Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: A systematic review

Annals of Internal Medicine

Volumn 157, Issue 11, 2012, Pages 796-807

  Adam, Soheir S ^a   McDuffie, Jennifer R ^b   Ortel, Thomas L ^a   Williams, John W ^b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DURHAM VA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

APIXABAN; DABIGATRAN; FRESH FROZEN PLASMA; RIVAROXABAN; WARFARIN;

ANTICOAGULANT THERAPY; BLEEDING; BRAIN HEMORRHAGE; CEREBROVASCULAR ACCIDENT; DRUG EFFICACY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; EPISTAXIS; GASTROINTESTINAL HEMORRHAGE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HEMOPERICARDIUM; HUMAN; KIDNEY FAILURE; MORTALITY; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; SYSTEMATIC REVIEW; VENOUS THROMBOEMBOLISM;

EID: 84870517411     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-157-10-201211200-00532     Document Type: Review

References (69)

1. Wysowski DK, Nourjah P, Swartz L. Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action. Arch Intern Med. 2007;167:1414-1419. [PMID: 17620536]
2. Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994;154:1449-1457. [PMID: 8018000]
3. Stein PD, Alpert JS, Bussey HI, Dalen JE, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest. 2001;119:220S-227S. [PMID: 11157651]
4. Cannegieter SC, Rosendaal FR, Briët E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation. 1994; 89:635-641. [PMID: 8313552]
5. Gohlke-Bärwolf C, Acar J, Oakley C, Butchart E, Burckhart D, Bodnar E, et al. Guidelines for prevention of thromboembolic events in valvular heart disease. Study Group of the Working Group on Valvular Heart Disease of the European Society of Cardiology. Eur Heart J. 1995;16:1320-1330. [PMID: 8746900]
6. Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, et al; American College of Chest Physicians. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e4190S-e4194S. [PMID: 22315268]
7. Thrombosis prevention trial: randomised trial of low-intensity oral anticoagu-lation with warfarin and low-dose aspirin in the primary prevention of ischaemic heart disease in men at increased risk. The Medical Research Council's General Practice Research Framework. Lancet. 1998;351:233-241. [PMID: 9457092]
8. Baker RI, Coughlin PB, Gallus AS, Harper PL, Salem HH, Wood EM; Warfarin Reversal Consensus Group. Warfarin reversal: consensus guidelines, on behalf of the Australasian Society of Thrombosis and Haemostasis. Med J Aust. 2004;181:492-497. [PMID: 15516194]
9. Pautas E, Peyron I, Bouhadiba S, Golmard JL, Gouronnec A, Oboa N, et al. Reversal of overanticoagulation in very elderly hospitalized patients with an INR above 5.0: 24-hour INR response after vitamin K administration. Am J Med. 2011;124:527-533. [PMID: 21605730]
10. Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G; American College of Chest Physicians. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:160S-198S. [PMID: 18574265]
11. Denas G, Marzot F, Offelli P, Stendardo A, Cucchini U, Russo R, et al. Effectiveness and safety of a management protocol to correct over-anticoagulation with oral vitamin K: a retrospective study of 1,043 cases. J Thromb Thrombol-ysis. 2009;27:340-347. [PMID: 18338109]
12. 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;91:472-477. [PMID: 15772203]
13. Wrigley BJ, Lip GY, Shantsila E. Novel oral anticoagulants: the potential relegation of vitamin K antagonists in clinical practice [Editorial]. Int J Clin Pract. 2010;64:835-838. [PMID: 20584215]
14. Fareed J, Thethi I, Hoppensteadt D. Old versus new oral anticoagulants: focus on pharmacology. Annu Rev Pharmacol Toxicol. 2012;52:79-99. [PMID: 21819239]
15. Avorn J. The relative cost-effectiveness of anticoagulants: obvious, except for the cost and the effectiveness [Editorial]. Circulation. 2011;123:2519-2521. [PMID: 21606400]
16. Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, et al; EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287-1297. [PMID: 22449293]
17. Wilczynski NL, McKibbon KA, Haynes RB. Response to Glanville et al.: How to identify randomized controlled trials in MEDLINE: ten years on [Letter]. J Med Libr Assoc. 2007;95:117-118; author reply 119-120. [PMID: 17443240]
18. Lane DA, Lip GY. Dabigatran in atrial fibrillation: balancing secondary stroke prevention against bleeding risk [Letter]. Lancet Neurol. 2010;9:1140-1142. [PMID: 21059485]
19. Eikelboom JW, Weitz JI. New anticoagulants. Circulation. 2010;121:1523-1532. [PMID: 20368532]
20. Betriu A. Clinical implications of the results of recent atherothrombotic trials on patient management. Eur Heart J Suppl. 2008;10:I30-I32.
21. Cooper NJ, Sutton AJ, Lu G, Khunti K. Mixed comparison of stroke prevention treatments in individuals with nonrheumatic atrial fibrillation. Arch Intern Med. 2006;166:1269-1275. [PMID: 16801509]
22. Akl EA, Barba M, Rohilla S, Terrenato I, Sperati F, Muti P, et al. Antico-agulation for the long term treatment of venous thromboembolism in patients with cancer. Cochrane Database Syst Rev. 2008:CD006650. [PMID: 18425959]
23. Lloyd NS, Douketis JD, Moinuddin I, Lim W, Crowther MA. Anticoagulant prophylaxis to prevent asymptomatic deep vein thrombosis in hospitalized medical patients: a systematic review and meta-analysis. J Thromb Haemost. 2008;6:405-414. [PMID: 18031292]
24. Carrier M, Le Gal G, Wells PS, Rodger MA. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med. 2010;152:578-589. [PMID: 20439576]
25. Lip GY, Lane DA. Does warfarin for stroke thromboprophylaxis protect against MI in atrial fibrillation patients? Am J Med. 2010;123:785-789. [PMID: 20655037]
26. Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med. 2012;172:397-402. [PMID: 22231617]
27. Agency for Healthcare Research and Quality. Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Rockville, MD: Agency for Healthcare Research and Quality; 2012. Accessed at www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=318on12January2011.
28. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177-188. [PMID: 3802833]
29. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539-1558. [PMID: 12111919]
30. MacLean S, Mulla S, Akl EA, Jankowski M, Vandvik PO, Ebrahim S, et al; American College of Chest Physicians. 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:e1S-e23S. [PMID: 22315262]
31. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence-imprecision. J Clin Epidemiol. 2011;64:1283-1293. [PMID: 21839614]
32. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151. [PMID: 19717844]
33. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992. [PMID: 21870978]
34. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891. [PMID: 21830957]
35. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, et al; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361:2342-2352. [PMID: 19966341]
36. Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al; EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499-2510. [PMID: 21128814]
37. Diener HC, Connolly SJ, Ezekowitz MD, Wallentin L, Reilly PA, Yang S, et al; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LYtrial. Lancet Neurol. 2010;9:1157-1163. [PMID: 21059484]
38. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, et al; RE-LY investigators. 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-LYtrial. Lancet. 2010;376: 975-983. [PMID: 20801496]
39. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011;123:2363-2372. [PMID: 21576658]
40. Hohnloser SH, Oldgren J, Yang S, Wallentin L, Ezekowitz M, Reilly P, 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. 2012;125:669-676. [PMID: 22215856]
41. Oldgren J, Alings M, Darius H, Diener HC, Eikelboom J, Ezekowitz MD, et al; RE-LY Investigators. 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. 2011;155:660-667, W204. [PMID: 22084332]
42. Casado Naranjo I, Portilla-Cuenca JC, Jimenez Caballero PE, Calle Escobar ML, Romero Sevilla RM. Fatal intracerebral hemorrhage associated with administration of recombinant tissue plasminogen activator in a stroke patient on treatment with dabigatran. Cerebrovasc Dis. 2011;32:614-615. [PMID: 22133608]
43. Legrand M, Mateo J, Aribaud A, Ginisty S, Eftekhari P, Huy PT, et al. The use of dabigatran in elderly patients. Arch Intern Med. 2011;171:1285-1286. [PMID: 21788545]
44. Moore CH, Snashall J, Boniface K, Scott J. Spontaneous splenic hemorrhage after initiation of dabigatran (Pradaxa) for atrial fibrillation. Am J Emerg Med. 2011. [PMID: 22196949]
45. Barton CA, McMillian WD, Raza SS, Keller RE. Hemopericardium in a patient treated with dabigatran etexilate. Pharmacotherapy. 2012;32:e103-e107. [PMID: 22488474]
46. Fellows SE, Rosini JM, Curtis JA, Volz EG. Hemorrhagic gastritis with dabigatran in a patient with renal insufficiency. J Emerg Med. 2012. [PMID: 22595629]
47. Kernan L, Ito S, Shirazi F, Boesen K. Case report: Fatal gastrointestinal hemorrhage after a single dose of dabigatran. Clin Toxicol (Phila). 2012. [PMID: 22800505]
48. De Smedt A, De Raedt S, Nieboer K, De Keyser J, Brouns R. Intravenous thrombolysis with recombinant tissue plasminogen activator in a stroke patient treated with dabigatran. Cerebrovasc Dis. 2010;30:533-534. [PMID: 20881383]
49. Matute MC, Guillán M, Garćia-Caldentey J, Buisan J, Aparicio M, Mas-juan J, et al. Thrombolysis treatment for acute ischaemic stroke in a patient on treatment with dabigatran [Letter]. Thromb Haemost. 2011;106:178-179. [PMID: 21505718]
50. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151. [PMID: 19717844]
51. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY trial [Letter]. N Engl J Med. 2010;363:1875-1876. [PMID: 21047252]
52. Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, et al. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study). Am J Cardiol. 2007;100:1419-1426. [PMID: 17950801]
53. Oldgren J, Budaj A, Granger CB, Khder Y, Roberts J, Siegbahn A, et al; RE-DEEM Investigators. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J. 2011;32:2781-2789. [PMID: 21551462]
54. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al; RE-MODEL Study Group. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5: 2178-2185. [PMID: 17764540]
55. Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, et al; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949-956. [PMID: 17869635]
56. Eriksson BI, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, et al; RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost. 2011;105: 721-729. [PMID: 21225098]
57. Moore TJ, Cohen MR, Furberg CD. Anticoagulants the Leading Reported Drug Risk in 2011. Alexandria, VA: Institute for Safe Medication Practices; 2012.
58. Moore TJ, Cohen MR, Furberg CD. Signals for Two Newly Approved Drugs and 2010 Annual Summary. Alexandria, VA: Institute for Safe Medication Practices; 2011.
59. Moore TJ, Cohen MR, Furberg CD. Signals for Dabigatran and Metoclo-pramide. Alexandria, VA: Institute for Safe Medication Practices; 2012.
60. Center for Drug Evaluation and Research. Summary Review: Application Number 022406Orig1s000. Silver Spring, MD: U.S. Food and Drug Administration; 2011. Accessed at www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022406Orig1s000SumR.pdf on 11 May 2012.
61. Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixa-ban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012;110: 453-460. [PMID: 22537354]
62. Bovio JA, Smith SM, Gums JG. Dabigatran etexilate: a novel oral thrombin inhibitor for thromboembolic disease. Ann Pharmacother. 2011;45:603-614. [PMID: 21540406]
63. Tzeis S, Andrikopoulos G. Novel anticoagulants for atrial fibrillation: a critical appraisal. Angiology. 2012;63:164-170. [PMID: 22007032]
64. Wann LS, Curtis AB, Ellenbogen KA, Estes NA 3rd, Ezekowitz MD, Jackman WM, et al; American College of Cardiology Foundation/American Heart Association Task Force. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011;123:1144-1150. [PMID: 21321155]
65. Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Parekh A, Pogue J, et al. Efficacy and safety of dabigatran compared to warfarin at different levels of INR control for stroke prevention in 18,113 patients with atrial fibrillation in the RE-LY trial. Circulation. 2010;120:2158.
66. Rubboli A, Becattini C, Verheugt FW. Incidence, clinical impact and risk of bleeding during oral anticoagulation therapy. World J Cardiol. 2011;3:351-358. [PMID: 22125670]
67. Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011;123:2562-2570. [PMID: 21606397]
68. Rose AJ, Berlowitz DR, Ash AS, Ozonoff A, Hylek EM, Goldhaber-Fiebert JD. The business case for quality improvement: oral anticoagulation for atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2011;4:416-424. [PMID: 21712521]
69. Song F, Loke YK, Walsh T, Glenny AM, Eastwood AJ, Altman DG. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ. 2009;338: b1147. [PMID: 19346285].