Balancing bleeding and thrombotic risk with new oral anticoagulants in patients with atrial fibrillation

Expert Review of Cardiovascular Therapy

Volumn 11, Issue 12, 2013, Pages 1619-1629

  Overvad, Thure F ^a,b   Larsen, Torben B ^b,c   Albertsen, Ida E ^a,b   Rasmussen, Lars H ^b,c   Lip, Gregory Y H ^a,c  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b AALBORG UNIVERSITY HOSPITAL   (Denmark)

^c AALBORG UNIVERSITY   (Denmark)

Author keywords

Anticoagulation; Atrial fibrillation; Bleeding; Stroke

Indexed keywords

ACETYLSALICYLIC ACID; APIXABAN; DABIGATRAN ETEXILATE; EDOXABAN; PROTHROMBIN COMPLEX; RIVAROXABAN; WARFARIN; XIMELAGATRAN;

AGE DISTRIBUTION; AORTA ATHEROSCLEROSIS; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CONGESTIVE HEART FAILURE; DIABETES MELLITUS; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; HYPERTENSION; INTENTION TO TREAT ANALYSIS; INTERNATIONAL NORMALIZED RATIO; LIVER TOXICITY; LUNG EMBOLISM; MEDICATION COMPLIANCE; META ANALYSIS (TOPIC); MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SCORING SYSTEM; SEX DIFFERENCE; SYSTEMATIC REVIEW (TOPIC); THROMBOEMBOLISM; THROMBOSIS;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; DRUG APPROVAL; FEMALE; HEMORRHAGE; HUMANS; MALE; RISK ASSESSMENT; RISK FACTORS; STROKE; THROMBOEMBOLISM; WARFARIN;

EID: 84888070688     PISSN: 14779072     EISSN: 17448344     Source Type: Journal    
DOI: 10.1586/14779072.2013.839214     Document Type: Review

References (71)

1. Majeed A, Moser K, Carroll K. Trends in the prevalence and management of atrial fibrillation in general practice in England and Wales, 1994-1998: analysis of data from the general practice research database. Heart 86(3), 284-288 (2001).
2. 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(2), 119-125 (2006).
3. Stefansdottir H, Aspelund T, Gudnason V, Arnar DO. Trends in the incidence and prevalence of atrial fibrillation in Iceland and future projections. Europace 13(8), 1110-7 (2011).
4. Benjamin EJ, Wolf PA, Agostino RBD, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 98(10), 946-952 (1998).
5. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 22, 983-988 (1991).
6. Jorgensen HS, Nakayama H, Reith J, Raaschou HO, Olsen TS. Acute stroke with atrial fibrillation: the Copenhagen Stroke Study. Stroke 27(10), 1765-1769 (1996).
7. Lin HJ, Wolf PA, Kelly-Hayes M et al. Stroke severity in atrial fibrillation: the Framingham Study. Stroke 27(10), 1760-1764 (1996).
8. Hart RG, Pearce LA, Aguilar MI. Metaanalysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann. Intern. Med. 146, 857-867 (2007).
9. Van Staa TP, Setakis E, Di Tanna GL, Lane DA, Lip GYH. A comparison of risk stratification schemes for stroke in 79,884 atrial fibrillation patients in general practice. J. Thromb. Haemost. 9, 39-48 (2011).
10. Hart R, Pearce L, Halperin J et al. Comparison of 12 risk stratification schemes to predict stroke in patients with nonvalvular atrial fibrillation. Stroke 39(6), 1901-1910 (2008).
11. Go AS, Hylek EM, Borowsky LH, Phillips KA, Selby J V, Singer DE. Warfarin use among ambulatory patients with nonvalvular atrial fibrillation: the anticoagulation and risk factors in atrial fibrillation (ATRIA) study. Ann. Intern. Med. 131(12), 927-934 (1999).
12. Gladstone DJ, Bui E, Fang J et al. Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated. Stroke 40(1), 235-240 (2009).
13. Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GYH. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am. J. Med. 123(7), 638-645 (2010).
14. Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 361, 1139-1151 (2009).
15. Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N. Engl. J. Med. 365, 883-891 (2011).
16. Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 365, 981-992 (2011).
17. Ezekowitz MD, Connolly S, Parekh A et al. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am. Heart. J. 157(5), 805-810.e2 (2009).
18. Becker R, Berkowitz SD, Breithardt G et al. 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. 159(3), 340-347.e1 (2010).
19. Lopes RD, Alexander JH, Al-Khatib SM et al. Apixaban for reduction in stroke and other Thromboembo Lic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am. Heart. J. 159(3), 331-339 (2010).
20. Connolly SJ, Eikelboom J, Joyner C et al. Apixaban in patients with atrial fibrillation. N. Engl. J. Med. 364, 806-817 (2011).
21. The SPORTIF Investigators. Stroke prevention in atrial fibrillation: pooled analysis of SPORTIF III and V trials. Am. J. Manag. Care. 10(14 Suppl.), s462-s473 (2004).
22. 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. 160(4), 635-641.e2 (2010).
23. Fang MC, Go AS, Chang Y et al. Warfarin discontinuation after starting warfarin for atrial fibrillation. Circ. Cardiovasc. Qual. Outcomes. 3(6), 624-631 (2010).
24. Raunsø J, Selmer C, Olesen JB et al. Increased short-term risk of thrombo-embolism or death after interruption of warfarin treatment in patients with atrial fibrillation. Eur. Heart. J. 33(15), 1886-1892 (2012).
25. Patel M, Hellkamp A, Lokhngina Y et al. Outcomes of discontinuing rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: analysis from the ROCKET AF trial (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Systemic Embolism Trial in Atrial Fibrillation). J. Am. Coll. Cardiol. 61(6), 651-658 (2013).
26. O'Neill WM, Welner SA, Lip GYH. Do open label blinded outcome studies of novel anticoagulants versus warfarin have equivalent validity to those carried out under double-blind conditions? Thromb. Haemost. 109(3), 497-503 (2013).
27. Hohnloser SH, Oldgren J, Yang S et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation 125, 669-676 (2012).
28. Larsen TB, Rasmussen LH, Skjøth F et al. Efficacy and safety of dabigatran etexilate and warfarin in "real world" patients with atrial fibrillation: a prospective nationwide cohort study. J. Am. Coll. Cardiol. 61(22), 2264-2273 (2013).
29. Lip GYH, Lane DA. Does warfarin for stroke thromboprophylaxis protect against MI in atrial fibrillation patients? Am. J. Med. 123(9), 785-789 (2010).
30. Hurlen M, Abdelnoor M, Smith P, Erikssen J, Arnesen H. Warfarin, aspirin, or both after myocardial infarction. N. Engl. J. Med. 347(13), 969-974 (2002).
31. Kaatz S, Kouides PA, Garcia DA et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am. J. Hematol. 87(1 Suppl.), s141-s145 (2012).
32. Eerenberg ES, Kamphuisen PW, Sijpkens MK, Meijers JC, Buller HR, Levi M. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation 124(14), 1573-1579 (2011).
33. Pengo V, Crippa L, Falanga A et al. Questions and answers on the use of dabigatran and perspectives on the use of other new oral anticoagulants in patients with atrial fibrillation. A consensus document of the Italian Federation of Thrombosis Centers (FCSA). Thromb. Haemost. 106(5), 868-876 (2011).
34. Deitelzweig S, Amin A, Jing Y et al. Medical cost reductions associated with the usage of novel oral anticoagulants vs warfarin among atrial fibrillation patients, based on the RE-LY, ROCKET-AF, and ARISTOTLE trials. J. Med. Econ. 15(4), 776-785 (2012).
35. Atrial Fibrillation Investigators. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Arch. Intern. Med. 154, 1449-1457 (1994).
36. 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 285, 2864-2870 (2001).
37. 2 clinical prediction rule to predict ischaemic stroke. A systematic review and meta-analysis. Thromb. Haemost. 106(3), 528-538 (2011).
38. 2 score for stroke risk stratification in atrial fibrillation-friend or foe? Thromb. Haemost. 104(1), 45-48 (2010).
39. 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 40(4), 1410-1416 (2009).
40. Friberg L, Benson L, Rosenqvist M, Lip GYH. Assessment of female sex as a risk factor in atrial fibrillation in Sweden: nationwide retrospective cohort study. BMJ 344, e3522 (2012).
41. Tsadok MA, Jackevicius CA, Rahme E, Humphries KH, Behlouli H, Pilote L. Sex differences in stroke risk among older patients with recently diagnosed atrial fibrillation. JAMA 307, 1952-1958 (2012).
42. Lane DA, Lip GYH. Female gender is a risk factor for stroke and thromboembolism in atrial fibrillation patients. Thromb. Haemost. 101, 802-805 (2009).
43. Olesen JB, Lip GYH, Lane DA et al. Vascular disease and stroke risk in atrial fibrillation: a nationwide cohort study. Am. J. Med. 125(8), e12-23 (2012).
44. Rasmussen LH, Larsen TB, Due KM, Tjønneland A, Overvad K, Lip GYH. Impact of vascular disease in predicting stroke and death in patients with atrial fibrillation: the Danish Diet, Cancer and Health cohort study. Thromb. Haemost. 9(7), 1301-1307 (2011).
45. Lip GYH, Nieuwlaat R, Pisters R, Lane DA, Crijns HJGM. 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, 263-272 (2010).
46. Olesen JB, Lip GYH, 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).
47. Camm AJ, Lip GYH, De Caterina R et al. 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. Eur. Heart. J. 33, 2719-2747 (2012).
48. 2 score 0-1: a nationwide cohort study. Thromb. Haemost. 107(6), 1172-1179 (2012).
49. Potpara TS, Polovina MM, Licina MM, Marinkovic JM, Prostran MS, Lip GYH. Reliable identification of "truly low" thromboembolic risk in patients initially diagnosed with "lone" atrial fibrillation: the Belgrade atrial fibrillation study. Circ. Arrhythm. Electrophysiol. 5(2), 319-326 (2012).
50. Eckman MH, Singer DE, Rosand J, Greenberg SM. Moving the tipping point: the decision to anticoagulate patients with atrial fibrillation. Circ. Cardiovasc. Qual. Outcomes. 4(1), 14-21 (2011).
51. Lip GYH. Can we predict stroke in atrial fibrillation? Clin. Cardiol. 35(Suppl. 1), 21-27 (2012).
52. Fang MC, Go AS, Chang Y, Borowsky L, Pomernacki NK, Singer DE. Comparison of risk stratification schemes to predict thromboembolism in people with nonvalvular atrial fibrillation. J. Am. Coll. Cardiol. 51(8), 810-815 (2008).
53. Camm JA, Kirchhof P, Lip GYH 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. 31(19), 2369-2429 (2010).
54. Lip GYH. The role of aspirin for stroke prevention in atrial fibrillation. Nat. Rev. Cardiol. 8(10), 602-606 (2011).
55. Fang MC, Go AS, Chang Y et al. A new risk scheme to predict warfarin-associated hemorrhage: the ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) Study. J. Am. Coll. Cardiol. 58(4), 395-401 (2011).
56. Pisters R, Lane DA, Nieuwlaat R, De Vos CB, Crijns HJGM, Lip GYH. 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(5), 1093-1100 (2010).
57. Friberg L, Rosenqvist M, Lip GYH. 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(12), 1500-1510 (2012).
58. Lip GYH, Banerjee A, Lagrenada I, Lane DA, Taillandier S, Fauchier L. Assessing the risk of bleeding in patients with atrial fibrillation: the Loire Valley Atrial Fibrillation Project. Circ. Arrhythm. Electrophysiol. 5(5), 941-948 (2012).
59. Apostolakis S, Lane DA, Guo Y, Buller H, Lip GYH. Performance of the HEMORR2HAGES, ATRIA, and HAS-BLED bleeding risk-prediction scores in patients with atrial fibrillation undergoing anticoagulation. J. Am. Coll. Cardiol. 60(9), 861-867 (2012).
60. Roldán V, Marín F, Fernández H et al. Predictive value of the HAS-BLED and ATRIA bleeding scores for the risk of serious bleeding in a "real world" anticoagulated atrial fibrillation cohort. Chest 143(1), 179-184 (2012).
61. Skanes AC, Healey JS, Cairns JA et al. Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Can. J. Cardiol. 28(2), 125-136 (2012).
62. Mcgrath ER, Kapral MK, Fang J, Eikelboom JW, Canavan M, O'Donnell MJ. Which factors are more associated with ischemic stroke than intracerebral hemorrhage in patients with atrial fibrillation? Stroke 43(8), 2048-2054 (2012).
63. Olesen JB, Lip GYH, Lindhardsen J et al. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a "real world" nationwide cohort study. Thromb. Haemost. 106(4), 739-749 (2011).
64. Banerjee A, Lane DA, Torp-Pedersen C, Lip GYH. 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. 107(3), 584-589 (2012).
65. 2 (Sex female, Age less than 60, Medical history, Treatment strategy [rhythm control], Tobacco use [doubled], Race [doubled] score. Chest doi:10.1378/chest. 13-0054 (2013). (Epub ahead of print)
66. Lip GYH, Larsen TB, Skjøth F, Rasmussen LH. Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J. Am. Coll. Cardiol. 60(8), 738-746 (2012).
67. Rasmussen LH, Larsen TB, Graungaard T, Skjøth F, Lip GYH. Primary and secondary prevention with new oral anticoagulant drugs for stroke prevention in atrial fibrillation: indirect comparison analysis. BMJ 345, e7097 (2012).
68. 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. 108(3), 407-409 (2012).
69. Mantha S, Ansell J. An indirect comparison of dabigatran, rivaroxaban and apixaban for atrial fibrillation. Thromb. Haemost. 108(3), 476-484 (2012).
70. Schneeweiss S, Gagne JJ, Patrick AR, Choudhry NK, Avorn J. Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation. Circ. Cardiovasc. Qual. Outcomes. 5(4), 480-6 (2012).
71. Kansal AR, Sharma M, Bradley-Kennedy C et al. Dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in atrial fibrillation in Canada. Comparative efficacy and cost-effectiveness. Thromb. Haemost. 108(4), 672-682 (2012).