A drug safety evaluation of apixaban for the treatment of atrial fibrillation, acute coronary syndrome, and percutaneous coronary intervention

References

• Lip GYH, Freedman B, De Caterina R, et al. Stroke prevention in atrial fibrillation: past, present and future. Thromb Haemost. 2017;117:1230–1239.
   PubMed Web of Science ®Google Scholar
• De Caterina R, Ageno W, Agnelli G, et al. The non-vitamin K antagonist oral anticoagulants in heart disease: section V-special situations. Thromb Haemost. 2019;119:014–038.
   PubMed Web of Science ®Google Scholar
• Krijthe BP, Kunst A, Benjamin EJ, et al. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013;34:2746–2751.
   PubMed Web of Science ®Google Scholar
• Zoni-Berisso M, Lercari F, Carazza T, et al. Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 2014;6:213–220.
   PubMed Web of Science ®Google Scholar
• Andersson T, Magnuson A, Bryngelsson I-L, et al. All-cause mortality in 272 186 patients hospitalized with incident atrial fibrillation 1995–2008: a Swedish nationwide long-term case–control study. Eur Heart J. 2013;34:1061–1067.
   PubMed Web of Science ®Google Scholar
• Thrall G, Lane D, Carroll D, et al. Quality of life in patients with atrial fibrillation: a systematic review. Am J Med. 2006;119:448.e1–448.e19.
   PubMed Web of Science ®Google Scholar
• Charitakis E, Barmano N, Walfridsson U, et al. Factors predicting arrhythmia-related symptoms and health-related quality of life in patients referred for radiofrequency ablation of atrial fibrillation. JACC Clin Electrophysiol. 2017;3:494–502.
   PubMedGoogle Scholar
• Thrall G, Lip GYH, Carroll D, et al. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007;132:1259–1264.
   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;146:857–867.
   PubMed Web of Science ®Google Scholar
• Lip GYH, Banerjee A, Boriani G, et al. Antithrombotic therapy for atrial fibrillation CHEST guideline and expert panel report. Chest. 2018. DOI:10.1016/j.chest.2018.07.040.
   Web of Science ®Google Scholar
• Olesen JB, Sørensen R, Hansen ML, et al. Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naive atrial fibrillation patients: Danish nationwide descriptive data 2011–2013. Europace. 2015;17:187–193.
   PubMed Web of Science ®Google Scholar
• Mazurek M, Huisman MV, Rothman KJ, et al. Regional differences in antithrombotic treatment for atrial fibrillation: insights from the GLORIA-AF phase II registry. Thromb Haemost. 2017;117:2376–2388.
   PubMed Web of Science ®Google Scholar
• FDA. HIGHLIGHTS OF PRESCRIBING INFORMATION.
   Google Scholar
• Raghavan N, Frost CE, Yu Z, et al. Apixaban metabolism and pharmacokinetics after oral administration to humans. Drug Metab Dispos. 2009;37:74–81.
   PubMed Web of Science ®Google Scholar
• Frost C, Wang J, Nepal S, et al. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013;75:476–487.
   PubMed Web of Science ®Google Scholar
• FDA. HIGHLIGHTS OF PRESCRIBING ANDEXXA.
   Google Scholar
• Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med. 2013;19:446–451.
   PubMed Web of Science ®Google Scholar
• Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. Subcommittee on control of anticoagulation of the Scientific and Standardization Committee of the International Society of Thrombosisan. J Thromb Haemost. 2005;3:692–694.
   PubMed Web of Science ®Google Scholar
• Granger CB, Finkelstein A. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:683–693.
   PubMed Web of Science ®Google Scholar
• Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364:806–817.
   PubMed Web of Science ®Google Scholar
• Bahit MC, Lopes RD, Wojdyla DM, et al. Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation. Heart. 2017;103:623–628.
   PubMed Web of Science ®Google Scholar
• Bahit MC, Lopes RD, Wojdyla DM, et al. Apixaban in patients with atrial fibrillation and prior coronary artery disease: insights from the ARISTOTLE trial. Int J Cardiol. 2013;170:215–220.
   PubMed Web of Science ®Google Scholar
• Easton JD, Lopes RD, Bahit MC, et al. Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of the ARISTOTLE trial. Lancet Neurol. 2012;11:503–511.
   PubMed Web of Science ®Google Scholar
• Flaker G, Lopes RD, Al-Khatib SM, et al. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: insights from the ARISTOTLE trial (Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation). J Am Coll Cardiol. 2014;63:1082–1087.
   PubMed Web of Science ®Google Scholar
• Hohnloser SH, Camm J, Cappato R, et al. Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial. Eur Heart J. 2019;40:3013–3021.
   Web of Science ®Google Scholar
• Kirchhof P, Haeusler KG, Blank B, et al. Apixaban in patients at risk of stroke undergoing atrial fibrillation ablation. Eur Heart J. 2018;39:2942–2955.
   PubMed Web of Science ®Google Scholar
• Eikelboom JW, O’Donnell M, Yusuf S, et al. Rationale and design of AVERROES: apixaban versus acetylsalicylic acid to prevent stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment. Am Heart J. 2010;159:348–53.e1.
   PubMed Web of Science ®Google Scholar
• Li X, Deitelzweig S, Keshishian A, et al. Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in “real-world” clinical practice: a propensity-matched analysis of 76,940 patients. Thromb Haemost. 2017;117:1072–1082.
   PubMed Web of Science ®Google Scholar
• Caldeira D, Rodrigues FB, Barra M, et al. Non-Vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis. Heart. 2015;101:1204–1211.
   PubMed Web of Science ®Google Scholar
• Al-Khalili F, Lindström C, Benson L. The safety and persistence of non-vitamin-K-antagonist oral anticoagulants in atrial fibrillation patients treated in a well structured atrial fibrillation clinic. Curr Med Res Opin. 2016;32:779–785.
   PubMed Web of Science ®Google Scholar
• Hohnloser SH, Basic E, Nabauer M. Changes in oral anticoagulation therapy over one year in 51,000 atrial fibrillation patients at risk for stroke: a practice-derived study. Thromb Haemost. 2019;119:882–893.
   PubMed Web of Science ®Google Scholar
• Hohnloser SH, Fudim M, Alexander JH, et al. Efficacy and safety of apixaban versus warfarin in patients with atrial fibrillation and extremes in body weight. Circulation. 2019;139:2292–2300.
   PubMed Web of Science ®Google Scholar
• Hohnloser S, Basic E, Hohmann C, et al. Effectiveness and safety of non–vitamin K oral anticoagulants in comparison to phenprocoumon: data from 61,000 patients with atrial fibrillation. Thromb Haemost. 2018;118:526–538.
   PubMed Web of Science ®Google Scholar
• Lip GYH, Keshishian A, Li X, et al. Effectiveness and safety of oral anticoagulants among nonvalvular atrial fibrillation patients: the ARISTOPHANES study. Stroke. 2018;49:2933–2944.
   PubMed Web of Science ®Google Scholar
• Larsen TB, Skjøth F, Nielsen PB, et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.
   PubMed Web of Science ®Google Scholar
• Lip GYH, Keshishian A, Kamble S, et al. Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin: a propensity score matched analysis. Thromb Haemost. 2016;116:975–986.
   PubMed Web of Science ®Google Scholar
• Wang TY, Robinson LA, Ou F-S, et al. Discharge antithrombotic strategies among patients with acute coronary syndrome previously on warfarin anticoagulation: physician practice in the CRUSADE registry. Am Heart J. 2008;155:361–368.
   PubMed Web of Science ®Google Scholar
• Steensig K, Olesen KKW, Thim T, et al. Should the presence or extent of coronary artery disease be quantified in the CHA2DS2-VASc score in atrial fibrillation? A report from the western denmark heart registry. Thromb Haemost. 2018;118:2162–2170.
   PubMed Web of Science ®Google Scholar
• Fox KAA, Anderson FA, Goodman SG, et al. Time course of events in acute coronary syndromes: implications for clinical practice from the GRACE registry. Nat Clin Pract Cardiovasc Med. 2008;5:580–589.
   PubMedGoogle Scholar
• Alexander JH, Lopes RD, James S, et al. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011;365:699–708.
   PubMed Web of Science ®Google Scholar
• Sherwood MW, Lopes RD, Sun JL, et al. Apixaban following acute coronary syndromes in patients with prior stroke: insights from the APPRAISE-2 trial. Am Heart J. 2018;197:1–8.
   PubMed Web of Science ®Google Scholar
• Chesebro JH, Knatterud G, Roberts R, et al. Thrombolysis in myocardial infarction (TIMI) trial, phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987;76:142–154.
   PubMed Web of Science ®Google Scholar
• Lopes RD, Vora AN, Liaw D, et al. An open-Label, 2 × 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: rationale and design of the AUGUSTUS trial. Am Heart J. 2018;200:17–23.
   PubMed Web of Science ®Google Scholar
• Lopes RD, Heizer G, Aronson R, et al. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med. 2019;380:1509–1524.
   PubMed Web of Science ®Google Scholar
• Lopes RD, Hong H, Harskamp RE, et al. Safety and efficacy of antithrombotic strategies in patients with atrial fibrillation undergoing percutaneous coronary intervention: a network meta-analysis of randomized controlled trials. JAMA Cardiol. 2019;4:747.
   Web of Science ®Google Scholar
• ACTIVE Writing Group of the ACTIVE Investigators, Connolly S, Pogue J, 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;367:1903–1912.
   PubMed Web of Science ®Google Scholar
• Steinberg BA, Simon DN, Thomas L, et al. Management of major bleeding in patients with atrial fibrillation treated with non–vitamin K antagonist oral anticoagulants compared with warfarin in clinical practice (from phase II of the outcomes registry for better informed treatment of atrial fibrill. Am J Cardiol. 2017;119:1590–1595.
   PubMed Web of Science ®Google Scholar
• McBane R, Weber C. Apixaban and dalteparin in active malignancy associated venous thromboembolism: the ADAM VTE trial. Thromb Haemost. 2017;117:1–10.
   PubMed Web of Science ®Google Scholar
• Agnelli G, Becattini C, Bauersachs R, et al. Apixaban versus dalteparin for the treatment of acute venous thromboembolism in patients with cancer: the caravaggio study. Thromb Haemost. 2018;118:1668–1678.
   PubMed Web of Science ®Google Scholar
• Brekelmans MPA, Scheres LJJ, Bleker SM, et al. Abnormal vaginal bleeding in women with venous thromboembolism treated with apixaban or warfarin. Thromb Haemost. 2017;117:809–815.
   PubMed Web of Science ®Google Scholar
• O’Brien SH, Li D, Mitchell LG, et al. PREVAPIX-ALL: apixaban compared to standard of care for prevention of venous thrombosis in paediatric acute lymphoblastic leukaemia (ALL)–rationale and design. Thromb Haemost. 2019;119:844–853.
   PubMed Web of Science ®Google Scholar