Dabigatran and other oral antithrombotic agents for the prevention of stroke in patients with atrial fibrillation

References

• Miyasaka Y, Barnes ME, Gersh BJ, et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006;114(2):119–125.
   PubMed Web of Science ®Google Scholar
• Lakshminarayan K, Solid CA, Collins AJ, Anderson DC, Herzog CA. Atrial fibrillation and stroke in the general medicare population: a 10-year perspective (1992 to 2002). Stroke. 2006;37(8):1969–1974.
   PubMed Web of Science ®Google Scholar
• Ezekowitz MD. Atrial fibrillation: the epidemic of the new millennium. Ann Intern Med. 1999;131(7):537–538.
   PubMed Web of Science ®Google Scholar
• Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2011 update: a report from the American Heart Association. Circulation. 2011;123(4):e18–e209.
   PubMed Web of Science ®Google Scholar
• Kwok CS, Loke YK, Hale R, Potter JF, Myint PK. Atrial fibrillation and incidence of dementia: a systematic review and meta-analysis. Neurology. 2011;76(10):914–922.
   PubMed Web of Science ®Google Scholar
• Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22(8): 983–988.
   PubMed Web of Science ®Google Scholar
• Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285(22):2864–2870.
   PubMed Web of Science ®Google Scholar
• Stroke Risk in Atrial Fibrillation Working Group. Comparison of 12 risk stratification schemes to predict stroke in patients with nonvalvular atrial fibrillation. Stroke. 2008;39(6):1901–1910.
   PubMed Web of Science ®Google Scholar
• Lip GY, Halperin JL. Improving stroke risk stratification in atrial fibrillation. Am J Med. 2010;123(6):484^88.
   Web of Science ®Google Scholar
• Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010;137(2):263–272.
   PubMed Web of Science ®Google Scholar
• European Heart Rhythm Association, European Association for Cardio- Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, et al. 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(19):2369–2429.
   PubMed Web of Science ®Google Scholar
• Fuster V Ryden LE, Cannom DS, et al. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011;123(10): e269–e367.
   PubMed Web of Science ®Google Scholar
• 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(12):857–867.
   PubMed Web of Science ®Google Scholar
• Waldo AL, Becker RC, Tapson VF, Colgan KJ. NABOR Steering Committee. Hospitalized patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol. 2005;46(9):1729–1736.
   PubMed Web of Science ®Google Scholar
• Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/ Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol. 2011;57(2):173–180.
   PubMed Web of Science ®Google Scholar
• Ellis DJ, Usman MH, Milner PG, Canafax DM, Ezekowitz MD. The first evaluation of a novel vitamin K antagonist, tecarfarin (ATI- 5923), in patients with atrial fibrillation. Circulation. 2009;120(12): 1029–1035.
   PubMed Web of Science ®Google Scholar
• Goldstein LB, Bushnell CD, Adams RJ, et al. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42(2):517–584.
   PubMed Web of Science ®Google Scholar
• Furie KL, Kasner SE, Adams RJ, et al. American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42(1):227–276.
   PubMed Web of Science ®Google Scholar
• Mant J, Hobbs FD, Fletcher K, et al. 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(9586): 493–503.
   PubMed Web of Science ®Google Scholar
• ACTIVE Writing Group of the ACTIVE Investigators; Connolly S, Pogue J, Hart R, et al. 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(9526):1903–1912.
   PubMed Web of Science ®Google Scholar
• ACTIVE Investigators; Connolly SJ, Pogue J, Hart RG, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009;360(20):2066–2078.
   PubMed Web of Science ®Google Scholar
• Akins PT, Feldman HA, Zoble RG, et al. Secondary stroke prevention with ximelagatran versus warfarin in patients with atrial fibrillation: pooled analysis of SPORTIF III and V clinical trials. Stroke. 2007;38(3): 874–880.
   Web of Science ®Google Scholar
• Wienen W, Stassen JM, Priepke H, Ries UJ, Hauel N. In-vitro profile and ex-vivo anticoagulant activity of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate. Thromb Haemost. 2007;98(1):155–162.
   PubMed Web of Science ®Google Scholar
• Stangier J, Stahle H, Rathgen K, Fuhr R. Pharmacokinetics and pharmacodynamics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet. 2008;47(1):47–59.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Product Information. 2010. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/ EPAR_-_Product_Information/human/000829/WC500041059.pdf. Accessed March 23, 2011.
   Google Scholar
• Stangier J, Eriksson BI, Dahl OE, et al. Pharmacokinetic profile of the oral direct thrombin inhibitor dabigatran etexilate in healthy volunteers and patients undergoing total hip replacement. J Clin Pharmacol. 2005;45(5):555–563.
   PubMed Web of Science ®Google Scholar
• Blech S, Ebner T, Ludwig-Schwellinger E, Stangier J, Roth W The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos. 2008;36(2):386–399.
   PubMed Web of Science ®Google Scholar
• Stangier J, Rathgen K, Stahle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabiga- tran etexilate: an open-label, parallel-group, single-centre study. Clin Pharmacokinet. 2010;49(4):259–268.
   PubMed Web of Science ®Google Scholar
• Stangier J, Stahle H, Rathgen K, Roth W, Shakeri-Nejad K. Pharmacokinetics and pharmacodynamics of dabigatran etexilate, an oral direct thrombin inhibitor, are not affected by moderate hepatic impairment. J Clin Pharmacol. 2008;48(12):1411–1419.
   PubMed Web of Science ®Google Scholar
• Boehringer-Ingelheim Corporate. Medication Guide. 2011. Available from: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20 Information/PIs/Pradaxa/Pradaxa.pdf. Accessed May 1, 2011.
   Google Scholar
• Food and Drug Administration (FDA). PRADAXA Drug Approval Package. October 19, 2010. Available from: http://www.accessdata.fda. gov/drugsatfda_docs/nda/2010/022512Orig1s000SumR.pdf. Accessed March 25, 2011.
   Google Scholar
• Food and Drug Administration. Drug Safety Communication. March 29, 2011. Available from: http://www.fda.gov/Drugs/DrugSafety/ ucm248746.htm. Accessed May 1, 2011.
   Google Scholar
• 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(12):1139–1151.
   PubMed Web of Science ®Google Scholar
• 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. NEngl J Med. 2010;363(19):1875–1876.
   PubMed Web of Science ®Google Scholar
• Diener HC, Connolly SJ, Ezekowitz MD, et al. RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010;9(12):1157–1163.
   PubMed Web of Science ®Google Scholar
• Ezekowitz MD, Wallentin L, Connolly SJ, et al; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010;122(22):2246–2253.
   Web of Science ®Google Scholar
• Shen AY, Yao JF, Brar SS, Jorgensen MB, Chen W. Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol. 2007;50(4):309–315.
   PubMed Web of Science ®Google Scholar
• Hori M, Connolly SJ, Ezekowitz MD, Reilly PA, Yusuf S, Wallentin L. The RE-LY Investigators. Efficacy and safety of dabigatran vs warfarin in patients with atrial fibrillation. Circ J. 2011;75(4): 800–805.
   Web of Science ®Google Scholar
• Olsson SB; Executive Steering Committee of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet. 2003;362(9397):1691–1698.
   PubMed Web of Science ®Google Scholar
• Gensch C, Hoppe U, Bohm M, Laufs U. Late-breaking clinical trials presented at the American Heart Association Congress in Chicago 2010. Clin Res Cardiol. 2011;100(1):1–9.
   Web of Science ®Google Scholar
• Wallentin L, James S, Storey RF, et al. PLATO investigators. Effect of CYP2C19 and ABCB1 single nucleotide polymorphisms on outcomes of treatment with ticagrelor versus clopidogrel for acute coronary syndromes: a genetic substudy of the PLATO trial. Lancet. 2010;376(9749): 1320–1328.
   PubMed Web of Science ®Google Scholar
• Beasley BN, Unger EF, Temple R. Anticoagulant options – why the FDA approved a higher but not a lower dose of dabigatran. N Engl J Med. 2011;364(19):1788–1790.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Summary of opinion on dabigatran. April 14, 2011. Available from: http://www.ema.europa.eu/docs/ en_GB/document_library/Summary_of_opinion/human/000829/ WC500105283.pdf. Accessed May 1, 2011.
   Google Scholar
• Health Canada. Product Monograph. April 1, 2010. Available from: http://webprod.hc-sc.gc.ca/dpd-bdpp/info.do?lang=eng&code=79795. Accessed May 1, 2011.
   Google Scholar
• Wann LS, Curtis AB, Ellenbogen KA, et al. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123(10):1144–1150.
   PubMed Web of Science ®Google Scholar
• Ezekowitz MD, Reilly PA, Nehmiz G, et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol. 2007; 100(9):1419–1426.
   PubMed Web of Science ®Google Scholar
• Stangier J, Rathgen K, Stahle H, Gansser D, Roth W. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007;64(3):292–303.
   PubMed Web of Science ®Google Scholar
• Samama MM, Guinet C. Review: laboratory assessment of new anticoagulants. Clin Chem Lab Med. 2011;49(5):761–772.
   PubMed Web of Science ®Google Scholar
• Mitchell LG, Dietrich K, Stang L, Etches W, Qayyum S. Comparison of hemoclot to standard coagulation assays for monitoring the direct thrombin inhibitor (dabigatran) in pediatric patients: an in vitro study [abstract]. J Thromb Haemost. 2009;7 Suppl 2:777.
   Google Scholar
• van Ryn J, Stangier J, Haertter S, et al. Dabigatran etexilate – a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost. 2010;103(6):1116–1127.
   PubMed Web of Science ®Google Scholar
• Nowak G. The ecarin clotting time, a universal method to quantify direct thrombin inhibitors. Pathophysiol Haemost Thromb. 2003;33(4):173–183.
   PubMed Web of Science ®Google Scholar
• Wienen W, Ruehl D, Stassen JM, Priepke H, Ries UJ, Hauel N. Effect of recombinant factor VIIa or activated prothrombin complex concentrate on the bleeding time in anaesthetized rats during anticoagulant treatment with the direct thrombin inhibitor dabigatran [abstract]. J Thromb Haemost. 2005;3 Suppl 1:P1703.
   Google Scholar
• Van Ryn J, Ruehl D, Priepke H, Hauel N, Wienen W. Reversibility of the anticoagulant effect of high doses of the direct thrombin inhibitor dabigatran, by recominant factro VIIa or activated prothrombin complex concentrate. [abstract]. Haematologica. 2008;93 Suppl 1: 148.
   Google Scholar
• Friberg L, Hammar N, Ringh M, Pettersson H, Rosenqvist M. Stroke prophylaxis in atrial fibrillation: who gets it and who does not? Report from the Stockholm Cohort-study on Atrial Fibrillation (SCAF-study). Eur Heart J. 2006;27(16):1954–1964.
   Web of Science ®Google Scholar
• Partington SL, Abid S, Teo K, Oczkowski W, O’Donnell MJ. Pre-admission warfarin use in patients with acute ischemic stroke and atrial fibrillation: The appropriate use and barriers to oral anticoagulant therapy. Thromb Res. 2007;120(5):663–669.
   Web of Science ®Google Scholar
• Sorensen SV Kansal AR, Connolly S, et al. Cost-effectiveness of dab- igatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: a Canadian payer perspective. Thromb Haemost. 2011;105(5):908–919.
   PubMed Web of Science ®Google Scholar
• Freeman JV Zhu RP, Owens DK, et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011;154(1):1–11.
   PubMed Web of Science ®Google Scholar
• Connolly SJ, Eikelboom J, Joyner C, et al. AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364(9):806–817.
   PubMed Web of Science ®Google Scholar
• ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010;159(3):340–347.
   PubMed Web of Science ®Google Scholar
• Wong PC, Crain EJ, Watson CA, Xin B. Favorable therapeutic index of the direct factor Xa inhibitors, apixaban and rivaroxaban, compared with the thrombin inhibitor dabigatran in rabbits. J Thromb Haemost. 2009;7(8):1313–1320.
   PubMed Web of Science ®Google Scholar
• Lopes RD, Alexander JH, Al-Khatib SM, et al; ARISTOTLE Investigators. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J. 2010;159(3):331–339.
   PubMed Web of Science ®Google Scholar
• Ruff CT, Giugliano RP, Antman EM, 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(4):635–641.
   PubMed Web of Science ®Google Scholar
• Ufer M. Comparative efficacy and safety of the novel oral anticoagulants dabigatran, rivaroxaban and apixaban in preclinical and clinical development. Thromb Haemost. 2010;103(3):572–585.
   Web of Science ®Google Scholar