![]() ![]() All clinical events were independently assessed for causality by 2 expert reviewers. Clinical events were comprehensively collected and described, and INR determinations were performed by a single laboratory and systematically captured in an integrated electronic medical record. Real-world patients with a variety of indications for warfarin and therapeutic INR targets were included. 9, 14 The large number of patients included in our analysis increases the generalizability of our results and reduces the likelihood that unmeasured bias may have influenced them. The data set used to complete this study is robust and has been used previously in health records and data extraction research. The stable group had a lower mean number of INRs measured per patient, 6.7 (SD = 1.3) during the observation period compared with 10.7 (SD = 4.5) per patient for comparators ( P <. The mean proportion of INR values in the therapeutic range for the comparator group was 46.9% (standard deviation = 22.0). Differences in duration of warfarin therapy between groups prior to inclusion in the study were not statistically significant. The mean chronic disease score was also lower in stable group patients. Stable group patients were older than comparator group patients and more likely to have had a target INR of 2.5 and to have been receiving warfarin for atrial fibrillation, but less likely to have had a target INR of 3.0 or higher, to have been receiving warfarin for heart valve replacement, to have comorbid diabetes, heart failure, or prior venous thrombosis, or to be receiving concurrent estrogen therapy. 12, 13īaseline characteristics of stable patients and comparators are presented in Table 1. Use of the CDS allows for the accounting of each patient's risk of mortality and future health care use. 12 Chronic disease scores can range from 0 to 35, with increasing scores indicating an increasing burden of chronic diseases under treatment. A validated measure of patient acuity, the chronic disease score (CDS), was calculated for each patient using ambulatory prescription drug data from the observation period. Estrogen therapy was defined as a prescription for a systemic estrogen-containing product sold within 90 days prior to the start of the observation period. Risk factors were considered present when a coded assessment for a given factor was identified in the 180 days prior to the start of the observation period. Patient-specific factors that could influence the risk for anticoagulant-related complications were also recorded: diabetes mellitus, hypertension, heart failure, prior venous thrombosis, hemorrhage or stroke, cancer, and estrogen therapy. Variables collected for analysis included the primary warfarin indication (atrial fibrillation, venous thromboembolism, heart valve disorder, other), age at start of the observation period, sex, INR target, duration of warfarin therapy, and INR values. We hypothesize that many patients demonstrating stable INR control could be safely treated with INR recall intervals greater than the traditional 4 weeks. Stable patients were significantly less likely to have target INR of 3.0 or higher or chronic diseases. Independent predictors of stable INR control were age older than 70 years and the absence of comorbid heart failure and diabetes. The combined rates of bleeding and thromboembolism were significantly lower in stable patients. There were 2504 stable and 3569 comparator patients. Multivariate logistic regression models were used to identify independent predictors of stable INR control. Occurrences of thromboembolism, bleeding, and death were compared between groups. We sought to identify patients with stable INRs (defined as having INR values exclusively within the INR range) and comparator patients (defined as at least one INR outside the INR range) in a retrospective, longitudinal cohort study. Less frequent INR monitoring may be feasible in stable patients. For patients on warfarin therapy, an international normalized ratio (INR) recall interval not exceeding 4 weeks has traditionally been recommended. ![]()
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