The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

N/ACompletedNCT02043808

Boehringer Ingelheim25,586 enrolled

Overview

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Study Design: Retrospective

Study Type

OBSERVATIONAL

Enrollment

25,586

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients must be continuously enrolled in a health plan during the pre-index period; * Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period; * Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date); * Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription; * Aged 18-89 on the index date; Exclusion criteria: * Patients with valvular procedures related to the baseline AF diagnosis will be excluded; * Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

Locations (1)

1160.183.01 Boehringer Ingelheim Investigational Site

Lexington, Massachusetts, United States

Outcomes

Primary Outcomes

Stroke (Hemorrhagic, Ischemic)

Event rate of stroke (hemorrhagic, ischemic). Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.

Time frame: From October 1, 2009 through July 31, 2013 (the study period)

Major Bleeding

Event rate of major bleeding. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.

Time frame: From October 1, 2009 through July 31, 2013 (the study period)

Secondary Outcomes

Ischemic Stroke

Event rate of ischemic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.

Time frame: From October 1, 2009 through July 31, 2013 (the study period)

Hemorrhagic Stroke

Event rate of hemorrhagic stroke. The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period.