Bivalirudin Anticoagulation for Cardiac Surgery_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LIANGBi-xia ,  YUKun

State Key Laboratory of Cardiovascular Disease, Fu wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, P. R. China;

Corresponding author：

YUKun, Email: yukunfw@163.com

Keywords：

Bivalirudin; Anticoagulants; Cardiac surgery; Mechanical circulation support

DOI：

10.7507/1007-4848.20160278

Video：

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Heparin has long been a preferred anticoagulant during cardiovascular surgery, although limitations exist, including heparin-induced thrombocytopenia (HIT) and/or anti-platelet factor Ⅳ/heparin (anti-PF4/H) antibodies. Bivalirudin is a direct thrombin inhibitor, which can overcome the shortcoming of heparin. This article reviewed the application of bivalirudin in the field of cardiac surgery, its safety and effectiveness in various surgical treatments as well as summarized the standard protocol, doses, monitoring parameters and targets of bivalirudin for anticoagulation in cardiac surgery and mechanical circulation support. Bivalirudin as an alternative to heparin provides a new selection for anticoagulation in cardiac surgery.

Citation： LIANGBi-xia, YUKun. Bivalirudin Anticoagulation for Cardiac Surgery. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2016, 23(12): 1189-1194. doi: 10.7507/1007-4848.20160278 Copy

1.	Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: replace-2, randomized, trial. JAMA, 2003, 289(7): 853-863.
2.	Schulz S, Mehilli J, Ndrepepa G, et al. Bivalirudin vs. unfractionated heparin during percutaneous coronary interventionsin patients with stable and unstable angina pectoris: 1 year results of the ISAR REACT 3 tria1. Eur Heart J, 2010, 31(5): 582-587.
3.	Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med, 2008, 358(21): 2218-2230.
4.	White H. Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial. Lancet, 2001, 358(9296): 1855-1863.
5.	Coppens M, Eikelboom JW, Gustafsson D, et al. Translational success stories: development of direct thrombin inhibitors. Circ Res, 2012, 111(7): 920-929.
6.	Dyke CM, Aldea G, Koster A, et al. Off-pump coronary artery bypass with bivalirudin for patients with heparin-induced thrombocyto-penia or antiplatelet factor four/heparin antibodies. Ann Thorac Surg, 2007, 84(3): 836-839.
7.	Stone GW, Witzenbichler B, Guagliumi G, et al. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. Lancet, 2011, 377(9784): 2193-2204.
8.	Mahaffey KW, Lewis BE, Wildermann NM, et al. The anticoagulant therapy with bivalirudin to assist in the performance of percutaneous coronary intervention in patients with heparin-induced thrombo-cytopenia (ATBAT) study: main results. J Invasive Cardiol, 2003, 15(11): 611-616.
9.	Valgimigli M, Frigoli E, Leonardi S, et al. Bivalirudin or unfractio-nated heparin in acute coronary syndromes. N Engl J Med, 2015, 373(11): 997-1009.
10.	Lind SE, Boyle ME, Fisher S, et al. Comparisons of the aPTT with alternative tests for monitoring direct thrombin inhibitors in patient samples. Am J Clin Pathol, 2014, 141(5): 665-674.
11.	Warkentin TE, Greinacher A, Koster A. Bivalirudin. Thromb Haemost, 2008, 99(5): 830-839.
12.	Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med, 2006, 355(21): 2203-2216.
13.	闫炀, 闫路勤, 耿希刚. 无肝素化体外循环转流及早期炎性因子的表达. 中国胸心血管外科临床杂志, 2012, 19(4): 414-418.
14.	许咏冬, 倪一呜, 余国伟, 等. 血小板减少症患者的心瓣膜置换术. 中国胸心血管外科临床杂志, 2005, 12(3): 210-211.
15.	Warkentin TE, Kelton JG. A 14-year study of heparin-induced thrombocytopenia. Am J Med, 1996, 101(5): 502-507.
16.	Han Y, Guo J, Zheng Y, et al. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA, 2015, 313(13): 1336-1346.
17.	Smedira NG, Dyke CM, Koster A, et al. Anticoagulation with bivalirudin for off-pump coronary artery bypass grafting: the results of the EVOLUTION-OFF study. J Thorac Cardiovasc Surg, 2006, 131(3): 686-692.
18.	Koster A, Spiess B, Jurmann M, et al. Bivalirudin provides rapid, effective, and reliable anticoagulation during off-pump coronary revascularization: results of the “EVOLUTION OFF” trial. Anesth Analg, 2006, 103(3): 540-544.
19.	George D, Thierry L, Christian K, et al. Bivalirudin versus heparin anticoagulation in transcatheter aortic valve replacement: the rando-mized BRAVO-[3] trial. J Am Coll Cardiol, 2015, 66(25): 2860-2868.
20.	Lange P, Greif M, Bongiovanni D, et al. Bivalirudin vs heparin in patients who undergo transcatheter aortic valve implantation. Can J Cardiol, 2015, 31(8): 998-1003.
21.	Sergie Z, Lefevre T, Van Belle E, et al. Current periprocedural anticoagulation in transcatheter aortic valve replacement: could bivalirudin be an option? Rationale and design of the BRAVO 2/3 studies. J Thromb Thrombolysis, 2013, 35(4): 483-493.
22.	Koster A, Spiess B, Derek P, et al. Effectiveness of bivalirudin as a replacement for heparin during cardiopulmonary bypass in patients undergoing coronary artery bypass grafting. Am J Cardiol, 2004, 93(3): 356-359.
23.	Koster A, Buz S, Krabatsch T, et al. Effect of modified ultrafiltration on bivalirudin elimination and postoperative blood loss after on-pump coronary artery bypass grafting: assessment of different filtration strategies. J Card Surg, 2008, 23(6): 655-658.
24.	Koster A, Yeter R, Buz S, et al. Assessment of hemostatic activation during cardiopulmonary bypass for coronary artery bypass grafting with bivalirudin: results of a pilot study. J Thorac Cardiovasc Surg, 2005, 129(6): 1391-1394.
25.	Dyke CM, Smedira NG, Koster A, et al. A comparison of bivalirudin to heparin with protamine reversal in patients undergoing cardiac surgery with cardiopulmonary bypass: The EVOLUTION-ON study. J Thorac Cardiovasc Surg, 2006, 131(3): 533-539.
26.	Zhao Q, Edrich T, Paschalidis IC. A predictive model for the anticoagulant bivalirudin administered to cardiac surgical patients. Proc IEEE Conf Decis Control, 2013: 121-126.
27.	Grubb KJ, Salehi P, Chedrawy EG. Bivalirudin: alternative anticoa-gulation during cardiopulmonary bypass in patients with heparin-induced thrombocytopenia. Recent Pat Cardiovasc Drug Discov, 2010, 5(1): 20-24.
28.	Greinacher A. The use of direct thrombin inhibitors in cardiovas-cular surgery in patients with heparin-induced thrombocytopenia. Semin Thromb Hemost, 2004, 30(3): 315-327.
29.	Dyke CM, Koster A, Veale JJ. Preemptive use of bivalirudin for urgent on-pump coronary artery bypass grafting in patients with potential heparin-induced thrombocytopenia. Ann Thorac Surg, 2005, 80(1): 299-303.
30.	Huebler M, Koster A, Buz S, et al. Cardiopulmonary bypass for complex cardiac surgery using bivalirudin anticoagulation in a patient with heparin antibodies. J Card Surg, 2006, 21(3): 286-288.
31.	Nikolaidis N, Velissaris T, Ohri SK. Bivalirudin anticoagulation for cardiopulmonary bypass, an unusual case. Tex Heart Inst J, 2009, 34(1): 115-118.
32.	Pericleous A, Sadek M, Fitzmaurice M, et al. Anticoagulation with bivalirudin during deep hypothermic circulatory arrest in a patient with heparin-induced thrombocytopenia. Tex Heart Inst J, 2014, 41(6): 645-648.
33.	Koster A, Dyke CM, Aldea G, et al. Bivalirudin during cardiopulmo-nary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON Trial. Ann Thorac Surg, 2007, 83(2): 572-577.
34.	Pappalardo F, Arnaez1 B, Celinska SM, et al. Bivalirudin or heparin: which anticoagulation strategy for critically ill cardiac surgery patients? Crit Care, 2014, 18(Suppl 1): 97-103.
35.	Ranucci M, Ballotta A, Kandil H, et al. Bivalirudin-based versus conventional heparin anticoagulation for postcardiotomy extracor-poreal membrane oxygenation. Crit Care, 2011, 15(6): R275.
36.	Oliver WC. Anticoagulation and coagulation management for ECMO. Semin Cardiothorac Vasc Anesth, 2009, 13(3): 154-175.
37.	Ranucci M. Bivalirudin and post-cardiotomy ECMO: a word of caution. Crit Care, 2012, 16(3): 427-429.
38.	Pieri M, Arnaez B, Prima AD, et al. Primary bivalirudin anticoagula-tion for patients with an implantable ventricular assist device. Crit Care, 2014, 18(Suppl 1): 100-104.
39.	Hamdy A, Richard B, Obaid M, et al. Thrombosis during off pump LVAD placement in a patient with heparin induced thrombocyto-penia using bivalirudin. J Cardiothorac Surg, 2013, 8: 115-117.
40.	Morshuisa M, Boergermanna J, Gummerta J, et al. A modified technique for implantation of the HeartWare^TM left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interact Cardiovasc Thorac Surg, 2013, 17(2): 225-226.
41.	Cook JA, Shah KB, Quader MA, et al. The total artificial heart. J Thorac Dis, 2015, 7(12): 2172-2180.
42.	Buck ML. Bivalirudin as an alternative to heparin for anticoagula-tion in infants and children. J Pediatr Pharmacol Ther, 2015, 20(6): 408-417.
43.	Malloy KM, McCabe TA, Kuhn RJ. Bivalirudin use in an infant with persistent clotting on unfractionated heparin. J Pediatr Pharmacol Ther, 2011, 16(2): 108-112.
44.	Rayapudi S, Torres A Jr, Deshpande GG, et al. Bivalirudin for anti-coagulation in children. Pediatr Blood Cancer, 2008, 51(6): 798-801.

1. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: replace-2, randomized, trial. JAMA, 2003, 289(7): 853-863.
2. Schulz S, Mehilli J, Ndrepepa G, et al. Bivalirudin vs. unfractionated heparin during percutaneous coronary interventionsin patients with stable and unstable angina pectoris: 1 year results of the ISAR REACT 3 tria1. Eur Heart J, 2010, 31(5): 582-587.
3. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med, 2008, 358(21): 2218-2230.
4. White H. Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial. Lancet, 2001, 358(9296): 1855-1863.
5. Coppens M, Eikelboom JW, Gustafsson D, et al. Translational success stories: development of direct thrombin inhibitors. Circ Res, 2012, 111(7): 920-929.
6. Dyke CM, Aldea G, Koster A, et al. Off-pump coronary artery bypass with bivalirudin for patients with heparin-induced thrombocyto-penia or antiplatelet factor four/heparin antibodies. Ann Thorac Surg, 2007, 84(3): 836-839.
7. Stone GW, Witzenbichler B, Guagliumi G, et al. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. Lancet, 2011, 377(9784): 2193-2204.
8. Mahaffey KW, Lewis BE, Wildermann NM, et al. The anticoagulant therapy with bivalirudin to assist in the performance of percutaneous coronary intervention in patients with heparin-induced thrombo-cytopenia (ATBAT) study: main results. J Invasive Cardiol, 2003, 15(11): 611-616.
9. Valgimigli M, Frigoli E, Leonardi S, et al. Bivalirudin or unfractio-nated heparin in acute coronary syndromes. N Engl J Med, 2015, 373(11): 997-1009.
10. Lind SE, Boyle ME, Fisher S, et al. Comparisons of the aPTT with alternative tests for monitoring direct thrombin inhibitors in patient samples. Am J Clin Pathol, 2014, 141(5): 665-674.
11. Warkentin TE, Greinacher A, Koster A. Bivalirudin. Thromb Haemost, 2008, 99(5): 830-839.
12. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med, 2006, 355(21): 2203-2216.
13. 闫炀, 闫路勤, 耿希刚. 无肝素化体外循环转流及早期炎性因子的表达. 中国胸心血管外科临床杂志, 2012, 19(4): 414-418.
14. 许咏冬, 倪一呜, 余国伟, 等. 血小板减少症患者的心瓣膜置换术. 中国胸心血管外科临床杂志, 2005, 12(3): 210-211.
15. Warkentin TE, Kelton JG. A 14-year study of heparin-induced thrombocytopenia. Am J Med, 1996, 101(5): 502-507.
16. Han Y, Guo J, Zheng Y, et al. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA, 2015, 313(13): 1336-1346.
17. Smedira NG, Dyke CM, Koster A, et al. Anticoagulation with bivalirudin for off-pump coronary artery bypass grafting: the results of the EVOLUTION-OFF study. J Thorac Cardiovasc Surg, 2006, 131(3): 686-692.
18. Koster A, Spiess B, Jurmann M, et al. Bivalirudin provides rapid, effective, and reliable anticoagulation during off-pump coronary revascularization: results of the “EVOLUTION OFF” trial. Anesth Analg, 2006, 103(3): 540-544.
19. George D, Thierry L, Christian K, et al. Bivalirudin versus heparin anticoagulation in transcatheter aortic valve replacement: the rando-mized BRAVO-[3] trial. J Am Coll Cardiol, 2015, 66(25): 2860-2868.
20. Lange P, Greif M, Bongiovanni D, et al. Bivalirudin vs heparin in patients who undergo transcatheter aortic valve implantation. Can J Cardiol, 2015, 31(8): 998-1003.
21. Sergie Z, Lefevre T, Van Belle E, et al. Current periprocedural anticoagulation in transcatheter aortic valve replacement: could bivalirudin be an option? Rationale and design of the BRAVO 2/3 studies. J Thromb Thrombolysis, 2013, 35(4): 483-493.
22. Koster A, Spiess B, Derek P, et al. Effectiveness of bivalirudin as a replacement for heparin during cardiopulmonary bypass in patients undergoing coronary artery bypass grafting. Am J Cardiol, 2004, 93(3): 356-359.
23. Koster A, Buz S, Krabatsch T, et al. Effect of modified ultrafiltration on bivalirudin elimination and postoperative blood loss after on-pump coronary artery bypass grafting: assessment of different filtration strategies. J Card Surg, 2008, 23(6): 655-658.
24. Koster A, Yeter R, Buz S, et al. Assessment of hemostatic activation during cardiopulmonary bypass for coronary artery bypass grafting with bivalirudin: results of a pilot study. J Thorac Cardiovasc Surg, 2005, 129(6): 1391-1394.
25. Dyke CM, Smedira NG, Koster A, et al. A comparison of bivalirudin to heparin with protamine reversal in patients undergoing cardiac surgery with cardiopulmonary bypass: The EVOLUTION-ON study. J Thorac Cardiovasc Surg, 2006, 131(3): 533-539.
26. Zhao Q, Edrich T, Paschalidis IC. A predictive model for the anticoagulant bivalirudin administered to cardiac surgical patients. Proc IEEE Conf Decis Control, 2013: 121-126.
27. Grubb KJ, Salehi P, Chedrawy EG. Bivalirudin: alternative anticoa-gulation during cardiopulmonary bypass in patients with heparin-induced thrombocytopenia. Recent Pat Cardiovasc Drug Discov, 2010, 5(1): 20-24.
28. Greinacher A. The use of direct thrombin inhibitors in cardiovas-cular surgery in patients with heparin-induced thrombocytopenia. Semin Thromb Hemost, 2004, 30(3): 315-327.
29. Dyke CM, Koster A, Veale JJ. Preemptive use of bivalirudin for urgent on-pump coronary artery bypass grafting in patients with potential heparin-induced thrombocytopenia. Ann Thorac Surg, 2005, 80(1): 299-303.
30. Huebler M, Koster A, Buz S, et al. Cardiopulmonary bypass for complex cardiac surgery using bivalirudin anticoagulation in a patient with heparin antibodies. J Card Surg, 2006, 21(3): 286-288.
31. Nikolaidis N, Velissaris T, Ohri SK. Bivalirudin anticoagulation for cardiopulmonary bypass, an unusual case. Tex Heart Inst J, 2009, 34(1): 115-118.
32. Pericleous A, Sadek M, Fitzmaurice M, et al. Anticoagulation with bivalirudin during deep hypothermic circulatory arrest in a patient with heparin-induced thrombocytopenia. Tex Heart Inst J, 2014, 41(6): 645-648.
33. Koster A, Dyke CM, Aldea G, et al. Bivalirudin during cardiopulmo-nary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON Trial. Ann Thorac Surg, 2007, 83(2): 572-577.
34. Pappalardo F, Arnaez1 B, Celinska SM, et al. Bivalirudin or heparin: which anticoagulation strategy for critically ill cardiac surgery patients? Crit Care, 2014, 18(Suppl 1): 97-103.
35. Ranucci M, Ballotta A, Kandil H, et al. Bivalirudin-based versus conventional heparin anticoagulation for postcardiotomy extracor-poreal membrane oxygenation. Crit Care, 2011, 15(6): R275.
36. Oliver WC. Anticoagulation and coagulation management for ECMO. Semin Cardiothorac Vasc Anesth, 2009, 13(3): 154-175.
37. Ranucci M. Bivalirudin and post-cardiotomy ECMO: a word of caution. Crit Care, 2012, 16(3): 427-429.
38. Pieri M, Arnaez B, Prima AD, et al. Primary bivalirudin anticoagula-tion for patients with an implantable ventricular assist device. Crit Care, 2014, 18(Suppl 1): 100-104.
39. Hamdy A, Richard B, Obaid M, et al. Thrombosis during off pump LVAD placement in a patient with heparin induced thrombocyto-penia using bivalirudin. J Cardiothorac Surg, 2013, 8: 115-117.
40. Morshuisa M, Boergermanna J, Gummerta J, et al. A modified technique for implantation of the HeartWare^TM left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interact Cardiovasc Thorac Surg, 2013, 17(2): 225-226.
41. Cook JA, Shah KB, Quader MA, et al. The total artificial heart. J Thorac Dis, 2015, 7(12): 2172-2180.
42. Buck ML. Bivalirudin as an alternative to heparin for anticoagula-tion in infants and children. J Pediatr Pharmacol Ther, 2015, 20(6): 408-417.
43. Malloy KM, McCabe TA, Kuhn RJ. Bivalirudin use in an infant with persistent clotting on unfractionated heparin. J Pediatr Pharmacol Ther, 2011, 16(2): 108-112.
44. Rayapudi S, Torres A Jr, Deshpande GG, et al. Bivalirudin for anti-coagulation in children. Pediatr Blood Cancer, 2008, 51(6): 798-801.

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