Antithrombotic therapy in Atrial Fibrillation-evaluation and positioning of new oral anticoagulant agents

Circulation Journal

Volumn 75, Issue 7, 2011, Pages 1539-1546

  Ogawa, Satoshi ^a   Koretsune, Yukihiro ^b   Yasaka, Masahiro ^c   Aizawa, Yoshifusa ^d   Atarashi, Hirotsugu ^e   Inoue, Hiroshi ^f   Kamakura, Shiro ^g   Kumagai, Koichiro ^h   Mitamura, Hideo ⁱ   Okumura, Ken ^j   Sugi, Kaoru ^k   Yamashita, Takeshi ^l  

^a International University of Health and Welfare Mita Hospital   (Japan)

^b OSAKA NATIONAL HOSPITAL   (Japan)

^c NATIONAL HOSPITAL ORGANIZATION   (Japan)

^d NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES   (Japan)

^e NIPPON MEDICAL SCHOOL TAMA NAGAYAMA HOSPITAL   (Japan)

^f UNIVERSITY OF TOYAMA   (Japan)

^g NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^h FUKUOKA SANNO HOSPITAL   (Japan)

ⁱ SAISEIKAI CENTRAL HOSPITAL   (Japan)

^j HIROSAKI UNIVERSITY   (Japan)

^k TOHO UNIVERSITY OHASHI MEDICAL CENTER   (Japan)

^l THE CARDIOVASCULAR INSTITUTE   (Japan)

more..

Author keywords

Anticoagulation; Atrial fibrillation; Dabigatran; Stroke; Warfarin

Indexed keywords

ACETYLSALICYLIC ACID; APIXABAN; DABIGATRAN; EDOXABAN; RIVAROXABAN; WARFARIN; XIMELAGATRAN;

ANTICOAGULANT THERAPY; ANTICOAGULATION; BLEEDING; BLOOD TRANSFUSION; BRAIN HEMORRHAGE; CARDIOVERSION; COMPRESSION THERAPY; CONTINUOUS INFUSION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG INDICATION; DRUG METABOLISM; DRUG MONITORING; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; HEART ATRIUM FIBRILLATION; HEMOSTASIS; HUMAN; INTERNATIONAL NORMALIZED RATIO; LIVER TOXICITY; REVIEW; RISK REDUCTION; STROKE; THROMBOEMBOLISM; THROMBOSIS PREVENTION; TOOTH EXTRACTION; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; FIBRINOLYTIC AGENTS; HUMANS; RISK FACTORS; STROKE; THROMBIN;

EID: 79959739642     PISSN: 13469843     EISSN: 13474820     Source Type: Journal    
DOI: 10.1253/circj.CJ-11-0304     Document Type: Review

References (59)

1. Schirmer SH, Baumhäkel M, Neuberger HR, Hohnloser SH, van Gelder IC, Lip GY, et al. Novel anticoagulants for stroke prevention in atrial fibrillation: Current clinical evidence and future developments. J Am Coll Cardiol 2010; 56: 2067-2076.
2. Writing Group Members, Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, et al. Heart disease and stroke statistics-2010 update: A report from the American Heart Association. Circulation 2010; 121: e46-e215.
3. Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG. Prevalence, age distribution, and gender of patients with atrial fibrillation: Analysis and implications. Arch Intern Med 1995; 155: 469-473.
4. JCS Joint Working Group. Guidelines for pharmacotherapy of atrial fibrillation (JCS 2008): Digest version. Circ J 2010; 74: 2479-2500.
5. Ohsawa M, Okayama A, Sakata K, Kato K, Itai K, Onoda T, et al. Rapid increase in estimated number of persons with atrial fibrillation in Japan: An analysis from national surveys on cardiovascular diseases in 1980, 1990 and 2000. J Epidemiol 2005; 15: 194-196.
6. Inoue H, Fujiki A, Origasa H, Ogawa S, Okumura K, Kubota I, et al. Prevalence of atrial fibrillation in the general population of Japan: An analysis based on periodic health examination. Int J Cardiol 2009; 137: 102-107.
7. Koretsune Y. The incidence of ischemic stroke: Paroxysmal AF vs persistent/permanent AF. Circ J 2009; 73: 1393-1394.
8. Mavrakanas T, Bounameaux H. The potential role of new oral anticoagulants in the prevention and treatment of thromboembolism. Pharmacol Ther 2011; 130: 46-58.
9. Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, et al. Rationale and design of RE-LY: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J 2009; 157: 805-810, 810.e801-e802.
10. 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.
11. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151.
12. 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. N Engl J Med 2010; 363: 1875-1876.
13. Matchar DB, Samsa GP, Cohen SJ, Oddone EZ, Jurgelski AE. Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: Results of the managing anticoagulation services trial. Am J Med 2002; 113: 42-51.
14. Umer Usman MH, Raza S, Raza S, Ezekowitz M. Advancement in antithrombotics for stroke prevention in atrial fibrillation. J Interv Card Electrophysiol 2008; 22: 129-137.
15. Inoue H, Nozawa T, Hirai T, Goto S, Origasa H, Shimada K, et al. Sex-related differences in the risk factor profile and medications of patients with atrial fibrillation recruited in J-TRACE. Circ J 2010; 74: 650-654.
16. Gao F, Zhou YJ, Wang ZJ, Shen H, Liu XL, Nie B, et al. Comparison of different antithrombotic regimens for patients with atrial fibrillation undergoing drug-eluting stent implantation. Circ J 2010; 74: 701-708.
17. Obata H, Watanabe H, Ito M, Hirono S, Hanawa H, Kodama M, et al. Effects of combination therapy with warfarin and bucolome for anticoagulation in patients with atrial fibrillation. Circ J 2010; 75: 201-203.
18. Kubitza D, Haas S. Novel factor Xa inhibitors for prevention and treatment of thromboembolic diseases. Expert Opin Invest Drugs 2006; 15: 843-855.
19. van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, et al. Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: Interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost 2010; 103: 1116-1127.
20. Mann KG. The biochemistry of coagulation. Clin Lab Med 1984; 4: 207-220.
21. Kumar R, Béguin S, Hemker HC. The effect of fibrin clots and clot-bound thrombin on the development of platelet procoagulant activity. Thromb Haemost 1995; 74: 962-968.
22. Weitz JI. New oral anticoagulants in development. Thromb Haemost 2010; 103: 62-70.
23. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008; 47: 285-295.
24. Weitz JI, Bates SM. New anticoagulants. J Thromb Haemost 2005; 3: 1843-1853.
25. Testa L, Andreotti F, Biondi Zoccai GG, Burzotta F, Bellocci F, Crea F. Ximelagatran/melagatran against conventional anticoagulation: A meta-analysis based on 22,639 patients. Int J Cardiol 2007; 122: 117-124.
26. Francis CW, Berkowitz SD, Comp PC, Lieberman JR, Ginsberg JS, Paiement G, et al. Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. N Engl J Med 2003; 349: 1703-1712.
27. Schulman S, Wåhlander K, Lundström T, Clason SB, Eriksson H, THRIVE III Investigators. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N Engl J Med 2003; 349: 1713-1721.
28. Fiessinger JN, Huisman MV, Davidson BL, Bounameaux H, Francis CW, Eriksson H, et al. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis: A randomized trial. JAMA 2005; 293: 681-689.
29. Olsson SB, Executive Steering Committee of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): Randomised controlled trial. Lancet 2003; 362: 1691-1698.
30. Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, et al. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: A randomized trial. JAMA 2005; 293: 690-698.
31. Ogata K, Mendell-Harary J, Tachibana M, Masumoto H, Oguma T, Kojima M, et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010; 50: 743-753.
32. Gerotziafas GT, Elalamy I, Depasse F, Perzborn E, Samama MM. In vitro inhibition of thrombin generation, after tissue factor pathway activation, by the oral, direct factor Xa inhibitor rivaroxaban. J Thromb Haemost 2007; 5: 886-888.
33. Kubitza D, Becka M, Mueck W, Zuehlsdorf M. Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban [an oral, direct factor Xa inhibitor] are not affected by aspirin. J Clin Pharmacol 2006; 46: 981-990.
34. ROCKET AF Study Investigators. 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 2010; 159: 340-347, e341.
35. Patel MR, ROCKET AF Executive Steering Committee. Stroke prevention using the oral direct factor Xa inhibitor rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation (ROCKET AF). Circulation 2010; 122: 2215-2226 (abstract 21839).
36. Lopes RD, Alexander JH, Al-Khatib SM, Ansell J, Diaz R, Easton JD, et al. Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial: Design and rationale. Am Heart J 2010; 159: 331-339.
37. Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011; 364: 806-817.
38. Blech S, Ebner T, Ludwig-Schwellinger E, Stangier J, Roth W. The metabolism and disposition of the oral direct thrombin inhibitor, dabigatran, in humans. Drug Metab Dispos 2008; 36: 386-399.
39. Stangier J, Rathgen K, Stähle H, Gansser D, Roth W. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007; 64: 292-303.
40. Hauptmann J, Stürzebecher J. Synthetic inhibitors of thrombin and factor Xa: From bench to bedside. Thromb Res 1999; 93: 203-241.
41. Wienen W, Stassen JM, Priepke H, Ries UJ, Hauel N. In-vitro profile and ex-vivo anticoagulant activity of the direct thrombin inhibitor dabigatran and its orally active prodrug, dabigatran etexilate. Thromb Haemost 2007; 98: 155-162.
42. Gage BF. Can we rely on RE-LY? N Engl J Med 2009; 361: 1200-1202.
43. Heidbuchel H, Verhamme P. Dabigatran for stroke prevention in atrial fibrillation: From RE-LY to daily clinical practice. Acta Cardiol 2010; 65: 491-497.
44. Oldgren J, Alings M, Darius H, Eikelboom J, Ezekowitz M, Parekh A, et al, editors. Dabigatran versus warfarin in atrial fibrillation patients with low, moderate, and high CHADS2 Score: A RE-LY subgroup analysis. In: Proceedings of ACC10, March 14-16, 2010. Atlanta: American College of Cardiology.
45. Nagarakanti R, Ezekowitz MD, Oldgren J, Yang S, Chernick M, Aikens TH, et al. Dabigatran versus warfarin in patients with atrial fibrillation: An analysis of patients undergoing cardioversion. Circulation 2011; 123: 131-136.
46. Evans IL, Sayers MS, Gibbons AJ, Price G, Snooks H, Sugar AW. Can warfarin be continued during dental extraction? Results of a randomized controlled trial. Br J Oral Maxillofac Surg 2002; 40: 248-252.
47. Ardekian L, Gaspar R, Peled M, Brener B, Laufer D. Does lowdose aspirin therapy complicate oral surgical procedures? J Am Dent Assoc 2000; 13: 331-335.
48. Morimoto Y, Niwa H, Yoneda T, Kimura K, Yasaka M, Minematsu K. Hemostatic management of tooth extraction in patients undergoing antithrombotic therapy. J Jpn Stomatol Soc 2004; 53: 74-80 (in Japanese).
49. Makiura N, Yasaka M, Minematsu K. Management of hemorrhagic complications at dental extraction in patients treated with warfarin. Jpn J Stroke 2005; 27: 424-427 (in Japanese).
50. Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, et al. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol 2005; 96: 1200-1206.
51. Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006; 114: 774-782.
52. Manoukian SV, Feit F, Mehran R, Voeltz MD, Ebrahimi R, Hamon M, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: An analysis from the ACUITY Trial. J Am Coll Cardiol 2007; 49: 1362-1368.
53. Stangier J, Rathgen K, Stähle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: An open-label, parallel-group, single-centre study. Clin Pharmacokinet 2010; 49: 259-268.
54. Benz K, Nauck MA, Böhler J, Fischer KG. Hemofiltration of recombinant hirudin by different hemodialyzer membranes: Implications for clinical use. Clin J Am Soc Nephrol 2007; 2: 470-476.
55. Sartori MT, Imbergamo S, Zanon E, Bonaccorso G, Pittoni G, Feltracco P, et al. Effect of recombinant activated factor VII in critical bleeding: Clinical experience of a single center. Clin Appl Thromb Hemost 2009; 15: 628-635.
56. Leissinger CA, Blatt PM, Hoots WK, Ewenstein B. Role of prothrombin complex concentrates in reversing warfarin anticoagulation: A review of the literature. Am J Hematol 2008; 83: 137-143.
57. Fernlöf G, Sjöström BM, Lindell KM, Wall UE. Management of major bleedings during anticoagulant treatment with the oral direct thrombin inhibitor ximelagatran or warfarin. Blood Coagul Fibrinolysis 2009; 20: 667-674.
58. Crowther MA, Warkentin TE. Managing bleeding in anticoagulated patients with a focus on novel therapeutic agents. J Thromb Haemost 2009; 7(Suppl 1): 107-110.
59. Baker WL, Cios DA, Sander SD, Coleman CI. Meta-analysis to assess the quality of warfarin control in atrial fibrillation patients in the United States. J Manag Care Pharm 2009; 15: 244-252.