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Semin Thromb Hemost 2015; 41(02): 146-153
DOI: 10.1055/s-0035-1544156
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Comparative Efficacy and Safety of the Non–Vitamin K Antagonist Oral Anticoagulants for Patients with Nonvalvular Atrial Fibrillation

Keitaro Senoo
1   Centre for Cardiovascular Sciences, City Hospital, University of Birmingham, Birmingham, United Kingdom
,
Gregory Y. H. Lip
1   Centre for Cardiovascular Sciences, City Hospital, University of Birmingham, Birmingham, United Kingdom
2   Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
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Publikationsdatum:
15. Februar 2015 (online)

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Abstract

The non–vitamin K antagonist oral anticoagulants (NOACs), such as the thrombin inhibitor (dabigatran) and the direct factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban), have been shown to be at least as efficacious and safe as conventional oral anticoagulants, such as the vitamin K antagonists (VKAs) (e.g., warfarin), for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Each NOAC has various advantages and specific features, and therefore decisions regarding appropriate stroke prevention require individual assessment of stroke and bleeding risk on anticoagulation with VKA therapy and NOACs when starting on any of these drugs. This review briefly describes the results of the four NOACs clinical randomized trials and discusses how they might impact clinical practice and choice of anticoagulants in atrial fibrillation patients. Moreover, this review discusses the differences of the proposed management of antithrombotic therapy in several international guidelines and pragmatic issues of NOACs for stroke prophylaxis.

Keywords

non-VKA oral anticoagulants - vitamin K antagonist - atrial fibrillation - stroke prevention - clinical trial
 

  • References

  • 1 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 2001; 285 (18) 2370-2375
    CrossrefPubMedGoogle Scholar
  • 2 Ansell J, Hirsh J, Poller L, Bussey H, Jacobson A, Hylek E. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2005; 127 (1) 415-416
    CrossrefPubMedGoogle Scholar
  • 3 You JJ, Singer DE, Howard PA , et al; American College of Chest Physicians. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2, Suppl): e531S-e575S
    CrossrefPubMedGoogle Scholar
  • 4 De Caterina R, Husted S, Wallentin L , et al. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis—Task Force on Anticoagulants in Heart Disease. Thromb Haemost 2013; 110 (6) 1087-1107
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 5 Le Heuzey JY, Ammentorp B, Darius H , et al. Differences among western European countries in anticoagulation management of atrial fibrillation. Data from the PREFER IN AF registry. Thromb Haemost 2014; 111 (5) 833-841
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 6 Lip GY, Laroche C, Dan GA , et al. ‘Real-world’ antithrombotic treatment in atrial fibrillation: The EORP-AF pilot survey. Am J Med 2014; 127 (6) 519-29.e1
    CrossrefPubMedGoogle Scholar
  • 7 De Caterina R, Husted S, Wallentin L , et al; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. General mechanisms of coagulation and targets of anticoagulants (Section I). Position Paper of the ESC Working Group on Thrombosis—Task Force on Anticoagulants in Heart Disease. Thromb Haemost 2013; 109 (4) 569-579
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 8 Husted S, de Caterina R, Andreotti F , et al; ESC Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Non-vitamin K antagonist oral anticoagulants (NOACs): No longer new or novel. Thromb Haemost 2014; 111 (5) 781-782
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 9 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
    CrossrefPubMedGoogle Scholar
  • 10 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
    CrossrefPubMedGoogle Scholar
  • 11 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
    CrossrefPubMedGoogle Scholar
  • 12 Giugliano RP, Ruff CT, Braunwald E , et al; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013; 369 (22) 2093-2104
    CrossrefPubMedGoogle Scholar
  • 13 Skjøth F, Larsen TB, Rasmussen LH, Lip GY. Efficacy and safety of edoxaban in comparison with dabigatran, rivaroxaban and apixaban for stroke prevention in atrial fibrillation. An indirect comparison analysis. Thromb Haemost 2014; 111 (5) 981-988
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 14 Verdecchia P, Angeli F, Lip GY, Reboldi G. Edoxaban in the evolving scenario of non vitamin K antagonist oral anticoagulants imputed placebo analysis and multiple treatment comparisons. PLoS One 2014; 9 (6) e100478
    CrossrefPubMedGoogle Scholar
  • 15 Skjøth F, Larsen TB, Rasmussen LH. Indirect comparison studies—are they useful? Insights from the novel oral anticoagulants for stroke prevention in atrial fibrillation. Thromb Haemost 2012; 108 (3) 405-406
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 16 Harenberg J, Marx S, Wehling M. Head-to-head or indirect comparisons of the novel oral anticoagulants in atrial fibrillation: what's next?. Thromb Haemost 2012; 108 (3) 407-409
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 17 Camm AJ, Lip GY, De Caterina R , et al; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012; 33 (21) 2719-2747
    CrossrefPubMedGoogle Scholar
  • 18 Ogawa S, Aonuma K, Tse HF , et al. The APHRS's 2013 statement on antithrombotic therapy of patients with nonvalvular atrial fibrillation. J Arrhythmia 2013; 29 (3) 190-200
    CrossrefPubMedGoogle Scholar
  • 19 January CT, Wann LS, Alpert JS , et al. AHA/ACC/HRS Guideline 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 Heart Rhythm Society. J Am Coll Cardiol 2014; 64 (21) 2246-2280
    CrossrefPubMedGoogle Scholar
  • 20 National Institute for Health and Clinical Excellence(NICE). NICE CG(180), Atrial Fibrillation(Update): The management of atrial fibrillation 2014. http://guidanceniceorguk/CG180 . Accessed August 18, 2014
    PubMedGoogle Scholar
  • 21 Skanes AC, Healey JS, Cairns JA , et al; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can J Cardiol 2012; 28 (2) 125-136
    CrossrefPubMedGoogle Scholar
  • 22 JCS Joint Working Group. Guidelines for pharmacotherapy of atrial fibrillation (JCS 2013). http://www.j-circ.or.jp/guideline/pdf/JCS2013_inoue_h.pdf . Accessed August 18, 2014
    PubMedGoogle Scholar
  • 23 Olesen JB, Fauchier L, Lane DA, Taillandier S, Lip GY. Risk factors for stroke and thromboembolism in relation to age among patients with atrial fibrillation: the Loire Valley Atrial Fibrillation Project. Chest 2012; 141 (1) 147-153
    CrossrefPubMedGoogle Scholar
  • 24 Banerjee A, Lane DA, Torp-Pedersen C, Lip GY. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study. Thromb Haemost 2012; 107 (3) 584-589
    PubMedGoogle Scholar
  • 25 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
    CrossrefPubMedGoogle Scholar
  • 26 Olesen JB, Lip GY, Kamper AL , et al. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med 2012; 367 (7) 625-635
    CrossrefPubMedGoogle Scholar
  • 27 Kubitza D, Becka M, Mueck W , et al. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct factor Xa inhibitor. Br J Clin Pharmacol 2010; 70 (5) 703-712
    CrossrefPubMedGoogle Scholar
  • 28 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 2012; 33 (22) 2821-2830
    CrossrefPubMedGoogle Scholar
  • 29 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 2011; 32 (19) 2387-2394
    CrossrefPubMedGoogle Scholar
  • 30 DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care 2002; 40 (9) 794-811
    CrossrefPubMedGoogle Scholar
  • 31 Zolfaghari S, Harenberg J, Froelich L, Wehling M, Weiss C. Development of a tool to identify patients' preference for vitamin K antagonist or direct oral anticoagulant therapy. Semin Thromb Hemost 2014; 40 (1) 121-128
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 32 Lane DA, Lip GY. Patient's values and preferences for stroke prevention in atrial fibrillation: balancing stroke and bleeding risk with oral anticoagulation. Thromb Haemost 2014; 111 (3) 381-383
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 33 Lahaye S, Regpala S, Lacombe S , et al. Evaluation of patients' attitudes towards stroke prevention and bleeding risk in atrial fibrillation. Thromb Haemost 2014; 111 (3) 465-473
    PubMedGoogle Scholar
  • 34 Apostolakis S, Sullivan RM, Olshansky B, Lip GY. Factors affecting quality of anticoagulation control among patients with atrial fibrillation on warfarin: the SAMe-TT2R2 score. Chest 2013; 144 (5) 1555-1563
    CrossrefPubMedGoogle Scholar
  • 35 Lip GY, Haguenoer K, Saint-Etienne C, Fauchier L. Relationship of the SAMe-TT2R2 score to poor-quality anticoagulation, stroke, clinically relevant bleeding, and mortality in patients with atrial fibrillation. Chest 2014; 146 (3) 719-726
    CrossrefPubMedGoogle Scholar
  • 36 Poli D, Antonucci E, Testa S, Lip GY. A prospective validation of the SAME-TT2R 2 score: how to identify atrial fibrillation patients who will have good anticoagulation control on warfarin. Intern Emerg Med 2014; 9 (4) 443-447
    CrossrefPubMedGoogle Scholar