Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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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.

Official Title
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Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial

Conditions
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PCI, Coronary Artery Disease, Aortic Valve Stenosis, TAVI

Intervention / Treatment
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* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter Exclusion Criteria: Life expectancy < 1 year due to other severe non-cardiac disease Severe renal failure with estimated glomerular filtration rate < 20 ml/min No PCI-eligible coronary artery stenosis, but rotablation is allowed Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx)) Only stenoses with thrombolysis in myocardial infarction grad < 3 Potential pregnancy Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium More than one chronic total occlusion (CTO)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TAVI only<br>TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion. | |
| Experimental: TAVI + FFR-guided complete revascularization<br>TAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis > 90% or FFR ≤ 0.80 in vessels ≥ 2.5 mm in diameter . | Procedure: PCI<br>* FFR guided PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality, myocardial infarction, or urgent revascularization | Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Number of patients experiencing all cause mortality | Until the last included patients have been followed for 1 year after the TAVI | 
| Myocardial infarction | Number of patients experiencing myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | 
| Urgent revascularization | Number of patients experiencing urgent revascularization | Until the last included patients have been followed for 1 year after the TAVI | 
| All cause mortality or myocardial infarction | Number of patients experiencing all cause mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | 
| Cardiovascular mortality | Number of patients experiencing cardiovascular mortality | Until the last included patients have been followed for 1 year after the TAVI | 
| Cardiovascular mortality, myocardial infarction, or urgent PCI | Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI | 
| Cardiovascular mortality or myocardial infarction | Number of patients experiencing cardiovascular mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | 
| Admission for new onset of heart failure | Number of patients experiencing admission for new onset of heart failure | Until the last included patients have been followed for 1 year after the TAVI | 
| Peri-procedural (PCI) myocardial infarction | Number of patients experiencing peri-procedural (PCI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | 
| Peri-procedural (TAVI) myocardial infarction | Number of patients experiencing peri-procedural (TAVI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | 
| Any revascularization | Number of patients experiencing any revascularization | Until the last included patients have been followed for 1 year after the TAVI | 
| Stroke or transient ischemic attack (TIA) | Number of patients experiencing stroke or transient ischemic attack (TIA) | Until the last included patients have been followed for 1 year after the TAVI | 
| Angina status (Seattle questionnaire), CCS and NYHA class | Number of patients experiencing CCS and NYHA class | 30 days and 1 year | 
| Bleeding | Number of patients experiencing bleeding | Until the last included patients have been followed for 1 year after the TAVI | 
| Quality of Life | Number of patients experiencing improvement in Quality of life | 30 days and 1 year | 
| Acute kidney injury | Number of patients experiencing acute kidney injury | Until the last included patients have been followed for 1 year after the TAVI | 
| Target vessel revascularization | Number of patients experiencing target vessel revascularization | Until the last included patients have been followed for 1 year after the TAVI | 
| Target lession revascularization | Number of patients experiencing target lession revascularization | Until the last included patients have been followed for 1 year after the TAVI | 
| Cost effectiveness analysis | Cost effectiveness analysis | Until the last included patients have been followed for 1 year after the TAVI | 
| Stent thrombosis | Number of patients experiencing stent thrombosis | Until the last included patients have been followed for 1 year after the TAVI |