Comparative Effectiveness of Oral Anticoagulants

Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

This cohort study plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 5982

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy

Description

Inclusion criteria:

• A recorded diagnosis of atrial fibrillation (AF).
• Initiation of anticoagulant medication (dabigatran or warfarin).
• At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score >=1

Exclusion criteria:

• Patients with missing or ambiguous age or sex information
• Patients with documented evidence of valvular disease
• Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
• Patients with prior use of any oral anticoagulant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Dabigatran
Warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Stroke	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.	From treatment initiation until end of follow-up; up to 20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Myocardial Infarction	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Venous Thromboembolism	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Deep Vein Thrombosis	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Pulmonary Embolism	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Lower Gastrointestinal Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Urogenital Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Other Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Transient Ischemic Attack	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Upper Gastrointestinal Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Stroke or Systemic Embolism	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Systemic Embolism	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Ischemic Stroke	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Hemorrhagic Stroke	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Stroke Uncertain Classification	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Intracranial Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Extracranial Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.	From treatment initiation until end of follow-up; up to 20 months
Incidence Rate of Major Gastrointestinal Bleeding	Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.	From treatment initiation until end of follow-up; up to 20 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): June 6, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1160.157