Atrial Fibrillation
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| 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 |
Outcome results
None listed