Self-management of Anticoagulation Monitoring for Patients Following Mechanical Heart Valve Replacement: A non-randomized Controlled Trial_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

CHENQiu-lin ¹ ,  DONGLi ¹ , SHIYing-kang ¹ , ZHAOShu-lin ² , CHENGHan ¹

1. Deparment of Cardiovascular Surgery, West China Hospital of Sichuan University, Chengdu 610041, P. R. China;
2. Department of Cardiovascular Surgery, Daping Hospital of Third Military Medical University, Chongqing 400042, P. R. China;

Corresponding author：

DONGLi, Email: donglikn199@163.com

Keywords：

Heart valve replacement; anticoagulation therapy; Portable coagulometer; Self-monitoring; Self-management; Time in therapeutic range; Fraction of time in therapeutic range

DOI：

10.7507/1007-4848.20160157

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Objective To discuss the application value in increasing the frequency of monitoring and ensuring the safety of anticoagulation therapy in patient self-monitoring (PST) and self-management (PSM) of portable coagulometer. Method This non-randomized prospective controlled study was conducted in 100 patients receiving oral warfarin anticoagulation therapy after heart valve replacement and met the inclusion criteria in our hospital between March 2013 and April 2014 year. All the patients were divided into three groups including an outpatient follow-up group(outpatient group), a self-monitoring group and a self-management group. Meanwhile, the patients in the outpatient group visited professional institutions, performed international normalized ratio (INR) testing with central lab and adjusted the dosage of orally administered warfarin by the doctors. And the other two groups performed INR testing with CoaguChek XS portable coagulometer by themselves, and the patients in the self-management group performed management by themselves. The follow-up time was 6 months. The dates of time in therapeutic range (TTR), fraction of time in therapeutic range (FTTR) and anticoagulation complications in the three groups were analyzed and compared. Results There was no significant difference in the INR results obtained from the follow-up time among the three groups (P=0.845) . TTR value of INR of the outpatient group, the self-monitoring group, and the self-management group was 45.9% (4368.0 days/9517.0 days), 61.2% (6057.0 days/9897.0 days), and 65.4% (2833.8 days/4333.0 days), respectively with a statistical difference among the three groups (P<0.001) . FTTR value of INR obtained from the outpatient group, the self-monitoring group, and the self-management group was 48.3% (99 times/205 times), 60.7% (164 times/270 times), and 64.9% (100 times/154 times) respectively. There was a statistical difference in the FTTR between the outpatient group and the self-monitoring group (P=0.007) , and also between the outpatient group and the self-monitoring group (P=0.002) . But there was no statistical difference between the self-monitoring group and the self-management group (P=0.392) . There were not any major bleeding and thrombosis complications in all study. And there was no statistical difference in the total complications, thrombosis, and bleeding complications rates between the outpatient group and the self-monitoring group, and also between the outpatient group and the self-management group (P>0.05) . Conclusions The patients receiving oral anticoagulation after heart valve replacement or their care providers were able to perform PST and PSM. The use of portable coagulometer for self-monitoring and self-management can increase the frequency of anticoagulation monitoring and achieve better INR target value control. PST and PSM could achieve higher quality of anticoagulation management and life and without increasing the risk of oral anticoagulation than the traditional monitoring method. The monitoring frequency of once a month is reasonable for the patients receiving oral anticoagulation more than half a year after heart valve replacement.

Citation： CHENQiu-lin, DONGLi, SHIYing-kang, ZHAOShu-lin, CHENGHan. Self-management of Anticoagulation Monitoring for Patients Following Mechanical Heart Valve Replacement: A non-randomized Controlled Trial. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2016, 23(7): 646-652. doi: 10.7507/1007-4848.20160157 Copy

1.	董力, 许建屏, 石应康.《瓣膜病术后抗凝个体化和低抗凝标准研究》阶段研究进展. 中国胸心血管外科临床杂志, 2013, 20(1) :1-2.
2.	李大鹏, 黄亚辉, 公兰兰. 风湿性心脏病15年调查报告. 心血管康复医学杂志, 2001, 10(3) :251-253.
3.	罗征祥. 心脏瓣膜病治疗的发展. 岭南心血管病杂志, 2010,16(5) :343-351.
4.	Haibo Z, Jinzhong L, Yan L, et al. Low-intensity international normalized ratio (INR) oral anticoagulant therapy in Chinese patients with mechanical heart valve prostheses. Cell Biochem Biophys, 2012, 62(1) :147-151.
5.	Butchart EG, Payne N, Li HH, et al. Better anticoagulation control improves survival after valve replacementJ. J Thorac Cardiovasc Surg, 2002, 123(4) :715-723.
6.	Erkens PM, Ten CH, Buller HR, et al. Benchmark for time in therapeutic range in venous thromboembolism:a systematic review and meta-analysis. PLoS One, 2012, 7(9) :e42269.
7.	Matchar DB, Love SR, Jacobson AK, et al. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481:The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis, 2015, 40(1) :17-25.
8.	Desantis G, Hogan-Schlientz J, Liska G, et al. STABLE results:warfarin home monitoring achieves excellent INR controlJ. Am J Manag Care, 2014, 20(3) :202-209.
9.	Mair H, Sachweh J, Sodian R, et al. Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions. J Interact Cardiovasc Thorac Surg, 2012, 14(3) :253-257.
10.	Lee JH, Lee KS, Kim DS, et al. Evaluation of CoaguChek XS for measuring prothrombin time in patients receiving long-term oral anticoagulant therapy. Korean J Lab Med, 2007, 27(3) :177-181.
11.	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) :I75-I78.
12.	Poli D, Antonucci E, Gensini GF, et al. Asymptomatic excessive coumarin anticoagulation is a risk factor for thrombotic and bleeding complications of oral anticoagulant therapy. J Thromb Haemost, 2003, 1(8) :1840-1841.
13.	Fihn SD, Mcdonell M, Martin D, et al. Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimized Outpatient Follow-up Study Group. Ann Intern Med, 1993, 118(7) :511-520.
14.	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.
15.	Rosendaal FR, Cannegieter SC, van der Meer FJ, et al. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost, 1993, 69(3) :236-239.
16.	Schmitt L, Speckman J, Ansell J. Quality assessment of anticoagula-tion dose management:comparative evaluation of measures of time-in-therapeutic range. J Thromb Thrombolysis, 2003, 15(3) :213-216.
17.	Razouki Z, Ozonoff A, Zhao S, et al. Improving quality measurement for anticoagulation:adding international normalized ratio variabi-lity to percent time in therapeutic rangeJ. Circ Cardiovasc Qual Outcomes, 2014, 7(5) :664-669.
18.	Samsa GP, Matchar DB. Relationship between test frequency and outcomes of anticoagulation:a literature review and commentary with implications for the design of randomized trials of patient self-management. J Thromb Thrombolysis, 2000, 9(3) :283-292.
19.	Erdman S, Vidne B, Levy MJ. A self control method for long term anticoagulation therapy. J Cardiovasc Surg (Torino), 1974, 15(4) :454-457.
20.	Jacobson AK. Patient self-management of oral anticoagulant therapy:an international update. J Thromb Thrombolysis, 1998, 5 Suppl 1(3) :25-28.
21.	Nagler M, Bachmann LM, Schmid P, et al. Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice:efficacy and safety in a nationwide long-term prospective cohort studyJ. PLoS One, 2014, 9(4) :e95761.
22.	Grunau BE, Wiens MO, Harder KK. Patient self-management of warfarin therapy:pragmatic feasibility study in Canadian primary care. Can Fam Physician, 2011, 57(8) :e292-e298.
23.	杨军, 刘海燕, 张真路, 等. CoaguChek XS国标标准化比值检测仪的临床应用. 岭南心血管病杂志, 2009, 15(5) :372-375.
24.	张丽, 申雪琴, 张璐, 等. CoaguChek XS血凝仪检测国际标准化比值和凝血酶原时间的准确性和可靠性. 中华老年心脑血管病杂志, 2010, 12(6) :521-522.
25.	申雪琴, 张丽. 罗氏血凝仪CoaguChek XS测定国际标准化比值准确性的临床研究. 军医进修学院学报, 2010, 31(12) :1217-1218.
26.	赵树林, 董力, 石应康, 等. 心脏瓣膜置换术后抗凝治疗自我监测的临床研究. 四川大学学报(医学版), 2014, 45(5) :844-847.
27.	Taborski U, Wittstamm FJ, Bernardo A. Cost-effectiveness of self-managed anticoagulant therapy in Germany. Semin Thromb Hemost, 1999, 25(1) :103-107.
28.	Kortke H, Korfer R. International normalized ratio self-management after mechanical heart valve replacement:is an early start advanta-geous? Ann Thorac Surg, 2001, 72(1) :44-48.
29.	Christensen TD, Johnsen SP, Hjortdal VE, et al. Self-management of oral anticoagulant therapy:a systematic review and meta-analysis. Int J Cardiol, 2007, 118(1) :54-61.

1. 董力, 许建屏, 石应康.《瓣膜病术后抗凝个体化和低抗凝标准研究》阶段研究进展. 中国胸心血管外科临床杂志, 2013, 20(1) :1-2.
2. 李大鹏, 黄亚辉, 公兰兰. 风湿性心脏病15年调查报告. 心血管康复医学杂志, 2001, 10(3) :251-253.
3. 罗征祥. 心脏瓣膜病治疗的发展. 岭南心血管病杂志, 2010,16(5) :343-351.
4. Haibo Z, Jinzhong L, Yan L, et al. Low-intensity international normalized ratio (INR) oral anticoagulant therapy in Chinese patients with mechanical heart valve prostheses. Cell Biochem Biophys, 2012, 62(1) :147-151.
5. Butchart EG, Payne N, Li HH, et al. Better anticoagulation control improves survival after valve replacementJ. J Thorac Cardiovasc Surg, 2002, 123(4) :715-723.
6. Erkens PM, Ten CH, Buller HR, et al. Benchmark for time in therapeutic range in venous thromboembolism:a systematic review and meta-analysis. PLoS One, 2012, 7(9) :e42269.
7. Matchar DB, Love SR, Jacobson AK, et al. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481:The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis, 2015, 40(1) :17-25.
8. Desantis G, Hogan-Schlientz J, Liska G, et al. STABLE results:warfarin home monitoring achieves excellent INR controlJ. Am J Manag Care, 2014, 20(3) :202-209.
9. Mair H, Sachweh J, Sodian R, et al. Long-term self-management of anticoagulation therapy after mechanical heart valve replacement in outside trial conditions. J Interact Cardiovasc Thorac Surg, 2012, 14(3) :253-257.
10. Lee JH, Lee KS, Kim DS, et al. Evaluation of CoaguChek XS for measuring prothrombin time in patients receiving long-term oral anticoagulant therapy. Korean J Lab Med, 2007, 27(3) :177-181.
11. 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) :I75-I78.
12. Poli D, Antonucci E, Gensini GF, et al. Asymptomatic excessive coumarin anticoagulation is a risk factor for thrombotic and bleeding complications of oral anticoagulant therapy. J Thromb Haemost, 2003, 1(8) :1840-1841.
13. Fihn SD, Mcdonell M, Martin D, et al. Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimized Outpatient Follow-up Study Group. Ann Intern Med, 1993, 118(7) :511-520.
14. 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.
15. Rosendaal FR, Cannegieter SC, van der Meer FJ, et al. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost, 1993, 69(3) :236-239.
16. Schmitt L, Speckman J, Ansell J. Quality assessment of anticoagula-tion dose management:comparative evaluation of measures of time-in-therapeutic range. J Thromb Thrombolysis, 2003, 15(3) :213-216.
17. Razouki Z, Ozonoff A, Zhao S, et al. Improving quality measurement for anticoagulation:adding international normalized ratio variabi-lity to percent time in therapeutic rangeJ. Circ Cardiovasc Qual Outcomes, 2014, 7(5) :664-669.
18. Samsa GP, Matchar DB. Relationship between test frequency and outcomes of anticoagulation:a literature review and commentary with implications for the design of randomized trials of patient self-management. J Thromb Thrombolysis, 2000, 9(3) :283-292.
19. Erdman S, Vidne B, Levy MJ. A self control method for long term anticoagulation therapy. J Cardiovasc Surg (Torino), 1974, 15(4) :454-457.
20. Jacobson AK. Patient self-management of oral anticoagulant therapy:an international update. J Thromb Thrombolysis, 1998, 5 Suppl 1(3) :25-28.
21. Nagler M, Bachmann LM, Schmid P, et al. Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice:efficacy and safety in a nationwide long-term prospective cohort studyJ. PLoS One, 2014, 9(4) :e95761.
22. Grunau BE, Wiens MO, Harder KK. Patient self-management of warfarin therapy:pragmatic feasibility study in Canadian primary care. Can Fam Physician, 2011, 57(8) :e292-e298.
23. 杨军, 刘海燕, 张真路, 等. CoaguChek XS国标标准化比值检测仪的临床应用. 岭南心血管病杂志, 2009, 15(5) :372-375.
24. 张丽, 申雪琴, 张璐, 等. CoaguChek XS血凝仪检测国际标准化比值和凝血酶原时间的准确性和可靠性. 中华老年心脑血管病杂志, 2010, 12(6) :521-522.
25. 申雪琴, 张丽. 罗氏血凝仪CoaguChek XS测定国际标准化比值准确性的临床研究. 军医进修学院学报, 2010, 31(12) :1217-1218.
26. 赵树林, 董力, 石应康, 等. 心脏瓣膜置换术后抗凝治疗自我监测的临床研究. 四川大学学报(医学版), 2014, 45(5) :844-847.
27. Taborski U, Wittstamm FJ, Bernardo A. Cost-effectiveness of self-managed anticoagulant therapy in Germany. Semin Thromb Hemost, 1999, 25(1) :103-107.
28. Kortke H, Korfer R. International normalized ratio self-management after mechanical heart valve replacement:is an early start advanta-geous? Ann Thorac Surg, 2001, 72(1) :44-48.
29. Christensen TD, Johnsen SP, Hjortdal VE, et al. Self-management of oral anticoagulant therapy:a systematic review and meta-analysis. Int J Cardiol, 2007, 118(1) :54-61.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Self-management of Anticoagulation Monitoring for Patients Following Mechanical Heart Valve Replacement: A non-randomized Controlled Trial

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