Self-management of oral anticoagulant therapy: A systematic review and meta-analysis

doi:10.1016/j.ijcard.2006.06.018

International Journal of Cardiology

Volume 118, Issue 1, 16 May 2007, Pages 54-61

https://doi.org/10.1016/j.ijcard.2006.06.018 Get rights and content

Abstract

Background

A number of randomized controlled trials have compared self-management of oral anticoagulant therapy with conventional management. However, the results have not appeared consistent and a systematic review and meta-analysis are therefore needed in order to evaluate self-management of oral anticoagulant therapy. The aim of this study was to evaluate the efficacy and safety of self-management of oral anticoagulant therapy for patients on long-term oral anticoagulant therapy.

Methods

A systematic review and meta-analysis including randomized controlled trials with highly selected patients comparing self-management of oral anticoagulant therapy with conventional treatment. Data were extracted in terms of study characteristics, quality of trials and outcome (death, minor and major complications (thromboembolic and bleeding events), and time within therapeutic INR target range).

Results

Ten trials with a total of 2724 patients were included. Two of the trials could be classified as high quality trials. Considering all trials, self-management was associated with a reduced risk of death (relative risk (RR) = 0.48, 95% confidence interval (CI) 0.29–0.79, p = 0.004), major complications (RR = 0.58, 95% CI 0.42–0.81, p = 0.001) and with increasing time within therapeutic INR target range (weighted mean difference = 6.53, 95% CI 2.24–10.82, p = 0.003). No clear effect was found regarding minor complications (RR = 0.98, 95% CI 0.49–1.99, p = 0.96).

Conclusions

A majority of the existing trials have various methodological problems. However, self-management of oral anticoagulant therapy appeared at least as good and possible better than conventional management in highly selected patients.

Introduction

Oral anticoagulant therapy with coumarin derivates is prescribed as prevention and treatment to patients with an increased risk of thromboembolism [1]. Since oral anticoagulant therapy increases the risk of bleeding, the therapy requires a careful attention to the balance between the risks of these two outcomes.

Oral anticoagulant therapy is conventionally monitored by laboratory analysis of the international normalized ratio (INR) on plasma obtained by venipuncture. Based on the INR value, health care providers determine the appropriate dosage of coumarin.

Self-management of oral anticoagulant therapy in which highly selected patients analyzes a drop of blood using a portable coagulometer and uses the displayed INR-value for coumarin dosage has over the last years gained interest and is now widely used in routine settings. However, findings from randomized controlled trials that have evaluated the efficacy of self-management compared to conventional management have been inconsistent and the scientific basis for implementing self-management has therefore been debated.

A systematic review [2] and a meta-analysis [3] on the efficacy of self-management of oral anticoagulant therapy are available. However, these papers did not include the most recent trials and did not assess the methodological quality of the included trials [4]. An updated systematic review and a subsequent meta-analysis are needed in order to further evaluate the efficacy and safety of self-management.

Section snippets

Study identification

We searched The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2005, issue 4) and PubMed (start 1951 to December 2005). The search was supplemented by a review of personal files and hand search of published reviews. No language restriction was applied. The following strategy was used to search the CENTRAL and adapted appropriately for the PubMed: ((((“4-hydroxycoumarins” [MeSH]) OR (acenocoumar* OR sinkumar OR sinthrome OR sintrom OR mini-sintrom OR syncoumar OR

Data extraction

Disagreement was present between the two reviewers regarding 32% of the extracted data, but consensus was reached in all cases.

Description of studies

Ten trials comparing self-management to conventional management with a total of 2724 patients were included (Fig. 1 and Table 1) [7], [8], [9], [10], [11], [12], [13], [14], [15], [16]. A description of the included studies is displayed in Table 1.

The included studies had a substantial inter-study variation, e.g., in terms of follow-up, number of patients, INR-interval

Discussion

We found that highly selected patients performing self-management had a reduced risk of death, major complications and spent an increased proportion of time within therapeutic INR target range compared to patients in conventional management. No clear difference in the risk of minor complications was found. There was substantial heterogeneity regarding two of the outcomes (minor complications and time within therapeutic INR target range).

The trials included were all (except two) ranked as lower

Acknowledgements

The secretaries, Linda Nielsen and Marianne Maegaard, RN from the Department of Cardiothoracic and Vascular Surgery, are thanked for their help in conducting this study.

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Self-management of oral anticoagulant therapy: A systematic review and meta-analysis

Abstract

Background

Methods

Results

Conclusions

Introduction

Section snippets

Study identification

Data extraction

Description of studies

Discussion

Acknowledgements

Chest

Lancet

Ann Thorac Surg

Ann Thorac Surg

J Thromb Haemost

Chest

Systematic review of studies of self-management of oral anticoagulation

Thromb Haemost

Self-management in anticoagulation—a meta-analysis [Norwegian language]

Tidsskr Nor Laegeforen

Self-management of oral anticoagulant therapy: a review

J Thromb Thrombolysis

Meta-analyses involving cross-over trials: methodological issues

Int J Epidemiol

A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management

J Clin Pathol