Initial Evaluation of Reasonableness of Target INR 1.60 to 2.20 and Warfarin Weekly Dosage Adjustment in Patients after Mechanical Heart Valve Replacement_Chinese Journal of Evidence-Based Medicine

Authors：

 XIAOXi-jun ¹ , LIUGuan-jian ² , LIANGMao-zhi ³ , RENRong ¹ , ZHUXi-liang ¹ , XIANGJing ³ , HEFan ¹

1. Division of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu 610041, China;
2. Chinese Evidance-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
3. Institution of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

Keywords：

Mechanical heart valve replacement; Anticoagulation management; Time in therapeutic range

DOI：

10.7507/1672-2531.20140004

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Objective To evaluate the reasonableness of anticoagulation management strategy in patients after mechanical heart valve replacement. Methods All patients were followed and registered continually at outpatient clinic from July 2011 to February 2013, with a minimum of 6 months after surgery. Targeted international normalized rate (INR) 1.60 to 2.20 and warfarin weekly dosage adjustment were used as the strategy of anticoagulation management. Except bleeding, thrombogenesis and thromboembolism, time in therapeutic range (TTR) and fraction of TTR (FTTR) were adopted to evaluate the quality of anticoagulation management. Results A total 1 442 patients and 6 461 INR values were included for data analysis. The patients had a mean age of 48.2±10.6 years (14-80 years) and the following up time were 6 to 180 months (39.2±37.4 months) after surgery. Of these patients, 1 043 (72.3%) was female and 399 (27.7%) was male. INR values varied from 0.90-8.39 (1.85±0.49) and required weekly doses of warfarin were 2.50-61.25 (20.89±6.93 mg). TTR of target INR and acceptable INR were 51.1% (156 640.5 days/306 415.0 days), 64.9% (198 856.0 days/306 415.0 days), respectively. FTTR of target INR and acceptable INR were 49.4% (3 193 times/6 461 times), 62.6% (4 047 times/6 461 times). There were 8 major bleeding events, 7 mild bleeding events, 2 thromboembolism events, and 2 thrombogenesis in the left atrium. Conclusion It is reasonable to use target INR 1.60-2.20 and warfarin weekly dosage adjustment for patients after mechanical heart valve replacement.

Citation： XIAOXi-jun, LIUGuan-jian, LIANGMao-zhi, RENRong, ZHUXi-liang, XIANGJing, HEFan. Initial Evaluation of Reasonableness of Target INR 1.60 to 2.20 and Warfarin Weekly Dosage Adjustment in Patients after Mechanical Heart Valve Replacement. Chinese Journal of Evidence-Based Medicine, 2014, 14(1): 16-20. doi: 10.7507/1672-2531.20140004 Copy

1.	Schmitt L, Speckman J, Ansell J. Quality assessment of anticoagulation does management:Comparative evaluation of measures of time-in-therapeutic range. J Thromb Thrombolysis, 2003, 15(3):213-216.
2.	Bayliss A, Faber P, Dunning J, et al. What is the optimal level of anticoagulation in adult patients receiving warfarin following implantation of a mechanical prosthetic mitral valve? Interact Cardiovasc Thorac Surg, 2007, 6(3):390-396.
3.	Fukui T, Shibata T, Sasaki Y, et al. Long-term experience with the Sorin Bicarbon and Edwards Mira mechanical valve prostheses in the mitral position. Gen Thorac Cardiovasc Surg, 2007, 55(3):91-97.
4.	Koertke H, Minami K, Boethig D et al. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation, 2003, 108(Suppl 1):1175-1181.
5.	Rosendaal FR, Cannegieter SC, van der Meer FJ, et al. A methoed to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost, 1993, 69(3):236-239.
6.	Osinbowale O, Al Malki M, Schade A, et al. An algorithm for managing warfarin resistance. Cleve Clin J Med, 2009, 76(12):724-730.
7.	Schulman S, El Bouazzaoui B, Eikelboom JW, et al. Clinical factors influencing the sensitivity to warfarin when restarted after surgery. J Intern Med, 2008, 263(4):412-419.
8.	Eriksson N, Wadelius M. Prediction of warfarin dose:Why, when and how? Pharmacogenomics, 2012, 13(4):429-440.
9.	Kimmel SE. Warfarin therapy:in need of improvement after all these years. Expert Opin Pharmacother, 2008, 9(5):677-686.
10.	Mahajan P, Meyer KS, Wall GC, et al. Clinical applications of pharmacogenomics guided warfarin dosing. J Clin Pharmacy, 2012, 33(1):10-19.
11.	Emery RW, Emery AM, Raikar GV, et al. Anticoagulation for mechanical heart valves:a role for patient based therapy. J Thromb Thrombolysis, 2008, 25(1):18-25.
12.	Dunning J, Versteegh M, Fabbri A, et al. Gudeline on antiplatelet and anticoagulation management in cardiac surgery. Eur J Cardiothorac Surg, 2008, 34(1):73-92.
13.	Piper C, Horstkotte D. State of the art anticoagulation Management. J Heart Valve Dis, 2004, 13(Suppl 1):S76-80.
14.	Horstkotte D, Piper C, Wiemer M. Optimal frequency of patient monitoring and intensity of oral anticoagulation therapy in valvular heart disease. J Thromb Thrombolysis, 1998, Suppl 1(3):19-24.
15.	Sconce EA, Kamali F. Appraisal of current vitamin K dosing algorithms for the reversal of over-anticoagulation with warfarin:the need for a more tailored dosing regimen. Eur J Haematol, 2006, 77(6):457-462.
16.	Wozniak M, Kruit A, Padmore R, et al. Prothrombin complex concentrate for the urgent reversal of warfarin. Assessent of a standard dosing protocol. Transfus Apher Sci, 2012, 46(3):309-314.
17.	Klein TE, Altman RB, Eriksson N, et al. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med, 2009, 360(8):753-764.
18.	Meijer K, Kim YK, Schulman S. Decreasing warfarin sensitivity during the first three months after heart valve surgery:Implications for dosing. Thromb Res, 2010, 125(3):224-229.
19.	Gong IY, Tirona RG, Schwarz UI, et al. Prospective evaluation of a pharmacogenetics-guided warfarin loading and maintenance dose regimen for initiation of therapy. Blood, 2011, 118(11):3163-3171.
20.	Herijgers P, Verhamme P. Improving the quality of anticoagulant therapy in patients with mechanical heart valves:what are we waiting for? Eur Heart J, 2007, 28(20):2424-2426.

1. Schmitt L, Speckman J, Ansell J. Quality assessment of anticoagulation does management:Comparative evaluation of measures of time-in-therapeutic range. J Thromb Thrombolysis, 2003, 15(3):213-216.
2. Bayliss A, Faber P, Dunning J, et al. What is the optimal level of anticoagulation in adult patients receiving warfarin following implantation of a mechanical prosthetic mitral valve? Interact Cardiovasc Thorac Surg, 2007, 6(3):390-396.
3. Fukui T, Shibata T, Sasaki Y, et al. Long-term experience with the Sorin Bicarbon and Edwards Mira mechanical valve prostheses in the mitral position. Gen Thorac Cardiovasc Surg, 2007, 55(3):91-97.
4. Koertke H, Minami K, Boethig D et al. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation, 2003, 108(Suppl 1):1175-1181.
5. Rosendaal FR, Cannegieter SC, van der Meer FJ, et al. A methoed to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost, 1993, 69(3):236-239.
6. Osinbowale O, Al Malki M, Schade A, et al. An algorithm for managing warfarin resistance. Cleve Clin J Med, 2009, 76(12):724-730.
7. Schulman S, El Bouazzaoui B, Eikelboom JW, et al. Clinical factors influencing the sensitivity to warfarin when restarted after surgery. J Intern Med, 2008, 263(4):412-419.
8. Eriksson N, Wadelius M. Prediction of warfarin dose:Why, when and how? Pharmacogenomics, 2012, 13(4):429-440.
9. Kimmel SE. Warfarin therapy:in need of improvement after all these years. Expert Opin Pharmacother, 2008, 9(5):677-686.
10. Mahajan P, Meyer KS, Wall GC, et al. Clinical applications of pharmacogenomics guided warfarin dosing. J Clin Pharmacy, 2012, 33(1):10-19.
11. Emery RW, Emery AM, Raikar GV, et al. Anticoagulation for mechanical heart valves:a role for patient based therapy. J Thromb Thrombolysis, 2008, 25(1):18-25.
12. Dunning J, Versteegh M, Fabbri A, et al. Gudeline on antiplatelet and anticoagulation management in cardiac surgery. Eur J Cardiothorac Surg, 2008, 34(1):73-92.
13. Piper C, Horstkotte D. State of the art anticoagulation Management. J Heart Valve Dis, 2004, 13(Suppl 1):S76-80.
14. Horstkotte D, Piper C, Wiemer M. Optimal frequency of patient monitoring and intensity of oral anticoagulation therapy in valvular heart disease. J Thromb Thrombolysis, 1998, Suppl 1(3):19-24.
15. Sconce EA, Kamali F. Appraisal of current vitamin K dosing algorithms for the reversal of over-anticoagulation with warfarin:the need for a more tailored dosing regimen. Eur J Haematol, 2006, 77(6):457-462.
16. Wozniak M, Kruit A, Padmore R, et al. Prothrombin complex concentrate for the urgent reversal of warfarin. Assessent of a standard dosing protocol. Transfus Apher Sci, 2012, 46(3):309-314.
17. Klein TE, Altman RB, Eriksson N, et al. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med, 2009, 360(8):753-764.
18. Meijer K, Kim YK, Schulman S. Decreasing warfarin sensitivity during the first three months after heart valve surgery:Implications for dosing. Thromb Res, 2010, 125(3):224-229.
19. Gong IY, Tirona RG, Schwarz UI, et al. Prospective evaluation of a pharmacogenetics-guided warfarin loading and maintenance dose regimen for initiation of therapy. Blood, 2011, 118(11):3163-3171.
20. Herijgers P, Verhamme P. Improving the quality of anticoagulant therapy in patients with mechanical heart valves:what are we waiting for? Eur Heart J, 2007, 28(20):2424-2426.

Chinese Journal of Evidence-Based Medicine

Initial Evaluation of Reasonableness of Target INR 1.60 to 2.20 and Warfarin Weekly Dosage Adjustment in Patients after Mechanical Heart Valve Replacement

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