THINRS Trial: Weekly home monitoring of blood clotting speed found to be as safe as monthly clinic testing for patients on warfarin.
Home monitoring of clotting speed is as safe as clinic
monitoring in patients taking warfarin, researchers reported at the American Heart
Association's Scientific Sessions 2008. The results of A Prospective Randomized
Controlled Trial of the Impact of Home INR testing on Clinical Outcomes: The Home
INR Study (THINRS) were presented as a late-breaking clinical trial.
But in the first study designed to determine whether
weekly home tests of blood clotting speed are better than monthly tests performed
at a clinic, researchers failed to find any superiority for home testing, said
Alan K. Jacobson, M.D., study co-chair, staff cardiologist at the Jerry L. Pettis
Memorial Veterans Administration (VA) Medical Center and an assistant professor
at Loma Linda University School of Medicine, Loma Linda, Calif.
The researchers randomized 2,922 patients to one of the
two testing methods and followed them for an average of three years. During that
time, 7.9 percent of the home testing participants had the composite endpoint
of stroke, major bleeds or death compared to 8.9 percent of the clinically tested
patients.
"There was a slight trend toward weekly home monitoring
providing a minor improvement over monthly clinic monitoring, but it failed to
reach statistical or clinical significance," Jacobson said. "Once a month at the
clinic seems to be just as good as weekly testing at home for most patients."
Home testing might be the better choice in certain situations
such as for patients whose disabilities or distance from a clinic might keep them
from appointments, Jacobson said.
The participants in the randomized study were among 3,745
veterans being treated with the anticoagulant warfarin at 28 VA hospitals across
the country. The patients all had either atrial fibrillation or had received a
mechanical heart valve -conditions that increase the risk for blood clots.
Furthermore, the participants were trained to use the
home monitors, which measure how quickly the blood clots, to reduce any effect
the training might have on the study results, said David B. Matchar, M.D., co-chair
of the trial and director of the Duke Center for Clinical Health Policy Research
in Durham, N.C. and Duke-NUS Graduate Medical School Program in Health Services
Research, Singapore.
The patients were deemed able and willing to perform home monitoring. The monitors
used just about four drops of blood.
In addition to the unpleasantness of drawing blood and
the constant risk that patients may decide to skip appointments - particularly
when blood draws are involved - many veterans must travel long distances to reach
a clinic.
"What we did show was that home testing is every bit
as effective as regular clinic monitoring," said Jacobson, whose clinic has been
using at-home testing since 1995 with a special computerized system to keep tabs
on many of its patients. "For patients where access is a problem either because
of disability or distance, this potentially has a huge impact."
"THINRS was far and away the largest and most ambitious
trial of home anticoagulation monitoring. The bad news is that we didn't show
home monitoring to be superior. The good news is that patients using home monitoring
did every bit as well as the patients in the clinic."
Other co-authors are: Rowena Dolor, M.D.; Robert G. Edson,
M.A.; and Lauren Uyeda, M.S., M.B.A. Individual author disclosures can be found
on the abstract.
The study was funded by the U.S. Department of Veterans
Affairs (Clinical Science Research and Development, Cooperative Studies Program,
project number CSP 481).
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