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Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation

  1. Karsten MH Bruins Slot*,
  2. Eivind Berge

Editorial Group: Cochrane Stroke Group

Published Online: 8 AUG 2013

Assessed as up-to-date: 29 APR 2013

DOI: 10.1002/14651858.CD008980.pub2


How to Cite

Bruins Slot KMH, Berge E. Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD008980. DOI: 10.1002/14651858.CD008980.pub2.

Author Information

  1. Oslo University Hospital, Department of Internal Medicine, Oslo, Norway

*Karsten MH Bruins Slot, Department of Internal Medicine, Oslo University Hospital, Oslo, NO-0407, Norway. kbruinsslot@yahoo.no.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 8 AUG 2013

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References

References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
AMADEUS 2008 {published and unpublished data}
  • The Amadeus Investigators. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. Lancet 2008;371:315-21.
ARISTOTLE 2011 {published data only (unpublished sought but not used)}
ARISTOTLE-J 2011 {published data only (unpublished sought but not used)}
  • Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor Xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. Circulation Journal 2011;75:1852-9.
Edoxaban Asia 2010 {published data only (unpublished sought but not used)}
  • Chung N, Jeon H-K, Lien L-M, Lai W-T, Tse H-F, Chung W-S, et al. Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation. Thrombosis and Haemostasis 2010;105:535-45.
Edoxaban US/Europe 2010 {published data only (unpublished sought but not used)}
  • Weitz JI, Connolly SJ, Patel I, Salazar D, Rohatagi S, Mendell J, et al. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thrombosis and Haemostasis 2010;104:633-41.
EXPLORE-Xa 2013 {published data only (unpublished sought but not used)}
J-ROCKET AF 2012 {published and unpublished data}
  • Hori M, Matsumoto M, Tanahashi N, Momomura SI, Uchiyama S, Goto S, J-ROCKET AF study investigators. Rivaroxaban vs warfarin in Japanese patients with atrial fibrillation. Circulation Journal 2012;76(9):2104-11. [doi: 10.1253/circj.CJ-12-0454]
OPAL-1 2010 {published and unpublished data}
  • Turpie AGGF, Lip GYH, Minematsu K, Goto S, Renfurm RW, Wong KSL. Safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation: a phase II study. European Heart Journal 2010;31 Suppl 1:173.
OPAL-2 2011 {published data only}
  • Lip GYH, Halperin JL, Petersen P, Rodger GM, Renfurm RW. Safety and tolerability of the oral factor Xa inhibitor YM150 vs warfarin in 1297 patients with non-valvular atrial fibrillation: a dose confirmation study (OPAL-2). Journal of Thrombosis and Haemostatis 2011;9 Suppl 2:748.
ROCKET AF 2011 {published data only (unpublished sought but not used)}

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
Camm 2011 {published data only}
Fox 2011 {published data only}
  • Fox KA, Piccini JP, Wojdyla D. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. European Heart Journal 2011;32(19):2387-94.
Hankey 2012 {published data only}
  • Hankey GJ, Patel MR, Stevens SR, ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurology 2012;11(4):315-22.
Harenberg 2010 {published data only}
  • Harenberg J. Idraparinux and idrabioparinux. Expert Review of Clinical Pharmacology 2010;3(1):9-16.
Lane 2011 {published data only}
Lopes 2010 {published data only}
  • Lopes RD, Alexander JH, Al-Khatib SM, the ARISTOTLE investigators. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. American Heart Journal 2010;159(3):331-9.
Partida 2011 {published data only}
  • Partida RA, Guigliano RP. Edoxaban: pharmacological principles, preclinical and early-phase clinical testing. Future Cardiology 2011;7(4):459-70.
ROCKET investigators 2010 {published data only}
  • ROCKET AF Study Investigators. Rivaroxaban once-daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation: rationale and design of the ROCKET AF study. American Heart Journal 2010;159(3):340-7.

References to studies awaiting assessment

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
BOREALIS AF 2007 {published data only}
  • Evaluation of weekly subcutaneous biotinylated idraparinux versus oral adjusted-dose warfarin to prevent stroke and systemic thromboembolic events in patients with atrial fibrillation (BOREALIS-AF). ClinicalTrials.gov 2007. [http://clinicaltrials.gov/show/NCT00580216]

References to ongoing studies

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
ENGAGE AF-TIMI 48 {published data only}
  • Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). American Heart Journal 2010;160(4):635-41.

Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. References to studies awaiting assessment
  4. References to ongoing studies
  5. Additional references
ACC/AHA/ESC 2006
  • Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, et al. Guidelines for the management of patients with atrial fibrillation. Circulation 2006;114:700-52. [DOI: 10.1161/CIRCULATIONAHA.106.177031]
Boulanger 2006
CHADS2
  • Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285(22):2864-70.
Cochrane Handbook 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Connolly 2007
Connolly 2008
  • Connolly SJ, Pogue J, Eikelboom J, Flaker G, Commerford P, Franzosi G, the ACTIVE W Investigators. Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of International Normalized Ratio control achieved by centers and countries as measured by time in therapeutic range. Circulation 2008;118:2029-37.
Deeks 2001
  • Deeks JJ, Altman DG, Bradburn MJ. Statistical methods for examining heterogeneity and combining results from several studies in meta-analysis. In: Egger M, Davey Smith G, Altman DG editor(s). Systematic Reviews in Health Care. Meta-analysis in Context. London: BMJ Books, 2001:285-312.
EHRA 2013
  • Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, et al. European Heart Rhythm Association practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15:625-51.
Eikelboom 2010
ESC 2010
ESC 2012
  • Camm AJ, Lip GYH, De Caterina R, Savelieva I, Atar D, Hohnloser SH, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. www.escardio.org/guidelines-surveys/esc-guidelines/Pages/atrial-fibrillation.aspx.
Go 2001
  • Go AS, Hylek EM, Philips KA, Henault, LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults. National implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001;285:2370-5.
Hart 2007
  • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have non-valvular atrial fibrillation. Annals of Internal Medicine 2007;146:857-67.
Heeringa 2006
  • Heeringa J, Van der Kuip DA, Hofman A, Kors JA, Van Herpen G, Stricker BH, et al. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. European Heart Journal 2006;27:949-53.
Hylek 2007
  • Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S. Major haemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 2007;115:2689-96.
Kirchhof 2007
  • Kirchhof P, Auricchio A, Bax J, Crijns H, Camm J, Diener H-C, et al. Outcome parameters for trials in atrial fibrillation: executive summary. Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork (AFNET) and the European Heart Rhythm Association (EHRA). European Heart Journal 2007;28:2803-17.
Lloyd-Jones 2004
Marini 2005
  • Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke. Results from a population study. Stroke 2005;36:1115-9.
Miller 2012
  • Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. American Journal of Cardiology 2012;110(3):453-60.
Miyasaki 2006
  • Miyasaki Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratna WP, et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projection for future prevalence. Circulation 2006;114:119-25.
Mousa 2010
  • Mousa SA. Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban. Anticoagulants, Antiplatelets, and Thrombolytics. Springer Science+Business Media, 2010:181-201.
Pisters 2010
  • Pisters R, Lane DA, Nieuwlaat R, De Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: The Euro Heart Survey. Chest 2010;138(5):1093-100.
RevMan 2012 [Computer program]
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
Sudlow 1997
Wallentin 2010
  • Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, the RE-LY investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010;18(9745):975-83.
Wallentin 2011
  • Wallentin L. Efficacy and safety of apixaban compared with warfarin at different levels of INR control for stroke prevention in atrial fibrillation. http://www.escardio.org/congresses/esc-2011/congress-reports/Documents/28-8-CTU/ARISTOTLE-presenter-Wallentin-slides.pdf 2011.
Watson 2009
Wattigney 2003
  • Wattigney WA, Mensah GA, Croft JB. Increasing trends in hospitalisation for atrial fibrillation in the United States, 1985 through 1999: implications for primary prevention. Circulation 2003;108:711-6.
Wolf 1991