Borris LC,Dahl OE,et al. A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement. Circulation.2006;114(22):2374-2381.

[16] 柴伟.利伐沙班预防成人全髋关节置换术后静脉血栓栓塞的有效性及安全性研究[D].中国人民解放军军医进修学院,2008.

[17] 马骊,王欣,蒋丽华.人工髋关节置换后的深静脉血栓形成:发生因素及其预防策略[J].中国组织工程研究与临床康复,2010,14(9):1677-1680.

[18] Harder S.Pharmacokinetic and pharmacodynamic evaluation of rivaroxaban: considerations for the treatment of venous thromboembolism. Thromb J.2014;12(1):22.

[19] 张晟,解笑宸,姚粤峰,等.全髋关节置换后下肢深静脉血栓形成的4项危险因素[J].中国组织工程研究, 2015, 19(13):1969-1973.

[20] 林梅清,古艳,何晓薇,等.彩色多普勒超声诊断下肢深静脉血栓形成的分析和探讨[J].中国医学创新, 2012, 7(25):157-158.

[21] Parisi R,Visonà A,Camporese G,et al.Isolated distal deep vein thrombosis: efficacy and safety of a protocol of treatment. Treatment of Isolated Calf Thrombosis (TICT) Study.Int Angiol.2009;28(1): 68-72.

[22] Weitz JI,Hirsh J,Samama MM,et al. New antithrombotic drugs: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).Chest. 2008;133(6 Suppl): 234S-256S.

[23] Turpie AG.Oral, direct factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler Thromb Vasc Biol.2007;27(6): 1238-1247.

[24] 程丈俊,王俊文,任义军,等.利伐沙班与低分子量肝素在初次全髋关节置换术后深静脉血栓形成防治中的比较研究[J].中华创伤骨科杂志,2012,6(14):480-483.

[25] Turpie AG,Kreutz R,Llau J,et al.Management consensus guidance for the use of rivaroxaban--an oral, direct factor Xa inhibitor.Thromb Haemost. 2012; 108:876-886.

[26] Mueck W,Becka M,Kubitza D,et al.Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct Factor Xa inhibitor-in healthy subjects.Int J Clin Pharmacol Ther. 2007;45: 335-344.

[27] Kubitza D,Becka M,Wensing G,et al.Safety, pharmacodynamics and phar-macokinetics of BAY 59-7939 - an oral, direct Factor Xa inhibitor - after multiple dosing in healthy male subjects.Eur J Clin Pharmacol.2005;61:873-880.

[28] 靖光武,叶树楠,杨述华.髋关节置换后利伐沙班与低分子肝素预防下肢深静脉血栓的比较[J].中国组织工程研究与临床康复,2011,15(22):4028-4031.

[29] 廖朝雨,付金玉.利伐沙班预防全髋关节置换术后静脉血栓的近期疗效及安全性[J].中外医疗,2015,35(24): 132-134.

[30] 王炜,翁习生,林进,等.单侧全膝关节置换术后依诺肝素与利伐沙班抗凝效果的随机对照研究[J].中国骨与关节外科,2012,5(3):198-202.

[31] Huisman MV，Quinlan DJ，Dahl OE,et al.Enoxaparin versus dabigatran or rivaroxaban for thromboprophylaxis after hip or knee arthroplasty：results of separate pooled analyses of phase III multicenter randomized trials.Circ Cardiovasc Qual Outcomes.2010; 3(6):652-660．

[32] Cao YB,Zhang JD,Shen H,et al.Rivaroxaban versus enoxaparin for thromboprophylaxis after total hip or knee arthroplasty:a meta analysis of randomized controlled trials.Eur J Clin Pharmacol.2010;66(11): 1099-1108．

[33] Kubitza D,Becka M,Voith B,et al.Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor.Clin Pharmacol Ther.2005;78(4):412-421.

[34] 李军,王健,史占军,等.全髋关节置换后应用利伐沙班安全性的Meta分析[J].中国组织工程研究,2012,16(9): 1618-1621.