A novel approach indirectly comparing benefit-risk balance across anti-thrombotic therapies in patients with atrial fibrillation

European Heart Journal - Cardiovascular Pharmacotherapy

Volumn 1, Issue 1, 2015, Pages 15-28

  Dogliotti, Ariel ^a,b   Giugliano, Robert P ^c  

^a CREAR   (Argentina)

^b Sanatorio Parque e Instituto Cardiovascular de Rosario   (Argentina)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

Anti coagulant; Anti platelet; Atrial fibrillation; Bleeding; Haemorrhage; Novel oral anti coagulant; Stroke; Vitamin K antagonist

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT; ANTIVITAMIN K; APIXABAN; CLOPIDOGREL; DABIGATRAN; EDOXABAN; RIVAROXABAN;

ARTICLE; ATRIAL FIBRILLATION; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CARDIOVASCULAR MORTALITY; HEART INFARCTION; HUMAN; META ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SYSTEMATIC REVIEW; THROMBOEMBOLISM; COMPLICATION; FIBRINOLYTIC THERAPY; GLOBAL HEALTH; INCIDENCE; PROCEDURES; RISK ASSESSMENT;

ANTICOAGULANTS; ATRIAL FIBRILLATION; GLOBAL HEALTH; HUMANS; INCIDENCE; RISK ASSESSMENT; THROMBOEMBOLISM; THROMBOLYTIC THERAPY;

EID: 84977874948     PISSN: 20556837     EISSN: 20556845     Source Type: Journal    
DOI: 10.1093/ehjcvp/pvu007     Document Type: Article

References (61)

1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146:857-867.
2. The ACTIVE Investigators. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009;360:2066-2078.
3. ACTIVE Writing Group of theACTIVE Investigators. 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 2006;367:1903-1912.
4. Zikria JC, Ansell J. Oral anticoagulation with factor Xa and thrombin inhibitors: on the threshold of change. Curr Opin Hematol 2009;16:347-356.
5. Weitz JI. New oral anticoagulants in development. Thromb Haemost 2010;103: 62-70.
6. Grip LT, Ruff CT, Giugliano RP. New oral antithrombotic strategies: 2013 update on atrial fibrillation. Hot Topics 2013;31:7-18.
7. Connolly SJ, Ezekowitz MD, Yusuf S et al. for the RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-1151.
8. Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-891.
9. Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-992.
10. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM, ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369:2093-2104.
11. Connolly SJ, Eikelboom J, Joyner C, Diener HC, HartRet al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011;364:806-817.
12. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. 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;383:955-962.
13. Thomas L. Network meta-analysis for indirect treatment comparisons. Stat Med 2002;21:2313-2324.
14. Dogliotti A, Paolasso E, Giugliano R. Current and new antithrombotics in nonvalvular atrial fibrillation: a network meta-analysis of 79,808 patients. Heart 2014; 100:396-405.
15. Salanti G, Higgins JP, Ades AE, Ioannidis JP. Evaluation of networks of randomized trials. Stat Methods Med Res 2008;17:279-301.
16. van Valkenhoef G, Lu G, de Brock B, Hillege H, Ades A, Welton N. Automating network meta-analysis. Res Syn Meth 2012;3:285-299.
17. Dias S, Welton N, Caldwell D, Ades A. Checking consistency in mixed treatment comparison meta-analysis. Stat Med 2010;29:932-944.
18. Tervonen T, Lahdelma R. Implementing stochastic multicriteria acceptability analysis. Eur J Oper Res 2007;178:500-513.
19. van Valkenhoef G, Tervonen T, de Brock J, Hillege H, Postmus D. Multi-criteria benefit-risk assessment using network meta-analysis. J Clin Epidemiol 2012;65: 394-403.
20. Tervonen T, Figueira JR. A survey on stochastic multicriteria acceptability analysis methods. J Multi-Criteria Decis Anal 2008;15:1-14.
21. Felli JC, Noel RA, Cavazzoni PA. A multiattribute model for evaluating the benefit-risk profiles of treatment alternatives. Med Decis Making 2009;29:104-115.
22. Lahdelma R, Hokkanen J, Salminen P.SMAA - stochastic multiobjective acceptability analysis. Eur J Oper Res 1998;106:137-143.
23. Lahdelma R, Salminen P. SMAA-2: Stochastic multicriteria acceptability analysis for group decision making. Oper Res 2001;49:444-454.
24. Post PN, Stiggelbout AM, Wakker PP. The utility of health states after stroke: a systematic review of the literature. Stroke 2001;32:1425-1429.
25. Teng TO, Wallace A. One thousand health-related quality-of-life estimates. Med Care 2000;38:583-637.
26. Lee HY, Hwang JS, Jeng JS, Wang JD. Quality-adjusted life expectancy (QALE) and loss of QALE for patients with ischemic strokeand intracerebral hemorrhage: a 13-year follow-up. Stroke 2010;41:739-744.
27. Lee S, Anglade MW, Pham D, Pisacane R, Kluger J, Coleman CI. Cost-effectiveness of rivaroxaban compared to warfarin for stroke prevention in atrial fibrillation. Am J Cardiol 2012;110:845-851.
28. Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation 2011;123:2562-2570.
29. Gage BF, Cardinalli AB, Owens D. The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life. Arch Intern Med 1996;156: 1829-1836.
30. OBrien CL, Gage BF. Costs and effectiveness of ximelagatran for stroke prophylaxis in chronic atrial fibrillation. JAMA 2005;293:699-706.
31. Thomson R, Parkin D, Eccles M, Sudlow M, Robinson A. Decision analysis and guidelines for anticoagulant therapy to prevent stroke in patients with atrial fibrillation. Lancet 2000;355:956-962.
32. Fryback DG, Dasbach EJ, Klein R, Klein BE, Dorn N, Peterson K, Martin P. The Beaver DamHealth Outcomes Study: initial catalog of health-state quality factors. Med Decis Making 1993;13:89-102.
33. Dyer MT, Goldsmith KA, Sharples LS, Buxton MJ. A review of health utilities using the EQ-5D in studies of cardiovascular disease. Health Qual Life Outcomes 2010; 28:8-13.
34. Schweikert B, Hunger M, Meisinger C, Ko nig HH, Gapp O, Holle R. Quality of life several years after myocardial infarction: comparing the MONICA/KORA registry to the general population. Eur Heart J 2009;30:436-443.
35. Deitelzweig S, Amin A, Jing Y, Makenbaeva D, Wiederkehr D, Lin J, Graham J. Medical cost reductions associated with the usage of novel oral anticoagulants vs. warfarin among atrial fibrillation patients, based on the RE-LY, ROCKET-AF, and ARISTOTLE trials. J Med Econ 2012;15:776-785.
36. Deitelzweig SB, Pinsky B, Buysman E, Lacey M, Makenbaeva D, Wiederkehr D, Graham J. Bleeding as an outcome among patients with nonvalvular atrial fibrillation in a large managed care population. J Clin Ther 2013;35:1536-1545.
37. Deitelzweig S, Amin A, Jing Y, Makenbaeva D, WiederkehrD, Lin J, Graham J. Medical costs in the US of clinical events associated with oral anticoagulant (OAC) use compared to warfarin among non-valvular atrial fibrillation patients >75 years of age, based on the ARISTOTLE, RE-LY, and ROCKET-AF trials. J Med Econ 2013;16: 1163-1168.
38. Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B. Placebocontrolled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet 1989;1:175-179.
39. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. N Engl J Med 1990;323:1505-1511.
40. Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C. Canadian Atrial Fibrillation Anticoagulation (CAFA) study. J Am Coll Cardiol 1991;18:349-355.
41. Stroke Prevention in Atrial Fibrillation study. Final results. Circulation 1991;84: 527-539.
42. Ezekowitz MD, Bridgers SL, James KE, Carliner NH, Colling CL, Gornick CC, Krause-Steinrauf H, Kurtzke JF, Nazarian SM, Radford MJ. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators. N Engl J Med 1992; 327:1406-1412.
43. Secondary prevention in non-rheumatic atrial fibrillation after transient ischemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) study group. Lancet 1993;342:1255-1262.
44. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II study. Lancet 1994;343:687-691.
45. Gullov AL, Koefoed BG, Petersen P, Pedersen TS, Andersen ED, Godtfredsen J, Boysen G. 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 1998; 158:1513-1521.
46. Hellemons BS, Langenberg M, Lodder J, Vermeer F, Schouten HJ, Lemmens T, van Ree JW, Knottnerus JA. Primary prevention of arterial thromboembolism in nonrheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin. BMJ 1999;319:958-964.
47. Posada IS, Barriales V. Alternate-day dosing of aspirin in atrial fibrillation. LASAF Pilot study group. Am Heart J 1999;138:137-143.
48. Sato H, Ishikawa K, Kitabatake A, Ogawa S, Maruyama Y, Yokota Y, Fukuyama T, Doi Y, Mochizuki S, Izumi T, Takekoshi N, Yoshida K, Hiramori K, Origasa H, Uchiyama S, Matsumoto M, Yamaguchi T, Hori M. Low-dose aspirin for prevention of stroke in low-risk patients with atrial fibrillation: Japan Atrial Fibrillation Stroke Trial. Stroke 2006;37:447-451.
49. Antithrombotic Therapy in Atrial Fibrillation Study Group. [The randomized study of efficiency and safety of antithrombotic therapy in nonvalvular atrial fibrillation: warfarin compared with aspirin]. Zhonghua Xin Xue Guan Bing Za Zhi, 2006, 34, 295-298.
50. Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E. BAFTA Investigators; Midland Research Practices Network (MidReC). 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 2007;370:493-503.
51. Rash A, Downes T, Portner R, Yeo WW, Morgan N, Channer KS. Arandomised controlled trial of warfarin versus aspirin for stroke prevention in octogenarians with atrial fibrillation (WASPO). Age Ageing 2007;36:151-156.
52. Roskell NS, Lip GY, Noack H, Clemens A, Plumb JM. Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate. Thromb Haemost 2010;104:1106-1115.
53. Harenberg J, Marx S, Diener HC, Lip GY, Marder VJ, Wehling M, Weiss C. Comparison of efficacy and safety of dabigatran, rivaroxaban and apixaban in patientswithatrial fibrillation using network meta-analysis. Int Angiol 2012;31:330-339.
54. 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.
55. Biondi-Zoccai G, Malavasi V, DAscenzo F, Abbate A, Agostoni P, Lotrionte M, Castagno D, Van Tassell B, Casali E, Marietta M, Modena MG, Ellenbogen KA, Frati G. Comparative effectiveness of novel oral anticoagulants for atrial fibrillation: evidence from pair-wise and warfarin-controlled network meta-analyses. HSR Proc Intensive Care Cardiovasc Anesth 2013;5:40-54.
56. Schneeweiss S, Gagne JJ, Patrick AR, Choudhry NK, Avorn J. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes 2012;5:480-486.
57. 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;60:738-746.
58. Rasmussen LH, Larsen TB, Graungaard T, Skjoth F, Lip GY. Primary and secondary prevention with new oral anticoagulant drugs for stroke prevention in atrial fibrillation: indirect comparison analysis. BMJ 2012;345:e7097.
59. Mantha S, Ansell J. An indirect comparison of dabigatran, rivaroxaban and apixaban for atrial fibrillation. Thromb Haemost 2012;108:476-484.
60. Skjoth F, Larsen TB, Rasmussen LH, Lip GY. Efficacy and safety of edoxaban in comparison with dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation. An indirect comparison analysis. Thromb Haemost 2014;111: 981-988.
61. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363; 1876-1876.