Trial Outcomes & Findings for Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare (NCT NCT04681482)
NCT ID: NCT04681482
Last Updated: 2023-05-22
Results Overview
Event rate per 100 participant-years for first occurrence of major bleeding (MB) event after index date in obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017 \[3.5 years\]). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of gastrointestinal (GI), intracranial hemorrhage (ICH), and other sites. MB was equal to 1 if bleeding event was greater than equal to (\>=) 1.
Recruitment status
COMPLETED
Target enrollment
107383 participants
Primary outcome timeframe
From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Results posted on
2023-05-22
Participant Flow
This was a retrospective population-based registry study. Data for participants diagnosed with non-valvular atrial fibrillation (NVAF) and treated with either oral anticoagulants (OAC \[Warfarin\]) or direct oral anticoagulants (DOAC \[Apixaban, Dabigatran and Rivaroxaban\]) retrieved from the Veterans Affairs (VA) Population and Centre for Medicare and Medicare Services (CMS) database from January 2013 to December 2017.
In this study, inverse probability of treatment weighted (IPTW) method was used in analysis of outcome measures to balance participant's characteristics among reporting groups. Baseline for this study was 6 months prior to the index date. The index date was the date of first prescription for an OAC (Warfarin) or DOAC (Apixaban, Dabigatran, and Rivaroxaban) pharmacy claim during the identification period from July 1, 2013 -December 31, 2017.
Participant milestones
| Measure |
Warfarin
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35051
|
38756
|
12148
|
21428
|
|
Overall Study
COMPLETED
|
35051
|
38756
|
12148
|
21428
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
Baseline characteristics by cohort
| Measure |
Warfarin
n=35051 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=38756 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
n=12148 Participants
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
n=21428 Participants
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Total
n=107383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-54 years
|
182 Participants
n=35051 Participants
|
94 Participants
n=38756 Participants
|
88 Participants
n=12148 Participants
|
105 Participants
n=21428 Participants
|
469 Participants
n=107383 Participants
|
|
Age, Customized
55-64 years
|
1380 Participants
n=35051 Participants
|
833 Participants
n=38756 Participants
|
580 Participants
n=12148 Participants
|
827 Participants
n=21428 Participants
|
3620 Participants
n=107383 Participants
|
|
Age, Customized
65-74 years
|
12410 Participants
n=35051 Participants
|
13037 Participants
n=38756 Participants
|
6873 Participants
n=12148 Participants
|
10070 Participants
n=21428 Participants
|
42390 Participants
n=107383 Participants
|
|
Age, Customized
75-79 years
|
5817 Participants
n=35051 Participants
|
6504 Participants
n=38756 Participants
|
1741 Participants
n=12148 Participants
|
3472 Participants
n=21428 Participants
|
17534 Participants
n=107383 Participants
|
|
Age, Customized
>=80 years
|
15262 Participants
n=35051 Participants
|
18288 Participants
n=38756 Participants
|
2866 Participants
n=12148 Participants
|
6954 Participants
n=21428 Participants
|
43370 Participants
n=107383 Participants
|
|
Sex: Female, Male
Female
|
456 Participants
n=35051 Participants
|
576 Participants
n=38756 Participants
|
139 Participants
n=12148 Participants
|
299 Participants
n=21428 Participants
|
1470 Participants
n=107383 Participants
|
|
Sex: Female, Male
Male
|
34595 Participants
n=35051 Participants
|
38180 Participants
n=38756 Participants
|
12009 Participants
n=12148 Participants
|
21129 Participants
n=21428 Participants
|
105913 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35051 Participants
|
0 Participants
n=38756 Participants
|
0 Participants
n=12148 Participants
|
0 Participants
n=21428 Participants
|
0 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=35051 Participants
|
0 Participants
n=38756 Participants
|
0 Participants
n=12148 Participants
|
0 Participants
n=21428 Participants
|
0 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35051 Participants
|
0 Participants
n=38756 Participants
|
0 Participants
n=12148 Participants
|
0 Participants
n=21428 Participants
|
0 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2086 Participants
n=35051 Participants
|
2024 Participants
n=38756 Participants
|
621 Participants
n=12148 Participants
|
1172 Participants
n=21428 Participants
|
5903 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
White
|
32246 Participants
n=35051 Participants
|
35847 Participants
n=38756 Participants
|
11184 Participants
n=12148 Participants
|
19732 Participants
n=21428 Participants
|
99009 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
More than one race
|
529 Participants
n=35051 Participants
|
654 Participants
n=38756 Participants
|
220 Participants
n=12148 Participants
|
343 Participants
n=21428 Participants
|
1746 Participants
n=107383 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
190 Participants
n=35051 Participants
|
231 Participants
n=38756 Participants
|
123 Participants
n=12148 Participants
|
181 Participants
n=21428 Participants
|
725 Participants
n=107383 Participants
|
|
Number of Participants From Different Regions of United States
Northeast
|
7016 Participants
n=35051 Participants
|
6821 Participants
n=38756 Participants
|
1887 Participants
n=12148 Participants
|
3718 Participants
n=21428 Participants
|
19442 Participants
n=107383 Participants
|
|
Number of Participants From Different Regions of United States
Midwest
|
10498 Participants
n=35051 Participants
|
10046 Participants
n=38756 Participants
|
3008 Participants
n=12148 Participants
|
5858 Participants
n=21428 Participants
|
29410 Participants
n=107383 Participants
|
|
Number of Participants From Different Regions of United States
South
|
11809 Participants
n=35051 Participants
|
15311 Participants
n=38756 Participants
|
5080 Participants
n=12148 Participants
|
8398 Participants
n=21428 Participants
|
40598 Participants
n=107383 Participants
|
|
Number of Participants From Different Regions of United States
West
|
5576 Participants
n=35051 Participants
|
6392 Participants
n=38756 Participants
|
2134 Participants
n=12148 Participants
|
3361 Participants
n=21428 Participants
|
17463 Participants
n=107383 Participants
|
|
Number of Participants From Different Regions of United States
Other/Unknown
|
152 Participants
n=35051 Participants
|
186 Participants
n=38756 Participants
|
39 Participants
n=12148 Participants
|
93 Participants
n=21428 Participants
|
470 Participants
n=107383 Participants
|
|
Number of Participants Classified According to OAC Index Year
2013
|
5090 Participants
n=35051 Participants
|
395 Participants
n=38756 Participants
|
974 Participants
n=12148 Participants
|
1135 Participants
n=21428 Participants
|
7594 Participants
n=107383 Participants
|
|
Number of Participants Classified According to OAC Index Year
2014
|
9024 Participants
n=35051 Participants
|
2548 Participants
n=38756 Participants
|
2462 Participants
n=12148 Participants
|
3996 Participants
n=21428 Participants
|
18030 Participants
n=107383 Participants
|
|
Number of Participants Classified According to OAC Index Year
2015
|
7770 Participants
n=35051 Participants
|
6792 Participants
n=38756 Participants
|
2178 Participants
n=12148 Participants
|
4370 Participants
n=21428 Participants
|
21110 Participants
n=107383 Participants
|
|
Number of Participants Classified According to OAC Index Year
2016
|
7289 Participants
n=35051 Participants
|
12705 Participants
n=38756 Participants
|
3336 Participants
n=12148 Participants
|
5600 Participants
n=21428 Participants
|
28930 Participants
n=107383 Participants
|
|
Number of Participants Classified According to OAC Index Year
2017
|
5878 Participants
n=35051 Participants
|
16316 Participants
n=38756 Participants
|
3198 Participants
n=12148 Participants
|
6327 Participants
n=21428 Participants
|
31719 Participants
n=107383 Participants
|
|
Dose of the Index DOAC
Standard Dose (5 mg Apixaban, 150 mg Dabigatran, 20 mg Rivaroxaban)
|
0 Participants
No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
30494 Participants
n=38756 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
11411 Participants
n=12148 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
16108 Participants
n=21428 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
58013 Participants
n=72332 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
|
Dose of the Index DOAC
Lower Dose (2.5 mg Apixaban, 75 mg Dabigatran, 15 mg Rivaroxaban)
|
0 Participants
No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
8262 Participants
n=38756 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
726 Participants
n=12148 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
4550 Participants
n=21428 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
13538 Participants
n=72332 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
|
Dose of the Index DOAC
Other Dose (10 mg Rivaroxaban , 110 mg Dabigatran)
|
0 Participants
No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
0 Participants
n=38756 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
11 Participants
n=12148 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
770 Participants
n=21428 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
781 Participants
n=72332 Participants • No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.
|
|
Body Weight
<=60 Kg
|
871 Participants
n=35051 Participants
|
1009 Participants
n=38756 Participants
|
149 Participants
n=12148 Participants
|
359 Participants
n=21428 Participants
|
2388 Participants
n=107383 Participants
|
|
Body Weight
61-99 Kg
|
22449 Participants
n=35051 Participants
|
25698 Participants
n=38756 Participants
|
6924 Participants
n=12148 Participants
|
13225 Participants
n=21428 Participants
|
68296 Participants
n=107383 Participants
|
|
Body Weight
100-119 Kg
|
7102 Participants
n=35051 Participants
|
7830 Participants
n=38756 Participants
|
3094 Participants
n=12148 Participants
|
4776 Participants
n=21428 Participants
|
22802 Participants
n=107383 Participants
|
|
Body Weight
>=120 Kg
|
3714 Participants
n=35051 Participants
|
3261 Participants
n=38756 Participants
|
1614 Participants
n=12148 Participants
|
2478 Participants
n=21428 Participants
|
11067 Participants
n=107383 Participants
|
|
Body Weight
Missing
|
915 Participants
n=35051 Participants
|
958 Participants
n=38756 Participants
|
367 Participants
n=12148 Participants
|
590 Participants
n=21428 Participants
|
2830 Participants
n=107383 Participants
|
|
Body Mass Index (BMI)
<18.5 kg/m^2
|
285 Participants
n=35051 Participants
|
296 Participants
n=38756 Participants
|
47 Participants
n=12148 Participants
|
121 Participants
n=21428 Participants
|
749 Participants
n=107383 Participants
|
|
Body Mass Index (BMI)
(18.5-24.9) kg/m^2
|
5921 Participants
n=35051 Participants
|
6890 Participants
n=38756 Participants
|
1586 Participants
n=12148 Participants
|
3158 Participants
n=21428 Participants
|
17555 Participants
n=107383 Participants
|
|
Body Mass Index (BMI)
(25-29) kg/m^2
|
8803 Participants
n=35051 Participants
|
10490 Participants
n=38756 Participants
|
3041 Participants
n=12148 Participants
|
5563 Participants
n=21428 Participants
|
27897 Participants
n=107383 Participants
|
|
Body Mass Index (BMI)
(30-39) kg/m^2
|
10293 Participants
n=35051 Participants
|
11425 Participants
n=38756 Participants
|
4357 Participants
n=12148 Participants
|
6923 Participants
n=21428 Participants
|
32998 Participants
n=107383 Participants
|
|
Body Mass Index (BMI)
>40 kg/m^2
|
2176 Participants
n=35051 Participants
|
1746 Participants
n=38756 Participants
|
896 Participants
n=12148 Participants
|
1294 Participants
n=21428 Participants
|
6112 Participants
n=107383 Participants
|
|
Body Mass Index (BMI)
Missing
|
7573 Participants
n=35051 Participants
|
7909 Participants
n=38756 Participants
|
2221 Participants
n=12148 Participants
|
4369 Participants
n=21428 Participants
|
22072 Participants
n=107383 Participants
|
|
International Normalized Ratio (INR)
Yes
|
15304 Participants
n=35051 Participants
|
9133 Participants
n=38756 Participants
|
3561 Participants
n=12148 Participants
|
3977 Participants
n=21428 Participants
|
31975 Participants
n=107383 Participants
|
|
International Normalized Ratio (INR)
No
|
19747 Participants
n=35051 Participants
|
29623 Participants
n=38756 Participants
|
8587 Participants
n=12148 Participants
|
17451 Participants
n=21428 Participants
|
75408 Participants
n=107383 Participants
|
|
CHADS2 Score
0
|
1424 Participants
n=35051 Participants
|
1506 Participants
n=38756 Participants
|
944 Participants
n=12148 Participants
|
1352 Participants
n=21428 Participants
|
5226 Participants
n=107383 Participants
|
|
CHADS2 Score
1
|
6829 Participants
n=35051 Participants
|
7280 Participants
n=38756 Participants
|
3640 Participants
n=12148 Participants
|
5413 Participants
n=21428 Participants
|
23162 Participants
n=107383 Participants
|
|
CHADS2 Score
2
|
11372 Participants
n=35051 Participants
|
12318 Participants
n=38756 Participants
|
3985 Participants
n=12148 Participants
|
6935 Participants
n=21428 Participants
|
34610 Participants
n=107383 Participants
|
|
CHADS2 Score
>=3
|
15426 Participants
n=35051 Participants
|
17652 Participants
n=38756 Participants
|
3579 Participants
n=12148 Participants
|
7728 Participants
n=21428 Participants
|
44385 Participants
n=107383 Participants
|
|
CHA2DS2-VASc Score
0
|
79 Participants
n=35051 Participants
|
70 Participants
n=38756 Participants
|
71 Participants
n=12148 Participants
|
87 Participants
n=21428 Participants
|
307 Participants
n=107383 Participants
|
|
CHA2DS2-VASc Score
1
|
1280 Participants
n=35051 Participants
|
1405 Participants
n=38756 Participants
|
886 Participants
n=12148 Participants
|
1227 Participants
n=21428 Participants
|
4798 Participants
n=107383 Participants
|
|
CHA2DS2-VASc Score
2
|
4703 Participants
n=35051 Participants
|
5764 Participants
n=38756 Participants
|
2709 Participants
n=12148 Participants
|
4007 Participants
n=21428 Participants
|
17183 Participants
n=107383 Participants
|
|
CHA2DS2-VASc Score
3
|
8196 Participants
n=35051 Participants
|
9734 Participants
n=38756 Participants
|
3520 Participants
n=12148 Participants
|
5718 Participants
n=21428 Participants
|
27168 Participants
n=107383 Participants
|
|
CHA2DS2-VASc Score
>=4
|
20793 Participants
n=35051 Participants
|
21783 Participants
n=38756 Participants
|
4962 Participants
n=12148 Participants
|
10389 Participants
n=21428 Participants
|
57927 Participants
n=107383 Participants
|
|
HAS-BLED Score
0
|
135 Participants
n=35051 Participants
|
109 Participants
n=38756 Participants
|
83 Participants
n=12148 Participants
|
130 Participants
n=21428 Participants
|
457 Participants
n=107383 Participants
|
|
HAS-BLED Score
1
|
3859 Participants
n=35051 Participants
|
4522 Participants
n=38756 Participants
|
1733 Participants
n=12148 Participants
|
2770 Participants
n=21428 Participants
|
12884 Participants
n=107383 Participants
|
|
HAS-BLED Score
2
|
11444 Participants
n=35051 Participants
|
13675 Participants
n=38756 Participants
|
5457 Participants
n=12148 Participants
|
8533 Participants
n=21428 Participants
|
39109 Participants
n=107383 Participants
|
|
HAS-BLED Score
>=3
|
19613 Participants
n=35051 Participants
|
20450 Participants
n=38756 Participants
|
4875 Participants
n=12148 Participants
|
9995 Participants
n=21428 Participants
|
54933 Participants
n=107383 Participants
|
|
Baseline Medication Use
ACE/ARB
|
13562 Participants
n=35051 Participants
|
14295 Participants
n=38756 Participants
|
4777 Participants
n=12148 Participants
|
8049 Participants
n=21428 Participants
|
40683 Participants
n=107383 Participants
|
|
Baseline Medication Use
Beta blockers
|
18486 Participants
n=35051 Participants
|
20198 Participants
n=38756 Participants
|
6177 Participants
n=12148 Participants
|
11211 Participants
n=21428 Participants
|
56072 Participants
n=107383 Participants
|
|
Baseline Medication Use
H2-receptor antagonist
|
2268 Participants
n=35051 Participants
|
2584 Participants
n=38756 Participants
|
695 Participants
n=12148 Participants
|
1288 Participants
n=21428 Participants
|
6835 Participants
n=107383 Participants
|
|
Baseline Medication Use
Proton pump inhibitor
|
12227 Participants
n=35051 Participants
|
13793 Participants
n=38756 Participants
|
3896 Participants
n=12148 Participants
|
7178 Participants
n=21428 Participants
|
37094 Participants
n=107383 Participants
|
|
Baseline Medication Use
Statins
|
23095 Participants
n=35051 Participants
|
25830 Participants
n=38756 Participants
|
7959 Participants
n=12148 Participants
|
13901 Participants
n=21428 Participants
|
70785 Participants
n=107383 Participants
|
|
Baseline Medication Use
Anti-platelets
|
8686 Participants
n=35051 Participants
|
10515 Participants
n=38756 Participants
|
2980 Participants
n=12148 Participants
|
5141 Participants
n=21428 Participants
|
27322 Participants
n=107383 Participants
|
|
Baseline Medication Use
NSAIDS
|
3819 Participants
n=35051 Participants
|
5319 Participants
n=38756 Participants
|
1904 Participants
n=12148 Participants
|
3388 Participants
n=21428 Participants
|
14430 Participants
n=107383 Participants
|
|
Bariatric Surgery
|
130 Participants
n=35051 Participants
|
125 Participants
n=38756 Participants
|
43 Participants
n=12148 Participants
|
93 Participants
n=21428 Participants
|
391 Participants
n=107383 Participants
|
|
Comorbid Conditions
Bleeding History
|
6021 Participants
n=35051 Participants
|
5564 Participants
n=38756 Participants
|
1367 Participants
n=12148 Participants
|
2886 Participants
n=21428 Participants
|
15838 Participants
n=107383 Participants
|
|
Comorbid Conditions
CHF
|
13188 Participants
n=35051 Participants
|
12385 Participants
n=38756 Participants
|
3025 Participants
n=12148 Participants
|
6062 Participants
n=21428 Participants
|
34660 Participants
n=107383 Participants
|
|
Comorbid Conditions
Diabetes Mellitus
|
15527 Participants
n=35051 Participants
|
15225 Participants
n=38756 Participants
|
4714 Participants
n=12148 Participants
|
8453 Participants
n=21428 Participants
|
43919 Participants
n=107383 Participants
|
|
Comorbid Conditions
Hypertension
|
29689 Participants
n=35051 Participants
|
32639 Participants
n=38756 Participants
|
10117 Participants
n=12148 Participants
|
17961 Participants
n=21428 Participants
|
90406 Participants
n=107383 Participants
|
|
Comorbid Conditions
Renal Disease
|
4540 Participants
n=35051 Participants
|
8022 Participants
n=38756 Participants
|
929 Participants
n=12148 Participants
|
2367 Participants
n=21428 Participants
|
15858 Participants
n=107383 Participants
|
|
Comorbid Conditions
Liver Disease
|
1430 Participants
n=35051 Participants
|
1388 Participants
n=38756 Participants
|
418 Participants
n=12148 Participants
|
814 Participants
n=21428 Participants
|
4050 Participants
n=107383 Participants
|
|
Comorbid Conditions
Myocardial Infarction
|
5344 Participants
n=35051 Participants
|
5628 Participants
n=38756 Participants
|
1200 Participants
n=12148 Participants
|
2841 Participants
n=21428 Participants
|
15013 Participants
n=107383 Participants
|
|
Comorbid Conditions
Dyspepsia or Stomach Discomfort
|
4322 Participants
n=35051 Participants
|
4201 Participants
n=38756 Participants
|
1110 Participants
n=12148 Participants
|
2438 Participants
n=21428 Participants
|
12071 Participants
n=107383 Participants
|
|
Comorbid Conditions
Non-stroke/SE Peripheral Vascular Disease
|
8994 Participants
n=35051 Participants
|
9560 Participants
n=38756 Participants
|
2276 Participants
n=12148 Participants
|
4836 Participants
n=21428 Participants
|
25666 Participants
n=107383 Participants
|
|
Comorbid Conditions
Stroke/SE
|
4468 Participants
n=35051 Participants
|
4731 Participants
n=38756 Participants
|
1062 Participants
n=12148 Participants
|
2186 Participants
n=21428 Participants
|
12447 Participants
n=107383 Participants
|
|
Comorbid Conditions
TIA
|
2750 Participants
n=35051 Participants
|
4508 Participants
n=38756 Participants
|
840 Participants
n=12148 Participants
|
1807 Participants
n=21428 Participants
|
9905 Participants
n=107383 Participants
|
|
Comorbid Conditions
Anemia and Coagulation Defects
|
10572 Participants
n=35051 Participants
|
9987 Participants
n=38756 Participants
|
2129 Participants
n=12148 Participants
|
4640 Participants
n=21428 Participants
|
27328 Participants
n=107383 Participants
|
|
Comorbid Conditions
Alcoholism
|
11323 Participants
n=35051 Participants
|
14181 Participants
n=38756 Participants
|
4241 Participants
n=12148 Participants
|
7567 Participants
n=21428 Participants
|
37312 Participants
n=107383 Participants
|
|
Comorbid Conditions
Peripheral Artery Disease
|
8817 Participants
n=35051 Participants
|
8927 Participants
n=38756 Participants
|
2156 Participants
n=12148 Participants
|
4610 Participants
n=21428 Participants
|
24510 Participants
n=107383 Participants
|
|
Comorbid Conditions
Coronary Artery Disease
|
19283 Participants
n=35051 Participants
|
21041 Participants
n=38756 Participants
|
5664 Participants
n=12148 Participants
|
10903 Participants
n=21428 Participants
|
56891 Participants
n=107383 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: Obese participants with or without DOAC treatment diagnosed with NVAF were included in the outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.
Event rate per 100 participant-years for first occurrence of major bleeding (MB) event after index date in obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017 \[3.5 years\]). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of gastrointestinal (GI), intracranial hemorrhage (ICH), and other sites. MB was equal to 1 if bleeding event was greater than equal to (\>=) 1.
Outcome measures
| Measure |
Warfarin
n=12918 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=13604 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants
|
7.27 Events Per 100 Participant-Years
|
4.06 Events Per 100 Participant-Years
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in the outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.
Event rate per 100 participant-years for first occurrence of MB event after index date in morbidly obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of GI, ICH, and other sites. MB was equal to 1 if bleeding event was \>=1.
Outcome measures
| Measure |
Warfarin
n=2176 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=1746 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants
|
5.52 Events Per 100 Participant-Years
|
3.94 Events Per 100 Participant-Years
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: Obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was \>=1.
Outcome measures
| Measure |
Warfarin
n=12918 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=13604 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants
|
2.09 Events Per 100 Participant-Years
|
1.51 Events Per 100 Participant-Years
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was \>=1.
Outcome measures
| Measure |
Warfarin
n=2176 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=1746 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants
|
1.51 Events Per 100 Participant-Years
|
0.92 Events Per 100 Participant-Years
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: Obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.
Outcome measures
| Measure |
Warfarin
n=12918 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=13604 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants
|
8.44 Event Rate Per 100 Participant-Years
|
5.12 Event Rate Per 100 Participant-Years
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.
Outcome measures
| Measure |
Warfarin
n=2176 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=1746 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants
|
6.48 Event Rate Per 100 Participant-Years
|
4.52 Event Rate Per 100 Participant-Years
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (6 months prior to index date)Population: Analysis population included obese or morbidly obese AF participants in the CMS and VA databases with newly prescribed OACs or DOACs between January 1, 2013 and December 31, 2017.
CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity.
Outcome measures
| Measure |
Warfarin
n=35051 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
n=38756 Participants
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
n=12148 Participants
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
n=21428 Participants
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Charlson Comorbidity Index (CCI)
|
3.13 Units on a scale
Standard Deviation 2.68
|
2.55 Units on a scale
Standard Deviation 2.39
|
2.21 Units on a scale
Standard Deviation 2.18
|
2.49 Units on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)Population: TTR was calculated only for the warfarin arm, therefore data was not collected/observed for DOACs cohorts - apixaban, dabigatran, rivaroxaban.
TTR was computed using INR values among warfarin participants during the follow-up. TTR was calculated based on the percentage of time a participant remained in therapeutic range evaluated during the entire follow-up period. TTR \>=65 percent (%) was observed as good and TTR less than (\<) 65% was observed as poor.
Outcome measures
| Measure |
Warfarin
n=35051 Participants
Participants diagnosed with NVAF, who initiated warfarin on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first warfarin prescription for participants without any DOAC claim.
|
Apixaban
Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Dabigatran
Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
Rivaroxaban
Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).
|
|---|---|---|---|---|
|
Time in Therapeutic Range (TTR) During Follow-up Period
|
14 Percentage of time
Interval 0.0 to 1461.0
|
—
|
—
|
—
|
Adverse Events
Warfarin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Apixaban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dabigatran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rivaroxaban
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
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER