Replication of the RELY Anticoagulant Trial in Healthcare Claims Data

Inclusion Criteria

• •Please see: https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
• •Eligible cohort entry dates: Market availability of dabigatran in the U.S. started on October 19, 2010. For Marketscan: Oct 19, 2010 -Dec 31, 2018 (end of data availability). For Optum: Oct 19, 2010 -Dec 31, 2019 (end of data availability). For Medicare: Oct 19, 2010 -Dec 31, 2017.
• •1\. AF documented as follows: (1a or 1b or 1c)
• •* 1a. There is ECG documented AF on the day of screening or randomization
• •* 1b. The patient has had a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG within 6 m before randomization
• •* 1c. There is documentation of symptomatic or asymptomatic paroxysmal or persistent AF on 2 separate occasions, at least 1 day apart, one of which is within 6 m before randomization.
• •2\. In addition to documented AF, patients must have one of the following: (2a or 2b or 2c or 2d or 2e)
• •* 2a. History of previous stroke, TIA, or systemic embolism
• •* 2b. Ejection fraction \<40% documented by echocardiogram, radionuclide or contrast angiogram in the last 6 m
• •* 2c. Symptomatic heart failure, New York Heart Association class 2 or higher in the last 6 m
• •* 2d. Age ≥75 y
• •* 2e. Age ≥65 y and one of the following:
• •* Diabetes mellitus on treatment
• •* Documented coronary artery disease (any of: prior myocardial infarction, positive stress test, positive nuclear perfusion study, prior CABG surgery or PCI, angiogram showing ≥75% stenosis in a major coronary artery
• •* Hypertension requiring medical treatment
• •3\. Age \>18 y at entry