Trial Outcomes & Findings for Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding (NCT NCT05471505)
NCT ID: NCT05471505
Last Updated: 2024-07-11
Results Overview
Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (excluding non-traumatic extradural hemorrhage). Stroke after index date not including the index date was identified using hospital claims which had a stroke diagnosis code as the first listed International Classification of Diseases 10th Revision (ICD-10) diagnosis code. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
COMPLETED
120722 participants
Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
2024-07-11
Participant Flow
Data of participants diagnosed with non-valvular atrial fibrillation (NVAF) who were newly prescribed apixaban or warfarin with at least one high bleeding risk factor were observed in this retrospective observational study.
Data of eligible participants were extracted from Medical Data Vision Company Limited (MDV Co. Ltd.) database for duration of 01-Mar-2011 to 30-Jun-2021. Extracted data was evaluated for objectives of this study in approximately 1 month of this study.
Participant milestones
| Measure |
Apixaban
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively.
|
Warfarin
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively.
|
|---|---|---|
|
Overall Study
STARTED
|
72095
|
48627
|
|
Overall Study
COMPLETED
|
72095
|
48627
|
|
Overall Study
NOT COMPLETED
|
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 |
Apixaban
n=72095 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively.
|
Warfarin
n=48627 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively.
|
Total
n=120722 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<= 64 years
|
4471 Participants
n=72095 Participants
|
4030 Participants
n=48627 Participants
|
8501 Participants
n=120722 Participants
|
|
Age, Customized
65-69 years
|
4978 Participants
n=72095 Participants
|
3855 Participants
n=48627 Participants
|
8833 Participants
n=120722 Participants
|
|
Age, Customized
70-79 years
|
20621 Participants
n=72095 Participants
|
14749 Participants
n=48627 Participants
|
35370 Participants
n=120722 Participants
|
|
Age, Customized
80-89 years
|
33567 Participants
n=72095 Participants
|
20677 Participants
n=48627 Participants
|
54244 Participants
n=120722 Participants
|
|
Age, Customized
=>90 years
|
8458 Participants
n=72095 Participants
|
5316 Participants
n=48627 Participants
|
13774 Participants
n=120722 Participants
|
|
Sex: Female, Male
Female
|
31786 Participants
n=72095 Participants
|
19856 Participants
n=48627 Participants
|
51642 Participants
n=120722 Participants
|
|
Sex: Female, Male
Male
|
40309 Participants
n=72095 Participants
|
28771 Participants
n=48627 Participants
|
69080 Participants
n=120722 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using Inverse probability treatment weighting (IPTW) method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (excluding non-traumatic extradural hemorrhage). Stroke after index date not including the index date was identified using hospital claims which had a stroke diagnosis code as the first listed International Classification of Diseases 10th Revision (ICD-10) diagnosis code. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts
|
61.352 Events Per 1000 Participant-Years
Interval 59.413 to 63.354
|
75.078 Events Per 1000 Participant-Years
Interval 72.748 to 77.483
|
PRIMARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of major bleeding event after index date was reported. Major bleeding was defined as any bleeding that required hospitalization for treatment. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts
|
16.788 Events Per 1000 Participant-Years
Interval 15.808 to 17.829
|
21.329 Events Per 1000 Participant-Years
Interval 20.138 to 22.59
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of ischemic stroke event after index date was reported. Ischemic stroke after index date not including the index date was identified using hospital claims which had an ischemic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Ischemic Stroke Event After Index Date: Balanced Cohorts
|
49.038 Events Per 1000 Participant-Years
Interval 47.317 to 50.823
|
48.917 Events Per 1000 Participant-Years
Interval 47.071 to 50.835
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of hemorrhagic stroke event after index date was reported. Hemorrhagic stroke after index date not including the index date was identified using hospital claims which had a hemorrhagic stroke diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Hemorrhagic Stroke Event After Index Date: Balanced Cohorts
|
9.384 Events Per 1000 Participant-Years
Interval 8.661 to 10.168
|
9.266 Events Per 1000 Participant-Years
Interval 8.498 to 10.104
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of SE event after index date was reported. SE after index date not including the index date was identified using hospital claims which had a SE diagnosis code as the first listed ICD-10 diagnosis code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Systemic Embolism (SE) Event After Index Date: Balanced Cohorts
|
5.285 Events Per 1000 Participant-Years
Interval 4.75 to 5.882
|
18.923 Events Per 1000 Participant-Years
Interval 17.799 to 20.118
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of major intracranial bleeding event after index date was reported. Major intracranial bleeding after index date was identified using hospital claims which had an intracranial bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Intracranial Bleeding Event After Index Date: Balanced Cohorts
|
14.490 Events Per 1000 Participant-Years
Interval 13.583 to 15.457
|
17.507 Events Per 1000 Participant-Years
Interval 16.436 to 18.649
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
Incidence rate per 1000 participant-years for the first occurrence of major GI bleeding event after index date was reported. Any GI bleeding after index date was identified using hospital claims which had a GI bleeding diagnosis code as the first listed ICD-10 or disease code. Index date: date when participants initiated warfarin or apixaban. Follow-up period: from next day of the index date till occurrence of target outcome event, discontinuation of apixaban or warfarin; switching from apixaban or warfarin; withdrawal from the database, whichever occurred first.
Outcome measures
| Measure |
Apixaban: Balanced Cohort
n=72141 Participants
Participants diagnosed with NVAF, who newly initiated apixaban, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
Warfarin: Balanced Cohort
n=48619 Participants
Participants diagnosed with NVAF, who newly initiated warfarin, were included in this cohort. Data from 01-Mar-2011 to 30-Jun-2021, available in MDV database was observed retrospectively. IPTW method was applied to balance the participants' characteristics.
|
|---|---|---|
|
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Gastrointestinal (GI) Bleeding Event After Index Date: Balanced Cohorts
|
36.836 Events Per 1000 Participant-Years
Interval 35.354 to 38.38
|
36.943 Events Per 1000 Participant-Years
Interval 35.35 to 38.607
|
Adverse Events
Apixaban
Warfarin
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