Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Criteria: Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Inclusion Criteria: \- Confirmed acute symptomatic proximal DVT without symptomatic PE Exclusion Criteria: * Age ≤ 18 * Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE two weeks prior to and including day of enrollment * Other indications for VKA than DVT and/or PE six months prior to and including day of enrollment * Any of the following six months prior to and including day of enrollment: * Creatine clearance \< 30 ml/min * Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\>3 ULN * Bacterial endocarditis * Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA * Systolic blood pressure \> 180 mgHg or diastolic blood pressure \> 110 mgHg * Childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding * Life expectancy \< 3 months in the last year prior to and including day of enrollment * Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers two weeks prior to and including day of enrollment * Symptomatic pulmonary embolism two weeks prior to and including day of enrollment