Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation: A RE-LY (Randomized evaluation of long-term anticoagulation therapy) trial analysis

Circulation

Volumn 129, Issue 9, 2014, Pages 961-970

  Hijazi, Ziad ^a   Hohnloser, Stefan H ^b   Oldgren, Jonas ^a   Andersson, Ulrika ^a   Connolly, Stuart J ^c   Eikelboom, John W ^c   Ezekowitz, Michael D ^d   Reilly, Paul A ^e   Siegbahn, Agneta ^a   Yusuf, Salim ^c   Wallentin, Lars ^a  

^a UPPSALA CLINICAL RESEARCH CENTER   (Sweden)

^b GOETHE UNIVERSITY   (Germany)

^c MCMASTER UNIVERSITY   (Canada)

^d THOMAS JEFFERSON UNIVERSITY   (United States)

^e BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

anticoagulants; atrial fibrillation; dabigatran; hemorrhage; renal insufficiency; stroke; warfarin

Indexed keywords

CREATININE; CYSTATIN C; DABIGATRAN; WARFARIN;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; BRAIN HEMORRHAGE; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CHRONIC KIDNEY DISEASE EPIDEMIOLOGY COLLABORATION; COCKCROFT GAULT; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; EMBOLISM; FEMALE; GLOMERULUS FILTRATION RATE; HEART ATRIUM FIBRILLATION; HUMAN; KIDNEY FUNCTION; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MODIFICATION OF DIET IN RENAL DISEASE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; URINARY EXCRETION;

ANTICOAGULANTS; ATRIAL FIBRILLATION; DABIGATRAN; HEMORRHAGE; RENAL INSUFFICIENCY; STROKE; WARFARIN;

AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; DOSE-RESPONSE RELATIONSHIP, DRUG; EMBOLISM; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; INTERNATIONALITY; KIDNEY; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; RISK FACTORS; STROKE; TREATMENT OUTCOME; WARFARIN;

EID: 84895546812     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.113.003628     Document Type: Article

References (24)

1. Ananthapanyasut W, Napan S, Rudolph EH, Harindhanavudhi T, Ayash H, Guglielmi KE, Lerma EV. Prevalence of atrial fibrillation and its predictors in nondialysis patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010;5:173-181.
2. Baber U, Howard VJ, Halperin JL, Soliman EZ, Zhang X, McClellan W, Warnock DG, Muntner P. Association of chronic kidney disease with atrial fibrillation among adults in the United States: REasons for Geographic and Racial Differences in Stroke (REGARDS) Study. Circ Arrhythm Electrophysiol. 2011;4:26-32.
3. Deo R, Katz R, Kestenbaum B, Fried L, Sarnak MJ, Psaty BM, Siscovick DS, Shlipak MG. Impaired kidney function and atrial fibrillation in elderly subjects. J Card Fail. 2010;16:55-60.
4. Fox KA, Piccini JP, Wojdyla D, Becker RC, Halperin JL, Nessel CC, Paolini JF, Hankey GJ, Mahaffey KW, Patel MR, Singer DE, Califf RM. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J. 2011;32:2387-2394.
5. Go AS, Fang MC, Udaltsova N, Chang Y, Pomernacki NK, Borowsky L, Singer DE; ATRIA Study Investigators. Impact of proteinuria and glomerular filtration rate on risk of thromboembolism in atrial fibrillation: the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study. Circulation. 2009;119:1363-1369.
6. Hohnloser SH, Hijazi Z, Thomas L, Alexander JH, Amerena J, Hanna M, Keltai M, Lanas F, Lopes RD, Lopez-Sendon J, Granger CB, Wallentin L. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J. 2012;33:2821-2830.
7. Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: Validation of the r2chads2 index in the ROCKET AF (Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) study cohorts. Circulation. 2013;127:224-232.
8. Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. 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;31:2369-2429.
9. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess one-year risk of major bleeding in atrial fibrillation patients: the Euro Heart Survey. Chest. 2010:1093-1100.
10. Marinigh R, Lane DA, Lip GY. Severe renal impairment and stroke prevention in atrial fibrillation: implications for thromboprophylaxis and bleeding risk. J Am Coll Cardiol. 2011;57:1339-1348.
11. Piccini JP, Hernandez AF, Zhao X, Patel MR, Lewis WR, Peterson ED, Fonarow GC; Get With The Guidelines Steering Committee and Hospitals. Quality of care for atrial fibrillation among patients hospitalized for heart failure. J Am Coll Cardiol. 2009;54:1280-1289.
12. Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157:805-810, 810.e1.
13. 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.
14. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150:604-612.
15. Flodin M, Jonsson AS, Hansson LO, Danielsson LA, Larsson A. Evaluation of Gentian cystatin C reagent on Abbott Ci8200 and calculation of glomerular filtration rate expressed in mL/min/1.73 m2 from the cystatin C values in mg/L. Scand J Clin Lab Invest. 2007;67:560-567.
16. Levey AS, Coresh J, Greene T, Marsh J, Stevens LA, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Expressing the Modification of Diet in Renal Disease Study equation for estimating glomerular filtration rate with standardized serum creatinine values. Clin Chem. 2007;53:766-772.
17. 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.
18. Reinecke H, Brand E, Mesters R, Schäbitz WR, Fisher M, Pavenstädt H, Breithardt G. Dilemmas in the management of atrial fibrillation in chronic kidney disease. J Am Soc Nephrol. 2009;20:705-711.
19. Shlipak MG, Stehman-Breen C, Fried LF, Song X, Siscovick D, Fried LP, Psaty BM, Newman AB. The presence of frailty in elderly persons with chronic renal insufficiency. Am J Kidney Dis. 2004;43:861-867.
20. Poli D, Antonucci E, Marcucci R, Fatini C, Alterini B, Mannini L, Falciani M, Abbate R, Gensini GF, Prisco D. Risk of bleeding in very old atrial fibrillation patients on warfarin: relationship with ageing and CHADS2 score. Thromb Res. 2007;121:347-352.
21. Stevens LA, Coresh J, Greene T, Levey AS. Assessing kidney function-measured and estimated glomerular filtration rate. N Engl J Med. 2006;354:2473-2483.
22. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992.
23. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
24. Lehr T, Haertter S, Liesenfeld KH, Staab A, Clemens A, Reilly PA, Friedman J. Dabigatran etexilate in atrial fibrillation patients with severe renal impairment: dose identification using pharmacokinetic modeling and simulation. J Clin Pharmacol. 2012;52:1373-1378.