Abstract
Introduction: Anticoagulation clinics (AC) have better impact on anticoagulation control than usual medical care (UMC). However, there is no randomized trial testing the results of AC in low-income realities. We sought to examine the performance of an AC in a group of patients treated at a Brazilian public hospital. Hypothesis: The assistance provided by AC presents difference in TTR when compared to the UMC. Methods: This was a randomized clinical trial to test the efficacy and safety of a recently-implemented AC over UMC in a group of outpatients with heart disease. The primary and secondary endpoints were time in the therapeutic range (TTR) and warfarin-associated complications, respectively. Overall, 280 patients were enrolled and randomly assigned to one of the two arms: group A: one year at AC (A1: first semester; A2: second semester); and group B: one semester receiving UMC (B1) and other at AC (B2). Results: The mean age was 56.8±13.1 years and patients were mostly female (54.6%). The median monthly income was 464 US dollars. Low literacy was predominant in this group of studied patients (>68%). A1 showed higher TTR (62.4±20.8%) than B1 (55.1±28.5%) (p=0.014). An improvement of TTR was observed within group B, rising from 55.1±28.5% (B1) to 62.2±23.1% (B2) (p=0.008). A1 showed lower incidence rate (IR) per patients-year (p-y) of total bleedings than B1 (incidence rate ratio (IRR): 0.78; p=0.041) and a decline in the IR p-y was found for intra-group comparisons, both presenting IRR 0.58; p<0.001. A1 showed lower IR p-y for thromboembolism than B1 (IRR=0.12; p=0.047). (Clinical trial registration: www.clinicaltrials.gov/. Identifier: NCT01006486) Conclusions: AC helped increase TTR and reduce warfarin-complications, even in low-income settings. Extending this assistance to similar populations in other Latin American countries could reduce hospitalizations and deaths related to warfarin use.
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