Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77814 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-10-19

Brief Summary

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The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF). In addition to the absolute age, effects on higher age-related risk factors on relative risk of apixaban to warfarin is also investigated through subgroup analyses.

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Detailed Description

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This is a retrospective non-intervention observational study to evaluate the difference in safety and effectiveness between apixaban and warfarin using a database provided by Medical Data Vision Co. Ltd. (MDV Co. Ltd.). Eligible patients will be extracted from the database and allocated to the pre-defined cohorts based on the actual age, age of NVAF diagnosis and types of anticoagulant therapy.

Patient characteristics will be balanced by an Inverse probability of treatment weighting (IPTW) method, and risk of stroke/SE (primary effectiveness endpoint) and major bleeding (primary safety endpoint) will be compared.

Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Warfarin cohort (Reference)

Patients with NVAF treated with warfarin

Warfarin

Intervention Type DRUG

This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings.

Apixaban cohort

Patients with NVAF treated with apixaban

Apixaban

Intervention Type DRUG

This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings.

Interventions

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Warfarin

This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings.

Intervention Type DRUG

Apixaban

This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with Atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
2. Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
3. No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)
4. Age of 18 years or older on the index date.
5. Index date is at age 80 or older

Exclusion Criteria

* Patients meeting any of the following criteria will not be included in the study:

1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
2. Having a cardiac surgery procedure record during the baseline period
3. Having a joint replacement procedure record during the baseline period
4. Having a procedure of prosthetic heart valve during the baseline period
5. Having a diagnosis of venous thromboembolism during the baseline period
6. Female patients with pregnancy during the follow-up period
7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.

Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No