Comparative Effectiveness of Oral Anticoagulants

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dabigatran<br> | |
| Warfarin<br> | |

What is the study measuring?
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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 |