Renal Outcomes in Anticoagulated Patients With Atrial Fibrillation

Journal of the American College of Cardiology

Volumn 70, Issue 21, 2017, Pages 2621-2632

  Yao, Xiaoxi ^a   Tangri, Navdeep ^b   Gersh, Bernard J ^a   Sangaralingham, Lindsey R ^a   Shah, Nilay D ^a,c   Nath, Karl A ^a   Noseworthy, Peter A ^a  

^a MAYO CLINIC   (United States)

^b UNIVERSITY OF MANITOBA   (Canada)

^c OPTUM   (United States)

Author keywords

acute kidney injury; apixaban; chronic kidney disease; dabigatran; kidney failure; rivaroxaban

Indexed keywords

APIXABAN; CREATININE; DABIGATRAN; RIVAROXABAN; WARFARIN; ANTICOAGULANT AGENT; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE;

ACUTE KIDNEY FAILURE; AGED; ANTICOAGULATION; ARTICLE; ATRIAL FIBRILLATION; CARDIOVERSION; CHA2DS2-VASC SCORE; CHRONIC KIDNEY FAILURE; COHORT ANALYSIS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ESTIMATED GLOMERULAR FILTRATION RATE; FEMALE; FOLLOW UP; HOSPITALIZATION; HUMAN; INFORMED CONSENT; INTERNATIONAL NORMALIZED RATIO; KIDNEY FAILURE; KIDNEY FUNCTION; KOLMOGOROV SMIRNOV TEST; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROBABILITY; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; SENSITIVITY ANALYSIS; SIDE EFFECT; BLOOD; COMPLICATION; GLOMERULUS FILTRATION RATE; KIDNEY DISEASE; MIDDLE AGED; PROPORTIONAL HAZARDS MODEL; TREATMENT OUTCOME; UNITED STATES;

ACUTE KIDNEY INJURY; AGED; ANTICOAGULANTS; ATRIAL FIBRILLATION; CREATININE; DABIGATRAN; FEMALE; FOLLOW-UP STUDIES; GLOMERULAR FILTRATION RATE; HUMANS; INTERNATIONAL NORMALIZED RATIO; KIDNEY DISEASES; MALE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; PYRAZOLES; PYRIDONES; RETROSPECTIVE STUDIES; RIVAROXABAN; TREATMENT OUTCOME; UNITED STATES; WARFARIN;

EID: 85033663265     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2017.09.1087     Document Type: Article

References (45)

1. Brodsky, S.V., Nadasdy, T., Rovin, B.H., et al. Warfarin-related nephropathy occurs in patients with and without chronic kidney disease and is associated with an increased mortality rate. Kidney Int 80 (2011), 181–189.
2. Brodsky, S.V., Collins, M., Park, E., et al. Warfarin therapy that results in an international normalization ratio above the therapeutic range is associated with accelerated progression of chronic kidney disease. Nephron Clin Pract 115 (2010), c142–c146.
3. Kirchhof, P., Benussi, S., Kotecha, D., et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace 18 (2016), 1609–1678.
4. Granger, C.B., Alexander, J.H., McMurray, J.J., et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365 (2011), 981–992.
5. Connolly, S.J., Ezekowitz, M.D., Yusuf, S., et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361 (2009), 1139–1151.
6. Patel, M.R., Mahaffey, K.W., Garg, J., et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365 (2011), 883–891.
7. Giugliano, R.P., Ruff, C.T., Braunwald, E., et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369 (2013), 2093–2104.
8. Yao, X., Abraham, N.S., Sangaralingham, L.R., et al. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc, 5, 2016, e003725.
9. Böhm, M., Ezekowitz, M.D., Connolly, S.J., et al. Changes in renal function in patients with atrial fibrillation: an analysis from the RE-LY Trial. J Am Coll Cardiol 65 (2015), 2481–2493.
10. Fordyce, C.B., Hellkamp, A.S., Lokhnygina, Y., et al. On-treatment outcomes in patients with worsening renal function with rivaroxaban compared with warfarin: insights from ROCKET AF. Circulation 134 (2016), 37–47.
11. Chatrou, M.L., Winckers, K., Hackeng, T.M., Reutelingsperger, C.P., Schurgers, L.J., Vascular calcification: the price to pay for anticoagulation therapy with vitamin K-antagonists. Blood Rev 26 (2012), 155–166.
12. Luo, G., Ducy, P., McKee, M.D., et al. Spontaneous calcification of arteries and cartilage in mice lacking matrix GLA protein. Nature 386 (1997), 78–81.
13. Schurgers, L.J., Joosen, I.A., Laufer, E.M., et al. Vitamin K-antagonists accelerate atherosclerotic calcification and induce a vulnerable plaque phenotype. PloS One, 7, 2012, e43229.
14. Sparkenbaugh, E.M., Chantrathammachart, P., Mickelson, J., et al. Differential contribution of FXa and thrombin to vascular inflammation in a mouse model of sickle cell disease. Blood 123 (2014), 1747–1756.
15. Lee, I.O., Kratz, M.T., Schirmer, S.H., Baumhäkel, M., Böhm, M., The effects of direct thrombin inhibition with dabigatran on plaque formation and endothelial function in apolipoprotein E-deficient mice. J Pharmacol Exp Ther 343 (2012), 253–257.
16. Chan, Y.H., Yeh, Y.H., See, L.C., et al. Acute kidney injury in Asians with atrial fibrillation treated with dabigatran or warfarin. J Am Coll Cardiol 68 (2016), 2272–2283.
17. Wallace, P.J., Shah, N.D., Dennen, T., Bleicher, P.A., Crown, W.H., Optum Labs: building a novel node in the learning health care system. Health Aff (Millwood) 33 (2014), 1187–1194.
18. Optum. Optum Research Data Assets. 2015. Available at: https://www.optum.com/content/dam/optum/resources/productSheets/5302_Data_Assets_Chart_Sheet_ISPOR.pdf. Accessed April 8, 2017.
19. Ray, W.A., Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 158 (2003), 915–920.
20. January, C.T., Wann, L.S., Alpert, J.S., et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 64 (2014), e1–e76.
21. Levey, A.S., Stevens, L.A., Schmid, C.H., et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 150 (2009), 604–612.
22. Noseworthy, P.A., Yao, X., Abraham, N.S., Sangaralingham, L.R., McBane, R.D., Shah, N.D., Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation. Chest 150 (2016), 1302–1312.
23. Levey, A.S., Inker, L.A., Matsushita, K., et al. GFR decline as an end point for clinical trials in CKD: a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration. Am J Kidney Dis 64 (2014), 821–835.
24. Hwang, Y.J., Shariff, S.Z., Gandhi, S., et al. Validity of the International Classification of Diseases, Tenth Revision code for acute kidney injury in elderly patients at presentation to the emergency department and at hospital admission. BMJ Open, 2, 2012, e001821.
25. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl 3 (2013), 1–150.
26. McCaffrey, D.F., Griffin, B.A., Almirall, D., Slaughter, M.E., Ramchand, R., Burgette, L.F., A tutorial on propensity score estimation for multiple treatments using generalized boosted models. Stat Med 32 (2013), 3388–3414.
27. Austin, P.C., Stuart, E.A., Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med 34 (2015), 3661–3679.
28. Grambsch, P.M., Therneau, T.M., Proportional hazards tests and diagnostics based on weighted residuals. Biometrika 81 (1994), 515–526.
29. Prasad, V., Jena, A.B., Prespecified falsification end points: can they validate true observational associations?. JAMA 309 (2013), 241–242.
30. Dusetzina, S.B., Brookhart, M.A., Maciejewski, M.L., Control outcomes and exposures for improving internal validity of nonrandomized studies. Health Serv Res 50 (2015), 1432–1451.
31. Hijazi, Z., Hohnloser, S.H., Andersson, U., et al. Efficacy and safety of apixaban compared with warfarin in patients with atrial fibrillation in relation to renal function over time: insights from the ARISTOTLE randomized clinical trial. JAMA Cardiol 1 (2016), 451–460.
32. Roldán, V., Marín, F., Fernández, H., et al. Renal impairment in a “real-life” cohort of anticoagulated patients with atrial fibrillation (implications for thromboembolism and bleeding). Am J Cardiol 111 (2013), 1159–1164.
33. Marzec, L.N., Wang, J., Shah, N.D., et al. Influence of direct oral anticoagulants on rates of oral anticoagulation for atrial fibrillation. J Am Coll Cardiol 69 (2017), 2475–2484.
34. Steinberg, B.A., Blanco, R.G., Ollis, D., et al. Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II: rationale and design of the ORBIT-AF II registry. Am Heart J 168 (2014), 160–167.
35. Pokorney, S.D., O'Brien, E.C., Granger, C.B., Assessing generalizability of trial results in general practice. Eur Heart J 37 (2016), 1154–1157.
36. Yao, X., Abraham, N.S., Alexander, G.C., et al. Effect of adherence to oral anticoagulants on risk of stroke and major bleeding among patients with atrial fibrillation. J Am Heart Assoc, 5, 2016, e003074.
37. Noble, W.S., How does multiple testing correction work?. Nat Biotechnol 27 (2009), 1135–1137.
38. Lip, G.Y., Keshishian, A., Kamble, S., et al. Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin: a propensity score matched analysis. Thromb Haemost 116 (2016), 975–986.
39. Graham, D.J., Reichman, M.E., Wernecke, M., et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation 131 (2015), 157–164.
40. Graham, D.J., Reichman, M.E., Wernecke, M., et al. Stroke, bleeding, and mortality risks in elderly Medicare beneficiaries treated with dabigatran or rivaroxaban for nonvalvular atrial fibrillation. JAMA internal medicine, 2016.
41. Hernandez, I., Baik, S.H., Piñera, A., Zhang, Y., Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern Med 175 (2015), 18–24.
42. Seeger, J., Bykov, K., Bartels, D., Huybrechts, K., Zint, K., Schneeweiss, S., Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost 114 (2015), 1277–1289.
43. Wang, S.V., Franklin, J.M., Glynn, R.J., Schneeweiss, S., Eddings, W., Gagne, J.J., Prediction of rates of thromboembolic and major bleeding outcomes with dabigatran or warfarin among patients with atrial fibrillation: new initiator cohort study. BMJ, 353, 2016, i2607.
44. Chang, H.Y., Zhou, M., Tang, W., Alexander, G.C., Singh, S., Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ, 350, 2015, h1585.
45. Maura, G., Blotière, P.O., Bouillon, K., et al. Comparison of the short-term risk of bleeding and arterial thromboembolic events in nonvalvular atrial fibrillation patients newly treated with dabigatran or rivaroxaban versus vitamin K antagonists: a French nationwide propensity-matched cohort study. Circulation 132 (2015), 1252–1260.