All adult patients with successful transfemoral trans-aortic valve implantation (TAVI ) for symptomatic aortic stenosis (AS) with no other indication for long term antiplatelet or anticoagulant therapy
Conditions
Brief summary
Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI
Detailed description
• Any non-procedure-related bleeding defined by the VARC classification 1 to 4, • Major or disabling or life threatening bleeding defined by VARC classification 2 or 3, • Major cardiovascular events defined by the composite of all cause death, myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, • Type 1 VARC classification bleeding, • Type 2 VARC classification bleeding, • Type 3 VARC classification bleeding, • Fatal bleeding defined by Type 4 VARC classification, • Death, • Cardiovascular death, • Type 1 myocardial infarction based on the universal definition, • Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, • Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury, • Transient cerebral ischemic attack defined by NeuroARC type 3a, • Any hospitalization, • Cardiovascular hospitalization, • VARC-defined prosthetic valve thrombosis, • VARC-3 defined Cardiovascular hospitalization, • Death at 2 years (national mortality database)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI | — |
Secondary
| Measure | Time frame |
|---|---|
| • Any non-procedure-related bleeding defined by the VARC classification 1 to 4, • Major or disabling or life threatening bleeding defined by VARC classification 2 or 3, • Major cardiovascular events defined by the composite of all cause death, myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, • Type 1 VARC classification bleeding, • Type 2 VARC classification bleeding, • Type 3 VARC classification bleeding, • Fatal bleeding defined by Type 4 VARC classification, • Death, • Cardiovascular death, • Type 1 myocardial infarction based on the universal definition, • Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, • Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury, • Transient cerebral ischemic attack defined by NeuroARC type 3a, • Any hospitalization, • Cardiovascular hospitalization, • VARC-defined prosthetic valve thrombosis, • VARC-3 defined Cardiovascular hospitaliza | — |
Countries
France