The efficacy and safety of oral anticoagulants in warfarin-suitable patients with nonvalvular atrial fibrillation: Systematic review and meta-analysis

Clinical and Applied Thrombosis/Hemostasis

Volumn 19, Issue 6, 2013, Pages 619-631

  Mitchell, Stephen A ^a   Simon, Teresa A ^b   Raza, Syed ^a   Jakouloff, David ^b   Orme, Michelle E ^c   Lockhart, Ian ^d   Drost, Pieter ^b  

^a Decision Resources Group   (United Kingdom)

^b BRISTOL MYERS SQUIBB   (United States)

^c Icera Consulting   (United Kingdom)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

anticoagulants; bleeding; stroke

Indexed keywords

ACENOCOUMAROL; ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; ANTIVITAMIN K; APIXABAN; ATECEGATRAN METOXIL; CLOPIDOGREL; DABIGATRAN; DALTEPARIN; EDOXABAN; FLUINDIONE; IDRAPARINUX; INDOBUFEN; RIVAROXABAN; WARFARIN; XIMELAGATRAN;

ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CEREBROVASCULAR ACCIDENT; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EMBOLISM; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HUMAN; META ANALYSIS; MORTALITY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SYSTEMATIC REVIEW; TREATMENT RESPONSE;

ANTICOAGULANTS; BLEEDING; STROKE;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS; STROKE; TREATMENT OUTCOME; WARFARIN;

EID: 84887986775     PISSN: 10760296     EISSN: 19382723     Source Type: Journal    
DOI: 10.1177/1076029613486539     Document Type: Article

References (60)

1. Cooper NJ, Sutton AJ, Lu G, Khunti K. Mixed comparison of stroke prevention treatments in individuals with nonrheumatic atrial fibrillation. Arch Intern Med. 2006 ; 166 (12). 1269-1275
2. Abcede HG, Ovbiagele B. Update on antithrombotic therapy for stroke prevention in atrial fibrillation. Curr Treat Options Cardiovasc Med. 2010 ; 12 (3). 250-260
3. Colilla S, Crow A, Simon T, Singer DE, Petkun W, Liu X. Projected estimates of prevalence and annual growth rate of atrial fibrillation in the U.S. from a dynamic age-period progression model. Circ Cardiovasc Qual Outcomes. 2012 ; 5: A206
4. Friberg L, Hammar N, Pettersson H, Rosenqvist M. Increased mortality in paroxysmal atrial fibrillation: report from the Stockholm Cohort-Study of Atrial Fibrillation (SCAF). Eur Heart J. 2007 ; 28 (19). 2346-2353
5. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 ; 22 (8). 983-988
6. Camm AJ, Kirchhof P, Lip GY, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 ; 31 (19). 2369-2429
7. National Institute for Health and Clinical Excellence. NICE guidance CG36 - The management of atrial fibrillation. Contract No.: Document Number. June 2006.
8. Luengo-Fernandez R, Gray AM, Rothwell PM. Population-based study of determinants of initial secondary care costs of acute stroke in the United Kingdom. Stroke. 2006 ; 37 (10). 2579-2587
9. Demaerschalk BM, Hwang HM, Leung G. US cost burden of ischemic stroke: a systematic literature review. Am J Manag Care. 2010 ; 16 (7). 525-533
10. Aguilar MI, Hart R. Oral anticoagulants versus antiplatelet therapy for preventing stroke in patients with nonvalvular atrial fibrillation and no history of stroke or transient ischemic attacks. Stroke. 2008 ; 39 (4). 1399-1400
11. Jones M, McEwan P, Morgan CL, Peters JR, Goodfellow J, Currie CJ. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart. 2005 ; 91 (4). 472-47
12. Currie CJ, McEwan P, Emmas C, Morgan CL, Peters JR. Anticoagulation in patients with non-valvular atrial fibrillation: an evaluation of stability and early factors that predict longer-term stability on warfarin in a large UK population. Curr Med Res Opin. 2005 ; 21 (12). 1905-1913
13. Ansell J, Caro JJ, Salas M, et al. Quality of clinical documentation and anticoagulation control in patients with chronic nonvalvular atrial fibrillation in routine medical care. Am J Med Qual. 2007 ; 22 (5). 327-333
14. Kimmel SE, Chen Z, Price M, et al. The influence of patient adherence on anticoagulation control with warfarin: results from the International Normalized Ratio Adherence and Genetics (IN-RANGE) Study. Arch Intern Med. 2007 ; 167 (3). 229-235
15. Fang MC, Go AS, Chang Y, et al. Thirty-day mortality after ischemic stroke and intracranial hemorrhage in patients with atrial fibrillation on and off anticoagulants. Stroke. 2012 ; 43 (7). 1795-1799
16. Gladstone DJ, Bui E, Fang J, et al. Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated. Stroke. 2009 ; 40 (1). 235-240
17. Nutescu E, Chuatrisorn I, Hellenbart E. Drug and dietary interactions of warfarin and novel oral anticoagulants: an update. J Thromb Thrombolysis. 2011 ; 31 (3). 326-343
18. National Institute for Health and Clinical Excellence. Atrial fibrillation: the management of atrial fibrillation. Costing report. NICE Clinical Guideline no. 36; July 2006.
19. Yiin G, Mehta Z, Rothwell PM. Population-based study of temporal trends in atrial fibrillation related incident ischaemic stroke: evidence of substantial failure of primary prevention. Abstract 1142 presented at the Association of British Neurologists Annual Meeting 2011. Neurol Neurosurg Psychiatry. 2012 ; 83 ( e1 ):
20. Nieuwlaat R, Olsson SB, Lip GY, et al. Guideline-adherent antithrombotic treatment is associated with improved outcomes compared with undertreatment in high-risk patients with atrial fibrillation. The Euro Heart Survey on Atrial Fibrillation. Am Heart J. 2007 ; 153 (6). 1006-1012
21. Mazzaglia G, Filippi A, Alacqua M, et al. A national survey of the management of atrial fibrillation with antithrombotic drugs in Italian primary care. Thromb Haemost. 2010 ; 103 (5). 968-975
22. Camm AJ, Lip GY, De Caterina R, et al. 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. 2012 ; 33 (21). 2719-2747
23. FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation. 2010 :
24. NICE Final Appraisal Determination: Dabigatran Dabigatran Etexilate for the Prevention of Stroke and Systemic Embolism in Atrial Fibrillation. 2011 :
25. FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm. 2011 :
26. NICE Final Appraisal Determination: Rivaroxaban for the Prevention of Stroke And Systemic Embolism in People With Atrial Fibrillation. 2012 :
27. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 ; 365 (11). 981-992
28. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 ; 361 (12). 1139-1151
29. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 ; 365 (10). 883-891
30. 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. Am J Cardiol. 2012 ; 110 (3). 453-460
31. Capodanno D, Capranzano P, Giacchi G, Calvi V, Tamburino C. Novel oral anticoagulants versus warfarin in non-valvular atrial fibrillation: a meta-analysis of 50,578 patients. [published online on April 9, 2012]. Int J Cardiol. 2012 ;:
32. Lip GY, Larsen TB, Skjoth F, Rasmussen LH. Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2012 ; 60 (8). 738-746
33. Testa L, Agnifili M, Latini RA, et al. Adjusted indirect comparison of new oral anticoagulants for stroke prevention in atrial fibrillation. QJM. 2012 ; 105 (10). 949-957
34. National Institute for Health and Care Excellence. NICE Guidelines Manual2009; http://www.nice.org.uk/media/633/21/The-guidelines-manual-2009- Appendix-D-Methodology-checklist-randomised-controlled-trials.pdf. Accessed February 2012.
35. Spiegelhalter DJ, Best NG, Carlin BP, Van der Linde A. Bayesain measures of model complexity and fit (with discussion). J Royal Statistical Society. 2002 ; 64 (4). 583-616
36. HigginsJPTGreenS (Eds). Cochrane Handbook for Systematic Reviews of InterventionsVersion 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. www.cochrane-handbook.org.
37. Med Decis Making.
38. Brooks SP, Gelman A. Alternative methods for monitoring convergence of iterative simulations. J Comput Graphical Stat. 1998 ; 7 (4). 434-455
39. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L. Newly identified events in the RE-LY trial. N Engl J Med. 2010 ; 363 (19). 1875-1876
40. Patel MR, Hellkamp AS, Lokhnygina Y, et al. Outcomes of discontinuing rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: analysis from the ROCKET AF trial (Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation). J Am Coll Cardiol. 2013 ; 61 (6). 651-658
41. European Medicines Agency. Rivaroxaban Summary of Product Characteristics, http://www.medicines.org.uk/emc/medicine/25586/SPC/ Xarelto+20mg+film-coated+tablets/
42. Food and Drug Administration. FDA draft briefing document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) - rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 2011; http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ ucm270796.pdf.
43. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP) assessment report for rivaroxaban. 2011; http://www.ema.europa.eu/docs/ en-GB/document-library/EPAR-Assessment-Report-Variation/human/000944/ WC500120735.pdf
44. Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 ; 3 (4). 692-694
45. Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran). A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Heart Rhythm. 2011 ; 8 (3). e1 - e8
46. Connolly SJ, Pogue J, Eikelboom J, et al. 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 (20). 2029-2037
47. Veeger NJ, Piersma-Wichers M, Tijssen JG, Hillege HL, van der Meer J. Individual time within target range in patients treated with vitamin K antagonists: main determinant of quality of anticoagulation and predictor of clinical outcome. A retrospective study of 2300 consecutive patients with venous thromboembolism. Br J Haematol. 2005 ; 128 (4). 513-519
48. Rao AK, Pratt C, Berke A, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial - phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988 ; 11 (1). 1-11
49. The GUSTO investigators. N Eng J Med. 1993 ; 329 (10). 673-682
50. National Institute for Health and Care Excellence. Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation. Technology appraisal TA256. http://guidance.nice.org.uk/TA256
51. Colditz GA, Miller JN, Mosteller F. How study design affects outcomes in comparisons of therapy. I: Medical. Stat Med. 1989 ; 8 (4). 441-454
52. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995 ; 273 (5). 408-412
53. Cucherat M Bias-Corrcted Indirect Comparison Meta-Analysis of New Oral Anticoagulant in Atrial Fibrillation. Berlin: ISPOR ; 2012 :
54. Hohnloser SH. Stroke prevention versus bleeding risk in atrial fibrillation: a clinical dilemma. J Am Coll Cardiol. 2011 ; 57 (2). 181-183
55. Suh JW, Mehran R, Claessen BE, et al. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2011 ; 58 (17). 1750-1756
56. Nikolsky E, Stone GW, Kirtane AJ, et al. Gastrointestinal bleeding in patients with acute coronary syndromes: incidence, predictors, and clinical implications: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. J Am Coll Cardiol. 2009 ; 54 (14). 1293-1302
57. Lopes RD, Subherwal S, Holmes DN, et al. The association of in-hospital major bleeding with short-, intermediate-, and long-term mortality among older patients with non-ST-segment elevation myocardial infarction. Eur Heart J. 2012 ; 33 (16). 2044-2053
58. Sharma PS, Boruah P, Ahmed I, Pancholy S. Bleeding as important as ischemic stroke in predicting mortality in atrial fibrillation. J Am Coll Cardiol. 2012 ; 59 ( 13 ):
59. Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol. 2011 ; 57 (2). 173-180
60. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 ; 364 (9). 806-817