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INR self-testing associated with improved quality of life for patients on warfarin vs. clinic testing
Matchar D. N Engl J Med. 2010;363:1608-1620.
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Weekly self-testing of the international normalized ratio for patients on warfarin did not delay the time to a first stroke, major bleeding episode or death when compared with high-quality clinic testing to the extent suggested by prior studies, new data from the THINRS trial indicated. However, statistically significant improvements in patient satisfaction and quality of life for self-testing were reported by researchers.
In the prospective, randomized, nonblinded trial, 2,922 patients taking warfarin (Coumadin, Bristol-Myers Squibb) were randomly assigned to either self-testing (n=1,465) or high-quality testing of INR in a clinic (n=1,457). The primary endpoint was the time to a first major event — stroke, major bleeding episode or death — and the secondary endpoints were time within the INR target range, patient satisfaction and quality of life.
During 8,730 patient-years of follow-up (time range, 2-4.75 years), study data revealed no significantly longer time to the first primary event in the self-testing group than in the clinic-testing group (self-testing HR= 0.88; 95% CI, 0.75-1.04). Clinical outcomes were similar between arms, with the exception of more minor bleeding episodes in the self-testing group (540 vs. 401, P<.001).
At 2 years, the self-testing arm showed improvements in patient satisfaction (P=.002) and quality of life (P<.001) with anticoagulation therapy vs. the clinic-testing arm, whereas during the entire follow-up, an improvement in the percentage of time INR was within target range was also noted in the self-testing group (P<.001).
“The results of THINRS do not establish the superiority of self-testing over high-quality clinic testing in preventing major clinical outcomes but do provide evidence of modest improvements in time within the therapeutic INR range, patient satisfaction with anticoagulation therapy and quality of life,” the researchers concluded.
Based on the findings of this study, they added, self-testing should be considered for patients whose access to high-quality anticoagulation care is limited by disability, geographic distance or other factors, if the alternative would be to withhold a highly effective treatment.
Access the THINRS trial scorecard here.
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