Trial Outcomes & Findings for Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data (NCT NCT05438888)
NCT ID: NCT05438888
Last Updated: 2024-05-20
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 ischemic and hemorrhagic stroke. International Classification of Diseases 10th Revision (ICD-10) diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first.
COMPLETED
77814 participants
Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study
2024-05-20
Participant Flow
Data of participants who received apixaban or warfarin (80 years or older) after getting diagnosed with non-valvular atrial fibrillation (NVAF) 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 26-Feb-2013 to 31-Dec-2021. Extracted data was evaluated for objectives of this study in approximately 3.5 months of this study.
Participant milestones
| Measure |
Warfarin Cohort
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study.
|
Apixaban Cohort
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
39936
|
37878
|
|
Overall Study
COMPLETED
|
39936
|
37878
|
|
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 |
Warfarin Cohort
n=39936 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study.
|
Apixaban Cohort
n=37878 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study.
|
Total
n=77814 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
85.3 Years
STANDARD_DEVIATION 4.15 • n=39936 Participants
|
85.7 Years
STANDARD_DEVIATION 4.22 • n=37878 Participants
|
85.5 Years
STANDARD_DEVIATION 4.19 • n=77814 Participants
|
|
Sex: Female, Male
Female
|
18804 Participants
n=39936 Participants
|
19171 Participants
n=37878 Participants
|
37975 Participants
n=77814 Participants
|
|
Sex: Female, Male
Male
|
21132 Participants
n=39936 Participants
|
18707 Participants
n=37878 Participants
|
39839 Participants
n=77814 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 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using inverse probability treatment weighting with stabilized weights (s-IPTW) method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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 ischemic and hemorrhagic stroke. International Classification of Diseases 10th Revision (ICD-10) diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts
|
75.227 Events Per 1000 Participant-Years
Interval 72.579 to 77.972
|
55.801 Events Per 1000 Participant-Years
Interval 53.328 to 58.388
|
PRIMARY outcome
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts
|
25.328 Events Per 1000 Participant-Years
Interval 23.836 to 26.914
|
17.306 Events Per 1000 Participant-Years
Interval 15.973 to 18.751
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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 cardiogenic cerebral embolism events after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts
|
21.386 Events Per 1000 Participant-Years
Interval 20.024 to 22.841
|
13.473 Events Per 1000 Participant-Years
Interval 12.306 to 14.751
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts
|
39.607 Events Per 1000 Participant-Years
Interval 37.713 to 41.596
|
33.279 Events Per 1000 Participant-Years
Interval 31.395 to 35.277
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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 intracranial hemorrhage event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts
|
20.787 Events Per 1000 Participant-Years
Interval 19.443 to 22.223
|
13.138 Events Per 1000 Participant-Years
Interval 11.988 to 14.399
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts
|
42.641 Events Per 1000 Participant-Years
Interval 40.673 to 44.704
|
36.595 Events Per 1000 Participant-Years
Interval 34.61 to 38.695
|
SECONDARY outcome
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this studyPopulation: Eligible participants registered on MDV database, whose data was observed in the study. Analysis was performed using s-IPTW method to balance participant characteristics among reporting groups. Here, "Overall Number of Participants Analyzed" is the number of participants after application of s-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 intraocular bleeding event after index date was reported. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from warfarin or apixaban, withdrawal from the database, whichever observed first.
Outcome measures
| Measure |
Warfarin: Balanced Cohort
n=43671 Participants
Participants included in this cohort were those who received warfarin in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
Apixaban: Balanced Cohort
n=33834 Participants
Participants included in this cohort were those who received apixaban in real world practice after getting diagnosed with NVAF. Data of the participants included were retrieved from MDV database and was observed retrospectively in this study. S-IPTW method was applied to balance the participant's characteristics.
|
|---|---|---|
|
Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts
|
4.224 Events Per 1000 Participant-Years
Interval 3.643 to 4.897
|
2.682 Events Per 1000 Participant-Years
Interval 2.19 to 3.284
|
Adverse Events
Warfarin Cohort
Apixaban Cohort
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