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. 2019 Apr 25;17:7. doi: 10.1186/s12959-019-0195-7

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)

INR International normalise ratio