2016


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2016/№6

Place and significance of observational studies of NOACs in patients with non-valvular atrial fibrillation from the standpoint of evidence-based medicine

Arutyunov G. P.
Federal State Budgetary Educational Institution of Higher Education, "N.I. Pirogov Russian National Research Medical University" of the Ministry of Health of the Russian Federation, Ostrovityanova 1, Moscow 117997

Keywords: atrial fibrillation, anticoagulant therapy, treatment

DOI: 10.18087/rhj.2016.6.2297

  1. Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002 Jan 5;359 (9300):57–61.
  2. Patel MR , Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365 (10):883–91.
  3. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361 (12):1139–51.
  4. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365 (11):981–92.
  5. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369 (22):2093–104.
  6. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383 (9921):955–62.
  7. 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 Feb;36 (2):61–7.
  8. Capodanno D, Capranzano P, Giacchi G, Calvi V, Tamburino C. Novel oral anticoagulants versus warfarin in non-valvular atrial fibrillation: a meta-analysis of 50578 patients. Int J Cardiol. 2013 Aug 20;167 (4):1237–41.
  9. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet. 2002 Jan 26;359 (9303):341–5.
  10. Euser AM, Zoccali C, Jager KJ, Dekker FW. Cohort studies: prospective versus retrospective. Nephron Clin Pract. 2009;113 (3):c214–7.
  11. Levin KA. Study design IV. Cohort studies. Evid Based Dent. 2006;7 (2):51–2.
  12. Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health. 2007 Sep-Oct;10 (5):326–35.
  13. Ho PM, Peterson PN, Masoudi FA. Evaluating the evidence: is there a rigid hierarchy? Circulation. 2008 Oct 14;118 (16):1675–84.
  14. Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report – Part I. Value Health. 2009 Nov-Dec;12 (8):1044–52.
  15. Camm AJ, Amarenco P, Haas S, Hess S, Kirchhof P, Kuhls S et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016 Apr 7;37 (14):1145–53.
  16. Hecker J, Marten S, Keller L, Helmert S, Michalski F, Werth S et al. Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost. 2016 May 2;115 (5):939–49.
  17. Tepper P, Mardekian J, Masseria C, Phatak H, Kamble S, Abdulsattar Y et al. Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients on apixaban, dabigatran, rivaroxaban: cohorts comprising new initiators and/or switchers from warfarin. P1975. Eur Heart J. 2015 Aug 1;36 (suppl 1):339.
  18. Kamble S, Pan X, Phatak H, Kawabata H, Masseria C, Mardekian J et al. Real World Comparison of Major Bleeding Risk Among Non-valvular Atrial Fibrillation Patients Newly Initiated on Warfarin versus Apixaban 5mg BID, Dabigatran 150 mg BID, or Rivaroxaban 20mg QD. Circulation. 2015 Nov 10;132 (suppl 3):A18465.
  19. Amin A, Keshishian A, Xie L, Baser O, Price K, Vo L et al. Comparison of Major-bleeding Risk and Health Care Costs Among Treatment-naive Non-valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin. Circulation. 2015 Nov 10;132 (suppl 3):A19672.
  20. Lip GYH, Pan X, Kamble S, Kawabata H, Mardekian J, MasseriaC et al. Real world comparison of major bleeding risk among non-valvular atrial fibrillation patients newly initiated on apixaban, dabigatran, rivaroxaban or warfarin. P6217. Eur Heart J. 2015 Aug 1;36 (suppl 1):1085.
  21. Lin I, Masseria C, Mardekian J, Frean M, Phatak H, Kamble S et al. Real-world bleeding risk among non-valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, rivaroxaban and warfarin: analysis of electronic health records. P6215. Eur Heart J. 2015 Aug 1;36 (suppl 1):1084.
  22. Deitelzweig S, Bruno A, Tate N, Ogbonnaya A, Shah V, Farrelly E et al. Major bleeding, hospitalisation rates and healthcare costs among non-valvular atrial fibrillation patients naive to oral anticoagulation and newly treated with novel oral anticoagulants. P1971. Eur Heart J. 2015 Aug 1;36 (suppl 1):338.
  23. Sorensen R , Gislason G, Torp-Pedersen C, Olesen JB, Fosbol EL, Hvidtfeldt MW et al. Dabigatran use in Danish atrial fibrillation patients in 2011: a nationwide study. BMJ Open. 2013 May 3;3 (5). pii: e002758.
  24. Larsen TB, Rasmussen LH, Gorst-Rasmussen A, Skjoth F, Lane DA, Lip GY. Dabigatran and warfarin for secondary prevention of stroke in atrial fibrillation patients: a nationwide cohort study. Am J Med. 2014 Dec;127 (12):1172–8.
  25. Hernandez I, Baik SH, Pinera A, Zhang Y. Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med. 2015 Jan;175 (1):18–24.
  26. Abraham NS, Singh S, Alexander GC, Heien H, Haas LR , Crown W et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015 Apr 24;350: h1857.
  27. Laliberte F, Cloutier M, Nelson WW, Coleman CI, Pilon D, Olson WH et al. Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients. Curr Med Res Opin. 2014 Jul;30 (7):1317–25.
  28. Tamayo S, Frank Peacock W, Patel M, Sicignano N, Hopf KP, Fields LE et al. Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27467 patients taking rivaroxaban. Clin Cardiol. 2015 Feb;38 (2):63–8.
  29. Lip GY, Keshishian A, Kamble S, Pan X, Mardekian J, Horblyuk R et al. Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin.Thromb Haemost. 2016 Aug 19;116 (5). [Epub ahead of print].
  30. Gorst-Rasmussen A, Lip GY, Bjerregaard Larsen T. Rivaroxaban versus warfarin and dabigatran in atrial fibrillation: comparative effectiveness and safety in Danish routine care. Pharmacoepidemiol Drug Saf. 2016 May 27. [Epub ahead of print].
  31. Yao X, Abraham NS, Sangaralingham LR , Bellolio MF, McBane RD, Shah ND et al. Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2016 Jun 13;5 (6). pii: e003725.
  32. Deitelzweig S, Bruno A, Trocio J, Tate N, Gupta K, Lin J et al. An early evaluation of bleeding-related hospital readmissions among hospitalized patients with nonvalvular atrial fibrillation treated with direct oral anticoagulants. Curr Med Res Opin. 2016;32 (3):573–82.
  33. Larsen TB, Skjoth F, Nielsen PB, Kjaeldgaard JN, Lip GY4. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016 Jun 16;353: i3189.
  34. Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015 Jan 13;131 (2):157–64.
  35. Weeda ER , White CM, Peacock WF, Coleman CI1. Rates of major bleeding with rivaroxaban in real-world studies of nonvalvular atrial fibrillation patients: a meta-analysis. Curr Med Res Opin. 2016 Jun;32 (6):1117–20.
  36. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Bull World Health Organ. 2007 Nov;85 (11):867–72.
  37. Asche CV. Applying Comparative Effectiveness Data to Medical Decision Making: A Practical Guide. – Springer International Publishing Switzerland. – 2016. - 113p.
  38. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet. 2002 Jan 26;359 (9303):341–5.
  39. Sarrazin MS, Rosenthal GE. Finding pure and simple truths with administrative data. JAMA. 2012 Apr 4;307 (13):1433–5.
  40. Cox E, Martin BC, Van Staa T, Garbe E, Siebert U, Johnson ML. Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secondary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report – Part II. Value Health. 2009 Nov-Dec;12 (8):1053–61.
  41. Kokotailo RA, Hill MD. Coding of stroke and stroke risk factors using international classification of diseases, revisions 9 and 10. Stroke. 2005 Aug;36 (8):1776–81.
  42. Frost L, Andersen LV, Vestergaard P, Husted S, Mortensen LS. Trend in mortality after stroke with atrial fibrillation. Am J Med. 2007 Jan;120 (1):47–53.
  43. Krarup LH, Boysen G, Janjua H, Prescott E, Truelsen T. Validity of stroke diagnoses in a National Register of Patients. Neuroepidemiology. 2007;28 (3):150–4.
  44. Zalfani J, Froslev T, Olsen M, Ben Ghezala I, Gammelager H, Arendt JF et al. Positive predictive value of the International Classification of Diseases, 10th edition diagnosis codes for anemia caused by bleeding in the Danish National Registry of Patients. Clin Epidemiol. 2012;4:327–31.
  45. Go AS, Hylek EM, Chang Y et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do random-ized trials translate into clinical practice? JAMA. 2003 Nov 26;290 (20):2685–92.
  46. Cunningham A, Stein CM, Chung CP, Daugherty JR , Smalley WE, Ray WA. An automated database case definition for serious bleeding related to oral anticoagulant use. Pharmacoepidemiol Drug Saf. 2011 Jun;20 (6):560–6.
  47. Nguyen E, White CM, Patel MR , Fields LE, Peacock WF, Crivera C et al. Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials. Curr Med Res Opin. 2016 Jul;32 (7):1277–9.
Arutyunov G.P. Place and significance of observational studies of NOACs in patients with non-valvular atrial fibrillation from the standpoint of evidence-based medicine. Russian Heart Journal. 2016;15 (6):441–447

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