Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K Antagonists | Vitamin K Antagonists dose as specified |
Not provided
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
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:
Exclusion Criteria:
For the two cohorts of interest, patients will be excluded if they meet the following criteria:
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |