Use of direct oral anticoagulants in patients with atrial fibrillation and valvular heart lesions

Journal of the American Heart Association

Volumn 5, Issue 2, 2016, Pages

  Biase, Luigi Di ^a,b,c  

^a MONTEFIORE MEDICAL CENTER   (United States)

^b The University of Texas at Austin   (United States)

^c UNIVERSITY OF FOGGIA   (Italy)

Author keywords

Anticoagulants; Atrial fibrillation; Treatment; Valvular heart disease

Indexed keywords

ACETYLSALICYLIC ACID; ANTICOAGULANT AGENT; ANTIVITAMIN K; APIXABAN; DABIGATRAN; EDOXABAN; IDARUCIZUMAB; RIVAROXABAN; WARFARIN;

ARTICLE; ATRIAL FIBRILLATION; CASE STUDY; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); COMORBIDITY; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; HEART VALVE PROSTHESIS; HIGH RISK PATIENT; HUMAN; INTERMETHOD COMPARISON; MECHANICAL HEART VALVE; MITRAL VALVE REGURGITATION; MITRAL VALVE STENOSIS; NONVALVULAR ATRIAL FIBRILLATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK FACTOR; RISK REDUCTION; THROMBOEMBOLISM; TREATMENT INDICATION; UNITED STATES; VALVULAR HEART DISEASE; BLEEDING; BLOOD; BLOOD CLOTTING; CHEMICALLY INDUCED; COMPLICATION; DRUG EFFECTS; EVIDENCE BASED MEDICINE; HEART VALVE DISEASES; MORTALITY; ORAL DRUG ADMINISTRATION; STROKE; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; BLOOD COAGULATION; CLINICAL TRIALS AS TOPIC; EVIDENCE-BASED MEDICINE; HEART VALVE DISEASES; HEMORRHAGE; HUMANS; RISK FACTORS; STROKE; TREATMENT OUTCOME;

EID: 85002549641     PISSN: None     EISSN: 20479980     Source Type: Journal    
DOI: 10.1161/JAHA.115.002776     Document Type: Article

References (50)

1. Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013;112:1142-1147.
2. Olesen JB, Lip GY, Hansen ML, Hansen PR, Tolstrup JS, Lindhardsen J, Selmer C, Ahlehoff O, Olsen AM, Gislason GH, Torp-Pedersen C. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011;342:d124.
3. You JJ, Singer DE, Howard PA, Lane DA, Eckman MH, Fang MC, Hylek EM, Schulman S, Go AS, Hughes M, Spencer FA, Manning WJ, Halperin JL, Lip GY; 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:e531S-e575S.
4. Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery. 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. 2010;31:2369-2429.
5. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 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. Europace. 2012;14:1385-1413.
6. Boehringer Ingelheim Pharmaceuticals, Inc. PRAXBIND (idarucizumab) prescribing information. Available at: http://us.boehringer-ingelheim.com/content/ dam/internet/opu/us_EN/documents/Media_Press_Releases/2015/ Praxbind.pdf. Accessed November 11, 2015.
7. Crowther M, Kitt M, Lorenz T, Mathur V, Lu G, Hutchaleelaha A, Hollenbach S, Curnutte J, Becker RC. A phase 2 randomized, double-blind, placebo-controlled trial of PRT064445, a novel, universal antidote for direct and indirect factor Xa inhibitors [Abstract]. J Thromb Haemost. 2013;11:30.
8. Laulicht B, Bakhru S, Lee C, Baker C, Jiang X, Mathiowitz E, Costin J, Steiner S. Small molecule antidote for anticoagulants [Abstract]. Circulation. 2012;126: A11395.
9. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-992.
10. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
11. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151.
12. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093-2104.
13. Molteni M, Polo Friz H, Primitz L, Marano G, Boracchi P, Cimminiello C. The definition of valvular and non-valvular atrial fibrillation: results of a physicians' survey. Europace. 2014;16:1720-1725.
14. Lip GY, Laroche C, Dan GA, Santini M, Kalarus Z, Rasmussen LH, Oliveira MM, Mairesse G, Crijns HJ, Simantirakis E, Atar D, Kirchhof P, Vardas P, Tavazzi L, Maggioni AP. A prospective survey in European Society of Cardiology member countries of atrial fibrillation management: baseline results of EurObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry. Europace. 2014;16:308-319.
15. Darby AE, Dimarco JP. Management of atrial fibrillation in patients with structural heart disease. Circulation. 2012;125:945-957.
16. Fuster V, Ryden LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Levy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG. American College of Cardiology, American Heart Association, European Society of Cardiology, North American Society of Pacing and Electrophysiology. ACC/AHA/ESC guidelines 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 European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to develop guidelines for the management of patients with atrial fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology. Eur Heart J. 2001;22:1852-1923.
17. Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. Europace. 2006;8:651-745.
18. January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW. 2014 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:e1-e76.
19. Lip GY, Windecker S, Huber K, Kirchhof P, Marin F, Ten Berg JM, Haeusler KG, Boriani G, Capodanno D, Gilard M, Zeymer U, Lane D; Document Reviewers, Storey RF, Bueno H, Collet JP, Fauchier L, Halvorsen S, Lettino M, Morais J, Mueller C, Potpara TS, Rasmussen LH, Rubboli A, Tamargo J, Valgimigli M, Zamorano JL. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS). Eur Heart J. 2014;35:3155-3179.
20. Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, Pais P, Erol C, Diaz R, Bahit MC, Bartunek J, De Caterina R, Goto S, Ruzyllo W, Zhu J, Granger CB, Alexander JH. Apixaban compared with warfarin in patients with atrial fibrillation and valvular heart disease: findings from the ARISTOTLE Trial. Circulation. 2015;132:624-632.
21. Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364:806-817.
22. Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM; for the ROCKET AF Steering Committee and Investigators. Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial. Eur Heart J. 2014;35:3377-3385.
23. Ezekowitz MD, Parise H, Nagarakanti R, Noack H, Brueckmann M, Clemens A, Reilly P, Connolly S, Yusuf S, Wallentin L. Comparison of dabigatran versus warfarin in patients with atrial fibrillation and valvular heart disease: the RELY trial. Poster presented at: ACC 2014; March 29-31, 2014; Washington, DC. Abstract.
24. Van de Werf F, Brueckmann M, Connolly SJ, Friedman J, Granger CB, Hartter S, Harper R, Kappetein AP, Lehr T, Mack MJ, Noack H, Eikelboom JW. 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). Am Heart J. 2012;163:931-937.e1.
25. Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Stroke incidence, prevalence, and survival: secular trends in Rochester, Minnesota, through 1989. Stroke. 1996;27:373-380.
26. Petty GW, Khandheria BK, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO. Predictors of cerebrovascular events and death among patients with valvular heart disease: a population-based study. Stroke. 2000;31:2628-2635.
27. Whitlock RP, Sun JC, Fremes SE, Rubens FD, Teoh KH; American College of Chest Physicians. Antithrombotic and thrombolytic therapy for valvular disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e576S-e600S.
28. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP III, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM III, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:2438-2488. Erratum in: J Am Coll Cardiol. 2014;63:2489.
29. Nakagami H, Yamamoto K, Ikeda U, Mitsuhashi T, Goto T, Shimada K. Mitral regurgitation reduces the risk of stroke in patients with nonrheumatic atrial fibrillation. Am Heart J. 1998;136:528-532.
30. Wada Y, Mizushige K, Ohmori K, Iwado Y, Kohno M, Matsuo H. Prevention of cerebral thromboembolism by low-dose anticoagulant therapy in atrial fibrillation with mitral regurgitation. J Cardiovasc Pharmacol. 2001;37: 422-426.
31. Kamath S, Lip GY. Mitral regurgitation and atrial fibrillation: milder the disease, higher the risk? Int J Cardiol. 2000;72:235-237.
32. Miyasaka Y, Tsuji H, Tokunaga S, Nishiue T, Yamada K, Watanabe J, Iwasaka T. Mild mitral regurgitation was associated with increased prevalence of thromboembolic events in patients with nonrheumatic atrial fibrillation. Int J Cardiol. 2000;72:229-233.
33. Bonow RO, Carabello BA, de Chatterjee K, Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;52: e1-e142.
34. Salem DN,O'Gara PT,MadiasC, Pauker SG;American College ofChest Physicians. Valvular and structural heart disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133 (6 suppl):593S-629S.
35. Grunkemeier GL, Li HH, Naftel DC, Starr A, Rahimtoola SH. Long-term performance of heart valve prostheses. Curr Probl Cardiol. 2000;25:73-154.
36. Butchart EG. Antithrombotic management in patients with prosthetic valves: a comparison of American and European guidelines. Heart. 2009;95:430-436.
37. Di Biase L, Trivedi C, Mohanty P, Mohanty S, Gianni C, Bai R, Santangeli P. Periprocedural and long term safety and feasibility of treatment with novel oral anticoagulants in patients with biological valve and atrial fibrillation. Presented at: American College of Cardiology 64th Annual Scientific Session [P-255]; March 14-16, 2015; San Diego, CA.
38. Atar S, Wishniak A, Shturman A, Shtiwi S, Brezins M. Fatal association of mechanical valve thrombosis with dabigatran: a report of two cases. Chest. 2013;144:327-328.
39. Akgullu C, Eryilmaz U, Kurtoglu T. [Severe thrombosis of bioprosthesis mitral valve after dabigatran]. Turk Kardiyol Dern Ars. 2013;41:529-533 [Turkish].
40. Coulter S, Campos K. Thrombosis on a mechanical mitral valve anticoagulated with dabigatran. J Thromb Thrombolysis. 2014;37:84-86.
41. Kuwauchi S, Watanabe S, Abe K, Yamasaki M, Ito J, Kawazoe K. Thromboembolism in a patient with a mechanical mitral valve during anticoagulation with dabigatran etexilate. Ann Thorac Surg. 2013;96:1863-1864.
42. Price J, Hynes M, Labinaz M, Ruel M, Boodhwani M. Mechanical valve thrombosis with dabigatran. J Am Coll Cardiol. 2012;60:1710-1711.
43. Chu JW, Chen VH, Bunton R. Thrombosis of a mechanical heart valve despite dabigatran. Ann Intern Med. 2012;157:304.
44. Stewart RA, Astell H, Young L, White HD. Thrombosis on a mechanical aortic valve whilst anti-coagulated with dabigatran. Heart Lung Circ. 2012;21:53-55.
45. Chaudhry M. Drowning in blood: a rare but fatal complication of rivaroxaban. Crit Care Med. 2012;40:316.
46. Luis SA, Poon K, Luis C, Shukla A, Bett N, Hamilton-Craig C. Massive left atrial thrombus in a patient with rheumatic mitral stenosis and atrial fibrillation while anticoagulated with dabigatran. Circ Cardiovasc Imaging. 2013;6:491-492.
47. ClnicalTrials.gov. Comparison of antithrombotic treatments after aortic valve replacement. Rivaroxaban: a new antithrombotic treatment for patients with mechanical prosthetic aortic heart valve (CATHAR). Available at: http://clinicaltrials. gov/ct2/show/NCT02128841. Accessed February 10, 2015.
48. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
49. Leung DY, Black IW, Cranney GB, Hopkins AP, Walsh WF. Prognostic implications of left atrial spontaneous echo contrast in nonvalvular atrial fibrillation. J Am Coll Cardiol. 1994;24:755-762.
50. Di Biase L, Santangeli P, Anselmino M, Mohanty P, Salvetti I, Gili S, Horton R, Sanchez JE, Bai R, Mohanty S, Pump A, Cereceda Brantes M, Gallinghouse GJ, Burkhardt JD, Cesarani F, Scaglione M, Natale A, Gaita F. Does the left atrial appendage morphology correlate with the risk of stroke in patients with atrial fibrillation? Results from a multicenter study J Am Coll Cardiol. 2012;60:531-538.