Zastosowanie idarucyzumabu u pacjenta leczonego dabigatranem w przypadku konieczności wykonania pilnej operacji kardiochirurgicznej – doświadczenia ośrodka krakowskiego Opis serii przypadków
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Opublikowane:
gru 31, 2019
Słowa kluczowe:
dabigatran, idarucyzumab, kardiochirurgia, krwawienie
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Abstrakt
Eteksylan dabigatranu (dabigatran) jest bezpośrednim, selektywnym i odwracalnym inhibitorem trombiny podawanym w postaci proleku, który po wchłonięciu z przewodu pokarmowego przekształca się w aktywny metabolit. Nagłe operacje w trakcie leczenia dabigatranem wiążą się z podwyższonym ryzykiem krwawienia. W 2015 r. FDA zaaprobowała idarucyzumab jako swoisty czynnik odwracający działanie dabigatranu w stanach zagrożenia życia. Idarucyzumab jest fragmentem przeciwciała monoklonalnego wiążącym dabigatran z wysokim powinowactwem, którego działanie zostało zweryfikowane w wieloośrodkowym badaniu nierandomizowanym RE-VERSE AD (NCT02104947). Aktualne wytyczne European Heart Rhythm Association i European Association of Cardio-Thoracic Surgery rekomendują idarucyzumab w sytuacjach krwotoku zagrażającego życiu czy w przypadku konieczności wykonania pilnego zabiegu (w tym kardiochirurgicznego). Niniejsze opracowanie przedstawia doświadczenia kliniczne z użyciem idarucyzumabu u pacjentów wymagających pilnej operacji kardiochirurgicznej.
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Jak cytować
Mazur, P., & Undas, A. (2019). Zastosowanie idarucyzumabu u pacjenta leczonego dabigatranem w przypadku konieczności wykonania pilnej operacji kardiochirurgicznej – doświadczenia ośrodka krakowskiego. Medycyna Faktów , 12(4(45), 331-339. https://doi.org/10.24292/01.MF.0419.4
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Artykuły
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Bibliografia
1. Caldeira D., Rodrigues F.B., Barra M. et al.: Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis. Heart 2015; 101: 1204-1211.
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.
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.