Atrial Fibrillation
Conditions
Brief summary
The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world Japanese clinical practice. The secondary objective of the study is to compare LoS of patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related costs between dabigatran and warfarin, and (2) to compare the rates of patients directly discharged at home after the index hospitalization between dabigatran and warfarin.
Interventions
DRUGDabigatran
Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day
DRUGWarfarin
Warfarin tablet (adjustment by each patients)
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1\. Hospitalized patients among patients having a visit record with a confirmed diagnosis of NVAF (ICD-10 Code: I48) and prescribed dabigatran or warfarin in the hospitalization period
Exclusion criteria
1. Having a record with a diagnosis of atrial flutter, valvular atrial fibrillation or postoperative atrial fibrillation diagnosis as standard disease name during the study period. 2. Having a record with a diagnosis of rheumatic atrial fibrillation (ICD-10 code I05 to I09 \[chronic rheumatic atrial fibrillation\])or mechanical-valvular atrial fibrillation (ICD-10 code T820 \[artificial cardiac valve mechanical complication\]) during the study period. 3. Having a record with a confirmed diagnosis of cancer (ICD-10 code C00-C97 \[malignant neoplasm\]) during the study period. 4. Having a record of dialysis (class J038 artificial kidney) during the study period. 5. Having a record of dabigatran use for a purpose other than prevention of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients. 6. Having a record of dabigatran or warfarin before the hospitalization 7. Having a record of new diagnosis of atrial fibrillation after the initiation of dabigatran or warfarin treatment in the hospitalization period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline | From the date of index treatment until the date of discharge from hospital, assessed upto 60 months. | The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Etexilate [Prazaxa®] The patients were administered Dabigatran Etexilate 75 mg\*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). | 899 |
| Warfarin Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF. | 3,414 |
| Total | 4,313 |
Baseline characteristics
| Characteristic | Dabigatran Etexilate [Prazaxa®] | Warfarin | Total |
|---|---|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 11.6 | 76.1 Years STANDARD_DEVIATION 10.4 | 74.9 Years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 297 Participants | 1398 Participants | 1695 Participants |
| Sex: Female, Male Male | 602 Participants | 2016 Participants | 2618 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline
The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.
Time frame: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.
Population: The analysis set included patients who received the treatment Dabigatran Etexilate \[Prazaxa®\] or Warfarin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dabigatran Etexilate [Prazaxa®] | Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline | 9.8 Months | Standard Deviation 13.5 |
| Warfarin | Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline | 14.9 Months | Standard Deviation 19.4 |
p-value: <0.00195% CI: [-3.717, -1.251]Abadie-Imbens