Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Study Overview
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Brief Summary
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To estimate annualized total cost rates (i.e. direct medical costs from hospitalizations, consultations, medications, and tests) of adequately controlling a patient (i.e. INR between 2-3 and TTR≥ 60%) diagnosed with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE), and treated with vitamin K antagonists (VKA) in Spain.

Official Title
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Cost of Monitoring Patients Treated With Vitamin K Antagonists in Spain

Conditions
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Anticoagulation

Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients aged 18 or older over the study period Patients with a diagnosis for NVAF or VTE anytime in their medical records Patients having at least one year of enrolment in the database prior to the index date Patients newly initiated with VKA during the study period (index date) Exclusion Criteria: Patients with a diagnosis for both NVAF and VTE anytime in their medical records

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NVAF-VKA cohort<br>NVAF patients who initiate a VKA treatment | |
| VTE-VKA cohort<br>VTE patients who initiate a VKA treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized total and per patient cost of patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records | Per patient cost: direct medical costs from hospitalizations, consultations, medications, and tests; Coagulation control status: adequately controlled patients defined by INR between 2-3 and TTR≥ 60% | Approximately 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and clinical characteristics for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records | Variables measured: age, gender, employment status, smoking status, BMI, major co-morbidities (including CHARLSON index), CHA2DS2-VASc score, presence and frequency of INR measurement, and INR therapeutic range. | Approximately 60 months | 
| Healthcare resource rates for all patients diagnosed with NVAF or VTE treated with VKA and according to coagulation control status based on electronic clinical records | Healthcare resources used (i.e. hospitalizations, consultations, medication, and tests) by patients will be measured according to coagulation control status. For each healthcare resource the number and percentage of patients using it and the mean, SD, median min, max and valid n will be reported; as well as the number of times that each patient uses the resource. | Approximately 60 months |