Quality of warfarin management in primary care: Determining the stability of international normalized ratios using a nationally representative prospective cohort.

Objective: To determine the stability of warfarin anticoagulation using a nationally representative sample of Canadian primary care patients and providers.

Design: Prospective cohort study.

Setting: Primary care practices associated with the Canadian Primary Care Sentinel Surveillance Network.

Participants: Adult warfarin users with 7 or more evaluable international normalized ratio (INR) readings.

Main Outcomes Measures: International normalized ratio time in therapeutic range (TTR) determined using the Rosendaal method; TTR above 75% was considered good INR control and TTR below 60% was considered poor INR control. The primary outcome was the proportion of all warfarin users (using an INR target range of 2.0 to 3.5) with good INR control during their first year taking warfarin who have poor INR control the following year. Secondary outcomes included the TTR using an INR target of 2.0 to 3.0 when restricted to patients with known atrial fibrillation (AF) or venous thromboembolism (VTE); and the proportion of INR values below the target of 2.0 and above the targets of 3.0 and 3.5 in the year before the availability of other oral anticoagulants.

Results: Among 18 303 adult warfarin users (mean age of 71.0 years, 46.6% female), the median TTR (INR target range of 2.0 to 3.5) was 77.4% (interquartile range of 64.6% to 86.4%). The TTR was above 75% in 56.0% of patients and below 60% in 19.3% of patients. Of those exhibiting good INR control in year 1 of anticoagulation therapy, only 10.2% had poor control the following year. When restricted to patients with known AF or VTE (89.7% with AF and 13.5% with VTE), and assuming an INR target range of 2.0 to 3.0, the TTR was 67.8% (interquartile range of 54.8% to 77.9%). Of these patients, 27.9% had INR values below 2.0, and 19.4% and 8.6% had values above 3.0 and 3.5, respectively.

Conclusion: Primary care warfarin management produces a TTR comparable to that in randomized trials, with out-of-range INR values 3 times more likely to predispose to thrombosis (INR of < 2.0) than to hemorrhage (INR of > 3.5). A history of good INR control does predict future INR stability and meaningfully informs decisions to switch established warfarin users onto newer agents.