Trial Outcomes & Findings for Anticoagulant Utilization Pattern (NCT NCT01847560)
NCT ID: NCT01847560
Last Updated: 2019-06-27
Results Overview
The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
Recruitment status
COMPLETED
Target enrollment
333664 participants
Primary outcome timeframe
From January 2009 to September 2015 (The study period)
Results posted on
2019-06-27
Participant Flow
This study used a cohort design with descriptive analyses, using data from January 2009 through September 2015. The study was conducted within two US-based longitudinal healthcare claims databases (MarketScan and UnitedHealth Research Database).
The data source for this project was a combination of claims data from UnitedHealth, a commercial health insurer, and MarketScan, a research claims database from commercial employer-sponsored health plans both of which provide comprehensive medical coverage for members with active policies.
Participant milestones
| Measure |
Cohort UnitedHealth Dabigatran Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan WarfarinUsers (After Dabigatran Available)
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan WarfarinUsers(Before Dabigatran Available)
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13464
|
19955
|
9731
|
56655
|
27731
|
28343
|
40971
|
19829
|
77547
|
39438
|
|
Overall Study
COMPLETED
|
13464
|
19955
|
9731
|
56655
|
27731
|
28343
|
40971
|
19829
|
77547
|
39438
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort UnitedHealth Dabigatran Users
n=13464 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
n=19955 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
n=9731 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)
n=56655 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)
n=27731 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
n=28343 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
n=40971 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
n=19829 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan WarfarinUsers (After Dabigatran Available)
n=77547 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan WarfarinUsers(Before Dabigatran Available)
n=39438 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin before Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Total
n=333664 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.07 Years
STANDARD_DEVIATION 11.4 • n=13464 Participants
|
70.04 Years
STANDARD_DEVIATION 11.45 • n=19955 Participants
|
72.18 Years
STANDARD_DEVIATION 11.05 • n=9731 Participants
|
73.64 Years
STANDARD_DEVIATION 10.28 • n=56655 Participants
|
71.7 Years
STANDARD_DEVIATION 10.8 • n=27731 Participants
|
67.17 Years
STANDARD_DEVIATION 12.11 • n=28343 Participants
|
67.63 Years
STANDARD_DEVIATION 12.21 • n=40971 Participants
|
69.42 Years
STANDARD_DEVIATION 12.32 • n=19829 Participants
|
71.03 Years
STANDARD_DEVIATION 12.11 • n=77547 Participants
|
69.1 Years
STANDARD_DEVIATION 12.4 • n=39438 Participants
|
70.4 Years
STANDARD_DEVIATION 11.9 • n=333664 Participants
|
|
Sex: Female, Male
Female
|
5017 Participants
n=13464 Participants
|
7939 Participants
n=19955 Participants
|
4225 Participants
n=9731 Participants
|
24620 Participants
n=56655 Participants
|
11699 Participants
n=27731 Participants
|
10096 Participants
n=28343 Participants
|
15305 Participants
n=40971 Participants
|
7776 Participants
n=19829 Participants
|
30293 Participants
n=77547 Participants
|
15539 Participants
n=39438 Participants
|
132509 Participants
n=333664 Participants
|
|
Sex: Female, Male
Male
|
8447 Participants
n=13464 Participants
|
12016 Participants
n=19955 Participants
|
5506 Participants
n=9731 Participants
|
32035 Participants
n=56655 Participants
|
16032 Participants
n=27731 Participants
|
18247 Participants
n=28343 Participants
|
25666 Participants
n=40971 Participants
|
12053 Participants
n=19829 Participants
|
47254 Participants
n=77547 Participants
|
23899 Participants
n=39438 Participants
|
201155 Participants
n=333664 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From January 2009 to September 2015 (The study period)Population: All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time.
The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
Outcome measures
| Measure |
Cohort UnitedHealth Dabigatran Users
n=13464 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Warfarin Users
n=56655 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
n=19955 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
n=9731 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
n=28343 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Warfarin Users
n=77547 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
n=40971 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
n=19829 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)
Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)
Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Apixaban (Apixaban vs Warfarin)
Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Apixaban)
Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Description of the Characteristics of Anticoagulant Initiators
CHA2DS2-VASc score
|
3.41 Scores on a scale
Standard Deviation 1.73
|
4.30 Scores on a scale
Standard Deviation 1.75
|
3.59 Scores on a scale
Standard Deviation 1.75
|
3.82 Scores on a scale
Standard Deviation 1.72
|
2.92 Scores on a scale
Standard Deviation 1.58
|
3.62 Scores on a scale
Standard Deviation 1.69
|
3.12 Scores on a scale
Standard Deviation 1.68
|
3.34 Scores on a scale
Standard Deviation 1.73
|
—
|
—
|
—
|
—
|
|
Description of the Characteristics of Anticoagulant Initiators
HAS-BLED score
|
2.52 Scores on a scale
Standard Deviation 1.15
|
2.91 Scores on a scale
Standard Deviation 1.18
|
2.63 Scores on a scale
Standard Deviation 1.15
|
2.76 Scores on a scale
Standard Deviation 1.16
|
2.18 Scores on a scale
Standard Deviation 1.02
|
2.51 Scores on a scale
Standard Deviation 1.12
|
2.32 Scores on a scale
Standard Deviation 1.1
|
2.47 Scores on a scale
Standard Deviation 1.14
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From January 2009 to September 2015 (The study period)Population: Source cohort in a calendar time window includes all patients with at least one day eligibility. A random date within the time window selected and set as the index date. Patients dispensed of an anticoagulant before assigned index date will be removed, unless they are identified as new initiators for that particular time period.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
Outcome measures
| Measure |
Cohort UnitedHealth Dabigatran Users
n=609201 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Warfarin Users
n=609201 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
n=609201 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
n=609201 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Warfarin Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)
Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)
Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Apixaban (Apixaban vs Warfarin)
Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Apixaban)
Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Initiating Specific Anticoagulant
January 2009 - September2010
|
15.7 Percentage of initiators (%)
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
October2010 - June2011
|
5.4 Percentage of initiators (%)
|
2.1 Percentage of initiators (%)
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
July2011 -Dec 2011
|
2.9 Percentage of initiators (%)
|
2.2 Percentage of initiators (%)
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
January2012-June2012
|
3.4 Percentage of initiators (%)
|
1.9 Percentage of initiators (%)
|
1.5 Percentage of initiators (%)
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
July2012-December2012
|
2.9 Percentage of initiators (%)
|
1.3 Percentage of initiators (%)
|
1.5 Percentage of initiators (%)
|
NA Percentage of initiators (%)
No treatment initiation during this period
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
January2013-June2013
|
2.3 Percentage of initiators (%)
|
0.8 Percentage of initiators (%)
|
1.8 Percentage of initiators (%)
|
0.3 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
July2013-December2013
|
2.0 Percentage of initiators (%)
|
0.6 Percentage of initiators (%)
|
1.9 Percentage of initiators (%)
|
0.7 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
January2014-June2014
|
1.7 Percentage of initiators (%)
|
0.5 Percentage of initiators (%)
|
2.2 Percentage of initiators (%)
|
1.0 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
July2014-December2014
|
1.6 Percentage of initiators (%)
|
0.4 Percentage of initiators (%)
|
2.0 Percentage of initiators (%)
|
1.3 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
January2015-June2015
|
1.6 Percentage of initiators (%)
|
0.3 Percentage of initiators (%)
|
2.0 Percentage of initiators (%)
|
1.7 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant
July2015-September2015
|
0.7 Percentage of initiators (%)
|
0.1 Percentage of initiators (%)
|
1.0 Percentage of initiators (%)
|
1.0 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From January 2009 to September 2015 (The study period)Population: Patients initiating treatment in source cohort.
Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Outcome measures
| Measure |
Cohort UnitedHealth Dabigatran Users
n=13464 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Warfarin Users
n=28343 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Warfarin Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)
Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)
Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Apixaban (Apixaban vs Warfarin)
Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Apixaban)
Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
150 milligram (mg)
|
90.7 Percentage of initiators (%)
|
90.7 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
75 mg
|
9.3 Percentage of initiators (%)
|
9.3 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From January 2009 to September 2015 (The study period)Population: Patients initiating treatment in source cohort.
Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Outcome measures
| Measure |
Cohort UnitedHealth Dabigatran Users
n=9731 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Warfarin Users
n=19829 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Warfarin Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)
Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)
Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Apixaban (Apixaban vs Warfarin)
Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Apixaban)
Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
5 mg
|
82.4 Percentage of initiators (%)
|
84.4 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
2.5 mg
|
17.6 Percentage of initiators (%)
|
15.6 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From January 2009 to September 2015 (The study period)Population: Patients initiating treatment in source cohort.
Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
Outcome measures
| Measure |
Cohort UnitedHealth Dabigatran Users
n=19955 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Warfarin Users
n=40971 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Warfarin Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)
Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)
Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Apixaban (Apixaban vs Warfarin)
Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Apixaban)
Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
20 mg
|
74.0 Percentage of initiators (%)
|
76.4 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
15 mg
|
18.4 Percentage of initiators (%)
|
16.7 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
10 mg
|
7.6 Percentage of initiators (%)
|
7.0 Percentage of initiators (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From January 2009 to September 2015 (The study period)Population: Patients were matched within calendar quarters (3 months period) the various NOACs were individually matched to warfarin on an exposure propensity score (PS) in a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.
Outcome measures
| Measure |
Cohort UnitedHealth Dabigatran Users
n=11927 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Warfarin Users
n=11927 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Rivaroxaban Users
n=15522 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort UnitedHealth Apixaban Users
n=15522 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in UnitedHealth cohort before treatment initiation.
|
Cohort MarketScan Dabigatran Users
n=7712 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Dabigatran who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Warfarin Users
n=7712 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Warfarin after Dabigatran became available who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban Users
n=24141 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Rivaroxaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Apixaban Users
n=24141 Participants
Patients with a diagnosis of non-valvular atrial fibrillation (NVAF) new initiators of Apixaban who were enrolled for a minimum of 12 months in MarketScan cohort before treatment initiation.
|
Cohort MarketScan Rivaroxaban (Rivaroxabna vs Warfarin)
n=26066 Participants
Patients exposed to rivaroxaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Rivaroxaban)
n=26066 Participants
Patients exposed to warfarin were matched to rivaroxaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Apixaban (Apixaban vs Warfarin)
n=12578 Participants
Patients exposed to apixaban were matched to warfarin on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
Cohort MarketScan Warfarin (Warfarin vs Apixaban)
n=12578 Participants
Patients exposed to warfarin were matched to apixaban on an exposure propensity score (PS) on a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Persistence Over Time
After 3 months of follow-up
|
52.19 Percentage of participants (%)
|
52.86 Percentage of participants (%)
|
53.17 Percentage of participants (%)
|
51.58 Percentage of participants (%)
|
51.84 Percentage of participants (%)
|
48.29 Percentage of participants (%)
|
57.92 Percentage of participants (%)
|
53.25 Percentage of participants (%)
|
58.33 Percentage of participants (%)
|
53.27 Percentage of participants (%)
|
58.24 Percentage of participants (%)
|
51.17 Percentage of participants (%)
|
|
Treatment Persistence Over Time
After 6 months of follow-up
|
30.96 Percentage of participants (%)
|
28.16 Percentage of participants (%)
|
31.53 Percentage of participants (%)
|
26.11 Percentage of participants (%)
|
27.71 Percentage of participants (%)
|
21.68 Percentage of participants (%)
|
33.09 Percentage of participants (%)
|
26.78 Percentage of participants (%)
|
35.49 Percentage of participants (%)
|
25.83 Percentage of participants (%)
|
33.25 Percentage of participants (%)
|
23.11 Percentage of participants (%)
|
|
Treatment Persistence Over Time
After 12 months of follow-up
|
15.07 Percentage of participants (%)
|
11.86 Percentage of participants (%)
|
13.54 Percentage of participants (%)
|
9.63 Percentage of participants (%)
|
9.14 Percentage of participants (%)
|
5.56 Percentage of participants (%)
|
15.47 Percentage of participants (%)
|
10.18 Percentage of participants (%)
|
16.50 Percentage of participants (%)
|
8.93 Percentage of participants (%)
|
13.20 Percentage of participants (%)
|
6.22 Percentage of participants (%)
|
Adverse Events
Cohort UnitedHealth Dabigatran Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort UnitedHealth Rivaroxaban Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort UnitedHealth Apixaban Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort UnitedHealth WarfarinUsers (After Dabigatran Available)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort UnitedHealth WarfarinUsers(Before Dabigatran Available)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort MarketScan Dabigatran Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort MarketScan Rivaroxaban Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort MarketScan Apixaban Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort MarketScan WarfarinUsers (After Dabigatran Available)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort MarketScan WarfarinUsers(Before Dabigatran Available)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER