N/A
Completed N=42,534
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
Source: ClinicalTrials.gov NCT03026556 ↗Enrolled (actual)
42,534
Serious AEs
—
Results posted
Jun 2019
Primary outcomePrimary: Stroke Overall (Hemorrhagic, Ischemic, Uncertain) — 0.52; 0.69; 0.46; 0.36 Event Rate in 100 person-years — p=0.0844
Summary
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroke Overall (Hemorrhagic, Ischemic, Uncertain) |
0.52; 0.69; 0.46; 0.36 | 0.0844 |
| PRIMARY Overall Major Bleeding |
1.82; 2.24; 1.69; 1.24 | 0.0182 sig |
| SECONDARY Ischemic Stroke |
0.5; 0.54; 0.39; 0.36 | 0.6307 |
| SECONDARY Hemorrhagic Stroke |
0.03; 0.16; 0.07; NA | 0.0023 sig |
| SECONDARY Major Intracranial Bleeding |
0.27; 0.41; 0.24; 0.21 | 0.0406 sig |
| SECONDARY Major Extracranial Bleeding |
1.55; 1.83; 1.44; 1.03 | 0.0901 |
| SECONDARY Major GI Bleeding |
1.45; 1.66; 1.36; 0.92 | 0.2073 |
| SECONDARY Major Urogenital Bleeding |
NA; 0.01; NA; NA | — |
| SECONDARY Major Other Bleeding |
0.13; 0.18; 0.11; 0.13 | 0.2663 |
| SECONDARY Upper GI Bleeding |
0.41; 0.55; 0.37; 0.34 | 0.1227 |
| SECONDARY Lower GI Bleeding |
1.08; 1.17; 0.98; 0.58 | 0.4727 |
| SECONDARY TIA |
0.26; 0.20; 0.28; 0.17 | 0.2309 |
| SECONDARY All-cause Mortality |
1.54; 1.37; 1.46; 1.25 | 0.9359 |
Eligibility Criteria
Inclusion Criteria
- Age 18+ on index date
- Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date;
- Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period.
- Patients must have at least 12 months of continuous eligibility prior to the index date;
- Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.
Exclusion Criteria
Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period
Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):
- Cardiac surgery
- Pericarditis
- Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with "valvular" Afib (pre-period):
- Mitral stenosis
- Mitral stenosis with insufficiency
- Mitral valve stenosis and aortic valve stenosis
- Mitral valve stenosis and aortic valve insufficiency
- Diseases of other endocardial structures
- Other and unspecified rheumatic heart diseases
- Open heart valvuloplasty without replacement
- Open and other replacement of unspecified heart valve
- Open and other replacement of aortic valve
- Open and other replacement of mitral valve
- Open and other replacement of pulmonary valve
- Open and other replacement of tricuspid valve
- Heart valve replaced by transplant
- Heart valve replaced by a mechanical device/prosthesis
- Atrioventricular valve repair
- Aortic valve valvuloplasty
- Unlisted procedure, cardiac surgery
- Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic approach
- Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; without cardiopulmonary bypass
- Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; with cardiopulmonary bypass
- Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve
- Valvuloplasty, mitral valve, with cardiopulmonary bypass
- Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring
- Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with or without ring
- Replacement, mitral valve, with cardiopulmonary bypass
- Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach
- Replacement, pulmonary valve
- Valvectomy, tricuspid valve, with cardiopulmonary bypass
- Valvuloplasty, tricuspid valve; without ring insertion
- Valvuloplasty, tricuspid valve; with ring insertion
- Replacement, tricuspid valve, with cardiopulmonary bypass
Data sourced from ClinicalTrials.gov (NCT03026556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.