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Meta-Analysis: Effect of Patient Self-Testing and Self-Management of Long-Term Anticoagulation on Major Clinical Outcomes
Study Questions:
Is patient self-testing (PST), alone or in combination with self-adjustment of doses (patient self-management [PSM]), associated with a reduction in thromboembolic complications and all-cause mortality without an increase in major bleeding events compared with usual care?
Methods:
A meta-analysis was conducted in studies published in English from 1966 to October 2010, which enrolled outpatient adults receiving long-term (>3 months) oral anticoagulant therapy, and which compared PST or PSM with care in a physician’s office or an anticoagulation clinic. Two investigators reviewed each article. Three investigators extracted data from articles that met inclusion criteria by using standardized data abstraction forms. The fixed-effects Peto model odds ratio (OR) was utilized because of the low event rates.
Results:
Mean age of participants was 65 years, 75% were men, and 90% were white. Twenty-two trials, with a total of 8,413 patients, were included. The great majority of trials were conducted in atrial fibrillation and mechanical prosthetic valves. In one-half of the trials, fewer than 50% of potentially eligible persons successfully completed the training and agreed to be randomly assigned. Patients randomly assigned to PST or PSM had lower total mortality (Peto odds ratio [OR], 0.74; 95% confidence interval [CI], 0.63-0.87), lower risk for major thromboembolism (Peto OR, 0.58; CI, 0.45-0.75), and no increased risk for a major bleeding event (Peto OR, 0.89; CI, 0.75-1.05). The strength of evidence was moderate for the bleeding and thromboembolism outcomes, but low for mortality. Eight of 11 trials reported that patient satisfaction, quality of life, or both were better with PST or PSM than with usual care.
Conclusions:
Compared with usual care, PST with or without PSM is associated with significantly fewer deaths and thromboembolic events, without increased risk for a serious bleeding event, for a highly selected group of motivated adult patients requiring long-term anticoagulation with vitamin K antagonists. Whether this care model is cost-effective and can be implemented successfully in typical US health care settings requires further study.
Perspective:
For those not involved in home PT, the training is reasonably rigorous; PST or PSM interventions usually include 2-4 small group-training sessions of 1-3 hours over several weeks. These are followed by home practice and a test to ensure competency in all procedures. One of the issues not addressed is the physician liability for untoward events. Our institutional-based anticoagulant program has experienced a rapid increase in patient preference for PST, but does not allow PSM.
For a patient perspective, see the story on CardioSmart.
Keywords: Vitamin K, Thromboembolism, Self Care, Heart Failure, Patient Satisfaction, Hemorrhage
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