Clinical evaluation of laboratory methods to monitor apixaban treatment in patients with atrial fibrillation

Thrombosis Research

Volumn 136, Issue 1, 2015, Pages 148-153

  Skeppholm, Mika ^a   Al Aieshy, Fadiea ^b   Berndtsson, Maria ^b   Al Khalili, Faris ^c   Rönquist Nii, Yuko ^b   Söderblom, Lisbeth ^b   Östlund, Annika Y ^b   Pohanka, Anton ^b   Antovic, Jovan ^b   Malmström, Rickard E ^b  

^a KAROLINSKA INSTITUTE   (Sweden)

^b KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^c Stockholm Heart Center   (Sweden)

Author keywords

Anti FXa assay; Apixaban concentration; aPTT; Atrial fibrillation; LC MS MS

Indexed keywords

APIXABAN; BLOOD CLOTTING FACTOR 10A; CREATININE; BLOOD CLOTTING FACTOR 10A INHIBITOR; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE;

AGE; AGED; ANTI BLOOD CLOTTING FACTOR 10A ASSAY; ARTICLE; ATRIAL FIBRILLATION; BLOOD CLOTTING TEST; BODY WEIGHT; CARDIOVASCULAR RISK; CHADS2 SCORE; CLINICAL EVALUATION; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG EXPOSURE; DRUG MONITORING; FEMALE; GENDER; GOLD STANDARD; HUMAN; INTERNATIONAL NORMALIZED RATIO; KIDNEY FUNCTION; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; PARTIAL THROMBOPLASTIN TIME; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SENSITIVITY AND SPECIFICITY; TANDEM MASS SPECTROMETRY; THROMBOEMBOLISM; BLOOD; EVALUATION STUDY; PROCEDURES; PROTHROMBIN TIME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ATRIAL FIBRILLATION; CHROMATOGRAPHY, LIQUID; DRUG MONITORING; FACTOR XA INHIBITORS; FEMALE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; PYRAZOLES; PYRIDONES; TANDEM MASS SPECTROMETRY;

EID: 84931576592     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2015.04.030     Document Type: Article

References (25)

1. B.F. Gage, A.D. Waterman, W. Shannon, M. Boechler, M.W. Rich, and M.J. Radford Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation JAMA 285 2001 2864 2870
2. R.G. Hart, L.A. Pearce, and M.I. Aguilar Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation Ann Intern Med 146 2007 857 867
3. S. Agarwal, R. Hachamovitch, and V. Menon Current trial-associated outcomes with warfarin in prevention of stroke in patients with nonvalvular atrial fibrillation Arch Intern Med 172 2012 623 631
4. R.D. Lopes, J.H. Alexander, S.M. Al-Khatib, J. Ansell, R. Diaz, and J.D. Easton ARISTOTLE Investigators. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale Am Heart J 159 2010 331 339
5. C.B. Granger, J.H. Alexander, J.J. McMurray, R.D. Lopes, E.M. Hylek, and M. Hanna Apixaban versus warfarin in patients with atrial fibrillation N Engl J Med 365 2011 981 992
6. A.J. Camm, G.Y. Lip, R. De Caterina, I. Savelieva, D. Atar, and S.H. Hohnloser 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 Eur Heart J 33 2012 2719 2747
7. H. Heidbuchel, P. Verhamme, M. Alings, M. Antz, W. Hacke, and J. Oldgren European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation Europace 15 2013 625 651
8. Summary of product characteristics, Eliquis (apixaban). Bristol-Myers Squibb/Pfizer http://www.ema.europa.eu [Accessed March 9, 2015]
9. M. Skeppholm, P. Hjemdahl, J.P. Antovic, J. Muhrbeck, J. Eintrei, and Y. Rönquist-Nii On the monitoring of dabigatran treatment in "real life" patients with atrial fibrillation Thromb Res 134 2014 783 789
10. D. Cohen Dabigatran: how the drug company withheld important analyses BMJ 349 2014 g4670
11. T. Baglin, A. Hillarp, A. Tripodi, I. Elalamy, H. Buller, and W.J. Ageno Measuring Oral Direct Inhibitors (ODIs) of thrombin and factor Xa: A recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis J Thromb Haemost 11 2013 756 760
12. Y.C. Barrett, Z. Wang, C. Frost, and A. Shenker Clinical laboratory measurement of direct factor Xa inhibitors: anti-Xa assay is preferable to prothrombin time assay Thromb Haemost 104 2010 1263 1271
13. R.C. Becker, J.H. Alexander, L.K. Newby, H. Yang, Y. Barrett, and P. Mohan Effect of apixaban, an oral and direct factor Xa inhibitor, on coagulation activity biomarkers following acute coronary syndrome Thromb Haemost 104 2010 976 983
14. R.C. Becker, H. Yang, Y. Barrett, P. Mohan, J. Wang, and L. Wallentin Chromogenic laboratory assays to measure the factor Xa-inhibiting properties of apixaban-an oral, direct and selective factor Xa inhibitor J Thromb Thrombolysis 32 2011 183 187
15. Y. Cui, Y. Song, J. Wang, Z. Yu, A. Schuster, and Y.C. Barrett Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects Clin Pharmacol 5 2013 177 184
16. J. Douxfils, C. Chatelain, B. Chatelain, J.M. Dogné, and F. Mullier Impact of apixaban on routine and specific coagulation assays: a practical laboratory guide Thromb Haemost 110 2013 283 294
17. I. Gouin-Thibault, C. Flaujac, X. Delavenne, S. Quenet, M.H. Horellou, and S. Laporte Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. A multicentre French GEHT study Thromb Haemost 111 2014 240 248
18. N. Yamahira, C. Frost, H. Fukase, Z. Yu, J. Wang, and J. Pursley Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of apixaban in healthy Japanese male subjects Int J Clin Pharmacol Ther 52 2014 564 573
19. A. Hillarp, K.M. Gustafsson, L. Faxälv, K. Strandberg, F. Baghaei, and I. Fagerberg Blixter Effects of the oral, direct factor Xa inhibitor apixaban on routine coagulation assays and anti-FXa assays J Thromb Haemost 12 2014 1545 1553
20. C. Frost, S. Nepal, J. Wang, A. Schuster, W. Byon, and R.A. Boyd Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects Br J Clin Pharmacol 76 2013 776 786
21. S. Ogawa, Y. Shinohara, and K. Kanmuri Safety and efficacy of the oral direct factor Xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study Circ J 75 2011 1852 1859
22. S.H. Hohnloser, Z. Hijazi, L. Thomas, J.H. Alexander, J. Amerena, and M. Hanna Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial Eur Heart J 33 2012 2821 2830
23. L. Friberg, M. Rosenqvist, and G.Y. Lip Net clinical benefit of warfarin in patients with atrial fibrillation: a report from the Swedish atrial fibrillation cohort study Circulation 125 2012 2298 2307
24. F.D.A. Apixaban Clinical Review http://www.accessdata.fda.gov/drugsatfda-docs/nda/2012/202155Orig1s000MedR.pdf 2012 [Accessed March 9, 2015]
25. P.A. Reilly, T. Lehr, S. Haertter, S.J. Connolly, S. Yusuf, and J.W. Eikelboom The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients: The RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) J Am Coll Cardiol 63 2014 321 328