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.
IMPACT OF EARLY PALLIATIVE CARE INTERVENTION ON MATERNAL STRESS IN MOTHERS OF INFANTS PRENATALLY DIAGNOSED WITH SINGLE VENTRICLE HEART DISEASE: A RANDOMIZED CLINICAL TRIAL
