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Trial record 60 of 333 for:    DABIGATRAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03026556
Recruitment Status : Completed
First Posted : January 20, 2017
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
Health ResearchTx, LLC (HRTX)
inVentiv Health Clinical (iVH)
United States Department of Defense (DOD)
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Atrial Fibrillation
Interventions Drug: Dabigatran vs. Rivaroxaban
Drug: Dabigatran vs. Apixaban
Enrollment 42534
Recruitment Details This is a Non-interventional retrospective cohort study based on existing data with propensity score matching (PSM) in Non-valvular Atrial Fibrillation (NVAF) patients with new Non-Vitamin K antagonist oral anticoagulant (NOAC) use.
Pre-assignment Details The study was a US retrospective database of the Department of Defense (DoD) beneficiary population. Data was extracted from July 1, 2010 to June 30, 2016. Thus there was no pre-assignment/screening details.
Arm/Group Title Dabigatran Rivaroxaban Apixaban
Hide Arm/Group Description Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran . OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban . OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban .
Period Title: Overall Study
Started 12763 17177 12594
Completed 12763 17177 12594
Not Completed 0 0 0
Arm/Group Title Dabigatran Rivaroxaban Apixaban Total
Hide Arm/Group Description Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran . OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban . OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban . Total of all reporting groups
Overall Number of Baseline Participants 12763 17177 12594 42534
Hide Baseline Analysis Population Description
The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Overall Number Analyzed 12763 participants 17177 participants 12594 participants 42534 participants
70.89  (10.03) 71.28  (9.70) 72.35  (8.93) 71.48  (9.60)
Dabigatran vs Rivaroxaban (matched pop) Number Analyzed 12763 participants 12763 participants 0 participants 25526 participants
70.89  (10.03) 70.92  (10.07) 70.91  (10.05)
Dabigatran vs Apixaban (matched pop) Number Analyzed 4802 participants 0 participants 4802 participants 9604 participants
70.15  (10.23) 70.20  (10.02) 70.18  (10.13)
[1]
Measure Analysis Population Description: The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Overall Number Analyzed 12763 participants 17177 participants 12594 participants 42534 participants
Male
7902
  61.9%
10389
  60.5%
7499
  59.5%
25790
  60.6%
Female
4861
  38.1%
6788
  39.5%
5095
  40.5%
16744
  39.4%
Dabigatran vs Rivaroxaban (matched pop) Number Analyzed 12763 participants 12763 participants 0 participants 25526 participants
Male
7902
  61.9%
7839
  61.4%
15741
  61.7%
Female
4861
  38.1%
4924
  38.6%
9785
  38.3%
Dabigatran vs Apixaban (matched pop) Number Analyzed 4802 participants 0 participants 4802 participants 9604 participants
Male
3028
  63.1%
3039
  63.3%
6067
  63.2%
Female
1774
  36.9%
1763
  36.7%
3537
  36.8%
[1]
Measure Analysis Population Description: The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Overall Number Analyzed 12763 participants 17177 participants 12594 participants 42534 participants
White
3771
  29.5%
5388
  31.4%
3744
  29.7%
12903
  30.3%
Black
302
   2.4%
358
   2.1%
272
   2.2%
932
   2.2%
Other/Unknown/Missing
8690
  68.1%
11431
  66.5%
8578
  68.1%
28699
  67.5%
Dabigatran vs Rivaroxaban (matched pop) Number Analyzed 12763 participants 12763 participants 0 participants 25526 participants
White
3771
  29.5%
3779
  29.6%
7550
  29.6%
Black
302
   2.4%
297
   2.3%
599
   2.3%
Other/Unknown/Missing
8690
  68.1%
8687
  68.1%
17377
  68.1%
Dabigatran vs Apixaban (matched pop) Number Analyzed 4802 participants 0 participants 4802 participants 9604 participants
White
1621
  33.8%
1622
  33.8%
3243
  33.8%
Black
157
   3.3%
152
   3.2%
309
   3.2%
Other/Unknown/Missing
3024
  63.0%
3028
  63.1%
6052
  63.0%
[1]
Measure Description: Ethnicity information was not collected for this trial.
[2]
Measure Analysis Population Description: The main analysis was on matched patients based on their baseline characteristics using the propensity score matching (PSM) for the two study cohorts (dabigatran vs rivaroxaban and dabigatran vs apixaban cohorts). Baseline measures were presented for overall treatment groups and matched populations.
1.Primary Outcome
Title Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
Hide Description

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.
Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.52
(0.41 to 0.66)
0.69
(0.56 to 0.84)
0.46
(0.28 to 0.70)
0.36
(0.21 to 0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0844
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.766
Confidence Interval (2-Sided) 95%
0.566 to 1.037
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4892
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.255
Confidence Interval (2-Sided) 95%
0.659 to 2.390
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Major Bleeding
Hide Description

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.

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
1.82
(1.60 to 2.05)
2.24
(2.00 to 2.49)
1.69
(1.33 to 2.11)
1.24
(0.94 to 1.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0182
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.696 to 0.967
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0702
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.374
Confidence Interval (2-Sided) 95%
0.974 to 1.939
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Ischemic Stroke
Hide Description

The event rate of ischemic stroke 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.5
(0.39 to 0.62)
0.54
(0.42 to 0.67)
0.39
(0.23 to 0.62)
0.36
(0.21 to 0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6307
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.923
Confidence Interval (2-Sided) 95%
0.667 to 1.278
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8777
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.054
Confidence Interval (2-Sided) 95%
0.540 to 2.055
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Hemorrhagic Stroke
Hide Description

The event rate of Hemorrhagic stroke 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.

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.03
(0.01 to 0.08)
0.16
(0.11 to 0.25)
0.07
(0.01 to 0.19)
NA [1] 
(NA to NA)
[1]
As there is no person with the event of interest in apixaban groups thus event rate and 95% CI is not calculated
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.223
Confidence Interval (2-Sided) 95%
0.085 to 0.585
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Major Intracranial Bleeding
Hide Description

The event rate of major intracranial 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.27
(0.19 to 0.37)
0.41
(0.31 to 0.53)
0.24
(0.12 to 0.43)
0.21
(0.10 to 0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0406
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.654
Confidence Interval (2-Sided) 95%
0.435 to 0.982
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8124
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.469 to 2.630
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Major Extracranial Bleeding
Hide Description

The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
1.55
(1.35 to 1.76)
1.83
(1.62 to 2.07)
1.44
(1.12 to 1.84)
1.03
(0.76 to 1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0901
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.856
Confidence Interval (2-Sided) 95%
0.716 to 1.025
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0616
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.431
Confidence Interval (2-Sided) 95%
0.983 to 2.083
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Major GI Bleeding
Hide Description

The event rate of major GI bleeding (Upper GI Bleeding and Lower GI 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
1.45
(1.26 to 1.66)
1.66
(1.46 to 1.89)
1.36
(1.04 to 1.74)
0.92
(0.66 to 1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2073
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.887
Confidence Interval (2-Sided) 95%
0.736 to 1.069
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0417
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.504
Confidence Interval (2-Sided) 95%
1.015 to 2.228
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Major Urogenital Bleeding
Hide Description

The event rate of major urogenital 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.

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
NA [1] 
(NA to NA)
0.01
(0.00 to 0.04)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
As there is no person with the event of interest for dabigatran in dabigatran vs rivaroxaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran.
[2]
As there is no person with the event of interest for dabigatran in dabigatran vs apixaban groups and also for the apixaban thus the event rate, 95% CI and Hazard ratio is not reported for dabigatran and for apixaban.
9.Secondary Outcome
Title Major Other Bleeding
Hide Description

The event rate of major other 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.13
(0.08 to 0.20)
0.18
(0.12 to 0.26)
0.11
(0.04 to 0.25)
0.13
(0.05 to 0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2663
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.709
Confidence Interval (2-Sided) 95%
0.387 to 1.299
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8112
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.864
Confidence Interval (2-Sided) 95%
0.261 to 2.863
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Upper GI Bleeding
Hide Description

The event rate of Upper GI 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.41
(0.31 to 0.52)
0.55
(0.44 to 0.69)
0.37
(0.22 to 0.59)
0.34
(0.19 to 0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1227
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.766
Confidence Interval (2-Sided) 95%
0.546 to 1.075
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7115
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.138
Confidence Interval (2-Sided) 95%
0.573 to 2.260
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Lower GI Bleeding
Hide Description

The event rate of Lower GI 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
1.08
(0.91 to 1.26)
1.17
(1.00 to 1.36)
0.98
(0.72 to 1.32)
0.58
(0.38 to 0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4727
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.923
Confidence Interval (2-Sided) 95%
0.741 to 1.149
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.721
Confidence Interval (2-Sided) 95%
1.062 to 2.790
Estimation Comments [Not Specified]
12.Secondary Outcome
Title TIA
Hide Description

The event rate of transient ischemic attack (TIA) 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
0.26
(0.18 to 0.35)
0.20
(0.13 to 0.29)
0.28
(0.15 to 0.48)
0.17
(0.07 to 0.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2309
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.346
Confidence Interval (2-Sided) 95%
0.828 to 2.189
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3333
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.557
Confidence Interval (2-Sided) 95%
0.635 to 3.821
Estimation Comments [Not Specified]
13.Secondary Outcome
Title All-cause Mortality
Hide Description

The event rate of all-cause mortality 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

Time Frame Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).
Arm/Group Title Dabigatran (Dabigatran vs Rivaroxaban) Rivaroxaban (Dabigatran vs Rivaroxaban) Dabigatran (Dabigatran vs Apixaban) Apixaban (Dabigatran vs Apixaban)
Hide Arm/Group Description:
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban; 1:1 matching of dabigatran to rivaroxaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for dabigatran; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban; 1:1 matching of dabigatran to apixaban was based on their baseline characteristics using the propensity score matching (PSM).
Overall Number of Participants Analyzed 12763 12763 4802 4802
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Event Rate in 100 person-years
1.54
(1.35 to 1.75)
1.37
(1.18 to 1.57)
1.46
(1.13 to 1.85)
1.25
(0.96 to 1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Rivaroxaban), Rivaroxaban (Dabigatran vs Rivaroxaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9359
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.008
Confidence Interval (2-Sided) 95%
0.829 to 1.226
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran (Dabigatran vs Apixaban), Apixaban (Dabigatran vs Apixaban)
Comments Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8947
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.024
Confidence Interval (2-Sided) 95%
0.716 to 1.465
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective observational study, in which all patient data were de-identified and analyzed in aggregate. Individual patient safety related information were not captured during this study. Thus, individual safety reporting (including adverse events reporting) was not applicable for this study.
 
Arm/Group Title Dabigatran Rivaroxaban Apixaban
Hide Arm/Group Description Oral anticoagulant (OAC) treatment naïve NVAF patients with at least one Non-Vitamin K antagonist oral anticoagulant (NOAC) prescription claim for dabigatran. OAC treatment naïve NVAF patients with at least one NOAC prescription claim for rivaroxaban. OAC treatment naïve NVAF patients with at least one NOAC prescription claim for apixaban.
All-Cause Mortality
Dabigatran Rivaroxaban Apixaban
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Rivaroxaban Apixaban
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Rivaroxaban Apixaban
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03026556     History of Changes
Other Study ID Numbers: 1160-0274
First Submitted: January 18, 2017
First Posted: January 20, 2017
Results First Submitted: August 20, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019