Hemorrhagic accidents of the new oral anticoagulants and coagulation assays;Accidents hémorragiques des nouveaux anticoagulants oraux et examens de la coagulation

Journal des Maladies Vasculaires

Volumn 38, Issue 4, 2013, Pages 259-270

  Samama, M M ^a,b   Conard, J ^a,c   Lillo Le Louet A ^d  

^a HÔTEL DIEU   (France)

^b Laboratoire Biomnis   (France)

^c SAINT JOSEPH HOSPITAL   (France)

^d HÔpital européen George Pompidou   (France)

Author keywords

Apixaban; Bleeding; Dabigatran; Reversal; Rivaroxaban

Indexed keywords

ACTIVATED PROTHROMBIN COMPLEX; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 10A; RECOMBINANT BLOOD CLOTTING FACTOR 7A; THROMBIN;

BLEEDING DISORDER; BLOOD CLOTTING TEST; CEREBROVASCULAR ACCIDENT; DEATH; EMERGENCY SURGERY; HEMOSTASIS; HUMAN; HYPOCOAGULABILITY; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; QUALITATIVE ANALYSIS; RECURRENT DISEASE; RISK ASSESSMENT; SHORT SURVEY;

APIXABAN; BLEEDING; DABIGATRAN; HÉMORRAGIE; NEUTRALISATION; REVERSAL; RIVAROXABAN;

ADMINISTRATION, ORAL; ANTICOAGULANTS; BLOOD COAGULATION TESTS; HEMORRHAGE; HUMANS; POSTOPERATIVE HEMORRHAGE;

EID: 84880733849     PISSN: 03980499     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jmv.2013.05.005     Document Type: Short Survey

References (62)

1. th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012, 141(Suppl. 2):120-151.
2. Yoshida R.D., Yoshida W.B., Maffei F.H., El Dib R., Nunes R., Rollo H.A. Systematic review of randomized controlled trials of new anticoagulants for venous thromboembolism prophylaxis in major orthopedic surgeries, compared with enoxaparin. Ann Vasc Surg 2013, 27:355-369.
3. Samama M.M., Guinet C. Laboratory assessments of new anti-coagulants. Clin Chem Lab Med 2011, 49:761-772.
4. Agnelli G., Buller H.R., Cohen A., Curto M., Gallus A.S., Johnson M., et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med 2013, 368:699-708.
5. Samama M.M., Guinet C., LeFlem L. Do new oral anticoagulants require laboratory monitoring? The clinician point of view. Thromb Res 2012, 130:S88-S89.
6. Bauersachs R., Berkowitz S.D., Brenner B., Buller H.R., Decousus H., Gallus A.S., et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010, 363:2499-2510.
7. Eriksson B.I., Borris L.C., Friedman R.J., Haas S., Huisman M.V., Kakkar A.K., et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008, 358:2765-2775.
8. Schulman S., Kearon C., Kakkar A.K., Mismetti P., Schellong S., Eriksson H., et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009, 361:2342-2352.
9. Connolly S.J., Ezekowitz M.D., 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.
10. The Executive Steering Committee 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. on behalf of the ROCKET AF study investigators.
11. Granger C.B., Alexander J.H., McMurray J.J., Lopes R.D., Hylek E.M., Hanna M., et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011, 365:981-992.
12. Connolly S.J., Eikelboom J., Campbell Joyner B.S., Diener H.C., Hart R., Golitsyn S., et al. Apixaban in patients with atrial fibrillation. N Engl J Med 2011, 364:806-817.
13. Samama M.M., Martinoli J.L., LeFlem L., Guinet C., Plu-Bureau G., Depasse F., et al. Assessment of laboratory assays to measure rivaroxaban-an oral, direct factor Xa inhibitor. Thromb Haemost 2010, 103:815-825.
14. Gerotziafas G.T., Baccouche H., Sassi M., Galea V., Chaan M., Hatmi M., et al. Optimisation of the assays for the measurement of clotting factor activity in the presence of rivaroxaban. Thromb Res 2012, 129:101-103.
15. Mani H., Hesse C., Stratmann G., Lindhoff-Last E. Ex vivo effects of low-dose rivaroxaban on specific coagulation assays and coagulation factor activities in patients under real life conditions. Thromb Haemost 2013, 109:127-136.
16. Lindhoff-Last E., Samama M.M., Ortel T.L., Weitz J.I., Spiro T.E. Assays for measuring rivaroxaban: their suitability and limitations. Ther Drug Monit 2010, 32:673-679.
17. Samama M.M., Gerotziafas G. Nouveaux anticoagulants. Ann Pharm Fr 2007, 65:85-94.
18. Samama M.M., Conard J., Flaujac C., Combe S., Horellou M.H. Hétérogénéité pharmacologique des nouveaux anticoagulants. J Mal Vasc 2011, 36:S10-S15.
19. Tripodi A., Chantarangkul Y., Guinet C., Samama M.M. The INR calibrated for rivaroxaban (INRivaroxaban) has the potential to normalize PT results for rivaroxaban-treated patients. Results of an in vitro study. J Thromb Haemost 2011, 9:226-228.
20. Harenberg J., Krämer R., Giese C., Marx S., Weiss C., Wehling M. Determination of rivaroxaban by different factor Xa specific chromogenic substrate assays: reduction of interassay variability. J Thromb Thrombolysis 2011, 32:267-271.
21. Samama M.M., Contant G., Spiro T.E., Perzborn E., LeFlem L., Guinet C., et al. Evaluation of the prothrombin time for measuring rivaroxaban plasma concentrations using calibrators and controls: the results of a multicenter field trial. Clin Appl Thromb Hemost 2012, 18:150-158.
22. Samama M.M., Contant G., Spiro T.E., Perzborn E., Guinet C., Gourmelin Y., et al. Rivaroxaban anti-factor Xa chromogenic assay field trial laboratories. Evaluation of the anti Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls. Thromb Haemost 2012, 107:379-387.
23. Samama M.M., Guinet C., Le Flem L., Ninin E., Debue J.M. Measurement of dabigatran and rivaroxaban in primary prevention of venous thromboembolism in 106patients, who have undergone major orthopedic surgery: an observational study. J Thromb Thrombolysis 2013, 35:140-146.
24. Freyburger G., Macouillard G., Lebrouche S., Sztark F. Coagulation parameters in patients receiving dabigatran etexilate or rivaroxaban: two observational studies in patients undergoing total hip or total knee replacement. Thromb Res 2011, 127:457-465.
25. Mueck W., Borris L.C., Dahl O.E., Haas S., Huisman M.V., Kakkar A.K., et al. Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement. Thromb Haemost 2008, 100:453-461.
26. Mueck W., Lensing A.W., Agnelli G., Decousus H., Prandoni P., Misselwitz F. Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet 2011, 50:675-686.
27. Stangier J., Feuring M. Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran. Blood Coagul Fibrinolysis 2012, 23:138-143.
28. Southworth R., Reichman M.E., Unger E.F. Dabigatran and postmarketing reports of bleeding. N Engl J Med 2013, 368:1272-1274.
29. McConeghy K., Bress A., Wing C. Reports of bleeding-related fatalities with dabigatran and warfarin: an analysis using the Food and Drug Administration adverse events reporting system. J Am Coll Cardiol 2013, 61:10_S.
30. Harinstein L.M., Morgan J.W., Russo N. Treatment of dabigatran-associated bleeding: case report and review of the literature. J Pharm Pract 2012, 10.1177/0897190012465955.
31. Holster I.L., Valkhoff V.E., Kuipers E.J., Tjwa E.T. New oral anticoagulants increase risk for gastrointestinal bleeding-A systematic review and meta-analysis. Gastroenterology 2013, 10.1053/j.gastro.2013.02.041.
32. Harper P., Young L., Merriman E. Bleeding risk with dabigatran in the frail elderly. N Engl J Med 2012, 366:864-866.
33. Legrand M., Mateo J., Aribaud A., Ginisty S., Eftekhari P., Tran Ba Huy P., et al. The use of dabigatran in elderly patients. Arch Intern Med 2011, 171:1285-1288.
34. Husari A., Beydoun A., Ammar A.S., Maakaron J.E., Tahzer A. The untold story of dabigatran etexilate; alveolar hemorrhage in an elderly patient with interstitial pulmonary fibrosis. J Thromb Thrombolysis 2013, 35:81-82.
35. Barton C.A., McMillian W.D., Raza S.S., Keller R.E. Hemopericardium in a patient treated with dabigatran etexilate. Pharmacotherapy 2012, 32:e103-e107.
36. Cano E.L., Miyares M.A. Clinical challenges in a patient with dabigatran-induced fatal hemorrhage. Am J Geriatr Pharmacother 2012, 10:160-163.
37. 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.
38. Wychowski M.K., Kouides P.A. Dabigatran-induced gastrointestinal bleeding in an elderly patient with moderate renal impairment. Ann Pharmacother 2012, 46. [abst].
39. Chen B.C., Viny A.D., Garlich F.M., Basciano P., Howland M.A., Smith S.W., et al. Hemorrhagic complications associated with dabigatran use. Clin Toxicol (Phila) 2012, 50:854-857.
40. Dy E.A., Shiltz D.L. Hemopericardium and cardiac tamponade associated with dabigatran use. Ann Pharmacother 2012, 46:e18.
41. Dumkow L.E., Voss J.R., Peters M., Jennings D.L. Reversal of dabigatran-induced bleeding with a prothrombin complex concentrate and fresh frozen plasma. Am J Health Syst Pharm 2012, 69:1646-1650.
42. Fellows S.E., Rosini J.M., Curtis J.A., Volz E.G. Hemorrhagic gastritis with dabigatran in a patient with renal insufficiency. J Emergency Med 2013, 44:e221-e225.
43. Lillo-Le Louët A., Wolf M., Soufir L., Galbois A., Dumenil A.S., Offenstadt G., et al. Life-threatening bleeding in four patients with an unusual excessive response to dabigatran: complications for emergency surgery and resuscitation. Thromb Haemost 2012, 108:583-585.
44. Moore C.H., Snashall J., Boniface K., Scott J. Spontaneous splenic hemorrhage after initiation of dabigatran (Pradaxa) for atrial fibrillation. Am J Emerg Med 2012, 30. [2082el-2082e2].
45. Aron J.L., Gosselin R., Moll S., Arkin C.F., Mantha S. Effects of recombinant factor VIIa on thrombin generation and thromboelastography in a patient with dabigatran-association intracranial hemorrhage. J Thromb Thrombolysis 2013, [Epub ahead of print]. 10.1007/s11239-013-0913-0.
46. Garber S.T., Sivakumar W., Schmidt R.H. Neurosurgical complications of direct thrombin inhibitors-catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran. J Neurosurg 2012, 116:1093-1096.
47. Saignement sous dabigatran, rivaroxaban ou apixaban. Pas d'antidote et peu d'expérience clinique. Prescrire 2013; 353:202-6.
48. Woo J.S., Kapadia N., Phanco S.E., Lynch C.A. Positive outcome after intentional overdose of dabigatran. J Med Toxicol 2013, 9:192-195.
49. Boland M., Murphy M., McDermott E. Acute-onset severe gastrointestinal tract hemorrhage in a postoperative patient taking rivaroxaban after total hip arthroplasty: a case report. J Med Case Reports 2012, 6:129.
50. Jameson S.S., Rymaszewska M., Hui A.C., James P., Serrano-Pedraza I., Muller S.D. Wound complications following rivaroxaban administration: a multicenter comparison with low-molecular-weight heparins for thromboprophylaxis in lower limb arthroplasty. J Bone Joint Surg Am 2012, 94:1554-4558.
51. Van Ryn J., Litzenburger T., Schurer J. Reversal of anticoagulant activity of dabigatran and dabigatran-induced bleeding in rats by a specific antidote (antibody fragment). AHA 2013, Boehringer Inhelheim Pharma GmbH& Co KG, Biberach, Germany, [abstract 9928].
52. Lu G., DeGuzman F.R., Hollenbach S.J., Karbarz M.J., Abe K., Lee G., et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013, 19:446-451.
53. Marlu R., Paris A., Hodaj E., Albaladejo P., Polack B., Pernod G. Reversal of anticoagulant effect of dabigatran and rivaroxaban by non-specific reversal agents: a randomized crossover ex vivo study in healthy volunteers. Thromb Haemost 2012, 108:217-224.
54. Levi M. Reverse engineering for new oral anticoagulants: non specific reversal agents and the anticoagulants activity of dabigatran and rivaroxaban. Thromb Haemost 2012, 108:201-202.
55. Wanek M.R., Horn E.T., Elapavaluru S., Baroody S.C., Sokos G. Safe use of hemodialysis for dabigatran removal before cardiac surgery. Ann Pharmacother 2012, 46:e21.
56. McLellan A.J.A., Schlaich M.P. Dabigatran elimination: is hemodialysis effective?. Thromb Haemost 2013, 109:580-581.
57. Khadzhynov D., Wagner F., Formella S., Wiegert E., Moschetti V., Slowinski T., et al. Effective elimination of dabigatran by haemodialysis. A phase I single-centre study in patients with end-stage renal disease. Thromb Haemost 2013, 109:596-605.
58. o1065].
59. Sie P., Samama C.M., Godier A., Rosencher N., Steib A., Llau J.V., et al. Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: thrombin of factor-Xa inhibitors. Recommendations of the Working Group on Perioperative Haemostasis and the French Study Group on Thrombosis and Haemostasis. Arch Cardiovasc Dis 2011, 104:669-676.
60. Douxfils J., Mullier F., Loosen C., Chatelain C., Chatelain B., Dogné J.M. Assessment of the impact of rivaroxaban on coagulation assays: laboratory recommendations for the monitoring of rivaroxaban and review of the literature. Thromb Res 2012, 130:956-966.
61. Lee V.H., Conners J.J., Prabhakaran S. Intravenous thrombolysis in a stroke patient taking dabigatran. J Stroke Cerebrovasc Dis 2012, 21. [916.e11-12].
62. Healey J.S., Eikelboom J., Douketis J., Wallentin L., Oldgren J., Yang S., et al. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin. Circulation 2012, 126:343-348.