Major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin: A “real-world” observational study in the United States

International Journal of Clinical Practice

Volumn 70, Issue 9, 2016, Pages 752-763

  Lip, Gregory Y H ^a,b   Pan, Xianying ^c   Kamble, Shital ^c   Kawabata, Hugh ^c   Mardekian, Jack ^d   Masseria, Cristina ^d   Bruno, Amanda ^c   Phatak, Hemant ^c  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b AALBORG UNIVERSITY   (Denmark)

^c BRISTOL MYERS SQUIBB   (United States)

^d PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; APIXABAN; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DABIGATRAN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HISTAMINE H2 RECEPTOR ANTAGONIST; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; RIVAROXABAN; WARFARIN; ANTICOAGULANT AGENT; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE;

ADULT; AGE; AGED; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; CEREBROVASCULAR ACCIDENT; CHA2DS2-VASC SCORE; CHARLSON COMORBIDITY INDEX; COHORT ANALYSIS; COMORBIDITY; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG USE; DYSPEPSIA; FEMALE; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; KIDNEY DISEASE; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MIDDLE AGED; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK; RISK ASSESSMENT; STOMACH DISCOMFORT; UNITED STATES; VERY ELDERLY; ADOLESCENT; AGE DISTRIBUTION; AMBULATORY CARE; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; MULTICENTER STUDY; RISK FACTOR; STATISTICS AND NUMERICAL DATA; YOUNG ADULT;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; AGED, 80 AND OVER; AMBULATORY CARE; ANTICOAGULANTS; ATRIAL FIBRILLATION; DABIGATRAN; FEMALE; HEMORRHAGE; HOSPITALIZATION; HUMANS; MALE; MIDDLE AGED; PYRAZOLES; PYRIDONES; RISK FACTORS; RIVAROXABAN; UNITED STATES; WARFARIN; YOUNG ADULT;

EID: 84983350862     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/ijcp.12863     Document Type: Article

References (33)

1. Rahman F, Kwan GF, Benjamin EJ. Global epidemiology of atrial fibrillation. Nat Rev Cardiol. 2014;11:639–654.
2. Savelieva I, Bajpai A, Camm AJ. Stroke in atrial fibrillation: update on pathophysiology, new antithrombotic therapies, and evolution of procedures and devices. Ann Med. 2007;39:371–391.
3. Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005;36:1115–1119.
4. Benjamin EJ, Chen PS, Bild DE, et al. Prevention of atrial fibrillation: report from a national heart, lung, and blood institute workshop. Circulation. 2009;119:606–618.
5. De Caterina R, Husted S, Wallentin L, et al. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013;110:1087–1107.
6. Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med 2010;123:638–645. e4.
7. Ruff CT, Giugliano RP, Braunwald E, 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;383:955–962.
8. Hylek EM, Ko D, Cove CL. Gaps in translation from trials to practice: non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation. Thromb Haemost. 2014;111:783–788.
9. Hankey GJ. Unanswered questions and research priorities to optimise stroke prevention in atrial fibrillation with the new oral anticoagulants. Thromb Haemost. 2014;111:808–816.
10. 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;20:560–566.
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. 2014;4:e001798.
12. Abraham NS, Singh S, Alexander GC, et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015;350:h1857.
13. Chang H-Y, Zhou M, Tang W, Alexander GC. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ. 2015;350:h1585.
14. 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.
15. 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.
16. 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.
17. Laliberte F, Cloutier M, Nelson WW, et al. Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients. Curr Med Res Opin. 2014;30:1317– 1325.
18. Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131:157–164.
19. Larsen TB, Rasmussen LH, Skjoth F, et al. 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.
20. Mani H, Lindhoff-Last E. New oral anticoagulants in patients with nonvalvular atrial fibrillation: a review of pharmacokinetics, safety, efficacy, quality of life, and cost effectiveness. Drug Des Devel Ther. 2014;8:789–798.
21. Azoulay L, Dell’Aniello S, Simon TA, Renoux C, Suissa S. Initiation of warfarin in patients with atrial fibrillation: early effects on ischaemic strokes. Eur Heart J 2014;35:1881–1887.
22. Hylek EM, Held C, Alexander JH, et al. Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin: The ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation): predictors, Characteristics, and Clinical Outcomes. J Am Coll Cardiol. 2014;63:2141–2147.
23. Ho CW, Ho MH, Chan PH, et al. Ischemic stroke and intracranial hemorrhage with aspirin, dabigatran, and warfarin: impact of quality of anticoagulation control. Stroke. 2015;46:23–30.
24. Connolly SJ, Ezekowitz MD, Yusuf S, et al.; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139–1151.
25. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–891.
26. Lader E, Martin N, Cohen G, et al. Warfarin therapeutic monitoring: is 70% time in the therapeutic range the best we can do? J Clin Pharm Ther. 2012;37:375–377.
27. Rose AJ, Ozonoff A, Henault LE, Hylek EM. Warfarin for atrial fibrillation in community-based practice. JTH. 2010;6:1647– 1654.
28. Camm AJ, Amarenco P, Haas 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;37:1145– 1153.
29. Tamayo S, Frank Peacock W, Patel M., et al. Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban. Clinical Cardiol 2015;38:63–68.
30. Beyer-Westendorf J, Förster K, Pannach S, et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124:955–962.
31. Granger CB, Alexander JH, McMurray JJ, et al.; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981–992.
32. Gallego P, Roldan V, Marin F, et al. Cessation of oral anticoagulation in relation to mortality and the risk of thrombotic events in patients with atrial fibrillation. Thromb Haemost. 2013;110:1189–1198.
33. Sjogren V, Grzymala-Lubanski B, Renlund H, et al. Safety and efficacy of well managed warfarin. A report from the Swedish quality register Auricula. Thromb Haemost. 2015;113:1370–1377.