Dabigatran versus Warfarin in Patients with Atrial Fibrillation Extending inference from the RE-LY trial to real world target population

Lead Investigator: Yu-Han Chiu, Harvard T.H. Chan School of Public Health
Title of Proposal Research: Dabigatran versus Warfarin in Patients with Atrial Fibrillation Extending inference from the RE-LY trial to real world target population
Vivli Data Request: 8753
Funding Source: This work was supported in part by Patient-Centered Outcomes Research Institute (PCORI) award ME-1502-27794 and American Heart Association (AHA) grant #834106
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Atrial fibrillation is the most common clinically significant arrhythmia (abnormal heart rhythm) and a potent risk factor for stroke and death. Direct oral anticoagulants (medications that thin the blood), including dabigatran, are recommended with at least similar efficacy as warfarin for prevention of stroke in patients with atrial fibrillation. This recommendation was based on findings from RE-LY and other four randomized trials. However, the findings from the RE-LY trial may not directly apply to the real-world population because trial participants and non-trial participants generally have different characteristics. Conducting another trial in a random sample of the target population can be costly, infeasible, and potentially unethical given the existing evidence. Therefore, we propose to assess the comparative effectiveness of dabigatran versus warfarin in the real-world target population by reweighing the trial data to reflect the patient characteristics of the target population in a routine care setting. Our target population data will be based on MarketScan, a large health insurance claims database that contains individual-level information on demographic characteristics, inpatient and outpatient diagnoses and procedures, as well as prescription medications for individuals with commercial insurance in the United State. Our approach requires individual patient data from the RE-LY trial. Data from the MarketScan database will be used to account for differences in patient characteristics between the trial populations and the target populations. We will also estimate subgroup-specific average treatment effects in the target population. The results will better inform clinical decisions for stroke prevention in the routine care of patients.

Requested Studies:

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes
Data Contributor: Boehringer Ingelheim
Study ID: NCT00808067
Sponsor ID: 1160.71

(Note: Additional study added 29-Nov-2023)

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Data Contributor: Boehringer Ingelheim
Study ID: NCT00262600
Sponsor ID: 1160.26