Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines

John J You, Daniel E Singer, Patricia A Howard, Deirdre A Lane, Mark H Eckman, Margaret C Fang, Elaine M Hylek, Sam Schulman, Alan S Go, Michael Hughes, Frederick A Spencer, Warren J Manning, Jonathan L Halperin, Gregory Y H Lip, John J You, Daniel E Singer, Patricia A Howard, Deirdre A Lane, Mark H Eckman, Margaret C Fang, Elaine M Hylek, Sam Schulman, Alan S Go, Michael Hughes, Frederick A Spencer, Warren J Manning, Jonathan L Halperin, Gregory Y H Lip

Abstract

Background: The risk of stroke varies considerably across different groups of patients with atrial fibrillation (AF). Antithrombotic prophylaxis for stroke is associated with an increased risk of bleeding. We provide recommendations for antithrombotic treatment based on net clinical benefit for patients with AF at varying levels of stroke risk and in a number of common clinical scenarios.

Methods: We used the methods described in the Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines article of this supplement.

Results: For patients with nonrheumatic AF, including those with paroxysmal AF, who are (1) at low risk of stroke (eg, CHADS(2) [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack] score of 0), we suggest no therapy rather than antithrombotic therapy, and for patients choosing antithrombotic therapy, we suggest aspirin rather than oral anticoagulation or combination therapy with aspirin and clopidogrel; (2) at intermediate risk of stroke (eg, CHADS(2) score of 1), we recommend oral anticoagulation rather than no therapy, and we suggest oral anticoagulation rather than aspirin or combination therapy with aspirin and clopidogrel; and (3) at high risk of stroke (eg, CHADS(2) score of ≥ 2), we recommend oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel. Where we recommend or suggest in favor of oral anticoagulation, we suggest dabigatran 150 mg bid rather than adjusted-dose vitamin K antagonist therapy.

Conclusions: Oral anticoagulation is the optimal choice of antithrombotic therapy for patients with AF at high risk of stroke (CHADS(2) score of ≥ 2). At lower levels of stroke risk, antithrombotic treatment decisions will require a more individualized approach.

References

    1. Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042–1046.
    1. 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.
    1. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22(8):983–988.
    1. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials [published correction in Arch Intern Med. 1994;154(19):2254] Arch Intern Med. 1994;154(13):1449–1457.
    1. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e326S–e350S.
    1. Lansberg MG, O’Donnell MJ, Khatri P, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2)(suppl):e601S–e636S.
    1. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH. Antithrombotic and thrombolytic therapy for valvular disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e576S–e600S.
    1. Bates SM, Greer IA, Middeldorp S, Veenstra D, Prabulos A-M, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e691S–e736S.
    1. MacLean S, Mulla S, Akl EA, et al. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e1S–e23S.
    1. Guyatt GH, Norris SL, Schulman S, et al. Methodology for the development of antithrombotic therapy and prevention of thrombosis guidelines: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:53S–70S.
    1. Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068–2072.
    1. 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.
    1. Lévy S, Camm AJ, Saksena S, et al. Working Group on Arrhythmias, Working Group on Cardiac Pacing of the European Society of Cardiology, North American Society of Pacing and Electrophysiology International consensus on nomenclature and classification of atrial fibrillation; a collaborative project of the Working Group on Arrhythmias and the Working Group on Cardiac Pacing of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Europace. 2003;5(2):119–122.
    1. Petersen P. Thromboembolic complications in atrial fibrillation. Stroke. 1990;21(1):4–13.
    1. Brand FN, Abbott RD, Kannel WB, Wolf PA. Characteristics and prognosis of lone atrial fibrillation. 30-year follow-up in the Framingham Study. JAMA. 1985;254(24):3449–3453.
    1. Hart RG, Pearce LA, Rothbart RM, McAnulty JH, Asinger RW, Halperin JL. Stroke Prevention in Atrial Fibrillation Investigators Stroke with intermittent atrial fibrillation: incidence and predictors during aspirin therapy. J Am Coll Cardiol. 2000;35(1):183–187.
    1. Hohnloser SH, Pajitnev D, Pogue J, et al. ACTIVE W Investigators Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. 2007;50(22):2156–2161.
    1. Stroke Risk in Atrial Fibrillation Working Group Independent predictors of stroke in patients with atrial fibrillation: a systematic review. Neurology. 2007;69(6):546–554.
    1. Hughes M, Lip GY. Guideline Development Group, National Clinical Guideline for Management of Atrial Fibrillation in Primary and Secondary Care, National Institute for Health and Clinical Excellence Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost. 2008;99(2):295–304.
    1. van Walraven C, Hart RG, Connolly S, et al. Effect of age on stroke prevention therapy in patients with atrial fibrillation: the atrial fibrillation investigators. Stroke. 2009;40(4):1410–1416.
    1. Lin LY, Lee CH, Yu CC, et al. Risk factors and incidence of ischemic stroke in Taiwanese with nonvalvular atrial fibrillation—a nation wide database analysis. Atherosclerosis. 2011;217(1):292–295.
    1. Frost L, Engholm G, Johnsen S, Møller H, Husted S. Incident stroke after discharge from the hospital with a diagnosis of atrial fibrillation. Am J Med. 2000;108(1):36–40.
    1. The Stroke Prevention in Atrial Fibrillation Investigators Committee on Echocardiography Transesophageal echocardiographic correlates of thromboembolism in high-risk patients with nonvalvular atrial fibrillation. Ann Intern Med. 1998;128(8):639–647.
    1. Olesen JB, Lip GY, Hansen ML, et al. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011;342:d124.
    1. Stroke Prevention in Atrial Fibrillation Investigators Risk factors for thromboembolism during aspirin therapy in patients with atrial fibrillation: the Stroke Prevention in Atrial Fibrillation Study. J Stroke Cerebrovasc Dis. 1995;5(3):147–157.
    1. van Latum JC, Koudstaal PJ, Venables GS, van Gijn J, Kappelle LJ, Algra A. European Atrial Fibrillation Trial (EAFT) Study Group Predictors of major vascular events in patients with a transient ischemic attack or minor ischemic stroke and with nonrheumatic atrial fibrillation. Stroke. 1995;26(5):801–806.
    1. Echocardiographic predictors of stroke in patients with atrial fibrillation: a prospective study of 1066 patients from 3 clinical trials. Arch Intern Med. 1998;158(12):1316–1320.
    1. Hart RG, Pearce LA, McBride R, Rothbart RM, Asinger RW. The Stroke Prevention in Atrial Fibrillation (SPAF) Investigators Factors associated with ischemic stroke during aspirin therapy in atrial fibrillation: analysis of 2012 participants in the SPAF I-III clinical trials. Stroke. 1999;30(6):1223–1229.
    1. Fuster V, Rydén LE, Cannom DS, et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines European Society of Cardiology Committee for Practice Guidelines European Heart Rhythm Association Heart Rhythm Society ACC/AHA/ESC 2006 Guidelines 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 European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006;114(7):e257–e354.
    1. 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.
    1. Albers GW, Dalen JE, Laupacis A, Manning WJ, Petersen P, Singer DE. Antithrombotic therapy in atrial fibrillation. Chest. 2001;119(suppl 1):194S–206S.
    1. Wang TJ, Massaro JM, Levy D, et al. A risk score for predicting stroke or death in individuals with new-onset atrial fibrillation in the community: the Framingham Heart Study. JAMA. 2003;290(8):1049–1056.
    1. van Walraven C, Hart RG, Wells GA, et al. A clinical prediction rule to identify patients with atrial fibrillation and a low risk for stroke while taking aspirin. Arch Intern Med. 2003;163(8):936–943.
    1. Singer DE, Albers GW, Dalen JE, Go AS, Halperin JL, Manning WJ. Antithrombotic therapy in atrial fibrillation: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(suppl 3):429S–456S.
    1. Lip GY, Lane D, Van Walraven C, Hart RG. Additive role of plasma von Willebrand factor levels to clinical factors for risk stratification of patients with atrial fibrillation. Stroke. 2006;37(9):2294–2300.
    1. 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.
    1. Gage BF, van Walraven C, Pearce L, et al. Selecting patients with atrial fibrillation for anticoagulation: stroke risk stratification in patients taking aspirin. Circulation. 2004;110(16):2287–2292.
    1. Baruch L, Gage BF, Horrow J, et al. Can patients at elevated risk of stroke treated with anticoagulants be further risk stratified? Stroke. 2007;38(9):2459–2463.
    1. Fang MC, Go AS, Chang Y, Borowsky L, Pomernacki NK, Singer DE. ATRIA Study Group Comparison of risk stratification schemes to predict thromboembolism in people with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2008;51(8):810–815.
    1. Poli D, Lip GY, Antonucci E, Grifoni E, Lane D. Stroke risk stratification in a “real-world” elderly anticoagulated atrial fibrillation population. J Cardiovasc Electrophysiol. 2010;22(1):25–30.
    1. Ruiz Ortiz M, Romo E, Mesa D, et al. Oral anticoagulation in nonvalvular atrial fibrillation in clinical practice: impact of CHADS(2) score on outcome. Cardiology. 2010;115(3):200–204.
    1. Lip GY, Frison L, Halperin JL, Lane DA. Identifying patients at high risk for stroke despite anticoagulation: a comparison of contemporary stroke risk stratification schemes in an anticoagulated atrial fibrillation cohort. Stroke. 2010;41(12):2731–2738.
    1. Van Staa TP, Setakis E, Di Tanna GL, Lane DA, Lip GY. A comparison of risk stratification schemes for stroke in 79,884 atrial fibrillation patients in general practice. J Thromb Haemost. 2011;9(1):39–48.
    1. Go AS, Hylek EM, Chang Y, et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003;290(20):2685–2692.
    1. Fang MC, Singer DE, Chang Y, et al. Gender differences in the risk of ischemic stroke and peripheral embolism in atrial fibrillation: the AnTicoagulation and Risk factors In Atrial fibrillation (ATRIA) study. Circulation. 2005;112(12):1687–1691.
    1. Healey JS, Hart RG, Pogue J, et al. Risks and benefits of oral anticoagulation compared with clopidogrel plus aspirin in patients with atrial fibrillation according to stroke risk: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (ACTIVE-W) Stroke. 2008;39(5):1482–1486.
    1. Arima H, Hart RG, Colman S, et al. PROGRESS Collaborative Group Perindopril-based blood pressure-lowering reduces major vascular events in patients with atrial fibrillation and prior stroke or transient ischemic attack. Stroke. 2005;36(10):2164–2169.
    1. Lip GY, Frison L, Grind M. SPORTIF Investigators Effect of hypertension on anticoagulated patients with atrial fibrillation. Eur Heart J. 2007;28(6):752–759.
    1. Eckman MH, Singer DE, Rosand J, Greenberg SM. Moving the tipping point: the decision to anticoagulate patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2011;4(1):14–21.
    1. National Collaborating Centre for Chronic Conditions . Vol. 104. London, England: Royal College of Physicians; 2006. Atrial fibrillation: national clinical guideline for management in primary and secondary care. Available at: .
    1. Singer DE, Chang Y, Fang MC, et al. The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med. 2009;151(5):297–305.
    1. Hart RG, Pearce LA. Current status of stroke risk stratification in patients with atrial fibrillation. Stroke. 2009;40(7):2607–2610.
    1. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: The Euro Heart Survey. Chest. 2010;138(5):1093–1100.
    1. van der Meer FJ, Rosendaal FR, Vandenbroucke JP, Briët E. Bleeding complications in oral anticoagulant therapy. An analysis of risk factors. Arch Intern Med. 1993;153(13):1557–1562.
    1. Petersen P, Boysen G, Godtfredsen J, Andersen ED, Andersen B. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study. Lancet. 1989;1(8631):175–179.
    1. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med. 1990;323(22):1505–1511.
    1. Connolly SJ, Laupacis A, Gent M, Roberts RS, Cairns JA, Joyner C. Canadian Atrial Fibrillation Anticoagulation (CAFA) Study. J Am Coll Cardiol. 1991;18(2):349–355.
    1. Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. 1991;84(2):527–539.
    1. Ezekowitz MD, Bridgers SL, James KE, et al. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. N Engl J Med. 1992;327(20):1406–1412.
    1. EAFT (European Atrial Fibrillation Trial) Study Group Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet. 1993;342(8882):1255–1262.
    1. van Walraven C, Hart RG, Singer DE, et al. Oral anticoagulants vs aspirin in nonvalvular atrial fibrillation: an individual patient meta-analysis. JAMA. 2002;288(19):2441–2448.
    1. Benavente O, Hart R, Koudstaal P, Laupacis A, McBride R. Antiplatelet therapy for preventing stroke in patients with atrial fibrillation and no previous history of stroke or transient ischemic attacks. In: Warlow C, Van Gijn J, Sandercock P, editors. Oxford, England: The Cochrane Collaboration; 1999. Stroke Module of the Cochrane Database of Systematic Reviews.
    1. Posada IS, Barriales V. LASAF Pilot Study Group Alternate-day dosing of aspirin in atrial fibrillation. Am Heart J. 1999;138(1 pt 1):137–143.
    1. Sato H, Ishikawa K, Kitabatake A, et al. Japan Atrial Fibrillation Stroke Trial Group Low-dose aspirin for prevention of stroke in low-risk patients with atrial fibrillation: Japan Atrial Fibrillation Stroke Trial. Stroke. 2006;37(2):447–451.
    1. Diener HC, Lowenthal A. Antiplatelet therapy to prevent stroke: risk of brain hemorrhage and efficacy in atrial fibrillation. J Neurol Sci. 1997;153(1):112.
    1. Edvardsson N, Juul-Möller S, Omblus R, Pehrsson K. Effects of low-dose warfarin and aspirin versus no treatment on stroke in a medium-risk patient population with atrial fibrillation. J Intern Med. 2003;254(1):95–101.
    1. Baigent C, Blackwell L, Collins R, et al. Antithrombotic Trialists’ (ATT) Collaboration Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009;373(9678):1849–1860.
    1. Antithrombotic Trialists’ Collaboration Baigent C, Blackwell L, Collins R, et al. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324(7329):71–86.
    1. Vemmos KN, Tsivgoulis G, Spengos K, et al. Primary prevention of arterial thromboembolism in the oldest old with atrial fibrillation—a randomized pilot trial comparing adjusted-dose and fixed low-dose coumadin with aspirin. Eur J Intern Med. 2006;17(1):48–52.
    1. Gulløv AL, Koefoed BG, Petersen P, et al. Fixed minidose warfarin and aspirin alone and in combination vs adjusted-dose warfarin for stroke prevention in atrial fibrillation: Second Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation Study. Arch Intern Med. 1998;158(14):1513–1521.
    1. 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.
    1. Pérez-Gómez F, Alegría E, Berjón J, et al. NASPEAF Investigators Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study. J Am Coll Cardiol. 2004;44(8):1557–1566.
    1. Hellemons BS, Langenberg M, Lodder J, et al. Primary prevention of arterial thromboembolism in non-rheumatic atrial fibrillation in primary care: randomised controlled trial comparing two intensities of coumarin with aspirin. BMJ. 1999;319(7215):958–964.
    1. Morocutti C, Amabile G, Fattapposta F, et al. SIFA (Studio Italiano Fibrillazione Atriale) Investigators Indobufen versus warfarin in the secondary prevention of major vascular events in nonrheumatic atrial fibrillation. Stroke. 1997;28(5):1015–1021.
    1. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II Study. Lancet. 1994;343(8899):687–691.
    1. Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. Lancet. 1996;348(9028):633–638.
    1. Rash A, Downes T, Portner R, Yeo WW, Morgan N, Channer KS. A randomised controlled trial of warfarin versus aspirin for stroke prevention in octogenarians with atrial fibrillation (WASPO) Age Ageing. 2007;36(2):151–156.
    1. Anand SS, Yusuf S. Oral anticoagulants in patients with coronary artery disease. J Am Coll Cardiol. 2003;41(4) suppl S:62S–69S.
    1. Chimowitz MI, Lynn MJ, Howlett-Smith H, et al. Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005;352(13):1305–1316.
    1. Connolly S, Pogue J, Hart R, et al. ACTIVE Writing Group of the ACTIVE Investigators 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.
    1. Connolly SJ, Pogue J, Hart RG, et al. ACTIVE Investigators Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009;360(20):2066–2078.
    1. 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.
    1. Albers GW, Diener HC, Frison L, et al. SPORTIF Executive Steering Committee for the SPORTIF V Investigators Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. JAMA. 2005;293(6):690–698.
    1. 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.
    1. Patel MR, Mahaffey KW, Garg J, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883–891.
    1. 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.
    1. 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(11):981–992.
    1. Roskell NS, Lip GY, Noack H, Clemens A, Plumb JM. Treatments for stroke prevention in atrial fibrillation: a network meta-analysis and indirect comparisons versus dabigatran etexilate. Thromb Haemost. 2010;104(6):1106–1115.
    1. Label approved on 03/04/2011 for Pradaxa, NDA no. 022512. In: United States Food and Drug Administration;2010.
    1. 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.
    1. Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e152S–e184S.
    1. Bloomfield HE, Krause A, Greer N, et al. Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. Ann Intern Med. 2011;154(7):472–482.
    1. 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.
    1. Hughes M, Lip GY. Guideline Development Group for the NICE national clinical guideline for management of atrial fibrillation in primary and secondary care Risk factors for anticoagulation-related bleeding complications in patients with atrial fibrillation: a systematic review. QJM. 2007;100(10):599–607.
    1. Beyth RJ, Quinn LM, Landefeld CS. Prospective evaluation of an index for predicting the risk of major bleeding in outpatients treated with warfarin. Am J Med. 1998;105(2):91–99.
    1. Landefeld CS, Goldman L. Major bleeding in outpatients treated with warfarin: incidence and prediction by factors known at the start of outpatient therapy. Am J Med. 1989;87(2):144–152.
    1. Shireman TI, Mahnken JD, Howard PA, Kresowik TF, Hou Q, Ellerbeck EF. Development of a contemporary bleeding risk model for elderly warfarin recipients. Chest. 2006;130(5):1390–1396.
    1. Gage BF, Yan Y, Milligan PE, et al. Clinical classification schemes for predicting hemorrhage: results from the National Registry of Atrial Fibrillation (NRAF) Am Heart J. 2006;151(3):713–719.
    1. 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.
    1. Holmes DR, Reddy VY, Turi ZG, et al. PROTECT AF Investigators Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374(9689):534–542.
    1. Ostermayer SH, Reisman M, Kramer PH, et al. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials. J Am Coll Cardiol. 2005;46(1):9–14.
    1. Block PC, Burstein S, Casale PN, et al. Percutaneous left atrial appendage occlusion for patients in atrial fibrillation suboptimal for warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study. JACC Cardiovasc Interv. 2009;2(7):594–600.
    1. Lechat P, Lardoux H, Mallet A, et al. FFAACS (Fluindione, Fibrillation Auriculaire, Aspirin et Contraste Spontané) Investigators Anticoagulant (fluindione)-aspirin combination in patients with high-risk atrial fibrillation. A randomized trial (Fluindione, Fibrillation Auriculaire, Aspirin et Contraste Spontané; FFAACS) Cerebrovasc Dis. 2001;12(3):245–252.
    1. Flaker GC, Gruber M, Connolly SJ, et al. SPORTIF Investigators Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation: an exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials. Am Heart J. 2006;152(5):967–973.
    1. Clinical review for Pradaxa, NDA 22-512. In: United States Food and Drug Administration; 2010:96.
    1. Hansen ML, Sørensen R, Clausen MT, et al. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med. 2010;170(16):1433–1441.
    1. Dentali F, Douketis JD, Lim W, Crowther M. Combined aspirin-oral anticoagulant therapy compared with oral anticoagulant therapy alone among patients at risk for cardiovascular disease: a meta-analysis of randomized trials. Arch Intern Med. 2007;167(2):117–124.
    1. Vandvik PO, Lincoff AM, Gore JM, et al. Primary and secondary prevention of cardiovascular disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e637S–e668S.
    1. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005;293(17):2126–2130.
    1. Serruys PW, Strauss BH, Beatt KJ, et al. Angiographic follow-up after placement of a self-expanding coronary-artery stent. N Engl J Med. 1991;324(1):13–17.
    1. Roubin GS, Cannon AD, Agrawal SK, et al. Intracoronary stenting for acute and threatened closure complicating percutaneous transluminal coronary angioplasty. Circulation. 1992;85(3):916–927.
    1. Foley JB, Brown RI, Penn IM. Thrombosis and restenosis after stenting in failed angioplasty: comparison with elective stenting. Am Heart J. 1994;128(1):12–20.
    1. Cook S, Windecker S. Early stent thrombosis: past, present, and future. Circulation. 2009;119(5):657–659.
    1. Cosmi B, Rubboli A, Castelvetri C, Milandri M. Ticlopidine versus oral anticoagulation for coronary stenting. Cochrane Database Syst Rev. 2001;(4):CD002133.
    1. Lip GY, Huber K, Andreotti F, et al. European Society of Cardiology Working Group on Thrombosis Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary intervention/ stenting published correction in Thromb Haemost. 2010;104(3):653. Dosage error in article text] Thromb Haemost. 2010;103(1):13–28.
    1. Faxon DP, Eikelboom JW, Berger PB, Holmes DR, Bhatt DL, Moliterno DJ, Becker RC, Angiolillo DJ. Consensus document: antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting: a North-American perspective. Thromb Haemost. 2011;106(4):572–584.
    1. Rossini R, Musumeci G, Lettieri C, et al. Long-term outcomes in patients undergoing coronary stenting on dual oral antiplatelet treatment requiring oral anticoagulant therapy. Am J Cardiol. 2008;102(12):1618–1623.
    1. Sarafoff N, Ndrepepa G, Mehilli J, et al. Aspirin and clopidogrel with or without phenprocoumon after drug eluting coronary stent placement in patients on chronic oral anticoagulation. J Intern Med. 2008;264(5):472–480.
    1. Sambola A, Ferreira-González I, Angel J, et al. Therapeutic strategies after coronary stenting in chronically anticoagulated patients: the MUSICA study. Heart. 2009;95(18):1483–1488.
    1. Gao F, Zhou YJ, Wang ZJ, et al. Comparison of different antithrombotic regimens for patients with atrial fibrillation undergoing drug-eluting stent implantation. Circ J. 2010;74(4):701–708.
    1. Rothberg MB, Celestin C, Fiore LD, Lawler E, Cook JR. Warfarin plus aspirin after myocardial infarction or the acute coronary syndrome: meta-analysis with estimates of risk and benefit. Ann Intern Med. 2005;143(4):241–250.
    1. Wallentin L, Becker RC, Budaj A, et al. PLATO Investigators Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045–1057.
    1. Holmes DR, Jr, Kereiakes DJ, Garg S, et al. Stent thrombosis. J Am Coll Cardiol. 2010;56(17):1357–1365.
    1. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001;345:494–502.
    1. Sherman DG, Kim SG, Boop BS, et al. National Heart, Lung, and Blood Institute AFFIRM Investigators Occurrence and characteristics of stroke events in the Atrial Fibrillation Follow-up Investigation of Sinus Rhythm Management (AFFIRM) study. Arch Intern Med. 2005;165(10):1185–1191.
    1. Krittayaphong R, Raungrattanaamporn O, Bhuripanyo K, et al. A randomized clinical trial of the efficacy of radiofrequency catheter ablation and amiodarone in the treatment of symptomatic atrial fibrillation. J Med Assoc Thai. 2003;86(suppl 1):S8–S16.
    1. Wazni OM, Marrouche NF, Martin DO, et al. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005;293(21):2634–2640.
    1. Oral H, Pappone C, Chugh A, et al. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med. 2006;354(9):934–941.
    1. Pappone C, Augello G, Sala S, et al. A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. J Am Coll Cardiol. 2006;48(11):2340–2347.
    1. Stabile G, Bertaglia E, Senatore G, et al. Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For The Cure Of Atrial Fibrillation Study) Eur Heart J. 2006;27(2):216–221.
    1. Jaïs P, Cauchemez B, Macle L, et al. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008;118(24):2498–2505.
    1. Wilber DJ, Pappone C, Neuzil P, et al. ThermoCool AF Trial Investigators Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010;303(4):333–340.
    1. Omran H, Jung W, Rabahieh R, et al. Left atrial appendage function in patients with atrial flutter. Heart. 1997;78(3):250–254.
    1. Seidl K, Hauer B, Schwick NG, Zellner D, Zahn R, Senges J. Risk of thromboembolic events in patients with atrial flutter. Am J Cardiol. 1998;82(5):580–583.
    1. Corrado G, Sgalambro A, Mantero A, et al. Thromboembolic risk in atrial flutter. The FLASIEC (FLutter Atriale Società Italiana di Ecografia Cardiovascolare) multicentre study. Eur Heart J. 2001;22(12):1042–1051.
    1. Schmidt H, von der Recke G, Illien S, et al. Prevalence of left atrial chamber and appendage thrombi in patients with atrial flutter and its clinical significance. J Am Coll Cardiol. 2001;38(3):778–784.
    1. Weiss R, Marcovitz P, Knight BP, et al. Acute changes in spontaneous echo contrast and atrial function after cardioversion of persistent atrial flutter. Am J Cardiol. 1998;82(9):1052–1055.
    1. Bikkina M, Alpert MA, Mulekar M, Shakoor A, Massey CV, Covin FA. Prevalence of intraatrial thrombus in patients with atrial flutter. Am J Cardiol. 1995;76(3):186–189.
    1. Moreyra E, Finkelhor RS, Cebul RD. Limitations of transesophageal echocardiography in the risk assessment of patients before nonanticoagulated cardioversion from atrial fibrillation and flutter: an analysis of pooled trials. Am Heart J. 1995;129(1):71–75.
    1. Gallagher MM, Hennessy BJ, Edvardsson N, et al. Embolic complications of direct current cardioversion of atrial arrhythmias: association with low intensity of anticoagulation at the time of cardioversion. J Am Coll Cardiol. 2002;40(5):926–933.
    1. Berger M, Schweitzer P. Timing of thromboembolic events after electrical cardioversion of atrial fibrillation or flutter: a retrospective analysis. Am J Cardiol. 1998;82:1545–1547. A8.
    1. Manning WJ, Leeman DE, Gotch PJ, Come PC. Pulsed Doppler evaluation of atrial mechanical function after electrical cardioversion of atrial fibrillation. J Am Coll Cardiol. 1989;13(3):617–623.
    1. Nagarakanti R, Ezekowitz MD, Oldgren J, et al. Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation. 2011;123(2):131–136.
    1. Manning WJ, Silverman DI, Gordon SP, Krumholz HM, Douglas PS. Cardioversion from atrial fibrillation without prolonged anticoagulation with use of transesophageal echocardiography to exclude the presence of atrial thrombi. N Engl J Med. 1993;328(11):750–755.
    1. Klein AL, Grimm RA, Murray RD, et al. Assessment of Cardioversion Using Transesophageal Echocardiography Investigators Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med. 2001;344(19):1411–1420.
    1. Hoppensteadt D, Fareed J, Klein AL, et al. Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II Investigators Comparison of anticoagulant and anti-inflammatory responses using enoxaparin versus unfractionated heparin for transesophageal echocardiography-guided cardioversion of atrial fibrillation. Am J Cardiol. 2008;102(7):842–846.
    1. Klein AL, Jasper SE, Katz WE, et al. ACUTE II Steering and Publications Committee for the ACUTE II Investigators The use of enoxaparin compared with unfractionated heparin for short-term antithrombotic therapy in atrial fibrillation patients undergoing transoesophageal echocardiography-guided cardioversion: Assessment of Cardioversion Using Transoesophageal Echocardiography (ACUTE) II randomized multicentre study. Eur Heart J. 2006;27(23):2858–2865.
    1. de Luca I, Sorino M, De Luca L, Colonna P, Del Salvatore B, Corlianò L. Pre- and post-cardioversion transesophageal echocardiography for brief anticoagulation therapy with enoxaparin in atrial fibrillation patients: a prospective study with a 1-year follow-up. Int J Cardiol. 2005;102(3):447–454.
    1. Wu LA, Chandrasekaran K, Friedman PA, et al. Safety of expedited anticoagulation in patients undergoing transesophageal echocardiographic-guided cardioversion. Am J Med. 2006;119(2):142–146.
    1. Stellbrink C, Nixdorff U, Hofmann T, et al. ACE (Anticoagulation in Cardioversion using Enoxaparin) Study Group Safety and efficacy of enoxaparin compared with unfractionated heparin and oral anticoagulants for prevention of thromboembolic complications in cardioversion of nonvalvular atrial fibrillation: the Anticoagulation in Cardioversion using Enoxaparin (ACE) trial. Circulation. 2004;109(8):997–1003.
    1. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–295.
    1. Antonielli E, Pizzuti A, Pálinkás A, et al. Clinical value of left atrial appendage flow for prediction of long-term sinus rhythm maintenance in patients with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2002;39(9):1443–1449.
    1. Berry C, Stewart S, Payne EM, McArthur JD, McMurray JJ. Electrical cardioversion for atrial fibrillation: outcomes in “real-life” clinical practice. Int J Cardiol. 2001;81(1):29–35.
    1. Arnar DO, Danielsen R. Factors predicting maintenance of sinus rhythm after direct current cardioversion of atrial fibrillation and flutter: a reanalysis with recently acquired data. Cardiology. 1996;87(3):181–188.
    1. Paraskevaidis IA, Dodouras T, Tsiapras D, Kremastinos DT. Prediction of successful cardioversion and maintenance of sinus rhythm in patients with lone atrial fibrillation. Chest. 2005;127(2):488–494.
    1. Pérez Y, Duval AM, Carville C, et al. Is left atrial appendage flow a predictor for outcome of cardioversion of nonvalvular atrial fibrillation? A transthoracic and transesophageal echocardiographic study. Am Heart J. 1997;134(4):745–751.
    1. Page RL, Wilkinson WE, Clair WK, McCarthy EA, Pritchett EL. Asymptomatic arrhythmias in patients with symptomatic paroxysmal atrial fibrillation and paroxysmal supraventricular tachycardia. Circulation. 1994;89(1):224–227.
    1. Stoddard MF, Dawkins PR, Prince CR, Ammash NM. Left atrial appendage thrombus is not uncommon in patients with acute atrial fibrillation and a recent embolic event: a transesophageal echocardiographic study. J Am Coll Cardiol. 1995;25(2):452–459.
    1. Kleemann T, Becker T, Strauss M, Schneider S, Seidl K. Prevalence of left atrial thrombus and dense spontaneous echo contrast in patients with short-term atrial fibrillation < 48 hours undergoing cardioversion: value of transesophageal echocardiography to guide cardioversion. J Am Soc Echocardiogr. 2009;22(12):1403–1408.
    1. Flaker GC, Belew K, Beckman K, et al. AFFIRM Investigators Asymptomatic atrial fibrillation: demographic features and prognostic information from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Am Heart J. 2005;149(4):657–663.
    1. Weigner MJ, Caulfield TA, Danias PG, Silverman DI, Manning WJ. Risk for clinical thromboembolism associated with conversion to sinus rhythm in patients with atrial fibrillation lasting less than 48 hours. Ann Intern Med. 1997;126(8):615–620.
    1. Arnold AZ, Mick MJ, Mazurek RP, Loop FD, Trohman RG. Role of prophylactic anticoagulation for direct current cardioversion in patients with atrial fibrillation or atrial flutter. J Am Coll Cardiol. 1992;19(4):851–855.
    1. Chalasani P, Cambre S, Silverman ME. Direct-current cardioversion for the conversion of atrial flutter. Am J Cardiol. 1996;77(8):658–660.
    1. Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med. 1999;131(7):492–501.
    1. Fang MC, Chang Y, Hylek EM, et al. Advanced age, anticoagulation intensity, and risk for intracranial hemorrhage among patients taking warfarin for atrial fibrillation. Ann Intern Med. 2004;141(10):745–752.
    1. Hylek EM, Go AS, Chang Y, et al. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003;349(11):1019–1026.
    1. Hylek EM, Skates SJ, Sheehan MA, Singer DE. An analysis of the lowest effective intensity of prophylactic anticoagulation for patients with nonrheumatic atrial fibrillation. N Engl J Med. 1996;335(8):540–546.
    1. Walker AM, Bennett D. Epidemiology and outcomes in patients with atrial fibrillation in the United States. Heart Rhythm. 2008;5(10):1365–1372.
    1. Singer DE, Chang Y, Fang MC, et al. Should patient characteristics influence target anticoagulation intensity for stroke prevention in nonvalvular atrial fibrillation?: the ATRIA study. Circ Cardiovasc Qual Outcomes. 2009;2(4):297–304.
    1. Rose AJ, Ozonoff A, Henault LE, Hylek EM. Warfarin for atrial fibrillation in community-based practise. J Thromb Haemost. 2008;6(10):1647–1654.
    1. Ageno W, Gallus AS, Wittkowsky A, Crowther M, Hylek EM, Palareti G. Oral anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141(2) suppl:e44S–e88S.
    1. Jones M, McEwan P, Morgan CL, Peters JR, Goodfellow J, Currie CJ. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart. 2005;91(4):472–477.
    1. White HD, Gruber M, Feyzi J, et al. Comparison of outcomes among patients randomized to warfarin therapy according to anticoagulant control: results from SPORTIF III and V. Arch Intern Med. 2007;167(3):239–245.
    1. Connolly SJ, Pogue J, Eikelboom J, et al. ACTIVE W Investigators Benefit of oral anticoagulant over antiplatelet therapy in atrial fibrillation depends on the quality of international normalized ratio control achieved by centers and countries as measured by time in therapeutic range. Circulation. 2008;118(20):2029–2037.
    1. Wan Y, Heneghan C, Perera R, et al. Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes. 2008;1(2):84–91.

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