Advanced search
Publication Cover
Expert Review of Cardiovascular Therapy Volume 11, 2013 - Issue 9
Submit an article Journal homepage
221
Views
6
CrossRef citations to date
0
Altmetric
Clinical Trial Report

A review of apixaban for stroke prevention in atrial fibrillation: insights from ARISTOTLE

Connie N HessCorrespondence[email protected]
,
Sana M Al-Khatib Duke Clinical Research Institute, Durham, NC, USA
,
Christopher B Granger Duke Clinical Research Institute, Durham, NC, USA
&
Renato Lopes Duke Clinical Research Institute, Durham, NC, USA
Pages 1105-1114 | Published online: 10 Jan 2014

References

  • Go AS, Hylek EM, Phillips KA et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 285, 2370–2375 (2001).
  • Lip GY, Brechin CM, Lane DA. The global burden of atrial fibrillation and stroke: a systematic review of the epidemiology of atrial fibrillation in regions outside North America and Europe. Chest 142, 1489–1498 (2012).
  • 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 114, 119–125 (2006).
  • Alonso A, Agarwal SK, Soliman EZ et al. Incidence of atrial fibrillation in whites and African-Americans: the Atherosclerosis Risk in Communities (ARIC) study. Am. Heart J. 158, 111–117 (2009).
  • DeWilde S, Carey IM, Emmas C et al. Trends in the prevalence of diagnosed atrial fibrillation, its treatment with anticoagulation and predictors of such treatment in UK primary care. Heart 92, 1064–1070 (2006).
  • Fuster V, Ryden LE, Cannom DS et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: 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). J. Am. Coll. Cardiol. 48, 854–906 (2006).
  • Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 22, 983–988 (1991).
  • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann. Intern. Med. 146, 857–867 (2007).
  • 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 367, 1903–1912 (2006).
  • Saxena R, Koudstaal P. Anticoagulants versus antiplatelet therapy for preventing stroke in patients with nonrheumatic atrial fibrillation and a history of stroke or transient ischemic attack. Cochrane Database of Systematic Reviews (2004).
  • Ansell J, Hirsh J, Hylek E et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 133, 160S–198S (2008).
  • Hankey GJ, Eikelboom JW. Dabigatran etexilate: a new oral thrombin inhibitor. Circulation 123, 1436–1450 (2011).
  • Fang MC, Stafford RS, Ruskin JN et al. National trends in antiarrhythmic and antithrombotic medication use in atrial fibrillation. Arch. Intern. Med. 164, 55–60 (2004).
  • Sellers MB, Newby LK. Atrial fibrillation, anticoagulation, fall risk, and outcomes in elderly patients. Am. Heart J. 161, 241–246 (2011).
  • Hylek EM, Evans-Molina C, Shea C et al. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation 115, 2689–2696 (2007).
  • Alberts MJ, Eikelboom JW, Hankey GJ. Antithrombotic therapy for stroke prevention in non-valvular atrial fibrillation. Lancet Neurol. 11, 1066–1081 (2012).
  • Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 361, 1139–1151 (2009).
  • Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N. Engl. J. Med. 365, 883–891 (2011).
  • Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 365, 981–992 (2011).
  • Gage BF, Waterman AD, Shannon W et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 285, 2864–2870 (2001).
  • Lip GY, Nieuwlaat R, Pisters R et al. 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 137, 263–267 (2010).
  • Pisters R, Lane DA, Nieuwlaat R et al. 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 138, 1093–1100 (2010).
  • Lopes RD, Al-Khatib SM, Wallentin L et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet 380, 1749–1758 (2012).
  • Oldgren J, Alings M, Darius H et al. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann. Intern. Med. 155, 660–667 (2011).
  • Independent predictors of stroke in patients with atrial fibrillation: a systematic review. Neurol. 69, 546–554 (2007).
  • Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch. Intern. Med. 154, 1449–1457 (1994).
  • 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. 11, 503–511 (2012).
  • Hankey GJ, Patel MR, Stevens SR et al. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 11, 315–322 (2012).
  • Kamel H, Easton JD, Johnston SC et al. Cost-effectiveness of apixaban vs warfarin for secondary stroke prevention in atrial fibrillation. Neurology 79, 1428–1434 (2012).
  • Kamel H, Johnston SC, Easton JD et al. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fibrillation and prior stroke or transient ischemic attack. Stroke 43, 881–883 (2012).
  • Coresh J, Selvin E, Stevens LA et al. Prevalence of chronic kidney disease in the United States. JAMA 298, 2038–2047 (2007).
  • Alonso A, Lopez FL, Matsushita K et al. Chronic kidney disease is associated with the incidence of atrial fibrillation: the Atherosclerosis Risk in Communities (ARIC) study. Circulation 123, 2946–2953 (2011).
  • Soliman EZ, Prineas RJ, Go AS et al. Chronic kidney disease and prevalent atrial fibrillation: the Chronic Renal Insufficiency Cohort (CRIC). Am. Heart J. 159, 1102–1107 (2010).
  • Marinigh R, Lane DA, Lip GY. Severe renal impairment and stroke prevention in atrial fibrillation: implications for thromboprophylaxis and bleeding risk. J. Am. Coll. Cardiol. 57, 1339–1348 (2011).
  • Hohnloser SH, Hijazi Z, Thomas L et al. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur. Heart J. 33, 2821–2830 (2012).
  • Fox KA, Piccini JP, Wojdyla D et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur. Heart J. 32, 2387–2394 (2011).
  • 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 342, d124 (2011).
  • Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur. Heart J. 33, 1500–1510 (2012).
  • McMurray JJ, Ezekowitz JA, Lewis BS et al. Left ventricular systolic dysfunction, heart failure, and the risk of stroke and systemic embolism in patients with atrial fibrillation: insights from the ARISTOTLE trial. Circulation accepted for publication (2013).
  • Jones M, McEwan P, Morgan CL et al. 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 91, 472–477 (2005).
  • 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. 349, 1019–1026 (2003).
  • Oake N, Jennings A, Forster AJ et al. Anticoagulation intensity and outcomes among patients prescribed oral anticoagulant therapy: a systematic review and meta-analysis. CMAJ 179, 235–244 (2008).
  • Connolly SJ, Pogue J, Eikelboom J et al. 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 118, 2029–2037 (2008).
  • 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. 167, 239–245 (2007).
  • Wallentin L, Lopes, RD, Hanna M et al. Efficacy and safety of apixaban compared with warfarin at different levels of predicted INR control for stroke prevention in atrial fibrillation. Circulation 127, 2166–2176 (2013).
  • Wallentin L, Yusuf S, Ezekowitz MD et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 376, 975–983 (2010).
  • Lip GY, Frison L, Grind M et al. Stroke event rates in anticoagulated patients with paroxysmal atrial fibrillation. J. Intern. Med. 264, 50–61 (2008).
  • Nieuwlaat R, Dinh T, Olsson SB et al. Should we abandon the common practice of withholding oral anticoagulation in paroxysmal atrial fibrillation? Eur. Heart J. 29, 915–922 (2008).
  • 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 developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J. Am. Coll. Cardiol. 57, e101–e198 (2011).
  • Al-Khatib SM, Thomas L, Wallentin L et al. Outcomes of Apixaban versus Warfarin by Type and Duration of Atrial Fibrillation: Results from the ARISTOTLE Trial. Eur. Heart J.; accepted for publication (2013).
  • Flaker G, Ezekowitz M, Yusuf S et al. Efficacy and safety of dabigatran compared to warfarin in patients with paroxysmal, persistent, and permanent atrial fibrillation: results from the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) study. J. Am. Coll. Cardiol. 59, 854–855 (2012).
  • de Lemos JA, Morrow DA, Bentley JH et al. The prognostic value of B-type natriuretic peptide in patients with acute coronary syndromes. N. Engl. J. Med. 345, 1014–1021 (2001).
  • Arakawa N, Nakamura M, Aoki H et al. Plasma brain natriuretic peptide concentrations predict survival after acute myocardial infarction. J. Am. Coll. Cardiol. 27, 1656–1661 (1996).
  • Fonarow GC, Peacock WF, Phillips CO et al. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J. Am. Coll. Cardiol. 49, 1943–1950 (2007).
  • Wang TJ, Larson MG, Levy D et al. Plasma natriuretic peptide levels and the risk of cardiovascular events and death. N. Engl. J. Med. 350, 655–663 (2004).
  • Hijazi Z, Wallentin L, Siegbahn A et al. NT-proBNP for Risk Assessment in Patients with Atrial Fibrillation:Insights from the ARISTOTLE trial. J. Am. Coll. Cardiol. accepted for publication (2013).
  • Hijazi Z, Oldgren J, Andersson U et al. Cardiac biomarkers are associated with an increased risk of stroke and death in patients with atrial fibrillation: a Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) substudy. Circulation 125, 1605–1616 (2012).
  • Rasmussen LH, Larsen TB, Graungaard T et al. Primary and secondary prevention with new oral anticoagulant drugs for stroke prevention in atrial fibrillation: indirect comparison analysis. BMJ 345, e7097 (2012).
  • Baker WL, Phung OJ. Systematic review and adjusted indirect comparison meta-analysis of oral anticoagulants in atrial fibrillation. Circ. Cardiovasc. Qual. Outcomes 5, 711–719 (2012).
  • Schneeweiss S, Gagne JJ, Patrick AR et al. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ. Cardiovasc. Qual. Outcomes 5, 480–486 (2012).
  • 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. Throm. Haem. 103, 1116–1127 (2010).
  • Eerenberg ES, Kamphuisen PW, Sijpkens MK et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 124, 1573–1579 (2011).
  • Van de Werf F, Brueckmann M, Connolly SJ et al. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: THE Randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN). Amer. Heart J. 163, 931–937 (2012).
  • Schulman S, Crowther MA. Blood 119, 3016–3023 (2012).
  • Eliquis® (apixaban) [prescribing information]. Bristol-Myers Squibb Company, Princeton, NJ, (2012).
  • Connolly SJ, Ezekowitz MD, Yusuf S et al. Newly identified events in the RE-LY trial. N. Engl. J. Med. 363, 1785–1786 (2010).

Website

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.