Use of idarucizumab to reverse dabigatran in a case of emergency heart surgery – the Cracow experience Case series report
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Published:
Dec 31, 2019
Keywords:
dabigatran, idarucizumab, cardiac surgery, bleeding
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Abstract
Dabigatran etexilate (dabigatran), a direct, selective and reversible thrombin inhibitor, who is administered as a prodrug, being transformed into an active metabolite upon absorption from the digestive tract. Patients on dabigatran can experience serious perioperative bleeding if the emergency surgery is performed while on anticoagulation. At the end of 2015, idarucizumab, a monoclonal antibody fragment that binds dabigatran with high affinity, was approved for use. The RE-VERSE AD trial (NCT02104947) has shown that idarucizumab is efficacious in dabigatran reversal. The current European Heart Rhythm Association and European Association of Cardio-Thoracic Surgery guidelines recommend idarucizumab use in the setting of severe bleeding, or if an emergency surgery is needed during dabigatran treatment. This report summarizes our clinical experience with idarucizumab in dabigatran-treated patients undergoing emergency cardiac surgery.
Article Details
How to Cite
Mazur, P., & Undas, A. (2019). Use of idarucizumab to reverse dabigatran in a case of emergency heart surgery – the Cracow experience. Medycyna Faktow (J EBM), 12(4(45), 331-339. https://doi.org/10.24292/01.MF.0419.4
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References
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28. Heidbuchel H., Verhamme P., Alings M. et al.: EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur. Heart J. 2013; 34: 2094-2106.
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34. Bijak M., Bobrowski M.: The importance of thrombin inhibitors in the antithrombotic pharmacotherapy. Postępy Nauk Medycznych 2010; 23(10): 819-825.
35. Vanassche T., Greinacher A., Verhamme P.: Reversal of dabigatran by idarucizumab: when and how? Expert Rev. Hematol. 2016; 9: 519-528.
36. Samuelson B.T., Cuker A.: Measurement and reversal of the direct oral anticoagulants. Blood Rev. 2017; 31: 77-84.
37. Czubek U., Goralczyk T., Zalewski J., Undas A.: Monitoring of anticoagulant effects of dabigatran in everyday practice: first experience in 32 Polish patients. Pol. Arch. Med. Wewn. 2014; 124: 487-489.
2. Undas A., Pasierski T., Windyga J., Crowther M.: Practical aspects of new oral anticoagulant use in atrial fibrillation. Pol. Arch. Med. Wewn. 2014; 124: 124-135.
3. Di Nisio M., van Es N., Buller H.R.: Deep vein thrombosis and pulmonary embolism. Lancet 2016; 388: 3060-3073.
4. Kearon C., Akl E.A., Ornelas J. et al.: Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest 2016; 149: 315-352.
5. Janion-Sadowska A., Sadowski M., Konieczynska M. et al.: Large regional differences in prescription patterns of oral anticoagulants and knowledge of the disease and therapy among Polish patients with atrial fibrillation. Kardiol. Pol. 2019.
6. Litwinowicz R., Konstanty-Kalandyk J., Goralczyk T. et al.: Dabigatran level monitoring prior to idarucizumab administration in patients requiring emergent cardiac surgery. J. Thromb. Thrombolysis 2018; 45: 9-12.
7. Charakterystyka produktu leczniczego Pradaxa.
8. Stein P., Bosshart M., Brand B. et al.: Dabigatran anticoagulation and Stanford type A aortic dissection: lethal coincidence: Case report with literature review. Acta Anaesthesiol. Scand. 2014; 58: 630-637.
9. Crapelli G.B., Bianchi P., Isgro G. et al.: A Case of Fatal Bleeding Following Emergency Surgery on an Ascending Aorta Intramural Hematoma in a Patient Taking Dabigatran. J. Cardiothorac. Vasc. Anesth. 2016; 30: 1027-1031.
10. Mastrobuoni S., Robblee J.A., Boodhwani M.: Spontaneous ascending aortic intramural haematoma in a patient on dabigatran. Interact. Cardiovasc. Thorac. Surg. 2012; 15: 299-300.
11. Ashikhmina E., Tomasello N., Connors J.M. et al.: Type A aortic dissection in a patient on dabigatran: hemostasis post circulatory arrest. Ann. Thorac. Surg. 2014; 98: 2215-2216.
12. Williamson L.D., Maxwell E., Silvers A.J., Marasco S.F.: Dabigatran anticoagulation and Stanford type A aortic dissection: not always a lethal coincidence? Acta Anaesthesiol. Scand. 2014; 58: 1160-1161.
13. Marchetti G., Giuliani E., Urbinati S., Barbieri A.: Dabigatran anticoagulation and Stanford type A aortic dissection: not a lethal coincidence. Acta Anaesthesiol. Scand. 2016; 60: 544.
14. Douketis J.D., Healey J.S., Brueckmann M. et al.: Urgent surgery or procedures in patients taking dabigatran or warfarin: Analysis of perioperative outcomes from the RE-LY trial. Thromb. Res. 2016; 139: 77-81.
15. Pollack C.V. Jr., Reilly P.A., Eikelboom J. et al.: Idarucizumab for Dabigatran Reversal. N. Engl. J. Med. 2015; 373: 511-520.
16. Heidbuchel H., Verhamme P., Alings M. et al.: Updated European Heart Rhythm Association practical guide on the use of non-vitamin-K antagonist anticoagulants in patients with non-valvular atrial fibrillation: Executive summary. Eur. Heart J. 2017; 38(27): 2137-2149.
17. Pagano D., Milojevic M., Meesters M.I. et al.: 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. Eur. J. Cardiothorac. Surg. 2018; 53: 79-111.
18. Tomaszuk-Kazberuk A., Lopatowska P., Mlodawska E. et al.: Successful use of idarucizumab as a reversal agent for dabigatran in a patient with acute dissected aortic aneurysm. Pol. Arch. Intern. Med. 2017; 127: 68-70.
19. Di Eusanio M., Trimarchi S., Patel H.J. et al.: Clinical presentation, management, and short-term outcome of patients with type A acute dissection complicated by mesenteric malperfusion: observations from the International Registry of Acute Aortic Dissection. J. Thorac. Cardiovasc. Surg. 2013; 145: 385-90 e1.
20. Pacini D., Leone A., Belotti L.M. et al.: Acute type A aortic dissection: significance of multiorgan malperfusion. Eur. J. Cardiothorac. Surg. 2013; 43: 820-826.
21. Geirsson A., Szeto W.Y., Pochettino A. et al.: Significance of malperfusion syndromes prior to contemporary surgical repair for acute type A dissection: outcomes and need for additional revascularizations. Eur. J. Cardiothorac. Surg. 2007; 32: 255-262.
22. Hagan P.G., Nienaber C.A., Isselbacher E.M. et al.: The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA 2000; 283: 897-903.
23. Schumer E.M., Chaney J.H., Trivedi J.R. et al.: Emergency Coronary Artery Bypass Grafting: Indications and Outcomes from 2003 through 2013. Tex. Heart Inst. J. 2016; 43: 214-219.
24. Malaisrie S.C., McCarthy P.M., Kruse J. et al.: Burden of preoperative atrial fibrillation in patients undergoing coronary artery bypass grafting. J. Thorac. Cardiovasc. Surg. 2018; 155: 2358-2367 e1.
25. Mazur P., Darocha T., Filip G. et al.: Idarucizumab for dabigatran reversal in patients with atrial fibrillation undergoing emergency surgery for acute aortic syndrome. Pol. Arch. Med. Wewn. 2016; 126: 579-581.
26. Vuylsteke A., Pagel C., Gerrard C. et al.: The Papworth Bleeding Risk Score: a stratification scheme for identifying cardiac surgery patients at risk of excessive early postoperative bleeding. Eur. J. Cardiothorac. Surg. 2011; 39: 924-930.
27. Connolly S.J., Ezekowitz M.D., Yusuf S. et al.: Dabigatran versus warfarin in patients with atrial fibrillation. N. Engl. J. Med. 2009; 361: 1139-1151.
28. Heidbuchel H., Verhamme P., Alings M. et al.: EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur. Heart J. 2013; 34: 2094-2106.
29. Crowther M., Cuker A.: How can we reverse bleeding in patients on direct oral anticoagulants? Kardiol. Pol. 2019; 77: 3-11.
30. Raval A.N., Cigarroa J.E., Chung M.K et al.: Management of Patients on Non-Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting: A Scientific Statement From the American Heart Association. Circulation 2017; 135: e604-e33.
31. Simon A., Domanovits H., Ay C. et al.: Recommended dose of Idarucizumab may not always be sufficient for sustained reversal of Dabigatran. J. Thromb. Haemost. 2017; 15(7): 1317-1321.
32. Vosko M.R., Bocksrucker C., Drwila R. et al.: Real-life experience with the specific reversal agent idarucizumab for the management of emergency situations in dabigatran-treated patients: a series of 11 cases. J. Thromb. Thrombolysis 2017; 43: 306-317.
33. Amsterdam E.A., Wenger N.K., Brindis R.G. et al.: 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 130: 2354-2394.
34. Bijak M., Bobrowski M.: The importance of thrombin inhibitors in the antithrombotic pharmacotherapy. Postępy Nauk Medycznych 2010; 23(10): 819-825.
35. Vanassche T., Greinacher A., Verhamme P.: Reversal of dabigatran by idarucizumab: when and how? Expert Rev. Hematol. 2016; 9: 519-528.
36. Samuelson B.T., Cuker A.: Measurement and reversal of the direct oral anticoagulants. Blood Rev. 2017; 31: 77-84.
37. Czubek U., Goralczyk T., Zalewski J., Undas A.: Monitoring of anticoagulant effects of dabigatran in everyday practice: first experience in 32 Polish patients. Pol. Arch. Med. Wewn. 2014; 124: 487-489.