Aortic Valve Stenosis, Coronary Artery Disease, PCI, TAVI
Conditions
Brief summary
The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
Interventions
PROCEDUREPCI
FFR guided PCI
Sponsors
Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg University Hospital
Odense University Hospital
Lund University Hospital
Karolinska University Hospital
Haukeland University Hospital
Helsinki University Central Hospital
Tampere University Hospital
Oulu University Hospital
Turku University Hospital
Sahlgrenska University Hospital
Pauls Stradins Clinical University Hospital
Thomas Engstrom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team 3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis \> 90% in a coronary artery ≥ 2.5 mm in diameter
Exclusion criteria
1. Life expectancy \< 1 year due to other severe non-cardiac disease 2. Severe renal failure with estimated glomerular filtration rate \< 20 ml/min 3. No PCI-eligible coronary artery stenosis, but rotablation is allowed 4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days 5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx)) 6. Only stenoses with thrombolysis in myocardial infarction grad \< 3 7. Potential pregnancy 8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium 9. More than one chronic total occlusion (CTO)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality, myocardial infarction, or urgent revascularization | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing myocardial infarction |
| Urgent revascularization | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing urgent revascularization |
| All cause mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing all cause mortality or myocardial infarction |
| Cardiovascular mortality | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing cardiovascular mortality |
| Cardiovascular mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI |
| Cardiovascular mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing cardiovascular mortality or myocardial infarction |
| Admission for new onset of heart failure | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing admission for new onset of heart failure |
| Peri-procedural (PCI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing peri-procedural (PCI) myocardial infarction |
| Peri-procedural (TAVI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing peri-procedural (TAVI) myocardial infarction |
| All cause mortality | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing all cause mortality |
| Stroke or transient ischemic attack (TIA) | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing stroke or transient ischemic attack (TIA) |
| Angina status (Seattle questionnaire), CCS and NYHA class | 30 days and 1 year | Number of patients experiencing CCS and NYHA class |
| Bleeding | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing bleeding |
| Quality of Life | 30 days and 1 year | Number of patients experiencing improvement in Quality of life |
| Acute kidney injury | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing acute kidney injury |
| Target vessel revascularization | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing target vessel revascularization |
| Target lession revascularization | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing target lession revascularization |
| Cost effectiveness analysis | Until the last included patients have been followed for 1 year after the TAVI | Cost effectiveness analysis |
| Stent thrombosis | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing stent thrombosis |
| Any revascularization | Until the last included patients have been followed for 1 year after the TAVI | Number of patients experiencing any revascularization |
Countries
Denmark, Finland, Latvia, Sweden
Outcome results
None listed