Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-valvular Atrial Fibrillation Treated With Vitamin k Antagonists

Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-Valvular Atrial Fibrillation Treated With Vitamin K Antagonists

The purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 16513

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective cohort with study period from January 1, 2003 to December 31, 2013 using the Clinical Practice Research Datalink (CPRD). The study will identify AF patients treated with VKA during the study period and will follow them from the first record of VKA use (index date). until the first of end of study period, leaving the database, VKA discontinuation/switch, or death. It will use person-time denominators to handle the varying length of follow-up of patients

Description

Inclusion Criteria:-

For the CPRD-HES cohort, patients will be included if they meet these criteria:

• Have CPRD data linked to HES

• Have an AF diagnosis (based on Read codes from CPRD or ICD-10 codes from HES) and have been treated with VKA during the study period

  -≥18 years old at index date

• CPRD acceptability quality criteria are present.

For the CPRD cohort, patients will be included if they meet the following criteria:

• Have an Atrial Fibrillation (AF) diagnosis (based on Read codes from CPRD) and have been treated with VKAs during the study period
• ≥18 years old at index date
• CPRD acceptability quality criteria are present.

Exclusion Criteria:

For the two cohorts of interest, patients will be excluded if they meet the following criteria:

• Fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). The date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's Up-to-Standard (UTS) date (when the practice is deemed to be contributing data of adequate quality)
• The practice is not UTS, or the patient is deemed "unacceptable" according to CPRD's quality criteria
• There is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period
• There are records of Novel anticoagulant (NOAC)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Vitamin K Antagonists; Vitamin K Antagonists dose as specified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios	Up to 24 months after initial treatment with VKA
Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios	Up to 24 months after initial treatment with VKA
Impact of bleeding events on the health-care costs in NVAF patients treated by VKAs assessed based on ratios of costs associated with number of bleeding events	Up to 24 months after initial treatment with VKA

Secondary Outcome Measures

Outcome Measure	Time Frame
Variation of impact of bleeding events on clinical events, the rate of HCRU, and health-care costs over time following each bleeding event in NVAF patients treated by VKA	Upto 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who experience bleeding events	Up to 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events	Up to 24 months after initial treatment with VKA

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Arrhythmias, Cardiac; Atrial Fibrillation; Financial Stress
• Other Study ID Numbers: CV185-338