Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data

被引：245

作者：

Heneghan, Carl ^{[1
]}

Ward, Alison ^{[1
]}

Perera, Rafael ^{[1
]}

Bankhead, Clare ^{[1
]}

Fuller, Alice ^{[1
]}

Stevens, Richard ^{[1
]}

Bradford, Kairen ^{[1
]}

Tyndel, Sally ^{[1
]}

Alonso-Coello, Pablo ^{[2
]}

Ansell, Jack ^{[3
,4
]}

Beyth, Rebecca ^{[5
,6
]}

Bernardo, Artur ^{[7
]}

Christensen, Thomas Decker ^{[8
,9
]}

Cromheecke, Manon ^{[10
]}

Edson, Robert G. ^{[11
]}

Fitzmaurice, David ^{[12
]}

Gadisseur, Alain P. A. ^{[13
]}

Garcia-Alamino, Josep M. ^{[1
]}

Gardiner, Chris ^{[14
]}

Hasenkam, Michael ^{[8
]}

Jacobson, Alan ^{[15
,16
]}

Kaatz, Scott ^{[17
]}

Kamali, Farhad ^{[18
]}

Khan, Tayyaba Irfan ^{[18
]}

Knight, Eve ^{[19
]}

Kortke, Heinrich ^{[20
]}

Levi, Marcel ^{[10
]}

Matchar, David Bruce ^{[21
,22
,23
]}

Menendez-Jandula, Barbara ^{[24
]}

Rakovac, Ivo ^{[25
]}

Schaefer, Christian ^{[26
]}

Siebenhofer, Andrea ^{[27
]}

Souto, Juan Carlos ^{[24
]}

Sunderji, Rubina ^{[28
,30
]}

Gin, Kenneth ^{[29
,30
]}

Shalansky, Karen ^{[28
,30
]}

Voller, Heinz ^{[31
]}

Wagner, Otto ^{[32
,33
]}

Zittermann, Armin ^{[32
,33
]}

机构：

[1] Univ Oxford, Dept Primary Care Hlth Sci, 23-38 Hythe Bridge St, Oxford OX1 2ET, England

[2] Inst Biomed Res IIB St Pau, Clin Epidemiol & Publ Hlth Dept, Iberoamer Cochrane Ctr, Barcelona 08041, Spain

[3] Lenox Hill Hosp, Dept Med, New York, NY USA

[4] New York Univ Sch Med, New York, NY USA

[5] Univ Florida, Div Internal Med, Gainesville, FL 32611 USA

[6] North Florida South Georgia Vet Hlth Syst, Gainesville, FL USA

[7] Klin Gais AG, Gais, Switzerland

[8] Aarhus Univ Hosp, Dept Cardiothorac & Vasc Surg, Aarhus, Denmark

[9] Aarhus Univ Hosp, Inst Clin Med, Aarhus, Denmark

[10] Univ Amsterdam, Acad Med Ctr, Dept Cardiopulm Surg, Amsterdam, Netherlands

[11] VA Cooperat Studies Program Coordinating Ctr, Palo Alto, CA USA

[12] Univ Birmingham, Med Sch Birmingham, Dept Primary Hlth Care & Gen Pract, Birmingham B15 2TT, W Midlands, England

[13] Univ Antwerp Hosp, Dept Haematol, Edegem, Belgium

[14] Univ Oxford, John Radcliffe Hosp, Nuffield Dept Obstet & Gynaecol, Oxford, England

[15] Loma Linda Univ, Res & Dev Serv, Jerry L Pettis VA Med Ctr, Loma Linda, CA 92350 USA

[16] Loma Linda Univ, Dept Internal Med, Loma Linda, CA 92350 USA

[17] Henry Ford Hosp, Dept Internal Med, Detroit, MI USA

[18] Univ Newcastle, Inst Cell Med, Newcastle, NSW 2308, Australia

[19] Anticoagulation Europe, Kent, OH USA

[20] Heart & Diabet Ctr N Rhine Westphalia, Inst Appl Telemedicine, Bad Oeynhausen, Germany

[21] Duke Ctr Clin Hlth Policy Research, Durham, NC USA

[22] Duke Univ, Med Ctr, Dept Internal Med, Div Gen Internal Med, Durham, NC USA

[23] Duke NUS Grad Med Sch, Program Hlth Serv & Syst Res, Singapore, Singapore

[24] Hosp Santa Creu & Sant Pau, Unidad Hemostasis & Trombosis, Barcelona, Spain

[25] Joanneum Res Forschungsgesell MBH, Inst Biomed & Hlth Sci, Graz, Austria

[26] ISMAAP, Geneva, Switzerland

[27] Goethe Univ Frankfurt, Inst Gen Practice, D-60590 Frankfurt, Germany

[28] Univ British Columbia, Fac Pharmaceut Sci, Vancouver, BC, Canada

[29] Univ British Columbia, Fac Med, Vancouver, BC, Canada

[30] Univ British Columbia, Vancouver Gen Hosp, Vancouver, BC, Canada

[31] Univ Potsdam, Rehabil Res Ctr, Potsdam, Germany

[32] Ruhr Univ Bochum, Dept Thorac & Cardiovasc Surg, Bad Oeynhausen, Germany

[33] Ruhr Univ Bochum, Heart & Diabet Ctr N Rhine Westphalia, Bad Oeynhausen, Germany

来源：

LANCET | 2012年 / 379卷 / 9813期

基金：

美国国家卫生研究院;

关键词：

ATRIAL-FIBRILLATION; PROTHROMBIN TIME; MANAGEMENT PROGRAM; STROKE PREVENTION; WARFARIN THERAPY; RANDOMIZED-TRIAL; OLDER PATIENTS; QUALITY; GUIDELINES; INR;

D O I：

10.1016/S0140-6736(11)61294-4

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Uptake of self-testing and self-management of oral coagulation has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. Methods We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. Findings Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12 800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0.51; 95% CI 0.31-0.85) but not for major haemorrhagic events (0.88, 0.74-1.06) or death (0.82, 0.62-1.09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0.33, 95% CI 0.17-0.66), as did participants with mechanical heart valve (0.52, 0.35-0.77). Analysis of major outcomes in the very elderly (age >= 85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. Interpretation Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up.

引用

页码：322 / 334

页数：13

共 49 条

[31] Effect of Home Testing of International Normalized Ratio on Clinical Events. [J].

Matchar, David B. ;

Jacobson, Alan ;

Dolor, Rowena ;

Edson, Robert ;

Uyeda, Lauren ;

Phibbs, Ciaran S. ;

Vertrees, Julia E. ;

Shih, Mei-Chiung ;

Holodniy, Mark ;

Lavori, Philip .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (17) :1608-1620

[32] Comparing self-management of oral anticoagulant therapy with clinic management -: A randomized trial [J].

Menéndez-Jándula, B ;

Souto, JC ;

Oliver, A ;

Montserrat, I ;

Quintana, M ;

Glch, I ;

Bonfill, X ;

Fontcuberta, J .

ANNALS OF INTERNAL MEDICINE, 2005, 142 (01) :1-10

[33]

Perera R, 2008, J HEART VALVE DIS, V17, P233

[34] European Concerted Action on Anticoagulation. Quality assessment of the CoaguChek mini and TAS PT-NC point-of-care whole-blood prothrombin time monitors [J].

Poller, L ;

Keown, M ;

Chauhan, N ;

van den Besselaar, AMHP ;

Tripodi, A ;

Shiach, C ;

Jespersen, J .

CLINICAL CHEMISTRY, 2004, 50 (03) :537-544

[35] Cost-effectiveness of self-managed versus physician-managed oral anticoagulation therapy [J].

Regier, Dean A. ;

Sunderji, Rubina ;

Lynd, Larry D. ;

Gin, Kenneth ;

Marra, Carlo A. .

CANADIAN MEDICAL ASSOCIATION JOURNAL, 2006, 174 (13) :1847-1852

[36]

ROSENDAAL FR, 1993, THROMB HAEMOSTASIS, V69, P236

[37] A structured teaching and self-management program for patients receiving oral anticoagulation - A randomized controlled trial [J].

Sawicki, PT .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1999, 281 (02) :145-150

[38] Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients [J].

Schulman, S ;

Kearon, C .

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2005, 3 (04) :692-694

[39] Self-managed anticoagulation: Results from a two-year prospective randomized trial with heart valve patients [J].

Sidhu, P ;

O'Kane, HO .

ANNALS OF THORACIC SURGERY, 2001, 72 (05) :1523-1527

[40] Systematic review of studies of self-management of oral anticoagulation [J].

Siebenhofer, A ;

Berghold, A ;

Sawicki, PT .

THROMBOSIS AND HAEMOSTASIS, 2004, 91 (02) :225-232

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