CLC number: R541.7+5
On-line Access: 2024-08-27
Received: 2023-10-17
Revision Accepted: 2024-05-08
Crosschecked: 2017-06-16
Cited: 1
Clicked: 7993
Citations: Bibtex RefMan EndNote GB/T7714
Wei-wei Xu, Shen-jiang Hu, Tao Wu. Risk analysis of new oral anticoagulants for gastrointestinal bleeding and intracranial hemorrhage in atrial fibrillation patients: a systematic review and network meta-analysis[J]. Journal of Zhejiang University Science B, 2017, 18(7): 567-576.
@article{title="Risk analysis of new oral anticoagulants for gastrointestinal bleeding and intracranial hemorrhage in atrial fibrillation patients: a systematic review and network meta-analysis",
author="Wei-wei Xu, Shen-jiang Hu, Tao Wu",
journal="Journal of Zhejiang University Science B",
volume="18",
number="7",
pages="567-576",
year="2017",
publisher="Zhejiang University Press & Springer",
doi="10.1631/jzus.B1600143"
}
%0 Journal Article
%T Risk analysis of new oral anticoagulants for gastrointestinal bleeding and intracranial hemorrhage in atrial fibrillation patients: a systematic review and network meta-analysis
%A Wei-wei Xu
%A Shen-jiang Hu
%A Tao Wu
%J Journal of Zhejiang University SCIENCE B
%V 18
%N 7
%P 567-576
%@ 1673-1581
%D 2017
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.B1600143
TY - JOUR
T1 - Risk analysis of new oral anticoagulants for gastrointestinal bleeding and intracranial hemorrhage in atrial fibrillation patients: a systematic review and network meta-analysis
A1 - Wei-wei Xu
A1 - Shen-jiang Hu
A1 - Tao Wu
J0 - Journal of Zhejiang University Science B
VL - 18
IS - 7
SP - 567
EP - 576
%@ 1673-1581
Y1 - 2017
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.B1600143
Abstract: Background: Antithrombotic therapy using new oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) has been generally shown to have a favorable risk-benefit profile. Since there has been dispute about the risks of gastrointestinal bleeding (GIB) and intracranial hemorrhage (ICH), we sought to conduct a systematic review and network meta-analysis using Bayesian inference to analyze the risks of GIB and ICH in AF patients taking NOACs. Methods: We analyzed data from 20 randomized controlled trials of 91 671 AF patients receiving anticoagulants, antiplatelet drugs, or placebo. Bayesian network meta-analysis of two different evidence networks was performed using a binomial likelihood model, based on a network in which different agents (and doses) were treated as separate nodes. Odds ratios (ORs) and 95% confidence intervals (CIs) were modeled using Markov chain Monte Carlo methods. Results: Indirect comparisons with the Bayesian model confirmed that aspirin+clopidogrel significantly increased the risk of GIB in AF patients compared to the placebo (OR 0.33, 95% CI 0.01–0.92). Warfarin was identified as greatly increasing the risk of ICH compared to edoxaban 30 mg (OR 3.42, 95% CI 1.22–7.24) and dabigatran 110 mg (OR 3.56, 95% CI 1.10–8.45). We further ranked the NOACs for the lowest risk of GIB (apixaban 5 mg) and ICH (apixaban 5 mg, dabigatran 110 mg, and edoxaban 30 mg). Conclusions: Bayesian network meta-analysis of treatment of non-valvular AF patients with anticoagulants suggested that NOACs do not increase risks of GIB and/or ICH, compared to each other.
[1]Alexander, J.H., Lopes, R.D., James, S., et al., 2011. Apixaban with antiplatelet therapy after acute coronary syndrome. N. Engl. J. Med., 365(8):699-708.
[2]Begg, C.B., Mazumdar, M., 1994. Operating characteristics of a rank correlation test for publication bias. Biometrics, 50(4):1088-1101.
[3]Biondi-Zoccai, G., Malavasi, V., D'Ascenzo, F., et al., 2013. Comparative effectiveness of novel oral anticoagulants for atrial fibrillation: evidence from pair-wise and warfarin-controlled network meta-analyses. HSR Proc. Intens. Care Cardiovasc. Anesth., 5(1):40-54.
[4]Camm, A.J., Lip, G.Y., de Caterina, R., et al., 2012. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur. Heart J., 33(21):2719-2747.
[5]Candel, F.J., Matesanz, M., Cogolludo, F., et al., 2004. Prevalence of atrial fibrillation and relationed factors in a population in the centre Madrid. An. Med. Interna (Madrid), 21(10):477-482.
[6]http://doi.org/10.4321/S0212-71992004001000003
[7]Chatterjee, S., Sardar, P., Biondi-Zoccai, G., et al., 2013. New oral anticoagulants and the risk of intracranial hemorrhage: traditional and Bayesian meta-analysis and mixed treatment comparison of randomized trials of new oral anticoagulants in atrial fibrillation. JAMA Neurol., 70(12):1486-1490.
[8]Chen, W.C., Chen, Y.H., Hsu, P.I., et al., 2014. Gastrointestinal hemorrhage in warfarin anticoagulated patients: incidence, risk factor, management, and outcome. BioMed Res. Int., 2014:463767.
[9]Chung, N., Jeon, H.K., Lien, L.M., et al., 2011. Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. Thromb. Haemost., 105(3):535-544.
[10]Connolly, S.J., Pogue, J., Hart, R., et al., 2006. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet, 367(9526):1903-1912.
[11]Connolly, S.J., Laupacis, A., Gent, M., et al., 1991. Canadian atrial fibrillation anticoagulation (CAFA) Study. J. Am. Coll. Cardiol., 18(2):349-355.
[12]Connolly, S.J., Pogue, J., Hart, R.G., et al., 2009a. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N. Engl. J. Med., 360(20):2066-2078.
[13]Connolly, S.J., Ezekowitz, M.D., Yusuf, S., et al., 2009b. Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med., 361(12):1139-1151.
[14]Connolly, S.J., Eikelboom, J., Joyner, C., et al., 2011. Apixaban in patients with atrial fibrillation. N. Engl. J. Med., 364(9):806-817.
[15]Dias, S., Welton, N.J., Sutton, A.J., 2011. NICE DSU technical support document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomised controlled trials. Technical Support Document in Evidence Synthesis, No. TSD2. National Institute for Health and Clinical Excellence.
[16]http://core.ac.uk/download/pdf/29025987.pdf
[17]Dias, S., Welton, N.J., Sutton, A.J., et al., 2013. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med. Decis. Making, 33(5):641-656.
[18]Dogliotti, A., Paolasso, E., Giugliano, R.P., 2014. Current and new oral antithrombotics in non-valvular atrial fibrillation: a network meta-analysis of 79 808 patients. Heart, 100(5):396-405.
[19]Dulli, D.A., Stanko, H., Levine, R.L., 2003. Atrial fibrillation is associated with severe acute ischemic stroke. Neuroepidemiology, 22(2):118-123.
[20]Ezekowitz, M.D., Bridgers, S.L., James, K.E., et al., 1992. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators. N. Engl. J. Med., 327(20):1406-1412.
[21]Fuster, V., Ryden, L.E., Cannom, D.S., et al., 2006. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. Circulation, 114(7):e257-e354.
[22]Gersh, B.J., Tsang, T.S., Seward, J.B., 2004. The changing epidemiology and natural history of nonvalvular atrial fibrillation: clinical implications. Trans. Am. Clin. Climatol. Assoc., 115:149-159.
[23]Gibson, C.M., Mega, J.L., Burton, P., et al., 2011. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am. Heart J., 161(5):815-821.e6.
[24]Giorda, C.B., Nada, E., Tartaglino, B., 2014. Pharmacokinetics, safety, and efficacy of DPP-4 inhibitors and GLP-1 receptor agonists in patients with type 2 diabetes mellitus and renal or hepatic impairment. A systematic review of the literature. Endocrine, 46(3):406-419.
[25]Giugliano, R.P., Ruff, C.T., Braunwald, E., et al., 2013. Edoxaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med., 369(22):2093-2104.
[26]Gomez-Outes, A., Terleira-Fernandez, A.I., Calvo-Rojas, G., et al., 2013. Dabigatran, rivaroxaban, or apixaban versus warfarin in patients with nonvalvular atrial fibrillation: a systematic review and meta-analysis of subgroups. Thrombosis, 2013:640723.
[27]Granger, C.B., Alexander, J.H., McMurray, J.J., et al., 2011. Apixaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med., 365(11):981-992.
[28]Gullov, A.L., Koefoed, B.G., Petersen, P., et al., 1998. Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation: Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study. Arch. Intern. Med., 158(14):1513-1521.
[29]Hellemons, B.S., Langenberg, M., Lodder, J., et al., 1999. Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin. BMJ, 319(7215):958-964.
[30]Higgins, J., Green, S., 2006. Cochrane Handbook for Systematic Reviews of Interventions. John Wiley & Sons, Ltd., Chichester, UK.
[31]Holster, I.L., Valkhoff, V.E., Kuipers, E.J., et al., 2013. New oral anticoagulants increase risk for gastrointestinal bleeding: a systematic review and meta-analysis. Gastroenterology, 145(1):105-112.e15.
[32]Hori, M., Matsumoto, M., Tanahashi, N., et al., 2012. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation. Circ. J., 76(9):2104-2111.
[33]Hu, D.Y., Zhang, H.P., Sun, Y.H., et al., 2006. The randomized study of efficiency and safety of antithrombotic therapy in nonvalvular atrial fibrillation: warfarin compared with aspirin. Chin. J. Cardiol., 34(4):295-298 (in Chinese).
[34]Jansen, J.P., Naci, H., 2013. Is network meta-analysis as valid as standard pairwise meta-analysis? It all depends on the distribution of effect modifiers. BMC Med., 11:159.
[35]January, C.T., Wann, L.S., Alpert, J.S., et al., 2014. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary. Circulation, 130(23):2071-2104.
[36]Levi, M., Eerenberg, E., Kamphuisen, P.W., 2011. Bleeding risk and reversal strategies for old and new anticoagulants and antiplatelet agents. J. Thromb. Haemost., 9(9):1705-1712.
[37]Luengo-Fernandez, R., Gray, A.M., Rothwell, P.M., 2006. Population-based study of determinants of initial secondary care costs of acute stroke in the United Kingdom. Stroke, 37(10):2579-2587.
[38]Lumley, T., 2002. Network meta-analysis for indirect treatment comparisons. Stat. Med., 21(16):2313-2324.
[39]Mant, J., Hobbs, F.D., Fletcher, K., et al., 2007. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet, 370(9586):493-503.
[40]Mega, J.L., Braunwald, E., Wiviott, S.D., et al., 2012. Rivaroxaban in patients with a recent acute coronary syndrome. N. Engl. J. Med., 366(1):9-19.
[41]Ogawa, S., Shinohara, Y., Kanmuri, K., 2011. Safety and efficacy of the oral direct factor Xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. Circ. J., 75(8):1852-1859.
[42]Patel, M.R., Mahaffey, K.W., Garg, J., et al., 2011. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N. Engl. J. Med., 365(10):883-891.
[43]Petersen, P., Boysen, G., Godtfredsen, J., et al., 1989. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation: the Copenhagen AFASAK Study. Lancet, 333(8631):175-179.
[44]Ruff, C.T., Giugliano, R.P., Braunwald, E., et al., 2014. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet, 383(9921):955-962.
[45]Sacco, R.L., Adams, R., Albers, G., et al., 2006. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack. Stroke, 37(2):577-617.
[46]Sato, H., Ishikawa, K., Kitabatake, A., et al., 2006. Low-dose aspirin for prevention of stroke in low-risk patients with atrial fibrillation: Japan Atrial Fibrillation Stroke Trial. Stroke, 37(2):447-451.
[47]Slot, K.B., Berge, E., Dorman, P., et al., 2008. Impact of functional status at six months on long term survival in patients with ischaemic stroke: prospective cohort studies. BMJ, 336(7640):376-379.
[48]Spiegelhalter, D., Thomas, A., Best, N., 2004. WinBUGS User Manual. MRC Biostatistics Unit, Cambridge.
[49]Sweeting, M.J., Sutton, A.J., Lambert, P.C., 2004. What to add to nothing? Use and avoidance of continuity corrections in meta-analysis of sparse data. Stat. Med., 23(9):1351-1375.
[50]The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators, 1990. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N. Engl. J. Med., 323(22):1505-1511.
[51]Yamashita, T., Koretsune, Y., Yasaka, M., et al., 2012. Randomized, multicenter, warfarin-controlled phase II study of edoxaban in Japanese patients with non-valvular atrial fibrillation. Circ. J., 76(8):1840-1847.
[52]Zhang, S., 2012. Clinical considerations of anticoagulation therapy for patients with atrial fibrillation. J. Zhejiang Univ.-Sci. B (Biomed. & Biotechnol.), 13(4):609-615.
Open peer comments: Debate/Discuss/Question/Opinion
<1>