N/A
Completed N=107,383
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
Atrial Fibrillation · Obesity · Anticoagulants
Source: ClinicalTrials.gov NCT04681482 ↗
Enrolled (actual)
107,383
Serious AEs
—
Results posted
Dec 2021
Primary outcomePrimary: Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants — 7.27; 4.06 Events Per 100 Participant-Years — p=<0.001
Summary
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who initiate therapy with OACs (oral anti-coagulants). The aim of this study is to compare all DOACs (direct oral anti-coagulants) to warfarin.
However, the primary analysis will be conducted among apixaban vs warfarin patients only. If sample size permits, we will also conduct other DOAC vs warfarin and DOAC vs DOAC analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants |
7.27; 4.06 | <0.001 sig |
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants |
5.52; 3.94 | — |
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants |
2.09; 1.51 | 0.088 |
| PRIMARY 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; 0.92 | — |
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants |
8.44; 5.12 | <0.001 sig |
| PRIMARY Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants |
6.48; 4.52 | — |
| PRIMARY Charlson Comorbidity Index (CCI) |
3.13; 2.55; 2.21; 2.49 | — |
| SECONDARY Time in Therapeutic Range (TTR) During Follow-up Period |
14 | — |
Eligibility Criteria
Inclusion Criteria
- Obese or severely obese.
- Initiated an OAC from July 1, 2013 - December 31, 2017; the first DOAC pharmacy claim date during the identification period will be designated as the index date. The first warfarin prescription date will be designated as the index date for patients without any DOAC claim.
- Individuals ≥18 years old as of the index date.
- Had 6 months continuous health plan enrollment with medical benefits (Parts A & B) for at least 6 months pre-index date (baseline period).
- At least 1 diagnosis of AF prior to or on index date, identified by any medical claim associated with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 427.31 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of I480-I482, and I4891.
- Had body weight or BMI value reported within ±6 months of the index date.
Exclusion Criteria
- Had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient AF 6 months prior to or on the index date.
- Had hip/knee replacement surgery within 6 weeks prior to or on the index date.
- Were pregnant during the study period.
- Had an OAC prescription during the 6 months pre-index date.
- Had follow-up time equal to 0 days.
- Had more than one OAC on the index date.
Data sourced from ClinicalTrials.gov (NCT04681482). 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. Informational only — not medical advice.