Key result
Patients with highly variable warfarin dosing had significantly poorer anticoagulation control (TTR 53% vs 79%) and higher rates of major hemorrhage compared to those with stable dosing.
Why the study?
Does high warfarin dose variability predict poor anticoagulation control and adverse events in patients on long-term oral anticoagulation?
Case-Control (n=327)
Single-blind
Yes
Does high warfarin dose variability predict poor anticoagulation control and adverse events in patients on long-term oral anticoagulation?
Absolute Event Rate: 53% vs 79%
p-value: p=<0.001
High warfarin dose variability, measured by the coefficient of variation, identifies patients at increased risk for poor anticoagulation control and adverse bleeding or thromboembolic events.
BACKGROUND: Patients who receive highly variable doses of warfarin may be at risk for poor anticoagulation control and adverse events. However, we lack a system to identify patients with the highest dose variability. Our objectives were to develop a scoring system to identify patients with high dose variability, and to validate this new measure by demonstrating that patients so identified have poor anticoagulation control and higher rates of adverse events (criterion validity). METHODS: We used a database of over 4, 000 patients who received oral anticoagulation in community practice between 2000-2002. We reviewed the charts of 168 patients with large warfarin dose variation and agreed on 18 risk factor definitions for high dose variability. We identified 109 patients with the highest dose variability (cases), as measured by coefficient of variation (CoV, SD/mean). We matched each case to two controls with low dose variability. Then, we examined all 327 charts, blinded to case/control status, to identify the presence or absence of the 18 risk factors for dose variability. We performed a multivariable analysis to identify independent predictors of high CoV. We also compared anticoagulation control, as measured by percent time in therapeutic range (TTR), and rates of adverse events between groups. RESULTS: CoV corresponded with other measures of anticoagulation control. TTR was 53% among cases and 79% among controls (p < 0.001). CoV also predicted adverse events. Six cases experienced a major hemorrhage versus 1 control (p < 0.001) and 3 cases had a thromboembolic event versus 0 control patients (p = 0.04). Independent predictors of high dose variability included hospitalization (OR = 21.3), decreased oral intake (OR = 12.2), use of systemic steroids (OR = 6.1), acetaminophen (OR = 4.0) and antibiotics (OR = 2.7; p < 0.05 for all). CONCLUSION: CoV can be used to identify patients at risk for poor anticoagulation control and adverse events. This new measure has the potential to identify patients at high risk before they suffer adverse events.
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Marrast et al. (2011) conducted a case-control in Patients receiving long-term oral anticoagulation (warfarin) (n=327). High warfarin dose variability (Coefficient of Variation > 0.2) vs. Low warfarin dose variability (Coefficient of Variation < 0.05) was evaluated on Percent time in therapeutic range (TTR) (p=<0.001). Patients with highly variable warfarin dosing had significantly poorer anticoagulation control (TTR 53% vs 79%) and higher rates of major hemorrhage compared to those with stable dosing.
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