Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective anticoagulation with factor xa next generation in atrial fibrillation-thrombolysis in myocardial infarction 48

Stroke

Volumn 45, Issue 8, 2014, Pages 2372-2378

  Giugliano, Robert P ^a   Ruff, Christian T ^a   Rost, Natalia S ^b   Silverman, Scott ^b   Wiviott, Stephen D ^a   Lowe, Cheryl ^a   Deenadayalu, Naveen ^a   Murphy, Sabina A ^a   Grip, Laura T ^a   Betcher, Joshua M ^c   Duggal, Anil ^d   Dave, Jay ^d   Shi, Minggao ^d   Mercuri, Michele ^d   Antman, Elliott M ^a   Braunwald, Eugene ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c IQVIA   (United States)

^d DAIICHI SANKYO INC   (United States)

Author keywords

anticoagulant; atrial fibrillation; cerebral hemorrhage; stroke

Indexed keywords

EDOXABAN; WARFARIN;

ANTICOAGULANT THERAPY; ARTICLE; BLOOD CLOT LYSIS; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG MEGADOSE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; LOW DRUG DOSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TRANSIENT ISCHEMIC ATTACK;

ANTICOAGULANT; ATRIAL FIBRILLATION; CEREBRAL HEMORRHAGE; STROKE;

AGED; ANTICOAGULANTS; ATRIAL FIBRILLATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PYRIDINES; STROKE; THIAZOLES; TREATMENT OUTCOME; WARFARIN;

EID: 84905259309     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.114.006025     Document Type: Article

References (25)

1. Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: populationbased estimates. Am J Cardiol. 1998;82(8A):2N-9N.
2. 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.
3. Chan PS, Maddox TM, Tang F, Spinler S, Spertus JA. Practice-level variation in warfarin use among outpatients with atrial fibrillation (from the NCDR PINNACLE program). Am J Cardiol. 2011;108:1136-1140.
4. Dlott JS, George RA, Huang X, Odeh M, Kaufman HW, Ansell J, et al. National assessment of warfarin anticoagulation therapy for stroke prevention in atrial fibrillation. Circulation. 2014;129:1407-1414.
5. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151.
6. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, et al; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093-2104.
7. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992.
8. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
9. 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 metaanalysis of randomised trials. Lancet. 2014;383:955-962.
10. Plitt A, Giugliano RP. Edoxaban: review of pharmacology and key phase i to iii clinical trials [published online ahead of print March 7, 2014]. J Cardiovasc Pharm Ther. http://cpt.sagepub.com/content/early/2014/03/ 06/1074248414523675.abstract. Accessed May 21, 2014.
11. Easton JD, Saver JL, Albers GW, Alberts MJ, Chaturvedi S, Feldmann E, et al; American Heart Association; American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Interdisciplinary Council on Peripheral Vascular Disease. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists. Stroke. 2009;40:2276-2293.
12. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010;160:635-641.
13. Rankin J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957;2:200-215.
14. Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke. 1988;19:1497-1500.
15. Gonzalez-Quesada CJ, Giugliano RP. Comparison of the phase III clinical trial designs of novel oral anticoagulants versus warfarin for the treatment of nonvalvular atrial fibrillation: implications for clinical practice. Am J Cardiovasc Drugs. 2014;14:111-127.
16. Wieloch M, Själander A, Frykman V, Rosenqvist M, Eriksson N, Svensson PJ. Anticoagulation control in Sweden: reports of time in therapeutic range, major bleeding, and thrombo-embolic complications from the national quality registry AuriculA. Eur Heart J. 2011;32:2282-2289.
17. Wan Y, Heneghan C, Perera R, Roberts N, Hollowell J, Glasziou P, et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.
18. Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003;349:1019-1026.
19. Rosand J, Eckman MH, Knudsen KA, Singer DE, Greenberg SM. The effect of warfarin and intensity of anticoagulation on outcome of intracerebral hemorrhage. Arch Intern Med. 2004;164:880-884.
20. Sjöblom L, Hårdemark HG, Lindgren A, Norrving B, Fahlén M, Samuelsson M, et al. Management and prognostic features of intracerebral hemorrhage during anticoagulant therapy: a Swedish multicenter study. Stroke. 2001;32:2567-2574.
21. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, et al. 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.
22. Morrow DA, Murphy SA, McCabe CH, Mackman N, Wong HC, Antman EM. Potent inhibition of thrombin with a monoclonal antibody against tissue factor (Sunol-cH36): results of the PROXIMATE-TIMI 27 trial. Eur Heart J. 2005;26:682-688.
23. Giugliano RP, Wiviott SD, Stone PH, Simon DI, Schweiger MJ, Bouchard A, et al; ANTHEM-TIMI-32 Investigators. Recombinant nematode anticoagulant protein c2 in patients with non-ST-segment elevation acute coronary syndrome: the ANTHEM-TIMI-32 trial. J Am Coll Cardiol. 2007;49:2398-2407.
24. Eriksson BI, Dahl OE, Lassen MR, Ward DP, Rothlein R, Davis G, et al; Fixit Study Group. Partial factor IXa inhibition with TTP889 for prevention of venous thromboembolism: an exploratory study. J Thromb Haemost. 2008;6:457-463.
25. Schuijt TJ, Bakhtiari K, Daffre S, Deponte K, Wielders SJ, Marquart JA, et al. Factor Xa activation of factor V is of paramount importance in initiating the coagulation system: lessons from a tick salivary protein. Circulation. 2013;128:254-266.