Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42,534
- 试验地点
- 1
- 主要终点
- Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Dabigatran vs. Rivaroxaban
OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).
干预措施: Dabigatran vs. Rivaroxaban (Drug)
Dabigatran vs. Apixaban
OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).
干预措施: Dabigatran vs. Apixaban (Drug)
结局指标
主要结局
Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
时间窗: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest: 1. The day of discontinuation of the index NOAC exposure; 2. The day before a switch to an anticoagulant different from the index exposure; 3. The day before a change in dose for the index NOAC; 4. The end of continuous eligibility of a patient in the health plan (disenrollment); 5. The end of the study observation period; or 6. The date of death of the patient.
Overall Major Bleeding
时间窗: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first.
次要结局
- Ischemic Stroke(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Hemorrhagic Stroke(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Major Intracranial Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Major Extracranial Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Major GI Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Major Urogenital Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Major Other Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Upper GI Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- Lower GI Bleeding(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- TIA(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)
- All-cause Mortality(Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years)