Hospital Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated with Oral Anticoagulants in the U.S.

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Major Bleeding
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Eliquis

Population studied

• Short description of the study population:
  Adult patients (age ≥18 years) hospitalized for NVAF, based on a primary or secondary discharge diagnosis code indicating NVAF, were identified from the Premier; Hospital database between January 1, 2013 and June 30, 2017. Patients who received apixaban, dabigatran, rivaroxaban, or warfarin during any time of the hospitalization (from admission to discharge) were identified and grouped into study cohorts based on the oral anticoagulant (OAC) initiated. The first of such NVAF hospitalizations were defined as the index hospitalization. Patients with more than one type of OAC drug usage during the index hospitalizations were excluded so that patients can be exclusively assigned into each of the OAC patient cohorts.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Non valvular atrial fibrillation patients
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  The primary objective of the study is to evaluate and compare 1-month MB-related readmission rates of hospitalized NVAF patients treated with dabigatran, rivaroxaban, or warfarin vs. apixaban.
• Outcomes:
  MB-related Readmission, All-cause Readmission, Stroke-related Readmission
• Data analysis plan:
  Means ± standard deviations, and medians will be provided for continuous variables. Numbers and percentages will be provided for dichotomous and polychotomous variables. Bivariate comparisons of baseline patient and hospital characteristics and readmission measurements will be provided, with appropriate tests (e.g. ANOVA test, chi-square test) used based on the distribution of the measure. A propensity score matching (PSM) 1:1 technique will be used to control for confounders when comparing each of the OAC cohorts vs. the apixaban cohort. A logistic regression analysis will be carried out on the matched patient cohorts to further evaluate the potential impact of treatment with the different OACs vs. treatment with apixaban on 1-month MB-related and all-cause readmissions.

Documents

Study results

Approved NVAF Premier NI Final Study Report