N/A
N=77,814
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
Non-valvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT05438888 ↗Enrolled (actual)
77,814
Serious AEs
—
Results posted
May 2024
Primary outcome: Primary: Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts — 75.227; 55.801 Events Per 1000 Participant-Years — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Warfarin (Drug); Apixaban (Drug)
- Age
- Older Adult · 80+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts |
75.227; 55.801 | <0.001 sig |
| PRIMARY Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts |
25.328; 17.306 | <0.001 sig |
| SECONDARY Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts |
21.386; 13.473 | <0.001 sig |
| SECONDARY Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts |
39.607; 33.279 | <0.001 sig |
| SECONDARY Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts |
20.787; 13.138 | <0.001 sig |
| SECONDARY Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts |
42.641; 36.595 | <0.001 sig |
| SECONDARY Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts |
4.224; 2.682 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.
- 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.
- 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
- No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)
- Age of 18 years or older on the index date.
- Index date is at age 80 or older
Exclusion Criteria
- Patients meeting any of the following criteria will not be included in the study:
- 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
- Having a cardiac surgery procedure record during the baseline period
- Having a joint replacement procedure record during the baseline period
- Having a procedure of prosthetic heart valve during the baseline period
- Having a diagnosis of venous thromboembolism during the baseline period
- Female patients with pregnancy during the follow-up period
- 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.
Data sourced from ClinicalTrials.gov (NCT05438888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.