Table 1 Main Outcome Measures in the RIVER Registry
Outcome | Category |
|---|---|
Clinical events | Stroke (ischaemic and haemorrhagic) |
Transient ischaemic attack | |
Peripheral/non-central nervous system embolism | |
Pulmonary embolism | |
Heart failure | |
Myocardial infarction | |
Hospitalization | |
Sudden cardiac death | |
Non-cardiovascular death | |
Bleeding events | |
Severity | Major |
Non-major clinically relevant | |
Minor | |
Location | Intracranial |
Ears, nose, throat | |
Gastrointestinal | |
Genitourinary | |
Vascular access site | |
Outcome | Recovered |
Permanently disabled | |
Fatal | |
Healthcare utilization used for bleeding event | Hospitalization |
Emergency room visit | |
Surgery for bleeding | |
Transfusion | |
Physician consultation | |
Therapy persistence | Rate of discontinuation |
Duration of time on therapy | |
Reasons for discontinuation | |
Hospitalization for any event | |
Any other hospital visits | Inpatient, outpatient, and emergency room |
Patients treated with vitamin K antagonists | Frequency and timing of monitoring |
INR recordings in relation to therapeutic range | |
Location of testing (self-monitoring, general practitioner clinic, anticoagulant clinic, etc.) | |
Dose adjustments | |
Use of bridging anticoagulation necessitated by interruption of vitamin-K antagonist | |
Outcomes in relation to INR fluctuation | |
Patients treated with additional antithrombotic therapy | Therapy changes (discontinuation, temporary interruptions and use of bridging therapy) |
Reasons of therapy changes (if applicable) | |
Patient treatment satisfaction using the Anti-Clot Treatment Scale (ACTS), depending on the cohort and country (at 4, 12, 24 months) | |