Atrial Fibrillation
Conditions
Brief summary
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF
Detailed description
This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (\<64, 65-74, \>75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.
Interventions
DRUGwarfarin
warfarin
DRUGdabigatran
Non-vitamin K dependent oral anti-coagulants (NOACs)
DRUGApixaban
Non-vitamin K dependent oral anti-coagulants (NOACs)
DRUGEdoxaban
Non-vitamin K dependent oral anti-coagulants (NOACs)
DRUGRivaroxaban
Non-vitamin K dependent oral anti-coagulants (NOACs)
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-\>18 year old non-valvular atrial fibrillation (NVAF) patients * Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin * Patients with confirmed date of initiation of OACs * Patients with a minimum of 6 months of enrolment data prior to index date * Has an index date between 14th of March 2011 to 30 June, 2016
Exclusion criteria
* Patients receiving two or more oral anti-coagulants at the same time at index date * Patients with prescriptions of index treatment in the 6 months prior to index date * Patients without enrolment period of at least six month in the database
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. | One year | The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With Cardiac Tamponade and Pericardiocentesis. | One year | The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI. |
Countries
Japan
Participant flow
Recruitment details
Non-interventional study based on existing health insurance claims data
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Patients met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Patients Prescribed With Non-warfarin Oral Anti Coagulants Patients prescribed with Non-warfarin Oral Anti Coagulants (NOACs) (dabigatran, rivaroxaban, apixaban, edoxaban) or warfarin were grouped as a single exposure group and analysed as a whole. On treatment duration was expressed in patient year for the follow-up duration to calculate the incidence of various clinical events during the on-treatment duration. | 53,969 |
| Total | 53,969 |
Baseline characteristics
| Characteristic | Patients Prescribed With Non-warfarin Oral Anti Coagulants |
|---|---|
| Age, Continuous | 76 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53969 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 53969 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 21587 Participants |
| Sex: Female, Male Male | 32382 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.
Time frame: One year
Population: Results are based on the number of patients meeting the inclusion and exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Prescribed With Non-warfarin Oral Anti Coagulants | The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. | Age <=64 | 14 Number of Patients |
| Patients Prescribed With Non-warfarin Oral Anti Coagulants | The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. | Age 65-74 | 35 Number of Patients |
| Patients Prescribed With Non-warfarin Oral Anti Coagulants | The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. | Age >=75 | 84 Number of Patients |
Secondary
The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.
Time frame: One year
Population: Results are based on the number of patients meeting the inclusion and exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Prescribed With Non-warfarin Oral Anti Coagulants | The Number of Patients With Cardiac Tamponade and Pericardiocentesis. | 1 Number of Patients |