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Patient self-monitoring linked to fewer deaths, thromboembolic events in anticoagulation with vitamin K antagonists
Bloomfield HE. Ann Intern Med. 2011;154:472-482.
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Patients assigned to long-term anticoagulation with vitamin K antagonists had better survival and fewer thromboembolic events when they engaged in self-testing and self-monitoring.
In a meta-analysis commissioned by the Department of Veterans Affairs, researchers reviewed data of 8,413 patients collected in 22 trials published from 1966 to 2010. Patients were assigned to more than 3 months of outpatient anticoagulation therapy with vitamin K antagonists. The potential for self-testing or self-monitoring to reduce death and thromboembolic was compared with treatment at a physician’s office or anticoagulation clinic.
The self-testing or self-monitoring intervention usually included small-group training sessions during the course of several weeks, followed by home practice and a test to ensure competency in all procedures. Patients learned about anticoagulant therapy, possible interactions with foods or medicines, how to use the international normalized ratio testing machine, how to dose, how often to check INR and when to call for help.
The control group received anticoagulation management in anticoagulation clinics.
Combined incidence of major thromboembolic events was 2.5% in the intervention group compared with 4% in the control group (OR=0.58; 95% CI, 0.45-0.75). Incidence of major bleeding was 7% in the intervention group compared with 7.9% in the control group (OR=0.89; 95% CI, 0.75-1.05). Twelve percent of patients in the control group died compared with 9.2% in the intervention group (OR=0.74; 95% CI, 0.63-0.87).
The difference in pooled weighted mean of percentage of time in the therapeutic range was 1.5% between groups, which researchers declared not statistically significant (95% CI, 0.63-3.63). There was no difference in the percentage of INRs in the therapeutic range between self-testing and self-monitoring and usual care.
Writing in an accompanying editorial, Paul Anaya, MD, PhD, and David J. Moliterno, MD, with Gill Heart Institute and the University of Kentucky, said the results confirm findings from earlier studies and demonstrate that a strategy of self-directed care for anticoagulation can be safely and effectively implemented.
“In some ways, self-directed care provides a glimpse into the future, with greater reliance on newer technologies and on the patient’s ability to measure specific chemical or biological variables and instantly communicate these to their provider electronically,” they wrote. “Should the clinical benefits of home INR testing and management reported in this meta-analysis continue to be realized, it is likely that this technology will soon join the ranks of other current self-directed care strategies.”
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It’s wonderful that people can do this testing and monitoring on their own, and this will save patients a great deal of money and time. Paradoxically, these results will be moot for most people because warfarin (Coumadin, Bristol-Myers Squibb) and INR testing are becoming obsolete. Dabigatran (Pradaxa, Boehringer Ingelheim) has just been approved for atrial fibrillation by the FDA and will soon be approved for thromboembolic disease of all kinds, and that does not recall any INR testing. Some patients could continue on Coumadin, but I can’t see any reason to do so at this point.
– Harry S. Jacob, MD, FRCPath(Hon)
HemOnc Today Chief Medical Editor
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