Dabigatran Versus Warfarin for Atrial Fibrillation in Real-World Clinical Practice: A Systematic Review and Meta-Analysis

Circulation: Cardiovascular Quality and Outcomes

Volumn 9, Issue 2, 2016, Pages 126-134

  Romanelli, Robert J ^a   Nolting, Laura ^a   Dolginsky, Marina ^a   Kym, Eunice ^b   Orrico, Kathleen B ^b  

^a PALO ALTO MEDICAL FOUNDATION RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

atrial fibrillation; dabigatran; evidence based medicine; meta analysis; stroke

Indexed keywords

DABIGATRAN; WARFARIN; ANTICOAGULANT AGENT; ANTITHROMBIN;

ATRIAL FIBRILLATION; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CLINICAL PRACTICE; COHORT ANALYSIS; COMPARATIVE EFFECTIVENESS; DRUG SAFETY; GASTROINTESTINAL HEMORRHAGE; HAZARD RATIO; HUMAN; LONGITUDINAL STUDY; META ANALYSIS; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW; SYSTEMATIC REVIEW; AGE; AGED; CHEMICALLY INDUCED; COMPLICATION; FEMALE; MALE; RISK FACTOR; STROKE; TREATMENT OUTCOME;

AGE FACTORS; AGED; ANTICOAGULANTS; ANTITHROMBINS; ATRIAL FIBRILLATION; DABIGATRAN; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMANS; INTRACRANIAL HEMORRHAGES; MALE; RISK FACTORS; STROKE; TREATMENT OUTCOME; WARFARIN;

EID: 84962601555     PISSN: 19417713     EISSN: 19417705     Source Type: Journal    
DOI: 10.1161/CIRCOUTCOMES.115.002369     Document Type: Review

References (33)

1. Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC., Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J 2006 27 949 953. doi: 10.1093/eurheartj/ehi825.
2. Coleman CI, Coleman SM, Vanderpoel J, Nelson W, Colby JA, Scholle JM, Kluger J., Patient satisfaction with warfarin-and non-warfarin-containing thromboprophylaxis regimens for atrial fibrillation. J Investig Med 2013 61 878 881. doi: 10.231/JIM.0b013e31828df1bf.
3. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L, RE-LY Steering Committee and Investigators Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009 361 1139 1151. doi: 10.1056/NEJMoa0905561.
4. Katapodi MC, Northouse LL., Comparative effectiveness research: using systematic reviews and meta-analyses to synthesize empirical evidence. Res Theory Nurs Pract 2011 25 191 209
5. Fleurence RL, Naci H, Jansen JP., The critical role of observational evidence in comparative effectiveness research. Health Aff (Millwood) 2010 29 1826 1833. doi: 10.1377/hlthaff.2010.0630.
6. Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R., Why observational studies should be among the tools used in comparative effectiveness research. Health Aff (Millwood) 2010 29 1818 1825. doi: 10.1377/hlthaff.2010.0666.
7. Norris S, Atkins D, Bruening W, Fox S, Johnson E, Kane R, Morton SC, Oremus M, Ospina M, Randhawa G, Schoelles K, Shekelle P, Viswanathan M., Selecting Observational Studies for Comparing Medical Interventions. Methods Guide for Effectiveness and Comparative Effectiveness Reviews 2008 Rockville, MD Agency for Healthcare Research and Quality
8. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB., Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000 283 2008 2012
9. DerSimonian R, Kacker R., Random-effects model for meta-analysis of clinical trials: an update. Contemp Clin Trials 2007 28 105 114. doi: 10.1016/j.cct.2006.04.004.
10. Avgil-Tsadok M, Jackevicius CA, Essebag V, Eisenberg MJ, Rahme E, Behlouli H, Pilote L., Dabigatran use in elderly patients with atrial fibrillation. Thromb Haemost 2015 115 152 160. doi: 10.1160/TH15-03-0247.
11. Lauffenburger JC, Farley JF, Gehi AK, Rhoney DH, Brookhart MA, Fang G., Effectiveness and safety of dabigatran and warfarin in real-world US patients with non-valvular atrial fibrillation: a retrospective cohort study. J Am Heart Assoc 2015 4 e001798. doi: 10.1161/JAHA.115.001798.
12. Abraham NS, Singh S, Alexander GC, Heien H, Haas LR, Crown W, Shah ND., Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ 2015 350 h1857
13. Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA., Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation 2015 131 157 164. doi: 10.1161/CIRCULATIONAHA.114.012061.
14. Hernandez I, Baik SH, Piñera A, Zhang Y., Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med 2015 175 18 24. doi: 10.1001/jamainternmed.2014.5398.
15. Larsen TB, Rasmussen LH, Skjøth F, Due KM, Callréus T, Rosenzweig M, Lip GY., Efficacy and safety of dabigatran etexilate and warfarin in "real-world" patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol 2013 61 2264 2273. doi: 10.1016/j.jacc.2013.03.020.
16. Thelus R, Villines TC, Coster TS., Dabigatran versus warfarin among patients with atrial fibrillation: real-world post-market results. Circulation 2012 126 A14877
17. Tsadok MA, Jackevicius C, Essebag V, Eisenberg MJ, Rahme E, Humphries KH, Tu JV, Pilote L., Comparative effectiveness and safety of dabigatran vs. warfarin in patients with atrial fibrillation-evidence from real world practice. Circulation 2013 128 A13884
18. Henriksen DP, Hansen MR, Damkier P., Patient characteristics and risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med 2015 175 1245. doi: 10.1001/jamainternmed.2015.1289.
19. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, Yang S, Alings M, Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Reilly P, Varrone J, Yusuf S., Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 2011 123 2363 2372. doi: 10.1161/CIRCULATIONAHA.110.004747.
20. Bender R., Number needed to treat (NNT). Encyclo Biostat 2005 6 3752 3761
21. Cook RJ, Sackett DL., The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995 310 452 454
22. Bender R., Calculating confidence intervals for the number needed to treat. Control Clin Trials 2001 22 102 110
23. Lubsen J, Hoes A, Grobbee D., Implications of trial results: the potentially misleading notions of number needed to treat and average duration of life gained. Lancet 2000 356 1757 1759. doi: 10.1016/S0140-6736(00)03215-3.
24. Altman DG, Deeks JJ., Meta-analysis, Simpson's paradox, and the number needed to treat. BMC Med Res Methodol 2002 2 3
25. Cates CJ., Simpson's paradox and calculation of number needed to treat from meta-analysis. BMC Med Res Methodol 2002 2 1
26. Ebrahim S., The use of numbers needed to treat derived from systematic reviews and meta-analysis. Caveats and pitfalls. Eval Health Prof 2001 24 152 164
27. Baker WL, Phung OJ., Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ Cardiovasc Qual Outcomes 2012 5 711 719. doi: 10.1161/CIRCOUTCOMES.112.966572.
28. Gómez-Outes A, Terleira-Fernández AI, Calvo-Rojas G, Suárez-Gea ML, Vargas-Castrillón E., Dabigatran, rivaroxaban, or apixaban versus warfarin in patients with nonvalvular atrial fibrillation: a systematic review and meta-analysis of subgroups. Thrombosis 2013 2013 640723. doi: 10.1155/2013/640723.
29. Cope S, Clemens A, Hammès F, Noack H, Jansen JP., Critical appraisal of network meta-analyses evaluating the efficacy and safety of new oral anticoagulants in atrial fibrillation stroke prevention trials. Value Health 2015 18 234 249. doi: 10.1016/j.jval.2014.10.012.
30. Dogliotti A, Paolasso E, Giugliano RP., Novel oral anticoagulants in atrial fibrillation: a meta-analysis of large, randomized, controlled trials vs warfarin. Clin Cardiol 2013 36 61 67. doi: 10.1002/clc.22081.
31. Hernandez I., Time to reconsider dabigatran 110 mg in the USA. Am J Cardiovasc Drugs 2015 15 307 309. doi: 10.1007/s40256-015-0137-0.
32. Beasley BN, Unger EF, Temple R., Anticoagulant options-why the FDA approved a higher but not a lower dose of dabigatran. N Engl J Med 2011 364 1788 1790. doi: 10.1056/NEJMp1103050.
33. Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG., International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J 2012 163 13 19.e1. doi: 10.1016/j.ahj.2011.09.011.